ML20148G250

Transmits Mgt Review Board Proposed Final Rept,Documenting Impep 970310-14 Review of Colorado Radiation Control Program.Review Team Recommended Mgt Review Board Find Colorado Program to Be Adequate to Protect Public Health

ML20148G250
Person / Time
Issue date:	05/23/1997
From:	Lohaus P NRC OFFICE OF STATE PROGRAMS (OSP)
To:	Bangart R, Paperiello C, Thompson H NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS), NRC OFFICE OF STATE PROGRAMS (OSP), NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO)
References
NUDOCS 9706050240
Download: ML20148G250 (3)

Text

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i p 4 UNITED STATES

. .j' s j NUCLEAR REGULATORY COMMISSION ,

WASHINGTON, D.C. 20066-0001

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May 23, 1997 l

l MEMORANDUM TO: Hugh L. Thompson, Jr.

Deputy Executive Director for Regulatory Programs i

Richard L. Bangart, Director Office of State Programs l

Carl J. Paperiello, Director i Office of Nuclear Material Safety )

and Safeguards 1 Karen D. Cyr, General Counsel i Denwood F. Ross, Director Office for Analysis and Evaluation of Operational Data FROM:

Paul H.State Office of Lohaus, Programs Deputy Director \ b

SUBJECT:

INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM (IMPEP) REVIEW OF COLORADO RADIATION CONTROL PROGRAM i

l This memorandum transmits to the Management Review Board (MRB) a proposed final report (Attachment 1) documenting the IMPEP review of the Colorado Radiation Control Program. The review of the Colorado program was conducted by an interoffice team during the period March 10-14,1997. The team issued a draft report to Colorado on April 10,1997, for factual comment. Colorado's factual comments, received by letter dated April 29,1997, from Ms. Patti Shwayder, Executive Director, Colorado Department I of Public Health and Environment have been incorporated into the proposed final report (Attachment 2).

The review team found, with one exception, Colorado's performance with respect to each  !

of the performance indicators to be satisfactory. The review team recommended that l Colorado's performance determination for the indicator, Legislation and Regulations, be I deferred until the State can send those regulations previously not reviewed by the NRC to the Office of State Programs for review. Accordingly, the team recommends that, the Management Review Board (MRB) find the Colorado program to be adequate to protect public health and safety. The recommendation to the MRB on program ciompatibility will l be provided upon staff completion of the compatibility review of Colorado regulations which will be completed prior to the MRB meeting.

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- 1 Multiple Addressees 2 $Y 2 8 g The MRB meeting to consider the Colorado report is scheduled for Tuesday, June 3,1997, )

from 1:00 - 3:00 p.m. In One White Flint North, Room 4-B-6. In accordance with l

Management Directive 5.6, the meeting is open to the public. The agenda for that meeting t

is attached (Attachment 3).

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If you have any questions prior to the meeting, please contact me at 415-2326 or Jack W.

Hornor at 510-975-0224. ,

Attachments: 1 Ag stated cc: Robert Quillin, CO Richard Ratliff, TX I

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. Multiple Addressses 2 MAY 2 31997

. , . The MRB meeting to consider the Colorado report is scheduled for Tuesday, June 3,1997, from 1:00 - 3:00 p.m. In One White Flint North, Room 4-B-6. In accordance with Management Directive 5.6, the meeting is open to the public. The agenda for that meeting is attached (Attachment 3),

a If you have any questions prior to the meeting, please contact me at 415-2326 or Jack W.

Hornor at 510-975-0224.

Attachments:

As stated cc: Robert Quillin, CO Richard Ratliff, TX Distribution:

DlR RF DCD (SPO1)

CMaupin, OSP PDR (YES v' i NO (_)

JHornor, RIV, WCFO DBunn, CA CHackney, RIV JCook, RIV DCool, NMSS SMoore, NMSS SMoore, NMSS HNewsome, OGC FCameron, OGC CO File DOCUMENT NAME: G:\KXS\COMRBMEM.KNS, G:\KXS\COlMP97.PFN, G:\KXS\COAPX97.PFN

r. r.c.i.. . copy ., ini. nocum.nt, indic.i. in in. bo.: c AvMnout .it. chm.nt,.nciosur. t . copy wita .tt. chm.nti ncio.ur. N' = No copy OFFICE OSP Kgfy OSF.QCf, OSP:D gjg / l NAME KSchneider:nb PHLoha u's ') RLBangart/ VB DATE 05/,\ /97 052f/97 054)3/97 OSP FILE CODE: SP-AG-5

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1 INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM REVIEW OF COLORADO AGREEMENT STATE PROGRAM March 10-14,1997 l

PROPOSED FINAL REPORT U.S. Nuclear Regulatory Commission l

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a Colorado Proposed Final Report Page 1

1.0 INTRODUCTION

This report presents the results of the review of the Colorado radiation control ,

program. The review was conducted during the periods February 18-20 and March 10-14, 1997, by a review team comprised of technical staff members from the Nuclear Regulatory

Commission (NRC) and the Agreement State of California. Team members are identified in Appendix A. The review was conducted in accordance 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 j the Policy Statement on Adequacy and Compatibility of Agreement State Programs,"

published in the Federal Reaister on October 25,1995, and the September 12,1995,NRC 4 Management Directive 5.6, " Integrated Materials Performance Evaluation Program (IMPEP)." Preliminary results of the review, which covered the period April 4,1993, to March 9,1997, were discussed with Colorado management on March 14,1997.

[ Paragraph on Results of MRB meeting will be included in final report. Attachment 1, Colorado's response, will be included in final report.)

The Colorado Department of Public Health and Environment (CDPHE) is the agency within the State of Colorado that regulates, among other public health issues, radiation hazards. Within the CDPHE, the Radioactive Materials Unit (RMU) of the Laboratory and Radiation Services (LARS) Division is responsible for the radiation control program except for uranium recovery operations, which is the responsibility of the Uranium and Special Projects Unit (USPU) of the Hazardous Materials and Waste Management Division.

Colorado organization charts are included as Appendix B. At the time of the review, the Colorado program regulated 348 specific licenses, including commercial irradiators, manufacturers, broad academic, broad medical, radiopharmacies, radiographers, and uranium recovery operations. The review focused on the materials 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 Colorado.

In preparation for the review, a questionnaire addressing the common and non-common indicators was sent to the State on November 21,1996. Colorado provided its response to the questionnaire on February 20,1997. A copy of that response is included as Apperidix C to this report.

The review team's general approach for conduct of this review consisted of: (1) examination of Colorado's response to the questionnaire, (2) review of applicable Colorado statutes and regulations, (3) analysis of quantitative information from the radiation control program licensing and inspection data base, (4) technical review of selected files, (5) field accompaniments of two Colorado inspectors, and (6) interviews with staff and management to answer questions or clarify issues. The team evaluated the information that it gathered against the IMPEP performance criteria for each common and non-common indicator and made a preliminary assessment of the radiation control program's performance.

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Colorado Proposed Final Report Page 2 Section 2 below discusses the State's actions in response to recommendations made following the previous review. Results of the current review for the IMPEP common performance indicators are presented in Section 3. Section 4 discusses results of the applicable non-common indicators, and Section 5 summarizes the review team's findings and recommendations.

2.0 STATUS OF ITEMS IDENTIFIED IN PREVIOUS REVIEWS The previous routine review concluded on April 9,1993, and the results were transmitted to Dr. Patricia A. Nolan, Executive Director of Health, on May 21,1993.

The review findings resulted in recommendations in four program indicators, three of which related to the uranium recovery program. The team's review of the current status of these recommendations are as follows:

(1) The review of the State's radiation control regulations disclosed that one regulatory amendment which is a matter of compatibility had not been adopted by the State within a three-year period after adoption by the NRC. This amendment deals with a requirement for an emergency plan for certain significant licensees. Because this regulation had just become due on April 7,1993, and given that the Radiation Control Division had already enforced this regulation by license condition, compatibility was not withheld. The recommendation that the above amendment and any others approaching the three-year period allowed after NRC adoption be promulgated as effective State radiation control regulations was identified in the report as a reminder to the State.

Current Status: The Emergency Planning Rule, Parts 30,40,70, became effective January 1,1994. This recommendation is closed.

(2) In 1983, Colorado brought suits against two uranium mill operators, Cotter Corporation and Umetco Minerals Corporation. As a result of these suits, Consent Decrees were issued that put in place remedial action plans for corrective actions at the two mill sites. The NRC staff found that certain parts of the Consent Decree did not fully meet the NRC requirements for Umetco's Uravan uranium mill. Groundwater issues such as background and point-of-compliance (POC) wel's at the Burbank Pit remained unresolved; the timing of remedial action, based upon a predetermined number of years or meeting agricultural standards, remained an outstanding issue: and the Ra-226 soil concentrations in the area of some of the ponds was still an issue. The staff recommended that the above issues be addressed in license conditions as they were for the Cotter uranium milllicense, it was suggested that the Division inform Umetco that byproduct material areas must be cleaned up to the Colorado Radiation Control Act Part 18 radium standard if they are to be released for unrestricted use. It was also suggested that the Cotter documentation be used as an example for the preliminary licensing statement for the Uravan site.

Current Status: Revisions to Part 18 of the Colorado Radiation Control Act which became effective on December 31,1990, had strengthened the requirements

Colorado Proposed Final Report Page 3 for groundwater cleanup to comply with NRC Standards set forth in 10 CFR Part

, 40. While the Umetco Uravan Consent Decree and Remedial Action Plan of February 23,1987, is still in effect, the review team verified that the licensee must comply with Colorado regulations that are passed after the Consent Decree became effective. The license is in timely renewal and the State is incorporating conditions in the new license which fully comply with 10 CFR Part 40 standards.

While negotiations between the State and the licensee are still underway, Umetco has agreed that all wells will be POC wells at the Burbank Pit and must meet standards for drinking water, background concentration, or alternate concentration levels based on ALARA and agreeable to the State. The Ra-226 soil concentration is an issue that will be addressed before the license is .

terminated and the site released for unrestricted use. Colorado regulations and the NRC Agreement require that both the State and the NRC concur in the final termination of the license. The Cotter license is being used as a model for the Uravan mill renewal license which is scheduled to be completed in 1998. This ,

recommendation is closed. I l

(3) From the review of the Uravan uranium recovery operation preliminary licensing

, statement for the amendment authorizing two disposal cells and the Cotter i preliminary licensing statement for the license renewal, it was not clear how '

the State is documenting the analysis of the licensee's environmental report as required in Section 18.4. The staff recommended that the State include as part ,

of its preliminary licensing statement documentation a statement or section I that specifically addresses the requirements in Section 18.4 for an i I

environmental assessment.

i Current Status: Rather than having a separate section in the preliminary licensing statement to document the entire evaluation of the licensee's remedial action plan, the State elected to evaluate each section immediately after the presentation of that section. This provides the reviewer with documentation which points to the State's decision based on their evaluation of the presented data. The review team reviewed the June 18,1996, Decision Analysis for the Cotter Canon City Milllicense amendment package, and found the State's evaluation and analysis to be well-documented with proposed changes and the ensuing projected environmentalimpacts clearly stated. This recommendation is closed.

(4) In the uranium recovery program, the NRC staff identified two surety situations which had not been fully satisfactory:

(a) The Long-Term Care amount for Hecla-Durita was inadequate ($330,728) and included a $50,000 bond from a bankrupt utility. The NRC recommended the Long-Term Care fund be increased to the required amount of $529,000 (i.e.

$250,000 in 1978 dollars) prior to license renewal, which was scheduled to occur by September 1993.

. l Colorado Proposed Final Report Page 4 (b) Sweeney Mining and Milling Company is a licensee with essentially no j assets to either perform reclamation nor provide a surety. The license  ;

for this facility was under timely renewal at the time of the review. I Since the licensee had not demonstrated the financial solvency to i address the existing wastes on site, there was concern that any continued operations could perpetuate the problem rather than mitigate it. The staff recommended that before authorizing a license renewal for continued operation of this facility, the State should: (1) determine whether any potential future operations will add to the quantities of  ;

licensed material (waste) existing at this facility; (2) establish how l the licensee will dispose of or reclaim any waste generated from future I operations as well as from the eventual dismantlement of the processing facility; and (3) ensure that the licensee has established an acceptable financial assurance arrangement to cover the costs from any future operations.

Current Status:

(a) Hecla-Durita license has been renewed and was last amended on August 22, 1996. License condition 30.2.2 requires an appropriate long-term care fund in future dollars at the time of the License termination, which is expected to occur after September 1998. The projected long-term care fund .is approximately $580,000 and the licensee is currently only

$200,000 short. However, the State currently holds a new bond which will cover the shortfall. This recommendation is closed.

(b) The current Sweeny Mining and Milling Company license is for storage and possession only. The State will not authorize the licensee to conduct future operations under any circumstances. With the owner's cooperation, the State has conducted a total financial analysis of the licensee and concluded that there is no funding availabla for remediation and that there never will be. The State also performed an engineering evaluation of the site and concluded that there is presently no danger to public health and safety. Based on new information gathered during the audit, the State is applying to the U.S. Department of Energy (USDOE) for an evaluation of entry into the Formally Utilized Sites Remedial Action Program (FUSRAP) program for remediation. If this fails, the State intends to approach the U.S. Environmental Protection Agency (USEPA) for assistance with the clean-up under the Comprehensive Environmental Response and Liability Act of 1980 as amended (CERCLA), or Superfund, program. The State is taking the necessary precautions to ensure cleanup of this f acility. 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

Colorado Proposed Final Report Page 5 inspection Program, (2) Technical Staffing and Training, (3) Technical Quality of Licensing Actions, (4) Technical Quality of Inspections, and (5) Response to incidents  !

and Allegations. l 3.1 Status of Materials insoection Procram The team focused on four factors in reviewing this indicator: (1) inspection frequency, (2) overdue inspections, (3) initial inspection of new licenses, and (4) timely dispatch of inspection findings to licensees. The team evaluation is based on l the Colorado questionnaire responses regarding this indicator, data gathered independently from the State's licensing and inspection data tracking system, the

, examination of licensing and inspection casework files, and interviews with managers  ;

and staff. l i

i The team's review of the State's inspection priorities verified that the inspection frequencies for various types or groups of licenses are the same as for similar license types listed in NRC Inspection Manual Chapter (IMC) 2800 with the following two exceptions: (1) The Colorado priority schedule lists gamma knife licensees as Priority 1 and inspects the licensees annually. The IMC 2800 groups gamma knife licensees with other teletherapy facilities which have 3-year inspection frequencies. (2) The NRC priority schedule requires annualinspections of medical facilities licensed to use high dose rate (HDR) remote afterloader deWees: however, the State does not differentiate between Priority 3 medical institu+ ions, which are inspected every three years, and institutions licensed to use remote ofterloader devices. Review of the files showed that four hospitals are licensed to use HDR remote afterloader devices.

The review team recommends that the State revise the inspection frequency for HDR remote afterloader licenses to the 1-year frequency specified in IMC 2800.

In their response to the questionnaire, Colorado indicated that as of January 21,1997, i two licenses identified as core inspections in IMC 2800 were overdue by more than 25 i percent of the NRC's frequency as a result of the State changing its inspection l frequency to a higher priority. Both inspections were completed in March 1997. This '

number is well within the 10 percent criterion for overdue inspections of Management Directive 5.6. The team noted that both inspections had been completed by the end of the review.

In reviewing the inspection files and computer reports generated within the LARS division, the review team found that the State's data control system is successfully tracking compliance data. Allinspections are placed in the system and used by the supervisor to track inspections, enforcement, correspondence, and closures. The supervisor uses the data to monitor inspections and follow-up actions and make staff assignments accordingly.

Records showed that all new licenses are entered into the data base and stated for inspection within four months after the license is issued. According to State policy, if the licensee indicates that they have not received radioactive material when contacted for the first inspection, the inspection is deferred until one year after the

Colorado Proposed Final Report Page 6 license is issued. If the licensee still has not received material after one year, then an inspection may or may not be done, depending on a decision by management. A notation is made in the file anc' the staff continue to follow up until an inspection can be scheduled. The State's policy differs from IMC 2800 which directs NRC to conduct an initial inspection after one year whether or not the licensee has received radioactive material. The review team found the State's policy for initialinspections acceptable.

There were 16 new licenses issued in 1995 and 17 new licenses issued in 1996; review of the records showed that all were inspected within six months after issuance.

Review of the files showed that the State is generally successful in meeting the IMPEP goal of sending inspection findings to the licensee within 30 days after the inspection. In the team's review of 20 inspection files, the team found that the two cases in which the issuance of the inspection findings failed to meet the 30-day goal involved escalated enforcement or special circumstances justifying the delay.

The State's system for tracking and inspecting licensees working under reciprocity was reviewed. The State does not charge a fee for reciprocity work by an out-of-state licensee but limits each permit to 180 days. They require that each reciprocity holder have a copy of the Colorado State Regulations at all times while working in the State.

If a Notice of Violation is issued, a copy is forwarded to the licensing State or NRC.

All reciprocity licensees are entered into the inspection tracking system, and a file is maintained for each entry notice, in their response to the questionnaire, Colorado reported that reciprocity was granted I to 52 licensees in the 4-year reporting period. Although 16 of the licensees fell into the categories oi NRC core licenses requiring inspection frequency of three years or less, only four inspections of the higher priority reciprocity licenses were performed during the review period. The State policy is to inspect as many industrial radiography licensees as possible under reciprocity. Due to location within the State, LARS was not always able to perform these inspections. The State was unaware that IMC 1220 frequency for reciprocity inspection applied to Agreement States. The review team recommends that the State adhere to the percentage of reciprocity licensees to be inspected each year as specified in Appendix 11 of the NRC IMC 1220.

Based on the IMPEP evaluation criteria, the review team recommends that Colorado's performance with respect to the indicator, Status of Materials Inspection Program, be found satisfactory.

3.2 Technical Staffino and Trainina in reviewing this indicator, the review team considered the radioactive materials program staffing level, staff training, technical qualifications of the staff, and staff turnover. To evaluate these issues, the review team examined the State's questionnaire responses relative to this indicator, interviewed program management and staff, and considered any possible backlogs in licensing or compliance actions.

Technical staffing and training for the sealed source and device evaluation program and uranium recovery program are addressed in Section 4 of this report.

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Colorado Proposed Final Report Page 7 At the time of the review, CDPHE's radioactive materials program was staffed by the LARS Director, the RMU Supervisor, and six other environmental protection specialists.

The review team found that the current staffing level is adequate to administer the regulatory program, as evidenced by the lack of backlogs in program functions.

The LARS Director, in a recent reorganization, became head of the state laboratory, and the LARS Division is in the process of moving their offices from their present location to the laboratory facilities located at the former Lowry Air Force Base. At the time of the review, the Director's office had moved to the new facilities, but the RMU staff had not. The entire Division expects to complete the move by the summer,1997.

The licensing and inspection functions of the program are segregated; however staff members are cross-trained, and the Director has the flexibility to assign staff as necessary to achieve the necessary balance between licensing and inspection. Licensing duties are performed by the senior reviewer and two staff members; compliance duties are performed by the head of compliance and two other inspectors; all RMU staff perform duties in incident and emergency response. Because of the need for specialized training, Sealed Source and Device (SS&D) evaluations are assigned to two trained individuals.

LARS staff turnover during the review period was minimal with one retirement, one staff transfer from USPU to RMU and one staff termination. The position of the staff member who retired will be eliminated. As a result of the staff termination, one vacancy has existed in the licensing section since December 1996. Management's goal is to fill this vacant position by July 1,1997. In order to maintain the staffing level necessary to keep abreast of the needs of the regulatory program, the review team recommends the State fill the existing vacancy in the radioactive materials unit.

From supervisor interviews and review of the job descriptions, the review team determined that successful candidates for technical positions are required to have a Bachelor's degree in science or math or direct experience on a year for-year basis.

From review of the technical qualifications of the current staff, the team concluded that the State has been able to recruit qualified individuals. There are three certified health physicists within CDPHE.

According to the information provided in the questionnaire, all newly hired technical staff are required to attend NRC training coursos which are equivalent to courses outlined in IMC 1246, as well as the five-week health physics course. However, because the NRC no longer pays for training courses for Agreement States, the State plans to do as much training internally as possible. For courses that cannot be done internally, the State will check with other Agreement States to find alternative courses and will only send staff to NRC courses if no alternative is feasible. The records show that one individual has not taken the Applied Health Physics (five-week) and SS&D registry courses; one individual has not taken the Safety Aspects of Well Logging course; and one individual has not taken the Safety Aspects of industrial Radiography course.

Management explained to the team that individuals w.ill be scheduled for courses they

Colorado Proposed Final Report Page 8 are lacking as soon as the NRC courses, or alternative equivalent courses become available.

The heads of licensing and inspection explained their in-house and on-the-job training processes during interviews with the review team. Briefly, a newly hired inspector is trained by accompanying the head of the inspection section, an experienced inspector, or the RMU supervisor. The supervisor continues accompaniments, gradually assuming the inspection duties, until it is decided the inspector is proficient and can perform the inspections independently. The new inspector is closely monitored as he or she conducts increasingly complex inspections. A newly hired license reviewer accompanies an inspector for a brief period in order to become familiar with the types of material they are licensing. The senior license reviewer then assigns the newly hired reviewer to assist with licensing actions of different types and increasing complexity before allowing the reviewer to perform independent licensing actions. The inspection reports and licensing actions of new staff are closely reviewed by senior staff and the RMU supervisor.

Based on the team's finding and the IMPEP evaluation criteria, the review team recommends that Colorado's performance with respect to this indicator, Technical Staffing and Training, be found satisfactory.

3.3 Technical Quality of Licensjna Actions i

The review team examined casework and interviewed the reviewers for 21 specific )

licenses. Licensing actions were reviewed for completeness, consistency, proper j isotopes and quantities used, qualifications of authorized users, adequate facilities I and equipment, and operating and emergency procedures sufficient to establish the basis '

for licensing actions. Casework was reviewed for timeliness, adherence to good health physics practices, reference to appropriate 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 authorities. Licenses were l reviewed for accuracv, appropriateness of the license and of its conditions and tie-down condit'ons, and overall technical quality. The files were checked for retention of necessary documents and supporting data.

The RMU licensing program is well managed and completes licensing actions in a timely manner. There are currently 348 specific licenses in effect. At the time of the review, there were only three licensing actions pending for over six months. Two of these licensing actions involved decommissioning pending termination, and one licensing action was delayed awaitir g information by the applicant on financial assurance arrangements. CDPHE's policy requires each licensee to review its license at 5-year intervals and submit a complete program for review by the staff as part of the license renewal. Licenses are amended as requested by the licensee or administrative amendments may be initiated by the State as needed. NRC regulatory guides and standard review plans were readily available for staff use,if needed.

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Colorado Proposed Final Report Page 9 Licensing casework selected provided a representative sample of licensing actions completed in the review period and included work by all reviewers. The cross-section licensing casework sampling included two of Colorado's major licenses and included the following types: well logging (with tracer studies and neutron logging), medical broad scope (with HDR afterloader and pacemaker), academic broad scope, nuclear pharmacy, research and development, irradiator (sealed), medical institution, gas chromatograph, manufacturing and distribution, nuclear medicine, teletherapy, and portable gauges.

Licensing actions included 1 new license, 9 five-year interval renewals, 7 amendments, and 4 terminations. A list of these licenses with case-specific comments can be found in Appendix D.

The review team found that, overall, the licensing actions were generally thorough, complete, consistent, and of acceptable quality with health and safety issues properly addressed. License tie-down conditions were stated clearly. In most cases, licensing actions were supported by information contained in the license files. The licensee's compliance history was taken into account when reviewing renewal applications. The Division's practice is to not issue any license if there are unresolved compliance issues. Licensing reviewers appropriately used new licensing guides; however, accompanying check sheets were not used. During the license file reviews, the team found omissions in documentation that might have been prevented by the effective use of l checklists. The review team suggests that the State institute the use of checklists {

for licensing actions and maintain these forms in the licensing file. 1 Peer and supervisory review of licensing actions were clearly documented in the licensing files on s tracking sheet, " licensing cover sheet." Peer review is normally conducted of alllicensing actions by the reviewers prior to issuance. Alllicensing actions are signed by the RMU supervisor, who also reviews complex licensing actions before they are issued.

The procedures for terminating licenses were adequately documented. All of the termination files reviewed were documented with information on disposition of materials, including verification of material transfers, and closeout survey.

RMU reviewers use copies of NRC's licer sing guides. The State's license conditions were consistent with those of the NRC in most cases. No potentially significant health and safety issue were identified. Horsver, during the licensing file reviews some discrepancies were noted. The review team suggests the State make the following changes in their licensing procedures:

(a) Devices which no longer are acceptable under Colorado's regulation equivalent to 10 CFR 34.20, " Performance Requirements for Radiography Equipment" should be removed from industrial radiography licenses.

(b) The State should implement the license conditions that it has developed addressing the use of HDRs and amend the State's four licenses authorized for HDR usage accordingly.

Colorado Proposed Final Report Page 10 (c) Procedures should be developed to ensure that a clear explanation and description of non-routine usage of materials is included.

(d) Procedures should be developed to ensure consistency between well logging license documents requesting the use of the same material, for the same use, and same quantities. Colorado stated in its response to the draft report, dated April 29,1997, that RMU did consistently use appropriate license conditions for well logging licenses. The review team disagrees with the State.

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

3.4 Technical Qualitv of insoections The team reviewed the inspection reports, enforcement documentation, and inspection field notes, and interviewed inspectors for 20 materials inspections conducted during the review period. The casework included all three of the State's materialinspectors and focused on the higher priority licenses of various types including academic and medical broad scope, radiography, institutional medical, HDR, teletherapy, research, nuclear pharmacy, pool irradiator, R&D, manufacture and distribution, and well logging. Appendix E lists the inspection cases reviewed in depth with case-specific comments. Prior to the review, a team member performed accompaniments of two state inspectors on two separate inspections of licensed facilities.

The inspection procedures and techniques utilized by Colorado were reviewed and determined to be generally consistent with the inspection guidance provided in IMC 2800. According to the State's policy, allinspections are to be unannounced except for initial inspections, inspections of licensees in remote geographical locations, or as necessary to observe specific operations or meet with specific licensee management or personnel. However, in the review of the inspection files, the team noted that 17 of the 20 inspections were announced in advance. Although some cases involved circumstances that would require advance notice of the inspection, it appeared that at least eight of the inspections could have been unannounced. The review team suggests the State place more emphasis on adhering to their policy of conducting unannounced inspections.

The State's inspection report forms were reviewed and found to have little narrative to describe the scope of the inspection. The team also reviewed a preliminary draft of a  ;

new form currently being tested by the LARS total quality management (TQM) team. '

Although severalimprovements were included on the revised form, the team noted that the form has no reference to the applicable regulation or license condition. Although in one of the inspections reviewed by the team, the inspector used the IMC 2800 attachment 87100 for teletherapy inspections, RMU does not make a practice of supplementing their general inspection form with forms designed for specific license categories. During interviews with the staff, the team learned that the TOM team plans

Colorado Proposed Final Report Page 11 to develop these supplements later, and the team encouraged them to do so. The review team recommends that the State consider modeling their primary and supplementary inspection and field note forms after those found in IMC 2800, attachment 87100, including reference to the regulation or license condition for the item under inspection.

The reports were reviewed to determine if the reports adequately documented the scope of the licensed program, licensee organization, personnel protection, posting and labeling, control of materials, equipment, use of materials, transfer, and disposal.

The reports were also checked to determine if the reports adequately documented operations observed, interview of workers, independent measurements, status of previous noncompliance items, substantiation of all items of noncompliance, and the substance of discussions during exit interviews with management. Overall the quality of the reports is satisfactory although some details were lacking in the routine reports.

Colorado uses their form RCD 59, Notice of Compliance inspection Results, as their primary method for communicating the results of the inspection to the licensee. This form is generally completed in the field by the inspector and handed to the licensee during the exit interview. The form, which must be signed and dated by the licensee, contains information meeting the posting requirements and requires the licensee to agree to correct the violations within 30 days or submit to the State in writing their plans for corrective actions. The team found that the form, which would be appropriate for minor violations, is being used almost exclusively by the irapectors to identify items of non-compliance regardless of the severity of the violavion. Also, the review team found this form difficult to read and understand, in most cases due to the inspector's handwriting. The review team recommends that the State restrict the use of the short form, RCD 59, to cases where minor violations are ide1tified during the inspection, and that the State issue a formal enforcement letter for more serious or multiple iterns of non-compliance.

The inspection files reviewed were complete and included a supervisor sign-off of the entire package. The State has an elaborate system for billing the licensee for their inspection services; therefore, the package must be complete before transfer to accounting for billing. The licensee's response is reviewed by the supervisor and if allitems are adequately addressed a close-file letter is signed by the Division Director. Allinspections reviewed showed appropriate regulatory action was taken by the program.

The files were found to be well organized, orderly, and easily accessed for information. The files were also found to be complete with alllicense and enforcement documents and correspondence. The enforcement letters and correspondence were determined to be written in appropriate regulatory language, inspection reports are filed in the same folder as the licensing actions; therefore, if the licensing staff need to look at a licensee's compliance history everything is in one place.

l

• I Colorado Proposed Final Report Page 12 Although Colorado has the authority to levy civil penalties, CDPHE relies primarily on

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the use of follow-up inspections for escalateo enforcement whenever the number and  ;

severity of violations merit it. The charge imposed by the State for follow-up l inspections, in effect, levies additional penalties on the licensee. Fourteen follow-up inspections were conducted during the review period. Information fumished to the review team showed that the State issued orders to revoke two licenses during the review period and turned jurisdiction of one bankrypt licensee to the USEPA At the time of the review, the State was in the process of conducting follow-up inspections j against two recalcitrant licensees.

A member of the review team conducted accompaniments of two Colorado inspectors prior to the team review. On February 19,1997, one inspector was accompanied during an inspection of a pharmaceutical research and manufacturing facility in Boulder, The l second inspector was accompanied on February 20,1997, during an inspection of the  !

Colorado Department of Agriculture, a gas chromatograph licensee. Both inspectors  ;

prepared well and performed thorough inspections of the licensees' radiation safety I programs. The inspectors demonstrated appropriate inspection techniques including observations, interviews, review of records, and knowledge of regulations. The l technical performance of the inspectors was satisfactory, and their inspections were I adequate to access the radiological health and safety of the licensee. The  !

accompaniments are identified in Appendix E.

l in their response to the questionnaire, LARS listed the inspectors accompanied by senior management during the review period and stated that, although not specifically i documented, the inspection supervisor makes frequent inspector accompaniments. During i interviews with LARS staff, the team found that, although inspector performance evaluations had not been documented during the accompaniments, the RMU senior inspector in charge of compliance had accompanied each inspector at least once during the I prcvious year. Because inspector accompaniments and the related performance j evaluations provide management with valuable insight into the quality of the inspection l program, the review team recommends that the RMU supervisor or senior inspector perform annual accompaniments of each inspector and document the results.

The program has an adequate supply of survey meters to support the staff during routine inspections and emergencies. There is one neutron-rem ball-meter; six GM pancake probes, six air proportional alpha meters; one portable multi-channel analyzer and two Victoreen 450 ion chambers. There is also an ample supply of emergency response protective clothing and equipment, including respirators for each inspector. The program has a respiratory protection program for each employee that includes an annual I physical and mask fitting.

The team found that instruments are calibrated annually, some each quarter, so that instruments are always available that have been calibrated within the current quarter.

1 In calibrating the instruments, LARS uses an in-house Cs-137,30 mci, source that is NationalInstitute of Standards and Technology (NIST) traceable. They do not have a calibration range, beam collimator, or attenuators to use for calibrations. Staff j l

Colorado Proposed Final Report Page 13 generally calibrate in an open area during off hours. Although this technique satisfies the minimum requirements, it is difficult to reproduce geometry and accuracy, and it does not meet ALARA requirements. The review team recommends the State acquire proper calibration equipment for the shielded area in the new facility in order to better perform calibrations and lower staff exposure to radiation.

At the time of the review the LARS radiochemistry and counting laboratory had just moved to new facilities at the former Lowry Air Force Base. The laboratory serves all of the State agencies requiring radiochemistry, including RMU and USPU. In addition, they can perform all bioassay work and possess a total body counter. They can measure radiation in any form. A review team member toured the facility on February 18,1997, and noted that the laboratory had acquired a good inventory of state-of-the-art analytical equipment. The laboratory participates in the EPA and NIST standards checking, and consistently performs well. The turn-around time, which the r3 view team confirmed with the inspectors, ranged from immediate in emergencies to a few days for i routine samples.  ;

Based on the IMPEP evaluation criteria, the review team recommends that Colorado's <

l performance with respect to the indicator, Technical Quality of Inspections, be found l satisfactory.

3.5 Resoonse to incidents and Alleaations i

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 relative to this indicator, reviewed the incidents reported for Colorado in the

" Nuclear Material Events Database" (NMED) against those contained in the Colorado files, and reviewed the casework and supporting documentation, as appropriate, for 12 l incidents. in addition, the review team interviewed the RMU supervisor and head of l licensing. The State recorded no allegations during the review period. l l

The review team examined Colorado's incident and misadministration logs for the period January 1,1994, through December 31,1996, and found that 47 incidents and 23 misadministrations were recorded during the 3-year period. The State treats allegations as incidents and they are not tracked separately. The 12 incidents selected for review included four misadministrations, two overexposures, one leaking source, two lost sources, one reported loss of control, one contamination event, and one radiography camera found at a non-licensed facility. A list of the incident response casework with comments is included as Appen 'x F.

Prior to the IMPEP review, the review team was asked by OSP to evaluate Colorado's lack of reporting of event information to NRC during the six-month trial program between the NRC and the Agreement States to assess the effectiveness of voluntary Agreement State reporting of such information to the NRC. Review of the records showed that during the 6-month trial period which began in April 1995, two incidents occurred in Colorado which met the NMED reporting criteria identified in " Handbook on Nuclear Material Event Reporting in the Agreement States," Draft Report, March 1995. One is hicd correctly

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Colorado Proposed Final Report Page 14 on the NMED log (NMED 951041), and the review team could not determine why Colorado was 2

listed as one of the States that did not report during the trial period. The team verified that the second incident was reported to the Region IV State Agreements

! Officer on August 3,1995 but not entered into NMED.

According to the State's response to the questionnaire, one incident occurred during

the review period which involved failure of equipment or an approved operating system,

and they notified the NRC appropriately. NMED contained three reportable incidents for

, this period. Four of the incidents included in the file reviews were reportable under NMED reporting criteria. Of these, two were reported correctly, one was inadvertently

. not reported, and as stated previously, one was reported to the NRC Region. The review team recommends that the State review the March 1995 " Handbook on Nuclear Material

Event Reporting in the Agreement States

Draft for Comment," and take the steps i necessary to report past and future incidents according to the procedures therein.

) In discussions with the RMU, the review team noted the list of contributing factors considered for misadminstration did not include an analysis as to why the event

. occurred. The State's event reporting form RCD 56, " Diagnostic Misadministration '

Report" is used by the staff for both diagnostic and therapeutic misadministration.

, The review team recommends that the form RCD 56 be revised to include an anaylsis as to j l why the event occurred and differentiate between diagnostic and therapeutic l misadminstrations.

The State's incident response program and written emergency plan are available to all staff on the local area network (LAN). During the incident file reviews, the plan's

effectiveness was demonstrated by RMU's response actions. For the most part, the

! response actions were appropriate and timely. The level of effort was typically commensurate with the hazard to the public. Responsibility for initial response and follow up actions to radioactive materials incidents and allegations rests with RMU.

Incident response procedures require that the RMU supervisor determines who responds to an incident and or allegation. The team verified that allincidents examined in the casework reviews were cross-referenced to the license file.

For those incidents in which on-site investigations are required, the team confirmed that the investigators are evaluating the licensee's compliance with regulations or license conditions and citing violations. For those incidents in which an on-site inspection is not necessary, the investigation is closed by a memo to file or by an acknowledgment letter to the licensee or individual reporting the incident or allegation. Letters regarding incident investigations were written in appropriate regulatory language.

Management review and involvement in incident and allegation response consists of a closeout technical review by the inspector, a closecut review by the RMU supervisor and a closeout review by the Director of the LARS Division.

Allegations are handled by the State as incidents. To protect the individual reporting an incident or making an allegation, a written procedure entitled " Preserving The

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Colorado Proposed Final Report Page 15 Confidentiality Of State Information Versus Your Role As A Public Servant" provides ,

guidance protecting the identity of individuals adequately and providing public access to State and licensee records as oermitted within the constraints of laws for protection of personal, private and proprietary information.

Based on the IMPEP evaluation criteria, the review team recommends that Colorado's l

performance with respect to the indicator, Response to incidents and Allegations, be l found satisfactory.

l 4.0 NON-COMMON PERFORMANCE INDICATORS IMPEP identifies four non-common performance indicators to be used in reviewing Agreement State programs: (1) Legislation and Regulations, (2) Sealed Source and 4

Device Evaluation Program, (3) Low-Level Radioactive Waste Disposal Program, and (4)

Uranium Recovery.

l 4.1 Leaislation and Reaulations

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4.1.1 Leaislative and Leoal Authority Along wi*h their response to the questionnaire, the State provided the review team with copies of legislation that affects the radiation control program. Colorado Revised Statutes (CRS) Title 25, Article 11, the Radiation Control Act, authorizes the Governor to enter into agreements with the Federal Government in matters relating to radiation safety, and designates the Department of Public Health and Environment as the radiation control agency for the State of Colorado. This act gives the Department specific powers and duties among which are authorities to promulgate regulations, issue licenses, perform inspections, collect fees, and issue civil penalties.

In addition, CRS 13-25-126.5,13-90-107 and 25-1-114.5 - Concerning Environmental Self-Evaluation, declares that if users of radioactive material identify, correct, and notify the State of potentially detrimental environmental issues, they may be relieved of civil and/or criminal penalties if the corrective actions meet with State approval.

4.1.2 States and Comoatibility of Reaulations The review team compared the State's regulations against the latest Chronology of Amendments and found that, with the exceptions identified below, the State has promulgated all necessary amendments which were due for adoption by the Agreement States through 1997. In addition, the State had adopted the " 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, and the " Compatibility with the International Atomic Energy Agency," 10 CFR Part 71 amendrnent (60 FR 50248) that becarne effective April 1,1996.

The status of the regulations which had becom due but were not effective at the time of the review is as follows:

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Colorado Proposed Final Report Page 16

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• " Licensing and Radiation Safety Requirements for Irradiators," 10 CFR Part 36 i amendments (58 FR 7715) that became effective July 1,1993, and which was due on  ;

July 1,1996. This was adopted in November 1996, and will become effective ,

, July 1,1997. Colorado has only one licensee affected by this amendment, and l the review team verified that the licensee must comply with this regulation  ;

through the use of license conditions.  !

1

!. * '" Decommissioning Recordkeeping and License Termination: Documentation 1

Additions," 10 CFR Parts 30,40,70, and 72 amendments (58 FR 39628) that became i

effective on October 25,1993, and which was due on October 25,1996. This . rule j was adopted on February 19,1997, and will become effective on July 1,1997, 4

• "Self-Guara,ntee as an Additional Financial Mechanism," 10 CFR Parts 30,40, and 70 amendments (58 FR 68726 and 59 FR 1618) that became effective on January 28,1994, and which became due on January 28,1997. This rule was also l adopted on February 19,1997, and will become effective on July 1,1997.

! * " Quality Management Program and Misadministrations," 10 CFR Part 35 amendments  ;

4 (56 FR 34104) that became effective January 27,1992. The State has deferred 1

!. adoption of this amendment pending the final Commission approval of the i Statement of Principles of Policy for the Agreement State Program and the Policy i

Statement on Adequacy and Compatibility of Agreement State Programs.  !

l i The State was reminded of the following regulations which will become due in the next l l review period: -  !

• " 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 j FR 65243,60 FR 322) that became effective on January 1,1995, and which will  ;

! become due on January 1,1998. I l * " 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, and which will become due on March 13,1998. Note, this rule is designated as a Division 2 matter of compatibility. Division 2 compatibility allows the Agreement States flexibility to be more stringent (i.e., the State

could choose to continue to require annual medical examinations).

l * " Performance Requirements for Radiography Equipment," 10 CFR Part 34 amendments

! (60 FR 28323) that became effective on June 30,1995, and which will become due l on June 30,1998.

• " Radiation Protection Requirements: Amended Definitions and Criteria,"

{ 10 CFR Parts 19 and 20 amendments (60 FR 36038) that became effective

[ August 14,1995, and which will become due on August 14,1998.

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Colorado Proposed Final Report Page 17 l l

• " Clarification of Decommissioning Funding Requirements," 10 CFR Parts 30,40, and 70 amendments (60 FR 38235) that became effective November 24,1995, and which will become due on November 24,1998.  !

• " Medical Administration of Radiation and Radioactive Materials" 10 CFR Parts 20 I and 35 (60 FR 48623) that become effective on October 20,1995, and which will l become due on October 20,1998.

l 1

• Termination or Transfer of Licensed Activities: Recordkeeping Requirements," 10 CFR Parts 20 and 30 (61 FR 24669) that became effective on May 16,1996,and which will become due on May 16,1999. I 1

l In reviewing the promulgation procedures and policies, the review team noted that, "A Notice of Rulemaking and Proposed Reguations" is published in The Colorado Reaister.

After an initialinformational hearing by the Board of Health a formal hearing is scheduled by the Board of Health and is noticed in the " Calendar of Hearings" of The Colorado Reaister. Once the rule is adopted, it is noticed in " Changes in the Code of Colorado Regulations" in The Colorado Reaister, in addition, the Division uses the Radioactive Materials newsletter to notice licensees. The State must respond to the comments and present them to the Board of Health before the regulation can be adopted.

Since the last review, only 1 of the 9 regulations required for compatibility became l effective within the 3-year time frame. By policy, regulations in Colorado become effective on the January 1st or July 1st following their adoption, thus increasing the lead time necessary for the State to begin the promulgation process in order to meet the due date. The review team recommends the State consider beginning the regulation promulgation process as soon as possible after the rule has been identified as a compatibility item.

A compatibility review for CDPHE regulations promulgated during this review period had not been conducted by NRC. The review team could not determine from the records whether the State was consistently following the Division policy of sending drafts of proposed and final regulations to the NRC for review and comment. Only one applicable cover letter transmitting a CDPHE regulation to NRC for review was found in the  !

correspondence files. The State indicated all other regulations were transmitted to i NRC Region iV by informal buckslip. Region IV has neither a record of receipt nor the j regulations. The review team recommends the State consider developing a system to track the progress of each regulation, tracking the due and completed dates of all reviews, comments, and actions taken, from the time it is identified as a compatibility rule throughout the promulgation process untilit becomes effective. As part of the  ;

tracking system, the team suggests that a file be maintained with the cover letters of  !

all regulations sent to the NRC for comment, the NRC response, and an explanation of whether the comments were incorporated into the final regulations.

The team notes that NRC staff is currently reviewing all Agreement State equivalent regulations to Part 20, Standards for Protection Against Radiation. These reviews are  ;

being conducted outside the IMPEP process and the States will be notified of the I results.

I

Colorado Proposed Final Report Page 18 The review team recommends that Colorado's performance determination for this indicator, Legislation and Regulations, be deferred until the State can send those regulations previously not reviewed by the NRC to the Office of State Programs for review. The finding will be based on the outcome of that review.

4.2 Sealed Source and Device Evaluation Proaram in assessing the SS&D evaluation program, the review team examined information provided by the State in response to the IMPEP questionnaire on this indicator. A review of new and amended SS&D evaluations and supporting documents covering the review period was conducted. The team observed the staff's use of guidance documents and procedures, and interviewed the staff involved in SS&D evaluations.

4.2.1 Technical Quality of the Product Evaluation Procram The review team examined three new, one inactivated, and two amended SS&D registry certificates and their supporting documentation. The certificates reviewed covered all of the SS&D sheets issued by the State since the last program review in April 1993 and represented cases completed by the two Colorado SS&D reviewers. The SS&D certificates issued by the State and evaluated by the review team are listed with case-specific comments in Appendix G. In addition, the team examined the 32 registry certificates that had been inactivated by the State during the review period; however, the files of these certificates were not reviewed.

In September 1995, two members of the Colorado staff attended the NRC sponsored " Sealed Source and Device Workshop." A review of the files confirms that Colorado utilized the )

information obtained during the SS&D Workshop and followed the recommended guidance. l The registration file contained all correspondence, photographs, engineering drawings, radiation profiles, and results of tests conducted by the applicant. In addition, a checklist received at the workshop is being used to assure all relevant materials have l been submitted and are reviewed, and was contained i,n the registration file. The l notebook and reference material received at the SS&D workshop are being routinely used in reviews. All pertinent ANSI Standards and Regulatory Guides are available and used. I in addition, the formats for device sheets are consistent with those of the NRC. i l

Moreover, subsequent to the workshop, the Division reexamined its register sheets and inactivated 32 register sheets based upon license terminations. Copies of these sheets had been distributed to the NRC and the team was able to confirm that they were a part of the national SS&D registry.

Based upon the review of the registration files, staff interviews, SS&D sheets issued, l the guidance documents and procedures, and the technical training received by the device reviewers during the NRC sponsored SS&D workshop, the review team found that the technical quality of the Colorado product evaluation program is adequate for the current device reviews.

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1 Colorado Proposed Final Report Page 19 >

4.2.2 Technica! Staffino and Trainina

, Colorado has two persons that have the experience and training needed to perform SS&D reviews. Both employees attended the NRC sponsored SS&D Workshop for training on device reviews and registrations. The State also plans to train an additional backup person for SS&D reviews, and the review team encourages the State to follow through on this plan.

The lead reviewer for SS&D reviews has a M.S. in Chemistry and has been with the Division for 27 years. He is an experienced health physicist who has served several years as supervisor of the licensing materials section and is responsible for evaluating all major or complex license applications. The person responsible for peer audits of SS&D reviews has a B.S. in Radiation Protection and has been with the Division a little over a year. Based upon the device reviews performed by Colorado and interviews with the staff, the review team believes that the Colorado's SS&D reviewers are qualified to understand and interpret appropriate prototype tests which ensure the integrity of the products under normal, and likely accidental conditions of use; understand and interpret test results; read and understand blueprints and drawings; understand how the devices work and how the safety features operate; understand and apply the appropriate regulations; understand the conditions of use; and understand external dose rates, source activities and nuclide chemical form.

Based upon the additional technical training received by the device reviewers during the SS&D workshop, the experience in performing complete device reviews since the previous review, and our interviews with the device reviewers, the review team found that the Colorado staff has adequate qualifications and training for the current device reviews.

4.2.3 Evaluation of Defects and incidents Reaardina SS&Ds The review team determined that there were no incidents or defects regarding SS&Ds as determined from the evaluation of the incident files and responses to the questionnaire from Colorado. ,

1 Based on the IMPEP evaluation criteria, the review team recommends that Colorado's performance with respect to the indicator, Sealed Source and Device Evaluation Program, be found satisfactory.

4.3 Low-Level Radioactive Waste ILLRW) Disoosal Procram in 1981, the NRC amended its Policy Statement, " Criteria for Guidance of States and NRC in Discontinuance of NRC Authority and Assumption Thereof by States Through Agreement"  ;

to allow a State to seek an amendment for the regulation of LLRW as a separate category.

Those States with existing Agreements prior to 1981 were determined to have continued LLRW disposal authority without the need of an amendment. Although Colorado has LLRW disposal authority, NRC has not required States to have a program for licensing a LLRW disposal facility until such time as the State has been designated as a host state for a

Colorado Proposed Final Report Page 20 LLRW disposal facility. Although Colorado was designated as a host state in the Rocky Mountain Low-Level Radioactive Waste Compact, that Compact subsequently joined the Northwest Low-level Radioactive Waste Compact where Washington is designated as host State. When an Agreement State has been notified or becomes aware of the need to I regulate a LLRW disposal facility, they are expected to put in place a regulatory i program which will meet the criteria for an adequate and compatible LLRW disposal program. There are no plans for a LLRW disposal facility in Colorado. Accordingly, the j review team did not review this indicator.

4.4 Uranium Recoverv Proaram in the process of evaluating this performance indicator, the review team studied the State's responses to the questionnaire; reviewed inforrnation provided by the State I regarding the license status, inspection history, site status, description of wastes, radiological hazard, financial assurances, and status of decommissioning activities of l each uranium recovery facility licensed by the State; compared the State's regulations against pertinent 10 CFR Part 40 regulations; reviewed selected licensing and i inspection files reviewed the State's written procedures, plans, and training materials; evaluated the qualifications of the technical staff; and interviewed all staff and managers assigned to the uranium recovery program. In addition, the review team reviewed various Consent Decrees, decision analyses, and remedial action plans.

USPU is responsible for the uranium recovery program and complex decommissioning ,

issues. Late in 1996, the unit was moved from the LARS to the Hazardous Materials and i Waste Management Division. USPU staff work closely with LARS, both reporting to the CDPHE Director and sharing the same laboratory.

At the time of the review, Colorado had eight active licenses for facilities in various phases of uranium recovery operations: one operating uranium mill, the Cotter Corporation Ca50n City Milling Facility; four sites in active reclamation or remediation, The Cotter Corporation Whitewater Ore Transfer Station Site, The Hecla Mining Company Durita Site, The Umetco Minerals Corporation Maybell Heap Leach Site end Uravan Mill Site; two inactive sites, Unocal Molycorp Louviers Metals Extraction Plant and Sweeny Mining and Milling Corporation; and one license for possession and storage, Colorado School of Mines Research Institute.

, 4.4.1 Status of Uranium Recoverv Ooerations insoection USPU maintains a computerized tracking system to follow alllicensing actions, inspections, enforcement, site operation or status, and financial standing of each licensee. The inspection schedule compares favorably with IMC 2801 in that all licensees, including stand-by and decommissioning sites are inspected annually. In addition, staff make frequent visits to licensed sites to keep abreast of work progress or decommissioning plans. The Cotter Ca5on City Milling Facility is presently retooling to begin alkaline teaching. When full operation begins, the State plans to increase the inspection frequency to 6-month intervals. There are no in situ mining facilities in Colorado.

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M Colorado Proposed Final Report Page 21

, 1 At the time of the review, there were no overdue inspections or backlogs in the uranium

, recovery program. The State conducted 31 of the 32 required annualinspections during the review period. The 1995 inspection of the Cotter Ca5on City Milling Facility was  !

missed; however, there were six site visits to the facility that, because of alternate resource demands, were not compiled into a formal report. The team verified that the ,

l visits were conducted and documented. I

The review team found that USPU is not meeting the IMPEP criteria of notifying the l licensee of inspection findings within 30 days. In only one out of seven cases reviewed I was the enforcement letter issued within the 30 day period. The average turn-around time was 60 days, but in one case, five months elapsed before the licensee was notified I in writing of the inspection findings. The team noted.that the letters in question had no items of non-compliance or only minor findings, so this issue is not considered a j significant health and safety problem. The staff explained that, in addition to heavy workload demands, inspection findings in uranium recovery operations are normally complex; consequently, the reports and enforcement letters require more time for preparation. The team did observe that the letters were very comprehensive with relatively long lists of items of concern or recommendations to the licensee to implement or consider in performing decommissioning. The review team recommends that 1 USPU place greater emphasis in timely dispatch of inspection findings to licensees.

4.4.2 Technical Staffina and Trainino Review of this indicator included considerations of the adequacy of the uranium I recovery program staffing strategy, which includes training, technical qualifications .

of the staff, and any staff turnover that may have occurred throughout the assessment  !

period.

USPU is an integrated program where all staff participate in alllicensing and inspection activities. USPU is organized by project site with a project manager who has lead responsibility for licensing and inspection of the site. The project managers have the flexibility to use any personnel within the unit to assist as needed in regulation of the site.

At the time of the review USPU had five environmental protection specialists, one half-time consultant (a State employee from another group), a working unit leader, and one vacancy, for a total of 6.5 FTEs. This number appears to be adequate because no backlogs exist in licensing or inspection activities; however, the vacancy only occurred in December 1996, so the effect of the vacancy has not yet become apparent. As a result of the new reorganization, USPU is in the process of developing new procedures, tracking systems, event response plans, and other supporting procedures, thus increasing the need for full staffing. Because of the importance of maintaining sound regulatory oversight of the extensive uranium recovery and decommissioning activities in Cclorado, the review team recommends that the State fill the' vacancy in the uranium recovery program.

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Colorado Proposed Final Report Page 22 1

The team found that USPU's minimum requirements for hiring include graduation from an accredited college or university in geology, hydrology, or a related scientific field, )

plus work experience in, or knowledge of, radiation control, environmental protection, decommissioning, financial analysis of environmental projects, hazardous waste management, and contingency operations. Review of the qualifications of the current staff, including the newest member, shows that they far exceed the minimum 2. Several of the staff have advanced degrees, including a Ph.D. in Physical Chemistry. The i records also showed that the program has qualified staff with backgrounds in health physics (including a Certified Health Physicist), civil engineering, geology  ;

(including a Certified Professional Geologist), hydrology, earth science, ,

environmental science, and risk assessment. In addition, USPU works closely with the

]

Colorado Geological Survey and currently has a contract with them to assist on several  !

sites.

Although the program has one vacancy, the staff continuity is very good, with six individuals with nine or more years in the program. The level of staff experience i ranges from one to eighteen years in uranium recovery and from four to eighteen years in I decommissioning.

In reviewing the training records provided by the State in their response to the questionnaire, the team found that the State has been diligent in sending staff to the NRC courses and other training courses, workshops, and meetings. Management's commitment to training and retraining is evidenced by the fact that staff in the uranium recovery program have collectively attended more than 100 training courses or similar meetings. The newest member of the staff has yet to complete the NRC core courses; however, she is a Certified Health Physicist who comes to the program with four years' experience in decommissioning activities including work at the Rocky Flats USDOE f acility. New staff are trained on the job by working with senior staff for a minirnum of a year, after which they are evaluated by management and senior staff before they are permitted to work independently. The team found that the assigned work is commensurate with the individual's training and experience.

4.4.3 Technical Qualitv of Licensino Actions The State completed 23 licensing actions during the review period including three renewals and one major amendment. USPU also administratively added requirements from Colorado's equivalent regulations to 10 CFR 20, Part 4, to all eight licenses. Because the review team lacked the time and technical expertise to perform in-depth reviews of uranium recovery licensing actions, the team concentrated on reviewing the evaluation process used by the State in making licensing decisions and on the status of decommissioning activities at licensed sites.

Amendment 32 of the Cotter Canon City Milling Facility, License No. 369-01, became effective February 9,1997. This was considered a major amendment as it authorized retooling to alkaline leaching. The review team reviewed the June 18,1996, Decision Analysis prepared by the State for the proposed amendment and discussed the document at length with USPU staff. The team found the document to be clearly written and complete,

Colorado Proposed Final Report Page 23 documenting the site geologic, topographic and hydrologic features, prior concerns and '

their resolution, proposed facility changes and projected impacts, regulation j requirements, proposed license conditions, and maps and drawings of the facility. The i public was provided opportunity for comment before the amendment was adopted.

Various decommissioning, remedial, and reclamation activities were underway at all eight sites at the time of the review, and the State provided the review team with a j summary of the status of the decommissioning activities and financial assurances in  !

place at each site. In each case the licensee had been required to submit detailed decommissioning and remedial action plans before the license or amendment was granted.

When new regulations or other circumstances dictate changes or additions to the decommissioning plans, the new plans are evaluated by the State, and after approval, are incorporated into the license as license conditions. The review team verified that the State is closely inspecting the decommissioning or remedial activities during annual inspections and interim site visits. Two of the licenses are in timely renewal.

It was apparent to the team that the State is ensuring the remedial and reclamation work j at each site will be completed to the satisfaction of the applicable State and Federal  !

agencies before the licensee is released from liability. l 1

The team reviewed the State's method of evaluating decommissioning plans and found that USPU reviews use a wide range of guidance materialin making the evaluations: NRC Title 10; USEPA Title 40; CDPHE Statutes and regulations: NRC documents such as Reg Guides 1.23, 8.11, 8.15, 3.5, 3.11, 4.14, 4.15, 3.11.1, 8.29, 3.51, 3.8, 8.31, 3.30, 8.22,  !

3.65, 3.66, NUREGS 0706 and 0859 with references therein, new draft guides, branch  !

technical positions, and responses to technical assistance requests; numerous internal {

communications, reports and studies, various professional publications, and other l disciplinary guidance.  !

i The review team noted that the team approach used by USPU provides effective peer and j supervisory review for licensing activities. I 4.4.4 Technical Quality of Insoections The team reviewed the inspection reports, enforcement documentation, and inspection field notes, and interviewed the inspectors for seven inspections of uranium mills or decommissioning sites conducted during the review period. All of USPU's inspectors were included in the casework which included licenses for uranium recovery operations  ;

in various stages of operation or decommissioning. Appendix E includes the list of  ;

inspection files with case-specific comments. '

The State's inspection guides are a compilation of guides used by the NRC, the USEPA, the USDOE, with supplements to suit USPU's needs.

The review team found that the reports, which are written in narrative style, are among the most complete reports that team members had seen. In addition to the standard items that are routinely inspected, inspection reports list each license condition with an evaluation of the licensee's performance with respect to that condition. The reports l

Colorado Proposed Final Report Page 24 appropriately document the scope of the inspection, show corrective actions taken in

, response to previous items of non-compliance, and identify and substantiate current items of non-compliance, items of concern and recommendations are also included and are clearly differentiated from items of non-compliance. The reports document the substance of discussions with the licensee, both at entrance and exit meetings. The completed inspection report is sent to the licensee along with a cover letter summarizing the inspection results and corrective actions required from the licensee.

The review team verified that the reports had been reviewed and signed off by the supervisor.

Licensee responses cra reviewed first by the inspector, then by the supervisor and, in cases of serious finding.s, by other unit members. USPU uses a team approach to determine the aporopriate enforcement or escalated enforcement action. The team found

+ hat letters to the hcensees were written in appropriate regulatory language.

During this review period, no follow-up inspections were required; however, a cursory examination of past inspections showed that follow-up inspections had been used effectively in the past. There was evidence that open items are followed in detail and not closed until the problem is satisfactorily resolved.

There are no formal procedures in place to identify root causes of licensees' problems.

However, root cause identification has been included in staff training courses, and the staff exalained that USPU uses the team approach in which they meet and discuss the passible root cause of poor licensee performance when it occurs.

The instrumentation and laboratory facilities are currently provided by the LARS and are discussed in Section 3.4 of this report.

The complexity of uranium mill and decommissioning facilities is such that all annual inspections are team inspections. Although a supervisor is sometimes part of that team, the State could only identify three cases during the four-year review period in which the supervisor had accompanied an inspector and documented his evaluation of the individual's performance. The supervisor stated that the experience level and quality of work of his inspectors were such that his time could be more effectively used in other program functions. The review team recognizes that conducting five inspector accompaniments each year at remote uranium facilities could divert the supervisor's attention from niore pressing responsibilities. The review team recommends that the USPU supervisor consider personally performing one or two inspector accompaniments each year on a rotating basis, and, after appropriate training, delegating the balance of the annual accompaniments to his lead inspectors.

4.4.5 Resoonse to incidents and Alleastions No incidents or allegations occurred during the review period that involved the uranium recovery program.

.~

3 Colorado Proposed Final Report Page 25

, 1 4 Because USPU has been separated from LARS, they plan to generate incident and i allegation procedures specific to the uranium recovery operations. Meanwhile the l Department's incident and allegation procedures apply to the uranium mill program. l Based on the IMPEP evaluation criteria for the above five performance areas, the review team recommends that Colorado's performance with respect to the indicator, Uranium

. Recovery Program, be found satisfactory.

4 5.0

SUMMARY

l As noted in Sections 3 and 4 above, the review team found, with one exception, Colorado's performance with respect to each of the performance indicators to be

! satisfactory. The review team recommends that Colorado's performance determination j for the indicator, Legislation and Regulations, be deferred until the State can send those regulations previously not reviewed by the NRC to the Office of State Programs

for review. Accordingly, the team recommends that, the Management Review Board (MRB) i find the Colorado program to be adequate to protect public health and safety. The recommendation to the MRB on program compatibility will be prpvided upon staff completion of the compatibility review of Colorado regulations.

Below is a summary list of suggestions and recommendations, as mentioned in earlier sections of the report, for consideration by the State.

1. The review team recommends that the State revise the inspection frequency for j HDR remote afterloader licenses to the 1-year frequency specified in IMC 2800.

l (Section 3.1) i

! 2. The review team recommends that the State adhere to the percentage of reciprocity licensees to be inspected each year as specified in Appendix 11 of the NRC IMC 1220. (Section 3.1) i 3. In order to maintain the staffing level necessary to keep abreast of the needs l of the regulatory program, the review team recommends the State fill the

! existing vacancy in the radioactive materials unit. (Section 3.2)

J

4. The review team suggests that the State institute the use of checklists for licensing actions and maintain these forms in the licensing file. (Section 3.3)

5. The review team suggests that the State make the following changes in their licensing procedures:

(a) Devices which no longer are acceptable under Colorado's regulation equivalent to 10 CFR 34.20, " Performance Requirements for Radiography Equipment" should be removed from industrial radiography licenses.

• Note: If resources permit, staff will complete its review prior to the MRB meeting.

. 1 i

.- l Colorado Proposed Final Report Page 26 j i

(b) The State should implement the license conditions that it has developed I addressing the use of HDRs and amend the State's four licenses authorizea for HDR usage accordingly.

(c) Procedures should be developed to ensure that a clear explanation and l description of non-routine usage of materials is included.  !

(d) Procedures should be developed to ensure consistency between well logging license documents requesting the use of the same material, for the same use, and same quantities. (Section 3.3)

6. The review team suggests the State place more emphasis on adhering to their policy of conducting unannounced inspections. (Section 3.4)

7. The review team recommends that the State consider modeling their primary and supplementary inspection and field note forms after those found in IMC 2800, attachment 87100, including reference to the regulation or license condition i for the item under inspection. (Section 3.4)

8. The review team recommends that the State restrict the use the short form, RCD 59, to cases where minor violations are identified during the inspection, and that the State issue a formal enforcement letter for more serious or multiple items of non-compliance. (Section 3.4) i

9. Because inspector accompaniments and the related performance evaluations provide management with valuable insight into the quality of the inspection l program, the review team recommends that the RMU supervisor or senior inspector  !

perform annual accompaniments of each inspector and document the results. I (Section 3.4)

10. The review team recommends the State acquire proper calibration equipment for the shielded area in the new facility in order to better perform calibrations and lower staff exposure to radiation. (Section 3.4)

11. The review team recommends that the State review the March 1995 " Handbook on Nuclear Material Event Reporting in the Agreement States: Draft for Comment,"

and take the steps necessary to report past and future incidents according to the procedures therein. (Section 3.5)

12. The review team recommends that the form RCD 56 be revised to include an anaylsis as to why the event occurred and differentiate between diagnostic and therapeutic misadminstrations. (Section 3.5)

13. The review team recommends the State consider beginning the regulation promulgation process as soon as possible after the rule has been identified as a compatibility item. (Section 4.1.2) l

l Colorado Proposed Final Report Page 27  :

I l 14. The review team recommends the State consider developing a system to track the l progress of each regulation, tracking the due and completed dates of all reviews, comments, and actions taken, from the time it is identified as a l compatibility rule throughout the promulgation process until it becomes l effective. As part of the tracking system, the team suggests that a file be maintained with the cover letters of all regulations sent to the NRC for comment, the NRC response, and an explanation of whether the comments were incorporated into the final regulations. (Section 4.1.2) l 15. The review team recommendr that USPU place greater emphasis in timely dispatch of inspection findings to licensees. (Section 4.4.1)

16. Because of the importance of maintaining sound regulatory oversight of the extensive uranium recovery and decommissioning activities in Colorado, the review team recommends that the State fill the vacancy in the uranium recovery program. (Section 4.4.2)

17. The review team recommends that the USPU supervisor consider personally performing one or two inspector accompaniments each year on a rotating basis, and, after appropriate training, delegating the balance of the annual

• accompaniments to his lead inspectors. (Section 4.4.4) j 4

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. . _ . . . .__._ _.__.._.._... _ _. . _- _ __._ _._.- __ -._ _.--._.~ __ -

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LIST OF APPENDICES AND ATTACHMENTS t l

Appendix A iMPEP Review Team Members ,

Appendix B Colorado Organization Charts Appendix C Colorado's Questionnaire Response Appendix 0 License File Reviews '

l Appendix E Inspection File Reviews Appendix F Incident File Reviews Appendix G SS&D File Reviews Attachment 1 Colorado's Response to Review Findings l

l l

k '.

APPENDIX A i

IMPEP REVIEW TEAM MEMBERS

l j Name Area of Responsibility i

Jack Homor, RIV, WCFO On-Site Team Leader Legislation and Regulations ]

4 Uranium Recovery Program Donald E. Bunn, California Status of Materials Inspection Technical Quality of Inspections j Jacqueline D. Cook, RIV Technical Staffing and Training 2

Response to incidents and Allegations Cardelia H. Maupin, OSP Technical Quality of Licensing Actions Sealed Source and Device Evaluations i

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APPENDIX C i

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i i INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAhi 8

(IMPEP) OUESTIONNAIRE i

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INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM OUESTIONNAIRE Name of State: Colorado Reporting Period: January 1994 to February 1997 A. COMMON PERFORMANCE INDICATORS

l. Status of Materials InsDection Proaram

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 inspections that are overdue.

As of January 21,1997, the following licensees are overdue for an inspection by more than 25% of the scheduled frequency set out in NRC Inspection Manual Chapter 2800 (issued 4/17/95).

INSP DUE MONTHS NAME FREO DATE OVER DUE I

Colorado Associates in Medical Physics 3 01/21/94 37  !

Maxim Technologies, Inc. 3 05/26/96 9 i

2. Do you currently have an action plan for completing overdue inspections? If so, i please describe the plan or provide a written copy with your response to this  ;

questionnaire.

Past due inspections have already been assigned to inspectors.

3. Please identify individual licensees or groups of licensees the State / Region is inspecting less frequently than called for in NRC Inspection Manual Chapter 2800 (isssed 4/17/95) and state the reason for the change.

With the d' vision's recently revised inspection frequency schedule, there are no licenses or groups of licenses that are inspected less frequently than called for in NRC Inspection Manual Chapter 2800 (issued 4/17/95)

_ _ _ _ _ _.____.__~____..=m_ . _ _ m. ._ . _

i

. Colorado Proposed Final Report Page C.2 State Questionnaire

4. How many licensees filed reciprocity notices in the reporting period?  ;

Fifty two (52) separate companies filed for reciprocity during the reporting period.

4

a. Of these, how many were industrial radiography, well-logging or other users with inspection frequencies of three years or less?

i 1994 -

6 1995 -

4 1

, 1996 -

6

b. For those identified in 4a, how many reciprocity inspections were conducted? j 4

i

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

l Six field radiography inspections were conducted during the review period.

1

. 6. For NRC Regions, did you establish numerical goals for the number of inspections to be performed during this review period? If so, please describe your goals, the number of inspections actually performed, and the reasons for any i

differences between the goals and the actuai number of inspections performed.

(NA)

11. Technical Staffina and Trainino i

7. Please provide a staffing plan, or complete a listing using the suggested format l 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 l

the radioactive materials program. Include all vacancies and identify all senior  !

personnel assigned to monitor work of junior personnel. If consultants were used to carry out the program's radioactive materials responsibilities, include their efforts, i 1

J h

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Colorado Proposed Final Report Page C.3 State Questionnaire NAME REV POSITION AREA OF INVOLVEMENT 1 %)

MATERIALS LlO URANIUM ADMIN &INSP EMERGENCY LLW RECOVERY Radioactive Materials - LABORATORY AND RADIATION SERVICES DIVISION DUILLIN X ' Dirdsor 10 JACOBI X EPS8V 70 20 5 HANRAHAN X EPSIV 65 30 i

j BONZER X EPS 111 10 75 10 MATTSON X EPS 111 95 PENTECOST EPSil 85 10 i PHELPS EPS il 95 5 MARTIN EPSI 65 i STROUD EPSI 95 VACANT EPSI 95 t_ARS FTF 1 85 6.9 08 0 0 Uranium and Special Pro ects - HAZARDOUS MATERIALS AND WASTE MANAGEMENT DIVISION ROITMAN X DIRECTOR 1 DECKLER X EPS V 1 SIMPSON X EPSIV 40 55 WEAVER EPSIV 95 BURNHAM EPS il 95 DAUGHERTY EPS Ill 90 STOFFEE EPSIV 95 NEIMEYER EPS11 95 EAKINS TEMPORARY 95 HMWMD FTE 0 42 62 TOTAL FTE 2.07 6.9 0.6 0 6.2

• EPS is the job classification for an Environmental Protection Specialist

Colorado Proposed Final Report Page C.4 State Questionnaire

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

Ed Stroud , RRPT -in the Radioactive Materials Unit

+ Asso ? late degree in Nuclear Engineering

.)

BS in nadiation Protection '

Inspection Procedures 8/96  !

Diagnostic & Therapeutic Nuclear Medicine 9/96 Safety Aspects of Industrial Radiography 6/95 Transportation of Radioactive Materials 12/95 l Radiological Emergency Response Operations 10/95 l

OSHA 40-Hour 8/94 i OSHA Refresher 8/95 Wynn Eakins, Environmental Protection Specialist - Temporary -in Uranium i Unit

Hired J,11y,1996, December 22,1996

BS Geology

. Professional Degree 1990 l  ;

Nancy Daugherty Environmental Protection Specialist -in Danium Unit i

' Hired May,1996 1 MS Radiation Health 1975

Certified HP since 1981 Inspection Procedures September,1996

} Mark Niemeyer, Environmental Protection Specialist-in Uranium Unit i

Hired February,1994 i BS in Environmental Health i

Applied Health Physics 7-8/94 l Ir.spection Procedures 9/94 4

Financial Assurance Workshop 8/95

Licensing Practices and Procedures 6/96 l 9. Please list all professional staff who have not yet met the qualification requirements of license reviewer / materials inspection staff (for NRC, inspection Manual Chapters 1245 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.

Nancy Daugherty, in the Uranium and Special Projects Unit, has not yet received training nor yet had the on-the-job experience to function independently as a license reviewer or inspector.

All other matieral license reviewers and inspections are required to have extensive on the-job training. Additionally, it is the division's policy to provide appropriate formal training. Attachment 1 lists the training for the staff through

4 Colorado Proposed Final Report Page C.5

State Questionnaire 1

December 1966.*. Future, formal training will be provided as available dependent on funding.

1

} 10. Please identify the technical staff who left the RCP/ Regional DNMS program

during this period.-

i

) Greg Brand left in June,1996; Wynn Eakins and Mike Monell left in December

1996; Tom Pentecost transferred from the Uranium and Special Projects Unit to j the Radioactive Materials Unit in 1994.

lil. TechnicalQualityof Licensina Actions l

) 11. Please identify any major, unusual, or complex licenses which were issued, received a major amendment, terminated or renewed in this period.

Colorado Division of Wildlife 348-02 Amendment lotech, Inc. 613-01 Termination

University of Colorado 082-08 Renewal 1 Colorado State University 002-27 Renewal

. The Cotter Corporation Canon City Mill 369-01 Renowal I

Additionally, all of the mill licenses were amended in 1994 to include the

radiation monitoring requirements of Part 4.

} 12. Please identify any new or amended licenses added or removed from the list of j licensees requiring emergency plans?

None

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

l '

{ a. Porter Hospital was granted an exemption relating to release of patients

, with temporary,1125 eye plaques.

The request was reviewed against NRC's policies regarding such a release. The application met NRC's policies of 1) instructions to the patient; 2) a wristband for the patient; and 3) periodic contact with the patient.

i

b. Colorade School of Mines was granted an exemption from the 6 month j leak test iequirement ter a Ra-226 source that was difficult to gain access i to.  !

i

)

T. Sis attachment was reviewed by the IMPEP team during the review and is not included in this document.

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Colorado Proposed Final Report Page C.6 i State Questionnaire '

The source is plumbed into a system to provide radon to a test chamber.

It is surroundod by lead bricks, and can not be accessed without removing l the lead shielding. It was debrmined that an extended leak test was  !

acceptable because 1) the source was shielded; 2) it is never handled or l manipulated while in use; and 3) removing the lead bricks would cause a protracted exposure.

c. Syncor was authorized to distribute F-18 for nuclear medicine studies even though there was not an IND or NDA.

The request was reviewed by the Division's Medical Advisory Committee.

d. Fermenta Animal Health was authorized to possess 62.5 microcuries of H-3 as labeled tamulin in chicken livers without a license.

This was approved because the amount of H-3 was less than an exempt quantity.

e. NORM instruments and Services, Inc. was told they did not rieed a license to distribute potassium chloride as an operational check source for survey )

meters.

Potassium chloride is sold in stores as a salt substitute.

f. A license for Toi!co Environmental was terminated even though they still possessed two sealed radium sources, each containing 0.06 microcuries of Ra-226.

The Regulations exempt any person who possesses less than 0.1 microcuries of Ra-226.

14. What, if any, chang 6: tere made in your written licensing procedures (new procedu es, updates, policy memoranda, etc.) during the reporting period?

a. Routine changes were made to the implicit Price Deflator used for reclamation cost estimates, effective 5/1/95

b. The license application for portable gauges has been changed to a self-certification format. (see Attachment 2)

c. A provisional license was developed for unlicensed facilities that discovered radioactive materials on their property. The license authorizes the storage of materials for six months during which time the licensee can arrange for disposal of the material.

(see Attachment 3)'

'This attachment was reviewed by the IMPEP team during the review and is not included in this document.

l 1

Colorado Proposed Final Report Page C.7 j State Questionnaire i l

15. For NRC Regions, identify by licensee name, license number and type, any l renewal applications that have been pending for one year or more. (NA) 1 IV. Technical OuMtv of Inspections i

16. What, if any, changes were made to your written inspection procedures during I the reporting period?

None ,

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

l Supervisor inspector License Cat. Date j M. Hanrahan Tim Bonzer & .

Tom Pentece v Portable Gauge 02/04/94 l W. Jacobi F. Phelps Therapy 03/02/94 l W. Jacobi T. Bonzer Medical 07/11/94 D. Simpson A. Burnham Mill 11/23/94 D. Simpson Mark Niemeyer, G. Brand Mill 10/19/94 D. Simpson Mark Niemeyer, P. Stoffee Mill 08/21/95 W. Jacobi F. Phelps Radiopharmacy 12/16/96 W. Jacobi E. Stroud Port. Gauge 01/07/97

18. Describe internal procedures for conducting supervisory accompaniments of inspectors in the field. If supervisory accompaniments were documented, please provide copies of the documentation for each accompaniment.

In addition to accompaniments by senior management, inspectors are routinely accompanied by the inspection supervisor. Only those accompaniments by senior management have been specifically documented. (see Attachment 4)'

Before a new inspector conducts independent inspections, he/she is accompanied and evaluated by several different inspectors.

This attachment was reviewed by the IMPEP team during the review and is not includ,ed in this document.

\

Colorado Proposed Final Report Page C.8 State Questionnaire

19. Describe or provide an update on your instrumentation and methods of calibration. Are all instruments properly calibrated at the present time?

Inspectors have access to sufficient numbers of bata-gamma, thin window and neutron survey meters. They also have access to liquid scintillation counting equipment, alpha spectroscopy and gamma spectroscopy. Instrumentation is calibrated in-house to NIST-traceable standards.

Instruments are properly calibrated at the present time. Instrumentation is available to both the Radioactive Materials Program, and to the Uranium and Special Projects Unit.

V. Responses to incidents and Alleaations

20. Please provide a list of the most sianificant incidents (i.e., medical misadministration, over exposures, 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 notification, etc.) that occurred in the Region / State during the review period. For Agreement States, information included in previous submittals to NRC need not be repeated. The list should be in the following format:

4

3 Colorado Proposed Final Report Page C.9 State Questionnaire LICENSEE NAME LICENSE # DATE OF TYPE OF INCIDENT / REPORT INCIDENT 1 Denver Autometrics 546-01 4/4/95 Unauthorized i receipt of  ;

material  !

l Rocky Mountain Phoenix 838-01 03/12/96 Source lost I down hole Amatel Corp. none 3/27/96 Receipt of contaminated Device Portor Hospital 210-01 07/18/96 Release of patient with eye implant.

Rocky Flats ETC None 09/19/96 Release of ,

uranium from smashing drums.

Southwest Mem Hosp 471-01 10/4/96 Receipt of contaminated package

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 notified?

In July 1993, there was a teletherapy overexposure resulting from the operating software being overndden. This was reported to the NRC as soon as the Division was notified.

a. For States, was tirnely notification made to the Office of State Programs?

For Regions, was an appropriate and timely PN generated?

See above.

22. For incidents involving 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 deficiency? Please provide details for each case.

NA

\

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Colorado Proposed Final Report Page C.10 State Questionnaire

23. In the 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.

i None

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

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

None VI. Geer,;;i

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.

March 22-26 and April 5-9,1993

s. Technical Quality of Licensing Actions - Groundwater issues for Uravan be modified to bring them into "better alignment ~ with the regulations.

CategoryI.

Umetco has designated background and point of compliance wells. The time limit for groundwater cleanup is still an issue.

b. Status and Compatibility of Regulations - Requirement for emergency response plans for certain significant licensees.

Has been incorporated.

c. Adopt new 10 CFR 20 and Safety Requirements for Radiographic Equipment. Recommendation.

Has been incorporated.

d. Licensing Procedures - It is not clear how the state is documenting the analysis of the licensee's (Cotter and Uravan) environmental report as requiredin Section 18.4. CategoryII.

All license renewals performed since this time have contained a section entitled environmental assessment, or similar language,

e. Administrative Procedures - Two surety situations exist which have not been fully resolved, Hecla Durita and Sweeney Mining and Milling Company. CategoryII.

L- .

i l

• l Colorado Proposed Final Report Page C.11 State Questionnaire Sweeney is still a problem. j i

26. Provide a brief description of your program's strengths and weaknesses. These strengths and weaknesses should be supported by examples of successes, problems or difficulties which occurred during this review period.

STRENGTHS 1

a. Improve efficiencies through flexible and innovative actions. Examples I include certification-based applications for portable gauges, and provisionallicenses.

l

b. Most staff has extensive experience. Within the two units responsible for i radioactive materials, there are three certified health physicists.

WEAKNESSES

a. Staffing - there is currently one vacant position, and another position will soon be eliminated.

b. Training - NRC's elimination of funding for training, makes it difficult to provide formal training to staff.

c. General Licensees - Few manufacturers provide routine reports. It is suspected that materials are being shipped to Colorado without being reported to the program.

d. Am-241 sources that can not be disposed - There are several licensees that have Am-241 sources, want to dispose of the sources, but are not able to - either because the licensee lacks necessary resources, or because the sources are not acceptable at commercial LLRW disposal sites. These licensees may declare bankruptcy, and/or die without properly disposing of this material.

B. NON-COMMON PERFORMANCE INDICATORS

1. Reaulations and Lecal Authority

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

CRS 25-11-010 et. seq - Radiation Control Act CRS 24-60-2201 et. seq. - Low-Level Radioactive Waste Act CRS 13-25-126.5,13-90107 and 25-1-114.5 - Concerning Environmental Self-Evaluation

. .. . ... . - -- .. . = - . . . _ - -

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Colorado Proposed Final Report Page C.12 State Questionnaire

28. Are your regulations subject to a " Sunset" or equivalent law? If so, explain and include the next expiration date for your regulations.

All new and revised regulations are subject to a review by the legislature, usually within the year of their promulgation. However, regulations will not be terminated without adequate notice.

1

29. Please complete the enclosed table based on NRC chronology of amendments.

Identify those that have not been adopted by the State, explain why they were not l

adopted, and discuss any actions being taken to adopt them. i

, See table at end of this questionnaire.

30. If you have not adopted all amendments within three years from the date of NRC I rule promulgation, briefly describe your State's procedures for amending regulations in order to maintain compatibility with the NRC, showing the normal 4

length of time anticipated to complete each step.

) Our policy is to adopt all regulations required for compatibility within 3 years of i l NRC 4 j  !

II. Sealed Source and Device Proaram

31. Prepare a table listing new and revised SS&D registrations of sealed sources and devices issued during the review period.

The following device sheets were moved to " inactive status".

(a) Kaman Sciences Corporation 1500 Garden of the Gods Road Colorado Springs, CO 80933 CO-0411-D-801 S Zetatron CO-0411-D-802-S A-3062 CO-0411-D-803-S A-320 CO-0411-D-804-S E 2010 or E-2011 '

CO-0411-D-805-S A-3041, A-3041H, A-3043, A-3045, A3046 CO-0411-D-806-S Series A-1000 CO-0411-D-807-S A-900 CO-0411 D-808-S A-700, A 702, A-710, A-711 CO-0411-D-809 S A-800, A-801, A-808, A-850 CO-0411-D-810-S A-3051 CO-0411 D-811-S E-3010 and E-3020 CO-0411-D-812-S W-90 CO-0411-D-813-S A 520 A letter was obtained from the Kaman Sciences Corporation which included the numbers of devices which they had manufactured and which were stillin use, or had not been

)

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Colorado Proposed Final Report Page C.13 State Questionnaire returned to their Company for disposal. This information was included in the respective device sheets.

(b) Because the following companies had gone out of business and no additional '

information could be obtained regarding changes in the programs or the numbers of devices which had been distributed, a single paragraph was added to each of the following SS&D Sheets:

"The is no longer in business in Colorado, and is no longer licensed by the State of Colorado to possess or distribute radioactive materials. This product w!!I no (

longer be commercially distributed. , j k

No information could be obtained regarding the number of these distributed.  !

The Company is not providing assistance in the repair or disposal of these devices. {

Based upon the review of the , and the information provided with the l original device evaluation, we continue to conclude that these devices are acceptable for I licensing purposes. Furthermore we continue to conclude that the would be expected to maintain their containment integrity for normal conditions of use specified ,

in this certificate." I B.K. Sweeney Manufacturing Co, Denver, CO.

CO-0624-D-801-G SWE-1118 CO-0624-D-802-G SWE-1123 CO-0624-D-803-G SWE-1127 CO-0624-D-804-G SWE-1128 CO-0624 D-805-G SWE 1149 CO-0624-D-806-G SWE-1188 and SWE-1189 CO-0624-D-807-G SWE-1193 and SWE-1195 CO-0624-D-808-G SWE-1196 CO-0624-D-809-G SWE-1133 CO-0624-D-810-G SWE-1134 CO-0624-D-811-G SWE-1145, SWE-1146 and SWE-1147 Fire Alert Company Division of 'Nalter Kidde Wheatridge, CO 80033 CO-0289-D-801-U FT-100, FT-200 Statitrol Corporation 1030 West Ellsworth Avenue Denver, CO CO-0618-D-801-G CO-0618-D-802-G CO-0618-D-803-U CO-0618-D-804-E Valitron, Inc. (also spelled Val-Tron, Inc.)

Morrison, CO 80465

, . i Colorado Proposed Final Report Page C.14 State Questionnaire CO-0660-D-801-U ,

Vicon Instrument Company Colorado Springs, CO CO-0664-D-801-U Bondar-Clegg & Co.

Instrument Division 6 Bexley Place Nepean, Ontario, Canada k2H 8W2 CO-0189-D-801-S CE801 A The following companies' device sheets were amended as Indicated:

Radiation Monitoring Devices, Inc.

44 Hunt Street Watertown, MA 02172 CO-0573-D-102-S The device sheet was modified to remove the words "or equivalent", and specify the sources which were authorized in the device. No new sources were approved.

MF Physics 5074 List Drive I Colorado Springs, CO 80919 CO-1012-D-101-S

This new device sheet was issued for a series of neutron generators which the Company wishes to manufacture and distribute. These are the same devices which were previously manufactured by the Kaman Sciences Company.

CO-1012-D-101-S The device sheet was amended to include a new model generator to an existing series. .

MSA Baseline North Star Route, Box 649 Lyons, CO 80540 CO-376-D-101-G These two, new device sheets were issued CO 376-S-102-S on February 15,1994.

Wedding and Associates,Inc.

209 Christman Drive #2 Fort Collins, CO 80524 CO-663-S-102-S This device sheet was amended on July 20,1994 to add a new source manufacturer. On January 31,1997, the Wedding and Associates, Inc. devices were moved to inactive status.

4

Colorado Proposed Final Report Page C.15 State Questionnaire

32. What guides, standards and procedures are used to evaluate registry applications?

The current information used is included or referenced in the SEALED SOURCE AND DEVICE WORKSHOP, September 12-15,1995, Course Notebook. All pertinent ANSI Standards and Regulatory Guides are available and used. The checklist from the CASEWORK portion of the workshop is used to assure all relevant materials have been submitted and are reviewed. Formats for Device Sheets are copied from those presented in the workshop.

l

33. Please include information on the following questions in Section A, as they apply to the Sealed Source and Device Program .

Technical Staffing and Training - A.II.7-10 l l

See Above - Additionally, Charles Mattson has attended to SS&D workshop.

Linda Martin is scheduled to take the next workshop.

Technical Quality of Licensing Actions - A.lli.11, A.Ill.13-14 1

Major, complex or unusual - None Variances - None Changes in procedures - None Responses to incidents and Allegations - A.V.20-23 None Ill. Low-Level Waste Proaram '

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

~

Status of Materials inspection Program - A.I.1-3, A.I.6 Technical Staffing and Training A.ll.7-10 Technical Quality of Licensing Actions - A.lli.11, A.Ill.13-14 Technical Quality of Inspections - A.IV.16-19 Responses to incidents and Allegations - A.V.20-23 NA IV. Uranium Mill Proaram

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

Colorado Proposed Final Report Page C.16 State Questionnaire Status of Materials inspection Program - A.I.1-3, A.I.6  !

1-3. See response to questions 1-3. None of the pest due inspections relate to the Uranium Mill Program.

6. NA Technical Staffing and Training - A.ll.7-10

7. See response to question 7. All Uranium Mill Program activities are currently performed in the Hazardous Materials and Waste Management Division (HMWMD).

i

8. See response to question 8. All except Ed Stroud are associated with the -

Uranium Mill Program.

9. See response to question 9. Nancy Daugherty is. in the Uranium Mill Program. Also note Attachment 2 in which training has been grouped by I Division. The Uranium Mill Program is currently in the HMWMD.

10. Greg Brand left in June,1996; Wynn Eakins left in December 1996; Tom Pentecost transferred from the Uranium and Special Projects Unit to the l Radioactive Materials Unit in 1994.

Technical Quality of Licensing Actions - A.lli.11, A.lli.13 '.4

11. The Cotter Corporation Canon City Mill 369-01 Renewal

13. None

14. See Question 14 response a.

Technical Quality of inspections - A.IV.1619

16. None -

17. See response to Question 17. Accompaniments by Mr. Simpson relate to the Uranium Mill Program.

18. See response to Question 18.

19. See response to Question 19.

Responses to incidents and Allegations - A.V.20 23

20. None for the Uranium Mill Program.

i .

Colorado Proposed Final Report Page C.17 State Questionnaire

21. NA

22. NA

23. None, i

". c Regulatory Amendments (Question 29)

OR DATE DATE DUE ADOPTED CURRENT EXPECTED 10 CFR RULE STATUS ADOPTION Any amendment due prior to 1991.

Identify each regulation (refer to the Chronology of Amendments) i Decommissioning: 7/27/91 12/30/90 Parts 30, 40, 70 Emergency Planning: 4/7/93 1/1/94 Parts 30,40,70 Standards for Protection Against Radiation; 1/1/94 1/1/94 Part 20 Safety Requirements for Radiographic 1/10/94 6/30/94 Equipment: Part 34 Notification of incidents: 10/15/94 11/30/94 Pans 20, 30, 31, 34, 39, 40, 70 Quality Management Program and 1/27/95

• On hold pending Misadministrations; Part 35 completion of NRC medical program Licensing and Radiation Safety 7/1/96 Effective Was adopted Requirements for Irradiators; Part 36 7/1/97 November 1996.

The effective date will be 7/1/97 Definition of Land Disposal 7/22/96 1/1/97 and Waste Site QA Program: Part 61 Decoinmissioning Recordkeeping: Docu- 10/25/96 Effective Adopted 2/19/97.

mentation Additions; Parts 30,40,70 7/1/97 The effective date will be 7/1/97 t Self Guarantee as an Additional Financial 1/28/97 Effective Adopted 2/19/97.

Mechanism; Parts 30,40,70 7/1/97 The effective date will be 7/1/97t Uranium Mill Tailings: Conforming to EPA 7/1/97 7/1/95 i Standards: Part 40 s Timeliness in Decomtrdssioning 8/15/97 7/1/95 Parts 30,40,70 Preparation, Transfer for Commercial Dis- 1/1/98 Not started tribution, and Use of Byproduct Material for Medical Use: Parts 30,32,35 Frequency of Medical Examinations for Use 3/13/98 Tentative briefing for of Respiratory Prota tion Equipment Board of Health 1/15/97 l

. +

4 OR DATE DATE 10 CFR RULE DUE ADOPTED CURRENT EXPECTED j STATUS ADOPTION Low-Level Waste Shipment Manifest 3/1/98 1/1/97 j information and Reporting Performance Requirements for Radiography 6/30/98 Not Started Equipment Radiation Protection Requirements: 8/14/98 Not Started Amended Definitions and Criteria Clarification of Decommissioning Funding 11/24/98 Out for comment Requirements 10 CFR Part 71: Compatibility with the 4/1/99 '1/1/97 International Atomic Energy Agency Medical Administration of Radiation and 10/20/98 Not Started Radioactive Materials.

Termination or Transfer of Licensed 5/16/99 Not Started Activities: Recordkeeping Requirements.

The adoption of this requirement is on hold pending final action of the NRC to the IOM report.

t Hearing on Rules scheduled for April 15,1997. By policy rules become effective the following January 1 or July 1. These rules were to be considered for adoption in November 1996. However, a few days before the hearing the NRC called and said they had issues, and it was not until af ter the hearing was postponed that we received the NRC comments.

1

~.. l APPENDIX D 1

LICENSE FILE REVIEWS l

I File No: 1 i Licensee: Lockheed Martin Astronautics License No. Colo 12-12 Location: Denver, CO Amendment No. 51 Ucense Type: Research & Development Type of Action: Renewal Jate Amendmentissued: 7/26/96 Licente Reviewers: LM

Comments

4 a) Sealed source indicated on sheet (ICN-MODEL CD-1) not found in SS&D registry.

b) Sealed source (Fe-55, Isotope Products Model GFS3) maximum quantity exceeds maximum amount in SS&D registry.

Filc No

2 i

! Licensee: MOS Inspection, Inc. License No. Colo-388-01  !

2 Location: Denver, CO (Elk Grove Village, IL) Amendment No.12

License Type: Radiography Type of Action: Renewal Date Amendment issued: 9/16/96 License Reviewers: CM Comment:

a) License authorizes the use of devices that are no longer acceptable under the State's )

equivalent of 10 CFR 34.20, " Performance Requirements for Radiography Equipment." '

File No: 3 Licensee: SchlumbergerTechnologyCorp. License No. Colo-39-01 Location: Fort Morgan, CO (Houston,TX) Amendment No. 31 License Type: Welllogging Type of Action: Renewal Date Amendment issued: 9/26/96 License Reviewers: LM Comment:

a) Neither diagrams nor sheets on custom sources available in licensing file. 4 b) Information on prototype well logging tool not available in licensing file.

File No: 4 Licensee: Mallinckrodt Nuclear Medicine License No. Colo-859-01 Location: Denver, CO (St. Louis, MO) Amendment No. 3 License Type: Radiopharmacy Type of Action: Amendment Date Amendment issued: 6/26/96 License Reviewers: CM

Colorado Proposed Final Report Page D.2 License File Reviews File No: 5 Licensee: Amgen Boulder License No. Colo-475-02 Location: Boulder, CO Amendment No. 2 License Type: Biomedical Research Type of Action: Amendment Date Amendment issued: 8/22/96 License Reviewers: MM File No: 6 Licensee: Troxler Electronic Laboratories,Inc License No. Colo-114-01 Location: Lakewood, CO (Research Triangle Park, NC) Amendment No. 23 License Type: Portable Gauge Type of Action: Amendment Date Amendment issued: 9/23/96 License Reviewers: LM File No: 7 Licensee: Public Service Company License No. Colo-32-03 Location: Henderson, CO Amendment No. 8 License Type: Radiography Type of Action: Amendment Date Amendmentissued: 8/22/96 License Reviewers: LM File No: 8 Licensee: University of Colorado License No. Colo-163-10 Location: Denver, CO Amendment No.13 License Type: Irradiator-self contained Type of Action: Renewal Date Amendment issued: 8/5/96 License Reviewers: CM File No: 9 Licensee: United Technologies License No. Colo-468-01 Location: Colorado Springs, CO Amendment No.11 License Type: Irradiator, Research & Development Type of Action: Renewal Date Amendment issued: 9/23/96 License Reviewers: TP Comments:

a) The file did not contain the qualifications for the radiation safety officer named in the license.

b) There was no explanation or description of the procedures for the irradiated integrated circuits contained in the file.

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e

• Colorado Proposed Final Re,nort Page D.3 License File Reviews File No: 10 Licensee: PorterCare Hospital License No. Colo 210-01 Location: Denver, CO Amendment No. 71 License Type: Medical Broad Scope Type of Action: Amendment Date Amendment issued: 8/26/96 License Reviewers: CM File No: 11 Licensee: Thermo Environmental Instruments, Inc. License No. Colo-659-01 Location: Fort Collins, CO Amendment No. 7 License Type: Manufacturing & Distribution Type of Action: Termination Date Amendment issued: 9/23/96 License Reviewers: CM Comment:

a) Licensing action supported by material in 41 censing files. The files contained documentation of inactivation of sheets issued by licensee; new license issued by NRC since licensee moved to Massachusetts; and contained closeout survey record.

File No: 12 Licensee: Public Service Company License No. Colo-032-01 Location: Denver, CO Amendment No.

License Type: Gauge and Gas Chromatograph Type of A,ction: Renewal Date Amendment Issued: 1/28/97 Licensa Reviewers: TP File No: 13 Licensee: Spencer Scientific Lab. License No. Colo-275-02 Location: Loveland, CO Amendment No.10 License Type: Gas Chromatography Type of Action: Amendment Date Amendment Issued: 4/5/96 License Reviewers: TP File No: 14 Licensee: University of Denver License No. Colo-108-05 Location: Denver, CO Amendment No. 22 License Type: Academic Type of Action: Amendment Date Amendment issued: 10/11/96 License Reviewers: TP l

i

Colorado Proposed Final Report Page D.4 License File Reviews File No: 15 Licensee: Analytical Environmental Labs. License No. Colo-919-01 Location: Broomfield, CO Amendment No.1 License Type: Invitro Type of Action: Termination Date Amendmentissued: 7/29/96 License Reviewers: CM Comment:

a) Licensee indicated that no material received and licensee requested termination.

File No: 16 Licensee: Landmark Labs. Ltd. License No. Colo-158-03 Location: Loveland, CO Amendment No. 6 License Type: Gauge Type of Action: Renewal Date Amendment issued: 2/25/97 License Reviewers: TP File No: 17 Licensee: Avista Hospital License No. Colo-793-01 Location: Louisville, CO Amendmer,t No. 2 License Type: Medical Type of Action: Renewal Date Amendment issued: 1/10/96 License Reviewers: MM Comment:

a) Subsequent amendment following renewal was issued; however, documentation of request for amendment not contained in the files. State personnel was able to locate request in archived files.

File No: 18 Licensee: Ecova Corporation License No. Colo-895-01 Location: Golden, CO Amendment No. 3 License Type: Invitro Lab. Type of Action: Termination Date Amendment issued: 9/23/96 License Reviewers: TP File No: 19 Licensee: Morrison Knudsen Corporation License No. Colo-717-01 l Location: Grand Junction, CO (Boise, Idaho) Amendment No. 6 License Type: Gauge Type of Action: Termination l Date Amendment issued: 9/23/96 License Reviewers: TP l

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Colorado Proposed Final Report Page D.5 License File Reviews File No: 20 Licensee: Columbia HealthOne LLC License No. Colo-632-01 i Location: Denver, CO Amendment No.13 l License Type: Medical Broad Scope (HDR& Pacemaker) Type of Action: Renewal {

Date Amendment issued: 7/1/96 License Reviewers: TP j Comment; a) Licensing document should contain specific licensing conditions for HDR therapy.

File No: 21 Licensee: Mercy Wireline, Inc. License No. Colo-921-01  !

Location: Weston, CO (Hays, KS) l License Type: Welllogging Type of Action: New Date Amendmentissued:7/26/96 License Reviewers: MM

- Comments:

a) License authorizes 1131 in any form, but no bioassay tie down condition was used.

Although reviewer indicates this is in State's regulation, another well logging license for  !

similar material and same use contained tie down condition.

b) Licensing document should contain specific licensing conditions for downhole abandonment of sources.

c) License document inconsistent with other well logging licence (File #1) examined.

1

APPENDIX E INSPECTION FILE REVIEWS 4

File No.: 1

. Licensee: Columbia Presbyterian / St Luke's Med. Center License No. 632-06 l

Location

Denver inspection Type: Routine, Announced  ;

License Type: Institutional Medical with HDR Priority: 3 I Inspection Date: 5/25/94 Inspector: FP l I  ;

. Comment:  ;

a) HDR last inspected 5/94; priority not consistent with IMC 2800 )

File No.: 2 I Licensee: Landmark Laboratories LTD License No.158-01 Location: Loveland Inspection Type: Routine, Announced License Type: Portable Gauge Priority: 5 Inspection Date: 3/4/96 Inspector: ES Comment:

a) Reason for announcing inspection not apparent.

File No: 3 Licensee: Boart Longyear Co. License No: 589-02 Location: Denver .

Inspection Type: Follow-up; Announced License Type: Portable Gauge Priority: 5 Inspection Date: 8/9/96 Inspector: TB Comments:

a) The licensee replied to the items of noncompliance (INC) on 9/5/96 and produced records of two gauge transfers however, one record was still missing.

b) Reason for announcing inspection not apparent.

File No: 4 Licensee: COBE Cardiovascular Inc. License No: 494-01 Location: Lakewood Inspection Type: Routine, Announced License Type: Irradiator Priority: 1 Inspection Date: 6/14/96 Inspector: FP Comment: I a) This license requires an annual inspection but the State has not inspected at that frequency. An inspection was done on 8/28/92, another on 4/27/94, and again on 6/14/96. Eight months late the first period and ten months late the second period.

File No: 5 Licensee: Midwest inspection Service License No: 902-01 l

I k

Colorado Proposed Final Report Page E.2

. Inspection File Reviews Location

Brighton (Perryton TX) Inspection Type: Field Radiography, Unannounced License Type: Radiography Priority: 1 ,

i inspection Date: 11/13/96 Inspector: FP i  !

^

File No 6 Licensee: Colorado Department of Agriculture License No: 268-01 Location: Denver inspection Type: Routine, Announced l Licensee Type: Laboratory - Gas Chromatograph Priority: 7  ;

inspection Date: 2/20/97 Inspector: TP l Comment:

i a) Inspection announced to accommodate IMPEP team accompaniment.

File No: 7 License: Nexstar Pharmaceuticals, Inc. License No: 841-01 j Location: Boulder inspection Type: Routine, Announced i l License Type: Bio research Priority: 3 i inspection Date: 2/19/97 Inspector: ES Comments:

a) Inspection announced to accommodate IMPEP team accompaniment. a b) Inspection on 3/10/94 resulted in 8 INCs and 17 items of concern. Enforcement letter was not sent till 10/3/94, seven months after the inspection. All items were cleared on 12/6/94. No INCs were found during 4/11/95 follow-up.

File No: 8 l License: Intemational Mountain Testing Co. License No: 060-01 l Location: Englewood Inspection Type: Routine, Unannounced

! License Type: Radiography Priority: 1 l Inspection Date: 9/20/96 Inspectors: TB,ES File No: 9 License: Protechnics Intemational Inc. License No: 545-01 Location: Denver Inspection Type: Routine, announced License Type: Well Logging Priority: 3 Inspection Date: May 3,1996 Inspector: FP l

Comment-a) Reason for announcing inspection not apparent.

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Colorado Proposed Final Report Page E.3 Inspection File Reviews ,

)

File No: 10  !

4 License: University of Colorado, Health Science Center License No: 835-01 )

I Location: Denver inspection Type: Follow-up Unannounced

. License Type: Broadscope Academic Priority 2

! Inspection Dates: 1/25,26,30/97 Inspectors: TB, ES l

File No: 11 License: Coors Brewing Co. License No: 273-01 Location: Golden inspection Type: Routine, Announced

, License Type: Fixed Gauges Priority: 4 l j inspection Date: 9/27/95 Inspector: FP i

3- Comment:

l a) Reason for announcing inspection not apparent.

i File No: 12 License: Rocky Mountain Gamma Knife License No: 857-01

Location

St. Thomas Moore Hospital, Denver Inspection Type: Routine, Announced j License Type: Teletherapy - Gamma Knife Priority: 1 inspection Date: 5/23/96 inspector: FP File No: 13 License: Saint Joseph Hospital License No: 038-02 Location: Denver inspection Type: Routine, Announced License Type: General Medical Priority: 3 inspection Date: 3/18/94 hspector: FP File Nc: 14 License: Syncor international Corp License No: 392-01 Locaticn: Denver Location inspection Type: Routine, Announced License Type: Nuclear Pharmacy Priority: 2 Inspection Date: 1/17/97 inspector: FP Comment:

a) Reason for ennouncing inspection not apparent.

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. 1 Colorad.o Proposed Final Report Page E.4 inspection File Reviews l

l File No: 15 i License: MSA Baseline Industries License No: 884-01 Location: Lyons inspection Type: Initial; Announced l License Type: Manufacture / Distribution Priority: 3 l Inspection Date: 10/20/95 Inspector: FP Comment:

a) Inspection overdue; license was issued 11/93; radioactive material first received 6/94.

I File No: 16 License: Golden Pharmaceuticals, Inc. License No: 162-04 l Location: Golden Inspection Type: Follow-up, Announced l License Type: Pharmaceuticals / Manufacture Priority: 2 inspection Date: 3/21/96 Inspector: FP l Comment: ,

a) Reason for announcing inspection not apparent. l File No: 17 License: Troxler Electronics Labs License No: 114-01 i Location: Lakeland inspection Type: Routine, Announced I License Type: Gauge Distribution; Specific license Priority: 4 ;

inspection Date: 8/1/94 Inspector: RS l Comment:

a) Reason for anr.cancing inspection not apparent. l File No: 18 License: Colorado State University License No: 00219 Location: Fort Collins inspection Types: Incident Investigation; Routine and Follow-up License Type: Academic Broad Scope Priority: 2 Inspection Dates: 4/26/96; 6/20-21/96; 1/24/97 -

Inspectors: TB, FP i

Comments:

a) 4/26/96 inspection during incident response resulted in 3 INCs.

b) 6/20-21/96 inspection resulted in multiple INCs and recommendations.

c) 1/24/97 follow-up inspection showed there were still compliance problems.

d) Another follow up inspection is planned during the week of March 17th.

e) License has history of noncompliance apparently due to an ineffective radiation control program and lack of oversight by the radiation safety committee. Local newspaper on 3/12/97 said the licensee has a major problem with radiation use.

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

Colorado Proposed Final Report Page E.5 Inspection File Reviews File No: 19 License: Colorado College License No: 776-01 Location: Colorado Springs inspection Type: Routine, Announced License Type: Academic non Broad Priority: 4 Inspection Date: 1/22/96 Inspector: FP File No: 20 License: National Jewish Center for Immunology License No: 222-03 Location: Denver J Inspection Type: Routine, Announced l License Type: Research/ Immunology Priority: 1 Inspection Date: 3/27/96 Inspector: TB Comment:

a) Reason for announcing inspection not apparent.

File No: 21 License: Umetco Minerals Corporation - Uravan Site License No: RML 660-02 Location: Uravan Inspection Type: Team, Annual Routine License Type: Uranium Mill- Decommissioning Priority: 1 Inspection Date: Office: 10/2,3/96; Field: 10/1/96 and 11/4-6/96 Inspectors: MN, ND, KW Comment:

a) Report of inspection findings sent 3/11/97; did not meet 30 day turn-around time.

File No: 22 License: Umetco Minerals Corporation - Uravan Site License No: RML 660-02 Location: Uravan Inspection Type: Team, Annual Routine License Type: Uranium Mill - Decommissioning Priority: 1 Inspection Date: 8/2123/95 Inspectors: MN, DS, PS Comment:

a) Report of inspection findings 60 days overdue.

File No: 23 License: Cotter Corporation (Ca6on City Mill) License No: RML 369-01 Location: Ca6on City inspection Type: Team, Annual Routine License Type: Uranium Mill - Operating Priority: 1 Inspection Date: 9/23,24/96 Inspectors: AB, MN Comments:

a) Report of inspection findings very late; sent 2/27/97.

b) Missed 1995 annual inspection report.

Colorado Proposed Final Report Page E.6 Inspection File Reviews File No: 24 License: Umeteo Minerals Corporation - Maybell Heap Leach Site License No: RML 660-01 Location: Maybell Inspection Type: Team, Annual Routine License Type: Uranium Mill Decommissioning Priority: 1 Inspection Date: 10/28,29/96 inspectors: WE, KW File No: 25 License: Hecla Mining Co. (Hecla-D'u rita Mill) License No: RML 317-02 Location: Naturita inspection Type: Team, Annual Routine License Type: Uranium Mill - Decommissioning Priority: 1 Inspection Date: 8/20-21/96 Inspectors: AB, WE Comment:

a) Report of inspection findings took 90 days to dispatch.

File No: 26 '

License: Cotter Corporation (Whitewater Ore Facility) License No: RML 369-02 Location: Whitewater Inspection Type: Team, Annual Routine License Type: Uranium Ore Transfer Station (in decommissioning) Priority: 1 Inspection Date: 8/24/95 Inspectors: MN, PS Comment:

a) Report of inspection findings took 90 days to dispatch to licensee.

File No: 27 License: Cotter Corporation (Schwartzwalter Facility) License No: RML 369-03 Location: Jefferson County inspection Type: Team, Annual Routine License Type: Uranium Ore Sorter Priority: 1 Inspection Date: 11/28/95 Inspectors: MN, KW Comment:

a) Report of inspection findings took 5 months to dispatch to licensee.

Also, the following inspection accompaniments were made as part of the on-site IMPEP review:

File No 1 Licensee: Colorado Department of Agriculture License No: 268-01 Location: Denver Inspection Type: Routine, announced Licensee Type: Gas Chromatograph Priority: 7 Inspection Date: 2/20/97 Inspector: TP Comment:

a) Inspector is primarily assigned licensing duties; was relatively new as inspcetor.

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Colorado Proposed Final Report Page E.7 Inspection File Reviews File No: 2 License: Nexstar Pharmaceuticals, Inc. License No: 841-01 Location: Boulder Inspection Type: Routine, announced License Type: Bio research Priority: 3 Inspection Date: 2/19/97 Inspector: ES Comment:

a) Very good inspection by experienced inspector l

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• APPENDIX F

, INCIDENT FILE REVIEWS File No.1 Licensee: Basin Resources Location: Weston License #: General License 763-01

Date of Event: Between October 1994 and April 1995; reported to State 8/7/95

Type of Event

Loss of RAM Summary of incident: Licensee notified CDPHE of the loss of a 100 mci Kay Ray density gauge. State inspector found gauge in storage crate at facility during 8/10/95 onsite inspection.

4 Comments: l a) NMED 951041. l b) PN states 100 mci Cs 137; whereas letter from licensee indicates 100 pCi Cs 137.  ;

sealed source. RMU verified 100 mci Cs-137 source.

File No. 2 ,

j Licensee: Rocky Mountain Phoenix Surveys, Inc.

Location: Brighton

)

License #

838-01 Date of Event: March 12,1996 Type of Event: L.oss of RAM Summary of incident: Lost well logging source down oil well.

Comment:

a) Met NMED reporting criteria; not sent.

i 1 File No. 3 Licensee: Colorado State University Location: Fort Collins, CO License #: 002-19 Date of Event: April 19,1996 Type of Event: Contami,1ation Event i Summary of Incident: Werker removed a 1.0 mci vial of Pb-210 from a waste drum that was )

i returned frorn RAMP Industric:,. The worker held the vial in his bare hands and contaminated l himself, his clothing and the room.

. Comments: .

i 4 a) The licensee reported it within 5 days and the State responded in one day, b) Licensee cited for 3 violations.

c) Very good report by the licensee, includes bioassay result and training manual.

d) Exposure to hands (< 50 Rem) did not require NMED report.

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! Colorado Proposed Final Report Page F.2 incident File Reviews

'. File No. 4

Licensee: St. Joseph's Hospital

Location: Denver  :

! License #: 038-02 Date of Event: unknown; reported to State 4/17/96 l

_ Type of Event

Loss of Control 4

Summary of incident: The licensee noted higher than normal radiation levels outside of a utility

, room in the basement of the hospital. The State responded and dose rates of 5 mrem were j' noted. They found two sources below the floor in a 4 X 4' case. An assay determined that the. ,

l sources were Ra-226 needles apparently lost for many years.

s i Comments: _

i-a) Report by US Ecology describes all decontamination work done. .

b) Dose Assessment Report by US Ecology shows employees and Gl tors received minimal  ;

exposures.

c)_ Sources buried on 9/23/96.

d)- Hospital 8/13/96 said all closed out - their response not in file. (Head of inspection stated that they will close out emergency order.) '

File No. 5 Licensee: Not licensee Location: Cryenco,Inc. facilities License #: N/A )

Date of Event: 1/6/97

_ Type of Event: Other Summary of Incident: Radiography camera found at facility that did radiography many years ago.

File No. 6 . .,

Licensee: Pace incorporated j Location: Golden '

License #: 817-01 Date of Event: 6/2/95 Type of Event: Possible Leaking Source Summary of incident: During routine leak test of Hewlett-Packard electron capture detector, i results indicated the presence of .0077 pCl. removable contamination.

i Comments:

a)- Not reported to NMED with 30 days, b) Incident closed 8/3/95 when reported to Region IV RSAO on 8/3/95. Was never entered in NMED log.

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Colorado Proposed Final Report Page F.3 ,

Incident File Reviews File No. 7 -

Licensee: Lutheran Medical Center Location: Wheat Ridge i

License #: 227-01

l. Date of Event: February 17,1995 Type of Event: Misadministration -

Summary of incident: Dosage given differing from prescribed dosage by more than 50%.

! File No. 8

! Licensee: Aspen Valley Hospital i Location: Aspen i License #: 861-01

Date of Event

February 22,1996 Type of Event: Misadministration Summary of incident: Wrong chemical form given to patient.

1 File No. 9 Licensee: Columbia Health One LLC. Aurora Presbyterian l Location: Aurora

License #

632-02 Date of Event: September 19,1996

-Type of Event: Misadministration Summary of incident: Wrong radiopharmaceutical given to patient j ' File No.10

. Licensee: Columbia Aurora Presbyterian Hosp;tal l Location: Aurora

License #: 632-02 ,

!~

Date of Event: January 7,1997 l Type of Event: Misadministration Summary of incident: Incorrect isotope administered.

j File No.11 Licensee: Coors Brewing Company 1- Location: Golden i License #: 476-01 Date of Event: March 8,1995 Type of Event: Overexposure

Summary of incident: Overexposure of 14.5 Rem to one radiographer.

Comment:

a) NMED 950292.

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I Colorado Proposed Final Report Page F.4  !

-Incident File Reviews l

File No: 12 License: International Mountain Testing Co.

License #: 060-01 ,

t.ocation: Englewood l

Date of Event: 6/27/95 Type of Event: Overexposure Summary of incident: Licensee reported an incident when member of the public walked through their barricade during field radiography and was exposed. The incident report was reviewed and found complete. Exposure to the individual was minimal.

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l APPENDIX G l

SEALED SOURCE AND DEVICE EVALUATION REVIEWS File No.: 1 Registry No.: Co-663-S-102-S SS&D Type: Beta Gauge Manufacturer: Wedding and Associates, Inc. Date issued: 7/24/94 Type of Action: Amendment License Reviewer: CM Peer Audit: ES File No.: 2 Registry No.: Co-663-S-102-S SS&D Type: Beta Gauge Manufacturer: Wedding and Associates, Inc. Date issued: 1/31/97 Type of Action: Inactivation License Reviewer: CM Peer Audit: ES Comments:

a) On January 31,1997, the device sheets were assigned new numbers and moved to the inactive status (Co-8079-S-802-S) because company was purchased by Thermo Environmental and the purchaser decided to terminate its Colorado license.

b) File contained letter to NRC dated 2/11/97 transmitting the inactivated sheets, and sheets were located in the SS&D national registry.

File No.: 3 Registry No.: Co-376-S-102-S SS&D Type: Gas Chromatograph Source Manufacturer: MSA Baseline Date issued: 2/15/94 Type of Action: New License Reviewer: CM Peer Audit: ES File No.: 4 Registry No.: Co-376 D-101-D SS&D Type: Gas Chromatograph Device Manufacturer: MSA Baseline Date issued: 2/15/94 Type of Action: New License Reviewer: CM Peer Audit: ES File No.: 5 Registry No.: Co-1012-D-101 S SS&D Type: Neutron Generator Tubes Manufacturer: MF Physics Corporation Date issued: 4/30/96 Type of Action: New License Reviewer: CM

, Peer Audit: ES 1

Colorado Proposed Final Report Page G.2 Sealed Source & Device Reviews File No.: 6 Registry No.: Co-1012-D-101-S SS&D Type: Neutron Generator Tubes Manufacturer: MF Physics Corporation Date issued: 12/31/96 Type of Action: Amendment License Reviewer: CM Peer Audit: ES 1

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Roy Romar, Covernor STATEO: CO10XADO Patti shwayder, Executive Director i Dedicated to protecting and improving the health and erwitonenent of the people of Colorado '

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4300 Cherry Creek Dr. s. Laboratory and Radiation services Division Denver, colorado 802221530 8100 Lowry Blvd.

Phone 003) 692 2000 Denver CO 80220-6928 0 03) 692-3090 Colorado Department l ofPublicHealth I and Environment 1

April 29,1997 Richard Bangart, Director  !

Office of State Programs U.S. Nuclear Regulatory Commission Washington, D.C. 20555-0001

Dear Mr. Bangart:

The following are Colorado's comments on the draft Integrated Materials Performance Evaluation Program (IMPEP) Review of Colorado Agreement State Program, March 10-14, 1997. As requested, these comments focus only on factual correctness of information reported by the team.

1. Sections 1 and 3.3 of the report state the program regulated 350 specific licenses. At the time of the IMPEP review, Colorado had 348 specific licenses.

2. Section 3.3, page 10, item a infers that license reviewers do not recheck the SS&D register for source and device inclusion. This is not true. The register is routinely checked. The inspection team identified one licensed source that was not in the registry. This is an old source that has been on the license for many years, possibly originally licensed by the AEC.

3, Section 3.3, page 11, item e infers the State is inconsistent in the application of well logging license conditions. The State is consistent in applying the same license conditions when operations are the same. The issue noted by the IMPEP team related to bioassay requirements for well loggers using iodine. One license did not require bioassays, though the maximum possession limit exceeded the trigger for bioassay. A bioassay condition was not included because the license contained restrictions on the amount of iodine that could be used at any one time, and that amount was below the trigger for bioassay.

4. Section 3.4, page 11 states that the program uses a " general inspection form." We do not have a general form. We use separate inspection forms for gauges; industrial radiography; field inspections for industrial radiography; research and academic institutions; medical facilities; and teletherapy facilities.

ATTACHMENT 2 h C M @ % ---

.h Richard Bangart, NRC -

j April 29,1997 -

Page 2 ,

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5. Section 3.4, page 13 states a founh of the survey instruments are calibrated each  ;

quarter. The Division generally calibrates instruments annually. However, some are  ;

! calibrated more frequently to ensure that an inspector's instrument has been calibrated )

within the frequency required of the licensee being inspected.

6. Section 3.5, page 18 - The draft report states "In reviewing the promulgation procedures and policies, the review team noted that proposed regulations are published in local newspapers, the Colorado Renister, and the CDPHE newsletter to licensees to provide opportunity for public comment". In fact, "A Notice of Rulemaking and Proposed Regulations" is published in The Colorado Renister. After an initial informational hearing by the Board of Health a formal hearing is scheduled by the Board of Health and is noticed in the " Calendar of Hearings" of The Colorado Renister. Once the rule is adopted, it is noticed in " Changes in the Code of Colorado Regulations" in The Colorado Renister. In addition, the Division uses the Radioactive Materials newsletter to notice licensees. Local newspapers are not used.

If you have any questions, please contact Robert Quillin at (303) 692-3038.

l Sincerely,  !

Patti Shwayder Executive Director i cf: Lee Thielen Robert Quillin Howard Roitman O

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Aaenda for Manaaement Review Board Meetina l Tuesday, June 3,1997,1:00 p.m., OWFN, 4-B-6 I l

1. Convention. MRB Chair convenes meeting. (RBangart) '

2. New Business - Consideration of Colorado IMPEP Report.

. A. Introduction of Colorado IMPEP Team Members. (J. Hornor)

B. Introduction of Colorado representative and other State representatives participating through telephone bridge. (KSchneider) I 1

C. Findings regarding Colorado Program. (IMPEP Team)

Status of Inspection Program

- Technical Staffing / Training

- Technical Quality of Licensing

- Technical Quality of Inspections

- , Response to incidents / Allegations Legislation and Regulations

- Sealed Source and Device Evaluation Program

- Uranium Recovery Program ,  ;

D. Questions. (MRB Members)

E. Comments from State of Colorado. (RQuillin)

F. MRB Consultation / Comments on issuance of Report. (RBangart)

Recommendation for next IMPEP review )

3. Old Business - Approval of the May 14, Mississippi MRB Minutes. (OSP) j

4. Status of Upcoming Reviews. (KSchneider) l

5. Adjournment. (RBangart) invitees: Richard Bangart, Acting MRB Chair, OSP Karen Cyr, MRB Member, OGC Carl Paperiello, MRB Member, NMSS Denwood Ross, MRB Member, AEOD Richard Ratliff, Agreement State Liaison to MRB, TX Robert Quillin, Colorado Paul Lohaus, OSP Don Cool, NMSS Jack Hornor, IMPEP Team Leader, RIV, WCFO Don Bunn, IMPEP Member, CA Jacqueline Cook, IMPEP Member, RIV Lance Rakovan, OSP Kathleen Schneider, OSP ATTACHMENT 3