Radioactive Materials Safety Manual 2408 Wanda Daley Drive | Ames, IA 50011-3602 | (515) 294-5359 | www.ehs.iastate.edu Copyright © | Reviewed 2022
2 Radioactive Materials Safety Manual Environmental Health and Safety Protecting the Safety, Health, and Environment of the Iowa State Community Iowa State University strives to be a model for safety, health, and environmental excellence in teaching, research, extension, and the management of its facilities. IN pursuit of this goal, appropriate policies and procedures have been developed and must be followed to ensure the Iowa State community operates in an environment free from recognized hazards. Faculty, staff, and students are responsible for following established policies and are encouraged to adopt practices that ensure safety, protect health, and minimize the institutions’ impact on the environment. As an institution of higher learning, Iowa State University ● fosters an understanding of and a responsibility for the environment, ● encourages individuals to be knowledgeable about safety, health and environmental issues that affect their discipline, and ● shares examples of superior safety, health and environmental performance with peer institutions, the State of Iowa and the local community. As a responsible steward of facilities and the environment, Iowa State University ● strives to provide and maintain safe working environments that minimize the risk of injury or illness to faculty, staff, students, and the public, ● continuously improves the operations, with the goal of meeting or exceeding safety, health and environmental regulations, rules, policies, or consensus standards, and ● employs innovative strategies of waste minimization and pollution prevention to reduce the use of toxic substances, promote reuse, and encourage the purchase of renewable, recyclable and recycled materials. The intent of this statement is to promote environmental stewardship, protect health, and encourage safe work practices within the Iowa State University community. The cooperative efforts of the campus community will ensure that Iowa State University continues to be a great place to live, work, and learn. Wendy Wintersteen President
3 Radioactive Materials Safety Manual Environmental Health and Safety Service and Emergency Providers Environmental Health and Safety 2408 Wanda Daley Drive | (515) 294-5359 Iowa State University Occupational Medicine Department G11 Technical and Administrative Services Facility (TASF), 2408 Pammel Drive | (515) 294-2056 McFarland Clinic PC, Occupational Medicine 1018 Duff Avenue | (515) 239-4496 Thielen Student Health Center 2647 Union Drive | (515) 294-5801 Emergency Emergency - Ambulance, Fire, Police 911 Department of Public Safety/ Iowa State University Police Armory, 2519 Osborn Drive | (515) 294-4428 Mary Greeley Medical Center 1111 Duff Avenue | (515) 239-2011 Non-discrimination Statement “Iowa State University does not discriminate on the basis of race, color, age, ethnicity, religion, national origin, pregnancy, sexual orientation, gender identity, genetic information, sex, marital status, disability, or status as a U.S. veteran. Inquiries regarding non-discrimination policies may be directed to Office of Equal Opportunity, 3350 Beardshear Hall, 515 Morrill Road, Ames, Iowa 50011, Tel. (515) 294-7612, email eooffice@iastate.edu”
4 Radioactive Materials Safety Manual Environmental Health and Safety Table of Contents Service and Emergency Providers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Non-discrimination Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Table of Acronyms 7 A Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 B Regulatory Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 University Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 C Administrative Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Environmental Health and Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Radiation Safety Committee . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Radiation Safety Officer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 University Compliance Committees . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Animals - Institutional Animal Care and Use Committee (IACUC). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11 Biohazards - Institutional Biosafety Committee (IBC) . . . . . . . . . . . . . . . . . . . . . 11 Humans - Institutional Review Board (IRB) . . . . . . . . . . . . . . . . . . . . . . . . . 11 Radiation - Radiation Safety Committee (RSC) . . . . . . . . . . . . . . . . . . . . . . . .11 D Process Planning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Authorization Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Personnel Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 Facility Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Project Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Research Centers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 Review and Approval of Application 14 Summary of the Radiation Authorization Application, Review and Approval Process ���������������������������� 15 Radiation Authorization Amendments 15 Adding Authorized Personnel . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 Approval in Concept . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Authorization Termination and Laboratory Closure 16 E Training Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Radioactive Material Users . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 Awareness Training for Laboratory Personnel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 Service Personnel Working in a Radiation Laboratory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
5 Radioactive Materials Safety Manual Environmental Health and Safety Minors Visiting or Completing Work in a Radiation Laboratory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 Laboratory Specific Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 F Responsibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 Responsibilities of the Principal Investigator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 Responsibilities of the Authorized Personnel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 G Obtaining Radioactive Material . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 Ordering Radioactive Material . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 Radioactive Material Ordering Procedures: . . . . . . . . . . . . . . . . . . . . . . . 22 Receipt and Delivery of Radioactive Material . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 Receipt of Free/Gifted/Evaluation Materials and Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 H Security, Storage, Transfer, and Transportation of Radioactive Materials 24 Security of Radioactive Material . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 Storage of Radioactive Material: RAM Sources, Labeled Materials and Waste 24 On-Campus Transfers of RAM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 Off-Campus RAM Transfers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 Transportation of Radioactive Material . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 Transportation of RAM on Public Roadways . . . . . . . . . . . . . . . . . . . . . . . 25 Package Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 Other important considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 Transportation of RAM or Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 Temporary Job Sites and Remote Locations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 Reciprocal Licensing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 I Radioactive Waste . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 Radioactive Waste Handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 Summary of solid waste criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 Summary of liquid waste criteria . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 Other important considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 Disposal of Equipment with Embedded Sources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 Radioactive Waste Minimization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 J Personnel Exposure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 Occupational Dose Limits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 External Dose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
6 Radioactive Materials Safety Manual Environmental Health and Safety Internal Dose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 Sum Of External and Internal Doses . . . . . . . . . . . . . . . . . . . . . . . . . 30 Regulatory Dose Limits to Declared Pregnant Workers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31 Occupational Dose Limits for Minors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32 Regulatory Limits for Dose to Individual Members of the Public . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32 K Personnel Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 Personnel Dosimeters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 Whole Body . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 Extremity/Ring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 Bioassays . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 ALARA and Personnel Exposure Records/Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 L Laboratory Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 Facility Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 Procedures, Practices, and Rules for the Safe Use of Radioactive Materials 36 Approved Locations and Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 Contamination Surveys by Authorized Personnel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 Annual Reviews . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 Radioactive Material Audits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 Radioactive Material Surveys . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 M Emergency & Decontamination Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 Minor Spills and Contaminations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 Major Spills and Contaminations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 Restricting Access to Areas Due to RAM Contamination . . . . . . . . . . . . . . . . . . 40 Accidents Involving Radioactive Material . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 Decontamination Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 Clean-up of Radioactive Contamination and Legacy Materials or Devices . . . . . . . . . . . . . . . . . . . . 42 N Other Uses of Radioactive Materials 43 Radioiodination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 Animal and Biological Specimen Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 Environmental Releases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 Appendix I - Guidelines for the Safe Use of Radionuclides . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44 Appendix II - Dictionary and Glossary 58
7 Radioactive Materials Safety Manual Environmental Health and Safety Table of Acronyms ALARA As Low as Reasonably Achievable CDE Committed Dose Equivalent CEDE Committed Effective Dose Equivalent DDE Deep-Dose Equivalent DOT U.S. Department of Transportation EH&S Environmental Health and Safety ISU Iowa State University IDPH Iowa Department of Public Health IAC Iowa Administrative Code ORE Office of Research Ethics PPE Personal Protective Equipment PI Principal Investigators RAM Radioactive Materials RPD Radiation Producing Devices RSC Radiation Safety Committee RSO Radiation Safety Officer SDE Shallow-Dose Equivalent TEDE Total Effective Dose Equivalent TODE Total Organ Dose Equivalent VPR Vice President for Research
8 Radioactive Materials Safety Manual Environmental Health and Safety A Introduction Radioactive materials and radiation producing devices have long been used as important tools in research and teaching. Concern over health risks associated with radiation exposure has led to occupational exposure limits and strict regulatory controls governing the possession and use of all sources of ionizing radiation. Current radiation exposure limits are based upon the conservative assumption that there is no completely safe level of exposure. This assumption has led to the general philosophy and regulatory requirement of not only keeping exposures below recommended levels or regulatory limits, but of also maintaining all exposures ALARA. This is a fundamental tenet of current radiation safety practice. In order to ensure that all users of ionizing radiation at ISU are in compliance with existing regulatory requirements, and that radiation exposures are maintained ALARA, EH&S has implemented the policies and procedures contained in this Radioactive Materials Safety Manual. This manual is intended to provide sufficient information to ensure that radiation safety practices at ISU are of the highest quality. It is the responsibility of each person working with RAM to become familiar with the contents of this manual and to observe those procedures and requirements contained herein that are applicable to their work. This manual is intended to supplement the requirements found in the ISU Laboratory Safety Manual. For individuals seeking initial authorization approval to use RAM at ISU, a detailed list of the necessary steps for obtaining approval and initiating the use of RAM has been prepared and can be found on the EH&S website.
9 Radioactive Materials Safety Manual Environmental Health and Safety B Regulatory Requirements The possession and use of RAM and RPDs in the United States are governed by strict regulatory controls. Regulations controlling the use of radiation in Iowa are found in Chapter 136C of the Iowa Administrative Code and are administered by the Bureau of Radiological Health of the IDPH. ISU holds a broadscope radioactive materials license issued by IDPH. This license grants ISU the authority and responsibility for setting the specific requirements for radioactive material use within its facilities. All use of RAM under the authorization of the broad scope license is governed by RSC, and is subject to inspections and audits by the IDPH and EH&S for rules compliance and safety performance. ISU holds separate licenses for Generally Licensed Materials and RPDs. The RSC has oversight of these items. Sealed source users must comply with the requirements in the Sealed Source Safety Manual and RPD users must comply with requirements in X-Ray Safety Manual, respectively. University Policy ISU has established its commitment to the safe use of RAM and RPDs through policies that minimize the hazards of radiation and maintaining radiation exposures ALARA. These policies can be viewed on the ISU Policy Library web page.
10 Radioactive Materials Safety Manual Environmental Health and Safety C Administrative Controls Environmental Health and Safety EH&S oversees the radiation safety program for ISU. Functions of the radiation safety program include: • accountability for RAM use on campus • radiation safety training • laboratory inspections • waste handling • personnel dosimetry • public exposure EH&S also has the responsibility for administering all university health and safety programs including: biological, chemical, emergency management, environmental, fire, laboratory, and occupational safety. Radiation Safety Committee In accordance with the specific requirements of the university’s broad scope license for radioactive material use, ISU has established a RSC. The committee consists of university faculty trained in a safe use of radioactive material and includes a member representing university administration, and the RSO. Members are appointed by the Vice President for Research for terms of three years. The principal function of the committee is to oversee the safe use of RAM and RPDs on campus. The RSC reviews all requests for use of RAM and RPDs, grants authorization, and performs audits of the radiation safety program. Functions of the RSC are outlined in the RSC Charter. Radiation Safety Officer The RSO is designated as the radiation safety expert and responsible person who oversees the daily administration and operation of the university’s radiation safety program. The RSO is a permanent member of the RSC and is assisted by EH&S radiation safety staff and student technicians to carry out the daily functions of the ISU radiation safety program.
11 Radioactive Materials Safety Manual Environmental Health and Safety University Compliance Committees Iowa State University’s compliance program includes conflict of interest, research integrity, export control, and research compliance review committees. The purpose of the compliance review committees is to review and approve all relevant proposals to ensure that they are in compliance with university, local, state, federal, and funding agency regulations for research. The four review committees administratively reside within the Office of Research Ethics (ORE) and include: Animals - Institutional Animal Care and Use Committee (IACUC) All activities involving the use of live vertebrate animals must be approved by the IACUC prior to the use of the animals in research or teaching activities. Research activities include field studies, clinical trials, the use of blood donor animals, and breeding colonies. Teaching activities include scheduled courses and continuing education offerings. Biohazards - Institutional Biosafety Committee (IBC) The IBC must approve any teaching or research project that involves: the use of recombinant or synthetic nucleic acid molecules including transgenic animals or plants; the use of human, animal, or plant pathogens (e.g., bacteria, viruses, prions, parasites); the use of biological toxins; materials received under the USDA APHIS permit the administration of experimental biological products to animals; or field releases of plant pests or genetically modified organisms (GMO). Humans - Institutional Review Board (IRB) The IRB reviews any research involving human participants, including proposals to gather data from participants for theses, dissertations, and other student projects. Radiation - Radiation Safety Committee (RSC) All research using radiation must be approved by the RSC. IRB, IACUC and IBC applications using radiation must be reviewed and approved by the RSC, as these committees do not have the authority to approve radiation use.
12 Radioactive Materials Safety Manual Environmental Health and Safety D Process Planning All research and teaching uses of radiation requires the approval of the RSC. Each new project, changes to existing approvals, and the addition of new research will be reviewed and approved by the RSC. A PI requesting approval to provide services to other laboratories or to use material in an academic course must request approval from the RSC to operate as a research center. Authorization Process The individual responsible for the proposed project, referred to as the PI, begins the authorization process by submitting a completed radioactive materials use application to EH&S. Other application forms are available from the radiation safety section of the EH&S website. The application must include detailed information in three general categories: information on personnel, facility information and a project description. Personnel Information It is critical that persons working with radiation have the proper experience and knowledge to safely use radiation and maintain radiation exposures ALARA. The RSC and RSO evaluate all requests from the following information: Principal Investigator (PI) and/or Device Manager: The person who is responsible for radiation use within their assigned laboratories. This person will establish and lead radiation safety within their laboratories. As the radiation safety lead, the PI is required to maintain their safety training on an annual basis. Alternate PI: A person authorized to act on behalf of the PI in their absence. The Alternate PI shall maintain their safety training on an annual basis. Laboratory Supervisor: The person most familiar with daily laboratory functions and radiation use. This person is authorized to make administrative changes to the radiation authorization. The laboratory supervisor shall maintain their safety training on an annual basis. Authorized Personnel: The people who will work with radiation under the supervision of the PI. The PI must be listed as authorized personnel.Annual radiation safety training is required for all authorized personnel. Education and Laboratory Experience: Title and credit hours of any course taken in nuclear science, radiation safety or radionuclide use; an indication of whether Iowa State’s radiation safety training program has been completed (including the completion date), duration of experience, type, and quantity of radionuclides used, the Note: All new applications must be reviewed and approved by the RSC.
13 Radioactive Materials Safety Manual Environmental Health and Safety specific experimental procedures employed, procedures followed for laboratory safety and waste handling. Attach additional sheets to the application if needed. Facility Description A facility must meet certain requirements in order to be used for work with radiation materials or devices. Determination of facility suitability includes: Locations of use: Building, floor, room number, department Room Diagram for each location: Locations of hoods, sinks, benches, exterior/interior walls, windows, doors, intended use, and storage areas Construction materials: Floors, bench tops, hoods, and sinks Ventilation: Air exchange rate for the laboratory and the number and type of hoods or glove boxes Radiation safety equipment: Shielding, waste containers, trays, absorbent paper, spill kit, type of radiation detectors, and radiation counting equipment Occupancy of facility and adjacent areas: Use of facility by individuals not approved for radionuclide work and use of areas adjacent to the facility Project Description The project description should include: • standard operating procedures • diagrams • types of equipment used • safety procedures • radionuclides and radioactivity • radiation detection methods • hazardous materials • duration of project • any other information describing the procedure A journal article, kit instructions, or similar written techniques can be used to satisfy some of these descriptions.
14 Radioactive Materials Safety Manual Environmental Health and Safety Research Centers Research centers are laboratories that provide research services to multiple customers, both on and off campus, offer equipment for use by other laboratories, or that serve as an academic laboratory. These centers are required to: • Provide EH&S with written documentation detailing how training records will be maintained (who is in charge, location of records, etc.). • Maintain records of radiation training for all users. • Maintain records of laboratory specific training (i.e. how to properly and safely use the equipment). • Maintain a usage logs. • Ensure that only people with current radiation safety training are allowed to use the equipment. • Allow EH&S to review training records, usage logs, etc during audits. • Contact EH&S prior to making major changes to, or adding new research protocols. • Be aware of other approvals that may be needed (IACUC, IRB, IBC, etc.). EH&S will audit research centers at least annually. The RSC may require a laboratory to operate as a center based on information provided by the PI. Prior authorization of a procedure does not grant approval for the PI to provide services to other laboratories or operate as a research centers. Review and Approval of Application The completed application must be submitted to EH&S, where it will receive an initial review by the RSO. The RSO may require additional information from the applicant to assess the safety of the procedure. EH&S will also review procedures for additional hazards involving chemical and biological materials, physical hazards, and the use of human and animal subjects. Approval for procedures involving additional hazards may be delayed until safety and regulatory measures are addressed. Once the application appears to be adequate, the RSO forwards it to the RSC chair for approval. If the application is approved, the PI will receive a copy of the official authorization form listing any special conditions that may apply. The RSC reserves the authority for line item approvals on all applications. Should any portion of the application be denied, the PI will be provided with an explanation for this decision.. The notification will include a description of possible modifications to the project necessary to obtain approval.
15 Radioactive Materials Safety Manual Environmental Health and Safety Summary of the Radiation Authorization Application, Review and Approval Process 1. PI completes application. 2. PI submits completed application and supporting documents to EH&S. 3. EH&S reviews application. 4. EH&S submits application with recommendations to RSC. 5. RSC reviews application. 6. RSC notifies EH&S of their decision. 7. EH&S notifies PI and arranges details to set up the laboratory. Radiation Authorization Amendments Modifications to a PIs original authorization may be requested through EH&S in either written or electronic form. Minor changes, such as changes in personnel, additional projects, increased possession limits, or changes in location are reviewed and approved by the RSO. Extensive changes to the authorization such as: adding additional radionuclides or devices, or adding new radiation procedures will be subject to the same review and approval process as the original application. Adding Authorized Personnel Authorized Personnel are added through the training process. If authorized personnel join another radiation laboratory the change must be submitted to EH&S. You must list a currently approved PI who has approved your addition to their Radioactive Materials Use Authorization. 1. Complete the Radioactive Material Worker Application. 2. Submit the Worker Application to: EH&S, 2408 Wanda Daley Drive, Ames, Iowa 50011-3602 or by e-mail. 3. EH&S will add personnel to the PI’s authorization and send an updated copy to the PI and laboratory supervisor. Note: All new protocols must be approved by the RSC.
16 Radioactive Materials Safety Manual Environmental Health and Safety Approval in Concept Approval in Concept may be issued to PIs by the RSC and ORR for funded projects where the funding agency has approved an initial period for development of the final protocol and related studymaterials. No research with radiation may be conducted under an Approval in Concept. Submission of a RAM or RPDs authorization application will be required to obtain an authorization prior to conducting research. Authorization Termination and Laboratory Closure When a PI no longer uses RAM in their research: they must submit a written request to EH&S for laboratory decommissioning. EH&S will schedule a time to collect materials, complete close out surveys and remove postings from the laboratory. Authorizations and laboratories may be decommissioned for noncompliance of policies, rules, and regulations under the provisions of the RSC Charter. An authorization may be decommissioned for actions such as the deliberate misuse of materials or devices, or the PI failing to complete annual training requirements. Authorizations and laboratories with no active radiation projects will be subject to closure. Seeking future funding does not mean an active project. PIs storing material for later use will be subject to all requirements of the rules, including annual training. Note: A new user may request an Approval in Concept when applying for a grant.
17 Radioactive Materials Safety Manual Environmental Health and Safety E Training Requirements Radiation specific training provides PIs and authorized personnel with knowledge of basic radiation safety theory, techniques, and ISU procedures. Radiation safety training is an ongoing process and consists of an initial training course and annual retraining. Multiple training courses are required for multiple types of authorizations since policies, rules, and procedures differ for RAM. Additionally, laboratory safety training, as specified in the Laboratory Safety Manual shall be completed to meet Occupational Health and Safety Administration (OSHA) requirements. Personnel Initial Training Course(s) Retraining Course and Frequency Radioactive Materials (RAM) Users Radiation Safety for Material Users - Part 1 (online) Radiation Safety for Material Users - Part 2 (online) Radiation Safety for Material Users - Part 3 (online) Radiation Safety for Material Users - Part 4 (Laboratory) Radiation Safety for Material Users Refresher (online) Jan.- Feb. is retraining period Laboratory Personnel in a RAM laboratory Radiation Awareness Training (online) Radiation Awareness Training 3 yrs. Service Personnel – Custodial and Maintenance staff Radiation Awareness Training (online) Radiation Awareness Training 3 yrs. Note: See Sealed Source and/or X-Ray Manual for appropriate training courses. Note: RAM refresher training is required annually!!
18 Radioactive Materials Safety Manual Environmental Health and Safety Radioactive Material Users RAM training is required for all authorized personnel using radioactive materials, especially any type of open form radionuclides. This training will provide a basic understanding of ionizing radiation and its potential hazards, as well as knowledge of the particular rules, regulations, and university processes governing RAM use. Online training modules are available through Learn@ISU with a performance based laboratory module held at the EH&S Learning Center. All modules must be completed to satisfy the initial radiation safety training requirement. Annual retraining is online through LEARN@ISU. PIs and authorized personnel will be reminded by EH&S of dates to complete the training (January - February). Those who do not complete the annual retraining within the established time frame will be removed as authorized personnel and may need to repeat the initial four part radiation safety training for materials users. Awareness Training for Laboratory Personnel Anyone working in laboratories that are not approved radiation personnel, but have access to locations where radiation is used, are required to complete radiation awareness training. Topics include a basic introduction to radiation; recognizing the meaning of radiation symbols and warning signs; and understanding safety rules, security rules and emergency procedures when working in a containing RAM. This training is required when personnel join a laboratory and then every three years. Service Personnel Working in a Radiation Laboratory This online awareness course provides non-laboratory support staff, such as custodians and maintenance workers, with an overview of basic radiation safety. Participants will learn what is required of them when providing services for laboratories in which radioactive materials are used. Topics include a basic introduction to radiation; recognizing the meaning of radiation symbols and warning signs; and understanding safety rules and emergency procedures when entering a laboratory containing radioactive materials. This training is required prior to providing services to a radiation laboratory and then every three years. Radiation awareness training is an online course available through Learn@ISU.
19 Radioactive Materials Safety Manual Environmental Health and Safety Minors Visiting or Completing Work in a Radiation Laboratory Iowa State University policies outline the requirements of laboratory access for people less than 18 years of age. The policies exist to reduce risks to minors who visit or work in laboratories or shops. Consult the ISU policy library for Children in the Workplace. Authorization of minors to use radiation will be at the discretion of the RSC based on input from the PI. At a minimum, minors working in laboratories approved for radiation use are required to complete radiation awareness training. Laboratory Specific Training Documented lab-specific training is required annually. Recommended topics include: • laboratory SOPs • manufacturer’s operating instructions • potential hazards • transfer and disposal requirements See the ISU Laboratory Safety Manual for more information.
20 Radioactive Materials Safety Manual Environmental Health and Safety F Responsibilities At ISU trained radiation users share the responsibility for ensuring the safe use of radiation. Failure to comply with this responsibility may result in termination of a user’s authorization to use radiation. These responsibilities are summarized below. Responsibilities of the Principal Investigator The individual authorized by the RSC as the PI on a project involving the use of radiation is responsible for all activities conducted under the scope of that authorization. The PI has the responsibility for ensuring that: • All individuals working with radiation have completed all university and laboratory safety training requirements including the required annual refresher training. • All individuals working with radiation have been formally authorized by the RSC. • All rules, regulations and procedures for the safe use of radiation are followed. • An accurate record of the types, quantities and locations of radioactive materials and devices is maintained. • EH&S is notified of any changes in the storage or use of radiation materials (RAM) and devices prior to implementing the changes. • All uses of radiation are constantly evaluated to further reduce exposures to individuals ALARA. • All procedures for using RAM are current and accurate. • All radioactive sources or source material are secure from unauthorized access or removal. • EH&S is notified of all unusual events or conditions that occur in the laboratory, including spills, releases, missing inventory, etc. • EH&S is informed when authorized personnel leave the laboratory. • EH&S is informed when ending the use of RAM or devices • EH&S is notified when leaving the university. The entire laboratory authorization for radiation use may be revoked for non-compliance of policies, rules, and regulations following the guidelines set forth in the RSC Charter.
21 Radioactive Materials Safety Manual Environmental Health and Safety Responsibilities of the Authorized Personnel Personnel authorized to use RAM are responsible for its safe use. Each user must: • Minimize their personal exposure to ALARA. • Minimize public exposure to ALARA. • Wear assigned dosimetry as specified in this manual. • Understand and comply with all sections of this manual that apply to their work. • Identify the location of all radiation sources in the work area and the extent of their potential risks, and use the appropriate procedures to minimize the risks. • Monitor the work area frequently for contamination or exposure and document the results. • Clean all identified contaminations as soon as possible. Do not leave for others to clean up. • Dispose of radioactive waste properly • Maintain postings, labels, and markings for all sources, containers, and work areas. • Maintain usage logs, records, and inventories. • Prevent unauthorized persons from access to radioactive material and devices. This includes service personnel in the laboratory for maintenance or repair. • Notify EH&S of all unusual events or conditions that occur in the laboratory, including spills, releases, missing inventory, etc. • Complete all required training within the set time period specified by the RSC. • Report spills, contaminations, or personal contamination to EH&S. The individual’s authorization to use radiation may be revoked for non-compliance of policies, rules and regulations under the provisions of the RSC Charter.
22 Radioactive Materials Safety Manual Environmental Health and Safety G Obtaining Radioactive Material In order to ensure proper management of the types and amounts of RAM and devices entering the ISU campus, all purchases of these items must be approved and processed by EH&S. ISU is required to provide proof of licensing to the vendor prior to transfer or shipment. Ordering Radioactive Material A copy of ISU’s current broad scope license must be on file with all companies or licensees before ordering. Contact EH&S at (515) 2945359 to request a copy of this license be sent to the vendor. It is the vendor’s responsibility to obtain the license prior to shipment. Radioactive Material Ordering Procedures: • Authorized personnel initiate the procurement process by contacting EH&S (rad_log_num@iastate.edu) to obtain a log number. Information required for issuing a log number: ○ Name of PI ○ Name of end user ○ Phone number to contact when delivered ○ Nuclide supplier/vendor ○ Nuclide(s) being ordered ○ Total nuclide activity, in mCi ○ Chemical form • EH&S checks the type and amount of the radionuclide to be ordered against the authorized PI’s approved amount and current inventory. • If the request does not increase the PI’s inventory beyond authorized activity limits, EH&S will assign the order a log number. • If the user is utilizing Perkin Elmer, the order may be placed in the cyBUY system by accessing the Perkin Elmer catalog. The log number should be entered in the “attention” line of the cyBUY release. All Perkin Elmer orders will ship to the EH&S address shown at the end of this section. • If the user is using a different vendor for ordering RAM, they must complete a requisition to Procurement Services requesting that a purchase order (P.O.) be issued to the vendor. The requisition should reference the log number in the purchasing notes. Procurement Services also has contracts in place for radioactive materials. Contact the Procurement Services to get information on the radionuclide contracts and how to place orders on those contracts. Procurement Services will not issue a P.O. number if the order has not been assigned an EH&S log number.
23 Radioactive Materials Safety Manual Environmental Health and Safety • The vendor must also be instructed to reference the log number on the packing slip accompanying the order. • A log number is required even if a purchase order is not used to procure the material (examples: evaluation materials, materials transfer from non-vendors, or materials forwarded to a new PI). • In accordance with RAM license requirements, the vendor must be instructed to address the shipment to EH&S. Do not address RAM packages for delivery directly to your laboratory. Iowa State University Environmental Health and Safety 1122 Environmental Health & Safety Services Bldg 2408 Wanda Daley Drive Ames, Iowa 50011-3602 Log Number: xxxx-xxxx RAM, devices with embedded sources, sealed sources, or generally licensed materials must be purchased through an university issued purchase order number or established vendor contract issued by Procurement Services. Receipt and Delivery of Radioactive Material Upon receipt of a radionuclide shipment, EH&S staff will check the RAM package to ensure that radiation exposure levels and contamination levels are within regulatory limits. If a RAM package is mistakenly delivered directly to your laboratory, inform EH&S immediately EH&S staff will then enter the radionuclide data into the PI’s RAM inventory and deliver the shipment to the user’s laboratory. Late packages received by EH&S will be processed when received, but may not be delivered to the PI until the following day. An approved RAM user must sign for the RAM package upon delivery to the laboratory. At least one radionuclide usage and inventory form will accompany each package stating the activity and radionuclide present. The lower portion of the inventory sheet (the source/vial consignment sheet) must be returned to EH&S with the RAM when work with the material is completed or the material is no longer useful. EH&S will then remove the material from the PI’s inventory and ensure proper disposal. Receipt of Free/Gifted/Evaluation Materials and Devices Free, gifted, or evaluation materials or devices must follow the same procedures outlined above. Additionally, RAM, devices, and other radiation sources transferred to ISU by new faculty and staff require EH&S notification and approval of the RSC. Note: A log number is still needed for Free/Gifted materials.
24 Radioactive Materials Safety Manual Environmental Health and Safety H Security, Storage, Transfer, and Transportation of Radioactive Materials Any transfer of RAM or devices or equipment containing RAM or embedded sourced must be approved by EH&S before the transfer takes place. Security of Radioactive Material Security of RAM must be practiced at all times. RAM (i.e. source material, sealed sources, devices containing sources, labeled materials, and waste) must be in constant attendance by the trained user, or otherwise locked or secured to prevent unauthorized removal or tampering. Storage of Radioactive Material: RAM Sources, Labeled Materials and Waste RAM shall be secured from unauthorized access in cabinets, refrigerators, freezers or waste areas, unless attended by authorized personnel. These storage containers must have locks with keys or combinations available only to authorized individuals. RAM shall be stored in sealed containers to prevent accidental spillage, breakage, contamination and to prevent release. If the radionuclide requires shielding, containers will be shielded to maintain ALARA and prevent excessive or unnecessary exposure. Radioactive material stored in a freezer, should be thawed, opened, and handled in a fume hood or biological safety cabinet. Aerosols from stored RAM may cause contamination of adjacent areas and RAM intake by personnel if not handled properly after storage. All RAM must be marked radioactive and indicate the radionuclide. Any material or collection of items, such as a bag of trash or pieces of equipment, that are contaminated with RAM are considered a radioactive material and must be labeled or marked as RAM with the radionuclide indicated. On-Campus Transfers of RAM Transfer of RAM or devices between laboratories at the university must be approved by EH&S and is dependent upon the PIs respective authorizations. EH&S will update inventories for both laboratories and issue new inventory forms after the transfer. The following information must be submitted to EH&S: • dates when the material will be moved • sending and receiving locations • radionuclide(s) being moved • chemical form of the radionuclide
25 Radioactive Materials Safety Manual Environmental Health and Safety • total activity (dpm,µCi, mCi or Bq) • number of containers • telephone numbers or responsible person(s) • mode of transport • any special conditions (biological or chemical hazards or presence of dry ice) Off-Campus RAM Transfers Off campus transfers of RAM will necessitate shipment of the material using a commercial carrier or occur over public roadways and DOT regulations will apply. Transportation of RAM using an ISU or personal vehicle is not authorized without prior consent by EH&S. The PI’s laboratory is responsible for all costs associated with RAM shipments including packaging and carrier costs. Contact EH&S to initiate the process, the following information is required: • the name and phone number of the receiver’s RSO • the receiver’s full address a copy of the receiver’s RAM license • dates when the material will be moved • sending and receiving locations • radionuclide(s) being moved • chemical form of the radionuclide • total activity (dpm, μCi, mCi or Bq) • number of containers • telephone numbers or responsible person(s) • mode of transport • any special conditions (biological or chemical hazards or presence of dry ice) Shipments of RAM must be planned at least two weeks in advance to complete approvals, licensing, packaging, and shipping papers. Transportation of Radioactive Material Transportation of RAM on Public Roadways Transportation of radioactive material must be in accordance with ISU, IDPH, and DOT rules. EH&S must be notified before any shipments take place. Package Preparation All packaging used to transport RAMmust meet the performance criteria for the material being shipped. To assist in this process EH&S will: • Offer advice in selecting proper performance packaging. • Help determine the best mode of shipment.
26 Radioactive Materials Safety Manual Environmental Health and Safety After the package is obtained, laboratories must submit the RAM in the unsealed package to EH&S with a parcel post mail card. EH&S will verify packing and affix proper markings, labels, shipping papers, and arrange for pickup by the courier. Other important considerations Liquid RAM requires either double containment or the container be packaged with an over-pack and box with enough absorbent material to contain twice the actual volume of liquid. Any other questions concerning transportation and packaging should be directed to EH&S. Transportation of RAM or Devices Iowa State University personnel may be required to transport RAM to non-ISU property for diagnostic or research purposes. IDPH and DOT rules for shipment and carriage must be followed. EH&S must approve all transportation of RAM to off-site locations. The approval will include the shipper, carriage, and security measures. Only ISU vehicles may be used to transport RAM or devices containing RAM, unless specific approval is given by EH&S. Temporary Job Sites and Remote Locations Occasionally, RAM, instruments, and devices containing radioactive sources will be used at temporary job sites or remote laboratories. Job sites located outside of Iowa require reciprocal licensing to be in place and three days advance notice before travel may begin. All transportation, posting, security and notification requirements under the local rules apply to remote locations. Remote job sites are subject to audits and inspections by EH&S and the governing regulatory agency. The use of RAM at all temporary job sites and remote locations must have the prior approval of the RSO. Reciprocal Licensing The use of RAM or devices outside of Iowa requires licensing by the regulatory agency with jurisdiction at the work location. Typically, the governing agency will grant a one year reciprocal license allowing ISU to operate within their jurisdiction for 180 working days. All costs for reciprocal licensing are the responsibility of the PI or department conducting the work. Reciprocal licensing must be planned well in advance. Allow at least four weeks to complete approvals and licensing procedures. Note: Reciprocity may take four to six weeks for approval.
27 Radioactive Materials Safety Manual Environmental Health and Safety I Radioactive Waste Radioactive Waste Handling EH&S is responsible for the collection, processing, and disposal of all radioactive waste generated at ISU. For radioactive waste collection, submit an online waste removal request form. More information found here. A radioactive waste tag must be affixed to the waste container prior to pickup. In order to facilitate waste management, RAM users are required to follow a number of specific procedures regarding radioactive waste generated in their laboratories. These procedures guide the user in segregating their waste by both physical and chemical forms, and according to the radionuclide’s half-life. Segregation by half-life sorts the radionuclides into three categories: • Very short-lived – half-lives less than 15 days • Short-lived – half-lives between 15 and 90 days • Long-lived – half-lives greater than 90 days Diagrams of the waste segregation schemes can be found in the appendixes and on the EH&S website. It is possible that multiple waste containers will be required for proper segregation. Waste bins for solids must be lined with a plastic bag. Other criteria are listed below. Summary of solid waste criteria • Separate and label according to whether it is combustible (plastics, paper, etc.) or noncombustible (glass, metal, etc.). • Sharp items such as needles, razor blades, and broken glass must be placed in rigid, leak proof, puncture-resistant, plastic containers. Items that are also contaminated with biohazardous material must be packaged according to the criteria above and be denatured before EH&S collection. • Lead (Pb) source containers and source vials must be bagged separately from other solid waste. • RAM waste consignment sheets must be submitted with the source vials, but must not be placed inside the waste bag. Summary of liquid waste criteria • Liquid radioactive waste must be separated and labeled according to whether it is aqueous (miscible in water) or bears solvents. • The PI must inform the RSO if solvent bearing wastes containing radionuclides will be generated.
RkJQdWJsaXNoZXIy NTkwNTUw