SY15 Radiation-Producing Instruments
Subject Matter Expert:
Policy Steward:Assistant Vice-President for Police and Public Safety / Director of Environmental Health and Safety>
- Acquisition, Transfer and Disposal of Equipment
- Facility Design Requirements
- Further Information
- Cross References
To establish a policy for radiation-producing instruments that addresses the acquisition, installation, operation, control, disposal, and University compliance with state and federal regulations. This policy applies to all radiation-producing instruments in Penn State radiation producing equipment safety program at all locations except the Hershey Medical Center, and the College of Medicine.
The ownership and use of a radiation-producing instrument is governed by the Pennsylvania Department of Environmental Protection, Bureau of Radiation Protection. Specific requirements can be found in Title 25 of the Pennsylvania Code: Chapters 216, 219, 221, 223, 225, 227 and 228. Additional regulations of the U. S. Nuclear Regulatory Commission, U. S. Food and Drug Administration, and ANSI standards may also apply.
The following definitions apply to the terms used in this policy:
Analytical System: An assembly of components utilizing x-rays to determine the elemental, chemical, structure or composition of a material on a microscopic scale, typically by means of x-ray diffraction, fluorescence or attenuation techniques.
Electron Microscope: Equipment utilizing the wave characteristics of electrons that have been accelerated by an electric field to visualize the microscopic structure of material.
Industrial Radiography: The industrial examination of the macroscopic structure of materials by nondestructive methods utilizing radiation sources.
Open-beam Configuration: A radiation-producing instrument configuration in which the primary beam is not enclosed or shielded so that any portion of an individual's body could accidentally be placed in the beam.
Operating Procedure: Step-by-step instructions necessary to accomplish a specific task, function or analysis.
Radiographic System: X-ray producing equipment intended for imaging items on a macroscopic scale. This typically includes medical, veterinary and industrial x-ray systems.
Radiation-Producing Instrument: A device capable of producing ionizing radiation except those devices with radioactive material as the only source of radiation. This specifically includes analytical x-ray instruments; industrial, medical and veterinary radiographic instruments; electron microscopes; electron beam welders; x-ray vacuum spectroscopy systems; x-ray gauging devices; and, any electrical equipment that produces radiation incidental to its operation for other purposes, if the dose equivalent rate averaged over an area of 10 square centimeters exceeds 0.5 mrem (0.005 mSv) per hour at 5 centimeter from an accessible surface. Devices utilizing radioactive material as the source of x-rays are governed under additional regulations of either the Pennsylvania Department of Environmental Protection or the U.S. Nuclear Regulatory Commission.
Registrant: The entity in possession of a radiation-producing instrument. The registrant is always Penn State University.
Supervisor: The individual responsible for the radiation-producing instrument.
User: An individual engaged in work with a radiation-producing instrument.
X-ray gauging instrument: A machine utilizing x-rays to detect, measure, gauge or control thickness, density, level or interface location.
Supervisors and users of radiation-producing instruments are only permitted to use these devices if they comply with the requirements of this policy.
Environmental Health and Safety:
Environmental Health and Safety (EHS) is responsible for the oversight, implementation, coordination, and enforcement of the radiation-producing instrument safety program for Penn State University, except at the Hershey Medical Center. In this capacity, EHS is responsible for registering radiation-producing instruments with the Pennsylvania Department of Environmental Protection, Bureau of Radiation Protection (PA DEP BRP), maintaining the University's inventory of instruments, evaluating system installations for suitable location and conformance to applicable standards and regulations, providing radiation safety training, establishing policies for issuing personal dosimetry, issuing personal dosimetry, providing general oversight and guidance as to sources of ionizing radiation, and for performing and documenting required safety inspections and surveys of radiation-producing instruments, where applicable.
Supervisors are responsible for the safe operation and maintenance of the radiation-producing instruments under their control, adhering to the requirements of this policy, and for immediately informing EHS of the acquisition, modification, transfer, or disposal of systems. The supervisor is responsible for developing written operating procedures for each instrument and providing training on those procedures to respective users. In addition, supervisors of analytical and radiographic x-ray equipment are required to complete the radiation-producing equipment safety orientation provided by EHS, and ensuring that personnel under their supervision attend the same training provided by EHS. Each supervisor is responsible to pay the Pennsylvania Department of Environmental Protection registration fee for use of each radiation producing device under their jurisdiction or control. Procedures for payment are established through EHS.
Users of radiation-producing instruments are responsible for following the written operating procedures and performing all work in a safe manner. Users are also responsible for reporting to the supervisor any unusual or unsafe condition they discover with the radiation-producing instrument, and for suspending work with that instrument until the unsafe condition is rectified. In addition, users of analytical and radiographic x-ray equipment are required to complete the radiation-producing equipment safety orientation provided by EHS before beginning work with sources of ionizing radiation.
Prior to the use of radiation-producing instruments, supervisors shall prepare written operating procedures and review them with the user(s). The scope of these procedures will vary depending on the type and intended use of the instrument. The content shall be as a minimum that which satisfies the state regulations governing the specific type of instrument. Specific regulations can be accessed at the following links:
- Link to all Regulations
- Medical Regulations
- Veterinary Regulations
- Industrial Regulations
- Analytical Regulations
- Accelerators Regulations
Personnel monitoring of users is dependent on the type of radiation-producing instrument in use and the scope of the work to be performed. Users of veterinary, medical and most radiographic x-ray instruments are required to wear whole body dosimeters. For analytical x-ray instruments, individuals responsible for performing beam alignment or maintenance of the system that requires the presence of an open beam configuration are required to wear an extremity dosimeter. Personnel monitoring is not required for users of electron microscopes.
EHS is responsible for providing personnel radiation monitors and maintaining dosimetry records. Monitors will be issued only to individuals who have completed and passed the required radiation-producing equipment safety orientation. Individuals who have been issued personnel dosimetry are required to wear their dosimeter whenever working with systems that require monitoring.
Users performing industrial radiography techniques are required to have radiation survey meters in use during all radiographic procedures. A survey meter is also required during maintenance or beam alignment procedures on analytical or radiographic equipment if these procedures require the x-ray tube to be energized, or if the procedure requires an open beam configuration.
Inspections of the safety devices and radiological surveys of analytical and radiographic equipment will be performed by EHS upon initial installation of the instrument and annually thereafter. Additional surveys may be required depending on changes in components or configuration of a system. Records of these inspections will be maintained by EHS.
System safety devices, including shielding, interlocks, warning lights and alarms, may not be circumvented or bypassed without the written permission of the University's Radiation Safety Officer. The only exception to this requirement are system maintenance or beam alignment procedures that require the presence of a primary beam provided these procedures are documented and only performed by individuals approved to do so by the system supervisor. All safety devices must be reinstated before returning the system to routine operation.
Use of University-owned instruments at non-University locations shall be approved by EHS in advance of use. Notification shall include the name of the supervisor responsible for the system, type of system to be used, intended location, purpose, duration of work, and a contact name and phone number of a responsible individual representing the non-University location.
ACQUISITION, TRANSFER, AND DISPOSAL OF EQUIPMENT:
Faculty, supervisors, and users are strongly encouraged to consult with EHS as early as possible prior to ordering or installing any radiation-producing equipment. EHS can provide useful information concerning appropriate safety features, suitability of installation location and the safe operation of the equipment. All radiation-producing instruments are required to be registered with the PA DEP BRP. This includes, but is not limited to, any instrument maintained in storage or donated to the University.
Once installed, the supervisor must contact EHS and arrange to have the system inspected for required labeling, safety devices, radiation levels, and evaluation of the system location to assure user and non-user safety. This also applies to relocation of current systems to another University location. The system may not be put into routine service and operation until approved by EHS.
Transferring a device to another supervisor within the University may require a safety evaluation of the new location and the new supervisor's radiation safety training status. Instruments being transferred, donated, or sold to another institution, company, or individual, requires a written notification to the PA DEP BRP. Supervisors are responsible for informing EHS prior to the transfer of the equipment. EHS is responsible for providing the written notification to the state.
Supervisors must also inform EHS when a system is permanently removed from service and is to be either disposed of or used for parts. EHS is responsible for notifying the state that these systems are no longer in service and they will be removed from the University's inventory.
Disposal of radiation-producing equipment through University salvage must take into account the proper disposal of all hazardous substances. Lead, oils, and x-ray tubes containing beryllium must be removed and disposed of as hazardous waste. Contact EHS for guidance on proper disposal.
Supervisors and users of analytical and radiographic x-ray equipment must complete the radiation-producing equipment safety orientation provided by EHS prior to beginning work with sources of ionizing radiation. The training will consist of the following general topics: fundamentals of radiation safety; characteristics of radiation; units of radiation dose and quantity of radioactivity; significance of radiation dose; radiation protection standards; biological effects of radiation dose; levels of radiation from radiation sources; methods of controlling radiation dose: working time, distance and shielding; radiation detection instrumentation to be used; use of radiation survey instruments: operation, calibration and limitations; safety devices; survey techniques; use of personnel monitoring equipment; and the requirements of pertinent Federal and State regulations.
FACILITY DESIGN REQUIREMENTS:
Location and use of radiation-producing equipment must be approved in advance by EHS, and shall be limited to areas that ensure the safety of users and non-users. The facility design or location shall be such that the dose rate in unrestricted areas does not exceed 0.002 rem in any one hour, if an individual were continuously present in the area, and shall not result in an individual member of the public receiving a total effective dose in excess of 0.1 rem in a year.
Exposure to the primary beam of an analytical or radiographic x-ray source may result in serious injury. If a situation arises where an individual is accidentally exposed to the primary beam of a radiation-producing instrument, or if you suspect that an individual has been exposed, the following action is to be taken immediately:
- Shut off the x-ray equipment and secure it from use by other individuals. Do not change the experimental or equipment configuration. The exposed individual's dose can best be evaluated and reconstructed if the system set-up is not altered in any way following the event.
- Contact EHS at 814-865-6391. Inform them that an individual working with an x-ray device may have received an accidental radiation overexposure and that you need to contact the Radiation Safety Officer immediately.
- Inform the supervisor of the system of the accident.
- If this is a life threatening emergency such as electrical shock, fire, etc., dial 911 for emergency response.
In conjunction with the individual involved, system supervisor, and respective department safety officer, EHS will begin an investigation as to the circumstances of the event. The system in question shall remain out of service pending the results of the investigation and completion of any corrective actions, if needed. EHS is responsible for notifying the PA DEP BRP within 5 days of the occurrence, even if it is later determined that no accidental exposure occurred. The system may only be returned to service following written approval from the EHS office.
For questions, additional detail, or to request changes to this policy, please contact the Director of Environmental Health and Safety.
Other Policies in this manual should also be referenced, especially the following:
SY01 - Environmental Health and Safety Policy
SY04 - Employee Accidents - Reporting and Investigation
SY20 - Hazardous Waste Disposal
Most recent changes:
- January 6, 2022 - Changed Subject Matter Expert.
Revision History (and effective dates):
- November 5, 2021 - Updated links under OPERATIONS section.
March 12, 2019 - Editorial change. In In RESPONSIBILITIES, financial responsibilities for device registration fees is moved from Users to Supervisors. In PURPOSE, revised from "This policy applies to University-owned radiation producing instruments at all location except the Hershey Medical Center" to "This policy applies to all radiation-producing instruments in Penn State radiation producing equipment safety program at all locations except the Hershey Medical Center, and the College of Medicine".
- June 11, 2014 - Editorial change to ANSI X-ray standards made in REFERENCES section. Added policy steward/ further information references, in the event that there are questions or requests for changes to the policy.
- March 12, 2010 - Editorial changes. In RESPONSIBILITIES, clarified financial responsibilities for device registration fees in section pertaining to Users (verbiage added to end of paragraph).
- May 29, 2002 - New Policy.
Date Approved:November 5, 2021>
Date Published:November 5, 2021>