May 8, 2001

Mr. David Butcher, Director

Laboratory and Radiation Services Division

Colorado Department of Public Health and Environment

8100 Lowry Blvd.

Denver, CO 80230-6928

Dear Mr. Butcher:

On April 24, 2001, the Management Review Board (MRB) met to consider the proposed final

Integrated Materials Performance Evaluation Program (IMPEP) report on the Colorado Agreement

State Program. The MRB found the Colorado program adequate to assure public health and

safety and compatible with the Nuclear Regulatory Commission’s program. 

Section 5.0, page 18, of the enclosed final report presents the IMPEP team’s recommendations. 

We request your evaluation and response to these recommendations within 30 days from receipt

of this letter.

Based on the results of the current IMPEP review, the next full review will be in approximately four

years.

I appreciate the courtesy and cooperation extended to the IMPEP team during the review and your

support of the Radiation Control Program. I look forward to our agencies continuing to work

cooperatively in the future.

Sincerely,

/RA/

Carl J. Paperiello

Deputy Executive Director 

 for Materials, Research

 and State Programs

Enclosure:

As stated

cc: Warren E. Jacobi, Manager

Radiation Services Program

Laboratory and Radiation Services Division

Roland Fletcher, Maryland

Agreement State Liaison to

 the Management Review Board
Mr. David Butcher, Director May 8, 2001

Laboratory and Radiation Services Division

Colorado Department of Public Health and Environment

8100 Lowry Blvd.

Denver, CO 80230-6928

Dear Mr. Butcher:

On April 24, 2001, the Management Review Board (MRB) met to consider the proposed final

Integrated Materials Performance Evaluation Program (IMPEP) report on the Colorado Agreement

State Program. The MRB found the Colorado program adequate to assure public health and

safety and compatible with the Nuclear Regulatory Commission’s program. 

Section 5.0, page 18, of the enclosed final report presents the IMPEP team’s recommendations. 

We request your evaluation and response to these recommendations within 30 days from receipt

of this letter.

Based on the results of the current IMPEP review, the next full review will be in approximately four

years.

I appreciate the courtesy and cooperation extended to the IMPEP team during the review and your

support of the Radiation Control Program. I look forward to our agencies continuing to work

cooperatively in the future.

Sincerely,

/RA/

Carl J. Paperiello

Deputy Executive Director 

 for Materials, Research

 and State Programs

Enclosure:

As stated

cc: Warren E. Jacobi, Manager bcc: Chairman Meserve

Radiation Services Program Commissioner Dicus

Laboratory and Radiation Services Division Commissioner Diaz

Commissioner McGaffigan

Roland Fletcher, Maryland Commissioner Merrifield

Agreement State Liaison to

 the Management Review Board

Distribution: DCD (SP01) PDR (YES/)

DIR RF DChamberlain, RIV GBaker, NYSH

EDO RF CHackney, RIV RWoodruff, RIIKCyr, OGC

SDroggitis, STP DCool, NMSS FCameron, OGC MVirgilio, NMSS

KSchneider, STP GDeegan, NMSS STreby, OGC

LRakovan, STP KHooks, NMSS TCombs (2)

Colorado File VCampbell, RIII CMaupin, ASPO

DOCUMENT NAME: I:\Reviews\Co01\2001COimpfnl ltr&rpt.wpd

To receive a copy of this document, indicate in the box: "C" = Copy without attachment/enclosure "E" = Copy with attachment/enclosure "N" = No copy

OFFICE STP STP:ADD STP:D DEDMRS

NAME RLBlanton:gd KSchneider PHLohaus

(By SCDroggitis)

CJPaperiello

DATE 5/01/01 5/01/01 5/02/01 05/08/01

STP-AG-5
INTEGRATED MATERIALS PERFORMANCE EVALUATION PROGRAM

REVIEW OF COLORADO AGREEMENT STATE PROGRAM

February 5 - 9, 2001

FINAL REPORT

U.S. Nuclear Regulatory Commission
Colorado 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 period of February 5 - 9, 2001, by a review team comprised of

technical staff members from the Nuclear Regulatory Commission (NRC) and the Agreement State

of New York. Team members are identified in Appendix A. The review was conducted in

accordance with the "Implementation of the Integrated Materials Performance Evaluation Program

and Rescission of a Final General Statement of Policy," published in the Federal Register on

October 16, 1997, and the November 5, 1999, NRC Management Directive (MD) 5.6, "Integrated

Materials Performance Evaluation Program (IMPEP)." Preliminary results of the review, which

covered the period March 10, 1997 to February 5, 2001 were discussed with Colorado

management on February 9, 2001.

A draft of this report was issued to Colorado for factual comment on March 9, 2001. The State

responded in a letter dated March 30, 2001. The Management Review Board (MRB) met on April

24, 2001, to consider the proposed final report. The MRB found the Colorado program was

adequate to protect public health and safety and compatible with NRC’s program.

The Colorado Agreement State program is administered by the Department of Public Health and

Environment (the Department), and is located within the Laboratory and Radiation Services

Division (the Division). The Division manages two programs: the Radiation Services Program (the

Program) and the State Laboratories. The Program is under the supervision of a Program

Manager. An organization chart for the Department is included as Appendix B. At the time of the

review, the Colorado program regulated 332 specific licenses authorizing Agreement materials. 

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 Program on October 17, 2000. The Program provided a response to the

questionnaire on January 10, 2001. During the review, discussions with the Program staff

resulted in the responses being further developed. A copy of the final response is included in

Appendix G to the proposed final 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 Program licensing and inspection data

base; (4) technical review of selected licensing and inspection actions; (5) field accompaniments

of five 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.

Section 2 below discusses the Program'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

performance indicators, and Section 5 summarizes the review team's
Colorado Final Report Page 2

findings and recommendations. Recommendations made by the review team are comments that

relate directly to performance by the Program. A response is requested from the Program to all

recommendations in the final report. 

2.0 STATUS OF ITEMS IDENTIFIED IN PREVIOUS REVIEWS

During the previous routine review, which concluded on March 14, 1997, 18 recommendations

were made and the results transmitted to Ms. Patti Shwayder, Executive Director, on June 16,

1997. The team’s review of the current status of these recommendations is as follows:

1. The review team recommends that the Program revise the inspection frequency for HDR

remote afterloader licenses to the 1-year frequency specified in NRC Inspection Manual

Chapter (IMC) 2800.

Current Status: The Program implemented this recommendation, and inspections of the

two HDR licensees’ were performed at the scheduled frequency. This recommendation is

closed.

2. The review team recommends that the Program adhere to the percentage of reciprocity

licensees to be inspected each year specified in Appendix II of the IMC 1220. 

Current Status: The Program followed, but did not adhere strictly to Appendix II of IMC

1220. This recommendation is closed, but the inspection of reciprocity licensees is further

evaluated in Section 3.1 under the indicator "Status of Materials Inspection Program." 

3. In order to maintain the staffing level necessary to keep abreast of the needs of the

regulatory program, the review team recommends that the Program fill the existing vacancy

in the radioactive materials unit.

Current Status: All currently authorized staff positions are filled. This recommendation is

closed.

4. The review team recommends that the Program 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. 

Current Status: The Program has implemented the use of a new inspection form; however,

the form does not include reference to regulations. The Program chooses to cite the

applicable regulation or license condition after the inspection results have been reviewed

with management. This recommendation is closed.

5. Because inspector accompaniments and the related performance evaluations provide

management with valuable insight into the quality of the inspection program, the review

team recommends that the Radioactive Materials Unit supervisor or senior inspector

perform annual accompaniments of each inspector and document the results.
Colorado Final Report Page 3

Current Status: The Program Manager and the senior inspector accompanied inspectors

annually and documented the results on a form which is based on the NRC form. This

recommendation is closed.

6. The review team recommends that the Program acquire proper calibration equipment for

the shielded area in the new facility in order to better perform calibrations and lower staff

exposure to radiation.

Current Status: Shortly after the 1997 review, the Program completed the move of its

offices to the new facility. The Program chose to contract for calibration service in place of

performing in-house calibrations. This recommendation is closed.

7. The review team recommends that the Program 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.

Current Status: The Program followed the requirements specified in the current Handbook

for entering events into the NMED. However, the Program did not report events to the

NRC Headquarters Operations Center. This recommendation is closed, but events

reporting is evaluated further in Section 3.5 under the indicator “Response to Incidents

and Allegations.”

8. The review team recommends that the form RCD 56 be revised to include an analysis as

to why the event occurred and differentiate between diagnostic and therapeutic

misadministrations. 

Current Status: The Program modified the regulations pertaining to the definition of

misadministrations and created a new form, LARS-100, applicable only to therapeutic

misadministration. This recommendation is closed.

9. The review team recommends the Program consider beginning the regulation

promulgation process as soon as possible after an NRC rule change has been identified

as a compatibility item. 

Current Status: The Program addressed this recommendation as part of its response to

recommendation 14. This recommendation is closed. 

10. The review team recommends that the Program 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 until it becomes effective.

Current Status: The Program established a database program to track the regulations as

they are being promulgated. The tracking system is operated by the Program Manager. 

This recommendation is closed. 
Colorado Final Report Page 4

11. The MRB recommends that the Program implement the requirement to tag sealed sources

contained in NRC’s 10 CFR Part 34.25, “Leak Testing, Repair, Tagging, Opening,

Modification, and Replacement of Sealed Sources,” through some form of legally binding

requirement, such as a license condition, until the final regulation is promulgated. 

Current Status: After the 1997 IMPEP review, NRC adopted a revision of 10 CFR Part 34

effective June 27, 1997. Colorado adopted regulations, effective March 30, 1998, that

were compatible with former section 34.25. Subsequently, Colorado adopted regulations,

effective March 24, 2000, compatible with the revised Part 34 that became effective for

NRC licensees on June 27, 1998. This recommendation is closed.

12. 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 Program fill the vacancy in the Uranium and Special Projects Unit. 

Current Status: The vacant position and two other positions in the Uranium and Special

Projects Unit were eliminated during two reorganizations. The reorganizations are

discussed further in Section 4.4. The number of uranium recovery licensees dropped by

one, slightly reducing the workload. The Program also used two environmental protection

specialists and one engineer from other programs on a part-time basis to meet the

regulatory needs. This recommendation is closed.

13. The review team recommends that the Uranium and Special Projects Unit 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. 

Current Status: The supervisor (now the uranium lead) conducted inspector

accompaniments each year during the review period. This recommendation is closed.

The 1997 review team also offered five suggestions for the Program to consider. The team found

that the Program considered and adopted all five suggestions.

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 Inspection

Program; (2) Technical Quality of Inspections; (3) Technical Staffing and Training; (4) Technical

Quality of Licensing Actions; and (5) Response to Incidents and Allegations. 

 

3.1 Status of Materials Inspection Program

The team focused on four factors in reviewing this indicator: inspection frequency, overdue

inspections, initial inspection of new licenses, and timely dispatch of inspection findings to 

licensees. The review team's evaluation is based on the Program’s questionnaire responses, 
Colorado Final Report Page 5

data gathered independently from the Program's licensing and inspection data tracking system,

the examination of completed licensing and inspection casework, and interviews with management

and staff.

The team found that Colorado inspection priorities required inspections as frequent as, or more

frequent than, IMC 2800 for similar license types. For example, the inspection of Portable

Moisture/Density Gauges was Priority 4 on the State schedule and Priority 5 in IMC 2800. 

At the time of the review, no licenses were overdue for inspection. Inspections were conducted at

the required frequency or greater for all 24 license files reviewed. The Program has the capability

to adjust the inspection frequency based on the compliance history of the licensee, but has not

done so.

Colorado policy required initial inspections of new licenses within six months after the license was

issued or materials were received. All of the initial inspections reviewed in a random sampling

were performed within six months of license issuance or receipt of materials. New licenses were

hand delivered to the licensees. The inspectors used the opportunity to discuss the requirements

of the license and the regulations with the licensee. Program management felt that this initial

face-to-face meeting with the licensees was a very valuable tool for achieving future compliance

with license conditions. The visit allowed the Program to make sure that the safety program was

in place and permitted open discussion with the licensee about the compliance requirements.

During the inspection casework review, the team evaluated the timeliness of the Program in

providing inspection findings to the licensees. Program procedure required providing inspection

findings to the licensees within 30 days after the inspection. Of the 24 files reviewed, only three

inspection reports were issued late (from 11 to 33 days). In 19 of the 24 files, the inspection

findings were provided to the licensee at the end of the inspection, via the Program's Form 59. 

The inspectors followed a written procedure to determine when to use the Form 59. The Form 59

included a summary of the violations and required a signed compliance commitment by the

licensee. For inspections with significant findings, the procedure required a Notice of Violation

(NOV) be provided to the licensee by letter. The review team believes that the procedure is

acceptable. In the 24 files reviewed, the Program followed the procedure.

To evaluate the reciprocity inspection program, the review team evaluated a summary printout of

reciprocity inspections, and the State’s response to the IMPEP questionnaire. Overall during the

period since the last review, the inspections of reciprocity core licenses exceeded IMC 1220

requirements. However, in 1998 and 1999, no Priority 3 licenses under reciprocity were

inspected. IMC 1220 required two such inspections in 1998, and one inspection in 1999. The

review team discussed reciprocity inspections with the program staff, and learned that the

program chose not to conduct the Priority 3 inspections in 1998 and 1999, based on the

apportionment of resources to program needs. For the year 2000, all inspections required under

IMC 1220 were completed. The team concluded that the missed inspections do not indicate a

programmatic deficiency. 
Colorado Final Report Page 6

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

performance with respect to the indicator, Status of the Materials Inspection Program, be found

satisfactory.

3.2 Technical Quality of Inspections

The team evaluated the inspection reports, enforcement documentation, and inspection field notes

and interviewed inspectors for 24 radioactive materials license inspections conducted during the

review period. The casework included five of the Program's materials license inspectors, and

covered inspections of various types including radiography, medical, academic, portable gauge,

nuclear pharmacy, and gamma knife. Appendix C lists the inspection casework files reviewed for

completeness and adequacy with case-specific comments. 

Based on the casework, the review team noted that routine inspections covered all aspects of the

licensees’ radiation programs. The review team found that inspection reports were thorough,

complete, consistent, and of high quality, with sufficient documentation to ensure that licensee’s

performance with respect to health and safety was acceptable. The documentation supported

violations, recommendations made to the licensee, unresolved safety issues, and discussions held

with the licensee during exit interviews. Team inspections were performed when appropriate and

for training purposes.

The inspection procedures utilized by the Program were consistent with the inspection guidance

outlined in NRC’s IMC 2800. Inspection reports are in a format that covers all inspection areas for

each inspection type. 

The Program has an adequate number and types of survey meters to support the current

inspection program. Survey meters are calibrated at least annually by a contractor. Appropriate

calibrated survey instruments such as GM meters, scintillation detectors, ion chambers, micro-R

meters and neutron meters were observed. The Program also has access to a laboratory for

counting wipes and other samples. 

During the review period, the compliance lead performed inspector accompaniments with each of

the staff at least annually. These accompaniments are listed in the Program’s response to the

IMPEP Questionnaire. 

Five inspectors were accompanied by an IMPEP team member during the week of January 30,

2001. The accompaniments included inspections of a nuclear pharmacy, an industrial

radiographic facility (including a temporary job site) and an operating uranium mill facility. The

facilities inspected are identified in Appendix C, with comments on the accompaniments.

During the accompaniments, each inspector demonstrated appropriate inspection techniques, 

knowledge of the regulations, and conducted performance based inspections. The inspectors

were trained, well prepared for the inspection, and thorough in their audits of the licensees’

radiation safety programs. Each inspector conducted effective interviews with appropriate

licensee personnel, observed licensed operations, conducted confirmatory measurements, and

utilized good health physics practices. Their inspections were adequate to assess radiological

health and safety at the licensed facilities.
Colorado Final Report Page 7

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

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

3.3 Technical Staffing and Training

Issues central to the evaluation of this indicator include the Program’s staffing level and staff

turnover, as well as the technical qualifications and training histories of the staff. 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 workload

backlogs. Technical staffing and training for the sealed source and device evaluation program

and the uranium recovery program are addressed in Sections 4.2 and 4.4 of this report.

At the time of the review, the Program had a total of ten technical staff positions and one manager. 

The Program Manager reports to the Division Director. The technical staff positions are classified

as environmental protection specialists. Two senior staff members are to be designated leaders. 

One senior staff member has been designated as a unit leader for compliance. Another will be

designated as a unit leader for licensing.

Six staff members departed during the IMPEP review period, and three of the six positions were

eliminated. The Program filled the other three vacancies expediently. The last vacancy was filled

in January 2001, and the Program was fully staffed at the time of the review. Five members of the

Program staff will become eligible for retirement over the next five years. 

Although licensing and inspection functions are separate, all of the technical staff members are

trained to perform license reviews and inspections, as well as emergency response. The review

team determined that the Program has a well balanced staff, and a sufficient number of trained

personnel to carry out its regulatory duties. 

All environmental protection specialists in the Program are required to have bachelor’s degrees in

health physics or equivalent training in the physical and/or life sciences. New hires are assigned

basic responsibilities in the program until sufficient training and experience can be obtained. New

staff are allowed to work with the senior staff and under the guidance of the Program Manager

until appropriate training and experience is received. The Program Manager determines when the

individual is proficient and can perform the assigned tasks independently. 

The inspection reports and licensing actions of new staff are closely reviewed by senior staff and

the Program Manager. The Program has established a tracking system for all staff training. The

staff receives training in health physics, inspection procedures, licensing procedures, diagnostic

and therapeutic nuclear medicine, industrial radiography, well logging, transportation as well as

several emergency response courses. The Program has used on-the-job training to supplement

the course work so that individuals may broaden their work areas. The team confirmed the

qualifications of the staff hired since the l997 IMPEP review and verified their performance through

the review of licensing and compliance casework. 

The Program has limited funding (reduced 15% this fiscal year) for out-of-State travel, which limits

the staff participation in out-of-State training courses. The review team is concerned that reduced
Colorado Final Report Page 8

training can degrade the technical quality of the Program, and may become a significant issue due

to the anticipated loss of senior staff over the next five years. The Program does not have a

documented training plan. Such a plan should specify minimum training requirements, and

supervisory sign off on completion of that training. The review team recommends that the

Program develop and document a training and qualification program which address the training

requirements in the NRC/Organization of Agreement States Training Working Group Report or

IMC 1246.

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

performance with respect to the indicator, Technical Staffing and Training, be found satisfactory.

3.4 Technical Quality of Licensing Actions

The review team examined completed licensing casework and interviewed the staff for 19 specific

licenses. Licensing actions were evaluated for completeness, consistency, proper isotopes and

quantities used, qualifications of authorized users, adequate facilities and equipment, and

operating and emergency procedures sufficient to establish the basis for licensing actions. 

Licenses were evaluated for overall technical quality including accuracy, appropriateness of the

license, its conditions, and tie-down conditions. Casework was evaluated 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 authority. The files were checked for retention of necessary documents and

supporting data.

The licensing casework was selected to provide a representative sample of licensing actions that

were completed during the review period. The sampling included the following types: well

logging, industrial radiography, medical (institution, private practice, and broad scope), nuclear

pharmacy, academic (broad scope and irradiator), research and development, analytical, portable

gauge and provisional possession. Types of licensing actions selected for evaluation included

one new license, ten amendments to existing licenses, three license renewals, and five license

terminations. A list of the licenses evaluated with case-specific comments can be found in

Appendix D.

Overall, the review team found that the licensing actions were thorough, complete, consistent, of

high quality and properly addressed health and safety issues. The staff followed appropriate

licensing guides during the review process to ensure that licensees submit information necessary

to support their request. Complicated deficiencies were addressed in letters containing

appropriate regulatory language. Telephone conversations addressed and documented simple

deficiencies on the action tracking sheet. The use of license templates by the staff resulted in

notable consistency between reviewers. 

A second individual reviewed each licensing action, then the Program Manager reviewed the

license before it was issued. The peer and supervisory reviews contributed to the notable

consistency between reviewers and the high quality of licensing documents. All licenses

evaluated were signed by the Program Manager, or by designated staff in his absence. The

Division Director signed all correspondence evaluated. 
Colorado Final Report Page 9

The team noted that the Program had started a new practice of not specifically identifying

authorized users on medical institution licenses. This was part of an effort to streamline the

processing of licensing actions. The Program required the medical institution’s radiation safety

committee to review and approve all authorized users in accordance with the training and

experience requirements specified in Colorado Regulations. The Program’s inspectors reviewed

the committee’s approval at the next scheduled inspection. The team did not observe any

performance issues from this practice. However, because this practice has been in place only

one year, there is not enough data to determine the effectiveness. The review team discussed

the practice with the Program staff, and the staff agreed to share information on their experience

with NRC.

The team also noted, however, that Colorado Regulation RH 7.2 defines the term “authorized

user.” An authorized user is a practitioner of the healing arts identified on a license that

authorizes the medical use of radioactive material. The review team discussed this issue with the

Program staff. The Program Manager will consider seeking legal advice to determine if the new

practice is in conflict with the regulations. 

The team examined the Program’s handling of financial assurance. The State keeps original

financial assurance instruments in the Colorado Treasury Department. The Program maintains

copies of the documents in the license files. The Program reviewed financial assurance

instruments annually. The team concluded that the Program handles financial assurance

appropriately.

The team found that actions terminating licenses were well documented, and included the

appropriate material survey records. The evaluation revealed that most license terminations were

for licensees possessing only sealed sources. All files reviewed contained documentation of

proper disposal or transfer.

Colorado renewed licenses every five years. Licenses under timely renewal were amended

separately from the renewal as necessary to assure public health and safety during the renewal

process. 

The team discussed the subject of potentially contaminated sites formerly licensed by AEC/NRC

located in Colorado with the Program Manager. The Program requested in a letter dated

February 5, 2001, that Region IV transfer the files for these licenses. A total of 11 files were

transferred February 9, 2001. Although the Program had not reviewed any of the files, the

Program intended to apply for funding from the Grant Program for Funding Assistance for formerly

License Sites in Colorado.

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

performance with respect to the indicator, Technical Quality of Licensing Actions, be found

satisfactory.

3.5 Response to Incidents and Allegations

In evaluating the effectiveness of the Program’s actions in responding to incidents, the review

team examined the Program’s response to the questionnaire relative to this indicator, evaluated
Colorado Final Report Page 10

selected incidents reported for Colorado in the Nuclear Material Events Database (NMED) against

those contained in the Colorado files, and evaluated the casework and supporting documentation

for 14 material incidents. A list of the incident casework examined with case-specific comments is

included in Appendix E. The team also reviewed the Program’s response to seven allegations

involving radioactive materials including one allegation referred to the Program by the NRC during

the review period. 

The review team discussed incident and allegation procedures, file documentation, the Program’s

event and allegation tracking system, NMED, and notification of incidents to the NRC Operations

Center with the Program Manager and selected staff.

The team found that responsibility for initial response and follow up actions to materials events

and allegations rests solely with the Program. The Program Manager, the compliance lead, and

others as appropriate, evaluate events to determine the appropriate response. They evaluate all

complex incidents and events, and those with potential for affecting public safety.

 

The Program had 78 materials incidents during the review period, of which 34 incidents were

reportable under the NRC criteria. Fourteen incidents were selected for review. The incidents

included: stolen and lost gauges; equipment failure; contamination; damaged devices; a leaking

source; and misadministrations. The review team found that the Program’s response to incidents

was complete and comprehensive. Initial responses were prompt and well-coordinated and the

level of effort was commensurate with the health and safety significance. The Program

dispatched inspectors for on-site investigations when appropriate, and took suitable enforcement

action. Actions were coordinated with the license reviewers and other agencies, and

appropriately followed up. 

The team found that the Program had a practice but did not have written procedures for handling

incidents. The compliance lead explained the principal elements of the Program’s practice. 

These included the actions to be taken upon the notification of an event, the tracking system,

event evaluation and investigation, documentation, coordination with other agencies, and the

reporting of incidents to the NMED system. The team noted inconsistencies in the implementation

of the practice, however, and believes that the casework comment items could have been avoided

if written incident response procedures were in place.

The team discussed the comments with the Program staff. The team also discussed the

numbering system used by the tracking system and the similarity between incident numbers and

misadministrations that could cause reporting discrepancies. The team concluded that Program

should have written procedures to meet the IMPEP criteria in MD 5.6 Handbook, particularly in

view of anticipated staff turnover due to retirements. 

The review team recognized that the Program self identified the lack of written procedures, and

that the Program Manager directed the staff to develop them. The procedures are expected to be

completed and implemented by the end of the fiscal year, June 30, 2001. The team discussed the

Program’s planned development and implementation of written Incident Response Procedures. 

The team noted that the Program had two individuals trained on submitting event reports to

NMED. Both individuals had copies of the Handbook of Office of State and Tribal Programs
Colorado Final Report Page 11

(STP) Procedure SA-300, “Reporting Material Events.” The Program sent copies of all event

reports except one to the NMED contractor. However, the team noted that only one of 10

significant events was reported to the NRC’s Emergency Operations Center. The other nine

significant events were first reported to NRC in the written reports to NMED. The team discussed

this issue with the Program Manager and the staff members responsible for NMED data entry. 

The review team recommends that the Program report all significant events to the NRC

Emergency Operations Center in accordance with STP Procedure SA-300, “Reporting Material

Events.”

During the review period, NRC referred one allegation to the Program, and the Program received

six allegations directly. All allegations were reviewed. The casework indicated that the Program

took prompt and appropriate action in response to the concerns raised and made every effort to

protect the alleger’s identity. All of the allegations reviewed were appropriately closed with written

letters to the alleger as appropriate. The team noted that allegations were treated and

documented internally in the same manner as events. There were no performance issues

identified from the review of the allegation files and documentation. 

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

performance with respect to the indicator, Response to Incidents and Allegations, be found

satisfactory.

4.0 NON-COMMON PERFORMANCE INDICATORS

IMPEP identifies four non-common performance indicators to be used in reviewing Agreement

State programs: (1) Legislation and Program Elements Required for Compatibility; (2) Sealed

Source and Device Evaluation Program; (3) Low-Level Radioactive Waste Disposal Program; and

(4) Uranium Recovery Program. 

4.1 Legislation and Program Elements Required for Compatibility

4.1.1 Legislation 

The State of Colorado has posted its laws on an Internet website. The team had the opportunity

to review the statutes applicable to radiation control, along with the responses to the

questionnaire. 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 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. The review team noted that no legislation affecting the radiation control program was

passed since this indicator was found satisfactory during the previous review. 

4.1.2 Program Elements Required for Compatibility 

The Colorado Rules and Regulations Pertaining to Radiation Control apply to all ionizing

radiation, whether emitted from radionuclides or devices. Colorado requires a license for
Colorado Final Report Page 12

possession, and use, of all radioactive material including naturally occurring materials, such as

radium, and accelerator-produced radionuclides. 

The review team examined the procedures used in the Program’s regulatory process and found

that the public and other interested parties are offered an opportunity to comment on proposed

rules. The NRC is provided with drafts for comment. The Program obtains departmental approval

and publishes a rulemaking notice of intent and public hearing. The Program develops the new

rules and consults the Radiation Advisory Committee in a meeting that is open to the public. The

rule is revised as needed based on the comments, and is then sent to the Board of Health for

adoption. The State has a Rules Review Commission that reviews and approves new rules and

the General Assembly is provided a time period in which to veto the rule. During the review

period, none of the Program’s proposed rules were rejected. Typically, rule promulgation requires

4 to 14 months. The Program’s Rules and Regulations are exempt from the State “sunset” law.

The team evaluated Colorado’s responses to the questionnaire, reviewed the status of regulations

required to be adopted by the State under the Commission’s adequacy and compatibility policy. 

The team identified six regulation changes that will be needed in the future. Colorado has

rulemaking in progress for the following three:

! “Minor Corrections, Clarifying Changes, and a Minor Policy Change” 10 CFR Parts 20, 35,

36 amendments (63 FR 39477 and 63 FR 45393) that became effective October 26, 1998;

! “Transfer for Disposal and Manifests: Minor Technical Conforming Amendment” 10 CFR

Part 20 amendment (63 FR 50127) that became effective November 20, 1998;

! “Radiological Criteria for License Termination of Uranium Recovery Facilities” 10 CFR

Part 40 amendment (64 FR 17506) that became effective June 11, 1999.

Colorado will need to address the following three regulations in upcoming rulemaking or by

adopting alternate legally binding requirements: 

! “Respiratory Protection and Controls to Restrict Internal Exposures,” 10 CFR Part 20

amendment (64 FR 54543 and 64 FR 55524) that became effective February 2, 2000;

! “Energy Compensation Sources for Well Logging and Other Regulatory Clarifications,” 10

CFR Part 39 amendment (65 FR 20337) that became effective May 17, 2000;

! “New Dosimetry Technology” 10 CFR Parts 34, 36, 39 amendments (65 FR 63749) that

became effective January 8, 2001.

It is noted that MD 5.9, Handbook, Part V, (A)(1)(a) provides that the above regulations should be

adopted by the State as expeditiously as possible, but not later than three years after the effective

date of the NRC rule.

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

performance with respect to the indicator, Legislation and Program Elements Required for

Compatibility, be found satisfactory.
Colorado Final Report Page 13

4.2 Sealed Source and Device (SS&D) Evaluation Program

In assessing the State's Sealed Source & Device (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 selected new and amended SS&D evaluations and supporting documents

covering the review period was conducted. The team interviewed the staff involved in SS&D

evaluations. 

4.2.1 Technical Quality of the Product Evaluation Program

The review team examined one new, one amended, two inactivated, and one transferred SS&D

registry certificates and their supporting documentation. The certificates reviewed covered the

period since the last program review in 1997 and represented the work of three reviewers. The

SS&D certificates issued by the State and evaluated by the review team are listed with casespecific comments in Appendix G. 

The review of the SS&D casework confirmed that Colorado uses NUREG-1556, Volume 3, to

guide product evaluations and the preparation of registry sheets. The casework files contained

appropriate correspondence, photographs, engineering drawings, radiation profiles, and results of

tests conducted by the applicant. All pertinent ANSI Standards and Regulatory Guides are

available and used. The device sheets were forwarded to NRC when completed, and were

observed by the team to be posted on the STP website.

Based upon the review of the registration files, guidance documents and procedures, and the

SS&D sheets issued, the review team found that the technical quality of the Colorado product

evaluation program is adequate for the current device reviews.

4.2.2 Technical Staffing and Training

The Program’s senior evaluator at the time of the last IMPEP review left the Program during the

IMPEP review period. The individual that was the junior evaluator is now the Program’s senior

reviewer. A new individual was trained to conduct SS&D reviews, and the current Program

Manager is qualified to conduct reviews. 

The new evaluator has a bachelor degree in Health Physics, plus an associate degree in

engineering. He also has experience in the use and maintenance of sources and devices. He

demonstrated understanding of prototype testing, test set-ups and results, engineering drawings,

how devices and safety features work, the appropriate regulations, conditions of use, external

dose rates, source activities, nuclide chemical form, engineering materials and materials

properties.

4.2.3 Evaluation of Defects and Incidents Regarding SS&Ds

The review team determined, based on the responses by Colorado to the questionnaire, and

based on the response to queries to NMED, that there were no incidents or defects regarding

SS&Ds evaluated by the Program.
Colorado Final Report Page 14

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 (LLRW) Disposal Program

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 LLRW disposal facility. When an

Agreement State has been notified or becomes aware of the need to regulate a LLRW disposal

facility, they are expected to put in place a regulatory 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 review team did not review this indicator.

4.4 Uranium Recovery Program

In conducting this review, five sub-indicators were used to evaluate the Program’s performance

regarding the uranium recovery program. These sub-indicators include: (1) Status of Uranium

Recovery Inspection Program; (2) Technical Quality of Inspections; (3) Technical Staffing and

Training; (4) Technical Quality of Licensing Actions; and (5) Response to Incidents and

Allegations. The results of the uranium recovery program review will be discussed under each of

these sub-indicators.

The uranium recovery program was transferred from the Radiation Control Division to the

Hazardous Materials and Waste Management Division in December 1996. Both the personnel

and the regulatory responsibilities transferred. The program was subsequently transferred to the

Laboratory and Radiation Services Division, Radiation Services Program, effective December 1,

1999. 

During the review period, the program regulated seven licensees under Part 18, “Milling of

Uranium, Thorium and Related Radioactive Materials” of the Colorado Department of Public

Health and Environment’s “Rules and Regulations Pertaining to Radiation Control.” The program

also regulated eight sites under Part 3, “Licensing of Radioactive Material.”

4.4.1 Status of the Uranium Recovery Inspection Program

The review team focused on several factors in evaluating the uranium recovery program’s

performance for this sub-indicator, including inspection frequency, overdue inspections, timely

issuance of inspection reports and findings to licensees, inspection follow up, and retrievability of

uranium recovery inspection materials. The review team’s evaluation is based on an evaluation of

the responses to the questionnaire, the uranium recovery inspection schedule, inspection files,

and interviews with inspection staff and management. 
Colorado Final Report Page 15

The team determined that the uranium inspection frequency was consistent with IMC 2801,

“Uranium Mill and 11e.(2) Byproduct Material Disposal Site and Facility Inspection Program.” The

Program performed site visits (limited, partial inspections) almost monthly at the Cotter Cañon City

Mill, with each visit addressing different areas. The inspection frequency was adjusted on the

basis of licensee performance and activities at the site. The team believes this practice to be

satisfactory. 

The Program identified one overdue inspection (by 14 months) of a uranium licensee, the

Colorado School of Mines Research Institute. Although a Part 18 license, the facility engaged in

research and development, and was in remediation at the time of the overdue inspection. The

team’s review of the Part 18 license files did not identify any other overdue inspections. 

Considering the reorganizations of the uranium recovery program and the nature of the licensee,

the team concluded that the missed inspection did not indicate a programmatic deficiency.

Inspectors communicated inspection results to the licensees before they left the site. When

inspectors identified substantial noncompliance, the Program sent a written NOV within 30 days of

the inspection. However, one of the seven inspection reports reviewed was not completed until

after 30 days. Further, the files reviewed did not indicate that the site visit memoranda had been

sent to the licensees. The Program sent summary letters each 6 months for the site visits at one

licensee. There was no written procedure, and the Program staff did not follow a consistent

process. The review team recommends that the uranium recovery program consistently provide

written results of inspections and site visits to all licensees within 45 days of the completion of the

inspection.

When an inspection identified a noncompliance, the Program took appropriate follow-up actions. 

Inspection files were easily retrieved and accessible. Management reviewed and gave

appropriate attention to the letters and inspection reports.

It was not clear from the files that all of the site visit memoranda were transmitted to the licensees. 

The team discussed this with the Program staff, and does not believe that this was a performance

deficiency. The Program staff agreed to consider transmitting all site visit memoranda to

licensees, and adding information to the inspection schedule documentation.

The review team noted that the inspection reports and site visit memoranda for Hecla Durita

contained color photographs of site reclamation activities. At the exit meeting, the team discussed

this as a potential good practice for use at the other uranium recovery sites. After further

consideration, the team notes that a good practice was identified previously for using 

photographs to document licensee facilities, equipment, and operations. The photographs were

used to help supervisors and future inspectors, i.e., persons within the program staff, have a

visual indication of licensee operations. 

The review team believes the Colorado Program photographs of decommissioning construction

activities, such as riprap placement, diversion channels, erosion/gullying, etc., will be useful to

interested persons outside the program staff. They will be particularly useful during license

termination and long term surveillance. Based on the extended usefulness of photo

documentation of decommissioning construction activities, the team identified this to be a good

practice.
Colorado Final Report Page 16

4.4.2 Technical Quality of Inspections

In reviewing this sub-indicator, the review team examined inspection files, inspection reports, and

enforcement documentation for the licensees regulated under Part 18. The team also briefly

reviewed the files of four Part 3 licensees, and had no comments. The review of records covered

inspections conducted during the review period representing a range of uranium recovery

inspection activities in various stages of license operations. Members of the IMPEP team also

accompanied two uranium program inspectors on an inspection of the Cotter Corporation Cañon

City Mill. Inspectors and management were interviewed to assess the adequacy of their

preparation for the inspections, the depth and content of the actual inspections, and the

appropriateness of inspection findings. The review team's findings are discussed below. 

Periodic compliance inspections were team (two inspectors) inspections. The site visits were one

inspector, and focused on a specific item or area of inspection. The inspection teams reviewed

relevant license requirements, previous inspection reports, and other background information prior

to the inspection. The inspectors did not use checklists, however, the team did not find

deficiencies in the inspections caused by this.

The review determined that, during a typical inspection, inspectors observed licensee operations;

interviewed workers, managers, and contractors; reviewed facility records; examined site

operating plans and procedures; and made independent measurements, as appropriate. The

team verified these activities during the inspection accompaniment at the Cotter Corporation

Cañon City Mill. 

Although the Program inspectors primarily focused on health physics and radiation safety issues,

they also inspected for geotechnical, environmental monitoring, management and organizational

issues, and general housekeeping practices. The review team found that the inspection reports

provided appropriate depth of coverage. They addressed compliance conditions for the

licensees, and demonstrated that the inspectors pursued root causes where problems or

violations were identified. 

The review team determined that during the review period, the Program Manager did not

accompany inspectors each year. The two primary inspectors are senior personnel with twentyplus years of experience each. The uranium lead accompanied staff inspectors on both routine

inspections and as accompaniments. However, it was not always clear from program records

which inspections were considered to be the formal accompaniments. The review team discussed

this with the staff, and they agreed to consider how to clarify the records. The review team found

that the Program Manager met with the uranium inspectors after their inspections to review

findings and plan follow-up strategy. The team found no signs of performance deficiency due to

lack of supervisory accompaniment by the Program Manager.

There are no written inspection procedures applicable to the Part 18 licenses. The team found

the inspections to be satisfactory without procedures, due to the experience of the staff. The

review team discussed the benefit of procedures with the inspection staff, and the uranium

recovery program will consider developing specific inspection procedures in view of the

anticipated staff turnover. 
Colorado Final Report Page 17

4.4.3 Technical Staffing and Training

In reviewing this sub-indicator, the review team evaluated the uranium recovery program staffing

level, the technical qualifications of the staff, staff training, and staff turnover. This evaluation

included general examination of the qualifications of the inspectors and reviewers. 

Various members of the uranium recovery program staff participated in inspections and licensing

activities at the uranium recovery sites. The amount of participation varied, depending on the

individual’s qualifications and workload. Three individuals, who were primarily uranium recovery

reviewers and inspectors, left the uranium recovery program during 1999 and 2000. However, the

departures were balanced in part by utilizing materials program staff for uranium recovery

activities.

Review of the uranium recovery program staff qualifications indicates that the inspectors and

technical reviewers have appropriate education and experience. 

4.4.4 Technical Quality of Licensing Actions

Colorado’s regulations require that a preliminary decision to amend a Colorado uranium milling

license be accompanied by a written analysis of the basis of decision. The decision analysis

summarizes a review of the applicant’s qualifications and presents notice to the public of an

opportunity to comment on the amendment. The team looked at three decision analyses, for

Cotter Corporation Cañon City, Umetco Maybell, and Hecla Durita.

The analyses reviewed covered all aspects of the licenses, including site/mill history, radiological

and non-radiological public health impacts, impacts on surface water and groundwater, and

surety. The analyses were performed to ensure that the amended/renewed license requires

compliance with all applicable State requirements. 

Based on this review, the team determined that the analyses are of acceptable technical quality. 

The analyses addressed technical evaluations in areas such as flood determinations, water

surface profiles, erosion protection design, sediment analyses, and rock durability.

The team also evaluated licensing actions related to the Cotter Corporation Cañon City mill. 

Based on an inspection accompaniment and a review of the licensing file, the team concluded that

licensing actions were appropriate and that the license conditions were clear and well-written. 

Requirements associated with these conditions were based on a need to meet the regulations

and to protect health and safety.

4.4.5 Response to Incidents and Allegations

For this sub-indicator, the review team examined files related to uranium recovery incidents and

allegations. During the review period, the Program responded to one allegation in the uranium

recovery area. Based on the review of the files, the team determined that the Program personnel

acted promptly and appropriately in addressing the concerns. The review team determined that

the Program’s process, procedures, and overall performance for uranium recovery facilities were

acceptable. 
Colorado Final Report Page 18

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

performance with respect to the indicator, Uranium Recovery Program, be found satisfactory.

5.0 SUMMARY

As noted in Sections 3 and 4 above, the review team found Colorado’s performance to be

satisfactory for all nine performance indicators reviewed. Accordingly, the review team

recommended and the MRB concurred in finding the Colorado Agreement State program to be 

adequate to protect public health and safety and compatible with NRC's program. Based on the

results of the current IMPEP review, the next full review will be in approximately four years

Below is a summary list of recommendations, as mentioned in earlier sections of the report, for

implementation and evaluation, as appropriate, by the State. 

RECOMMENDATION:

1. The review team recommends that the Program develop and document a training and

qualification program which address the training requirements in the NRC/Organization of

Agreement States Training Working Group Report or IMC 1246. (Section 3.3)

2. The review team recommends that the Program report all significant events to the NRC

Emergency Operations Center in accordance with STP Procedure SA-300, “Reporting

Material Events.” (Section 3.5)

3. The review team recommends that the uranium recovery program consistently provide

written results of inspections and site visits to all licensees within 45 days of the

completion of the inspection. (Section 4.4.1)

GOOD PRACTICE:

Based on the extended usefulness of photo documentation of decommissioning construction

activities, the review team identified this to be a good practice. (Section 4.4)
LIST OF APPENDICES AND ATTACHMENTS

Appendix A IMPEP Review Team Members

Appendix B Colorado Organization Charts

Appendix C Inspection Casework Reviews

Appendix D License Casework Reviews

Appendix E Incident Casework Reviews

Appendix F Sealed Source & Device Casework Reviews

Attachment March 30, 2001 Letter from David A. Butcher -

 Colorado’s Response to Draft IMPEP Report
APPENDIX A

IMPEP REVIEW TEAM MEMBERS

Name Area of Responsibility

Richard Blanton, STP Team Leader

Legislation and Program Elements 

 Required for Compatibility

Sealed Source and Device Evaluation Program

Richard Woodruff, R(II) Inspection Accompaniments

Response to Incidents & Allegations

Vivian Campbell, R(IV) Technical Staffing and Training 

Technical Quality of Licensing Actions

Kenneth Hooks, NMSS Uranium Recovery Program

Uranium Inspector Accompaniment

Gary Baker, NY State Health Department Status of Materials Inspection Program

Technical Quality of Inspections
APPENDIX B

Colorado

Department of Public Health and Environment

ORGANIZATION CHART

ML010860279