May 16, 2012 

Steve Tarlton, Program Manager 

Radiation Control Program 

Hazardous Material & Waste 

 Management Division 

Colorado Department of Public 

 Health & Environment 

HMWMD-RAD-B2 

4300 Cherry Creek Drive South 

Denver, Colorado 80246-1530 

Dear Mr. Tarlton: 

A periodic meeting with you, your staff, and your management was held on April 17, 2012. The 

purpose of this meeting was to review and discuss the status of the Colorado Agreement State 

Program. The NRC was represented by Duncan White and Stephen Poy from the Office of 

Federal and State Materials and Environmental Management Programs (FSME), Vivian 

Campbell from the Division of Nuclear Materials Safety (DNMS) in NRC Region IV, and me. I 

have completed and enclosed a general meeting summary, including any specific actions 

resulting from the discussions. 

If you feel that our conclusions do not accurately summarize the meeting discussion, or have 

any additional remarks about the meeting in general, please contact me at 817-200-1143 or 

e-mail Randy.Erickson@nrc.gov to discuss your concerns. 

 Sincerely, 

 /RA/ 

 Randy Erickson 

 Regional State Agreements Officer 

Enclosure: 

Periodic Meeting Summary for Colorado 

UNITED STATES

NUCLEAR REGULATORY COMMI SSI ON

REGION IV

1600 EAST LAMAR BLVD

ARL INGTON, TEXAS 76011- 4511
Colorado Department of Public 

 Health and Environment - 2 - 

cc w/enclosure: 

Gary W. Baughman, P.E., Director 

Hazardous Material & Waste 

 Management Division 

Colorado Department of Public 

 Health & Environment 

HMWM-B2 

4300 Cherry Creek Drive South 

Denver, Colorado 80246-1530 
Colorado Department of Public 

 Health and Environment - 3 - 

bcc (via e-mail distribution): 

Anton Vegel, D:DNMS 

Vivian Campbell, DD:DNMS 

Brian McDermott, FSME 

Pamela Henderson, FSME 

Duncan White, FSME 

Rachel Browder, SAO 

Randy Erickson, SAO 

Lisa Dimmick, FSME 

Janine Katanic, FSME 

Michelle Beardsley, FSME 

Karen Meyer, FSME 

 

 

ML12137A866 

S:\DNMS\!SAO\Periodic Meetings\2012\Colorado\2012Colorado Periodic Meeting Summary.doc 

ADAMS 9 Yes  No ; SUNSI Review 

Complete 

Reviewer Initials: RRE 

Publicly Available 9 Yes  No Non Sensitive 

RIV: RSAO FSME: FSME: DD:DNMS 

RRErickson;dlf DWhite SPoy VHCampbell 

 /RA/ E - RRErickson E - RRErickson /RA/ 

5/16/12 5/14/12 5/14/12 5/16/12 

OFFICIAL RECORD COPY T=Telephone E=E-mail F=Fax
ENCLOSURE 

AGREEMENT STATE PERIODIC MEETING SUMMARY FOR THE 

COLORADO DEPARTMENT OF PUBLIC HEALTH AND ENVIRONMENT 

DATE OF MEETING: APRIL 17, 2012 

NRC Attendees Colorado Attendees

Randy Erickson, RSAO Christopher Urbina, MD (Entrance Only) 

Vivian Campbell, R-IV Martha Rudolph, Director (Entrance Only) 

Duncan White, FSME Gary Baughman, P.E., Director 

Stephen Poy, FSME Steve Tarlton, Program Manager 

 Jennifer Opila, HP, Unit Leader 

 Ed Stroud, HP, Inspection Lead 

 James Grice, HP, Licensing Lead 

 James Jarvis, HP, Special Projects 

DISCUSSION: 

The Colorado Agreement State Program is administered by the Radiation Management 

Program (the Program). The Program is part of the Division, within the Department of Public 

Health and Environment (the Department). 

The previous IMPEP review (ML1017903490) was conducted the week of April 12-16, 2010. At 

the conclusion of the review the team found Colorado’s performance to be satisfactory for seven 

of the eight performance indicators reviewed and satisfactory, but needs improvement, for the 

performance indicator, Sealed Source and Device Evaluation Program. The review team made 

four recommendations regarding program performance by the State and kept open one 

recommendation from the previous review. Accordingly, the review team recommended and the 

MRB agreed that the Colorado Program is adequate to protect public health and safety and 

compatible with NRC’s program. Additionally, the MRB agreed with the team’s recommendation 

that the next full IMPEP review should take place in four years. 

The current status of the recommendations identified during the 2010 Colorado final IMPEP 

report are summarized below. 

• The review team recommends that the State develop and implement a policy and 

procedure for the handling, marking, transmitting, and storing of documents containing 

sensitive information. (Section 3.3) (Recommendation also applies to Sections 3.4 

and 3.5) 

Current Status: The Program reported that they have developed a policy and 

implemented procedures specific to the handling, marking, transmitting and storing of 

documents containing sensitive information. They have also trained the staff on the new 

policy and procedures. This was completed and implemented on October 1, 2010. 
Colorado Periodic Meeting Summary 

-2- 

ENCLOSURE 

• The review team recommends that the State evaluate its license termination and 

decommissioning processes to ensure that reviews are appropriate, thorough, and 

consistent. (Section 3.4 of the 2006 IMPEP Review) (Modified in 2010) 

Current Status: The Program reported that they are finalizing procedures related to 

license termination and decommissioning. Once the procedures are finalized, they plan 

to provide staff training. The Program expects to have specific procedures for these two 

program areas in place by June 1, 2012. 

• The review team recommends that the State development and implement guidance that 

outlines the roles and responsibilities for staff and the expectations regarding record 

retention to ensure that the Program’s files are complete and comprehensive. 

(Section 3.4) (Recommendation also applies to Sections 3.5 and 4.4.2) 

Current Status: The Program reported that they are developing a specific policy related 

to records retention which guidance on the types and manner in which records will now 

be maintained; including the use of the Division’s new electronic records system. When 

the guidance is completed, they plan to provide training to staff. The Program expects to 

have specific procedures in place by June 1, 2012. 

• The review team recommends that the State review its implementation of the prelicensing guidance to ensure that all of the essential elements of the guidance are 

consistently met. (Section 3.4) 

Current Status: The Program reported that they reviewed the revised NRC pre-licensing 

guidance and used it to make changes to their documentation where needed, and then 

re-implemented the guidance on September 15, 2010. The Program currently uses a 

pre-licensing checklist similar to NRC’s checklist and now visits all unknown entities. 

The Program also provided training to the staff. 

• The review team recommends that the State establish a means to ensure that SS&D 

evaluations are appropriately documented and conducted with thoroughness; 

consistency with the current version of NUREG-1556, Volume 3; and adherence to 

existing guidance in product evaluations. (Section 4.2.2) 

Current Status: The Program reported they have developed a formal tracking system for 

SS&D reviews and also use current NRC guidance. Reviews are complete and 

documentation is now fully accessible. The Program has removed SS&D sheets from 

license files and placed them into their own files to better track activities. Inactive sheets 

also have been inactivated. The Program expects to have this completed by June 1, 

2012. 
Colorado Periodic Meeting Summary 

-3- 

ENCLOSURE 

Other topics covered at the meeting included. 

Program Strengths: The Colorado Program is a busy program with a highly motivated 

staff that is responsible for the licensing and inspection of 351 specific materials 

licensees. Management support to the Program is outstanding and access to senior 

management is unencumbered. The Program noted that the dedication of their staff to 

making the program successful is a huge strength for them. 

While the Program has experienced several staff losses in recent years mainly due to 

retirements, they have been very successful in filling positions with talented individuals 

bolstering the Program’s already broad knowledge base. Approximately 60 percent of 

the staff has been with the Program less than five years. Staff members work well 

together providing a high level of customer service to their licensees, and Program 

management has worked diligently to ensure that a proper balance is achieved within 

the Program. 

Program Weaknesses: While the Program has experienced success in filling positions 

in the materials program, they have not had as much success in filling a position in their 

uranium recovery program. With the departure of a long time staff member, the Program 

has struggled to find the right person to backfill his position. The uranium recovery 

program takes up a lot of the Program’s resources so filling this position is something 

they are anxious to complete. 

Feedback on NRC’s Program: 

The Program discussed several issues affecting the Program including the following: 

 The Program feels that guidance affecting the uranium recovery program is old and 

outdated. The Program would like to see updated guidance since uranium recovery 

is such a large part of their Program’s activities. 

 The Program expressed their appreciation for the support they receive in the form of 

training from NRC. They further stated that they are having difficulty into certain 

training courses such as the Brachytherapy course. The Program requested that 

NRC expand the number of seats available for Agreement State staff. 

 The Program asked if NRC could broadcast some of the training courses as Webinar 

courses. This would allow additional staff to receive the training without the cost of 

travel. 

 The Program expressed their appreciation for the support they have received from 

NRC staff on the Web Based Licensing (WBL) / Licensing Tracking System (LTS). 

 The Program stated that they receive a lot of information from NRC, with quite a bit 

of it requesting information from the States. With all they have to do, sometimes a 

30 day limit doesn’t give them adequate time to respond. The Program believes it 
Colorado Periodic Meeting Summary 

-4- 

ENCLOSURE 

would be better if NRC could allow them additional time to respond to requests for 

information. 

 The Program stated that a lot of the information received from NRC is not related to 

Program activities. Often these documents involve information related to reactor 

activities. The Program asked if documents such as Regulatory Issues Summary 

documents, FSME letters and Information Notices could be conspicuously marked, 

or the email messages they’re attached to be marked as Reactor or Materials related 

to allow them to quickly sort through them. 

Staffing and training: 

The Colorado Program is a busy program which is divided into several program areas. 

Approximately 60 percent of the staff have been with the program less than five years and 

most are still working towards full qualification in each program area. At the time of the 

meeting, the Program reported they were fully staffed with 13 staff in the materials 

program, but had one vacancy in the uranium program they were working towards filling. 

The status of Agreement State staff members who fail NRC core training courses was 

discussed. Program managers indicated it is their policy to provide other forms of training 

whenever this might occur. 

Program reorganizations: 

 The Program has not been subject to reorganization since the 2010 IMPEP review. 

Changes in Program budget/funding: 

 The Program has not experienced any problems with budgeting or funding. The Program 

is fee funded with the last increase occurring in 2009. The Program is no longer subject to 

furloughs and a requirement for staff to contribute an additional 2.5 percent of their 

salaries to their retirement will come to an end in 2013. Currently, the Program appears to 

be well positioned financially. 

Materials Inspection Program: 

The Program reported that they currently have no overdue inspections although the 

Program reported that most inspections are performed after the due date but before 

becoming overdue (within the + 25% window). Initial inspections are typically performed 

within 12 months of issuance. They continue to inspect reciprocity licensees and have not 

had difficulty performing inspections on at least 20 percent of candidate reciprocity 

licensees. The Program performs Increased Controls inspections concurrent with health 

and safety inspections. Supervisory accompaniments are being conducted by the 

Inspection Program lead and accompaniments of this individual are now performed by the 

Unit Leader. 
Colorado Periodic Meeting Summary 

-5- 

ENCLOSURE 

Licensing Program: 

The Program reported that the licensing program is very active, having issued more 

actions recently than they have over the last five years. They average about 10-15 

terminations each year and currently have 351 specific licenses. The Program also has 

an active General License Program (GL) with approximately 1600 registered devices. 

They do not perform inspections of GL devices currently, but have that as a goal for the 

future. The Program also reported they now use licensing templates to make the process 

more consistent. Licensing meetings are conducted with staff every two months that 

provide the opportunity for sharing information. 

The Program reported they have developed and implemented a formal procedure on how 

they address pre-licensing guidance requirements including pre-licensing visits. Because 

the 2010 IMPEP review team noted inconsistencies in the way pre-licensing actions were 

implemented, the Program revised their pre-licensing guidance and re-implemented it on 

September 15, 2010. The Program now uses a pre-licensing checklist similar to NRC’s 

checklist and now visits all unknown entities. The Program also provided training to the 

staff on this procedure. 

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

The Program reported that the SS&D Program is a small part of their activities with only 

five or less amendments being processed since the 2010 IMPEP review. The Program 

had previously explored returning this part of their Program to NRC, but has since 

committed to maintain it. In response to that decision, they have begun to formalize and 

refresh the Program with the development of new policies and procedures, development of 

a formal tracking system for SS&D reviews and the use current NRC guidance. They 

have found they now have more standardization in their reviews and better retention of 

documentation. The Program has removed SS&D sheets from license files and placed 

them into their own files to better track activities. The Program expects to complete 

implementation of the SS&D Program and to complete the inactivation of all inactive 

sheets by June 2012. 

Uranium Recovery Program: 

At the time of the periodic review, Colorado’s uranium recovery program had regulatory 

oversight of four licenses that are in the process of decommissioning. Three of the 4 sites 

in closure have been remediated and are in the process of NRC concurrence for license 

termination and/or appropriate transfer to the U.S. Department of Energy’s long-term care 

program. The status of each of the site undergoing decommissioning was discussed and 

FSME staff provided a status for those currently with the Commission. The Program 

issued a license to a new conventional mill site, but the operator has not received all their 

permits from other groups within the Department. The license is being challenged in state 

court with the Department awaiting a decision from the court. The Program also 

mentioned that that they anticipate an application for an in-situ recovery facility in the 

future. 
Colorado Periodic Meeting Summary 

-6- 

ENCLOSURE 

Regulations and Legislative changes: 

The Program reported that three legislative packages were finalized following the 2010 

IMPEP review that affected the Program. These included 

 Legislation affecting groundwater contamination at uranium recovery sites. 

 Legislation affecting public comment periods associated with financial assurance. 

 Legislation affecting the Program’s enforcement process increasing penalties. 

The following are regulations that still need to be addressed by the Program. 

• “Minor Amendments,” 10 CFR Parts 20, 30, 32, 35, 40, and 70 amendments (71 FR 

15005), that is due for Agreement State implementation by March 27, 2009. 

• “Medical Use of Byproduct Material – Minor Corrections and Clarifications,” 10 CFR 

Parts 32 and 35 amendments (72 FR 45147, 72 FR 54207), that was due for Agreement 

State implementation by October 29, 2010. 

• “Requirements for Expanded Definition of Byproduct Material,” 10 CFR Parts 20, 30, 31, 

32, 33, 35, 61, and 150 amendments (72 FR 55864), that was due for Agreement State 

implementation by November 30, 2010. 

• “Medical Use of Byproduct Material – Authorized User Clarification,” 10 CFR Part 35 

amendment (74 FR 33901), that is due for Agreement State implementation by 

September 28, 2012. 

• “Decommissioning Planning,” 10 CFR Parts 20, 30, 40, and 70 amendments (76 FR 

35512), that is due for Agreement State implementation by December 17, 2015. 

• “Licenses, Certifications, and Approvals for Materials Licensees,” 10 CFR Parts 30, 36, 

39, 40, 70, and 150 amendments (76 FR 56591), that is due for Agreement State 

implementation by November 14, 2014. 

NRC and Program staff also discussed the State’s progress in addressing the NRC letters dated 

October 13 and 24, 2011 regarding their legislation, uranium recovery regulations and three 

NRC amendments. The Program discussed their approach to addressing the comments raised 

in the letters and have started work on a majority of them. Although clearly committed to 

addressing the legislative comments in the October 24, 2011 letter, the Program described the 

process challenges to expediently addressing the legislative comments. 
Colorado Periodic Meeting Summary 

-7- 

ENCLOSURE 

Event reporting, including follow-up and closure information in NMED.

Since the 2010 IMPEP review, the Program had reported eight events to NMED, with 3 

remaining open. The Program will close the open events when they are able to obtain the 

necessary information. 

Response to incidents and allegations.

The Program continues to be sensitive to notifications of incidents and allegations. 

Incidents are quickly reviewed for their affect on public health and safety. Incidents are 

evaluated for safety significance and staff is dispatched to perform onsite investigations 

whenever possible. 

One item noted during the 2006 IMPEP review and again during the 2010 IMPEP review 

was that the Program did not have formal procedures for the handling of incidents and 

allegations. Following the 2010 IMPEP review, the Program provided staff training for 

handling incidents and allegations. 

Status of allegations and concerns referred by the NRC for action. 

The Program continues to process allegations as they are received. In addition to 

13 allegations received directly by the Program since the 2010 IMPEP review, NRC also 

referred three allegations to the Program. Each of the allegations received by the 

Program have been investigated and closed. The Program continues to be sensitive to 

issues of identity protection regarding allegers. 

Significant events and generic implications. 

The Program reported that the most significant event since the 2010 IMPEP review was a 

medical event at the University of Colorado Hospital. It involved an ablative dose of 

iodine-131, meant for a cancer patient but given to the wrong patient. The Program has 

completed their investigation in this medical event continues to monitor the situation and 

enforcement action will be issued. 

In September 2011, CDPHE issued a compliance order to one of their licensees regarding 

a number of violations including receipt and re-distribution of sources, receipt and analysis 

of sealed radioactive source leak tests and providing services not authorized on their 

license. The licensee was also cited for performing licensed activities at locations not 

authorized on their license including locations in other Agreement States and under NRC 

jurisdiction. CDPHE and the licensee are still negotiating a settlement to the order and the 

proposed monetary penalties and back fees. 
Colorado Periodic Meeting Summary 

-8- 

ENCLOSURE 

Current State Initiatives. 

The Program reported that current initiatives they are involved with include: 

 Implementing the WBL system as their new main database. 

 Specific licensing for Generally Licensed Devices that have activities greater than 

1/10 IAEA Category 3. The Program has been actively doing this for the last year. 

 Applying T-NORM guidance to the collection and disposal of NORM concentrates 

related to drinking water treatment facilities. 

 The new Colorado enforcement policy allowing for larger civil penalties. 

Emerging Technologies. 

The Program reported that new emerging technologies the Program is actively working 

with include: 

 The use of Cardio-Gen generators. 

 The use of iodine-125 seeds for palpable lesions. 

 The Perfexion Gamma Knife. 

 New mining/milling technology proposed by Black Range Minerals. 

Large, complicated, or unusual authorizations for use of radioactive materials.

 The Program reported the following as examples of large and complicated authorizations: 

 Uranium facilities including Energy Fuels Piñon Ridge, Cotter-Cañon City, and 

Hecla-Durita. 

 Cotter-Schwardzwalder Mine – Mining and water treatment systems. 

 The University of Colorado-Denver which is the Program’s only medical Broad 

Scope license. 

 

State’s mechanisms to evaluate performance. 

The Program reported the following as examples of how they evaluate program 

performance: 

 Staff performs self audits twice yearly. 

 Management meets with each staff member twice yearly 

 Inspector accompaniments are performed to ensure they are performing at the 

expected level. 
Colorado Periodic Meeting Summary 

-9- 

ENCLOSURE 

Current NRC initiatives: 

The following NRC initiatives were discussed with the Program: 

 NRC senior management changes (Virgilio, Satorius, McDermott) 

 Region IV senior management changes (Caniano, Vegel) 

 NRC’s inspector qualification program 

 Updates on the NUREG 1556 series revisions 

 Status of the WBL/LTS roll-out 

 The reduction of security levels for LTS 

 NRC’s response to the import of contaminated products 

 Updates on the Adequacy and Compatibility statement out for public comment 

 Status of the MD 5.9 revision 

 Updates to the General License program 

 Status of the Trans-boundary Policy Statement 

 Status of the new Proposed Part 35 revision 

 Status of the revision of Part 61 (LLRW revision) 

 10 CFR 20.2002 Alternate Disposal 

 Updates on NRC’s Safety Culture Policy Statement 

 

Schedule for the next IMPEP review:

 It is recommended that the next IMPEP review to be held on schedule in April 2014.