3. Licensing Requirements

The Radiation Safety Program at UC Berkeley is operated in compliance with federal and state regulations. The CDPH granted UC Berkeley a facility-specific license to address the varied uses of radioactive materials and radiation on campus. This “Broad-Scope Type A” license provides UC Berkeley broad flexibility in meeting regulatory requirements and identifies specific requirements for the use of radioactive materials at UC Berkeley.

When requesting approval to use radioactive materials or RPMs, the applicant needs to understand the requirements set by UC Berkeley, and that the license itself carries special requirements. The UC Berkeley policies on radiation safety are outlined in this manual and are available electronically on the EH&S website. The RSO serves as the lead for the program documents, and for understanding and interpreting regulatory and campus requirements.

State regulations that apply to radioactive materials are found in Title 17 of the California Code of Regulations (CCR). For most applications in California, the CDPH develops and enforces regulations, licenses uses, and performs inspections and investigations. In some cases, the NRC regulations contained in Chapter 10 apply directly to UC Berkeley.

Some uses of radiation and radioactive materials are not regulated under the UC Berkeley Radioactive Materials license. Exemptions include specific consumer products containing radioactive material (e.g., unmodified products such as some balances, smoke detectors listed in 17 CCR 30180(b).) Radiation safety staff should be consulted for requirements on the proper use and disposal of these items.

Specific uses of radiation and radioactive material at UC Berkeley must be pre-authorized in writing. The written authorization is referred to as an RUA and is fundamental to the campus radiation safety program. An approved RUA is required before taking possession of (purchasing, borrowing, constructing, etc.) most sources of ionizing radiation. Application for an RUA is made using forms available on the EH&S website.

The radiation safety staff evaluates the radiation safety aspects of the proposed use. If additional information is required, the RSO may need to meet with the applicant to discuss the proposed use.

RUA approval for any proposed use of radioactive materials and/or RPMs is based on the use, the risk/hazard evaluation, the adequacy of health and safety measures to be employed, and the evaluation of the RSO.

3.3.1. Application for Material or Machine Use

For an initial application, complete and submit the following forms, available on the EH&S radiation safety website:

• Radiation Use Authorization Application
• Standard Operating Procedures for each type of experiment
• Radiation User Information Record(s) for each radiation worker

3.3.2. Instructional Use

An RUA is required for any use of radiation or radiation sources in academic course work or laboratories. Such RUAs are issued in the name of the instructor.

3.3.3. Use of Radiation in Animals

In addition to the process described previously, if the research will involve the use of animals that:

1. fall under the jurisdiction of the Animal Care and Use Committee (ACUC), and
2. will be exposed to radiation or given radioactive materials,

then both an RUA and approval by the ACUC are required before exposure to radioactive materials or radiation may occur.

3.3.4. Use of Radiation in Human Research

Research involving radioactive material or radiation from radioactive materials in or on humans is not authorized by the UC Berkeley Radioactive Materials License and is not permitted. Requests to perform research using radioactive material can be coordinated with another campus licensed to perform that type of research.

3.3.5. Application for Use of Radioactive Materials or RPMs Offsite and/or in the Field

Requests to use radioactive materials in the environment (field applications of dispersible radionuclides) at use locations specified in the Radioactive Material License (License Condition 10) should be made 90 days in advance of the planned use to allow for review of the proposed work by the Radiation Safety Committee and for submittal to the state for final approval.

In cases where an RH wishes to use radiation or radioactive material at a location which has not been listed on the Radioactive Materials License, the RSO will have to apply for a license amendment and approval may require multiple months.

After the application for a RUA is submitted, the RSO reviews the materials and generates an RUA. Based on the review, the RSO determines the precautions necessary for use and the level of review required. In the case of Class 1 RUAs, the RSO may approve the application. In the case of Class 2 RUAs, the RSO and the Chair of the RSC is required for approval. In the case of Class 3 RUAs, the RSO and a quorum of the RSC is required to approve the application. Details of the review and approval process are found in Appendix A: Radiation Use Authorization (RUA) Application Process.

Any change to or modification of an existing RUA must be reviewed and approved before implementation. Revisions and amendments to approved RUAs may be requested at any time by submitting your request electronically using an RUA Change Request form from the website or by contacting the RSO or an EH&S RST staff member.

3.5.1. Amendments

Amendments involve significant changes to the form, quantity, protocol, standard operating procedures, or use of radioactive materials such that the RUA Class increases or a substantive change to the radiation safety precautions is necessary. Amendments may require the approval of the RSC or the RSC Chair. The RSO determines the level of review required.

3.5.2. Revisions

Revision to RUA can be made at the request of the RH or radiation safety staff and they only require approval by the RSO or a designee. Revisions do not involve changes to the RUA Class. Revisions typically involve the addition or deletion of personnel, minor adjustments to an authorized limit for a radioisotope, changes to survey frequency, or other changes of minor safety significance.

3.5.3. RUA Renewal

Annually, an RST member performs a complete review with the RH and Lab Contact of the RUA to determine if any changes are needed. The RUA is amended if needed and renewed for another year if the project plans to continue. If a project is at completion, a termination survey will be scheduled.

An RUA may be placed “On Hold” at the request of the RH if no use is planned for at least 6 months. The frequency of EH&S RST oversight surveys may be reduced to a minimum of semi-annual visits. However, the RST will continue to periodically audit on-hold RUAs to confirm that radioactive materials and RPMs are not being received, used, moved, or disposed of. These surveys may be conducted by telephone, email, or unannounced inspection of the storage or authorized use locations.

The UC Berkeley campus uses a wide variety of ionizing radiation producing machines (RPMs) such as:

• Electron microscopes
• Medical machines
• Cabinet X-ray machines
• X-ray diffraction and fluorescence analysis machines
• Miscellaneous machines including accelerators

All machines that produce ionizing radiation must be registered with the CDPH within 30 days of arrival on campus by the RSO. RHs are responsible for notifying the RSO so that the required registration can be completed. An approved RUA for each RPM is also required.

The RSO must also notify CDPH within sixty days prior to the acquisition, construction or reconstruction of a room to house:

• Any RPM capable of operating at a potential in excess of 500kVp
• Any RPM that operates at a potential in less than 500kVp, but that for other reasons presents a similar radiological hazard

The RST performs periodic surveys of areas in which radioactive materials or RPMs are used.

3.7.1. Safety Survey Frequency and Content

The frequency of the surveys is based on a number of factors, such as potential risk and past RUA compliance. The typical frequency of surveys is within the following time ranges:

• Class 1- Semiannually to Annually
• Class 2- Quarterly to Semi-Annually
• Class 3- Monthly to Quarterly

All RPMs will at minimum be surveyed annually and all sealed sources will be surveyed at minimum semiannually. Survey frequencies can be increased or decreased based on compliance history. The CDPH expects that no less than 50 percent of the surveys performed by EH&S staff will be performed “unannounced.” More frequent surveys may be mandated by the Radiation Safety Committee based on the compliance record.

These surveys are performed to determine if operations are being conducted properly and safely. Specifically, EH&S surveys will include checking the following:

• Are the form and quantity of radioactive material present consistent with the limits on the RUA?
• Are radionuclides used in accordance with the conditions of the RUA and RSM?
• Are only authorized individuals granted access to and use of radioactive material and RPMs?
• Is eating and drinking properly prohibited from posted RUA locations that authorize possession of radioactive material?
• Are laboratory procedures available and followed?
• Are required safety notifications posted and adequate?
• Is proper PPE being used?
• Are contamination/area surveys performed as scheduled, and are they appropriate?
• Are all radioactive materials and RPMs controlled and secured?
• Is radioactive waste being properly managed?

If problems (such as contamination and/or external radiation areas) are found, the RH will be asked to take corrective action. A copy of the survey report is kept on file in EH&S and a copy is sent to the RH.

3.7.2. Consequences of Noncompliance

When problems are identified, EH&S staff members prepare a survey report detailing the issue(s) and the needed corrective action(s). The RSO reviews all reports of significant radiation safety problems, determines what action(s) must be taken, and sets the date by which corrective action must be completed. The report is sent to the RH and a copy is filed with the EH&S records for the laboratory

In the event of any single serious violation, the discovery of unsafe conditions, or chronic non-compliance indicative of a programmatic breakdown, the RSO brings the matter to the attention of the RH as soon as possible. The RH will be requested to respond in writing to the RSO by acknowledging or denying the unacceptable situation, describing the corrective actions taken or planned, and when corrective actions will be complete. The RSO may take additional action approved by the RSC or may refer the matter to the RSC or its Chair.

Serious or chronic noncompliance can result in review by the RSC and may lead to restrictions, more frequent EH&S surveys, additional training, or, in severe cases, cancellation of the RUA.

In the event that an RH (or person working under the supervision of the RH) is found to be willfully and/or negligently violating federal, state, or University requirements governing the use of radioactive material and/or RPMs, any or all RUAs under that RH may be suspended or revoked (with RSC concurrence) and radioactive materials may be confiscated.

If at any time the RSO is not satisfied with a project’s safety and health practices, the project may be halted until corrections have been made. The RSO’s action(s) may be appealed to the RSC.

RUA Holders who are approaching the termination of a project that uses radioactive materials or radiation producing devices should notify the EH&S RST to schedule the termination survey of the use areas. The termination survey will include an accounting of radionuclide inventory and satisfaction of requirements for decontamination. The area cannot be released for other uses until this termination process has been completed.

Upon termination of the RUA, all remaining radioactive materials must be transferred to another active RUA project authorized for the same type and quantities of radionuclides, or to EH&S for proper disposal as radioactive waste. In the case of RPM’s, the RUA is not terminated until the machine has been transferred or disposed of. The RST must notify the state within 30 days of transfer or disposal of RPM’s.

3.8.1. Termination of Use of Facilities

Once an area has been under an RUA, it cannot be transferred to unrestricted use for other purposes until the RST has released it. If necessary, areas will need to be decontaminated to a level that satisfies regulatory requirements. Decontamination is the responsibility of the RH, but the RST can provide technical assistance and will perform independent surveys to confirm the effectiveness of the decontamination effort.

All remodeling to areas where radioactive materials had been used or stored must be coordinated with the EH&S RST.

Unrestricted release of buildings, or of locations specified in the license, require prior approval of CDPH. The RH must notify EH&S RST well in advance of plans to terminate the use of radioactive materials in a campus building or at an offsite use location.

As a condition of use of radioactive materials and RPMs, the user agrees to personal monitoring required by regulation to determine his/her dose. This may include wearing dosimeters, using air sampling devices, and/or participating in a bioassay program as specified on the RUA. It may also include a medical examination and medical monitoring.