Radioactive Materials Safety Manual

Transcription

1 Safety Manual 2408 Wanda Daley Drive Ames, Iowa (515) Copyright Reviewed 2018

2 2 Radioactive Materials

3 Directory of Service and Emergency Providers Services Environmental Health and Safety 2408 Wanda Daley Drive (515) Iowa State University Occupational Medicine Department G11 Technical and Administrative Services Facility (TASF), 2408 Pammel Drive (515) McFarland Clinic PC, Occupational Medicine 1018 Duff Avenue (515) Thielen Student Health Center 2647 Union Drive (515) Emergency Emergency - Ambulance, Fire, Police 911 Department of Public Safety/ Iowa State University Police Armory, 2519 Osborn Drive (515) Mary Greeley Medical Center 1111 Duff Avenue (515)

4 Table of Contents Directory of Service and Emergency Providers 3 Table of Acronoyms 8 A. Introduction 9 B. Regulatory Requirements 10 University Policy 10 C. Administrative Controls 11 Environmental Health and Safety 11 Radiation Safety Committee 11 Radiation Safety Officer 11 University Compliance Committees 12 Animals - Institutional Animal Care and Use Committee (IACUC) 12 Biohazards - Institutional Biosafety Committee (IBC) 12 Humans - Institutional Review Board (IRB) 12 Radiation - Radiation Safety Committee (RSC) 12 D. Process Planning 13 Authorization Process 13 Personnel Information 13 Facility Description 14 Project Description 14 Research Centers 15 Review and Approval of Application 15 Summary of the Radiation Authorization Application, Review and Approval Process 16 Radiation Authorization Amendments 16 Adding Authorized Personnel 16 Approval in Concept 17 Authorization Termination and Laboratory Closure 17 E. Training Requirements 18 4

5 Radioactive Material Users 19 Awareness Training for Laboratory Personnel 19 Service Personnel Working in a Radiation Laboratory 19 Minors Visiting or Completing Work in a Radiation Laboratory 20 Laboratory Specific Training 20 F. Responsibilities 21 Responsibilities of the Principal Investigator 21 Responsibilities of the Authorized Personnel 22 G. Obtaining Radioactive Material 23 Ordering Radioactive Material 23 Radioactive Material Ordering Procedures: 23 Receipt and Delivery of Radioactive Material 24 Receipt of Free/Gifted/Evaluation Materials and Devices 25 H. Security, Storage, Transfer, and Transportation of Radioactive Materials 26 Security of Radioactive Material 26 Storage of Radioactive Material: RAM Sources, Labeled Materials and Waste 26 On-Campus Transfers of RAM 26 Off-Campus RAM Transfers 27 Transportation of Radioactive Material 27 Transportation of RAM on Public Roadways 27 Package Preparation 28 Other important considerations 28 Transportation of RAM or Devices 28 Temporary Job Sites and Remote Locations 28 Reciprocal Licensing 29 I. Radioactive Waste 30 Radioactive Waste Handling 30 Summary of solid waste criteria 30 Summary of liquid waste criteria 30 5

6 Other important considerations 31 Disposal of Equipment with Embedded Sources 31 Radioactive Waste Minimization 32 J. Personnel Exposure 33 Occupational Dose Limits 33 External Dose 33 Internal Dose 33 Sum Of External and Internal Doses 33 Regulatory Dose Limits to Declared Pregnant Workers 34 Occupational Dose Limits for Minors 35 Regulatory Limits for Dose to Individual Members of the Public 35 K. Personnel Monitoring 36 Personnel Dosimeters 36 Whole Body 36 Extremity/Ring 36 Bioassays 37 ALARA and Personnel Exposure Records/Reports 37 L. Laboratory Safety 38 Facility Requirements 38 Procedures, Practices, and Rules for the Safe Use of Radioactive Materials 39 Approved Locations and Equipment 40 Contamination Surveys by Authorized Personnel 40 Annual Reviews 41 Radioactive Material Audits 41 Radioactive Material Surveys 41 M. Emergency & Decontamination Procedures 42 Minor Spills and Contaminations 42 Major Spills and Contaminations 42 Restricting Access to Areas Due to RAM Contamination 43 6

7 Accidents Involving Radioactive Material 43 Decontamination Procedures 44 Clean-up of Radioactive Contamination and Legacy Materials or Devices 45 N. Other Uses of Radioactive Materials 46 Radioiodination 46 Animal and Biological Specimen Use 46 Environmental Releases 46 Appendix I - Guidelines for the Safe Use of Radionuclides 47 Appendix II - Dictionary and Glossary 61 Non-Discrimination Statement 69 7

8 Table of Acronoyms Radioactive Materials ALARA CDE CEDE DDE DOT EH&S ISU IDPH IAC ORR PPE PI RAM RPD RSC RSO SDE TEDE TODE VPR As Low As Reasonably Achievable Committed Dose Equivalent Committed Effective Dose Equivalent Deep-Dose Equivalent U.S. Department of Transportation Environmental Health and Safety Iowa State University Iowa Department of Public Health Iowa Administrative Code Office for Responsible Research personal and protective equipment Principal Investigators radioactive materials radiation producing devices Radiation Safety Committee Radiation Safety Officer Shallow-Dose Equivalent Total Effective Dose Equivalent Total Organ Dose Equivalent Vice President for Research 8

9 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

10 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

11 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 and RPD use on campus radiation safety training laboratory inspections laser safety 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

12 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 for Responsible Research (ORR) 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

13 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 Note: All new applications must be reviewed and approved by the RSC. 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): 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 13

14 safety training program has been completed (including the completion date), duration of experience, type, and quantity of radionuclides used, the 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

15 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

16 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 Note: All new protocols must be approved by the RSC. 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 or by EH&S will add personnel to the PI s authorization and send an updated copy to the PI and laboratory supervisor. 16

17 Approval in Concept Note: A new user may request an Approval in Concept when applying for a grant. 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 study materials. 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. 17

18 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 Note: RAM refresher training is required annually!! 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 Refresher (online) Jan.- Feb. is retraining period Radiation Safety for Material Users - Part 4 (Laboratory) 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. 18

19 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 will 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

20 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

21 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

22 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 minor contaminations immediately; Do not leave contamination for another person 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. Protect service personnel, by restricting all maintenance or repairs 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 noncompliance of policies, rules and regulations under the provisions of the RSC Charter. 22

23 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) 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. Note: All RAM must be delivered to EH&S. Radioactive Material Ordering Procedures: Authorized personnel initiate the procurement process by contacting EH&S 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 cctivity, 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 23

24 an EH&S log number. 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 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. 24

25 Note: A log number is still needed for Free/Gifted materials. 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. 25

26 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 26

27 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) 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. 27

28 Package Preparation All packaging used to transport RAM must 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. 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. 28

29 Note: Reciprocity may take four to six weeks for approval. 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. 29

30 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. 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 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. 30

31 Compatible liquid waste can be co-mingled, otherwise multiple waste containers are required. Appropriate secondary containment is required. Flammable solvent bearing waste, such as those containing toluene or xylene, must be placed in containers specifically approved for flammable liquids. Original solvent containers are acceptable. Other important considerations Radioactive animal carcasses, viscera and blood must be sealed in a plastic bag or plastic container, labeled, and frozen prior to removal by EH&S. Laboratory personnel must also notify EH&S in advance of any special problems regarding the waste (animal size, fluid leakage, putrefaction, biohazard, etc.) and be prepared to provide assistance at the time of removal. Unless approved by EH&S, all scintillation vials must be emptied into a liquid waste container and recapped prior to disposal. The only exceptions are plastic vials with biodegradable cocktails containing 14 C or 3 H. All radioactive waste awaiting collection by EH&S must be properly packaged and labeled, and placed in a designated waste accumulation area. Solid and liquid waste containers, plastic bags, and radioactive waste labels are supplied by EH&S. EH&S will provide guidance for unwanted RAM that do not fit established disposal processes. Items may include equipment with embedded RAM sources such as gas chromatographs and liquid scintillation counters, or contaminated equipment, abandoned legacy materials, and materials with multiple hazards. Note: Storing items for the purpose of avoiding disposal fees is not allowed. Note: The PI may be responsible for disposal costs. Disposal of Equipment with Embedded Sources Disposal of equipment containing embedded sources will be completed through ISU Surplus and the equipment manufacturer, under guidance of EH&S. Disposal will be completed following the laboratory equipment disposal method through ISU Surplus website. If the equipment manufacturer cannot be located or refuses transfer then EH&S will assist the PI or department with an alternate disposal method. The PI and/or department may be responsible for all costs associated with current and legacy equipment disposal. Equipment storage is not permitted to avoid disposal expense. Non-operational equipment containing embedded sources should be identified, repaired, transferred or disposed within a reasonable amount of time. Common equipment containing embedded sources includes gas chromatographs, liquid scintillation counters, emergency exit signs and static elimination devices. 31

32 Radioactive Waste Minimization Each user is encouraged to develop methods and procedures that reduce the amount of radioactive waste generated. Waste minimization techniques include: Reviewing procedures to ensure that unnecessary waste is not being generated. Ordering minimal amounts of RAM. Avoiding accumulation of RAM. Monitoring waste items for detectable contamination prior to disposal as radioactive waste. If the item, such as gloves, is not contaminated, dispose of the item as non-radioactive waste. Restricting work to easily decontaminated surfaces (stainless steel trays or absorbent paper) to minimize the amount of waste generated from a small spill. Using plastic LSC vials instead of glass, whenever practical. Substituting non-ram methods, such as fluorescence. When possible, use short-lived radionuclides instead of longer lived radionuclides. 32

33 J. Personnel Exposure Occupational Dose Limits Current limits for occupational radiation exposure have been established at levels to: prevent deterministic/acute radiation effects (erythema, epilation), and minimize late/stochastic effects such as cancer or genetic damage to very low levels. These limits set by IDPH are based on the combination of external and internal exposures. To better understand the annual occupational exposure limits set by these regulatory agencies, the definitions of these limits are discussed below: External Dose Shallow-Dose Equivalent (SDE) is the dose to the skin from an external source of ionizing radiation. Eye (Lens) Dose Equivalent (LDE) is the dose equivalent to the lens of the eye from an external source of ionizing radiation. Deep-Dose Equivalent (DDE) is the whole-body dose from an external source of ionizing radiation. Internal Dose Committed Dose Equivalent (CDE) is the dose equivalent to organs or tissue that will be received from an uptake of radioactive material. Committed Effective Dose Equivalent (CEDE) is the dose equivalent for the whole body from an uptake of radioactive material. Sum Of External and Internal Doses Total Organ Dose Equivalent (TODE) is the dose equivalent to the maximally exposed organ or tissue from external and internal sources of ionizing radiation. TODE = DDE + CDE Total Effective Dose Equivalent (TEDE) is the dose equivalent to the whole body from the combination of external and internal sources of ionizing radiation. TEDE = DDE + CEDE Table 1 provides a summary of the current annual occupational dose limits for external and internal exposures. 33

34 TABLE 1. Annual Occupational Dose Limits for Adult Workers Limit rem* Sievert (sv) Shallow Dose Equivalent, Whole-body Shallow Dose Equivalent, Max. Extremity Eye Dose Equivalent to the Lens of the Eye Total Organ Dose Equivalent Total Effective Dose Equivalent (TEDE) *rem = the special unit of dose equivalent. Sievert is the S.I. dose equivalent unit. (1 rem = 0.01 sievert). Internal exposure limits are addressed through the establishment of annual limits on intake. The annual limits on intake is the activity of a radionuclide taken into the human body over one year that will deliver 5 rems (0.05 Sv) of committed effective dose equivalent to the body or organ committed does equivalent of 50 rems to any individual organ. Regulatory Dose Limits to Declared Pregnant Workers Note: The first trimester is the most critical. Declare early! Federal and state regulatory agencies have adopted the National Council on Radiation Protection recommendations on radiation dose limits during pregnancy. However, the regulations only apply when a worker voluntarily declares their pregnancy. If a declaration of pregnancy is made, the worker grants consent to their employer to limit their dose to a TEDE of 500 mrem (5 msv) throughout the entire pregnancy. If no declaration is made to the employer, their occupational dose limits remain the same. A declaration of pregnancy must be made to the RSO in writing, and can be made at any time during the pregnancy. Upon receiving the Declaration of Pregnancy form, EH&S will schedule a counseling session with the worker to review their dose history, current work, dose limits and explore methods for minimizing radiation exposure. The declaration of pregnancy can be revoked by the worker at any time and will end upon parturition. The records of dose for the embryo/ fetus will be permanently maintained by EH&S in the declared pregnant worker s dosimetry files. 34

35 Occupational Dose Limits for Minors A minor is anyone under 18 years of age. The annual occupational dose limits for minors are ten percent of the annual dose limits specified for adult workers. This equals a TEDE of 500 mrem (5 msv)/year). Regulatory Limits for Dose to Individual Members of the Public The limit for radiation doses to non-radiation workers and members of the public is two percent of the annual occupational dose limits. For the whole-body dose, this is a TEDE of 100 mrem (1 msv) per year. 35

36 K. Personnel Monitoring A number of devices and methods exist for assessing an individual s exposure to radiation. Whether one or more of these personnel monitoring methods is employed for a given situation will depend upon a number of factors, including the type and quantity of RAM used and the amount of time spent working with the material, or the use of devices. Personnel Dosimeters State and federal laws require that any individual likely to receive a dose in excess of 10% of the limits be monitored. There are numerous types of materials or devices that are used to assess an individual s cumulative external radiation dose. These are collectively termed dosimeters. Dosimeters are issued to monitor both whole-body and extremity exposures. Periodically, dosimeters are exchanged by EH&S and forwarded to the vendor s laboratory for analysis. Whole Body Whole-body dosimeters are issued for work with or near sources emitting penetrating radiation (energetic beta particles, x-rays, gamma rays, or neutrons). Whole body dosimeters monitor external radiation exposures. Extremity/Ring Ring dosimeters are worn by individuals handling relatively large quantities of energetic beta or gamma emitting radionuclides, such as 32 P or 125 I. Ring dosimeters monitor extremity exposures or exposures to limbs beyond the elbow and knee. A whole body badge will be worn on the front of the torso between the shoulders and the waist near the portion of the body that is most likely to receive the maximum radiation exposure and under any protective clothing. If a protective apron is worn, the dosimeter should be near the midline of the body under the apron. An additional dosimeter will be worn for the purpose it was issued such as eye, upper extremity or fetal monitoring. A dosimeter issued to monitor the eyes will be worn on the collar. A dosimeter issued to monitor an upper extremity exposure will be worn on the sleeve. Ring badges should be worn beneath gloves and turned towards the radiation source. The ring badge is usually worn upside down or facing the palm side of the hand. Further instruction on proper dosimeter use and storage can be found on the EH&S website. 36

37 Bioassays Assessing internal radiation exposures is far more difficult than the determination of external exposure. Procedures for this purpose are collectively termed bioassays. For many water-soluble compounds labeled with low energy beta emitters, such as ³H and 14 C, urinalysis bioassay is conducted utilizing liquid scintillation counting. For radionuclides of iodine, internal exposure may be assessed by using a NaI scintillation probe to externally measure the amount of ionizing radiation emitted from the thyroid. In general, urinalyses are performed by EH&S only for unusual situations such as accidents involving potential radionuclide uptake or for certain experimental procedures where ingestion or inhalation of radionuclides is possible. Thyroid bioassays, on the other hand, are conducted whenever individuals perform radio iodinations or may have come into contact with volatile iodine compounds. Personnel who receive an intake of RAM will be referred to Occupational Medicine Office. ALARA and Personnel Exposure Records/Reports At ISU, all authorized personnel will have a radiation dose history record, regardless of their monitoring requirement. All personnel monitoring records are maintained by EH&S. Personnel monitoring results are reviewed quarterly by EH&S radiation safety staff to assure that radiation doses are kept ALARA. An annual occupational dose report will be sent to any individual whose dose exceeds 100 mrem. Dose reports will be supplied to any participant at their request. EH&S will only release dose reports when a signed request is submitted by the participant. An individual will be notified by EH&S whenever current monitoring results exceed established ALARA limits. EH&S will meet with the individual to determine the cause of elevated dose, and will review work practices to identify methods to reduce exposure. 37

38 L. Laboratory Safety The Laboratory Safety Manual outlines the minimum requirements for safe laboratory operations at ISU. PIs and authorized personnel will be subject to the requirements of the Laboratory Safety Manual. The potential hazards associated with working with RAM and other sources of ionizing radiation can be minimized through the use of appropriately designed and constructed facilities and by adherence to standard laboratory safety rules and practices. Facility Requirements The majority of research laboratories at ISU can be classified as chemical laboratories. In most cases, these laboratories are adequate for the use of RAM. For certain types and uses of RAM, however, additional facility requirements must be met. The specific requirements, which will likely vary from one situation to another, are determined by EH&S. General minimum facility requirements for use of RAM: Floors must have smooth, nonporous, easily cleanable surfaces. Appropriate floor materials include vinyl, tile and sealed concrete. Benches must have nonporous, easily decontaminated surfaces. Surfaces of high-quality plastic laminate or stainless steel are preferable. Sinks should be stainless steel or of seamless molded construction. Hoods, when required, must be currently tested and certified by EH&S, preferably constructed of stainless steel or molded fiberglass. For additional guidance see the Laboratory Safety Manual. ISU s current design manual states that laboratories will be designed with eight air exchanges per area occupied; four air exchanges unoccupied. The actual rate required will vary with the potential for radionuclide release to the air within the particular laboratory. Shielding must be provided when appropriate (for laboratories using large quantities of gamma or high-energy beta-emitting radionuclides). Specific requirements will be determined by EH&S on a case-by case basis. In addition to the above requirements, the following guidelines should be considered for facilities used to house animals containing RAM: Floors should be designed so that they may be cleaned and the wash water either drained to the sanitary sewer or to a container that can be removed for proper disposal. Holding pens and cages should be designed and positioned in a 38

39 manner which will minimize contamination, allow for the collection of radioactive urine and feces, and facilitate cleaning. Procedures, Practices, and Rules for the Safe Use of Radioactive Materials Note: Contamination surveys keep RAM from going home with you! In general, both internal and external exposures to ionizing radiation can be maintained ALARA through the adherence to a number of standard procedures, practices and rules. These include: RAM must be protected from unauthorized removal or access at all times. Eating or drinking is not permitted in radionuclide laboratories. Food, drink, tobacco products, gum, medications, or cosmetics are not allowed in areas where radioactive materials are used or stored. Pipetting by mouth is not permitted in radionuclide laboratories. Microwave ovens in radionuclide laboratories must not be used for heating food or beverages. Individuals who have not been approved for radionuclide use must neither work with nor handle RAM. Security of RAM, sources, samples and waste must be maintained at all times to prevent unauthorized removal or tampering. A Caution-Radioactive Material sign must be conspicuously posted at each entrance of a radionuclide laboratory. Locations within the laboratory where radionuclides are used or stored (hoods, refrigerators, microwave ovens, etc.) must also be labeled indicating the presence of radioactive material. A Radiation Safety posting including emergency procedures and a State of Iowa Notice to Employees must be posted. Radionuclide work areas must be clearly designated and should, to the extent possible, be isolated from the rest of the laboratory. The work area must be within a hood if the RAM to be used is in a volatile form. All work surfaces must be covered with absorbent paper, which should be changed regularly to prevent the build-up of contamination. Work involving relatively large volumes or activities of liquid RAM should be performed in a spill tray lined with absorbent paper. Procedures involving RAM should be well-planned and, whenever possible, practiced in advance using non-ram. Protective clothing appropriate for the work conditions must be worn when working with RAM. This includes laboratory coats, gloves, protective footwear, and safety glasses. Open footwear 39