Section 4: Permitting for Radioactive Material Use

Radiation sources can only be used and stored by individuals issued a radioisotope use permit, or under the supervision of individuals issued a radioisotope permit (i.e., permit holder). There are two different types of radiation permits (1) Human-Use and (2) Non-Human Use. The process and eligibility for individuals requiring either type of radiation permit is set forth below.

Once a radioisotope permit application is determined to be complete by the RSO, it will be reviewed by the RSC for final approval. The RSO may provide provisional approval of permits prior to approval by the RSC.

The Permit Holder in the R&D setting is generally the Principal Investigator (PI).

• The applicant must have a faculty/staff position within BU/BMC. Technically qualified individuals from outside BU/BMC may be given a temporary use authorization to carry out a relatively long-term or repetitive experiment; such authorizations are governed by the same requirements as any other permit holder.
• The applicant must complete DMPRS-provided radiation safety training.
• The applicant must submit the following to the DMPRS for review:
• Resume or Curriculum Vitae (CV), which explicitly includes the applicant’s radioisotope use history.
• Radioactive Material Permit Application (Non-Human Use). This application should be completed online in SciShield or can be obtained from DMPRS.
• Radioisotope work history attestation from a previous employer indicating that:
• The applicant’s use of radioactive material was safe and they have the ability to use radioisotopes independently.
• The applicant has a minimum of 6 months of radiation work experience using similar radionuclides and quantities as those being applied for. Otherwise, the applicant must work under the supervision of an existing permit holder using similar radionuclides and quantities for a minimum of 6 months before the application will be acted upon by the RSC.
• The applicant must be familiar with the requirements of this Manual and have made adequate provisions for radiation safety and control within their lab.
• The applicant must be able to secure the appropriate facilities and equipment to safely conduct permitted activities.
• The use of radiation sources by minor undergraduate students for educational purposes requires approval of the RSO and the direct supervision of a PH or RSO-approved researcher. The Permit Holder must request permission from the RSO or designee to use radioisotopes with minor students. Each request will be handled on a case by case basis. The Permit Holder is required to submit a safety plan as part of their request. DMPRS will ensure that no minor student’s exposure will exceed 10 mrem per year. The Permit Holder must meet appropriate BU/BMC policy requirements including the BU Policy on Minors in Laboratories.

Application for Radioisotope Use Permit: Human Use

Radioactive material involved in clinical trials must be used under the direct supervision of an approved permit holder with approved clinical privileges and through a protocol approved by the Institutional Review Board (IRB) and RSO. Human use (i.e., clinical) permit holders are referred to as ‘Clinical Authorized Users’.

• The applicant must be a Massachusetts licensed physician.
• The applicant must acquire clinical privileges granted by the BMC Credentialing Committee.
• The applicant must complete DMPRS-provided radiation safety orientation/training.
• The applicant must submit the following to the DMPRS for review:
• Appropriate Board Certification (or proof of eligibility to take the certification test).
• Resume or Curriculum Vitae (CV), which explicitly includes the applicant’s radioisotope use history.
• Radioactive Material Permit Application (Human Use).
• License from previous institution showing applicant’s authorization for use of the requested isotope(s) OR signed attestation that the applicant has the required training and experience (as applicable in 105 CMR 120.500) and has achieved a level of competency to function independently as an authorized user for medical uses (sample attestations are available from the DMPRS upon request).

Application for Authorized and/or Qualified Medical Physicist

Machines which deliver therapeutic radiation are required to be calibrated and maintained by an ‘Authorized Medical Physicist’, for Ir-192 in HDR, or ‘Qualified Medical Physicist’ for radiation generating machines such as a linear accelerator.
Individuals requesting to become an authorized medical physicist and/or qualified medical physicist must supply the following to the DMPRS:

• Appropriate Board Certification (or proof of eligibility to take the certification test).
• Resume or Curriculum Vitae (CV), which explicitly includes the applicants’ radioisotopes and/or linear accelerator use history.
• License from previous institution showing applicant’s authorization for use of the requested isotope(s) OR signed attestation that the applicant has the required training and experience (as applicable in 105 CMR 120.500) and has achieved a level of competency to function independently as an authorized and/or qualified medical physicist (sample attestations are available from the DMPRS upon request).

Permit holders (PH) are responsible for implementing radiation safety rules, regulations, and procedures and are directly responsible for laboratory safety. More specific responsibilities can be found in APPENDIX II: PERMIT HOLDER RESPONSIBILITIES, which a PH must sign prior to receiving their approved radioisotopes permit.

Permits may be considered either active, suspended or inactive. A permit holder’s status may change from active to inactive or active/inactive to suspended by one of four methods:

1. The RSO will evaluate the status of all permit holders annually, and those who have not used or ordered radioactivity in one calendar year will be contacted. If their future use of radioactive materials is unknown or known to be not at all, the PH may request to change their status to “inactive” by removing all radioactive materials, radioactively contaminated items and objects, and waste. Removal of all radioactive materials and contamination will be verified by the RSO. Their status will then be changed to inactive.
2. The PH may request to change their permit status to “inactive” but maintain their permit for grant purposes. The request will be handled by the RSO as indicated above.
3. The RSO may change a permit holder’s status to “inactive” due to other circumstances as considered appropriate after the conditions in No. 1 above have been satisfied.
4. The RSO and/or RSC may change a permit holder’s status to “suspended” if radiation safety refresher training is overdue. Reinstatement of PH status to “active” will require completion of Basic Radiation Safety Training.

Suspended Status
A permit holder’s status may become suspended if training requirements for the PH and/or users listed on the permit are not met. Once training has been completed, the DMPRS will confirm that training has been completed and reinstate active status.

Inactive Status
Inactive permit holders and individual users of radioactive materials whom they supervise must maintain all the conditions of their permit including completion of radiation safety refresher training every two years. Laboratories that apply or are designated for inactive status must meet the following requirements:

1. Inactive laboratories cannot possess radioactive material. All radioactive waste, samples, contaminated items, etc. must be properly removed and/or disposed of and disposition verified by the DMPRS.
2. A survey for “Release for Unrestricted Use” must be performed by the DMPRS and the change in use status approved by the RSO.
3. The ordering or transfer of radioactive material to a laboratory designated inactive must be approved by the DMPRS and the laboratory will be re-designated as an “Active” laboratory. In that regard, all labeling, posting, surveying, recordkeeping, etc. pertaining to an active status laboratory are applicable.
4. Inactive Use permit holders will be considered to possess a permit for grant purposes only. Inactive permit holders will not be required to perform the recordkeeping, surveys, inspections and other duties associated with possessing radioactive materials. Additionally, the RSO will not perform inspections of inactive permit holders until the status changes, but will maintain cognizance of their status.
5. Inactive permit holders and radioisotope users are required to perform Radiation Safety Refresher Training every two years.

In many instances, the PH will not always be available to provide direct supervision of radioactive material users. Therefore, the PH may designate a Laboratory Supervisor to act on their behalf. The ultimate responsibility for the use of radioactive materials, however, remains with the PH. The Laboratory Supervisor will be identified on the permit as the permit holder’s designee.

Research radioisotope users working under a PH must follow the policies and procedures outlined in this Manual. Use of radiation sources must be under the direct supervision of the PH and in the manner specified in the application for authorization to use such sources. The research radioisotope user must read and understand the laboratory permit prior to beginning work.

• Individuals who work with radioisotopes are required to complete the Basic Radiation Safety training (both part 1 and 2) offered by the DMPRS. The training schedule and sign up is available in SciShield.
  The goal of basic radiation protection training is to familiarize the radioisotope user with the following:
• Basic radiation science
• Radiation risk, biological effects, protection, and safety
• The concept of ALARA (As Low As Reasonably Achievable)
• Federal and state regulations and institutional policies
• The responsibilities of the radioisotope user, permit holder, and the BU/BMC radiation safety program
• Basic laboratory safety procedures
• Emergency response procedures
• Before the radioisotope user is allowed to handle radioactive material, the user must undergo site-specific safety training provided by the permit holder or designee.
• Laboratory personnel not specifically handling or working with radiation sources will receive radiation hazard awareness training as part of the introductory laboratory safety training that all users receive upon hire.
• Clinical use of radioisotopes requires obtaining clinical privileges, which are granted by Trustees of BMC.

Any individual at BU/BMC who works with radioisotopes is considered a radioisotope user. Radioisotope users at BU/BMC are responsible for:

• Completing basic radiation safety training provided by the DMPRS prior to entering the designated radiation work site.
• Completing training provided by the laboratory’s PH (or designee) on specific radiation safety practices within the laboratory.
• Following the BU/BMC ALARA program by keeping his/her radiation exposure As Low As Reasonable Achievable in addition to keeping his/her radiation exposure levels below the state and federal limits presented in Table 1: Occupational Effective Dose Equivalents Limits (rem/year).
• Participating in the whole body and/or ring dosimetry program if directed by the RSO.
• Using standard laboratory protective measures when working with radioactive material. Such measures include, but are not limited to:
• Wearing appropriate protective clothing (note: shorts and open toe shoes are not appropriate clothing).
• Using appropriate radiation shielding.
• When possible and practical, using mechanical devices or remote handling tools to reduce radiation exposure to the extremities.
• Whenever practical, minimizing the amount of time the user is exposed to radiation and performing experiments in an efficient, expeditious manner.
• Performing work in an approved hood or glove box if it is possible that radioactive material may be released into the air.
• Ensuring that no eating, drinking, smoking, or applying of cosmetics or lotions occur in areas where radioactive materials are present. Storage of food or beverages in a laboratory is prohibited.
• Maintaining good work habits and safe laboratory techniques as specified in APPENDIX I: RADIOISOTOPE LABORATORY RULES.
• Performing a radiation survey:
• At the end of each day when radioactive materials have been used/accessed;
• Following the transfer of radioactive materials from stock solutions; and
• After each experimental run if there is a possibility of a change in radiation levels or contamination.
• Immediately cleaning up contaminated areas and reporting spills and skin contamination to the DMPRS as soon as possible (see Emergency Contact Information).
• Keeping the laboratory neat and organized.
• Labeling and isolating radioactive sources, waste, and radiation emitting equipment.
• Understanding how to procure/purchase radioactive materials as described in Purchase of Radioactive Materials and Devices.
• Being familiar with the safe use and storage of radiation emitting materials and devices as described in Working with Radioactive Materials and Devices.
• Properly storing and disposing of radioactive waste as described in Radioactive Waste Management and Disposition of Radioactive Materials and Devices.
• Contacting the PH or a member of the DMPRS when unsure of how to handle a radiation safety related issue.

The PH must correct all deficiencies identified by the DMPRS within two weeks of notification. If a corrective action cannot be completed within the two week time frame, the reason must be communicated to the RSO with an estimated time to completion. The RSO may grant a one-time extension or suspend the permit until the issue is resolved.

Permits are reauthorized/renewed by the RSC, at minimum, every two years. All permit amendments will be treated and reviewed as renewals. The DMPRS monitors permits monthly for issues of noncompliance. Permit holders will be notified by the DMPRS two (2) months prior to the expiration date of their permit. Permit holders must submit a renewal permit application to the DMPRS, ensuring that all radiation users have completed their radiation safety refresher training for radioisotope users.

Permit holders who do not complete the refresher training within two (2) months of their expiration date will be prevented from purchasing radioactive materials, the permit will be deemed suspended, and all radioactive work must stop until training is completed. In some instances, the DMPRS may confiscate all radioactive materials. After ninety (90) days, the PH will need to reapply for a new radioisotope permit with retraining of all users.