Report 2007-114 All Recommendation Responses

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 (Release Date: June 2008)

Recommendation #1 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.

Annual Follow-Up Agency Response From August 2015

RHB has implemented the following systems to store, retrieve, & maintain reliable data that enable RHB to manage the inspection workload: Certification/Registration- Health Application Licensing (HAL). RHB has implemented several procedures to minimize data integrity issues with HAL. First, CSA had discovered that records appeared to be in open status but were actually no longer eligible for renewal. All X-ray Technician Limited Permits (prefix RHP) & all Supervisor & Operator Certificates/Permits with expiration dates prior to January 1, 2007 were administratively revoked in HAL. These records now reflect the following: Primary Status Code 9 & Renewal Process Code V. The status code "9V" indicates that the certificate/permit has been administratively revoked & not eligible for reinstatement. Secondly, in order to help ensure that HAL data is accurately reflected, HAL procedures were implemented to help ensure that HAL data was correctly & accurately input. For example, The Request for Information procedure formally puts into place a process for staff to change, delete or add data into HAL. The Staff Access procedure formally puts into place the process of allowing a staff member to access HAL with read/write privileges. Only properly trained & experienced staff are given these rights. Finally, the Change Request Procedure formally puts into place the process of requesting ITSD to perform a business operational programming change in HAL. The ICE X-ray section has also implemented two new procedures to ensure that inspections are performed within their allotted time. The MQSA procedure requires the CAMIS data base be cross checked against the FDA's data base. The inspection dates are verified & validated that they match. Also, the ICE X-ray internal access data base where inspection data is recorded & stored, such as the last inspection date, is cross checked against the HAL last inspection date to verify that they match.

California State Auditor's Assessment of Annual Follow-Up Status: Resolved

Annual Follow-Up Agency Response From October 2014

The status of this recommendation is unchanged.

California State Auditor's Assessment of Annual Follow-Up Status: Not Fully Implemented

Annual Follow-Up Agency Response From October 2013

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.

California State Auditor's Assessment of Annual Follow-Up Status: Not Fully Implemented

The department asserts that it has developed controls to improve the quality of the data in its computer systems. However, the department did not provide evidence of this control actually being used in practice.

Annual Follow-Up Agency Response From September 2012

The California Department of Public Health (CDPH) agrees with the Bureau of State Audits; CDPH Radiologic Health Branch (RHB) will make functional system modifications to address data reliability and quality concerns with existing systems. CDPH has continued to take specific quality control steps on the existing data in the Health Application Licensing (HAL) system to identify and subsequently correct any anomalies. The status of RHB's implementation of this recommendation is noted below.

1) a. To assist in decisions on managing data reliability and quality

i. Completed; does not require status update.

ii. Completed; does not require status update.

iii. Completed; does not require status update.

iv. Change Request (CR) in progress include the following:

1. Implementing delinquent billing for licentiates

a. Completed April 2011

2. Implementing delinquent billing for nuclear medicine

a. Completed April 2011

3. Correcting fee cap issue on facility renewals

a. Corrected November 2010

4. Correcting association issues with specific license types

a. RHB has determined that the workload associated with correcting technologist association issues requires a review of approximately 19,000 hard copy files to determine what licensing database updates are needed. Therefore, RHB will submit a request for information to the CDPH Information Technology Services Division to determine a process to administratively inactivate technologists. The estimated date of completion is December 31, 2013.

5. Inactivating expired certificate records

a. RHB has submitted CRs to administratively inactivate certificate records for licentiates and limited permit technicians. The estimated date of completion is December 31, 2012.

California State Auditor's Assessment of Annual Follow-Up Status: Not Fully Implemented

Recommendation #2 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.

Annual Follow-Up Agency Response From June 2018

The Radiological Health Branch (RHB) completed an independent workload study using workload time expectancies and the sustainability of current fees linked to these time expectancies. This study analyzed the work being done by non-management positions in 15 functional units located across six programmatic sections of RHB. This report presents the development and validation of reasonable time expectancies for required work in each program unit and the sustainability of the corresponding fee structure related to the work outputs by utilizing historical work records, structured task measurements, and supplemental time/data collection tools. The workload study utilized a systematic methodology to ensure that the fee structure and its calculations are based using fiscal and workload factors. To accomplish this, a standardized task list for each of the work units was developed first. Next, a plan was developed to collect multiple sources of data using a self-report time log to collect real-time data as well as a long-term estimation form to capture time estimations for tasks not performed during the time log period. Extensive review of the real-time data and task-time estimation by each unit supervisor was also performed to ensure data accuracy and quality. The results of the analysis demonstrate the link between the fees charged and the actual program costs that are recovered by RHB.

California State Auditor's Assessment of Annual Follow-Up Status: Fully Implemented

Annual Follow-Up Agency Response From May 2017

The Radiologic Health Branch (RHB) has contracted with a professional organization to perform a workload quantitative analysis (QA) on all of the programs operations. The scope of work for this project includes calculating reasonable time expectancies for each program task. The QA will demonstrate the link between the fee and the cost for regulating those subject to the fee. Estimated completion time and issuance of the final report is October 2017.

California State Auditor's Assessment of Annual Follow-Up Status: Pending

Annual Follow-Up Agency Response From May 2016

The Radioactive Health Branch (RHB) has partially addressed the California State Audits (CSA) recommendation by implementing a quantitative analysis on future regulation packages, where fees were involved, as evidenced in two fee packages shown in the following links. The 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. These regulation packages demonstrate the commitment from RHB to implement the fee analysis recommended by CSA. RHB does, and will continue, to consider fiscal and workload factors by performing a quantitative analysis (QA) for all future regulations that include fee proposals. Documentation includes how the fee is developed and calculated, demonstrating the link between the fee and the cost for regulating those that would be subject to the fee. In addition, the RHB is investigating the possibility of hiring a contractor to assist in a QA project for all of the fees shown on page 53 of the CSA audit report, with the expectation of having the project completed in 2017.

California State Auditor's Assessment of Annual Follow-Up Status: Not Fully Implemented

Annual Follow-Up Agency Response From October 2014

The status of this recommendation is unchanged.

California State Auditor's Assessment of Annual Follow-Up Status: Not Fully Implemented

Annual Follow-Up Agency Response From October 2013

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

California State Auditor's Assessment of Annual Follow-Up Status: Not Fully Implemented

Although the department provided more transparency for how it determined the amounts for two fees it implemented following our audit, a significant portion of its fee structure remains unchanged since our audit. The department provided no evidence that it evaluated the fees we originally discussed in the audit report.

Annual Follow-Up Agency Response From September 2012

The California Department of Public Health (CDPH) disagrees with the auditor's determination that this recommendation is not fully implemented. CDPH believes it has fully implemented this recommendation and resubmits its response from last year.

CDPH Radiologic Health Branch (RHB) completed its evaluation of workload and staffing data. To ensure a reasonable link between fees charged and the actual costs associated for administering the program, CDPH-RHB has completed and continues to conduct routine thorough fiscal and workload analysis. Workload standards were developed and implemented 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, CDPH-RHB developed cost and revenue information for the various program components and demonstrated that the fees assessed are appropriate and have a link to the actual costs associated with administering the programs.

A recent review of CDPH-RHB revenues and expenditures continues to support the program assessment and the established fee schedule.

In addition, to ensure transparency and accountability when submitting future fee proposals for adoption CDPH-RHB initiates a fiscal and workload analysis for the particular fee proposal. For example, CDPH-RHB recently adopted regulations requiring users of certain devices that contain radioactive material to register as possessing the device and to pay an annual registration fee. The adoption of these regulations also pertained to maintaining regulatory compatibility with the U.S. Nuclear Regulatory Commission (NRC) as required by California's agreement with NRC and as specified in law. The following supporting documents, from the official rulemaking file can be accessed at: http://www.cdph.ca.gov/services/DPOPP/regs/Pages/DPH07-002GeneralLicenseRequirements.aspx:

1. Notice of Proposed Rulemaking

2. Initial Statement of Reasons

3. Proposed Regulation text

The following supporting document is attached to this response:

4. STD-399 including the Cost Estimating Methodology signed by CDPH, Health and Human Services Agency, and the Department of Finance.

California State Auditor's Assessment of Annual Follow-Up Status: Not Fully Implemented

Recommendation #3 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.

Annual Follow-Up Agency Response From June 2018

The Radiological Health Branch (RHB) completed an independent study of existing workload time expectancies, the sustainability of current fees linked to these time expectancies, and recommendations for changes to future staffing levels. This study analyzed the work being done by non-management positions in 15 functional units located across six programmatic sections of RHB. The study reviewed current program work backlogs and developed and validated reasonable time expectancies for required work in each program unit as related to the work outputs by utilizing historical work records, structured task measurements, and supplemental time/data collection tools. Based on this data collection and validation methodology, actual staffing levels needed across the entire program were developed. The outcome of the study demonstrates the program staffing needs, assesses the quantity of backlogged work, and the human resources needed to accomplish that work as well as all routine program work. The RHB will evaluate the results of the study.

California State Auditor's Assessment of Annual Follow-Up Status: Fully Implemented

Annual Follow-Up Agency Response From May 2017

The Radiologic Health Branch (RHB) has contracted with a professional organization to perform a workload quantitative analysis (QA) on all of the programs operations. The scope of work for this project includes reasonable time expectancies for each program task including inspections, application processing and other vital program workloads. Estimated completion time and issuance of the report is October 2017.

California State Auditor's Assessment of Annual Follow-Up Status: Pending

Annual Follow-Up Agency Response From May 2016

In 2015, the X-Ray Inspection, Compliance, and Enforcement program completed a staffing review. This review shows that by July 1, 2016, assuming that no current staff are lost through retirement or transfer, inspection staffing levels will be sufficient to meet workload demands. In addition, the Radioactive Health Branch will perform a branch workload and staffing quantitative analysis.

California State Auditor's Assessment of Annual Follow-Up Status: Not Fully Implemented

Annual Follow-Up Agency Response From October 2014

The status of this recommendation is unchanged.

California State Auditor's Assessment of Annual Follow-Up Status: Not Fully Implemented

Annual Follow-Up Agency Response From October 2013

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.

California State Auditor's Assessment of Annual Follow-Up Status: Not Fully Implemented

The department's response claims that it developed a data backlog correction plan in September 2009. However, the department did not include this plan with its response.

Annual Follow-Up Agency Response From September 2012

The California Department of Public Health (CDPH) disagrees with the auditor's determination that this recommendation is not fully implemented. CDPH believes it has fully implemented this recommendation and resubmits its response from last year.

CDPH Radiologic Health Branch (RHB) implemented and continues to use a plan that identifies existing backlogs. The plan ensures that CDPH measures and validates compliance with federal and state inspection frequency and quality requirements. Furthermore, the implementation of an on-line licensing system will provide a timelier, more accurate, and more complete data analysis. CDPH is currently able to review production and staffing information that reflects monthly management program inspection activities.

In September 2009, CDPH completed its data backlog correction plan and continues to resolve backlog associated with the Health Applications Licensing (HAL) system. Both managers and staff continue to conduct data quality checks using independent and computerized data edit checks. Management routinely evaluates error rates and the need for new procedures or quality assurance checks to ensure an error rate of less than five percent. Using information technology tools and procedures, this error rate reduction has been achieved.

In addition, CDPH-RHB has completed a reevaluation of the X-Ray Inspection, Compliance, and Enforcement (ICE) program. As part of this reevaluation, the existing inspection database was modified to allow real time tracking of each inspector's inspection history (HAL does not track inspector workload).

CDPH-RHB has implemented procedures that routinely evaluate workload and staff resources.

California State Auditor's Assessment of Annual Follow-Up Status: Not Fully Implemented

Recommendation #4 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.

Annual Follow-Up Agency Response From June 2018

The Radiological Health Branch (RHB has completed and generated a sample Low Level Radioactive Waste (LLRW) Report that demonstrates each section of the Health and Safety Code (H&SC) 115000.1 is reported and that no portion of the H&SC 115000.1 is left un-reported. While the report does provide all the information required by the H&SC, it also specifically reports the amount of low-level waste stored in California, the capacity of storage in California or exported for disposal out of California. This new computer-based LLRW tracking report will be used for all future LLRW reporting each year. RHB posts information on the annual report on the RHB website and instructions on how to obtain a copy of the report.

California State Auditor's Assessment of Annual Follow-Up Status: Pending

CDPH submitted a "sample" report to us, not a copy of the actual report as state law requires. CDPH says that, at this time, it only has a sample and that the actual report will not be ready "until IT finishes the programming." Once CDPH submits a copy of the actual report, we will review it to ensure that it contains all information required by law.

Annual Follow-Up Agency Response From May 2017

The Radiologic Health Branch (RHB) continues its ongoing task of receiving data from California generators for the issuance of the required reports. The RHB published and posted the 2013 Low Level Radioactive Waste (LLRW) report on the RHB website. The 2014 and 2015 reports are currently being aggregated and processed by the departments IT program and will be made available to the public in the fall of 2017. To obtain complete data and improve the timeliness of the reports, the department's Information Technology (IT) office has completed a web based tracking system and the RHB is currently testing the software. The tracking program includes data for all sections of the Health and Safety Code, Section 115000.1. Once the tracking system has been verified and validated a sample report will be generated for CSA review to ensure that each section of the H&SC is reported. Completion date is estimated to be September, 2017.

California State Auditor's Assessment of Annual Follow-Up Status: Pending

Annual Follow-Up Agency Response From May 2016

The Radiologic Health Branch (RHB) continues its ongoing task of receiving data from California generators for the issuance of the required reports. The RHB published and posted the 2007, 2008, 2009, 2010, 2011 and 2012 Low Level Radioactive Waste (LLRW) reports on the RHB website. All data for the 2013 report has been entered into our tracking system with an expected publication date of June 2016. The 2014 data is now being received and entered by the RHB, and is expected to be published by December 2016. To obtain complete data and improve the timeliness of the reports, the department's Information Technology (IT) office has approved and is working on a web based solution. IT staff have started programming and it is anticipated that this web based solution will be completed in 2016. This solution will have each generator utilize a drop down box format, send the data to RHB where it would be collated, summarized, and automatically generate the annual report. Design of the new LLRW Tracking System included a cross check of the law against its tracking data base and as generators begin using the new on line system, future reports will include all legislative data requirements. Therefore, amending legislation is unnecessary.

California State Auditor's Assessment of Annual Follow-Up Status: Not Fully Implemented

Annual Follow-Up Agency Response From October 2014

The status of this recommendation is unchanged.

California State Auditor's Assessment of Annual Follow-Up Status: Not Fully Implemented

Annual Follow-Up Agency Response From October 2013

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.

California State Auditor's Assessment of Annual Follow-Up Status: Not Fully Implemented

The department has not fully implemented this recommendation. It stated that it is still reviewing the data for its 2009 low-level radioactive waste report. The department also stated that it is researching a new computer system to simplify and automate its data collection efforts but provided no further details. In addition, the department did not discuss whether it can now report all statutorily required data elements in its report to the Legislature.

Annual Follow-Up Agency Response From September 2012

The California Department of Public Health (CDPH) Radiologic Health Branch (RHB) agrees with the Bureau of State Audits. The 2007 annual report required by Health and Safety (H&S) Code section 115000.1 was completed in Apri1 2010. Pursuant to H&S Code section 115000.1, the report summarized by type of generator and county location of generation within the State, the nature, characteristics, and quantities of low-level radioactive waste (LLRW) generated in California. The report for public review is posted on the CDPH-RHB website, while the other confidential report contains specific information about the location of radioactive materials and is available to members of the Legislature upon request. The 2008 LLRW annual report required by H&S Code section 115000.1 was completed in January 2011, and is posted on the CDPH-RHB website. The 2009 LLRW report is currently in the review process. CDPH intends for these reports to be generated annually.

California State Auditor's Assessment of Annual Follow-Up Status: Not Fully Implemented

Recommendation #5 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.

Annual Follow-Up Agency Response From May 2016

After former Governor Davis issued his Executive Order (EO) directing California Department of Public Health (CDPH) to promulgate a "dose based" decommissioning standard, known as Radiological Criteria for License Termination (RCLT) by the U.S. Nuclear Regulatory Commission (NRC), CDPH determined costs of developing and promulgating such a standard/ criteria, was prohibitive and beyond the ability of the program to afford. CDPH continues to use the current, legal regulatory license termination process described in California Code of Regulations, Title 17, Section 30256, which consistently provided a more protective public health clean-up outcome than NRC's decommissioning standard of 25 millirem/year (mrem/yr). The decommissioning process in place is protective of public health and environment as evidenced by 1,272 license terminations tracked and documented since 2003 found only 4 exceeding a projected dose of 1 mrem/yr, and no site exceeded 3 mrem as compared to NRC's 25 mrem dose standard. This data demonstrates CDPH's decision not to adopt a specific dose-based release standard, but maintain its current case by case evaluation method led to residual dose results that are substantially lower than those that might be permitted under NRC's dose-based standard. By not developing a dose-based standard, protection of the public health's safety and environment has been strengthened. NRC accepted CDPH's process, as determined during the recent NRC audit, where the RHB was compatible and compliant with NRC RCLT requirements. CDPH believes requesting a rescission of the EO is problematic; the EO requires the State Water Resources Control Board and the Regional Water Quality Control Boards to enforce a moratorium barring the disposal of "decommissioned material" into unclassified waste management units or municipal landfills. By requesting the Governor to rescind this order, this enhanced environmental safety oversight would be eliminated.

California State Auditor's Assessment of Annual Follow-Up Status: Resolved

In January 2016 the U.S. Nuclear Regulatory Commission (NRC) completed its review of California's low-level radioactive waste program. The NRC review found that California's policies and regulations were generally compatible with federal requirements, notwithstanding the lack of regulations concerning "dose based" decommissioning standards. With the NRC's acceptance of California's current practices and its overall conclusion that the public's health and safety is adequately protected, we conclude that the original audit finding that prompted this recommendation has been resolved.

Annual Follow-Up Agency Response From August 2015

In 2003, CDPH explored the costs of developing and promulgating a CEQA dose-based decommissioning standard. The estimated cost at that time was between $3 and $4.9 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. Also, 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 than the U.S. Nuclear Regulatory Commission (NRC) decommissioning standard of 25 millirem (mrem)/year. California has consistently achieved a decommissioning level of under 10 mrem/year, with a large majority of the cleanup levels in the non-detectable range. The current process is protective of public and environmental health and has not faced legal challenges.

California State Auditor's Assessment of Annual Follow-Up Status: Will Not Implement

Annual Follow-Up Agency Response From August 2015

CDPH determined that the costs of developing & promulgating "dose based" decommissioning standard using the CEQA process would be cost prohibitive. Also, any adoption of a new, dose-based standard would likely result in protracted litigation at substantial additional expense. The decommissioning process currently used is fully protective of public health & the environment. In evaluating its options, CDPH decided to continue to use the current, legal regulatory license termination process. This process is described in (CCR) title 17 section 30256 mandates use of a case by case approach to decommissioning & license termination which, when implemented, consistently provides a more protective clean up outcome than the U.S. Nuclear Regulatory Commission's decommissioning standard of 25 millirem (mrem)/yr. Section 30256 sets out the requirements that radioactive materials licensees must meet prior to terminating their license. The Dept. has used CCR section 30256 as the basis for termination of radioactive materials licenses for the past 13 yrs, CDPH has achieved protectiveness by mandating licensee compliance. Of the 1201 terminations since 2003, only 4 exceeded a projected dose of 1 mrem/yr &no site exceeded 3 mrem/yr. This data proves that CDPH decision not to adopt a specific dose-based release standard has led to residual dose results that are substantially lower than those that might be permitted under a dose-based standard. CDPH believes that pursuing a new "dose-based" decommissioning standard is unwarranted & unnecessary. CDPH believes requesting rescission of Gov. Davis' (EO) would be problematic, in that the EO includes a requirement that State Water Resources Control Board & Regional Water Quality Control Boards should bar the disposal of "decommissioned material" into unclassified waste management units or municipal landfills. EO instead mandates that the WRCB & RWQCB restrict disposal of "decommissioned material" to Class I & II hazardous waste landfills.

California State Auditor's Assessment of Annual Follow-Up Status: Will Not Implement

Annual Follow-Up Agency Response From October 2013

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.

California State Auditor's Assessment of Annual Follow-Up Status: Will Not Implement

Annual Follow-Up Agency Response From November 2010

The California Department of Public Health (CDPH) has determined that it will not seek rescission of Executive Order D 62 02. The implementation of the Bureau of State Audits recommendation to develop a dose based decommissioning standard following the California Environmental Quality Act (CEQA) process and the rescinding of Executive Order (EO) D 62 02 will not further enhance or improve current decommissioning standards upheld by the court in the Committee to Bridge the Gap lawsuit. The development of a new dose based standard will likely result in protracted litigation and raise uncertainty as to the effectiveness of the standards currently in place to protect public health. It should be emphasized that 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. None of the clean up levels following the process required by CDPH approach the 25 mrem/year NRC federal decommissioning standard. California has been able to consistently achieve a decommissioning level of radioactive material under 10 mrem/year, with a large majority of the analyses in the nondetectable range. The current process has been proven to be protective of public health and has remained free from legal challenges as to the public health protective outcome of the current standard.

In June 2003, the Department explored the costs of promulgating a dose based decommissioning standard. CDPH explored this option through an interagency agreement with the Department of General Services (DGS) to develop a CEQA compliant decommissioning standard. This feasibility assessment continued through September 2004. Through this collaboration, the Department concluded by February 2005, that it would not move forward with this effort. This decision was informed by:

• The costs that DGS estimated for developing and promulgating the dose based standard was approximately $5 million, with the likelihood of additional annual costs. Program funding has remained insufficient to fully support the regulatory development while maintaining CDPH inspection and response operations; and

• CDPH's assessment that public and environmental health and safety are rigorously protected through the current decommissioning process and have been shown to be health protective and legally compliant, making pursuit of a CEQA based decommissioning standard unwarranted.

California State Auditor's Assessment of Annual Follow-Up Status: Will Not Implement

Recommendation #6 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.

Annual Follow-Up Agency Response From June 2018

The Radiological Health Branch has developed an updated low-level waste disposal plan. This plan outlines the management, treatment, and disposal of low-level waste, including a contingency plan in case out-of-state disposal facilities are closed. The plan also includes waste storage capacity information.

California State Auditor's Assessment of Annual Follow-Up Status: Fully Implemented

Annual Follow-Up Agency Response From May 2017

RHB met the statutory requirement for developing a low-level radioactive waste disposal site in 1982. In 2011, RHB performed a survey of all LLRW generators and found that the current quantity of waste in storage (119 cubic meters) is well below the storage space capacity (5,752 cubic meters). In reviewing the 2013 LLRW report, as well as the reported storage data in both the 2014 and 2015 reports, it is apparent that the total amount of LLRW stored in California continues to remain well below waste storage capacity. Through its new LLRW tracking system, referenced in recommendation 4 above and estimated to be completed and operational by September 2017, RHB will track waste storage, waste storage capacity, and waste volume annually and make that information available to the Legislature. In addition, LLRW disposal options are available to California generators including licensed disposal sites in both Utah and Texas.

California State Auditor's Assessment of Annual Follow-Up Status: Pending

Annual Follow-Up Agency Response From May 2016

California has met the requirements of developing a low-level waste disposal plan under Health and Safety (H&S) Code Section 115005 by submitting a 100-page report to the California Legislature in 1982, which resulted in the Department pursuing a permanent disposal facility at the proposed Ward Valley site that never came to fruition. In 2011, the Radioactive Health Branch (RHB) performed a statewide survey of all waste generators. This survey showed that current class B and C storage waste quantity was at 119 cubic meters, well below the total storage capacity of 5,752 cubic meters. RHB believes that by implementing the low-level waste tracking solution referenced in recommendation 4, an ongoing monitoring process of waste storage capacity, and all other requirements of the law, will be monitored so future development of another low-level waste disposal plan is quickly identified.

California State Auditor's Assessment of Annual Follow-Up Status: Not Fully Implemented

Annual Follow-Up Agency Response From October 2013

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.

California State Auditor's Assessment of Annual Follow-Up Status: Will Not Implement

Annual Follow-Up Agency Response From November 2010

CDPH continues to collect data from California's low level radioactive waste (LLRW) producers across the State and make that data available to legislators and interested parties. The Energy Solution disposal facility in Clive, Utah, remains available for California generators of class A LLRW. In August 2011, CDPH performed a survey of California generators of their storage capacity for class B and C LLRW. Based on the responses of these generators, 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.

California State Auditor's Assessment of Annual Follow-Up Status: Will Not Implement

Recommendation #7 To: Public Health, Department of

To make certain that the branch uses sufficiently reliable data from its current systems to manage its inspection workload, the department should improve the accuracy of the branch’s data for inspection timeliness and priority level. The branch can do so by comparing existing files to the information recorded in the data systems.

Annual Follow-Up Agency Response From January 2010

New procedures for quality control were initiated in 2008 and 2009. With this experience RHB improved the overall data reliability for all data management systems. This quality control system includes data entry associated with maintaining the accuracy of the inspection tables and the subsequent inspection reports. For the HAL data system, CDPH provides ongoing maintenance of the accuracy of facility and x-ray machine status and data entry for these processes. CDPH refined its quality control procedures for data entry and maintenance of facility inspection itineraries and inspection reports. The quality control changes to CAMIS and HAL provided needed improvements to the accuracy, timeliness, and priority level assignments that BSA is seeking.

To better identify current inspection needs, RHB initiated new measures to update existing paper and electronic-based reports. As an example, previously compliance history was in a paper report. Now the data is electronically captured and made available to all inspectors via a secured Internet site. In bi-weekly status meetings, RHB program and Information Technology managers define processes and procedures that better control and improve the timeliness, accuracy, and completeness of the data. This team approach facilitates the development and application of improved data validation methods, including periodic programming logic checks.

These procedures have greatly improved the accuracy of current data and will be maintained until a new data management is available in 2011. (2009-041, p. 80)

California State Auditor's Assessment of Annual Follow-Up Status: Fully Implemented

Recommendation #8 To: Public Health, Department of

To make certain that the branch uses sufficiently reliable data from its current systems to manage its inspection workload, the department should improve its internal controls over data entry so that it can maintain accurate data on an ongoing basis. Such controls might include developing a quality assurance process that periodically verifies the contents of licensee files to the data recorded electronically. Other controls might include formalizing data entry procedures to include managerial review or directing the information technology staff to perform periodic logic checks of the data.

Annual Follow-Up Agency Response From January 2010

The Department's Radiologic Health Branch (RHB) and Information Technology Services Division (ITSD) staff work together to implement changes to the inspection reports to ensure better accuracy. In addition, to improve data integrity during data entry of inspection-related information, RHB implemented specific programmatic and business controls. These modifications and processes changes were updated in the technical coding and business procedures documentation. This CDPH team continues additional application and/or business process changes as identified that would further increase the accuracy, integrity, and timeliness of inspection data entered, retrieved, and maintained in the HAL system.

For data quality control functions, the CAMIS database has core data field validation and a program change history capability. Improvements in the CAMIS database procedures for additional quality control measures have been initiated and are expected to be fully operational by January 2009. These measures include an auto-review of work products, as well as benchmark by January 2009. These measures include an auto-review of work products, as well as benchmark levels for margin of error that will apply to data entry for the processes associated with facility and unit accreditation status. Improvements will also include advances in data entry accuracy that is necessary for maintaining the timeliness, accuracy, and completeness of the inspection tables and the subsequent inspection reports.

To verify data quality for the Radioactive Materials 2000 database, a 100 percent quality assurance review of all coding sheets used for RAM data entry was completed. Because the review found nominal errors, supervisors now must only review 50 percent of all coding sheets to maintain excellent quality control standards. This process verified that the electronic files match the hard copy record. The error rate is tracked and adjustments made as needed. (2009-041, pp. 80-81)

California State Auditor's Assessment of Annual Follow-Up Status: Fully Implemented

Recommendation #9 To: Public Health, Department of

To better manage its performance in meeting key strategic objectives, the branch should establish a new strategic plan that contains all essential elements, including performance metrics and goals that the branch believes would be relevant to ensuring its success.

Annual Follow-Up Agency Response From January 2010

CDPH RHB completed the Branch's Strategic Plan in mid-summer 2009. The revised plan includes performance goals and objectives. The plan recognizes the public health mission of RHB related to the safe use of ionizing radiation and its leadership role to industry, medicine, and research. (2009-041, p. 83)

California State Auditor's Assessment of Annual Follow-Up Status: Fully Implemented

All Recommendations in 2007-114

Agency responses received after June 2013 are posted verbatim.