UNITED STATES 

NUCLEAR REGULATORY COMMISSION 

REGION IV 

612 E. LAMAR BLVD., SUITE 400 

ARLINGTON, TEXAS 76011-4125 

November IO, 2010 

Gary W. Butner, Branch Chief 

Radiological Health Branch 

Division of Food, Drug & Radiation Safety 

California Department of Health Services 

Sacramento, California 95899-7414 

P.O. BOX 997414, MS-7610 

Dear Mr. Butner: 

A periodic meeting with you and your staff was held on October 13, 201 0. The purpose of this 

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

NRC was represented by Dr. Janine Katanic from the 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 Randv.Erickson@nrc.gov to discuss your concerns. 

Sincerely, ,- 

Randy Erickson 

Regional State Agreements Officer 

Enclosure: 

Periodic Meeting Summary for California 
California Department of Health Services 

-2- 

cc w/e n cI os u re: 

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 

Randy Erickson, SA0 

Rachel Browder, SA0 

Monica Orendi, FSME 

Janine Katanic, FSME 

Michelle Beardsley, FSME 

Karen Meyer, FSME 

MLXXXXXXXXX 

S:\DNMS\!SAO\PeriodicMeetings\201 O\CA\2010 California Periodic Meeting Summary.doc 

Final: 
AGREEMENT STATE PERIODIC MEETING SUMMARY FOR THE 

CALIFORNIA DEPARTMENT OF PUBLIC HEALTH 

NRC Attendees 

Randy Erickson, RSAO 

Janine Katanic, FSME 

_^ll_lll_ll I_x xxIII - -- - I_ I __ ”I 

I 

DATE OF MEETING: OCTOBER 13,201 0 

-- - California Attendees 

Robert Schlag,-Division Chief I 

Gary Butner, Branch Chief 

Gonzalo Perez, Senior Health Physicist 

--- ^- - 

I 

1 John Fassell, Senior Health Physicist 

1 Phillip Scott, Health Physicist 

Ron Rogus, Health Physicist 

I Steve Hsu, Health Physicist 

DISCUSSION: 

1 

9 

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 Branch 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. Additionally, the MRB 

agreed with the team’s recommendation that the next full IMPEP review should take place in 

four years and that a Periodic Meeting be held within one year. 

The initial Periodic Meeting was held on April 29, 2009 (ML091480762). This Periodic Meeting 

covers the period from April 30, 2009 through October 13, 2010. The meeting was conducted in 

lieu of a scheduled Monitoring call with the Branch and therefore includes additional specific 

details of the Branch’s progress on completing each of the recommendations from the 2008 

follow-up IMPEP review. 

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

summarized below. 

0 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) 

ENCLOSURE 
California Periodic Meeting Summary 

Status on April 29, 2009: 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. 

0 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) 

Status on April 29, 2009: 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 it 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. 

Current Status: The Department reported they continue to make progress on the 

regulation backlog. California processes rule packages by “Parts”, such as Part 20 or 

Part 35, instead of by amendments containing several smaller parts similar to the 

manner in which NRC promulgates rules. This method of rule promulgation gives the 

impression that the California program remains seriously behind on regulation 

development, when in fact they continue to steadily implement regulations. The Branch 

completed and filed Part 35 regulations (including some subsequent amendments) with 

the California Secretary of State on the date of the meeting. They will become effective 

on January 1, 201 1. The Branch also reported that the Department’s new rule 

development and promulgation process is working well. The process hasn’t significantly 

reduced the amount of time it takes to promulgate new rules, but it has brought 

efficiencies to the process that have helped the Branch, primarily in the area of 

concurrent processing of rule packages. 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 staff that at the time of the meeting had responsibility for 191 3 specific 

materials licensees. Management support to the Branch is outstanding and access to 

senior management is unencumbered. 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. 

ENCLOSURE 
California Periodic Meeting Summary 

While the Branch continues to experience minor staff losses, they have been very 

successful in filling positions with talented individuals bolstering the Branch’s already 

broad knowledge base. The Branch has successfully integrated the added workload 

associated with Increased Controls, as well as fingerprinting and NSTS 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 Branch. 

Program Weaknesses: The Branch was previously a strong supporter of staff 

involvement in NRC working groups and participation on IMPEP teams; however, due to 

the state’s economic downturn and the high negative visibility associated with sending 

staff out of state to participate in these activities, senior management has restricted 

travel for both. Additionally, for approximately the last year, staff has been restricted 

from traveling out of state to attend NRC training courses. Because of this, Region IV 

has coordinated with TTC to bring the licensing and inspection procedures courses to 

California. Additionally, furloughs have now been in place for over a year and continue 

for the staff at the rate of three days per month. 

Feedback on NRC’s Program: 

The Branch discussed issues associated with environmental remediation of several 

Department of Defense facilities located in California, but the majority of the Branch’s 

concerns are focused on clean-up activities at the former Treasure Island Naval Station 

(Treasure Island), a Base Realignment and Closure (BRAC) site undergoing 

decommissioning. The Branch discussed their concerns about jurisdiction of Treasure 

Island both prior to and during the Periodic Meeting. The Branch has experienced 

difficulty in determining who (the State, the NRC or someone else) is responsible for 

oversight of ongoing environmental remediation activities involving byproduct materials 

at the site, and has also experienced difficulties in obtaining access to the site. 

Subsequent to the meeting, Region IV staff was able to confirm with the Navy Master 

Materials License (MML) Project Manager that NRC has no jurisdiction on the site at this 

time. This is because the only material identified at Treasure Island thus far has been 

radium, and due to current NRC policy regarding military use. This was conveyed to the 

Branch telephonically on October 20, 201 0. The Branch reported that on October 27, 

201 0, staff members from the Branch would be provided escorted access to the site by 

members of the Naval Radiological Affairs Support Office (RASO) and BRAC so that the 

Branch could perform independent radiological surveys. 

The Branch expressed their concerns about requests by the Domestic Nuclear Detection 

Office (DNDO) for access to licensee information contained in the Branch’s licensee 

database. DNDO provided the Branch with a Memorandum of Understanding (MOU) 

detailing the access needed. As of the date of the meeting, the Branch has not 

responded to DNDO’s request. They are uncomfortable providing specific licensee 

information to anyone outside of direct coordination with, or working through NRC. 

ENCLOSURE 
California Periodic Meeting Summary 

-4- 

Staffing and training: 

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

The Branch has an average of 150 total staff members with approximately one third of 

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

the Branch reported they were fully staffed but anticipated losing one licensing reviewer in 

the near future. In addition to hiring experienced staff, the Branch also aggressively 

recruits from local universities, and continue to do so. The Branch continues to assess 

their staffing needs which are in part, dependent on additional requirements placed upon 

them by NRC. 

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

discussed. Branch managers indicated it is their policy to provide other forms of remedial 

training whenever this might occur. They discussed one staff member who recently failed 

NRC’s “Transportation of Radioactive Materials” course (H-308). They worked with this 

individual, providing alternate methods of training until they were satisfied the individual 

was sufficiently capable of understanding and applying DOT regulations. 

Program reorganizations: 

The Branch has not been subject to reorganization since the last meeting. A change in 

the Governor’s office will occur with the upcoming election, but this is not expected to 

result in Department reorganization. Since the last meeting, the Branch rotated the 

individuals occupying the positions of Chief of the Radioactive Materials Inspection, 

Compliance and Enforcement Section, and Chief of the Strategic Planning and Quality 

Assurance Section to each other’s position. 

C h a n g e s i n P rog ram b u dg et/f u n d i n 9: 

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

fee funded. The FYI 1 budget has been passed by the legislature. The only issue that 

has affected the Branch irrespective of their funding levels is the overriding requirement 

that all state government offices close three days per month which has had a net effect of 

an approximate 15 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 the allowed +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 (IC). At the time of the meeting, the Branch reported they currently have 138 IC 

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

ENCLOSURE 
California Periodic Meeting Summary 

-5- 

inspections to perform but during the April 2009 meeting reported that all IC inspections 

had been completed. Also during that meeting the Branch noted that all but three 

licensees had completed the fingerprinting implementation. All fingerprinting requirements 

have now been implemented. IC inspections are now performed in conjunction with 

routine health and safety inspections. Fingerprinting and NSTS requirements are also 

reviewed at the time of inspection. 

Increased ControIslFingerprinting files are locked in uniquely keyed file cabinets and are 

not subject to release under FOIA. 

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

they address pre-licensing guidance requirements including pre-licensing visits. At the 

time of the April 2009 meeting, the Branch stated that only new IC licensees received a 

site visit. During this meeting the Branch stated that all new licensees now receive a prelicensing visit. Additionally, a non-IC licensee who requests an increase in license 

authorization that now subjects them to IC requirements also receives a pre-licensing visit, 

even though the Branch has a relationship with the licensee. 

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 large number of overdue amendments. The period of Heightened 

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

months, quarterly calls with the Branch were conducted to update NRC on the Branch’s 

progress towards compatibility with NRC’s program. The most recent Monitoring call with 

the Branch took place on June 9, 2010 (ML1016601 IO). At the time of that call, the 

Branch reported on the remaining 11 out of the original 13 outstanding amendments. 

During the Periodic Meeting, the Branch confirmed that on October 13, 201 0, Part 35 

(medical) regulations had been adopted and had been filed with the Secretary of State. 

These regulations will become effective for licensees on January 1 , 201 1, and licensee 

workshops for Part 35 are scheduled for early December 2010 in both northern and 

southern California. The adoption of Part 35 resulted in the completion of three 

amendments and the partial completion of four additional amendments. The remaining 

eight amendments continue to work their way through the rulemaking process. 

The incompatibility of legislation found in Section 1 15261 of California’s “Health and Safety 

Code - Radiation Control Law” to NRC’s 10 CFR Part 61 with regards to low-level 

radioactive waste disposal was also discussed with the Branch. This incompatibility was 

initially noted in an amendment submission to NRC on June 25, 2007. At that time, NRC 

notified the Branch that their statute was more restrictive than 10 CFR 61.41, and 

therefore did not meet the Compatibility “A designation assigned to the rule. To date this 

compatibility issue has not been resolved. On November 3, 2010, the Branch notified 

NRC by telephone and email that they will be requesting additional time to resolve the 

issue due to the upcoming change in administration following the 201 0 elections 

(MLI 031 40535). 

ENCLOSURE 
California Periodic Meeting Summary 

-6- 

As noted in the Discussion section of this summary, a scheduled Monitoring meeting with 

the Branch was held in conjunction with the Periodic Meeting, and therefore this section 

includes additional specific details of the Branch’s status of overdue amendments. 

0 “Quality Management Program and Misadministration,” IO CFR Part 35 amendment (56 

FR 34104), that was due for Agreement State implementation on January 27, 1995. 

Status: This amendment has been completed. It was adopted on October 13, 2010. 

0 “Timeliness in Decommissioning of Materials Facilities,” 10 CFR Parts 30, 40, and 70 

amendments (59 FR 36026), that was due for Agreement State implementation on 

August 15, 1997. 

Status: This amendment remains open. This amendment is tied to the amendment, 

“Radiological Criteria for License Termination,” noted below. 

0 “Medical Administration of Radiation and Radioactive Materials,” 10 CFR Parts 20 and 

35 amendments (60 FR 48623), that was due for Agreement State implementation on 

October 20, 1998. 

Status: This amendment has been completed. The Part 20 portion of this amendment 

was adopted on September IO, 1998. The Part 35 portion of this amendment was 

adopted on October 13, 2010. 

0 “Recognition of Agreement State Licenses in Areas under Exclusive Federal Jurisdiction 

within an Agreement State,” 10 CFR Part 150 amendment (62 FR 1662), that was due 

for Agreement State implementation on February 27, 2000. 

Status: This amendment remains open. The Branch has completed the 45-day public 

comment period. Based on comments received, they are about to place the amendment 

out for an additional 15-day comment period. 

0 “Criteria for the Release of Individuals Administered Radioactive Material,” 10 CFR Parts 

20 and 35 amendments (62 FR 4120), that was due for Agreement State implementation 

on May 29,2000. 

Status: This amendment remains open. The Part 35 portion of this amendment was 

adopted on October 13,2010. The Part 20 portion of this amendment has been filed 

with the Office of Administrative Law for review. The review has a deadline of November 

23, 2010. 

ENCLOSURE 
California Periodic Meeting Summary 

-7- 

0 “Radiological Criteria for License Termination,” 10 CFR Parts 20, 30, 40, and 70 

amendments (62 FR 39057), that was due for Agreement State implementation on 

August 20,2000. 

Status: This amendment remains open. The 10 CFR Part 20 portion of the regulation 

was adopted and then challenged in State court by “The Committee to Bridge the Gap, 

et al.” The challenge was successful, and the “Radiological Criteria for License 

Termination” portion of the regulation was repealed on August 8, 2002. The Branch is 

currently terminating licenses on a case-by-case basis. 

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

35, and 36 amendments (63 FR 39777 and 63 FR 45393), that was due for Agreement 

State implementation on October 26, 2001, 

Status: This amendment remains open. The Part 35 portion of this amendment was 

adopted on October 13, 2010. The Part 36 portion of this amendment was completed by 

License Condition. The Part 20 portion of this amendment has been filed with the Office 

of Administrative Law for review. The review has a deadline of November 23, 2010. 

0 “Requirements for Certain Generally Licensed Industrial Devices Containing Byproduct 

Material,” 10 CFR Part 30, 31 , and 32 amendments (65 FR 79162), that was due for 

Agreement State implementation on February 16, 2004. 

Status: This amendment remains open. The Branch has completed the 45-day public 

comment period. Based on comments received, they are about to place the amendment 

out for an additional 15-day comment period. 

0 “Medical Use of Byproduct Material,” 10 CFR Parts 20, 32, and 35 amendments (67 FR 

20250), that was due for Agreement State implementation on October 24, 2005. 

Status: This amendment remains open. The Part 35 portion of this amendment was 

adopted on October 13,2010. The Part 20 portion of this amendment has been filed 

with the Office of Administrative Law for review. The review has a deadline of November 

23, 2010. 

0 “Medical Use of Byproduct Materials - Recognition of Specialty Boards - Part 35,” 

10 CFR Part 35 amendment (70 FR 16336 and 71 FR 1926), that was due for 

Agreement State implementation on April 29, 2008. 

Status: This amendment has been completed. It was adopted on October 13, 2010. 

ENCLOSURE 
California Periodic Meeting Summary 

-8- 

“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. 

Status: This amendment remains open. The Part 35 portion of this amendment was 

adopted on October 13, 2010. The Part 20 portion of this amendment has been filed 

with the Office of Administrative Law for review. The review has a deadline of November 

23, 2010. Changes for Parts 30, 40 and 70 are compatibility Category D so they are not 

being addressed. Change to Part 32 is already addressed through the licensing review 

process. 

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

Between the date of the 2008 IMPEP review and the April 2009 Periodic Meeting, the 

Branch had reported 129 events to NMED, with 72 remaining open. The majority of those 

events were landfill radiation monitor alarm trips. Between the April 2009 meeting and 

October 13, 2010, the Branch reported 143 events to NMED, with 56 remaining open. The 

Branch continues to monitor open events and closes them as rapidly as possible. Their 

goal for event closure is I20 days from the date of the event. 

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. Incidents are 

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

whenever possible. The Branch has taken the position that if they demonstrate 

responsiveness to incidents and allegations, no matter how trivial they might be, licensees 

and individuals will realize that reporting incidents and allegations should be important to 

them as well. 

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

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

allegations received by the Branch directly, since the 2009 Periodic Meeting, NRC has 

referred two allegations to the Branch. One did not require a response to NRC; the other 

was immediately investigated by the Branch and a response to NRC was generated within 

a week. The Branch continues to be sensitive to issues of identity protection regarding 

allegers. 

Significant events and qeneric implications. 

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

new significant events have originated following the 2008 IMPEP review. One specific 

issue noted was the Branch’s tracking of radioactive materials being sold on Ebay. 

ENCLOSURE 
California Periodic Meeting Summary 

-9- 

Current State Initiatives. 

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

The Branch also noted they continue to work with RASO and BRAC on the environmental 

remediation of various former military installations within the State. Specifically, the 

Branch is concerned with clean-up of Treasure Island, and to a lesser extent Hunter’s 

Point. 

Emerqinq Technologies. 

Nothing specific noted. 

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

Nothing specific noted. 

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 NRC initiatives with the Branch. These included in part, 

NRC’s draft safety culture policy statement, web based licensing, NSTS, the NUREG 1556 

revision process, the revisions to IMC 2800, the proposed Part 37 and accompanying 

guidance document, and potential changes to Part 20. 

Sum marv: 

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

issues that were initially facing them. While the rulemaking process in California continues 

to be a cumbersome and sometimes difficult regulatory process, the Branch has taken 

advantage of some of the recent changes in the process that allow for concurrent 

streaming of regulations which allows them to get regulatory packages out sooner. While 

the Branch has completed several amendments and partially closed others, they still have 

several to complete. It is recommended that the Management Review Board consider 

continuing the period of Monitoring for the California Program until the next IMPEP review. 

Schedule for the next IMPEP review: 

It is recommended that the next IMPEP review to be held on schedule in April 2012. 

ENCLOSURE