General

To obtain a Controlled Radiation Authorization (CRA) the PI must submit a CRA application and obtain the approval of the appropriate LCC or the APRS. All radioactive materials must be specified.

Application format

Send an application to Health Physics that provides the following information. If the following instructions are not clear, if you need assistance, or if you have special circumstances, please call. You may submit a hard copy, fax, or e‐mail. For an application form go to https://radforms.stanford.edu

Facilities

1.a. Facilities. Identify the department, and list receiving, storage, work, and waste areas. Facilities must be adequate for the safe use of the materials. Benches must have impervious surfaces; secondary containment is needed both in work and storage areas; floors must be sealed and waxed if unsealed radioactive materials are handled. Materials must be secured against unauthorized removal; materials in common use areas must be locked when unattended.

A list of rooms is e‐mailed out each quarter for updating by the Health Physics contact.

Ventilation

1.b. Ventilation. Describe enhanced ventilation, fume hoods, and biological containment hoods. These must be working and fume hoods must be checked within the last year for flow rate, typically 100 to 180 feet per minute and with the proper sash height marked. An externally‐exhausted biosafety cabinet is required for using volatile iodine in conjunction with pathological or infectious agents.

Personnel

2. Personnel. Identify the Project Director, senior staff members who will directly supervise the project, and other personnel participating in the project. Identify the individual who will serve as Health Physics contact; this individual coordinates day‐to‐ day radiation safety activities such as room surveys and reports. Note if individuals under age 18 will be in the lab.

For the PI, key supervisors, and Health Physics contact, provide work telephone, fax, e‐ mail, mail code, department, building and room, and SUNetID if available.

Lists of personnel, inventory, assigned rooms, sealed sources and instruments are mailed out each quarter for the Health Physics contact to update.

Proposed materials

3. Materials. For each radionuclide that will be used, provide: radionuclide; chemical forms; maximum quantity to be used per experiment and frequency of experiments; maximum quantity to be obtained per order; and maximum to be possessed at any time. For scintillation cocktails, please provide information on whether it is biodegradable, recommended, or has other hazards associated with it. See page 56.

Characterize volumes as milliliters or liters, and identify other hazardous materials such as toxic chemicals, corrosives, or pathogens that might be mixed with radioactivity. See this website to identify materials.

Proposed uses

4. Laboratory procedure. Characterize the steps in the laboratory procedure by using the form Worksheet for Radiochemical Protocols.

Append copies of the experimental protocols. Look for processes that have caused problems in the past: inadequate secondary containment, long‐term heating, failed automatic timers, violent vortex mixing, expansion during heating, containment during centrifuging.

Perform a cold run with mock materials to ensure that you can perform manipulations with gloves, handling tools, and shielding in place.

Deliberate introduction of radionuclides into the environment for investigational purposes requires issuance of a special license by the California Department of Health on an experiment‐by‐experiment basis. To initiate this procedure discuss the environmental impact and include an estimate of risks to the population that may be exposed. Consult Health Physics for details.

Work rules

5. Work rules. State that you will adhere to the standard work rules in Table I.3. If special circumstances make those work rules inappropriate, call Health Physics. In your application you will have to explain why they are inappropriate, and submit alternative work rules for review.

Waste

6. Waste. Normal radioactive waste service is included in overhead charges. Projects that generate large volumes of radioactive waste, or mixed waste that must be disposed of through a special broker, or for projects who do not contribute to Stanford University overhead will be billed for waste services.

Generation of mixed radioactive and hazardous chemical waste must be approved by the LCC before it is generated. All chemical materials are considered hazardous unless specifically tested or otherwise reviewed against specific criteria. An explanation on how to determine whether a chemical is non‐hazardous can be found under Aqueous waste, p.53 If you must generate mixed waste, explain why the waste must be generated. Describe alternative research methods that have been explored, and explain why they are not suitable for this project.

Instruments and equipment

7. Radiation measurement and safety equipment.  Review Table 3.4 under Surveys, p.50, to determine which instruments are appropriate. List instruments that are available. Each project must have suitable detection and measurement instrumentation; sharing is permitted. Consult with Health Physics if you need assistance.

Identify any safety equipment that will be used such as splash shields, trays, or remote handling equipment. Shielding, particularly stacked lead bricks, and heavy equipment should be secured for earthquakes. Large volumes of liquid waste must have secondary containment.

Training and experience

8. Training and Experience. If this is an initial application, provide information regarding the previous training and experience of each PI and user. Training and Experience forms are available online at radforms.stanford.edu, or may be copied from Forms.

Training and experience are evaluated by Health Physics. Those with little or no experience and previous formal coursework in radiation protection must complete an eight‐hour course that is offered by Health Physics. Those who have received comparable training and have laboratory experience must complete an open‐book examination on basic principles and institutional procedures.

On‐the‐job training

In addition to the course or examination, the PI or supervisor must provide specific on‐the‐job training for each user on each protocol. The training must include survey techniques, record keeping in the lab and a review of waste requirements. On‐the‐job training forms are provided for each user after completion of Radiation Safety Training. Training must be logged on OJT forms and filed in the lab’s Radioisotope Journal.

Refresher training

Each project must hold a staff meeting following a CRA renewal at which radiation safety topics, including the contents of the renewal Hazards Evaluation, are reviewed. The Hazards Evaluation will include an agenda and signature block for documenting the meeting. The signed agenda must be filed in the Radioisotope Journal.

Concurrent review

9. If applicable, confirm that the project has also been submitted for biohazards and animal care review. A project cannot begin until all committees with jurisdiction have approved it.

TABLE 3.2 CONTROLLED RADIATION AUTHORIZATION (CRA) QUANTITIES AND TERMS. This table defines the CRA categories, which provide the basis for documented survey frequency and renewal term. Users should conduct surveys before, during, and after each experiment; these do not require a record. Quantities of Licensed Materials (QLM) are found in 10 CFR Part 20, Appendix C, which is duplicated in Part 4, Appendices.