Report 2007-114 Recommendations and Responses in 2013-041

Report 2007-114: Low-Level Radioactive Waste: The State Has Limited Information That Hampers Its Ability to Assess the Need for a Disposal Facility and Must Improve Its Oversight to Better Protect the Public

Department Number of Years Reported As Not Fully Implemented Total Recommendations to Department Not Implemented After One Year Not Implemented as of 2012-041 Response Not Implemented as of Most Recent Response
Department of Public Health 5 9 9 6 6

Recommendation To: Public Health, Department of

To make certain that it can identify and address existing work backlogs and comply with all of its federal and state obligations, the department should develop a staffing plan for the branch based on current, reliable data. The plan should involve a reevaluation of the branch's assumptions about workload factors, such as how many inspections an inspector can perform annually. The plan should also include the following components:
• An assessment of all backlogged work and the human resources necessary to eliminate that backlog within a reasonable amount of time.
• An assessment of all currently required work and the human resources necessary to accomplish it.

Response

The Radiologic Health Branch (RHB) continues to measure backlogs and ensure compliance with federal and state inspection frequency and quality requirements.

In September 2009, RHB completed a data backlog correction plan. Managers and staff conduct data quality checks using independent and computerized data edit checks. Management evaluates error rates and the need for new procedures to ensure we maintain an error rate of less than 5%.

The Radiation & Certification Section (RCS) found the registration workload was beyond the skills of the staff assigned and upgraded two positions to complete complex registrations. RCS uses a registration procedure known as "Making the Facility Whole." Staff addresses all outstanding requests associated with a facility. This reduces error and rework. RCS tracked all unprocessed registration forms to create an accurate registration inventory. RCS tracked expedites separately from the backlogged work and reduced portions of the backlog that could be addressed quickly.

The X-Ray Inspection, Compliance, and Enforcement (ICE) program crosschecks federal Mammography Quality Standards Act inspection due dates with the US FDA database. The analyst who does all data entry for ICE Inspection performs the cross check, minimizing the opportunity for error. The two inspection reports are checked by the Senior Health Physicist. X-Ray ICE tracks non-mammographic state inspection workload independently from the Health Applications Licensing (HAL) database and cross checks the X-Ray inspection database with HAL. RHB will digitize inspection files to increase reliability and save time. In 2012, RHB hired 3 new X-ray inspection staff. Funding for the new staff resulted from an analysis of the X-ray inspection workload. The X-ray inspection section also implemented a remote inspection program called CARRD that allows an individual facility to perform its own test and return the test kit via mail.

Recommendation To: Public Health, Department of

To inform the Legislature when it is likely to receive the information to evaluate the State's need for its own disposal facility, the department should establish and communicate a timeline describing when the report required by Section 115000.1 of the Health and Safety Code will be available. The department should also see that its executive management and the branch discuss with appropriate members of the Legislature as soon as possible the specific information required by state law that it cannot provide. Further, to the extent that the department cannot provide the information required by law, it should seek legislation to amend the law.

Response

The Radiologic Health Branch (RHB) continues to receive data from California generators and develop reports based on that data. The reports are available for review by the Legislature upon request. RHB completed the 2008 report in January 2011; the 2009 report is still under review. RHB will continue to produce these reports using existing staff time as available. To obtain more complete data and improve the timeliness of the reports, RHB continues to pursue ways to simplify and automate data collection for both low-level radioactive waste (LLRW) generators and RHB staff. RHB is investigating an information technology-based solution that another state has successfully implemented that would allow each LLRW generator to enter its own data using a drop-down box format and send the data to RHB via the Internet. RHB would collate and summarize the data through a programmed algorithm. All of the LLRW annual data elements necessary to meet the report requirements will be included in the IT solution, eliminating any need for legislation.

Recommendation To: Public Health, Department of

To provide greater public transparency and accountability of its decommissioning practices, the department should begin complying with the Executive Order D-62-02 and develop dose-based decommissioning standards formally. If the department believes that doing so is not feasible, it should ask the governor to rescind this 2002 executive order.

Response

Developing a dose-based decommissioning standard following the California Environmental Quality Act (CEQA) process will not enhance or improve current decommissioning standards upheld by the court in the Committee to Bridge the Gap lawsuit. A new, dose-based standard would likely result in protracted litigation and raise uncertainty about the effectiveness of the standards currently in place to protect public health. Following the Court's decision in Committee to Bridge the Gap, CDPH applied a decommissioning process standard under existing law that has consistently provided a more protective public health clean up outcome measure than the U.S. Nuclear Regulatory Commission (NRC) decommissioning standard of 25 millirem (mrem)/year. No cleanup levels following the CDPH process approach federal decommissioning standard. California has consistently achieved a decommissioning level of under 10 mrem/year, with a large majority of the analyses in the non-detectable range. The current process is protective of public health and has not faced legal challenges.

In 2003, CDPH explored the costs of developing and promulgating a CEQA dose-based decommissioning standard. The estimated cost at that time was $5 million, with additional annual costs likely. Because public and environmental health and safety are rigorously protected by the current decommissioning process, CDPH believes pursuing a CEQA-based decommissioning standard is unwarranted.

Recommendation To: Public Health, Department of

When the Radiologic Health Branch has an understanding of the disposal needs for generators in California, it should develop an updated low-level waste disposal plan.

Response

CDPH does not believe an update to the low level waste disposal plan is necessary. CDPH continues to collect data from California's low level radioactive waste (LLRW) producers across the State and makes that data available to legislators and interested parties. The Energy Solution disposal facility in Clive, Utah, is available for California generators of class A LLRW. The Waste Control Specialists LLRW disposal facility located near Andrews, TX is available for California generators of class A, B, and C LLRW. In August 2011, CDPH surveyed California generators about their storage capacity for class B and C LLRW. Based on the survey responses, the storage capacity for class B and C LLRW will last for the next 10 to 20 years provided the options for thermal destruction and the Texas LLRW disposal facility remain available. CDPH remains committed to collecting data and working with the regulated community to inform any future updates that may be necessary to the LLRW disposal plan.

Recommendation To: Public Health, Department of

To ensure that the branch uses sufficiently reliable data from its future data system to manage its inspection workload, the department should develop and maintain adequate documentation related to data storage, retrieval, and maintenance.

Response

RHB has implemented the following systems to store, retrieve, and maintain reliable data that enable RHB to manage the inspection workload:

The RHB X-Ray Inspection, Compliance, and Enforcement (ICE) program instituted a method to crosscheck federal Mammography Quality Standards Act inspection due and overdue dates with the federal database maintained by the U.S. Food and Drug Administration. The first crosscheck of all dates is performed by the analyst who performs all data entry for ICE Inspection. This single point of entry minimizes the opportunity for error. The two reports are checked by the Senior Health Physicist who manages the routine contract management functions. In addition, X-Ray ICE tracks the non-mammographic state inspection workload information independently from the Health Applications Licensing (HAL) database and performs cross checks of the X-Ray inspection database with HAL data to identify missing or erroneous data.

Recommendation To: Public Health, Department of

To ensure that the branch can sufficiently demonstrate that the fees it assesses are reasonable, the department should evaluate the branch's current fee structure using analyses that consider fiscal and workload factors. These analyses should establish a reasonable link between fees charged and the branch's actual costs for regulating those that pay specific fees. Further, the analyses should demonstrate how the branch calculated specific fees.

Response

To ensure a reasonable link between fees charged and the actual costs associated for administering the program, the Radiologic Health Branch (RHB) has completed and continues to review fiscal and workload analyses. We developed and implemented workload standards that identify responsible classifications, tasks to be accomplished, time, and allocated resources (e.g., on an average, one inspector can perform approximately 300 inspections annually). Based on this information, RHB developed cost and revenue information for the various program components and demonstrated that the fees assessed are appropriate and linked to the actual costs associated with administering the programs.

A recent review of RHB revenues and expenditures continues to support the program assessment and the established fee schedule that was set via regulations in 2005. RHB followed methodologies established at that time in determining fees; the Department of Finance approved the methodologies. RHB fees vary widely based on the processes supported by the fees. The RHB X-ray Section registers facilities and certifies and permits users while the RHB Radioactive Materials Licensing Section licenses facilities and operations. The licensing process is specific for each use and those with higher fees require significantly greater staff time to complete the individual action.

RHB recently adopted two new regulations and followed BSA's recommended approach for developing the fees. Supporting documents from the official rulemaking file are available at:

DPH-07-002 (pages 8-10)

http://www.cdph.ca.gov/services/DPOPP/regs/Documents/DPH-07-002-ISOR.pdf

and DPH 10-006 (pages 10-12)

http://www.cdph.ca.gov/services/DPOPP/regs/Documents/DPH_10_006_ISOR_SOD_EIA_DRU_For_PN.doc

Current Status of Recommendations

All Recommendations in 2013-041