UNITED STATES

NUCLEAR REGULATORY COMMISSION

R EGI ON IV

612 E. LAMAR BLVD., SUITE 400

ARLINGTON, TEXAS 76011-4125

May 28, 2009 

Gary W. Butner, Branch Chief 

Radiological Health Branch 

Division of Food, Drug & Radiation Safety 

California Department of Health Services 

P.O. Box 997414, MS-7610 

Sacramento, California 95899-7414 

Dear Mr. Butner: 

A periodic meeting with you and your staff was held on April 29, 2009. The purpose of this 

meeting was to review and discuss the status of the California Agreement State Program. The 

NRC was represented by Mr. Arthur Howell from NRC’s Region IV office, Mr. William Rautzen 

from NRC’s Office of Federal and State Materials and Environmental Management Programs 

(FSME), and me. I have completed and enclosed a general meeting summary, including any 

specific actions resulting from the discussions. 

In addition to a discussion of general topics associated with your program, discussions to 

ascertain the status of overdue regulations specific to your status under Monitoring was 

performed. This will replace your upcoming Monitoring call with NRC and the next call will be 

held in 4 months. 

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) 860-8143 or 

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

 Sincerely, 

 /RA/ 

 

 Randy Erickson 

 Regional State Agreements Officer 

Enclosure: 

Periodic Meeting Summary for California 
California Department of Health Services 

-2- 

cc w/enclosure: 

Robert Schlag, M.Sc. 

California Department of Public Health 

Division of Food, Drug & Radiation Safety 

1500 Capitol Avenue, Suite 72.524 

P.O. Box 997377, MS7600 

Sacramento, California 95899-7377 
California Department of Health Services 

-3- 

bcc (via e-mail distribution): 

Arthur Howell 

Chuck Cain 

Robert Lewis, FSME 

Terry Reis, FSME 

James Luehman, FSME 

Duncan White, FSME 

Linda McLean 

Randy Erickson 

Aaron McCraw, FSME 

Janine Katanic, FSME 

William Rautzen, FSME 

Kathleen Schneider, FSME 

Monica Orendi, FSME 

 

 ML091480762 

S:\DNMS\!SAO\PeriodicMeetings\2009\CA\2009 California Periodic Meeting Summary.doc 

Final: S:\DNMS\Ltrs-Memos\2009 California Periodic Meeting Summary.doc 

ADAMS 9 Yes  No ; SUNSI Rev 

Complete 

Reviewer Initials: RRE 

Publicly Available 9 Yes  No Non Sensitive 

RIV: RSAO 

RRErickson 

 /RA/ 

5/28/09 

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

AGREEMENT STATE PERIODIC MEETING SUMMARY FOR THE 

CALIFORNIA DEPARTMENT OF PUBLIC HEALTH 

DATE OF MEETING: APRIL 29, 2009 

NRC Attendees California Attendees

Randy Erickson, RSAO Robert Schlag, Division Chief 

Arthur Howell, Division Director Gary Butner, Branch Chief 

William Rautzen, FSME Gonzalo Perez, Senior Health Physicist 

 Victor Anderson, Senior Health Physicist 

 Phillip Scott, Health Physicist 

 Marilyn Willis, Regulation Services 

 Peter Sapunor, Senior Staff Council 

DISCUSSION: 

The Radiological Health Branch (the Branch), located within the Division of Food, Drug, and 

Radiation Safety (the Division), administers the California Agreement State Program. The 

Division is a part of the Department of Public Health (the Department). 

The previous IMPEP review was conducted the week of March 31 – April 4, 2008. At the 

conclusion of the review the team found California’s performance to be satisfactory for six 

performance indicators and unsatisfactory for the performance indicator Compatibility 

Requirements. The review team made two recommendations regarding Program performance 

and identified one good practice. Accordingly, the review team recommended and the MRB 

agreed that the California Program is adequate to protect public health and safety and not 

compatible with NRC’s program. The MRB also concluded that the period of Heightened 

Oversight should end and a period of Monitoring should be initiated. The MRB also concluded 

that the next full IMPEP review should take place in four years and that a Periodic Meeting be 

held within one year. 

The proposed status of the recommendations from the 2008 California final IMPEP report is 

summarized below. 

• The review team recommends that the State reevaluate its justification for inspecting 

HDR licensees on a 3-year interval and demonstrate that the health, safety, and security 

of HDR devices are not compromised. (Section 3.2) 

Current Status: The Branch has changed the frequency of HDR inspections from a 

3-year interval to a 2-year interval to be compatible with NRC’s frequency. This 

recommendation should be verified and closed at the next IMPEP review. 
California Periodic Meeting Summary 

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ENCLOSURE 

• The review team recommends that the Branch develop and implement an action plan to 

adopt NRC regulations in accordance with the current NRC policy on adequacy and 

compatibility. (Section 4.1.2) 

Current Status: The Department recognized that the rulemaking process in place at the 

time of the 2008 IMPEP review was inefficient and needed revision. In response to that 

need, the Department hired a consulting firm to assess the rulemaking process and 

make recommendations on how to improve the process within the confines of state law. 

The consulting firm made recommendations to the Department, and in December 2008 

the Branch in coordination with the Office of Regulations, drafted an Action Plan to 

streamline the Branch’s rulemaking process. Additionally, they implemented a team 

approach to development and promulgation of regulations and are now just beginning to 

follow the Action Plan. More time will be needed to fully evaluate the effectiveness of 

this approach. This recommendation remains open and should be evaluated at the next 

IMPEP review. 

Other topics covered at the meeting included. 

Program Strengths: The California Program is a large and busy program with a highly 

motivated and progressive staff that has approximately 2000 licensees. As a result of 

the Heightened Oversight process, funding has not been a problem, even with the 

State’s well publicized financial issues. Management support to the Branch is 

outstanding and access to senior management is unencumbered. Two senior managers 

have offices on the same floor as the Branch. The close physical location allows easy 

access to both Branch and Division management and allows managers to be more 

intimately involved in staff activities. 

While the Branch had experienced some staff losses, it has successfully filled those 

positions with talented individuals bolstering the Program’s already broad knowledge 

base. The Branch supports staff involvement in NRC working groups and encourages 

participation on IMPEP teams. The Branch has successfully integrated the added 

workload associated with Increased Controls and Fingerprinting requirements. Staff 

members work well together providing a high level of customer service to their licensees, 

and Branch management has worked diligently to ensure that a proper balance is 

achieved within the program. 

Program Weaknesses: The Branch noted issues with obtaining training for the newly 

hired staff. Because of staff depth within the program, newly hired individuals often have 

to wait to get into classes because other programs with less depth have been identified 

as having a more serious need. They identified this as an issue, but have been able to 

manage staff training successfully. 
California Periodic Meeting Summary 

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ENCLOSURE 

Feedback on NRC’s Program: 

The Branch discussed issues associated with clean up of Department of Defense 

facilities; low level radioactive waste disposal including questions associated with the 

jurisdiction of mixed waste from Antarctica returning to the United States; issues 

associated with NRC review of regulation packages, and compatibility questions 

regarding a burial site that communicates with the Colorado River; and, questions about 

what NRC public meetings would be beneficial for the Branch to listen to. These 

questions are being answered separately. 

Staffing and training: 

The California Program is a large program which is divided into several program areas. 

The Branch has an average of 147 total staff members with approximately 50 of those 

being associated with the radioactive materials program. At the time of the meeting, the 

Branch reported they were fully staffed. They have aggressively recruited from local 

universities in addition to hiring experienced staff. The Branch recently lost the senior 

member in the Brea office, but has recently filled that position. The Branch continues to 

assess their staffing needs which tend to be dependent on additional requirements placed 

upon them by NRC. 

Program reorganizations: 

 The Branch has not experienced any program reorganizations since the previous IMPEP 

review and none are expected. 

Changes in Program budget/funding: 

 The Branch has not experienced any problems with budgeting or funding. The Branch is 

fee funded. The only issue that has affected the program irrespective of their funding 

levels is the overriding requirement that all state government offices close two days per 

month which has had a net effect of a 10 percent pay cut to all employees. 

Materials Inspection Program: 

The Branch reported that they currently have no overdue inspections. Routine inspections 

are generally performed by the due date, but occasionally inspections are performed 

within a +25 percent 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 Branch initially identified 140 licensees who were required to implement Increased 

Controls. At the time of the 2008 IMPEP review, the Branch still had 12 of these 

inspections to perform but now report that all Increased Controls inspections have been 

completed. The Branch also reported that all but three licensees have completed the 
California Periodic Meeting Summary 

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ENCLOSURE 

fingerprinting implementation. Increased Controls/Fingerprinting files are locked in 

uniquely keyed file cabinets and are not subject to release under FOIA. 

The Branch reported they have a process in place for addressing pre-licensing guidance 

requirements and are currently developing a formal procedure. The Branch stated that at 

the present time only new Increased Controls licensees currently receive a site visit. 

Regulations and Legislative changes: 

During the 2008 follow-up IMPEP review, the Branch was found to not be compatible with 

NRC’s program due to number of late regulations. The period of Heightened Oversight 

was terminated and a period of Monitoring had been initiated. Over the successive 

months, calls with the Branch have been held to update NRC on their compatibility with 

NRC’s program. The most recent call with the Branch occurred on February 17, 2009. At 

the time of the call, the Branch still had 13 outstanding regulations. During the Periodic 

Meeting, the Branch confirmed that two regulations were scheduled to become effective 

on May 24, 2009. The remaining regulations continue to work their way through the 

process. 

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

The Branch had reported 129 events to NMED since the 2008 IMPEP review with 72 still 

open. The majority of events are landfill alarm trips. The Branch is monitoring the open 

events and closing them as information to close them becomes available. 

Response to incidents and allegations.

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

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

dispatched to perform onsite investigations when necessary. The Branch Manager has 

placed a high emphasis on maintaining an effective response to incidents and allegations. 

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

While the Branch processed several allegations since the 2008 IMPEP review, no 

allegations were formally referred by NRC during the same period. 

Significant events and generic implications. 

While the Branch continues to monitor several significant events, they reported that no 

new significant events have originated following the 2008 IMPEP review. 
California Periodic Meeting Summary 

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ENCLOSURE 

Current State Initiatives. 

The Branch noted that furloughs continue. No specific end date has been identified. Due 

to budget shortfalls, the State has begun a round of layoffs. The Branch is uncertain if the 

layoffs will affect them. 

 

Emerging Technologies. 

None noted. 

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

 The Branch identified pipeline decommissioning work on Bureau of Land Management 

lands as a non-standard project they are working. 

State’s mechanisms to evaluate performance. 

Branch managers review performance reports involving licensing actions, inspections 

performed, incidents reported, and reports reviewed. 

Inspector accompaniments are also performed to ensure they are performing at the 

expected level. 

Current NRC initiatives: 

NRC staff discussed ongoing initiatives with the Branch. These included pre-licensing 

guidance, fingerprint orders, national source tracking, web based licensing, generally 

licensed devices, and the issues associated with tritium exit signs. 

Summary:

 The Branch appears to have spent a significant amount of time and effort to correct the 

issues that were initially facing the Program. The remaining recommendation involving 

Compatibility Requirements continues to be a challenge for the Branch. While a 

cumbersome and often difficult regulatory process is being revised, the Branch has not 

demonstrated a sustained period of success in implementing regulations. For that reason, 

it is recommended that the Management Review Board consider continuing the period of 

Monitoring for the California Program and have another Periodic Meeting with the Program 

in approximately 18 months. 

 

Schedule for the next IMPEP review:

 It is recommended that the next IMPEP review to be held on schedule in three years.