A. Radiation Use Authorization (RUA) Application Process

The RSO or a designee reviews the completed application form and conducts a detailed review of the proposed project. Normally this review includes a personal interview with the applicant and an inspection of the proposed workplace(s) and encompasses training, the experience of the applicant, the radioisotope, its activity, its chemical and physical form, experimental protocol, adequacy of all workplaces, ALARA practices, monitoring methods, radiation detection equipment, contamination-control procedures, waste practices, etc.

Based on the analysis, a Hazard Guide Value (HGV) is calculated, in order to establish the classification of the use as Class 1, 2, or 3 (low, medium, or high radiological hazard.)

1.1. Determination of the Hazard Guide Value (HGV)

Each proposed RUA is assigned an HGV according to the method below. This value determines the RUA classification and the depth of review required for approval or renewal. The RUA’s HGV is the sum of the highest individual HGVs for each listed radionuclide, experiment, order or possession unit and is calculated using this formula:

Individual HGV = Q_i Ti U_i Wi

Where:

Q_i = Quantity of a radionuclide in microcuries

Ti = Relative Toxicity Factor

U_i = Use Factor

Wi = weighting factor for experiment, order, or possession

Total HGV = sum of the highest individual HGVs for each listed radionuclide

1.2. Factors Used in HGV Formula

• Quantity of the radionuclide (Q_i) is expressed in microcuries.
• Relative Toxicity Factor (T_i) is based on 10 CFR §20, Appendix B, Table 5. The T_i of DNAseeking compounds is increased by a factor of 10 for H-3, C-14, and I-125.

Table 5: Ti Values for Radioisotopes According to Relative Radiotoxicity

• Use Factor (U_i) is based on the proposed use of the radioisotope. Consideration is given to the probability of:
  • Release of the radioisotope to the environment,
  • Contamination of persons engaged in the operation, and
  • Contamination of equipment and facilities.

Here are some examples:

Table 6: Use Factors

• Weighting factor (Wi) recognizes the change in risk associated with different phases of use for the purposes of the HGV determinations:

Table 7: Weighting Factors

1.3. Determination of RUA Classification for Radioactive Material and RPM Use

The RUA classification is as follows:

Class 1- Low Hazard

• Radionuclides with HGV 0-500
• RPM’s –electron microscopes; on-hold or non-operational RPM’s; other electronic devices with low personnel exposure potential

Class 2- Medium Hazard

• Radionuclides with HGV 500-50,000
• RPM’s- most diffraction, industrial radiography, diagnostic, cabinet, XRF, and portables

Class 3- Higher Hazard

• Radionuclides with HGV >50,000
• RPM’s- most accelerators and other high hazard devices or as designated by the RSO.

1.4. Determination of RUA Dosimetry and Bioassay Requirements

Personnel exposure monitoring is provided if a person is likely to receive a radiation dose in excess of 10 percent of CDPH limits. Dosimetry is also required for individuals entering an area of “high” radiation (>100 mrem/hour). The RSO reviews the RUA uses, radionuclides, and amounts and determines what dosimetry and bioassay requirements will be required.

1.5. Determination of Survey Instruments for RUAs

The RSO reviews the RUA uses, radioisotopes, and amounts and determines what survey meters are required. Survey meters must be calibrated for their intended purpose and should be checked prior to each use to confirm they are in good working order (batteries, etc.) and respond appropriately to a known source of radiation.

1.6. Determination of Frequency and Types of EH&S Radiation Safety Surveys of RUAs

The RSO reviews the RUA uses, radionuclides, and amounts. Using the procedures below, the RSO establishes an initial survey (audit) frequency for EH&S radiation safety surveys of the RUA. This is typically indicated on the RUA.

These surveys are typically categorized for radioactive material and RPM’s as follows:

• Routine
  • monthly - quarterly: Class 3
  • quarterly - semi-annual: Class 2
  • semi-annually - annual: Class 1
• Renewal - typically not less than once every year
• Termination
• More frequently surveys are conducted for new users, based on need or for experienced users based on poor performance.

1.7. Details of the Radiation Safety Surveys (audits)

Routine surveys are performed in order to ensure that radioactive materials are being used properly, that RUA requirements are being met, that requirements of the Radiation Safety Manual (and associated documents) are being met, and that contamination and radiation levels are within administrative requirements.

Renewal surveys entail a more detailed review than routine surveys. In addition to the routine survey elements, in a renewal survey, the radiation safety surveyor meets with the RUA RH or his/her laboratory contact and reviews the SOP protocol(s) and reviews the compliance history for the RUA for the past year.

Special surveys are performed as needed to address issues in the laboratory. An example would be a spill.

Termination surveys are performed if a user will be ceasing operations that use radioactive materials. The scope of the survey is determined by the history of use and by the intended future use of the space. That is, a survey of a laboratory area that will be used by another RUA Holder for radioactive materials use will be different from one for unrestricted release.

Vacating surveys are performed to release a building or authorized use location for unrestricted use. These surveys must be approved in advance by CDPH.

1.8. Frequency of EH&S Radiation Safety Surveys

Audit (EH&S survey) frequency is based on potential hazards as determined by the RSO. The RSO or designee’s review establishes an initial radiation safety survey for EH&S. However, survey frequency can be modified by the RSO based on RUA compliance, use changes, or professional judgment.

1.9. Frequency of RUA Holder (RH) Self-Surveys

RH self- survey frequency is specified on the individual RUA. The following conditions must also be met:

• A documented self-survey must be conducted of the immediate work area after all iodinations, and if more than one mCi of any other radionuclide is used.
• Problems found during self-surveys must be corrected, and the RH must document the correction(s). Problems such as spills, lost dosimetry, and injuries must be reported to the RSO. EH&S periodically reviews self-survey documentation
• The minimum user self-survey frequency is indicated on the RUA. Required survey frequencies may be modified at the discretion of the RSO or RSC.

1.10. Determination of Additional Required Precautions

The RSO uses a combination of typical requirements, experience, and professional judgment to determine any additional required precautions. The RSO updates these required precautions based on the performance of the RUA and other issues.

Once the Standard Operating Procedures (SOPs) are finalized, the RST sends the pending RUA to the RH, who signifies agreement and approval by signing the RUA and by obtaining the signature of the Department Chair. The signed RUA is returned to the RSO.

After receiving the signed RUA, the RSO obtains the appropriate RSC approval if needed, making the RUA approval final. Questions or disagreements concerning review and approval of an individual RUA are resolved by the RSC.

3.1. Initial Applications to Use Radioactive Materials and Ionizing Radiation

An RUA must be appropriately reviewed, classified, and approved before work can begin under it.

3.1.1. Class 1 (low radiological hazard)

Initial Class 1 - draft RUAs are reviewed by the RSO. The RSO with their discretion may choose to involve the RSC chair. Work cannot start until the RUA approval process has been completed and an approved RUA has been issued. A copy of the approved RUA is supplied to the RSC at their next meeting.

3.1.2. Class 2 (medium radiological hazard)

Following the RSO’s review, the pending RUA is submitted to the RSC Chair for review and approval. If the RSC Chair approves the RUA, it is finalized and granted approval. Work cannot start until the RUA approval process has been completed and an approved RUA has been issued. A copy of the approved RUA is supplied to the RSC at their next meeting.

3.1.3. Class 3 (high radiological hazard)

Following the RSO’s review, the pending RUA is submitted to the RSC for approval. The full RSC considers the RUA and either vote to approve the RUA or directs the RSO to take actions it recommends. Work cannot start until the RUA approval process has been completed and an approved RUA has been issued.

RUAs are valid for a maximum of one year. Prior to expiration, a renewal survey is performed and an updated draft RUA is prepared. Renewal for each of the three RUA classifications is essentially the same as the initial processing, with the exception that the signatures of the RH and Department Chair remain in effect from the time at which they were last required.

If no planned use of the radioactive materials or RPM is planned for >6 months, it is an option to place the RUA on hold. During the period the RUA is on hold, the RST will usually not perform routine surveys but the RST must perform the semi-annual inventory of radioactive sources.

Normal radiation safety surveys and oversight will resume when RH notifies the RSO that use is to be recommended. The RH will be instructed to notify the RSO prior to actual work with radioactive materials or radiation producing machines is begun.

The RSO updates RSIS and notifies the RH of the updated RUA.

There are two reasons for termination of an RUA: for cause, and routine.

6.1. Termination for Cause

Any RH found to be willfully and/or negligently violating any campus, NRC, or state regulations governing the RUA may have that RUA suspended or terminated. Examples of termination for cause also include:

• Repeated unnecessary exposure of personnel
• Repeated unnecessary contamination of work areas
• Non-reporting of spills, suspected high exposures, loss of radioactive materials or RPMs
• Non-reporting of required RUA changes (such as isotope or personnel)
• Inadequate security of radioactive materials or RPM
• Use of unauthorized work areas and/or equipment
• Improper acquisition or transfer of radioactive materials
• Improper disposal of radioactive waste
• Disregard for specified laboratory safety procedures or RUA precautions
• Failure to complete required training or annual retraining
• Failure to pay required monetary fees
• Poor “housekeeping”

If violations threaten termination for cause, the Chair of the RSC (or designee) notifies the RH that continued violations will result in RUA termination. If problems remain unresolved, the RSC discusses the situation with the RH. The RSO can immediately suspend any activity that presents an undue or unevaluated risk. The RUA may be provisionally reissued on a monthly or quarterly renewal, during which time improvement is assessed by the RSO and the RSC. The RSC discusses compliance and determines whether to terminate the RUA or take other action.

RSC decisions to revoke or suspend an RUA may be appealed to the Vice-Chancellor for Research (VCR). In such cases, the VCR meets with the petitioner and the RSC (or RSC representatives) to determine the appropriate actions. Decisions to modify actions of the RSC are transmitted to the RSC in writing and included in the RH’s file.

For conditions that result in imminent (immediately hazardous to life or health) radiological hazards, the RUA may be terminated on the RSO’s own authority.

6.2. Routine Termination

Ordinarily, RUAs are terminated upon:

• Completion of the project
• Change in the RH
• Expiration of the RUA
• Rendering the RPMs inoperable
• Termination by RH of relationship with UC Berkeley

6.3. Action Taken on RUA Termination

Upon termination of an RUA, all radionuclides acquired thereunder must be accounted for to the RSO. Remaining materials must be transferred to another RH who has been authorized to receive them, or disposed of as radioactive waste.

RHs are asked to notify the RSO of a proposed RUA termination sufficiently ahead of time (at least one week) to permit scheduling of termination procedures, including:

• Termination survey
• Return of personnel dosimeters
• Removal of radiation-hazard warning signs
• Removal of radioactive waste
• Removal or transfer of radioactive materials
• Collection of RUA records if needed

If an RH determines that a revision of the RUA is required, the request for change must be made to the RSO. Items that require specific pre-approval (via updating the RUA) include any of the following:

• Changes in personnel
• Use of radioisotopes or compounds not listed on the RUA
• Change of use location
• Increase in use or possession limits
• Use of processes or procedures not previously authorized

Changes cannot be implemented until the modification to the RUA has been approved. If a new RUA must be issued, the process for amendment is the same as for each classification’s initial RUA application and approval process.

7.1. Revision and Amendment Process

A revision of an existing RUA is a minor change that does not affect the safety review previously performed and approved. Examples of revisions include: adding a new person to the RUA, adding a new room, deleting a person from the RUA, or making minor changes to items such as the dosimetry requirement or sink-disposal limits.

An amendment to an RUA is a major change that has an impact on the previously performed safety assessment and approval(s). Examples of an amendment include: adding a new radioisotope(s), radioisotope-limit changes that change the Hazard Guide Value and RUA Class, use of a new protocol, the addition of the use of animals, etc. The RSO decides what level of review is required by the amendment.