ML19298E233
| ML19298E233 | |
| Person / Time | |
|---|---|
| Issue date: | 06/27/1990 |
| From: | Kammerer C NRC OFFICE OF GOVERNMENTAL & PUBLIC AFFAIRS (GPA) |
| To: | Ortciger T ILLINOIS, STATE OF |
| References | |
| NUDOCS 9007050152 | |
| Download: ML19298E233 (10) | |
Text
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June 27, 1990 Thomas W. Ortciger, Director Illinois Department of Nuclear Safety 1035 Outer Park Drive Springfield, IL 62704
Dear Mr. Ortciger:
This is to confirm the exit briefing B. J. Holt and James Shaffner held on February 9,1990 with Terry Lash, James Van Vliet, Paul Eastvold and other management staff of the Office of Radiation Safety following our review of the Illinois radiation control program.
Vandy Miller, Assistant Director for State Agreements Program, State Programs, and Carl Paperiello, Deputy Administrator, Region III, were also present and participated in the briefing.
Our staff has determined, as a result of the regulatory review and the routine exchange of information between the NRC and the State, that the Illinois arogram for regulating agreement materials is adequate to protect tie public health and safety and is compatible with the Commission's program. This finding of compatibility is contingent on the Commission's evaluation of your response to Chairman Carr's letter to you dated June 15, 1990 in which he addressed the 1 millirem issue and requested clarification.
Since the review, time has expired for the State to adopt rules relating to bankruptcy notification and the reporting of medical misadministrations. We understand that rulemaking is underway to adopt these and other rules under the Radiation Protection Act. We would appreciate being kept informed of the steps being taken by the Department to adopt these rules.
Our staff, however, identified several circumstances which need prompt attention so that they will not detract from the ability of the IDNS regulatory program to license a low level radioactive waste (LLW) disposal facility.
First, the current staffing level, both in numbers and diversity of expertise, may not be sufficient for completing a review of two complex license applications in less than six months.
- Second, review procedures may not be completed by October 1,1990, the date the first license application is scheduled to be submitted.
Third, mobilizing and training of entry level staff has yet to be accomplished, but must be for the review of the license application. And finally, IDNS staff may need to develop internal procedures for determining that the applicant has met the requirements in 32 Ill. Adm. Code 601 and 32 Ill. Adm. Code 606. Details on each of these conditions can be found in Enclosure 3.
We observed that closure of the Sheffield LLW disposal facility is currently being regulated pursuant to the terms of a settlement agreement between US Ecology and IDHS. We recommended to your staff that they incorporate the 9007050152 700627 PDR STPRG E5GIL n
PDC i 4
e JW12 7 1993 Thomas W. Ortciger 2
terms of the agreement into the active State license issued to US Ecology for the Sheffield site. Your staff was receptive to the recommendation, but wished to obtain prior advice from your legal counsel.
Please keep us informed of any progress on this matter.
An explanation of our policies and practices for reviewing Agreement State programs is included as Enclosure 1. contains our summary of assessments regarding the program.
These should be reviewed and a response from your Department addressing each recommendation is requested.
In reviewing your plans for licensing a LLW disposal facility, we identified several areas of concern. These were discussed with your staff prior to the exit briefing and are included as observations in Enclosure 3.
We would appreciate your consideration of these concerns and any comments.
We are pleased with several aspects of the State's program.
Your management staff is knowledgeable of technical and administrative issues affecting your program and initiates, in most cases, prompt resolution of problems. Your technical staff is well qualified and appears to be highly motivated. There is no significant backlog of overdue inspections and your staff responds to most licensing requests within 30 days of receipt. We look forward to receiving confirmation that the Illinois legislature has enacted legislation extending the Illinois Radiation Protection Act beyond the current December 31, 1990 " sunset."
I appreciate the courtesy and cooperation extended by your staff ;o our representatives during the review and look forward to your response. A copy of this letter and the enclosures are provided for placement in the State Public Document Room or otherwise to be made available for public information.
Sincerely, 1
Carlton Kammerer, Director State Programs Office of Governmental and Public Affairs
Enclosures:
As stated cc:
J. M. Taylor, Executive Director for Operations, NRC A. B. Davis, Regional Administrator, RIII State Liaison Officer NRC Public Document Room State Public Document Room
APPLICATION OF " GUIDELINES FOR NRC REVIEW 0F AGREEMENT STATE RADIATION CONTROL PROGRAMS" The " Guidelines for NRC Review of Agreement State Radiation Control Programs" were published in the Federal Register on June 4, 1987, as an NRC Policy Statement. The Guide provides 29 indicators for 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 1 indicators address program functions which directly relate to the State's ability to protect the public health and safety.
If significant problems exist in one or more Category I indicator areas, then the need for improvements may be critical.
Category II indicators address program functions which provide essential technical and administrative support for the primary program functions.
Good performance in meeting the guidelines for these indicators is essential in order to avoid the development of problems in one or more of the principal program areas, i.e., those that fall under Category I indicators.
Category II indicators frequently can be used to identify underlying problems that are causing or contributing to difficulties in Category I 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 comment made.
If no significant Category I comments are provided, this will indicate that the program is adequate to protect the public health and safety and is compatible with the NRC's program.
If one or more significant Category I comments are provided, the 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 for improvement in particular program areas is critical.
If, following receipt and evaluation, the State's response appears satisfactory in addressing the significant Category I comments, 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 correspondence or perform a 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 Commission will be informed 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 Atomic Energy Act of 1954, as amended.
ENCLOSURE 1
SUMMARY
OF THE ASSESSMENTS AND COMMENTS FOR THE ILLIN0IS RADIATION CONTROL PROGRAM FOR THE PERIOD DECEMBER 19, 1987 TO FEBRUARY 9, 1990 Scope of Review This program review was conducted in accordance with the NRC Policy Statement.
" Guidelines for NRC Review of Agreement State Radiation Control Programs,"
published in the Federal Register on June 4, 1987. The administrative and technical aspects of the State's program were reviewed against the 29 program indicators provided in the Guidelines. The review included an examination of the program's funding and personnel resources; licensing, inspection and enforcement activities; and incident response capabilities.
In addition, there was an evaluation of the State's responses to an NRC questionnaire and field accompaniments of State inspectors.
The review was conducted in Springfield, Illinois, from January 29 through February 9,1990. Discussions with and field accompaniments of the State's regional inspection staff were conducted throughout the review period prior to the formal review. The review utilized a team approach which provided for a more in-depth examination of the Illinois program.
The State was represented by Terry Lcsh, Director, Illinois Department of Nuclear Safety (IDNS) end his management staff:
Paul Eastvold, Manager, Office of Radiation Safety; John Cooper, Manager, Office of Environmental Safety; Steve Collins, Chief, Division of Radioactive Materials, Joe Klinger, Head, Licensing Section; and Bruce Sanza, Head, Inspection and Enforcement Section. The NRC was represented by B. J. Holt, Regional State Agreements Officer.
Assistance during the review was provided by the following NRC personnel.
Reviews of selected compliance files and an accompaniment of a State inspector at a medical facility were conducted by Robert J. Doda, Region IV.
Reviews of sealed source and device evaluations were conducted by Steve Baggett and Tom Rich, NMSS.
Reviews of selected license files were conducted by a team from the Region 111 Materials Licensing Section, George McCann, William Adam, Patricia Pelke, and Cassandra Fraizer. A review of the State's response to selected incidents involving agreement materials was conducted by Darrel Wiedeman, Region III. A review of the status of the Sheffield disposal site and the plans for licensing a low-level radioactive waste facility was conducted by staff members from the Low-Level Waste Management and Deconnissioning Division, NMSS, James Shaffner, John Starmer, Michael Tokar, Derek Widmayer and Lynn Deering.
ENCLOSURE 2
2 Conclusion The Illinois program for the control of agreement materials was found to be adequate to protect public health and safety and compatible with the Comission's program.
Concerns in three Category I indicators necessitated minor comments and recommendations to the State.
Previous NRC Findings The results of the NRC's previous routine review were reported to Illinois in a letter dated January 2,1988.
The Illinois program was found to be adequate to protect public health and safety and compatible with the programs of the NRC.
The State was commended for its successful implementation of the Agreement State program.
It was noted that because Illinois had adopted an inspection frequency system more stringent than that of the NRC, a backlog of overdue inspections existed which the State planned to reduce in 1988.
No specific comments or recommendations for program improvements were made.
Current Review Comments and Recommendations and Observations All 29 program indicators were reviewed and the State satisfies 26 of these indicators.
Specific comments and recommendations for the remaining indicators are described in Enclosure 2.
The State's plans for licensing a low-level radioactive waste disposal facility were also reviewed. Observations on the administrative and technical aspects of the plans are provided in Enclosure 3.
Comments and Recommendations on the Illinois Radiation Control Program Other Than Low-Level Radioactive Waste Disposal I.
LEGISLATION AND REGULATIONS Status and Compatibility of Regulations is a Category I indicator.
The following comment with our recommendation is of minor significance.
Comment For regulations deemed to be a matter of compatibility by the NRC, State regulations should be amended as soon as practicable, but no later than three years. On February 11, 1987, the NRC amended its regulations to require licensees to notify the Commission upon filing of a petition for bankruptcy, and this amendment is a matter of compatibility.
It has not yet been adopted by Illinois.
3 This amendment has, however, been drafted by the IDNS and is one of several pro)osed amendments to 32 Ill. Adm. Code 330 which the State plans to pualish in May-June,1990.
Recommendation We recommend that the State keep our Region III office informed of the status of the draft amendment, the date the amendment is proposed, and the date the rule becomes effective.
The State should also undertake, as necessary, other rulemaking to maintain compatibility.
These include:
Rule 10 CFR Effective Date of State Suma ry Part Equivalent Rule for Compatibility Medical 35 April 1, 1990 Misadministration Decommissioning 30,40,70 July 12, 1993 Rule II.
COMPLIANCE 1.
Responses to Incidents and Alleged Incidents is a Category I indicator.
The following comment and recomendation is of minor significance.
Comment Investigations of incidents should include in-depth reviews of circumstances and should be completed on a high priority basis.
Investigation or inspection results should be documented and enforcement action taken when appropriate. The State received 121 reports of incidents during the review period. There are indications that the State, in a few cases, did not adequately follow-up on incidents reported by licensees.
In one incident involving a missing moisture / density gauge, the State did not investigate the circumstances in sufficient detail to determine if enforcement actions were warranted.
A review of the files and a subsequent discussion with the licensee indicated that there may have been violations associated with the incident.
In an incident occurring at a medical facility, the State did not investigate the circumstances in sufficient detail to determine if the licensee's response was adequate.
In another incident occurring at a medical facility, the State did not investigate the circumstances of the
.e 4
incident during the next scheduled inspection to determine the cause and the measures taken to prevent reoccurrence.
In an incident occurring at a manufacturer's facility, the State did not cite the licensee for violations associated with the incident.
Three of the four incidents mentioned above were not required by Illinois' regulations to be reported to the State. The State has responded satisfactorily to a number of other reported incidents.
We do not consider the above examples to be indicative of the quality of the State's incident response efforts and we, therefore, do not consider this finding to be of major significance at this time.
Recommendation We recommend that the State reevaluate its procedures for incident response and modify them accordingly to insure that:
(1) inquiries of sufficient depth and scope are promptly made upon notification of an incident to determine the need for onsite investigations; (2) investigations, either onsite or not, include an in-depth evaluation of the circumstances; (3) investigation results are documented, and enforcement action taken as appropriate; (4) incidents, not promptly and (5) gated, are followed up during the next scheduled inspection; investi there is a system for tracking, documenting, and reporting incidents to insure proper actions by the licensee.
2.
Enforcement Procedures is a Category I indicator. The following comment and recommendation is of minor significance.
Comment The IDNS has been given authority to impose civil penalties authority, and is in the process of promulgating rules for implementing this authority.
Recommendation IDNS should complete the process for adopting implementing rules for civil penalties.
Summary Discussions with State Representatives Meetings were held with staff and management throughout the review to discuss findings relative to a particular subject area.
Meetings summarizing the results of the regulatory review were held on February 9, 1990 initially with the technical staff of the Office of Radiation Safety and then with Terry Lash and his management staff.
The findings were
5 presented by B. J. Holt and James Shaffner.
Vandy Hiller, Assistant Director, State Programs and Carl Paperiello, Deputy Director, Region III, were also present and participated in the summary meetings.
OBSERVATIONS ON THE ILLIN0IS LOW-LEVEL RADI0 ACTIVE WASTE DISPOSAL FACILITY LICENSING ACTIVITIES 1.
The low-level waste (LLW) licensing staff is tasked with the review of two formal license applications within a 24 week time frame starting in October 1990.
Four FTEs have been assigned to this project. Two
>ositions were vacant at the time of the program review, but offers 1ad been extended to fill the vacancies.
Each staff meber, including the license coordinator, will be responsible for reviewing a major technical area (s) in the license application.
IDNS plans to acquire technical assistance from contractors and have them perform much of the reviews. The current staffing level appears to fall short cf what is needed to accomplish this task within the schedule provided.
Even with contractor support, it still appears that the effort of working with and overseeing the contractor's work will severely tax this small of a staff.
2.
Discussions with the current staff indicated that they are qualified and knowledgeable in the Illinois regulatory process and in the general requirements for licensing and regulation of low-level waste disposal.
The four full-time licensing staff will consist of three health physicists and one engineer. There is a need for broader staff experience. The technical area that is the most noteworthy in its absence from the staff's experience is geologic or earth sciences.
It is difficult to see how the staff will be able to accomplish license review work or oversee contractor's work in the technical areas of hydrogeology, tectonics, geomorphology, etc.
3.
During the program review, the staff was in the process of determining contractors for the license review effort.
Contracts for reviewing the areas of hydrogeology and quality assurance had already been let.
The staff was attempting to contract with a large environmental or engineering firm with multidisciplinary expertise for the remainder of the review. The firms who had submitted Statements of Qualifications did not have specialized expertise in radwaste disposal, or even in hazardous or municipal waste disposal.
Neither did they appear to have experience in the review of permits or license applications.
The NRC's experience with technical assistance contractors is that it is very difficult to educate design firms in the regulatory process. The Statement of Work intended for a technical assistance contractor should be detailed and specific with respect to contractor effort, performance standards, and expected work product.
ENCLOSURE 3
2 4.
The LLW licensing staff is in the process of developing the tools needed for review of the two license applications. These include a licensing plan, a licensing guide, and standard review plans.
The licensing guide is the State's equivalent of NUREG-1199. An attempt has been made to incorporate the requirements of Part 606 as well as Part 601 in the guide; however, there is minimum guidance for the applicant with respect to demonstrating compliance with the "com>1ete containment requirement" specifi< d in Section 606.30(a)(4) or tie dose limits in Parts 601 and 606. A standard review plan had not been drafted, however, the staff indicated that they will use NUREG-1200 for guidance. NUREG-1200 does not contain procedures for evaluating compliance with regulatory requirements equivalent to those contained in Part 606.
5.
In order to facilitate the license review, the LLW licensing staff will be receiving draft sections of the license application for review on a staggered schedule prior to submittal of the formal application. There are two concerns regarding this process:
(1) The facility design information is being submitted relatively late in the schedule, af ter facility operations and closure information are submitted.
Changes required in the design will affect operations and closure.
It would seem more logical that facility design information be submitted and reviewed by the staff prior to review of the operations and closure information to enable the preliminary reviews to be the most useful and efficient.
(2) The preliminary reviews of independent draft sections of the application should not take the place of a more integrated approach to the review process. Since most of the studies are interrelated, they must be reviewed as a whole in order to obtain a valid conclusion about the overall application.
6.
The LLW licensing staff has conducted a preliminary review of a draft section of the license application on site characteristics.
It appeared, within the limits of the review team's expertise, that the staff was conducting a thorough review.
The application, however, relied heavily in some areas on site characterization documents developed by IDNS which contained conclusions about the site's ability to meet siting requirements. The LLW licensing staff may have difficulty in conducting an independent evaluation of the application.
7.
The LLW licensing staff has not developed inspection and enforcement procedures specific to the regulatory requirements in Part 606.
Procedures should be developed for determining the means by which regulatory compliance can be achieved by the licensee and verified by IDNS.