Radiation Safety Manual - … · · 2013-06-06Geology Department, Chair John Rakovan ... The...

Radiation Safety Manual

Amended for 2013

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Radiation Safety Committee

Current Membership (as of 3-8-13)

Association Name

Geology Department, Chair John Rakovan

Academic Procurement* Robert Baier

Botany Department Q. Quinn Li

Chemistry and Biochemistry Department Christopher Makaroff

Finance and Business Services Dennis Fleetwood

Microbiology Department, Vice Chair Luis Actis

Physics Department Herbert Jaeger

Radiation Safety Officer Jeff Johnson

Recording Secretary* Mary Stone

Zoology Department David Pennock Office for Advancement of Research and Scholarship, Research Compliance Officer

Neal Sullivan

*ex officio

Contents

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Miami University Radiation Safety Manual

Contents

Radiation Safety Committee: Current Membership i

Contents ii

List of Tables and Figures vii

Abbreviations and Acronyms viii

Introduction Radiation Generating Equipment and Radioactive Materials 1

Why Ionizing Radiation is Regulated 1

As Low As Reasonably Achievable (ALARA) Philosophy 1

Radiation Safety Manual 2

Purpose 3

Program Management Radiation Safety Committee 5

Radiation Safety Office 6

Approved User 7

Principal Investigator 7

RGE Supervisor 7

Radiation Safety (Yellow) Binders 8

Actions In Response To Non-Compliance 9

Radioactive Material Users User Definitions 11

Approved User 11

Principal Investigator 11

Radiation Worker 12

Short-term Radiation User 12

Student Radiation User 12

Ancillary Staff 12

User Responsibilities—General 13

Approved User Responsibilities 15

Radiation Generating Equipment Operators and Devices

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Operator Definitions 17

RGE Supervisors 17

RGE Users 17

RGE User-in-Training 17

Ancillary Staff 17

RGE Supervisor Responsibilities 18

RGE User Responsibilities 18

RGE Supervisors, Users, and Users in Training Responsibilities - General 19

Radiation generating Equipment Devices 19

X-ray Diffraction 19

Electron Microscopy 20

Health Care Radiography 20

Radiation Safety Training Radiation Worker Training 23

Web-based Radiation Basics modules 23

Radioactive Materials class 23

Student Radiation User Training 24

Radiation Safety Awareness 24

Continuing Education 24

Radiation Generating Equipment Training 24

Analytical Devices 24

Electron Microscopy 25

Health Care Radiography 25

Performance-Based Training 25

Control of Procurement and Use General Use Procedures 27

Proper Marking of Work Areas and Equipment 27

Shielding of Sources 27

Aerosols, Dusts, and Gaseous Products 30

Sealed Sources 30

Radioactive Material in Gas Chromatography Equipment 30

Work Surfaces 31

Control of Procurement and Use (continued) Equipment Removal and Repair 31

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Notification of Radiation Generating Equipment Procurement 31

Application For Use of Radioactive Material 32

Evaluation of Proposed Uses and Facilities 32

Proposal For Radioisotope Use 32

Procurement 34

Splitting Orders Between Principal Investigators 34

Receipt and Distribution of Packages 34

Isotope Use Record 36

Transfer of Equipment or Material 37

Security and Control of Radioactive Material 37

Radiation Monitoring Survey For Radiation 39

Survey Meter Operations Check 39

Wipe Testing for Removable Contamination 39

Determining Wipe Test Frequency 40

Using the Controlled Area Wipe Testing Record 40

Personal Monitoring Program 42

Bioassays 43

Monitoring Equipment and Devices 43

Survey Meters 43

Liquid Scintillation Counting 43

Thermoluminescent Dosimeters and Film Badges 43

Emergency Procedures Minor Spills of Liquids or Solids (typically <100 µCi) 45

Major Spills of Liquids or Solids (typically ≥100 µCi) 45

Fires Involving Radiation 46

Decontamination 46

Skin 46

Ingestion by swallowing 47

Surface and Equipment 47

Animal Studies General Animal Care Instructions 49

Handling Radioactive Animals, Cages, and Bedding 49

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Waste Disposal 50

Equipment and Material Disposal Disposition of Radiation Generating Equipment 51

Sale or Transfer 51

Disposal 51

Radioactive Material Waste Management 51

General Collection and Storage Procedures 51

Radioactive Waste Drum System 52

Color-coded Drums 52

Packaging Instructions 52

General 52

Orange Drums 53

Yellow Drums 53

Drum Log 53

Drum Pickup and Delivery 54

Sanitary Sewer (Hot Sink) Disposal 54

Decay 55

Incineration 55

Other Waste 55

De minimus 55

Animals 56

Appendices Glossary of Terms 61

Isotope Material Data and Safety Considerations 69

Calcium-45 (45Ca) 69

Carbon-14 (14C) 69

Cesium-137 (137Cs) 70

Chromium-51 (51Cr) 70

Cobalt-57 (57Co) 70

Hydrogen-3 (3H or tritium) 71

Iodine 125 (125I) 71

Phosphorus-32 (32P) 72

Phosphorus-33 (33P) 72

Sodium-22 (22Na) 73

Sulfur-35 (35S) 73

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Uranium Isotopes 74

Technetium-99 (99Tc) 75

Thorium Isotopes 75

Radium-226 (226Ra) 73

Forms and Notices 77

Ohio Department of Health; NOTICE TO EMPLOYEES 78

Statement of Prior Training and Experience for Approved User Status 79

Application and Certification for Radiation Worker/Approved User 80

Proposal For Radioisotope Use At Miami University 81

Principal Investigator Annual Protocol Review 83

Isotope Order and Receipt Form 84

Isotope Use Record 85

Controlled Area Wipe Testing Record 87

Quarterly (RAM) Inspection Report 88

Semi-annual (RGE) Inspection Report 89

Instructions for Use of Orange Radioactive Waste Drums Notice 90

Instructions for Use of Yellow Radioactive Waste Drums Notice 91

Radioactive Waste Drum Log 92

Regulatory Guides 93

8.13 Instruction Concerning Prenatal Radiation Exposure 95

Contents

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List of Tables and Figures

Table 1. Radiation Producing Devices and RGE Supervisors 21 Table 2. Criteria For Monitoring Radioactive Materials–Surveys and Wipe Tests 41 Table 3. Guidelines for Maximum Permissible Doses 42 Table 4. Sanitary Sewer Disposal–Maximum Permissible Activities 57 Figure 1. Penetration Ability of Beta Radiation 28 Figure 2. Penetration Ability of Gamma Radiation 29

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Abbreviations and Acronyms

ALARA As Low As Reasonably Achievable CRT Cathode Ray Tube EHSO Environmental Health and Safety Offices EM Electron Microscope IACUC Institutional Animal Care and Use Committee IUR Isotope Use Record LPO Limited Purchase Order LV Local Violation NEP No Experiments Performed NRC US. Nuclear Regulatory Commission ODH Ohio Department of Health PI Principal Investigator RAM Radioactive Material RGE Radiation Generating Equipment RS- Prefix meaning Radiation Safety (e.g., RSManual, RSUpdate) RSC Radiation Safety Committee RSO Radiation Safety Officer SEM Scanning Electron Microscope TEM Transmission Electron Microscope TLD Thermoluminesent Dosimeter

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»INTRODUCTION Radiation Generating Equipment and Radioactive Materials Miami University is authorized to procure, use, store, and dispose of radiation-generating equipment (RGE) and radioactive materials (RAM) on the Oxford campus by registration and under a broad scope type B materials license, respectively, issued by the Ohio Department of Health (ODH). The registration and license are administered through a university radiation safety program to ensure that:

• Operators of RGEs and users of RAM are qualified by training and experience, have the facilities and equipment for safe handling and storage, and establish protocol that offer an acceptable level of protection.

• Safety standards established or referenced by regulatory agencies relevant to RGEs and RAM are observed.

• Records of the receipt, storage, use, transfer, and ultimate disposal of all RGEs and regulated RAM at Miami University are maintained.

• Monitoring of personnel and property for ionizing radiation is conducted. Miami University is subject to periodic inspections by the ODH. Inspections are thorough and include the review of user qualifications, laboratory inspection results, area survey and personal monitoring results, and procurement and disposition records. Violations can result in a variety of regulatory actions with the most severe being the revocation of our registration and/or license. Why Ionizing Radiation Is Regulated Ionizing radiation is among the most versatile and useful tools of physical science research. However, like many other instruments of science, ionizing radiation is potentially harmful to human health and the environment unless used with strict adherence to safety rules and procedures. Regulations and procedures governing equipment and materials that emit ionizing radiation have been developed to protect the health and safety of exposed and potentially exposed individuals. Exposure to ionizing radiation can result in biological damage to current as well as future generations. Compliance with established rules and procedures will minimize potential radiation exposures to well below established regulatory levels. As Low As Reasonably Achievable (ALARA) Philosophy Whereas radiation safety is a shared responsibility, individuals approved to operate RGEs and use RAM at Miami University are held accountable for their actions and for failure to comply with established rules and procedures through the radiation safety program.

Introduction

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Practices and techniques that reduce potential and expected radiation exposures to levels As Low As Reasonably Achievable (ALARA) are expected and include: minimizing duration of exposure, establishing a reasonable distance from a source, and provision of shielding; control of personnel access into and around a controlled area; proper ventilation; use of trays or plastic-backed absorbent liners; and the use of gloves, lab coats, and eye protection. The ALARA philosophy is stated in the US. Nuclear Regulatory Commission (NRC) regulation 10 CFR 20.1101. The Radiation Safety Manual The Miami University Radiation Safety Manual (RSManual) describes rules and procedures for the procurement, use, storage, and disposal of RAM at Miami University. It is designed as a regulatory reference and training tool and is based on the terms of the ODH Materials License Agreement with Miami University. All federal, state, and local codes and regulations expressed in this manual are available for review through the Radiation Safety Office (RSOffice). Any questions or clarifications regarding this manual or radiation safety in general should be directed to the Radiation Safety Officer. It should be noted that specific rules and use procedures addressing RGEs are not contained in this manual; however, procurement requirements, operator information and training, RGE inventory, general information regarding devices, and disposition procedures are contained herein. Contact the RGE Supervisor of the RGE in question for specific information. The RSManual focuses on RAM issues in research and teaching at Miami University unless specifically noted to include RGEs. Requirements pertaining to the healthcare x-ray unit are not addressed in this manual.

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The purpose of this manual is to protect all faculty, staff, students, and visitors

and the environment against unnecessary and potentially harmful radiation

exposure by providing relevant radiation safety rules and procedures for use toward regulatory and safety compliance.

Introduction

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Program Management

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»Program Management The ultimate responsibility for RGE and RAM management and regulatory compliance lay with the President of Miami University. The Certifying Official representing the President is the Senior Vice President for Finance and Business Services or designee who serves as the senior management representative in all matters of radiation safety. Three primary groups participate in the radiation safety program (RSProgram) and have varying degrees of management responsibility. They are the Radiation Safety Committee, Radiation Safety Office, and Approved Users/RGE Supervisors. A management tool integral to the success of the RSProgram, with respect to RAM, is the Radiation Safety (Yellow) Binder maintained by each Principal Investigator (PI) in their primary laboratories. Many of the RSProgram records and references as they relate to the day-to-day activities of PIs in research laboratories are maintained in a radiation safety binder. The participatory groups and binder are addressed below. Radiation Safety Committee The Radiation Safety Committee (RSC) is appointed by and reports to the President of Miami University. At minimum, membership of the RSC shall consist of: 1) the Senior Vice President for Finance and Business Services or a designated representative; 2) a representative for academic departments that operate RGEs; 3) representatives from each of the academic departments deemed major users of RAM; 4) a representative from the Office for the Advancement of Scholarship and Teaching; 5) a representative from the Office of Purchasing; and 6) the Radiation Safety Officer (RSO). Business brought before the RSC including the authorization of Approved Users and approval of proposals for RAM use require a quorum. A quorum is defined as the RSC Chair, RSO, the technical committee member representing the department from where the proposal originated, and any other committee member whose field of expertise may be necessary to address pertinent safety matters. Minutes of all RSC meetings shall be recorded and distributed to RSC members and to the University Secretary (upon RSC approval). The RSC has dispensed with the reading of the minutes and are automatically approved two weeks after distribution of the draft. Meetings shall be held as often as necessary to conduct business (e.g., quarterly). The RSC addresses RGEs and RAM used in research and teaching endeavors. Requirements pertaining to the healthcare x-ray unit are not addressed by the RSC. The functions of the RSC include: 1. Approving local regulations pertaining to the operation of RGEs and use of RAM at

Miami University. Local regulations are rules and procedures more stringent than ODH regulations and are addressed in this manual.

2. Reviewing periodic activities of the RSProgram to ensure the adequacy of the current

management control system to include: RSOffice records; routine reports from the RSO; results of laboratory/user inspections; material use protocols; procedures

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addressing the procurement, inventory, and transfer of RAM; possession limits; monitoring results; and disposal activities.

3. Granting Approved User status, approving use proposals, and approving facilities prior

to installation of controlled areas. 4. Reviewing training and testing criteria for each worker classification. 5. Considering methods for maintaining records of committee proceedings and safety

evaluations of proposed users, protocol, and facilities. 6. Reviewing the RSManual as necessary to ensure proper program management,

education of persons working with RAM, and good health physics practices. 7. Specifying and approving permissible revisions to the ODH material license application

without notification to the regulatory agency. These revisions include: rule changes dictated by ODH; changes in internal management forms; members of the RSC except those specifically listed on the material license; specific dates; changes in contractors for bioassay, waste disposal, dosimetry, or for the servicing or calibrating equipment; changes in percentage of total waste disposed by disposal method; and references to specific equipment.

8. Reviewing and approving RAM training courses for staff and students. 9. Administering the RSProgram through the RSO. Radiation Safety Office The RSOffice provides a variety of administrative and technical services designed to achieve compliance with the ODH Materials License agreement and with rules and procedures established by the RSC. The RSOffice is a function of the Environmental Health and Safety Offices (EHSO), and is staffed by the RSO and trained professional staff responsible for RSProgram management. The RSO acts on decisions made by the RSC and has the authority to immediately stop a procedure involving RAM or an RGE if, in the opinion of the RSO, it is unsafe to continue. The RSO shall direct the RSOffice in the following activities: 1. Determine compliance with the ODH materials license, RSC rules and procedures, and

the conditions of use proposals specified by the RSC. 2. Monitor all activities involving RAM including routine monitoring and special surveys

of all areas in which RAM is used. 3. Provide radiation safety consultation to personnel at all levels of responsibility. 4. Supervise the receipt, survey, and release of RAM packages arriving and the packaging

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and shipping of all RAM leaving Miami University. 5. Supervise the distribution of personnel monitoring equipment and determine the need

for bioassays. Monitor personnel exposure and bioassay records. Notify individuals and their supervisors of unusual exposures and recommend appropriate remedial action.

6. Conduct and/or supervise training programs that present RSProgram procedures for the

use of RAM. 7. Supervise and coordinate the radioactive waste disposal program. 8. Monitor the storage of RAM not currently in use. 9. Perform or arrange for leak tests on sealed sources. 10. Schedule the calibration of radiation survey instruments. 11. Maintain an inventory of all radioisotopes and ensure that individual and total

quantities are in accordance with amounts authorized by the current materials license. 12. Terminate any activity found to be a threat to health or property. 13. Supervise significant decontamination and recovery operations. 14. Supervise maintenance of radiation safety program records in accordance with the

current regulatory requirements. Approved User/RGE Supervisor Approved User status is granted by the RSC based on training and experience. It carries responsibilities that include procurement, storage, and use of RAM and other sources of ionizing radiation in their research. Approved Users are expected to provide the day-to-day supervision of students and staff under their direction and radiation safety training (RSTraining) specific to their research. A Principal Investigator (PI) is a faculty member with Approved User status who has one or more radioisotope use proposals approved by the RSC. PIs are held accountable for managing the RSProgram as it relates to their research and for maintaining records in the radiation safety binder. RGE Supervisor status is granted by the RSC based on training and experience. RGE Supervisors are expected to provide the day-to-day direct supervision of students and staff under their direction and radiation safety training (RSTraining) specific to their research.

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Radiation Safety (Yellow) Binders Radiation safety binders (referred to as Yellow Binders) are maintained in primary use laboratories where RAM is used. They are an important management tool that links PI activities with RSProgram management. A Yellow Binder is provided to each PI and must be kept in the primary use laboratory in a location where it may be located without obstruction (on a desktop or in an open bookshelf, not in a drawer or cabinet). Each Yellow Binder contains information and records regarding the users, isotopes, and monitoring conducted in the primary and secondary laboratories. Each binder contains: 1. Radiation Emergency Procedures (Inside Front Pocket). This information is a reprint of

the Emergency Procedures section in this manual for easy access in the event of a release or fire involving radiation. It is provided on laminated card stock for protection and easy decontamination.

2. Isotope Use Records - When radioisotopes are released to a PI by the RSOffice, an

Isotope Use Record (IUR) used for inventory control accompanies the package. Upon receipt, the PI places the IUR in the Yellow Binder. It is used by the PI and the RSOffice for inventory control and inspection purposes. (See Control of Procurement and Use, Isotope Use Record, page 85).

3. Wipe Tests - A floor plan diagram of rooms where RAM is used and the Controlled

Area Wipe Testing Record is maintained for compliance and inspection purposes. Note that although printouts of liquid scintillation counter results must be kept on file for three years, the RSOffice may request that any printouts stored in the Yellow Binder for more than a 90-day period be removed by the PI for archiving. (See Radiation Monitoring, Wipe Testing for Removable Contamination, page 39).

4. Approved Protocol – Copies of all proposals approved for use in the laboratory by the

RSC are available for reference and review. Originals are maintained by the RSOffice. 5. Certifications - Applications/Certifications of individuals who work with RAM in the

laboratory must be readily available for verification. Certifications are mailed to the PI for placement in the Yellow Binder. Anyone who handles RAM in any manner or is in a controlled area but does not have a certification on file must be identified to the RSOffice immediately. Their actions could place Miami University in violation of our material license agreement.

6. Inspection Reports - The RSOffice suggests that PIs file their Inspection Reports in the

Yellow Binder. 7. Radiation Safety Updates - Periodic updates used to disseminate changes made to the

RSManual as well as information relative to federal, state, and local regulations that complement the RSManual. The PI is responsible for ensuring that his/her staff and students review each RSUpdate before posting it in the Yellow Binder.

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8. Miscellaneous - Reserved for future use. May be used to file isotope manufacturer quotes, isotope reference sheets, etc.

9. Miami University Radiation Safety Manual. Actions In Response To Non-Compliance Compliance is defined as meeting or exceeding current mandates of ODH, agreements made as part of our material license application and subsequent amendments, and local regulations established by the RSC. Although non-compliant conditions or acts do not always result in a written violation from the ODH, they reflect the RSC’s ability to maintain effective management control through the RSProgram at Miami University. It is important to note that the procurement and use of RGEs and RAM are not a right but a privilege granted by the regulatory agencies. The non-compliant conditions or acts of a single user can jeopardize our entire program through monetary penalties, restrictions imposed by ODH, or a revocation of our equipment registration and/or material license. Therefore, accountability within the RSProgram is imperative to protect that privilege for everyone. Non-compliance is typically reported to the PI in writing via a quarterly inspection report (see Appendices, page 89) with a copy to the appropriate RSC departmental representative. Inspections involving RAM are conducted quarterly and RGE inspections are conducted semi-annually. A summary of each inspection is provided to the RSC and a verbal report made at each RSC meeting. If necessary, items of non-compliance are discussed for clarification. Actions taken by the RSC in response to non-compliance should be interpreted as a demonstration of management control of the RSProgram and as an effort to maintain accountability among the users. Non-compliance with inspection report items 1, 2, 4, 5, and 9 are in direct violation of ODH regulations and shall result in the following actions if they occur within a period defined by two or more consecutive inspections or within an academic year, whichever is most restrictive:

• 1st Occurrence - The inspection report will serve as written notification to the PI and respective RSC departmental representative. No further action will be taken.

• 2nd Occurrence - A memo from the RSC Chair addressing the repeat

violation and the corrective action required of the PI shall be issued. If no response is received from the PI by the specified date, the violation will be elevated to a 3rd occurrence violation.

• 3rd Occurrence - Termination of all protocol and possible RSC expropriation

of RAM. Use restrictions and/or reporting assignments may be placed on RGE operators.

Notifications of violations at all levels of occurrence may be contested in writing to the Chair of the RSC by a PI. The RSC will review the details of the alleged violation and the written

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appeal. Prior conditions and acts of non-compliance will be taken into consideration. If the violation is deemed valid, the violation will stand but may be downgraded to a local violation (LV, a violation of Miami University regulations that are more stringent than ODH regulations). Alleged violations successfully contested will be removed from the record and a response written to the PI. The remaining items on the inspection report and other regulatory issues (e.g., personal dosimeter exchange, survey meter calibration, protocol updates) demonstrate management control while assisting users and the RSC in their compliance efforts. Non-compliance with those items/practices and other safety and health issues (e.g., food and drink in laboratories) shall be handled on a case-by-case basis. Repeat occurrences and patterns of non-compliance may be interpreted by ODH as a breakdown in management control and, therefore, may result in actions described above.

Radioactive Material Users

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»Radioactive Material Users User Definitions Refer to Radiation Generating Equipment Operators and Devices (page 17) for information regarding equipment operator definitions and responsibilities. Approved User - Approved User status may be granted to faculty, students at the graduate level or above, or unclassified staff who have met the minimum training and experience requirements established by the RSC. Requirements for Approved User status are: 1. A baccalaureate degree in the physical or biological sciences or in a discipline where

radiological health is addressed; 2. Training in RSProgram practices and procedures with at least 40 hours of experience in

radiation physics and instrumentation, radiation protection, related mathematics, and radiation biology. The types and forms of RAM used in the past will be compared with the expected research at Miami University when determining status approval. (See Appendices, page 77).

3. Completion of Miami University’s Radiation Worker Training Course and a passing

grade of at least 80 percent on the written test; and 4. Approval of the RSC. Other Approved User responsibilities may include: 1. The day-to-day supervision of Radiation Workers under their direction and direct

supervision of any guest faculty, student, staff, or visitor not recognized by the RSProgram who enters a room where RAM is used or stored;

2. Providing performance-based and other RSTraining specific to their research; 3. Providing direct supervision to a Radiation Worker until confidence in his or her

abilities and understanding of applicable rules and procedures have been achieved; and 4. Maintaining records, logs, and other documentation as required by the RSProgram. Principal Investigator - Only a faculty member with Approved User status may become a PI—an individual having one or more approved protocol granted by the RSC. the PI status carries with it an increased level of accountability including direct responsibility for aspects of RSProgram management as it relates to the approved protocol (e.g., recordkeeping, wipe testing, inventory, security, quarterly inspection requirements).


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Radiation Worker - A Radiation Worker is any person engaged in activities related to research and development that involves the procurement, handling, use, or disposal of RAM. A Radiation Worker must: 1. Complete the Miami University Radiation Worker Training Course and achieve a

passing grade of at least 80 percent on the written test; 2. Work under the supervision of an Approved User; and 3. Receive performance-based training conducted by an Approved User. Individuals are

encouraged to document that training as it can be used toward Approved User status. Short-term Radiation User - An individual expecting to work at Miami University for one academic year or less and whose activities in controlled areas will be limited in scope may seek status as a Short-Term Radiation User. User certification may be extended beyond one year as determined by the Radiation Safety Officer and the Principal Investigator. Short-term Radiation Users shall: 1. Complete an abbreviated Radiation Safety Course and achieve a passing grade of at

least 80 percent on the written test; 2. Receive performance-based training conducted by an Approved User. Individuals are

encouraged to document this training as it can be used toward Approved User status; and

3. Work under the supervision of an Approved User. The Short-Term Radiation User status does not lead to Radiation Worker or Approved User status. While Short-term Radiation Users may perform experiments involving RAM in a research environment, responsibilities for radiation monitoring, maintenance of recordkeeping, and ordering RAM shall not be delegated to those individuals. Student Radiation User - A student in a controlled academic laboratory (classroom) environment that may handle microcurie quantities of RAM under the direct supervision of an Approved User is considered a Student Radiation User. The purpose of this status is to permit instruction and demonstration of safe RAM handling techniques with limited hands-on opportunities for the student. Radiation safety training will be provided by the Approved User(s) associated with the course. Ancillary Staff - Ancillary Staff are employees or contractors of Miami University who do not handle or use RAM but have the potential for exposure given the nature of their support function. Ancillary Staff shall be provided a level of training necessary to gain an understanding of the possible radiation hazards associated with their respective job functions and to safely perform their assigned duties.


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User Responsibilities - General All persons engaged in activities involving RAM are responsible for the safe use of materials in their possession. At minimum and when applicable, every user must: 1. Keep exposures as low as reasonably achievable (ALARA). 2. Wear the prescribed monitoring equipment (i.e., personal dosimeters) in controlled and

radiation areas. 3. Survey hands, shoes, and body for radioactivity and remove all loose contamination

before leaving a controlled area. 4. Utilize all appropriate protective measures to include:

a) At minimum, wearing easily removable protective clothing–a lab coat is most common. Do not wear protective clothing outside the laboratory. Note that street clothes are not considered protective clothing.

b) At minimum, wearing disposable gloves. Remove gloves before leaving a

controlled area. Always presume the gloves being worn are contaminated unless you have demonstrated otherwise.

c) At minimum, wearing eye protection appropriate for the hazard (e.g., a splash

hazard requires chemical splash goggles). d) Using protective shields and other physical barriers whenever possible. e) Using mechanical devices to reduce distance and exposure (e.g., tongs). f) Using mechanical pipetting devices. Never pipette by mouth. g) Using a laboratory hood or certified biological safety cabinet that has been

commissioned for use of radioactive materials if an inhalation hazard exists. h) Using the minimum quantity of radioactivity relative to the objectives of the

protocol. 5. Prohibit smoking, eating, drinking, and applying cosmetics in laboratories. Laboratory

space includes any office areas, work desks, or work stations within a room listed on an approved protocol.

6. Prohibit the use of refrigerators/freezers in laboratories for the storage of food and

drinks intended for human consumption.


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7. Maintain good personal hygiene. This includes:

a) Keeping fingernails short and clean. b) Avoiding all work with RAM if there is a break in skin below the elbow. c) Wash hands and arms thoroughly before handling any object which goes to the

mouth, nose, or eyes. 8. Monitor the controlled areas for contamination at least once each day RAM is used. A

record of these surveys and results should be maintained. Removable contamination must be reduced to less than 200 counts per minute (cpm) above background. A contaminated area greater than 2000 cpm should be decontaminated immediately and the RSO notified.

9. Practice good housekeeping.

a) Keep controlled areas as separated from non-radioactive work areas as possible. b) Work areas should be free from equipment and materials not required for the

immediate procedure. c) Store and transport RAM in a manner that prevents breakage and spillage (e.g.,

tube holders in a tray) while ensuring adequate shielding. d) Use plastic-backed absorbent paper in a tray or pan to contain a potential spill.

10. Isolate and label equipment used in conjunction with RAM. This equipment shall not

be used for other work nor shall it leave a controlled area until it has been demonstrated to be free of contamination.

11. Request RSOffice supervision of any emergency repair involving equipment that is

contaminated or contains RAM. At no time shall servicing personnel be permitted to work on equipment in controlled areas without the supervision of an Approved User.

12. Immediately report any incident of inhalation, ingestion, or injury involving RAM to

the PI and to the RSO. An individual shall cooperate in any and all attempts to evaluate an exposure and shall carry out prescribed corrective measures.

13. Prevent the spread of contamination to other areas in the event of a release and carry

out decontamination procedures. 14. Comply with RSOffice requests for body burden measurements. This may involve a

whole body counter or urine samples for radioassays.


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Approved User Responsibilities Approved Users are accountable for the actions of users under their supervision and for: 1. Adequate planning. Before RAM can be procured, an Approved User must determine

the types and amount of radiation or RAM to be used in a well-defined procedure. An evaluation shall be conducted by questionnaire, experimental plan, and written protocol review and submitted to the RSOffice for RSC approval (see Control of Procurement and Use, Evaluation of Proposed Uses and Facilities, page 32). A rehearsal, or “dry run” is recommended and may be required to identify any unexpected circumstances before a procedure is actually performed with radiation. The RSO is available for consultation in the preparation of the proposal.

2. Training. Approved Users must instruct all users under their supervision in safe

techniques and the application of approved radiation safety practices. 3. Requesting the addition and/or deletion of personal dosimeters for users under their

supervision through the RSOffice. 4. Requesting RAM waste drums through the RSOffice. 5. Furnishing the RSOffice with current information regarding individuals in their areas. 6. Contacting the RSOffice whenever changes in operational procedures, new techniques,

and facility alterations are anticipated. Approval by the RSC may be required prior to implementation.

7. Complying with the rules, procedures, and regulations governing the use of RAM as

established by Miami University, ODH, other applicable governmental agencies having jurisdiction.

8. Following the procedures for the procurement of RAM by purchase or transfer (see

Control of Procurement and Use, Procurement, page 34). 9. Posting areas where RAM is stored or used or where radiation areas exist. 10. Recording the use and disposal of RAM. 11. Consigning solid radioactive waste to the RSOffice for disposal. 12. Restricting the use of a RAM to RSC-approved users. 13. Keeping quantities of stored RAM to a minimum and in controlled areas. 14. Maintaining adequate records as required by the RSC. 15. Complying with the procedures for employee resignation or termination.


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16. Shipping all RAM through the RSOffice. 17. Promptly returning personnel monitoring devices to the RSOffice.

RGE Operators and Devices

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» Radiation Generating Equipment Operators and Devices Operator Definitions RGE Supervisor – RGE Supervisor status may be granted to faculty/staff that have met the minimum training and experience requirements set forth by the RGE manufacturer and/or the department operating the equipment. The RGE Supervisor oversees and coordinates RGE operations and maintenance to ensure appropriate and safe usage. Additionally, the RGE Supervisor serves as a conduit for communications between the RSO (and the RSCommittee) and the RGE users in matters concerning RGE operations, inspections, and safety. The Radiation Safety Committee departmental representative from the department housing the RGE nominates the RGE Supervisor for approval by the Committee. The RGE supervisor should be an RGE User who has sufficient knowledge, experience, and administrative authority to reasonably assure safety, oversight, and control of the RGE(s). RGE Supervisor responsibilities may include: 1. Develop training programs for RGE Users-in-Training 2. The day-to-day direct supervision of RGE Users-in-Training under their direction and

direct supervision of any guest faculty, student, staff, or visitor not recognized by the department who enters a room where RGEs are used;

3. Providing performance-based and other RSTraining specific to the RGE being used

until confidence in a RGE User-in-Training abilities and understanding of applicable rules and procedures have been achieved.

RGE User – Faculty, staff, or students that have met the minimum training and experience requirements set forth by the RGE manufacturer and or the department operating the equipment and have been authorized by the RGE Supervisor to use specific RGEs independently. RGE User in Training - Faculty, staff, or students unfamiliar with RGEs and who are receiving instruction and hands-on training will be considered RGE Users-in-Training. An RGE User-in-Training must work under the direct supervision of a RGE Supervisor. Ancillary Staff - Ancillary Staff are employees or contractors of Miami University who do not operate RGEs but have the potential for exposure given the nature of their support function. Ancillary Staff shall be provided a level of training necessary to gain an understanding of the possible radiation hazards associated with their respective job functions


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and to safely perform their assigned duties. RGE Supervisor Responsibilities RGE Supervisors are accountable for the actions of RGE Users and RGE Users-in-Training under their supervision and for: 1. Adequate planning and safe operation of RGE under their authority. 2. Providing instruction to RGE Users-in-Training. 3. Requesting the addition and/or deletion of personal dosimeters for users under their

supervision through the RSOffice. 4. Returning personnel monitoring devices to the RSOffice promptly. 5. Furnishing the RSOffice with current information regarding individuals in their areas. 6. Contacting the RSOffice whenever changes in operational procedures, new techniques,

and facility alterations are anticipated. Approval by the department operating the RGE may be required prior to implementation.

7. Complying with the rules, procedures, and regulations governing RGEs as established

by Miami University, ODH, other applicable governmental agencies having jurisdiction. 8. Following the procedures for the procurement or disposal of RGEs by purchase or

transfer. 9. Posting areas where radiation areas exist. 10. Restricting the operation of RGEs to RGE Users or RGE Users-in-Training. 11. Maintaining adequate records, logs, and other documentation as required by the RSC. RGE Users Responsibilities RGE Users are accountable for the proper use and safe operation of RGE(s) and for: 1. Adequate planning and safe operation of RGE under their authority. 2. Complying with the rules, procedures, and regulations governing RGEs as established

by Miami University, ODH, and other applicable governmental agencies having jurisdiction.

3. Notify the RGE Supervisor if unsafe conditions exist or of unauthorized use. 4. Maintaining adequate records, logs, and other documentation as required by the RSC.


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RGE Supervisors, Users, and Users-in-Training Responsibilities - General All persons engaged in activities involving RGEs are responsible for the safe use of devices in their possession. At minimum and when applicable, every user must: 1. Keep exposures as low as reasonably achievable (ALARA). 2. Wear the prescribed monitoring equipment (i.e., personal dosimeters) in radiation areas. 3. Utilize all appropriate protective measures. 4. Prohibit smoking, eating, drinking, and applying cosmetics in laboratories. 5. Prohibit the use of refrigerators/freezers in laboratories for the storage of food and

drinks intended for human consumption. 6. Maintain good personal hygiene. 7. Practice good housekeeping.

a) Keep areas of operation clearly identified. b) Work areas should be free from equipment and materials not required for the

immediate procedure. c) Store and transport x-ray generating tubes in a manner that prevents breakage.

8. Request RGE Supervisor for any emergency repair involving any RGE. 9. Immediately report any incident of exposure to the RSC departmental representative

and to the RSO. An individual shall cooperate in any and all attempts to evaluate an exposure and shall carry out prescribed corrective measures.

Radiation Generating Equipment Devices Table 1 (page 21) contains the current list of RGEs and their RGE Supervisor. X-ray Diffraction - X-ray diffraction machines are designed for and regulated as analytical devices. The mode of operation for x-ray diffraction involves a primary beam from an x-ray tube emerging through a collimator, striking a sample, and measured by a detector. This radiation chain is fully contained in a shielded, fail-safe cabinet sometimes referred to as cabinet radiography. The diffraction of x-radiation from sets of planes within a crystalline sample, typically a single-crystal on the order of 100 microns in size (single-crystal diffractometry) or a powdered sample (powder diffractometry), provides an examination of the macroscopic structure of materials by nondestructive methods.


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The primary beam in x-ray diffractometry is highly-collimated. In conjunction with the shielded and interlocking cabinet, x-ray diffraction machines are inherently safe and, therefore, do not present a radiation hazard when properly operated. However, Approved Operators are required to maintain utilization logs. Operators may be instructed to wear personal monitoring and conduct and record radiation surveys. Electron Microscopy - Electron microscopy (EM) encompasses a wide variety of technologies in which a coherent beam of electrons is used to generate a magnified image of a specimen. The two most common types of electron microscopes are transmission and scanning electron microscopes (TEM and SEM, respectively). In general, EM involves the following process: 1) free electrons are generated via a thermionic source (tungsten hairpin filament or a single LaB6 crystal) or via a hot or cold field emission effect; 2) the free electrons are collated into a coherent beam via an electrostatic lens; 3) the collated beam is accelerated through a single step linear accelerator (100 eV to 40 KeV for an SEM and 40-200, KeV for a TEM. Higher accelerations use two stages); and 4) the beam is focused via a series of electromagnetic lenses onto the specimen. In a TEM, the majority of electrons pass through the specimen and strike either a phosphorus screen, a photographic film plate, or a CCD array where they produce an image. In an SEM, the electron beam is focused to a fine point which is rastered across the specimen to produce a variety of signals generated via electron-electron, electron-proton interactions. These signals are detected with differing types of detectors and are displayed on a CRT rastered in sync with the beam raster. Since an electron beam in EM will only travel about 6 mm before degradation, the microscopes are operated under a high vacuum. Various safety interlocks prevent the operation of an electron microscope without a vacuum which are in place to prevent damage to the microscope and not the operator. The radiation exposure potential is from the excess photon emissions. X-radiation is produced with an energy range of about 1 eV to 35 KeV while the electron microscope is in operation. Shielding is inherent in the design of the microscope–massive copper and iron electromagnetic lenses and the brass and stainless steel framed construction requirements of a high vacuum environment. SEMs are completely enclosed with these materials. TEMs have a phosphorescent viewing screen which is viewed through a uranium-doped glass view port. Health Care Radiology (provided for information purposes only) - A fixed diagnostic x-ray unit is maintained and operated by the Student Health Service. No individual shall be permitted to hold patients during exposures except during emergencies. If a patient must be held by an individual, that individual must be protected with appropriate shielding devices positioned so that no part of the body, except hand and arms, will be struck by the useful beam. The primary beam must be collimated to a field size no greater than the size of the image. Exposure techniques for procedures are posted in or near the control booth. Techniques employed in diagnostic radiological examinations shall be selected to provide the required information with a minimum dose to the patient. Recommended operating techniques are posted on the radiographic unit.


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–Table 1–

Radiation Generating Equipment and RGE Supervisors Current list as of 3-8-2013

Device Location Department RGE Supervisors

GE Proteus x-ray equipment

Student Health Service

x-ray

Susan Daily

Rebecca Rader

Zeiss 10C Transmission EM Serail # 6195

16 Upham Hall

EM Facility College of Arts & Science

Richard Edelmann

Matthew Duley JEOL 100S Transmission EM

Serial # 145029-15 (Inoperable, training use only)

15 Upham Hall


Richard Edelmann

Matthew Duley

JOEL JEM-1200 TEM Serial # EM158062-182

20 Upham Hall


Richard Edelmann

Matthew Duley

JEOL JEM -2100 TEM Serial # EM174200-10

22 Upham Hall


Richard Edelmann

Mathew Duley Zeiss Supra 35 VP

Scanning EM Serial # SU35VP-2401

14 Upham Hall


Richard Edelmann

Matthew Duley JEOL JSM-840A SEM

Scanning EM Serial # EP130075-21

10 Upham Hall


Richard Edelmann

Matthew Duley Gandolfi Camera Blake Industries

Serial # 552 (Inoperable)

104 Shideler Hall

Geology

John Rakovan

Pecession Camera Huber (CM-7 tube)

Serial # 205-111/118V (Inoperable)

104 Shideler Hall

Geology

John Rakovan

Scintag X1 Powder Diffractometer

104 Shideler Hall

Geology

John Rakovan John Morton

Mark Krekeler

Bruker APEX Diffractometer Serial # 002142

42 Hughes Hall

Geology

Chemistry

John Rakovan

Bruker AXS Micro Star Serial # 2964

22 Hughes Hall

Chemistry Chemistry

Michael Kennedy

Shuisong Ni

Minishot M@%NH Serial # 14892

064 EGB

Paper Science

Steve Keller


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Radiation Safety Training

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»Radiation Safety Training Training is in accordance with Ohio regulation (reference NRC 10 CFR 19.12) and at a level based on past training, experience with the use of RAM, and the type of work to be performed. In order to effectively train individuals having a wide range of education and experience, courses and awareness programs are structured accordingly. Emphasis is placed on performance-based training for persons supervised by Approved Users. Ancillary staff shall be provided a level of training necessary for them to gain an understanding of the possible radiation hazards associated with their respective job functions and to safely perform their assigned tasks. Radiation Worker Training Anyone planning to use RAM at Miami University must successfully complete the Web-based Radiation Basics modules and attend the 2-hour Radioactive Materials Class offered by the RSOffice once each month. Following successful completion of these courses individuals will be granted the status of Radiation Worker. Radiation Worker Training is the only course that will lead to an Approved User status. Web-based Radiation Basics modules – This course is designed to provide a basic understanding of radiation through completion of the following six computer training modules:

• Radiation Properties • Background Radiation • Biological Effects • Regulations • External & Internal Dose Limits • Radiation Monitoring

Following completion of the Radiation Basics training modules participants must successfully complete the on-line Radiation Basics Test before attending the Radioactive Materials Class. Radioactive Materials Class – This course addresses the details of RSProgram management and the control of RGEs and RAM at Miami University. User definitions and responsibilities, procurement procedures, recordkeeping, radiation surveys, emergencies, and waste management will be presented. A multiple choice/short answer take-home test will be distributed at the end of the course and requires a passing grade of 80 percent or better. If tests are not returned within ten days of distribution, the student may be required to attend Radioactive Materials Class the following month and a new test completed.


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Student Radiation User Training Students will receive specific practical instruction and education in radiation safety as part of approved academic course work. All aspects of instructional training, material handling through disposal, monitoring for contamination, and recordkeeping will be the responsibility of the Principal Investigator under an experimental plan approved by the RSC. This user category does not lead to a Radiation Worker or Approved User status. Radiation Safety Awareness Persons working in laboratories and other areas where RGEs and RAM are located are encouraged to attend this one-hour awareness program designed to provide attendees with an appreciation for radiation safety. This program does not lead to a Radiation Worker or Approved User status. Continuing Education The RSOffice will disseminate radiation safety information through a periodic newsletter titled RSUpdate. This document is intended to inform the user community of regulatory changes that have not been integrated into the RSManual and of other information related to the operation of the RSProgram and the safe handling of materials. Distribution will be to all PIs and members of the RSC. It is the responsibility of each PI to inform all users under his/her supervision of this information. Ancillary Staff will be provided refresher training as required. Radiation Generating Equipment Training Training requirements are specific to the type of RGE. The State of Ohio requires that any operator of a health care radiographic unit be licensed through ODH. Training is provided by RGE Supervisors for all other devices. Table 1 (page 21) reflects the RGE Supervisors relative to the RGE under their authority at Miami University. Analytical Devices - X-ray diffraction units at Miami University are categorized by ODH as industrial analytical devices once referred to as cabinet radiography. Prior to operating a device, an individual must meet with the RGE Supervisor for training specific to each device. That training can lead to RGE User status or RGE Supervisor status granted by the RSC. At minimum, an RGE User-in-Training must: 1. If applicable, read NRC Regulatory Guide 8.13, Instruction Concerning Prenatal

Radiation Exposure (see Appendices, page 103). The guide provides information to women who become pregnant to help them make an informed decision regarding their choice to formally declare their pregnancy in accordance with regulations.

2. Participate in performance-based training. A User-in-Training must receive

instructions for use and a demonstration of the safe use of the device. The User-in-Training must then become familiar with the operation of the device and demonstrate a competent degree of familiarity in the presence of a RGE Supervisor.


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3. Operate the device under the direct supervision of the RGE Supervisor until a level of

competence is achieved and RGE User status is granted. Electron Microscopy - Users are provided training prior to the operation and use of an electron microscope. Users receive direct supervision during operation; however, unsupervised access may be granted after successfully passing a practical examination. Health Care Radiography (for information purposes only) - The operation of the x-ray unit at the Student Health Service is under the strict authority of the certified X-ray Technician on duty. Operators must complete the required course of study relative to their practice and possess a radiological license from ODH. Performance-Based Training Training that provides instruction or develops a person’s proficiency using a task-based approach and objectives written with an action verb is commonly defined as performance-based training. Students prove competency to an Approved User/RGE Supervisor by the actual performance of defined objectives. Performance-based training is commonly practiced in the laboratory environment; however, it is typically offered informally and without documentation by Approved Users/RGE Supervisors. Although not required, the RSOffice encourages documentation of performance-based training to enhance an individual’s records.


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Control of Procurement and Use

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»Control of Procurement and Use General Use Procedures The following procedures address use requirements expressed by regulation and are applicable to all aspects of registered RGEs and/or licensed RAM at Miami University. Proper Marking of Work Areas and Equipment 1. A “RADIOACTIVE MATERIAL USED IN THIS ROOM” sign placed at the entrance

of rooms where one or more specific areas within the room are labeled and used as controlled areas.

2. A “CAUTION RADIOACTIVE MATERIAL” sign or equivalent label tape shall be

conspicuously placed in controlled areas where RAM is being stored or used. 3. Containers in which materials are transported or stored shall bear a durable, clearly

visible label having the radiation caution symbol and the words “CAUTION RADIOACTIVE MATERIAL” or equivalent label tape. This labeling shall reflect the isotope and activity in the container, the date of assay, and the Isotope Use Record (IUR) number for reference to the corresponding form (See Appendices, page 85).

4. Controlled areas and locations around RGEs and RAM may be defined as radiation

areas—locations where radiation levels could expose individuals to 5 millirem at 30 cm in any one hour or a dose in excess of 100 millirem in any five consecutive days from any surface through which radiation penetrates. Radiation areas shall be posted with a “CAUTION RADIATION AREA” sign.

5. Disposal sinks shall be demarcated with RAM label tape and a sign posted designating

the sink is suitable for the disposal of radioactive isotopes. 6. All equipment contaminated with RAM shall be marked with radiation signs, decals,

tape, or by other conspicuous means. Labeling is not required for laboratory containers such as beakers, flasks, or test tubes used in laboratory procedures if those containers are in the controlled area or in the possession of trained personnel at all times and if those items are decontaminated immediately following the procedure.

7. Signs and labels referred to in this part, with the exception of RAM label tape, are

available through the RSOffice. All signage posted by the RSOffice must not be removed except under the direction of the RSO.

Shielding of Sources

Radiation sources shall be shielded in such a manner that the radiation levels in any unrestricted area will not expose individuals more than 2 millirem in any one hour. Figures 1 and 2 provide the penetration ability of beta and gamma radiation through various shielding materials, respectively.


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–Figure 1–

Penetration Ability of Beta Radiation


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–Figure 2–

Penetration Ability of Gamma Radiation


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Aerosols, Dusts, and Gaseous Products 1. Procedures that generate airborne contamination such as aerosols, dust, or gaseous

products shall be conducted in a functioning laboratory hood, certified biosafety cabinet, or other ventilation device approved by the RSOffice.

2. Incorporate traps into the experimental plan to ensure environmental releases will be as

low as possible. All releases from such systems shall not exceed the maximum permissible concentration as defined in 10 CFR 20 Appendix B.

3. Radioactive gases or materials with gaseous radioactive daughters must be stored in

gas-tight containers and stored in areas having adequate ventilation. 4. The performance of laboratory hoods and biosafety cabinets used for radionuclide work

should be certified at least annually. Sealed Sources 1. Procurement of sealed radioactive sources must be made through the RSOffice. An

amendment to our ODH Material License may be required prior to procurement of the source.

2. The RSOffice, in cooperation with individual users, shall establish strict accountability

procedures when sources are contained within portable units. 3. Sealed sources shall be leak tested by the RSOffice upon receipt and quarterly

thereafter. Sealed sources placed in storage within three months after receipt do not require leak testing until it is removed from storage.

Radioactive Material in Gas Chromatography Equipment 1. Radioactive foils used in gas chromatography cells must be procured through the

RSOffice. An amendment to our Materials License may be required prior to ordering of the source.

2. Each cell containing a radioactive foil shall be labeled or tagged with 1) signage

bearing the radiation caution symbol and the words “CAUTION RADIOACTIVE MATERIAL”, and 2) the identity and activity of the RAM.

3. The radioactive foil shall not be removed from its cell. 4. The following notice shall appear in a conspicuous location on the outside of each gas

chromatography unit:

“This equipment contains a radioactive source and is registered with the Radiation Safety Office at Miami University. Removing the source or transferring the equipment must be approved by the Radiation Safety Officer prior to removal or transfer”.


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5. Radioactive cells in gas chromatographic equipment shall be vented via an approved exhaust system or approved trap to avoid possible exposure of personnel and contamination of the work area.

6. Radioactive cells are sealed sources and shall be leak tested by RSOffice personnel

prior to initial use and quarterly thereafter. Work Surfaces All work surfaces including bench tops, laboratory hoods, and biosafety cabinets should be constructed of non-porous material and designed to contain spills and with decontamination in mind (e.g., one piece stainless steel with coved corners and edges) in the event of an unexpected release. Cover work surfaces with plastic-backed absorbent paper or equivalent for easier clean-up. It is recommended that storage areas and surfaces adjacent to set-ups and sinks be covered as well. The use of stainless steel or plastic trays, uncracked glass plates, or other impervious containment is encouraged. Always assume plastic-backed absorbent paper, trays, plates, etc. are contaminated. Frequent monitoring or replacement will prevent the spread of radioactive contamination. Equipment Removal and Repair 1. Once used in a RAM procedure, equipment shall not be used for other work or be

released from a controlled area until it has been demonstrated to be free of contamination by using monitoring procedures outlined in this manual.

2. Equipment to be repaired by the Central Instrumentation Laboratory, Physical Facilities

Department, or by commercial service contractors shall be monitored for contamination as outlined in this manual and shall not be released by the Approved User for service until it has been demonstrated to be free of contamination. If it becomes necessary to make emergency repairs on contaminated equipment, the work will be supervised by the RSOffice to ensure that all necessary safeguards are taken. It is the responsibility of the Approved User to request this supervision from the RSOffice.

Notification of Radiation Generating Equipment Procurement Prior notification must be made to the RSO that new RGE devices are being procured. An amendment to our ODH equipment registration will be necessary prior to acquisition. Manufacturer name, equipment make/model, tube type, power output, room location, anticipated date of receipt, and expected date of initial operation are necessary to update RSOffice files and to request an amendment. The RSOffice will work closely with the Approved Operator to expedite compliance with ODH regulatory requirements. Special design and construction materials may be necessary depending on the type of device installed. Seeking consultation through the RSOffice in the preliminary stages of room construction, renovation, and/or equipment acquisition will assist in our compliance efforts and avoid unnecessary delays.


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Application For Use of Radioactive Material Application must be made through the RSOffice to the RSC prior to any procurement or use of RAM. An Application and Certification for Radiation Worker/Approved User Status form (see Appendices, page 79) must be acquired from the RSOffice, 58 Hughes Hall. The form provides the following information: 1. Part A – Applicant Data. Information that includes Banner ID number and date of birth

is required for the issuance of personal radiation dosimetry devices. It is the responsibility of the applicant to identify the Approved User s/he will be working under so a certification document can be mailed. However, if an Approved User is unknown or undecided at the time of application, that information must be left blank.

3. Part B - Applicant signature certifying receipt and understanding of course content. 4. Part C - RSOffice approval and Approved User status information. Evaluation of Proposed Uses and Facilities A written proposal for experiments using RAM shall be submitted to the RSOffice for RSC approval prior to any procurement or use of RAM. A peer review process provides the PI with input from experienced researchers and support staff. The process is important in maintaining RSC management control of activities involving licensed RAM. Laboratories and other rooms must be commissioned (evaluated and approved) prior to the use or storage of RAM. An evaluation of facilities is conducted by the RSOffice and is based on the activity and form of isotopes to be used and the experiments to be performed. Consideration is given to shielding, containment, area controls, remote handling equipment, and monitoring instruments as they relate to the proposed use. The RSC approves facilities based on a recommendation by the RSO. Laboratories and other rooms should be released for unrestricted use if the use or storage of RAM is being discontinued in those areas. Released for unrestricted use demonstrates that a room is free of contamination and removes the room from further consideration in the RSProgram. Proposal For Radioisotope Use The Proposal for Radioisotope Use at Miami University form provides the RSC information required to conduct a peer review (see Appendices, page 81). The original form must be signed by the PI. The proposal (typically referred to as the “protocol”) must be submitted to the RSOffice for distribution and subsequent review by the RSC. The proposal will be dated upon receipt and it will be assigned a unique protocol number. Approved Users are encouraged to consult with the RSO during proposal development. A quorum of the RSC may grant tentative approval until reviewed and final approval is sought at the next RSC meeting. Approved protocol will be maintained by the RSOffice with a copy filed in the PI’s Yellow Binder. The proposal consists of:


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1. Part A - Questionnaire. Applicant information, clarifications about facilities and monitoring, and RSTraining course information.

2. Part B - Experimental Plan.

a. Radioactive Material. Isotopes and their chemical form, maximum activities per purchase, and maximum monthly usage must be determined and listed. Note that the activities approved by the RSC may affect procurement. The RSOffice will deny an order if it exceeds maximum activities reflected on an approved protocol.

b. Surveys/Monitoring. The frequency of wipe testing is based on material license

agreements, PI preference, and RSC determinations in special circumstances. Minimum frequency of wipe testing is 30 days when one millicurie or less of any RAM is used or disposed in a 30 day period. If more than one millicuries is used or disposed in a 7 day period, conduct wipe tests for that period. If isotopes are used that cannot be monitored with a survey meter (e.g., 3H, 14C, 35S, 45Ca), wipe tests are recommended after each use to detect contamination.

Whole body and ring dosimeters shall be issued by the RSOffice whenever the risk

of exposure in one year is ten percent of established limits for an adult or declared pregnant woman (see Table 3, Guidelines for Maximum Permissible Doses, page 42). Dosimeters may be issued for lower risks of exposure at the request of the Approved User.

c. Waste Disposal. An estimate of the percentage of radioactive waste streams for

each isotope complements management control and helps determine waste drum requirements. Current disposal options include aqueous waste disposal via the sanitary sewer system, storage for decay, and incineration. (See Equipment and Material Disposal, Radioactive Material Waste Management, page 51).

3. Part C - Written Protocol. Details of the proposal must be described in a typed

document not to exceed three pages and should be written to convince the RSC that the PI will be using RAM safely and in accordance with applicable regulations. The written protocol should include an introduction to and purpose of the research, a step-by-step process that involve isotopes (expressed in microcuries), rooms/locations that specific processes occur, storage practices, and disposal activities. Safety procedures and equipment must be addressed and protocol must reflect consideration of the ALARA philosophy.


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Procurement Orders of all regulated RAM shall be placed through and approved by the RSOffice. A PI must initiate an order; however, Procurement authorization may be granted to any Radiation Worker on the PI’s research team. The PI must provide the RSOffice with the name of each person authorized to order on his/her behalf. Each isotope ordered must agree with maximum activities stated in the RSC-approved protocol on file which will be verified by the RSOffice prior to placing an order. Information necessary to place an order includes: the isotope, its chemical form, and amount; manufacturer and catalog number; purchase order number; and RSC-approved protocol number. That information shall be entered onto an Isotope Order and Receipt Form by the RSOffice for inventory control and recordkeeping purposes (see Appendices, page 83). Orders shall be submitted to the RSOffice by one of the following procedures: 1. Miami University Requisition - Requisitions for RAM procurement must be initiated by

the PI and forwarded to the RSOffice for approval prior to submission to Purchasing. (NOTE: The Manager of Academic Procurement will only honor requisitions or limited purchase orders (LPOs) for RAM that have been approved by the RSOffice); or

2. Telephone Orders - Orders can be made through the RSOffice by telephone. As a

necessary measure of control, only the PI or member of his/her research team on the procurement authorization list may place an order.

Splitting Orders Between Principal Investigators A cost savings can sometimes be realized when multiple units of RAM are ordered or a volume is split between two or more PIs. While that is an acceptable practice, only one PI can place the order. Therefore, a split shall be approached as a transfer of material. The process must be approved by the RSOffice prior to placing the order (see Transfer of Equipment or Material, page 37). Coordination by the RSOffice is necessary to maintain inventory control of RAM. Receipt and Distribution of Packages All radioisotope packages shall be delivered directly to the RSOffice by common carrier for inspection and processing during normal business hours. Although highly unusual, special circumstances that would necessitate delivery of a package at another time shall be coordinated by the RSOffice. The integrity of the package and its contents shall be verified and control of the RAM shall be maintained by the RSOffice until released to the PI or member of his/her research team on the procurement authorization list. The RSOffice shall conduct the following receipt and distribution procedures: 1. The RSOffice shall monitor the package for radiation and radioactive contamination

upon receipt. The wipe testing procedure requires opening of the package.


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a. Until its has been demonstrated that the package is free of removable contamination, gloves shall be worn when handling a package.

b. Packages are inspected for signs of leakage and damage. c. Contents shall be compared with the packing slip. d. Package surfaces shall be surveyed as appropriate to ensure that external radiation

and contamination limits are not exceeded pursuant to current regulations. e. Wipe testing shall be conducted to determine removable contamination on the

exterior and interior of the package and on the exterior of the pig or packaging containing the RAM.

f. Results of package monitoring are maintained by the RSOffice.

2. The PI or a member of his/her research team on the procurement authorization list is

notified that the package is ready for pick-up. An Isotope Use Record will be provided with the package (see Appendices, page 85).

3. Contaminated shipping containers and packaging materials shall not be disposed as

regular trash; however, all RAM packages are surveyed and wipe tested prior to release by the RSOffice and have been demonstrated to be free of removable contamination.

Upon receipt of a RAM package, the research group must

a) immediately remove the shipping pig that contains the RAM (by end of business day) from the shipping container,

b) remove all dry ice and dispose accordingly, and c) remove or deface all labels and language referencing radioactive material.

Only then may the container and packaging material be discarded as regular trash. If RAM is not removed and the container is used for storage beyond the pick-up date,

the container and packing materials are presumed contaminated. Wipe testing must then be conducted by the PI prior to disposal to demonstrate that the package is not contaminated.

4. If a contaminated package is suspected, immediately isolate the package and contact the

RSOffice.


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Isotope Use Record An Isotope Use Record (IUR) is an inventory and tracking document that will accompany each radioisotope package distributed by the RSOffice (see Appendices, page 85). The responsibility for the maintenance and correctness of each IUR issued lies with the PI. Inventory of that material is maintained by the RSOffice. An IUR might not be issued if RAM 1) is used only for its radiation attributes, 2) is not to be removed from its original container, and 3) volume will not change. The IUR is designed to track the amount of isotope that is in use, in storage, decayed, disposed via the sanitary sewer (via an approved hot sink), discharged as gases to the air, and has been placed in a radioactive waste drum for eventual pick up and disposal by the RSOffice. Each IUR will reflect a unique isotope number and general information identifying the PI and isotope ordered. All transactions must be recorded in microcuries. Indelible ink must be used. The following is a brief explanation of how the IUR is used. 1. Date - Identifies each IUR transaction; 2. A blank that may be used for noting discharged gases to air, container volume, or for

calculation; 3. Decayed - Calculated decay of material currently in use and in storage only. Do not

decay any isotope that has been disposed via the hot sink or placed in a radioactive waste drum; however, decay should be calculated and recorded at that time, if applicable. Decay must be calculated and recorded at least monthly or every half-life, whichever is longer. The sum of the column provides the total isotope decayed.

4. In Use - Activity of isotope that has been removed from the original container and is

currently in process or is being held for eventual hot sink disposal or placement in a radioactive waste drum. Accumulating and storing radioactive waste in a small bag or jar (e.g., in a laboratory hood) with the intent of placing the waste in a radioactive waste drum or disposing it down the drain when a waste container is full is an efficient and acceptable practice; however, waste accumulating (e.g., in a hood) is not yet disposed and must be calculated as isotope In Use for inventory control purposes. Only the last transaction should reflect current isotope In Use.

5. Unused - Activity of unused isotope in the original container. Only the last transaction

reflects current isotope In Storage. 6. Sewer - Activity of aqueous waste isotope disposed via the hot sink. Accumulated and

stored waste prior to hot sink disposal is considered isotope In Use (see In Use above). The sum of the column provides the total isotope disposed via the hot sink.


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7. Drum - Activity of solid waste placed in a radioactive waste drum. Accumulated and stored waste prior to placement in a drum is considered isotope In Use (see In Use above). The sum of the column provides the total isotope placed in a drum.

The accuracy of RAM inventory is a dynamic process and is primarily dependent upon the PI’s timely maintenance of the IUR. Furthermore, the RSProgram database is most accurate when the PI promptly completes and returns the IUR to the RSOffice when all RAM has been depleted, disposed, or placed in a radioactive waste drum. Transfer of Equipment or Material A materials transfer is defined as the conveyance of RGE or RAM to a person or organization authorized by a regulatory agency to receive said material or equipment. Any materials transfer shall be approved by and coordinated through the RSOffice prior to its implementation. The splitting of isotope orders as described above under Procurement shall be considered a materials transfer. Security and Control of Radioactive Material A controlled area is identified for storage, use, and disposal of RAM and may include bench tops, laboratory hoods, refrigerators/freezers, and cold rooms. Access to those areas is not restricted except by security and control measures practiced by RAM users. A wide variety of people not certified as Radiation Workers have access to laboratories and to controlled areas—delivery persons, technical staff, colleagues, friends, and family. Responsibilities for security and control of RAM lay primarily with the PIs who use them. Although the RSProgram requires the use of an IUR for inventory purposes that can assist in the control process, physically securing RAM in the laboratory and controlling access to it can only be achieved by the user. Three levels of security and control have been established and will deter unauthorized persons from accessing RAM at Miami University:

• Lock the door – Locking the door to the laboratory limits access to the room to those individuals having a key. It is understood that others have key access (e.g., department personnel, maintenance); therefore, locking the door is considered the lowest level of security and control.

• Lock the refrigerator/freezer or utilize a lock-box – A good line of defense against unauthorized access is keeping RAM in a locked refrigerator/freezer. If refrigerator/freezer access must be provided to others in a laboratory, the use of a durable lock-box that can be stored in the refrigerator/freezer is acceptable.

• Line-of-site view of RAM – The best method of security and control is having a clear view of the laboratory, your RAM, and who is entering and leaving the area.

The above steps do not address deliberate acts by persons familiar to you. Contact the RSO and University Police if you suspect theft or contamination of a suspicious nature. Be proactive. Approach and challenge anyone you do not know who enters your laboratory or contact University Police for assistance.

Radiation Monitoring

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»Radiation Monitoring Monitoring for radiation involves surveying and wipe testing of rooms where RAM is used or stored, surveying radiation areas, and personal dosimetry. The timely maintenance, calibration, and turn-around of associated equipment and dosimetry helps minimize the potential spread of removable contamination (RAM) and radiation exposures (RGE and RAM). Surveys and wipe testing shall be conducted by the PI. Semi-annual surveys and wipe testing, monthly and quarterly personal dosimetry, and annual calibrations shall be conducted/coordinated by the RSOffice. Surveying for Radiation Surveying areas for radiation can identify the need for additional shielding of sources or can locate areas that require decontamination. Surveys shall be conducted at a the minimum frequency identified in Part B of the applicable RSC-approved protocol and as specified by RGE regulations. Note that monitoring with a survey meter does not take the place of wipe testing. 1. Each PI approved to use applicable isotopes (e.g., P32, P33, I125) shall purchase and

maintain a portable or semi-portable survey meter approved by the RSO (see Monitoring Equipment and Devices, page 43).

2. Care should be taken to prevent the contamination of the survey meter. Always

presume contamination. Avoid placing the meter in any controlled area or using the meter with gloved hands. Covering the probe window with a low density plastic wrap that can be easily removed and disposed will protect it against unexpected contact with contaminated surfaces.

3. Surveys shall be conducted using generally accepted practices. At minimum, the

survey meter probe window should be held about one inch from the surface being monitored and a 2 seconds per foot traverse used.

Survey Meter Operations Check Prior to each daily use, a survey meter must be checked against a radiation source for verification of operation. 1. Check battery level. Follow manufacturer’s instructions for this check and, if necessary,

for replacing the battery. 2. Locate the calibration label on the meter and determine the check source level in

mrem/hr or cpm. If no calibration label is present, contact the RSOffice. 3. Set the function switch of the meter to read the expected level. If unsure, begin at a

higher multiplication setting to avoid pegging the needle.


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4. Hold the probe window up to the check source attached to the meter and measure the

radiation level. 5. If the level is not within 20 percent of the expected measurement, the survey meter

should not be used. Contact the RSOffice. Wipe Testing for Removable Contamination Wipe testing surfaces demonstrates radiation control, provides evidence of good laboratory technique and, provides the RSOffice an opportunity to review housekeeping practices. Wipe tests shall be conducted at a the minimum frequency identified in Part B of the applicable RSC-approved protocol and should be conducted as often as necessary to verify that controlled areas are within acceptable limits of removable contamination. While background levels are desirable, ALARA levels have been established at 200 net counts per minute (~210-350 dpm, depending on machine counting efficiencies). Contamination above 200 counts per minute (cpm) requires decontamination and a follow-up wipe test to demonstrate that the desired levels have been achieved. If contamination is 2000 cpm or greater, follow procedures as above and inform the RSOffice the following business day. Areas where contamination cannot be reduced to below 200 cpm must be demarcated and the RSOffice contacted the following business day. Wipe testing procedures are as follows: 1. Develop a floor plan diagram of your room and identify wipe testing locations (e.g.,

bench tops, fume hoods, refrigerators/freezers, hot sinks). Include the floor where RAM is used and one location where you would not expect contamination (e.g., keyboard, telephone, door knob). Minimum locations will be established in concert with the RSO when establishing or modifying RAM use in a laboratory. Attach to back of wipe test tab separator.

2. Swab or wipe a representative 100 cm2 area where RAM is used. 3. Prepare an unwiped swab as a control. Count the blank to determine background

radioactivity. 4. Count the sample for gross counts per minute using a liquid scintillation counter or, if

applicable, dry gamma counting methods. For greater accuracy, counting windows may be set for the energy level of the radioisotopes used in the laboratory. Only biodegradable liquid scintillation cocktail may be used.

5. Record the wipe test results in gross counts per minute on the Controlled Area Wipe

Testing Record (see Appendices, page 87) located behind the Wipe Test tab in the Yellow Binder.


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Determining Wipe Test Frequency Determine the expected level of activity in a given month. If the total expected cumulative activity is less than or equal to 1 millicurie, conduct wipe testing at least every 30 days. If the total expected cumulative activity used is greater than 1 millicurie in a given 7 day period, conduct wipe testing at least every 7 days. If any procedure involves 5 millicuries or more, conduct wipe testing daily until the procedure is complete. Wipe test frequencies approved in Part B of the PI’s RSC-approved protocol that are more restrictive take precedence. For example, if the protocol reflects a 7-day wipe test schedule and the total expected cumulative activity used is less than 1 millicurie, the PI must wipe test and record the results at least every 7 days. (See Table 2, Criteria For Monitoring Radioactive Materials—Surveys and Wipe Tests, page 41.) Using the Controlled Area Wipe Testing Record 1. Record the wipe test results for locations that correspond with the floor plan diagram in

gross cpm. A background activity must be included. Note: Although it not necessary to store machine counter printouts in the yellow binder,

they must be made available for inspection upon request. Verify that the date and locations on the machine counter printout correspond with the Controlled Area Wipe Testing Record, print the primary room location and machine counting efficiency on the printout, and file it. Those printouts must be kept by the PI for three years after the record has been made and be available for review upon request.

2. If gross cpm are above 200 for any given location, take steps to reduce the removable

contamination and conduct a follow-up wipe test in that location. Record the former and latter results to demonstrate effort to reduce the contamination. Only those locations exceeding 200 cpm need retesting.

3. If RAM is not handled, used, or disposed in a given wipe test period or in specific

locations as referenced on the form, “NEP” may be entered across the results section or in the specific location(s) cell in lieu of wipe testing, unless otherwise instructed by the RSC. Should the PI not anticipate using RAM for an extended period (i.e. several months) NEP may be entered into the wipe test record in advance. Should RAM use re-start during this period the PI can strike a line through NEP and continue wipe testing. Any handling of RAM can result in some level of contamination requiring wipe testing. The abbreviation NEP, or “No Experiments Performed,” refers to no actions involving RAM.

Note: The Controlled Area Wipe Testing Record is designed to provide the information

necessary to calculate wipe test results in gross cpm to dpm. Locate the machine counting efficiency on each scintillation counter. Contact the RSOffice if assistance is needed.


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–Table 2–

Criteria For Monitoring Radioactive Materials Surveys and Wipe Tests

Level of Use/ Survey Minimum Radioisotope (w/GM Meter) Frequency Wipe Test Frequency ≤1 mCi/month (total expected cumulative activity)

3H, 14C, 35S no NA* yes 30 days 32P, 33P, 125I, yes during and yes 30 days 45Ca, and others after use

-----------------------------------------------------------------------------------------------------------

>1 mCi/week (total expected cumulative activity)

3H, 14C, 35S no NA* yes 7 days 32P, 33P, 125I, yes during and yes 7 days 45Ca, and others after use

-----------------------------------------------------------------------------------------------------------

≥5 mCi/procedure

3H, 14C, 35S no NA* yes daily 32P, 33P, 125I, yes during and yes daily 45Ca, and others after use

-----------------------------------------------------------------------------------------------------------

In Storage

3H, 14C, 35S no NA* yes semi-annually 32P, 33P, 125I, yes semi-annually yes semi-annually 45Ca, and others

* Although a typical survey meter used at Miami University will not effectively monitor 14C or 35S sources, some level dose rate may be measured verifying the presence of a radiation hazard.


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Personal Monitoring Program In accordance with the ALARA philosophy, personal dosimeters shall be issued by the RSOffice whenever the risk of exposure in a year is 10 percent of established limits for an adult or declared pregnant woman (see Table 3, Guidelines for Maximum Permissible Doses). However, dosimeters are generally recommended and may be issued at the request of the Approved User. Other methods of monitoring radiation exposures shall be instituted by the RSO as required. Personal dosimeters will be processed by a contract service on a monthly or quarterly basis depending on the dosimeter type.

–Table 3–

Guidelines for Maximum Permissible Doses

Dose in millirems

Organ1 Annual ALARA

2

Whole Body .................................................................................... 5,000 500

Any Organ ....................................................................................... 50,000 5,000

Lens of Eye ..................................................................................... 15,000 1,500

Skin ................................................................................................ 50,000 5,000

Extremities ..................................................................................... 50,000 5,000

Embryo/Fetus of Declared Pregnant Woman ............................... 500 50 1For information on specific tissues not listed, consult the RSO.

2ALARA levels are established at 10% of the allowable limits unless otherwise noted.

In addition to the above: 1. Individuals who are exposed to ionizing radiation below the ALARA levels on a

regular basis may be issued a personal whole-body dosimeter. 2. Individuals who handle quantities of RAM greater that 5 mCi on a regular basis may be

issued a finger (ring) dosimeter. 3. Personal whole body dosimeters must be worn exterior to any garment worn, located

between the neck and waist, and generally between the person and the source. Finger dosimeters must be worn under a protective glove on the hand that is primarily used to handle or remain in the vicinity of a radiation source.

4. The RSO will promptly review all exposure reports to identify individuals whose


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exposure is unexpectedly high or low. This procedure only applies to the dosimetry of record and does not apply to backup dosimeter types (e.g., pocket ionization chambers).

5. Other individuals who are potentially exposed to radiation on an occasional basis such

as emergency response personnel, Physical Facilities Department staff, or departmental support staff will not normally be issued personal dosimeters.

Bioassays Current and anticipated usage quantities do not require bioassays. Should usage requirements change significantly, appropriate monitoring based on nuclide, quantity, and types of use will be initiated. In the event of incidental exposure, appropriate biosampling will be accomplished through the University of Cincinnati, Department of Nuclear Medicine, Cincinnati, Ohio. Monitoring Equipment and Devices Survey meters are most often used for monitoring beta and gamma radiation. A survey meter is a Geiger-Mueller (G-M) counter and probe connected to a count rate meter with a scale reading in R/hr, mrem/hr, or cpm. Each survey meter must be calibrated annually in coordination with the RSOffice. The cost of battery replacement between annual calibrations and any repairs of the survey meter are the responsibility of the PI. Liquid scintillation counting involves dissolving a sample directly into a solvent media cocktail and counting low energy beta particles that scintillate as they pass through the cocktail. Counts may be calculated to disintegrations based on background radiation and equipment efficiency. Equipment efficiencies are calculated annually by the RSOffice and posted on each unit. The efficiencies are necessary to calculate disintegrations from net counts. Thermoluminescent dosimeters (TLDs) and film badges are personal monitoring devices that may be provided monthly or quarterly by the RSOffice. Personal dosimetry may be required when a person is working with or in the vicinity of:

• Beta emitters whose maximum energy is greater than 1 MeV,

• Gamma emitters,

• Neutron sources or neutron-generating devices, or

• X-ray generating equipment. Personal dosimeters are not required by regulation where it has been established by the RSO that exposures cannot exceed 25 percent of the maximum permissible dose. This determination will be based upon the intensity and energy of the radioisotopes used as well as techniques used in and the working conditions of a controlled area. As noted, the conservative approach at Miami University results in the issuance of personal dosimetry more often than required by regulatory requirements.


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Emergency Procedures

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»Emergency Procedures Minor Spills of Liquids or Solids (typically <100 µCi) 1. Notify persons in the area that a spill has occurred. 2. Prevent the spread of contamination by covering the spill with absorbent material (e.g.,

paper towels). Wear the appropriate personal protective equipment. 3. Clean up the spill using absorbent paper. Carefully fold the absorbent paper with the

clean side out and place in a plastic bag for transfer to the appropriate radioactive waste drum. Place disposable gloves and any other contaminated disposable material in the bag.

4. Monitor the area as appropriate (survey meter or wipe testing). Check the area around

the spill. Check your hands, clothing, and shoes for contamination. 5. The PI shall follow up on the cleanup of the spill and submit a report addressing spill

clean-up efforts and monitoring results to the RSO within 7 days of the incident. Major Spills of Liquids or Solids (typically ≥100 µCi) 1. Evacuate if spill is of a volatile material. 2. For non-volatile materials all persons not involved in the spill should vacate the room. 3. Prevent the spread of contamination by covering the spill with absorbent material (e.g.,

paper towels). Survey all personnel who may have been contaminated and immediately remove contaminated shoes or clothing.

4. Shield the source only if it can be done without further contamination or a significant

increase in radiation exposure. 5. Exit and secure the room. 6. Inform the PI and the departmental RSC representative as listed on page i of this

manual. Contact the RSO. Outside normal business hours, call University Police at 911 to notify the RSO.

7. Unless you are confident in approaching the clean-up of the contamination at hand,

prohibit entry into the room. RSOffice personnel will have authority over the scene when they arrive.

8. Decontamination of the facility will begin at the perimeter of the spill and proceed

toward the center, or higher area of contamination. An appropriate level of personal


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protective equipment shall be worn. Surface decontamination will be accomplished using soap and water or other response materials appropriate for the chemistry of the spill. Work shall be slow and deliberate with a continuous survey of radiation levels.

9. The PI (or RSO if present) shall supervise the cleanup of the spill. The PI shall

complete a report addressing spill clean-up efforts and monitoring results to the RSO within 7 days of the incident.

Fires Involving Radiation 1. Pull the fire alarm. Contact University Police at 911 of a fire situation involving a

radioactive material at your location and follow building evacuation procedures. University Police will contact the fire department and the RSO.

2. If the fire is confined and you have received training in the operation of the fire

extinguisher, attempt to put the fire out. If the fire is not manageable, evacuate the building and await University Police and the fire department. It is extremely important to the safety of the emergency responders that they be informed of the radiation and/or chemical hazards involved in the fire.

Decontamination Skin It is important to follow procedures 1 through 6 in the order they are presented. You should also take care not to abrade or scratch the skin. Avoid spreading contamination, protect uncontaminated areas with tape or plastic, and discontinue any step when less than 5 percent of the surveyed contamination is removed. It is recommended that a skin lotion be applied after decontamination of skin. All materials contaminated during cleanup shall be treated as radioactive waste. 1. Immediately wash wounds with copious amounts of water. Spread the edges of the

wound to permit flushing action by the water. Protect the wound with waterproof bandage.

2. Gently brush or wipe loose particles from the skin and into a bag or sink. Survey the

contaminated area of the skin. 3. Rinse the area with water and survey the contaminated area of the skin. 4. Wash with a mild soap and warm water building a thick lather. A soft brush may be

used on the skin. Wash fingernails and callused areas of the skin with a stiffer brush. Survey the contaminated area of the skin.

5. Scrub with a 1:1 mixture of commercial laundry detergent and cornmeal or use an

acceptable skin decontamination foam. Survey the contaminated area of the skin.


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6. If contamination remains, induce perspiration by covering the area with plastic. Then wash the affected area again to remove any contamination that was released by the perspiration.

Ingestion by swallowing If the material is not a corrosive, immediately induce vomiting and have the victim drink large amounts of water. Excretion analysis and/or a bioassay may be required to determine the amount of body burden. Surface and Equipment 1. Clothing - If levels permit, wash the clothes as usual. Wash water must be below

maximum permissible level for sewer disposal. If levels do not permit washing, dispose as radioactive-contaminated waste.

2. Glassware and laboratory tools - Wash in soap or detergent and water. Monitor wash

water and hot sink. 3. Walls, Floors, and Benches - Wash with soap or detergent and water. Detergents

should first be tested on surfaces.


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Animal Studies

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»Animal Studies General Animal Care Instructions 1. All work must be conducted in accordance with regulations as described in the

RSManual. 2. Animals must be housed in the Animal Care Facility located and in accordance with

IACUC standards. 3. Animals, cages, and used bedding used in conjunction with RAM must be segregated

from non-radioactive animals, cages, and bedding. 4. Animals, cages, and used bedding used in conjunction with RAM shall be presumed

contaminated. At minimum, gloves, eye protection, and protective clothing shall be worn whenever animals or cages are handled or bedding is changed.

5. Bedding used in conjunction with RAM must be collected in a manner determined by

the RSO and incorporated into the written protocol for approval by the RSC. 6. Prior to releasing cages to the Animal Care Facility for cleaning, the PI shall perform a

wipe test, record the results in the Yellow Binder, and report the results to the Laboratory Animal Resources Director. Counts above 200 net cpm shall be reported to the RSO prior to cage cleaning. Wipe testing of cage washers after the cleaning process may be necessary.

7. Cages must be constructed of a material easily decontaminated and approved by the

Laboratory Animal Resources Director. 8. This section, Animal Studies, shall be posted in all rooms used in conjunction with

RAM. Handling Radioactive Animals, Cages, and Bedding 1. Injections of RAM in animals shall be performed by or under the supervision of a PI in

a controlled area. 2. If volatile RAM is used, work shall be performed in a functioning laboratory hood or

certified biocabinet that is mechanically exhausted to the building exterior.

Animal Studies

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3. Cages used in conjunction with RAM shall be clearly posted with a “CAUTION RADIOACTIVE MATERIAL” sign or equivalent label tape and with the following information:

• Name and form of the radioisotope; • Amount and activity of the radioisotope injected into each animal; • Date of the injection(s); and • Name and telephone numbers (work and home) of the PI.

4. The PI is responsible for correct labeling, posting of signs, and the posting of the

animal care instructions as stated above. Waste Disposal 1. Animal excreta must be treated as radioactive waste. 2. Radioactive carcasses and dissected parts must be wrapped in absorbent paper, sealed

in a watertight bag or container, double-bagged, clearly labeled as radioactive material (see Equipment and Material Disposal, Packaging Instructions, page 52), and include the following information: • Name and form of the radioisotope; • Activity of the radioisotope at time of packaging; and • Name and telephone number of the PI.

3. Package animals in double plastic bags using as small a volume as possible. Teeth,

bones, claws and other sharp edges must not puncture the plastic bags. Waste shall be appropriately labeled, frozen, and stored by the PI until disposal by the RSOffice.

4. When possible, radioactive carcasses shall be blended (liquefied) using a blender or

garbage disposal and disposed via the sanitary sewer system at an approved hot sink.

Equipment and Material Disposal

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»Equipment and Material Disposal Disposition of Radiation Generating Equipment Sale or Transfer Prior to release of any RGE device, documentation must be provided to Miami University demonstrating acceptance or approval by the governmental regulatory authority administering radiation protection rules for buyer/transferee to receive, possess, or use the device being sold/transferred. Documentation may include, but not be limited to: copy of license or registration from governmental regulatory authority; copy of relevant regulatory code, rules, or regulation addressing exemption to receive, possess, or use the RGE device being sold/transferred; other governmental regulatory document reflecting allowance or approval to receive, possess, or use the RGE device being sold/transferred. The buyer/transferee must certify in writing that the RGE device and the supplies used in connection with that device will not be installed or placed in operation until all requirements of the buyer's/transferee’s governmental authority have been satisfied. Disposal X-ray tubes must be removed from the RGE device and disposed through the RSOffice. Documentation of the disposal will be prepared and submitted as required by regulation. the equipment housing the x-ray tube may be disposed through normal methods after the tube has been removed and disposed through the RSOffice. Radioactive Material Waste Management All forms of RAM waste (aqueous, solid, contaminated product) shall be disposed by one of five methods: decay in storage, sanitary sewer system, release to the atmosphere, incineration, contracted licensed broker. Activity and volume limitations are established by federal and state regulatory agencies and by our material license agreement. General Collection and Storage Procedures 1. Segregate RAM waste from non-radioactive waste. Keep volumes/quantities of waste

to a minimum. 2. Avoid unnecessary accumulation of RAM waste. Decontaminate containers and non-

combustible items to background levels for disposal via non-radioactive waste streams. 3. Secure and control RAM waste as it remains a licensed material and must not be stored

in unsecured areas. 4. Clearly identify and segregate RAM waste by isotope and from other work in the area.


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5. Maintain RAM waste records. Waste records are subject to inspection by the RSOffice staff and the RSC and will remain a principal item of inspection by regulatory agencies.

6. Account for all RAM received. Proper waste handling is dependent on waste

segregation and adherence to the packaging procedures described below. Handle and dispose of all radioactive waste in accordance with established procedures.

Radioactive Waste Drum System Radioactive waste drums are color-coded to designate segregated waste streams. Waste drums are light weight and are delivered ready to use including a plastic double liner with absorbent material to provide appropriate containment for residual fluids that might leak from the waste. The fiber drums and the plastic bags that contain the waste do not provide significant shielding from radiation. Additional shielding may be required depending on the storage location of the drums and the isotope the drums hold for disposal. Radioactive waste drums are used for decay in storage, incineration, and contracted licensed broker methods of disposal. Drums are delivered to and collected from approved areas through the RSOffice and at the request of a PI. Color-Coded Drums Drums are color-coded orange and yellow for easy identification in the laboratories and in storage at the Hazardous Residuals Facility (see Appendices, Instructions for Use of [color] Radioactive Waste Drums Notice, pages 95-97). Each drum is issued a unique ID number for tracking purposes. Yellow drums are used for radioactive-contaminated solid waste containing 3H, 14C, or other isotopes with a half-life of greater than 120 days. The contents of yellow drums will be disposed by either incineration or through a contracted licensed broker. Orange drums are used for radioactive-contaminated solid waste containing 32P, 33P, 35S, 125I, or other isotopes having a half-life of 120 days or less. the contents of orange drums will be disposed by using decay in storage methods. Packaging Instructions General – Place solid waste in approved bags tightly sealed with a twist tie or fashion a bundle and tape the waste in absorbent paper about the size of an American football (i.e., a size that can be easily handled with one hand). Labels, tapes, pigs, and any other item containing word or symbol references to “radioactive materials” must be removed or defaced before being placed in a drum. Wadding the tape up into a ball or blackening the label with an indelible marker is acceptable. Instructions for using the type of RAM waste drum issued are provided with each drum. The following are general restrictions when packaging a RAM waste drum:

• Remove or deface all labels referencing radiation and radioactive material. Waste in an orange drum is destined for a sanitary landfill. Removing labels, rolling labels up into a ball, or marking out all radiation symbols and the words “RADIOACTIVE MATERIALS”, or similar wording with a black indelible marker are acceptable.


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• No loose waste. All waste must be sealed in smaller bundles or bags for handling and placed inside the double-lined drum.

• No chemical waste. Flammable and non-flammable solvents (including alcohols), corrosives, and toxic compounds are strictly prohibited. Contact the Environmental Health and Safety Offices for the disposal of chemical waste.

• No Sharps. Pointed and sharp objects that include pipettes, blades, needles, capillary tubes, microscope slides, and broken glass are strictly prohibited. Decontaminate contaminated glass and metals to background levels and dispose via non-radioactive waste streams.

• Do not overfill a drum. The drum lid must fit securely and completely on the drum. Drums that are overfilled cannot be stacked for storage and the PI will repack the drum before it is removed from the assigned room.

Orange Drums – Orange drums are eventually stored in the Hazardous Residuals Facility for a period determined by multiplying the half-life of the isotope in the drum by ten (i.e., at least ten half-lives). Although the heat resistant bags provided by the RSOffice may be used, the waste is not handled in a high hazard situation and any sturdy 1-2 gallon-sized clear plastic bag may be used. Yellow Drums – Waste in yellow drums is typically disposed through a licensed waste broker, but may be incinerated by RSOffice staff. Proper packaging is imperative to the safe handling of the waste during a high risk operation. The use of high heat resistant bags and the size of the packages greatly reduce the risk to staff during waste incineration. The following are in addition to the general packaging instructions above:

• Packaging. All waste must be bundled or packaged and sealed in bags. Note: High heat-resistant bags used in packaging waste in yellow drums must be acquired through the RSOffice. a) Place solid waste in high heat-resistant bags provided by the RSOffice and tightly seal with a twist tie or b) bundle waste in absorbent paper about the size of an American football and seal with tape before placing in a drum. Loose waste or use of any other plastic bag in a yellow drum may delay removal of the drum and require repacking by the PI.

• No glass or foil. The incinerator will not accommodate glass or metals at this time. Drum Log Packaged waste that is placed in a drum shall recorded on a Radioactive Waste Drum Log (see Appendices, page 99). When a drum is issued, it is given a unique ID number reflected on the log sheet . The following information shall be recorded legibly on the log and in indelible black ink: 1. Date the bag or bundle was placed in the drum; 2. Brief description of the waste (e.g., paper, gloves, pipette tips);


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3. Activity of the bag or bundle. Record the activity in microcuries. DO NOT use the phrase “trace amounts” or mathematical symbols such as approximation (~), less than (<), or greater than (>). A mass balance of inventory must be maintained and the users are in the best position to determine an estimate to the nearest microcurie; and

4. Initials of the individual making the entry. Drum Pickup and Delivery Radioactive waste drums are transported by the Environmental Health and Safety Offices. However, the PI must contact the RSOffice to request an empty drum and to request pick-up of a full drum. Before the drum is removed from the area, it will be inspected to verify the following information: 1. Log entries are complete and legible; 2. Proper segregation (only one isotope per drum); 3. Waste has been packaged as described above; and 4. All radiation labels have been removed or defaced from materials with half life of less

than 120 days placed in the drum. Radioactive waste drums inconsistent with the procedures described in this section shall be corrected by the PI prior to pick-up of full drums. Sanitary Sewer (Hot Sink) Disposal Radioactive water soluble liquids shall be disposed via approved hot sinks and in amounts not to exceed the recommended permissible quantities indicated in Table 4 (page 57). Exceedences may be permissible on a case-by-case base with prior approval from the RSO. When disposing small quantities of radioactive water soluble liquids, carefully pour the liquid directly into the drain so not to pour or splash it onto the gasket between the drain and the sink. Avoid pouring liquid onto the gasket. Decontaminating the gasket is extremely difficult and not always successful. Follow the waste with copious amounts of tap water until monitoring of the drain indicates background levels of radiation. Large volumes of diluted aqueous waste, such as a tub of contaminated wash water from glassware, should be carefully poured into the sink to avoid splashing and followed with copious amounts of tap water. The sink, surrounding work surfaces, and the immediate area of the floor should be thoroughly washed, rinsed, and monitored for radiation. Hot sinks are often found contaminated to some degree. Decontamination must be performed as necessary to achieve ALARA levels.


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Decay Storage in Decay waste shall be stored for at least ten half-lives until it has decayed to background radiation levels and below 0.1 microcuries. A survey of the waste will be performed to demonstrate background levels. The contents will be inspected to ensure that all radioactive labeling has been removed. The waste will then be discarded as non-radioactive waste via regular trash. The date of disposal, background radiation, dose rate of waste, model and serial number of the survey meter used, and the name or initials of the responsible person shall be recorded on the Radioactive Waste Drum Log. Incineration Radioactive waste may be incinerated at the Steam Plant when boilers are using coal as a fuel source. Combustible waste products contaminated with 3H and 14C are candidates for incineration. The following requirements have been established when incineration of waste is conducted: 1. Incineration shall be conducted at a time when adequate temperatures and contact time

can be ensured (e.g., during the heating season) and shall be coordinated with the Steam Plant Superintendent.

2. Wipe testing shall be conducted before and after incineration. Monitoring will include

the floor where waste was handled, in the respective ash pit, and any other areas or items where contamination is suspected. Ash shall not be released until it has been demonstrated by the RSOffice that the ash is at background levels of radiation.

3. The handling and incineration of radioactive waste shall be under the direction of the

RSO. 4. Records are maintained by the RSOffice indicating the isotopes and amount of activity

per incineration. A dated and signed entry is placed in the Steam Plant log reflecting the isotopes and activity disposed.

Other Waste De minimus De minimus radioactive waste is limited to 3H and 14C in liquid form with an activity of less than 0.05 µCi/mL. Under the supervision of the RSO, de minimus waste may be disposed without regard to its radioactivity. Impervious materials (e.g. glassware, solid waste) may be disposed in regular trash if

1. The material has a background activity as determined with a portable survey meter or;

2. Wipe testing of the material surface reveals less than twice the background count

for an alpha or beta emitter.


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Animals Package animals in double plastic bags using as small a volume as possible. Teeth, bones, claws and other sharp edges must not puncture the plastic bags. Waste shall be appropriately labeled, frozen, and stored by the user until disposal by the RSOffice. When possible, radioactive carcasses shall be blended (liquefied) and disposed via the sanitary sewer system at an approved hot sink. (See Animal Studies, Waste Disposal, page 50).


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–Table 4–

Sanitary Sewer Disposal Maximum Permissible Activities

Isotope1 Max. Activity/Month

3H 5000 µCi 14C 5000 µCi 32P 5000 µCi

55Fe 1000 µCi 33P 1000 µCi 35S 1500 µCi

45Ca 5000 µCi 65Zn 500 µCi 99Tc 500 µCi 125I 500 µCi

1Contact the RSOffice for permissible activities of isotopes not listed.

Activities of Radioactive material disposed via the sanitary sewer are consistently well below the allowable monthly average concentration as defined in 10 CFR 20, Appendix B, Table 3. The following equation is used to determine activities of radioactive material that may be disposed via the sanitary sewer by a Principal Investigator in any given month (reference 10 CFR 20.2003(a)(4):

Where:

MPAI = Maximum permissible activity of isotope that may be disposed via the sanitary sewer system in µCi/month.

DDI = Ratio of total isotope disposed. 3H = 1; 14C = 1; All Other Isotopes = activity of isotope sink disposed ÷ sum of All Other Isotopes sink disposed.

MAR = Maximum annual releases per isotope category. 3H = 5 curies, 14C = 1 curie, and All Other Isotopes combined = 1 curie.

PIT = Number of Principal Investigators typically using isotope I in a given year.

I/DDI/PIT/MAC(FY2001): H3/1/5/1E-2; C14/1/5/3E-4; P32/.99/10/9E-5; P33/.1/1/8E-4; S35/.1/1/1E-3; Ca45/.1/1/2E-4; I125/.2/2/2E-5


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Appendices

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»APPENDICES Glossary of Terms Isotope Material Data and Safety Considerations Forms and Notices Regulatory Guides

Appendices

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Appendices: Glossary of Terms

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Glossary of Terms Absorbed Dose - The amount of energy imparted to matter by ionizing radiation per unit mass of irradiated material. (See Rad) Absorption - The phenomenon by which radiation imparts some or all of its energy to any material through which it passes. Activity - The number of nuclear disintegrations occurring in a given quantity of material per unit time. Alpha (a) Particle – An ionizing particle emitted from the nucleus of an atom during radioactive decay having a mass and charge equal in magnitude to a helium nucleus, consisting of 2 protons and 2 neutrons with a double positive charge. Alpha Ray - A stream of fast-moving helium nuclei (alpha particles). Strongly ionizing and weakly penetrating radiation. Analytical Radiation Generating Equipment – A group or system of components which produce ionizing radiation as either a primary or a secondary result and is used to determine or alter properties of materials being measured or analyzed (e.g., electron microscopes, x-ray diffraction). Annihilation (Electron) - An interaction between a positive and negative electron; their energy, including rest energy, being converted into electromagnetic radiation (annihilation radiation). Atom - Smallest particle of an element which is capable of entering into a chemical reaction. Atomic Number (Z) - The number of protons in the nucleus of a neutral atom of a nuclide. Auto radiograph - Record of radiation from radioactive material in an object, made by placing the object in close proximity to a photographic emulsion. Background Radiation - Ionizing radiation arising from radioactive material other than the one directly under consideration. Background radiation from cosmic rays and natural radioactivity is always present. There may also be background radiation due to the presence of radioactive substances in other parts of the building and in the building material itself. Beta (b) Particle - Charged particle emitted from the nucleus of an atom, having a mass and charge equal in magnitude to that of the electron. Beta Ray - A stream of high speed electrons or positrons of nuclear origin more penetrating but less ionizing than alpha rays.


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Bremsstrahlung - Electromagnetic (x-ray) radiation associated with the deceleration of charged particles passing through matter. Usually associated with energetic beta emitters such as phosphorus-32. Calibration - Determination of variation from standard (accuracy) of a measuring instrument to ascertain necessary correction factors. Carrier - A quantity of non-radioactive material or non-labeled material of the same chemical composition as its corresponding radioactive-labeled counterpart. When mixed with the corresponding radioactive labeled material, so as to form a chemically inseparable mixture, the carrier permits chemical (and some physical) manipulation. Carrier-Free - An adjective applied to one or more radionuclides of an element in minute quantity, essentially undiluted with stable isotope carrier. Contamination, Radioactive - Deposition of radioactive material any place it is not desired. Radioactive contamination may be harmful as a source of exposure to people or invalidate an experiment or procedure. Controlled Area - A defined area in which radioactive material is used or stored in a room, or where radiation generating equipment is located, and a potential exposure to ionizing radiation exists. Count (Radiation Measurements) - The indication of a device designed to enumerate ionizing events. A count may refer to a single detected event or to the total (counts) in a given period of time. The term is often erroneously used to designate a disintegration, ionizing event, or voltage pulse. Critical Organ - Organic tissue that, if irradiated, will result in the greatest hazard to the health of the individual or progeny. curie (Ci) - The quantity of any radioactive material where the number of disintegrations is 3.7 x 1010 per second. Decay, Radioactive - Disintegration of the nucleus of an unstable nuclide by the spontaneous emission of charged particles and/or photons. Direct Supervision - To personally observe or be located in the room or in the general vicinity of the room to respond to a situation involving all activities related to the use of radioactive material or radiation generating equipment. (See Supervision) Disintegration, Nuclear - A spontaneous nuclear transformation (radioactivity) characterized by the emission of energy and/or mass from the nucleus. Dose - A general term denoting the quantity of radiation or energy absorbed in a specified mass. For special purposes, dose must be appropriately qualified (e.g., See radiation


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absorbed dose). Dosimeter - Instrument to detect and measure accumulated radiation exposure. Dose Equivalent (DE) - A quantity used in radiation protection expressing all radiation on a common scale for calculating the effective absorbed dose. The unit of dose equivalent is the rem (radiation equivalent man), which is numerically equal to the absorbed dose in rads multiplied by certain modifying factors such as the quality factor, the distribution factor, etc. Efficiency (Counters) - A measure of the probability that a count will be recorded when radiation is incident on a detector. Usage varies considerably so it is well to make sure which factors (window, transmission, sensitive volume, energy dependence, etc.) are included in a given case. Electron - Negatively charged elementary particle which is a constituent of every neutral atom. Its unit of negative electricity equals 4.8 x 10-19 coulombs. Its mass is 0.00549 atomic mass units. Electron Capture - A mode of radioactive decay involving the capture of an orbital electron by its nucleus. Capture from the particular electron shell is designated as “K-electron capture,” “L-electron capture,” etc. Electron Volt (eV) - A unit of energy equivalent to the amount of energy gained by an electron in passing through a potential difference of 1 volt. Larger multiple units of the electron volt frequently used are: keV (thousand electron volts); MeV (million electron volts). Exposure - A measure of the ionization produced in air by x- or gamma-radiation. It is the sum of the electrical charges on all ions of one sign produced in air when all electrons liberated by photons in a volume element of air are completely stopped in air divided by the mass of air in the volume element. The special unit of exposure is the Roentgen. Film Badge - A packet of photographic film used for the approximate measurement of radiation exposure for personnel monitoring purposes. The badge may contain two or more films of differing sensitivity and it may contain filters which shield parts of the film from certain types of radiation. Filter (Radiology), Primary - A sheet of material, usually metal, placed in a beam of radiation to remove, as far as possible, the less penetrating components of the beam. Secondary - A sheet of material of lower atomic number, relative to that of the primary filter, placed in the filtered beam of radiation to remove characteristic radiation produced by the primary filter. Gamma (g) Ray - Penetrating short wavelength electromagnetic radiation of natural origin emitted from the nucleus from specific unstable atoms (range of energy from 10keV to 9 MeV). Identical to x-ray except for origin (x-rays are artificially produced).


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Geiger-Mueller (G-M) Counter - Highly sensitive gas-filled probe and associated circuitry used for radiation detection and measurement. Half-life, Biological - The time required for the body to eliminate one-half of an administered dose of any substance by the regular processes of elimination. Biological half-life is approximately the same for both stable and unstable nuclides of a particular element. Half-life, Effective - Time required for a radioactive nuclide in a system to be diminished 50 percent as a result of the combined action of radioactive decay and biological elimination. Biological half-life x Radioactive half-life

Effective half-life = Biological half-life – Radioactive half-life Half-life, Radioactive - Time required for a radioactive material to lose 50 percent of its activity by decay. Each radionuclide has a unique half-life.

At = A0e-λt -or- At = A0(0.5)n

At = Activity remaining after interval of time, t A0 = Initial activity where t = 0 e = The base of the natural log system, 2.71828... λ = Decay constant, 0.693/Τ1/2 t = Elapsed time Τ1/2 = Half-life of radioactive element t = Elapsed time interval n = Number of half-lives elapsed Half Value Layer (Half thickness) - The thickness of any specified material necessary to reduce the intensity of an x-ray or gamma ray beam to one-half its original value. Health Physics - A term in common use for that branch of radiological science dealing with the protection of personnel from harmful effects of ionizing radiation. Inverse Square Law - The intensity of radiation at any distance from a point source varies inversely as the square of that distance. For example, if a radiation exposure is 100 R/hr (I1) at 1 foot from a source (d1), the exposure will be 25 R/hr (I2) at 2 feet (d2).

Ion - Atomic particle, atom, or chemical radical bearing an electrical charge, either negative or positive.


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Ionization - The process by which a neutral atom or molecule acquires either a positive or a negative charge. Ionization Chamber - An instrument designed to measure the quantity of ionizing radiation in terms of the charge of electricity associated with ions produced within a defined volume. Ionization, Specific - The number of ion pairs per unit length of path of ionizing radiation in a medium, e.g., per centimeter of air or per micron of tissue. Ionizing Radiation - Any electromagnetic or particulate radiation capable of producing ions, directly or indirectly, in its passage through matter. Irradiation - Exposure to radiation Isotopes - Nuclides having the same number of protons in their nuclei (and the same atomic number) but having a different number of neutrons (and mass number). Nearly identical chemical properties exist between isotopes of a particular element. Stable Isotope - A non-radioactive isotope of an element. Labeled Compound - A compound consisting, in part, of labeled molecules. By observations of radioactivity or isotopic composition, a labeled compound or its fragments may be followed through physical, chemical, or biological processes. Laser - Light Amplification by Stimulated Emission of Radiation. The laser region is that portion of the spectrum which includes ultra-violet, visible light, and infrared. Liquid Scintillation Counter - A device in which light flashes produced by ionizing radiation in a solvent cocktail are converted into electrical pulses by a photomultiplier tube. Mass Number (A) - The number of nucleons (protons and neutrons) in the nucleus of an atom. Maximum Permissible Dose (MPD) - Maximum dose of radiation which may be received by persons working with ionizing radiation which will produce no detectable damage over the normal life span. Microcurie (µCi) - One millionth of a curie (3.7 x 104 disintegrations per second). Millicurie (mCi) - One-thousandth of a curie (3.7 x 107 disintegrations per second). Monitoring, Area – Surveying and/or wipe testing a specific location, room, building, or equipment for radiation or radioactive contamination. Monitoring, Personnel – Surveying and/or wipe testing any body part, breath, excretions, or clothing of an individual for radiation or radioactive contamination. Monitoring, Radiological - Periodic or continuous determination of the amount of ionizing


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radiation or radioactive contamination present in an occupied region as a safety measure for purposes of health protection. Neutron - Elementary particle with a mass approximately the same as that of a hydrogen atom and electrically neutral. It has a half-life of minutes and decays in a free state into a proton and an electron. Nuclide - A species of atom characterized by the constitution of its nucleus and specified by the number or protons (Z), number of neutrons (N), and energy content. To be regarded as a distinct nuclide, the atom must be capable of existing for a measurable time. Positron - Particle equal in mass to the electron and having an equal but positive charge. Protective Barriers (Shielding) - Radiation absorbing material (e.g., lead, concrete, plaster, plastic) that is used to reduce radiation exposure. Primary protective barriers are sufficient to attenuate the useful beam to the required degree. Secondary protective barriers are sufficient to attenuate stray or scattered radiation to the required degree. Protocol – General reference to a Proposal for Radioactive Material Use at Miami University that has been approved by the Radiation Safety Committee. A “Protocol” includes a Part A-Questionnaire, a Part B-Experimental Plan, and a Part C-Written Protocol. Proton - Elementary nuclear particle with a positive electric charge equal numerically to the charge of the electron and a mass of 1.007277 mass units. Quality Factor (QF) - The linear-energy-transfer-dependent factor by which absorbed doses are multiplied to obtain a quantity that expresses the effectiveness of the absorbed dose (on a scale for all ionizing radiation). Used for radiation protection purposes. Rad - See Radiation Absorbed Dose. Radiation - 1. The emission and propagation of energy through space or through a medium in the form of waves (e.g., electromagnetic waves, sound pressure, elastic waves). 2. The energy propagated through a medium as waves. The term “radiation” or “radiant energy” usually refers to electromagnetic radiation when unqualified and is commonly classified according to frequency as Hertzian, infrared, visible (light), ultra-violet, x-ray, and gamma ray. 3. By extension, corpuscular emission, such as alpha and beta radiation, or rays of mixed or unknown type, as cosmic radiation. Radiation Absorbed Dose (rad) - The energy imparted to matter by ionizing radiation per unit mass of irradiated material at the place of interest. The unit of absorbed dose is the rad, which is 100 ergs/gram. Radiation Areas - Locations where radiation levels might expose individuals to 5 millirem in any one hour at 30 cm or a dose in excess of 100 millirem in any five consecutive days.


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Radiation Generating Equipment – Any manufactured product, device, machine, or system that can generate or emit ionizing radiation during operation. Does not include radiation from radioactive material, microwave ovens, televisions or computer monitors, electric lamps and other appliances that generate very low levels of radiation. Radiochemistry - The chemistry of radioactive materials; the use of radionuclides in chemistry. Radiological Survey - Evaluation of radiation hazards relating to the production, use, or existence of radioactive material or other sources of radiation under a specific set of conditions. Surveys often include a physical evaluation of materials and equipment, a measurement or estimate of radiation quantities that may be involved, and interviews to acquire a sufficient level of knowledge about the procedures involved to predict hazards resulting from expected or possible changes in materials or equipment. Radionuclide - A nuclide with a ratio of neutrons to protons that places the nucleus in a state of instability. In an attempt to reorganize to a more stable state, a nuclide may undergo various types of re-arrangement that involves the release of radiation. Radiotoxicity - The potential toxic effects of radioactive material introduced into the body via ingestion, absorption, or inhalation. Relative Biological Effectiveness (RBE) - The ratio of the absorbed dose of a reference radiation that produces a specified biological effect to the absorbed dose of the radiation of interest that produces the same biological effect. rem (Roentgen Equivalent Man) - The special unit of dose equivalent. The dose equivalent in rems is numerically equal to the absorbed dose in rads multiplied by the quality factor, distribution factor, and any other necessary modifying factors. Roentgen (R) - The quantity of x- or gamma-radiation such that the associated corpuscular emission per 0.001293 grams of dry air produces ions carrying one electrostatic unit of quantity of positive or negative electricity. The roentgen is a unit of exposure. Scattering - Change of direction of subatomic particles or photons as a result of a collision or interaction. Sealed Source - A radioactive source sealed in an impervious container which has sufficient mechanical strength to prevent contact with and dispersion of the radioactive material under the conditions of use and wear for which it was designed. Shielding - Any material which is used to absorb radiation and thus effectively reduce the intensity of radiation, and in some cases eliminate it. Lead, concrete, aluminum, water, and plastic are examples of commonly used shielding material. Specific Activity - Total radioactivity of a given nuclide per gram of a compound, element,


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or radioactive nuclide. Supervision - To oversee all activities related the use of radioactive material or radiation producing devices. (See Direct Supervision) Tracer, Isotopic - An isotope or unnatural mixture of isotopes of an element that may be incorporated into a sample to observe the course of that element, alone or in combination, through a chemical, biological, or physical process. Observations may be made by measurement of radioactivity or of isotopic abundance. Thermoluminescent Dosimeter (TLD) - A dosimeter made of certain crystalline material which is capable of storing a fraction of absorbed ionizing radiation and releasing that energy in the form of visible photons when heated. The amount of light released can be used as a measure of radiation exposure. Wipe Test (may be referred to as a Smear or Swipe Test) - A procedure to determine if the surface is contaminated with loose radioactive material. A receptacle (e.g., disc of filter paper or cotton swab) is rubbed on a surface and is measured for radioactivity. X-rays - Penetrating electromagnetic radiation having wavelengths shorter than those of visible light, typically produced by bombarding a metallic target with fast electrons in a high vacuum. In nuclear reactions, photons originating in the nucleus are customarily referred to as gamma rays and those originating in the extranuclear part of the atom as x-rays. These rays are sometimes called roentgen rays after their discoverer, W.C. Roentgen.

Appendices: Isotope Material Data and Safety Considerations

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Isotope Data and Safety Considerations Calcium-45 (45Ca) Max beta energy: 0.257 MeV (100%) Effective half-life: 162d Max range in air: 52 cm (20.5 inches) Radioactive half-life: 162.7d Max range in water: 0.62 mm Monitoring: G-M detector Shielding: 1 cm Lucite

Considerations Millicurie quantities of 45Ca do not present a significant external exposure hazard because the low energy betas emitted barely penetrate gloves and the outer skin layer. The critical organ of uptake of 45Ca is the bone. The majority of 45Ca is deposited in the bone and is retained with a long biological half-life. A smaller fraction is rapidly eliminated. 45Ca is initially eliminated via the urine but eventually half the radionuclide is eliminated via the feces. ------------------------------------------------------ Carbon-14 (14C) Max beta energy: 0.156 MeV (100%) Effective half-life: 12d Max range in air: 24 cm (9.5 inches) Radioactive half-life: 5730y Max range in water: 0.28 mm Monitoring: liquid scintillation counter Shielding: 1 cm Lucite (3 mm effective but has poor mechanical properties)

Considerations Millicurie quantities of 14C do not present a significant external exposure hazard because the low-energy betas emitted barely penetrate the outer skin layer. The critical organ for uptake of many 14C-labeled carbonates is the bone and, for many other 14C-labeled compounds, fat. Most 14C-labeled compounds are rapidly metabolized and the radionuclide is exhaled as 14CO2. Some compounds and their metabolites are eliminated via the urine. Biological half-lives vary from a few minutes to 25 days. Some 14C-labeled compounds may penetrate gloves and skin; therefore, handle those compounds remotely, wear two pairs of gloves and change the outer layer frequently. Be especially cautious when handling 14C-labeled halogenated acids. Since these compounds may be incorporated in the skin, local dose commitments are in the order of 10-100 rad per µCi deposited. ------------------------------------------------------


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Cesium-137 (137Cs) Max beta energy: 1.174 MeV (5.4%) Effective half-life: 70d Max intensity: 0.512 MeV (94.6%) Radioactive half-life: 30.2y Gamma radiation: 0.662 MeV (85.1%) Monitoring: ϒ- or x-ray probe; G-M detector Ba K x-rays: 35 keV (7%) Shielding: 2.54 cm (0.1 inch) lead reduces exposure 90 percent

Considerations Unshielded exposure rate from 1 mCi point source at 1 meter is 0.32 mR/hr. Routine biological monitoring via the urine recommended. Maximum permissible concentration in air 6 x 10-8 µCi/ml. ------------------------------------------------------ Chromium-51 (51Cr) Gamma radiation: 320 keV (9.8%) Effective half-life: 27d x-rays: 5 keV (22.3%) Radioactive half-life: 27.7d Auger Electrons: 4 keV (66.9%) Monitoring: scintillation detector Shielding: 1.7 mm (HVL for lead)

Considerations Unshielded exposure rate from 1 mCi point source at 1 cm is 0.18 R/hr. The lower large intestine is the critical organ for intake of soluble 51Cr compounds and ingestion of insoluble compounds. The lung is the critical organ for inhalation of insoluble compounds. Uptake of 51Cr is slowly eliminated from the body via urine and feces. ------------------------------------------------------ Cobalt-57 (57Co) Gamma radiation: 14 keV (9.5%) Effective half-life: 9d 122 keV (85.5%) Radioactive half-life: 270.9d 136 keV (10.8%) Monitoring: y- or x-ray probe, G-M 570 keV (0.01%) detector 692 keV (0.16%) (others low intensity) Fe K x-rays: 6.7 keV (55%) Mode of decay: electron capture Shielding: 3.2 mm (0.13 inches) lead reduces exposure 90 percent.

Considerations Unshielded exposure rate from 1 mCi point source at 1 m is 8.9 x 10-2 mR/hr. Critical organ is lower large intestine. Routine monitoring via the urine. Maximum permissible concentration in air is 3 x 10-6 µCi/ml. ------------------------------------------------------


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Hydrogen-3 (3H or tritium) Max beta energy: 0.019 MeV (100%) Physical half-life: 12.4y Max range in air: 6 mm (0.24 inches) Effective half-life: 12d Max range in water: 0.006 mm Monitoring: liquid scintillation counter Shielding: none

Considerations Millicurie quantities of tritium do not present an external exposure hazard because the low energy betas emitted cannot penetrate the outer layer of skin. The critical organ for tritium uptake is the whole body. Three to four hours after intake, tritiated water is uniformly distributed in all body water. On average, tritiated water is eliminated within a 10-day biological half-life. Elimination rates may be increased by increasing water intake. Special Precautions Tritium cannot be monitored directly because of its low beta-energy. Therefore, good housekeeping is very important. Many tritium compounds readily penetrate gloves and skin due to the solvency of the carrier. Handle those compounds remotely, wear two pairs of gloves, and change the outer layer at least every twenty minutes. Tritiated DNA precursors are considered more toxic than tritiated water. However, they are generally less volatile and do not normally present a significantly greater risk. ------------------------------------------------------ Iodine-125 (125I) Gamma radiation: 35 keV 7% emitted, 93% internally converted Te K x-rays: 27-32 keV (140%) Radioactive half-life: 59.6d Effective half-life: 42d Shielding: 0.02 mm (HVL for lead) Monitoring: scintillation detector, G-M detector

Considerations Unshielded exposure rate from 1 mCi point source at 1 cm is 1.4 R/hr. Volatilization of iodine is the most significant problem with this isotope. Formation of aerosols when opening vial of iodinated compounds is a hazard. The thyroid is the critical organ for 125I (30 percent accumulation). Although individual metabolisms vary, 125I can be assumed eliminated via the urine. A reasonably conservative biological half-life for 125I in the thyroid is 138 days. Special Precautions 1. Store mCi quantities at about 23ºC in containers surrounded by 1/8 inch thick lead. 2. Use tools to prevent direct handling of unshielded mCi sources. 3. Wear two pairs of gloves, monitor frequently, and change the outer pair as necessary. ------------------------------------------------------


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Phosphorus-32 (32P) Max beta energy: 1.71 MeV (100%) Radioactive half-life: 14.3d Max range in air: 790 cm (26 feet) Effective half-life: 14d Max range in water: 0.86 mm Monitoring: liquid scintillation counter, Shielding: 0.95 cm Lucite G-M detector

Considerations Unshielded exposure rate from 1.6 mCi in 1 ml at the surface is 21 rem/hr. The bone is the critical organ for intake of transportable compounds of 32P. Phosphorus metabolism is complex, with 30% being rapidly eliminated from the body, 40% possessing a 19-day biological half-life, and the remaining 30% being eliminated by radioactive decay. The lung and lower large intestine are the critical organs for inhalation and ingestion of non-transportable 32P compounds. Special Precautions 1. Use shielding to minimize exposure while handling and storing 32P. 2. Wear extremity and whole body dosimeters while handling mCi quantities of 32P. 3. Do not work over an open container. Use tools to handle indirectly unshielded sources

and potentially contaminated vessels. ------------------------------------------------------ Phosphorus-33 (33P) Max beta energy: 0.249 MeV (100%) Max range in air: 49 cm (19 inches) Max range in water: 0.6 mm Radioactive half-life: 25.4d Effective half-life: 25d Shielding: 1 cm Lucite (3 mm effective but has poor mechanical properties) Monitoring: liquid scintillation counter, G-M detector

Considerations Millicurie quantities of 33P do not present a significant external exposure hazard because the low energy betas emitted barely penetrate gloves and the outer skin layer. The bone is the critical organ for intake of transportable compounds of 33P. Phosphorus metabolism is complex, with 30% being rapidly eliminated from the body, 40% possessing a 19-day biological half-life, and the remaining 30% being eliminated by radioactive decay. The lung and lower large intestine are the critical organs for inhalation and ingestion of non-transportable 33P compounds. ------------------------------------------------------


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Sodium-22 (22Na) Max beta(+) energy: 0.545 MeV Radioactive half-life: 2.6y Gamma-radiation 0.511 MeV (180%) Effective half-life: 11d 1.275 MeV (100%) Monitoring: y- or b-probe, G-M detector Max range in air: 49 cm (19 inches) Max range in water: 0.6 mm Shielding: 0.95 cm Lucite for beta; 0.7 cm (Half-value layer for lead)

Considerations Unshielded exposure rate from 1 mCi point source at 1 meter is 1.20 mR/hr. Critical organ is whole body. Body burden of 10 µCi whole body. Routine monitoring via the urine. Maximum permissible concentrations in air is 2.0 x 10-7 µCi/ml. Special Precautions 1. Shielding is required whenever small quantities are in use. Use shielding sufficient to

stop beta+ radiation (e.g., 1 cm Plexiglas). For larger quantities, 2.54 cm of lead will reduce the gamma intensity by a factor of ten.

2. The mode of decay is positron emission. When a positron undergoes annihilation, 2 gamma rays at 511 keV are produced. Otherwise, beta+ particles have a radiological hazard similar to beta- particles of the same energy.

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Sulfur-35 (35S) Max beta energy: 0.167 MeV (100%) Max range in air: 26 cm (10 inches) Max range in water: 0.32 mm Radioactive half-life: 87.4d Effective half-life: 76d Shielding: 1 cm Lucite (3 mm effective but has poor mechanical properties) Monitoring: liquid scintillation counter, G-M detector

Considerations Millicurie quantities of 35S do not present a significant external exposure hazard since the low energy emissions barely penetrate the outer layer of skin. The critical organ for 35S is the whole body. The elimination rate of 35S depends on the chemical form; however, most 35S-labeled compounds are eliminated via the urine, 90 days being an acceptably conservative biological half-life. Special Precautions 35S may be difficult to distinguish from 14C because the beta emissions are of similar energy. If both radioisotopes are being used in the same area, establish controls which are conservative for both radioisotopes. ------------------------------------------------------


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Uranium Isotopes Physical Properties of Uranium Isotopes

Isotope

Half-Life

Natural Abundance

(%)

Specific Activity

(Ci/g)

Primary

Decay Mode

Radiation Energy (MeV)

Alpha (α)

Beta (β)

Gamma (γ)

U-232 72 yr 0 22 α 5.3 0.017 0.0022 U-233 160,000 yr 0 0.0098 α 4.8 0.0061 0.0013 U-234 240,000 yr 0.0055 0.0063 α 4.8 0.013 0.0017 U-235 700 million yr 0.72 0.0000022 α 4.4 0.049 0.16 Th-231* 26 hr 540,000 β - 0.17 0.026 U-236 23 million yr 0 0.000065 α 4.5 0.011 0.0016 U-238 4.5 billion yr >99 0.00000034 α 4.2 0.010 0.0014 Th-234* 24 days 23,000 β - 0.060 0.0093 Pa-234m* 1.2 min 690million β - 0.82 0.012

* Properties of thorium-231, thorium-234, and protactinium-234m are included here because these radionuclides accompany the Uranium decays. Source: Argonne National Laboratory, EVS-HHFS, August 2005

Research activities can involve the use of natural, enriched, or depleted uranium. Natural isotopes of uranium are U-238, U235, and U-234 (see table above for natural abundances). Depleted uranium contains less of the isotopes U-235 and U-234. The specific activity of depleted uranium (5.0E-7 Ci/g) is less than that of natural uranium (7.1E-7 Ci/g). Certain uranium compounds, such as mass spectroscopy standards, uranyl acetate, and uranyl nitrate, may be acquired in small quantities without RSC approval. Uranium can pose a slight external hazard mainly from low-energy gamma and beta radiation when directly handling the material (potential skin effects). Uranium is primarily an alpha particle emitter, as well as a toxic heavy metal. Therefore, internal exposure through ingestion, inhalation, or injection through wounds is of primary concern. The bone surfaces and kidneys are the critical organs for internal exposure and toxicity to the kidney may be of greater concern than the radiation dose to bone surfaces for ingestion of soluble forms of uranium. Intake Data (annual for natural uranium) Ingestion: 20.0 µCi equals 5 rem TEDE (WHOLE BODY) 10.0 µCi equals 50 rem CEDE (BONE SURF) Inhalation: 2.0 µCi equals 5 rem TEDE (WHOLE BODY)

1.0 µCi equals 50 rem CEDE (BONE SURF) Survey Meters A survey meter is required to work with uranium. A thin window Geiger-Mueller tube or thin window NaI detector is necessary to detect uranium. Recommended Protective Clothing/Practices: When working with unsealed sources wear appropriate protective clothing such as laboratory coats, gloves, and safety glasses/goggles. A suitable fume hood should be used if the radioactive material is in the form of dust, powder, or if it is potentially volatile.


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Technetium-99 (99Tc) Max beta energy: 0.294 MeV (100%) Physical half-life: 2.13 x 105y Max range in air: 63 mm (25 inches) Monitoring: liquid scintillation counter, Shielding: none G-M detector

Considerations Millicurie quantities of 99Tc do not present a significant external exposure hazard because the low energy betas emitted barely penetrate gloves and the outer dead layer of skin. It may be assumed that technetium is retained in the transfer compartment with a biological half-life of 0.02 days. 4% of technetium leaving the transfer compartment is transferred to the thyroid where it is retained with a biological half-life of 0.5 days. 10%, 3%, and 83% of technetium leaving the transfer compartment are translocated to the stomach wall, liver and all other organs and tissues of the body, respectively; and 75%, 20%, and 5% of technetium in all organs and tissues, except the thyroid, retained with biological half lives of 1.6, 3.7 and 22 days, respectively. Intake Data (annual) Ingestion: 4 mCi equals 5 rem TEDE (WHOLE BODY) Inhalation: 700 µCi equals 5 rem TEDE (WHOLE BODY) Recommended Protective Clothing/Practices: When working with unsealed sources wear appropriate protective clothing such as laboratory coats (which must be monitored before leaving the laboratory) coveralls, gloves, safety glasses/goggles. A suitable fume hood should be used if the radioactive material is in the form of dust, powder, or if it is potentially volatile. ------------------------------------------------------ Thorium Isotopes As thorium-232 undergoes radioactive decay, it emits an alpha particle, with accompanying gamma radiation, and forms radium-228. This process of releasing radiation and forming a new radionuclide continues until stable lead-208 is formed. The half-life of thorium-232 is about 14 billion years. Two other isotopes of thorium, which can be significant in the environment, are thorium-230 and thorium-228. Both decay by alpha emission, with accompanying gamma radiation, in 75,400 years and 1.9 years, respectively.

Intake Data (Thorium-232, annual) Ingestion: 2 µCi equals 5 rem TEDE (WHOLE BODY) Inhalation: 0.003 µCi equals 5 rem TEDE (WHOLE BODY) Survey Meters A thin window Geiger-Mueller tube or liquid scintillation detector is necessary to detect uranium. Note: Lantern mantels impregnated with thorium salts typically have an activity of 0.02 µCi and are often used as check sources for Geiger-Mueller counters. Considerations


RSOffice 3-2013 76

The primary hazard with thorium isotopes is toxic effects associated with ingestion or inhalation. When using unsealed sources of thorium use standard laboratory procedures (protective gloves, lab coat, goggles). A suitable fume hood should be used if the radioactive material is in the form of dust, powder, or if it is potentially volatile. ------------------------------------------------------ Radium-226 (226Ra) Alpha energy: 4601 keV (5.5%) Radioactive half-life: 1600 years 4784 kev (94.5%) Effective half-life: 41.096 years Gamma energy: 11.7 kev (0.8%) Shielding: HVL Lead: 0.04 cm 81.0 kev (0.81%) Monitoring: liquid scintillation counter, 83.8 kev (0.23%) G-M detector 94.9 kev (0.14%) 186 kev (3.28%) 309 kev (0.007%)

Intake Data (annual) Ingestion: 5 µCi equals 5 rem TEDE (WHOLE BODY) 2 µCi equals 50 rem CEDE (BONE SURF) Inhalation: 0.6 µCi equals 5 rem TEDE (WHOLE BODY) Doses Skin Dose: Reported for 1 µCi over 10 cm2 of skin equals 0.217 mrad/hr (gamma dose) Protective Measures: Critical Organs: Bone tissue Exposure Routes: Ingestion, inhalation, puncture, wound, skin contamination/absorption Hazards: Long-term exposure (inhalation or ingestion) to radium increases the risk of developing diseases such as lymphoma, bone cancer, leukemia, and aplastic anemia. Recommended Protective Clothing/Practices: When working with unsealed sources wear appropriate protective clothing such as laboratory coats (which must be monitored before leaving the laboratory) coveralls, gloves, safety glasses/goggles. A suitable fume hood should be used if the radioactive material is in the form of dust, powder, or if it is potentially volatile. ------------------------------------------------------

Appendices: Forms and Notices

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Forms and Notices


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OHIO DEPARTMENT OF HEALTHNOTICE TO EMPLOYEES

In radiation protection rules adopted under Chapter 3748 of the Ohio Revised Code, the Ohio Department of Health hasestablished standards for your protection from radiation sources which are required to be licensed/registered with the OhioDepartment of Health.

POSTING REQUIREMENTSCopies of this notice must be posted in a sufficient number of places in every facility where employees are engaged inactivities subject to the radiation protection rules of the Ohio Administrative Code to permit employees working in orfrequenting any portion of a restricted area to observe a copy on their way to or from their place of employment. OSHArequires 29 CFR 24 Appendix A “Energy Reorganization Act” Poster be displayed when applicable.

ODH 4786.32 (Rev. 8/06))

YOUR EMPLOYER’S RESPONSIBILITYYour employer is required to:1) Inform you of the occurrence of radiation or radiation

sources and the presence of a restricted area;2) Instruct you in the safety problems associated with

exposure to radiation and in precautions or proceduresto minimize exposure to radiation; instruct you in theapplicable laws for the protection of personnel fromexposure to radiation;

3) Post or otherwise make available to you a copy of theoperating procedures applicable to work under thelicense/registration;

4) Apply the radiation protection rules to all workinvolving licensed/registered sources of radiation, and

5) Post notices of violation involving radiologicalworking conditions.

YOUR RESPONSIBILITY AS A WORKERYou should familiarize yourself with those provisions ofthe radiation protection rules and operating procedures thatapply to the work you are engaged in. You should observetheir provisions for your own protection, the protection ofyour co-workers and others. If you should observeviolations of the law, or have a safety concern, you shouldreport them to your supervisor. You may also report themto ODH.

WHAT IS COVERED BY THESE RULES1) Limits on exposure to radiation and radioactive

materials in restricted and unrestricted areas;2) Measures to be taken after accidental exposures;3) Personnel monitoring; surveys and equipment;4) Caution signs, labels, and safety interlock equipment;5) Exposure records and reports; and6) Related matters.

REPORTS ON YOUR RADIATION EXPOSUREHISTORYYour employer is required to advise you of your doseannually if you are exposed to radiation for whichmonitoring was required by ODH or upon request. Inaddition, you may request a written report of yourexposure when you leave your job.

INSPECTIONSAll activities covered by the ORC 3748 and other radiationprotection laws are subject to inspection by representativesof the Ohio Department of Health.

ODH inspectors want to speak or talk with you if you areworried about radiation safety or have other safetyconcerns about licensed/registered activities. Youremployer may not prevent you from talking with aninspector. The ODH will make all reasonable efforts toprotect your identity where appropriate and possible.

If you believe that your employer has not correctedviolations involving radiological working conditions, youmay request an inspection. Your request should beaddressed to the Ohio Department of Health, Bureau ofRadiation Protection, and must describe the allegedviolation in detail. It must be signed by you, or yourrepresentative.

DISCRIMINATIONYour employer is prohibited from firing or otherwisediscriminating against you for bringing safety concerns tothe attention of your employer or the ODH. You may notbe fired or discriminated against because you:- ask the ODH to enforce the law against your

employer;- refuse to engage in activities that violate the law;- provide information or are about to provide

information to the ODH or your employer aboutviolations of laws or safety concerns;

- are about to ask for , or testify, help, or take part in anODH or other state proceeding.

The ODH will investigate each allegation of harassment,intimidation, or discrimination.

CONTACT INFORMATIONBureau of Radiation ProtectionOhio Department of Health246 North High StreetColumbus, Ohio [email protected]

Radioactive MaterialsPhone 614-644-2727Fax 614-466-0381

Radiologic Technology Section (X-ray)Phone 614-644-2727Fax 614-466-0381

Miami University's radioactive materials license/registration and all applicable rulesin the Ohio Administrative Code may be examined by contacting theRadiation Safety Office at 529-2812 in Room 58 Hughes Hall.


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STATEMENT OF PRIOR TRAINING AND EXPERIENCE FOR APPROVED USER STATUS

Name: _________________________________ Department: _____________________ Degree(s) Earned: [ ] BS [ ] MS [ ] PhD [ ] Other: _____________________________ Formal Radiation Safety Courses: Provide information for non-MU didactic courses only; indicate total hours; the year(s) course(s) were taken and the location(s) course(s) were taken.

Subject Hours Years Location Radiation protection

Radiation Physics

Radiation Biology

Mathematics and calculations basic to radionuclide use

Total Hours TOTAL HOURS

Experience Using Radioactive Material: Summarize experience by radionuclide; include the maximum activity used in any single experiment or procedure, the time period of use (mm/Yr to mm/Yr), the estimated total hours of experience/use and the location(s) experience was gained. Radionuclide Max. mCi Period of Use Hours Location(s) Experience Gained

I, the undersigned, believe that the above information regarding my radiation safety training and experience is true and accurate to the best of my knowledge. I understand that supporting documentation from listed business and institutions may be requested by the Radiation Safety Office for verification purposes. ____________________________________________ ____________________________ Signature Date


RSOffice 3-2013 80

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APPLICATION AND CERTIFICATION FOR RADIATION WORKER/APPROVED USER STATUS

Miami University RADIATION SAFETY OFFICE

Part A

APPLICATION

Name: Faculty ___ Staff ___ Grad/Post ___ Undergrad

Gender: M ___ F ___ Banner ID #: ___________________ Date of Birth:

Address: Home Telephone:

Work Telephone:

Department: Principal Investigator’s Name: If you do not know who you will be working under, leave blank

Part B

CERTIFICATION (sign and date after coursework has been completed)

I certify that I have completed Miami University’s on-line Radiation Safety Training and that I have received classroom instruction in the safe use of radioactive materials and that I understand applicable regulations established by the Ohio Department of Health and by the Miami University Radiation Safety Committee. _____________________________________ ______________________ SIGNATURE DATE

Return the completed form to Radiation Safety Office, Room 58 Hughes Hall Part C FOR RSOffice UFOR RSOffice U SE ONLYSE ONLY

Date training was completed: _________________ Radiation Safety Training Test Score: Certification approved by: SIGNATURE TITLE

In accordance with our materials license agreement, 40-hours of training and experience has been confirmed and Approved User status has been granted on ______________


RSOffice 3-2013 81

For RSOffice Use OnlyFor RSOffice Use Only Protocol #

Rcvd RSOffice: Tentative Approval: Final Approval:

Modifications:

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PROPOSAL FOR RADIOISOTOPE USE AT MIAMI UNIVERSITY

———————————— PART A - QUESTIONNAIRE ————————————

• Principal Investigator ________________________________________ Date • Department ___________________________ Telephone (office) __________ (lab)

Title of Experiment:

Facilities • Primary room number and building where radioisotopes will be used

• List all other room number(s) where radioisotopes in the proposed plan will be used or stored

(e.g., cold rooms, equipment rooms, counting rooms) • Have the above locations been approved by the Radiation Safety Officer? ❑ No ❑ Yes • Room number(s) of each authorized radioactive material use and disposal sink • Are all of the authorized sinks listed above clearly defined and radioactive labeled? ❑ No ❑ Yes

Dosimeters/Survey Equipment • Indicate your use of the following: ❑ beta emitters with a maximum energy greater that one (1)

MeV; ❑ gamma emitters; ❑ neutron-generating devices or sources; ❑ x-ray-producing devices. NOTE: If you indicated your intent to use any of the above, radiation dose monitoring devices are required for persons

using the sources listed in this proposal that meet the above criteria.

If you indicated use of any of the above, have you contacted the Radiation Safety Office to request that personal dosimeters be issued upon Radiation Safety Committee approval? ❑ No ❑ Yes

• Do you have a survey meter? ❑ No ❑ Yes ❑ NA. If yes, provide the following information:

Mfgr _____________________________ Model # _______________ Serial #

Date last calibrated_______________ Storage location of the meter

Training/Certification • Have you attended the Miami University Radiation Safety Training course? ❑ No ❑ Yes

If no, indicate when you are scheduled to complete the required training

If yes, indicate the date you successfully completed the required training


RSOffice 3-2013 82

Proposal For Radioisotope Use At Miami University Protocol #____________________

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——————————— Part B - Experimental Plan ——————————— Radioactive Materials (continuation sheet available upon request)

Radioisotope

Chemical Form

Maximum Activity per Purchase

Maximum 30 Day Usage

a)

b)

Radiation Surveys/Personnel Monitoring NOTE: Conduct wipe testing as often as necessary to minimize the potential for removable contamination. If your

maximum monthly usage is one (1) millicurie or less, the minimum wipe test frequency is thirty (30) days. However, when your usage exceeds one (1) millicurie in any given seven (7) day period, you must perform wipe tests for that period or as often as necessary to ensure regulatory compliance.

• Will you perform wipe tests? ❑ No. ❑ Yes, every ❑ 30 days; ❑ 7 days; ❑ every ______ day(s). • Will you use a survey meter? ❑ No. ❑ Yes, ❑ during and/or ❑ after every experiment or use. • Will you request and wear a whole body dosimeter? ❑ No. ❑ Yes; ring dosimeter? ❑ No ❑ Yes

Waste Disposal • Estimate the percent of radioactive material listed above to be disposed by the following methods:

Radioisotope

Sanitary Sewer

Storage for Decay1

Other Methods2

a)

b)

1Orange drum 2Yellow Drum or loss to air

———————————— Part C - Written Protocol ————————————

• Attach the details of your experimental plan, in a typed protocol not to exceed 3 pages, to describe the use of the radioactive materials listed above. State activities in microcuries and your methods that will ensure the ultimate fate of all material described will be accounted for through decay or disposal. Your proposal should convince the RSCommittee of the applicability of your research and that radioactive materials will be used safely in accordance with applicable regulations. Review the Miami University Radiation Safety Manual prior to writing your protocol.

• You are responsible for safety in your laboratory and are expected to minimize potential radiation exposures. Methods used to achieve ALARA levels include: time of exposure, distance from a source, and shielding; control of access into and around the controlled area; proper ventilation; use of trays or plastic-backed absorbant liners; and at minimum, gloves, lab coats, and eye protection. Acknowledge that as the Approved User you will be providing Radiation Workers in your lab with performance-based and other Radiation Safety training specific to your research.

Detail safety procedures in your written protocol. Submission

• Sign and submit the original proposal to the Radiation Safety Office, 58 Hughes Hall. Signature of Approved User __________________________________ Date ___________________


RSOffice 3-2013 83

R08171

Protocol Number

Radiation Safety OfficePrincipal Investigator Annual Protocol Review

Sample Protocol Review Form

Title of Experiment

Johnson JeffPrincipal Investigator

RSOfficeDepartment

RETURN THIS REPORT TO 58 HUGHES HALL NLT January 24, 2008

January 10, 2008

RSOffice | 10-2004

1. Status of protocol ...............Active _____ Terminate this protocol _____

- If you are terminating this protocol, stop here. Sign and return form to the RSOffice. -

2. List all individuals working under this protocol: __________________________________________

_________________________________________________________________________________

3. Do the individuals named above know and understand the procedures in the Protocol? ....Y___ N___

4. Are current procedures, chemical forms, and maximum monthly usage/purchases

of radioactive materials accurately stated? .........................................................................Y___ N___

5. Are wipe tests being performed by you or your staff at the stated frequency? ...................Y___ N___

6. Are you maintaining wipe test printouts for three years? ....................................................Y___ N___

7. Do individuals wear personal dosimeters while using radioactive material? .........NA___ Y___ N___

8. Are your radioactive materials used, stored, or disposed in controlled areas? ....................Y___ N___

9. Do you possess only those materials received through the RSOfficer? ..............................Y___ N___

10. Have all radioactive materials in your possession been used exclusively by you

and you staff under this protocol? .......................................................................................Y___ N___

If you answered NO to question 10, complete the following:

_______µCi of_________ was transferred ___to ___from __________________________

The transfer of this material ___was ___was not authorized by the Radiation Safety Officer.

11. If you arrange travel that will not allow you to directly supervise any work under this

protocol for 30 days or longer, will you contact the RSOffice prior to your departure? .....Y___ N___

If you answered NO to any question, please provide an explanation on the back of this report and number

your responses to the corresponding question. When completed, return this report to the RSOffice no later

than the date indicated above. Failure to do so may result in the termination of your protocol. Thank you.

Signature of Principal Investigator___________________________________ Date_________________

isotope person or licensee


RSOffice 3-2013 84

Isotope Requested _________

Package was surveyed by ______________________________

Were surface wipes above 220 dpm (β)?..........................

Were exposure rates >20 mrem/hr @ package surface?...

Equipment used:

Radiation Safety OfficeIsotope Order and Receipt Form

Activity Ordered (in µCi) _______

RSC-Approved Protocol# __________________________

Order Information

Receipt InformationDate Received ________________ Reference Date of Activity Ordered ________________

❏ NA

❏ Beckman LC 8100 SN 7816107

❏ Yes❏ No

❏ Ludlum Model # SN 182307❏ Ludlum Model 3 SN 57051 ❏ Other _____________________

------------------------------------------------------------------------------------------------

------------------------------------------------------------------------------------------------

❏ Include a completed Isotope Use Record with the package.

❏ Reseal the package before releasing to user.

❏ File Isotope Order and Receipt form with a copy of wipe test print-out in the RSOffice.

Package will be shipped on ______________

RSOffice|3-2013

1

1 Contact the Radiation Safety Officer immediately

Principal Investigator Name _____________________________

Company Contact Name __________________________ Cost of order ______________

Amount received __________

______dpm

______mrem/hr

2,3

2 Wipe test results on back

❏ NA❏ Yes❏ No 1

3 bdl - Below Detectable Levels

------------------------------------------------------------------------------------------------

------------------------------------------------------------------------------------------------

L/PO# ____________________

Office Phone _________

Chemical Form ____________________________________

Company ________________Catalog# _____________

Package will be delivered on ______________

Manufacturer's Lot # ______________________________

Date _________________

IUR#

v v v v v v v v v v v v v v v v

❏ Company Reference# __________________

❏ Prior to ordering, verify that the isotope has been approved for use and maximum quantities will not be exceeded under the protocol # provided.

Package Released To _________________________________________ Date _________________

------------------------------------------------------------------------------------------------

❏ Shipper/Tracking# __________________


RSOffice 3-2013 85

Isotope Use Recordfor ODH-licensed materialsIsotope # _______________ Protocol # ____________________

Principal Investigator _________________________________ Department___________________ Phone # ________

Activity Ordered ____________________ Company ____________________

Lot # ____________________Reference Date ____________________

Catalog # ____________________ L/PO # ____________________

ISOTOPE

Date(mm/dd/yy)

Activity(in microcuries)

Waste(in microcuries)

Decayed In Use Unused Sewer Drum

Activity:

Waste:

Decayed - Calculated decay of material In Use and Unused* (monthly or per halflife, whichever is greater).In Use - Activity of isotope currently in process or being accumulated for disposal.Unused - Activity of isotope in the original container.

Sewer - Activity of aqueous waste disposed via hot sink.Drum - Activity of solid waste packaged in an orange or yellow drum. * Do not calculate or record decay after it has been sink disposed or placed in a drum.

3-2013Return to Radiation Safety in 58 Hughes Hall when all material has been depleted or disposed.


RSOffice 3-2013 86

Isotope Use Record-continued-

Date(mm/dd/yy)

Activity(in microcuries)

Decayed In Use Unused Sewer Drum

Isotope # _______________

Activity:

Waste:

Decayed - Calculated decay of material In Use and Unused* (monthly or per halflife, whichever is greater).In Use - Activity of isotope currently in process or being accumulated for disposal.Unused - Activity of isotope in the original container.

Sewer - Activity of aqueous waste disposed via hot sink.Drum - Activity of solid waste packaged in an orange or yellow drum. * Do not calculate or record decay after it has been sink disposed or placed in a drum.

3-2013Return to Radiation Safety in 58 Hughes Hall when all material has been depleted or disposed.


RSOffice 3-2013 87

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RSOffice 3-2013 88

MIAMI UNIVERSITY Radioactive MaterialsRadiation Safety Office 2nd Quarter Inspection Report

John Doe

Yesna

NOSee comments

Yesna

NOSee comments

Yesna

NOSee comments

Yesna

NOSee comments

Yesna

NOSee comments

Yesna

NOSee comments

Yesna

NOSee comments

1/23/2013

To: Principal Investigator

Primary Controlled Area:

This is a report of the inspection for the room(s) indicated above with comments and corrective actions noted. In accordancewith Miami University’s ODH license agreement, radiation safety program management will make every effort to maintainradiation exposures as low as reasonably achievable (10 CFR 20.1101(b)). A quarterly inspection of your RSC-approvedcontrolled areas for radioactive material use is one mechanism employed to ensure management control and regulatorycompliance. Items 1, 2, 4, 5, and 9 when in non-compliance, are in direct violation of regulation. The remaining items aretools that demonstrate management control and assist material users and the RSOffice in their compliance efforts.

Yesna

NOSee comments

Are all required documents,notices, and labels in place?

1.

RESULTS OF QUARTERLY INSPECTION

2.Are RAM controlledareas provided asrequired?

3a.Are Isotope Use Recordscomplete?

3b.Do IURs correspond withcurrent inventory?

-----------------------------------------------------------------------------------------------------------

0 0of were noted.

Yesna

NOSee comments

4.Were surveys completed andrecorded in a timely manner?

5.Were protective gloves, labcoats, and eye protectionused as required?

6a.Were drums labeled and wastelogged and segregated?

6b.Was waste correctlypackaged in drum(s)?

7.Have the Radiation SafetyUpdates been filed?

Item Result Corrective Action

-----------------------------------------------------------------------------------------------------------

-----------------------------------------------------------------------------------------------------------

No action necessary

No action necessary.

No isotopes on inventory.

-----------------------------------------------------------------------------------------------------------

No isotopes on inventory.

-----------------------------------------------------------------------------------------------------------

Perform surveys at the frequency agreed upon and record theresults in the yellow binder.

-----------------------------------------------------------------------------------------------------------



No action necessary.-----------------------------------------------------------------------------------------------------------

-----------------------------------------------------------------------------------------------------------No action necessary.

-----------------------------------------------------------------------------------------------------------

Comments4. Second Occurrence. Wipe tests recorded on 9/2/12, 10/1/12, 11/1/12, and 12/1/12. REMINDER: wipe testingfrequencies are at a minimum, every 30 calendar days. Using a monthly frequency without regard to the 30 dayrequirement will result in a violation when a 31-day month occurs.

MicrobiologyDepartment:Date of Inspection:

41F PearsonSecondary Area(s): 41J, 41K, 53J Pearson

Were monitoring results1 mrem/hr or lower (ALARA)?

-----------------------------------------------------------------------------------------------------------8. Yes

naNO

See comments <0.02 mrem/hr. No action necessary.

-----------------------------------------------------------------------------------------------------------

From: Jeff Johnson Radiation Safety OfficerRe: Quarterly Inspection of Controlled Areas

9. Are RAM control and securitymeasures being used?

Yesna

NOSee comments

-----------------------------------------------------------------------------------------------------------


30 days wipe test frequency

RSOffice|2-2003


RSOffice 3-2013 89

RGE Supervisor ______________________________________

Yes No NA

Yes No NA

Yes No NA

Yes No NA

Are all required notices and labels in place?..................................................1.

2.Does equipment correspond with current inventory?.....................................

3.Are equipment use logs complete?.................................................................

7.Did interlock systems and visible alarms function properly?........................

Yes No NA6.Are GM monitoring results background (0.02 mrem/hr) or less?..................

Radiation Safety OfficeSemi-annual RGE Inspection Report

Room/Building _________________

Inspection Date _________________

-----------------------------------------------------------------------------------------------------------

-----------------------------------------------------------------------------------------------------------

-----------------------------------------------------------------------------------------------------------

-----------------------------------------------------------------------------------------------------------

-----------------------------------------------------------------------------------------------------------

-----------------------------------------------------------------------------------------------------------

Were area control and security measures in use?.......................................... Yes No NA4.

-----------------------------------------------------------------------------------------------------------

RGE Supervisor Radiation Safety Officer/InspectorEntered

Additional comments __________________________________________________________________

___________________________________________________________________________________

___________________________________________________________________________________

RSOffice|3-2013

If No, specify discrepancies in comments


Do not energize equipment until all systems are functioning properly. Report to RSOffice when completed.


Lock entrances to area and/or have equipment supervised by an RGE Supervisor at all times.

Equipment Insepcted:[ ] Gandolfi/Precession Camera[ ] Scintag X1 Powder Difractometer[ ] Bruker APEX Diffractometer[ ] Bruker AXS Microstar[ ] MINISHOT M25NH X-ray cabinet[ ] Other:_______________________

Is the RGE operable?..................................................................................... Yes No NA5.No action necessary.

Contact the RSOffice when operable to complete items 6 & 7.

If No, specify discrepancies in comments


Maintain logs as agreed upon.


RSOffice 3-2013 90

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INSTRUCTIONS FOR USE

ORANGE RADIOACTIVE WASTE DRUM


An Orange drum is for the storage of your solid radioactive waste contaminated by an isotope with a halflife of 120 days or less (e.g., P32, P33, S35, I125). Please comply with the following when placing radioactive waste material in a drum. All items below will be verified before an orange drum is picked up for disposal. 1. REMOVE OR DEFACE ALL LABELS REFERENCING RADIATION

AND RADIOACTIVE MATERIAL. Waste in an orange drum is destined for a sanitary landfill. Removing labels, rolling labels up into a ball, or marking out all radiation symbols and the words “RADIOACTIVE MATERIALS”, or similar wording with a black indelible marker are acceptable.

2. PACKAGE ALL WASTE. a) Place solid waste in 1-2 gallon-sized bags

and seal (e.g., with a twist tie) or b) bundle waste in absorbent paper about the size of an American football and seal with tape before placing in a drum. PUT NO LOOSE WASTE IN A WASTE DRUM.

3. NO CHEMICAL WASTE. Flammable and non-flammable solvents

(including alcohols), corrosives, and toxic compounds are strictly prohibited. Contact the Environmental Health and Safety Offices at 529-2829 for the disposal of chemical waste.

4. NO SHARPS. Pointed and sharp objects that include pipettes, blades,

needles, capillary tubes, microscope slides, and broken glass are strictly prohibited. Decontaminate contaminated glass to background levels and dispose via non-radioactive waste streams.

5. COMPLETE LOG SHEET.

a) Date you placed waste into the drum; b) Description of the waste material (e.g., tips, plastic vials, paper, gloves); c) Amount of activity in microcuries (do not enter “trace” or use math

symbols for approximate (~), less than (<), or greater than (>)); and d) Initials of person completing the log.

6. DO NOT OVERFILL DRUM. Your cooperation in packaging radioactive waste drums is appreciated. If you have questions, call the RSOffice at x2812. Thank you.


RSOffice 3-2013 91

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INSTRUCTIONS FOR USE

YELLOW RADIOACTIVE WASTE DRUM


A yellow drum is for the storage of your solid radioactive waste contaminated by an isotope with a halflife greater than 120 days (e.g., H3, C14). Please comply with the following when placing radioactive waste material in a drum. All items below will be verified before a yellow drum is picked up for disposal. 1. PACKAGE ALL WASTE. a) Place solid waste in plastic bags and tightly

seal with a twist tie or b) bundle waste in absorbent paper about the size of an American football and seal with tape before placing in a drum. PUT NO LOOSE WASTE IN A WASTE DRUM.

2. NO CHEMICAL WASTE. Flammable and non-flammable solvents

(including alcohols), corrosives, and toxic compounds are strictly prohibited. Contact the Environmental Health and Safety Offices at 529-2829 for the disposal of chemical waste.

3. NO SHARPS, GLASS, OR METAL. Pointed and sharp objects that

include pipettes, blades, needles, capillary tubes, microscope slides, and broken glass are strictly prohibited. Glass and metal cannot be incinerated at this time. Decontaminate glass and metal to background levels and dispose via non-radioactive waste streams.

4. COMPLETE LOG SHEET.

a) Date you placed waste into the drum; b) Description of the waste material (e.g., tips, plastic vials, paper, gloves); c) Amount of activity in microcuries (do not enter “trace” or use math

symbols for approximate (~), less than (<), or greater than (>)); and d) Initials of person completing the log.

5. DO NOT OVERFILL DRUM. Your cooperation in packaging radioactive waste drums is appreciated. If you have questions, call the RSOffice at x2812. Thank you.


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Miami University Radiation Safety Office

RADIOACTIVE WASTE DRUM LOG

Drum Number Principal Investigator: ___________________________ Date Issued: _____________ Department: _________________________ Room/Building: ____________________

Date Isotope Type of Waste Amt in µCi Initials mm/dd/yy describe materials placed in drum don’t use trace amounts

^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^ ^

*****USE THE BACK OF THIS LOG FOR ADDITIONAL ENTRIES***** FOR RSOFFICE USE ONLY |

PU date _____________ by ______ Net Wt of drum in lbs _____ Total activity in µCi ______

Disposal date ______________ by ______ Method: Incineration____ Decay ____Broker____

Survey meter model and serial # _____________________ Waste dose rate ________ Bg ________

Appendices: Regulatory Guides

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Regulatory Guides

8.13 Instruction Concerning Prenatal Radiation Exposure


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Revision 3JUNE 1999

REGULATORY GUIDE 8.13(Draft was issued as DG-8014)

INSTRUCTION CONCERNING PRENATAL RADIATION EXPOSURE

A. INTRODUCTION

The Code of Federal Regulations in 10 CFR Part 19, “Notices, Instructions and Reports to Workers:Inspection and Investigations,” in Section 19.12, “Instructions to Workers,” requires instruction in “the healthprotection problems associated with exposure to radiation and/or radioactive material, in precautions orprocedures to minimize exposure, and in the purposes and functions of protective devices employed.” Theinstructions must be “commensurate with potential radiological health protection problems present in the workplace.”

The Nuclear Regulatory Commission's (NRC's) regulations on radiation protection are specified in10 CFR Part 20, “Standards for Protection Against Radiation”; and 10 CFR 20.1208, “Dose to anEmbryo/Fetus,” requires licensees to “ensure that the dose to an embryo/fetus during the entire pregnancy, dueto occupational exposure of a declared pregnant woman, does not exceed 0.5 rem (5 mSv).” Section 20.1208also requires licensees to “make efforts to avoid substantial variation above a uniform monthly exposure rate toa declared pregnant woman.” A declared pregnant woman is defined in 10 CFR 20.1003 as a woman who hasvoluntarily informed her employer, in writing, of her pregnancy and the estimated date of conception.

This regulatory guide is intended to provide information to pregnant women, and other personnel, tohelp them make decisions regarding radiation exposure during pregnancy. This Regulatory Guide 8.13supplements Regulatory Guide 8.29, “Instruction Concerning Risks from Occupational Radiation Exposure” (Ref.1), which contains a broad discussion of the risks from exposure to ionizing radiation.

Other sections of the NRC's regulations also specify requirements for monitoring external and internaloccupational dose to a declared pregnant woman. In 10 CFR 20.1502, “Conditions Requiring IndividualMonitoring of External and Internal Occupational Dose,” licensees are required to monitor the occupational doseto a declared pregnant woman, using an individual monitoring device, if it is likely that the declared pregnantwoman will receive, from external sources, a deep dose equivalent in excess of 0.1 rem (1 mSv). According toParagraph (e) of 10 CFR 20.2106, “Records of Individual Monitoring Results,” the licensee must maintain


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records of dose to an embryo/fetus if monitoring was required, and the records of dose to the embryo/fetus mustbe kept with the records of dose to the declared pregnant woman. The declaration of pregnancy must be kepton file, but may be maintained separately from the dose records. The licensee must retain the required form orrecord until the Commission terminates each pertinent license requiring the record.

The information collections in this regulatory guide are covered by the requirements of 10 CFR Parts19 or 20, which were approved by the Office of Management and Budget, approval numbers 3150-0044 and3150-0014, respectively. The NRC may not conduct or sponsor, and a person is not required to respond to,a collection of information unless it displays a currently valid OMB control number.

B. DISCUSSION

As discussed in Regulatory Guide 8.29 (Ref. 1), exposure to any level of radiation is assumed to carrywith it a certain amount of risk. In the absence of scientific certainty regarding the relationship between low doseexposure and health effects, and as a conservative assumption for radiation protection purposes, the scientificcommunity generally assumes that any exposure to ionizing radiation may cause undesirable biological effects andthat the likelihood of these effects increases as the dose increases. At the occupational dose limit for the wholebody of 5 rem (50 mSv) per year, the risk is believed to be very low.

The magnitude of risk of childhood cancer following in utero exposure is uncertain in that bothnegative and positive studies have been reported. The data from these studies “are consistent with a lifetimecancer risk resulting from exposure during gestation which is two to three times that for the adult” (NCRP ReportNo. 116, Ref. 2). The NRC has reviewed the available scientific literature and has concluded that the 0.5 rem(5 mSv) limit specified in 10 CFR 20.1208 provides an adequate margin of protection for the embryo/fetus. Thisdose limit reflects the desire to limit the total lifetime risk of leukemia and other cancers associated with radiationexposure during pregnancy.

In order for a pregnant worker to take advantage of the lower exposure limit and dose monitoringprovisions specified in 10 CFR Part 20, the woman must declare her pregnancy in writing to the licensee. A formletter for declaring pregnancy is provided in this guide or the licensee may use its own form letter for declaringpregnancy. A separate written declaration should be submitted for each pregnancy.

C. REGULATORY POSITION

1. Who Should Receive Instruction

Female workers who require training under 10 CFR 19.12 should be provided with the informationcontained in this guide. In addition to the information contained in Regulatory Guide 8.29 (Ref. 1), this informationmay be included as part of the training required under 10 CFR 19.12.

2. Providing Instruction

The occupational worker may be given a copy of this guide with its Appendix, an explanation of the


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contents of the guide, and an opportunity to ask questions and request additional information. The information inthis guide and Appendix should also be provided to any worker or supervisor who may be affected by adeclaration of pregnancy or who may have to take some action in response to such a declaration.

Classroom instruction may supplement the written information. If the licensee provides classroominstruction, the instructor should have some knowledge of the biological effects of radiation to be able to answerquestions that may go beyond the information provided in this guide. Videotaped presentations may be used forclassroom instruction. Regardless of whether the licensee provides classroom training, the licensee should giveworkers the opportunity to ask questions about information contained in this Regulatory Guide 8.13. The licenseemay take credit for instruction that the worker has received within the past year at other licensed facilities or inother courses or training.

3. Licensee's Policy on Declared Pregnant Women

The instruction provided should describe the licensee's specific policy on declared pregnant women,including how those policies may affect a woman's work situation. In particular, the instruction should include adescription of the licensee's policies, if any, that may affect the declared pregnant woman's work situation aftershe has filed a written declaration of pregnancy consistent with 10 CFR 20.1208.

The instruction should also identify who to contact for additional information as well as identify whoshould receive the written declaration of pregnancy. The recipient of the woman's declaration may be identifiedby name (e.g., John Smith), position (e.g., immediate supervisor, the radiation safety officer), or department (e.g.,the personnel department).

4. Duration of Lower Dose Limits for the Embryo/Fetus

The lower dose limit for the embryo/fetus should remain in effect until the woman withdraws thedeclaration in writing or the woman is no longer pregnant. If a declaration of pregnancy is withdrawn, the doselimit for the embryo/fetus would apply only to the time from the estimated date of conception until the time thedeclaration is withdrawn. If the declaration is not withdrawn, the written declaration may be considered expiredone year after submission.

5. Substantial Variations Above a Uniform Monthly Dose Rate

According to 10 CFR 20.1208(b), “The licensee shall make efforts to avoid substantial variationabove a uniform monthly exposure rate to a declared pregnant woman so as to satisfy the limit in paragraph (a)of this section,” that is, 0.5 rem (5 mSv) to the embryo/fetus. The National Council on Radiation Protection andMeasurements (NCRP) recommends a monthly equivalent dose limit of 0.05 rem (0.5 mSv) to the embryo/fetusonce the pregnancy is known (Ref. 2). In view of the NCRP recommendation, any monthly dose of less than 0.1rem (1 mSv) may be considered as not a substantial variation above a uniform monthly dose rate and as such willnot require licensee justification. However, a monthly dose greater than 0.1 rem (1 mSv) should be justified bythe licensee.


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D. IMPLEMENTATION

The purpose of this section is to provide information to licensees and applicants regarding the NRCstaff's plans for using this regulatory guide.

Unless a licensee or an applicant proposes an acceptable alternative method for complying with thespecified portions of the NRC's regulations, the methods described in this guide will be used by the NRC staffin the evaluation of instructions to workers on the radiation exposure of pregnant women.

REFERENCES

1. USNRC, “Instruction Concerning Risks from Occupational Radiation Exposure,” Regulatory Guide 8.29,Revision 1, February 1996.

2. National Council on Radiation Protection and Measurements, Limitation of Exposure to IonizingRadiation, NCRP Report No. 116, Bethesda, MD, 1993.


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APPENDIX

QUESTIONS AND ANSWERS CONCERNING PRENATAL RADIATION EXPOSURE

1. Why am I receiving this information?

The NRC's regulations (in 10 CFR 19.12, “Instructions to Workers”) require that licensees instructindividuals working with licensed radioactive materials in radiation protection as appropriate for the situation. Theinstruction below describes information that occupational workers and their supervisors should know about theradiation exposure of the embryo/fetus of pregnant women.

The regulations allow a pregnant woman to decide whether she wants to formally declare herpregnancy to take advantage of lower dose limits for the embryo/fetus. This instruction provides information tohelp women make an informed decision whether to declare a pregnancy.

2. If I become pregnant, am I required to declare my pregnancy?

No. The choice whether to declare your pregnancy is completely voluntary. If you choose to declareyour pregnancy, you must do so in writing and a lower radiation dose limit will apply to your embryo/fetus. If youchoose not to declare your pregnancy, you and your embryo/fetus will continue to be subject to the same radiationdose limits that apply to other occupational workers.

3. If I declare my pregnancy in writing, what happens?

If you choose to declare your pregnancy in writing, the licensee must take measures to limit the doseto your embryo/fetus to 0.5 rem (5 millisievert) during the entire pregnancy. This is one-tenth of the dose that anoccupational worker may receive in a year. If you have already received a dose exceeding 0.5 rem (5 mSv) inthe period between conception and the declaration of your pregnancy, an additional dose of 0.05 rem (0.5 mSv)is allowed during the remainder of the pregnancy. In addition, 10 CFR 20.1208, “Dose to an Embryo/Fetus,”requires licensees to make efforts to avoid substantial variation above a uniform monthly dose rate so that all the0.5 rem (5 mSv) allowed dose does not occur in a short period during the pregnancy.

This may mean that, if you declare your pregnancy, the licensee may not permit you to do some ofyour normal job functions if those functions would have allowed you to receive more than 0.5 rem, and you maynot be able to have some emergency response responsibilities.

4. Why do the regulations have a lower dose limit for the embryo/fetus of a declared pregnant womanthan for a pregnant worker who has not declared?

A lower dose limit for the embryo/fetus of a declared pregnant woman is based on a considerationof greater sensitivity to radiation of the embryo/fetus and the involuntary nature of the exposure. Several scientificadvisory groups have recommended (References 1 and 2) that the dose to the embryo/fetus be limited to afraction of the occupational dose limit.


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5. What are the potentially harmful effects of radiation exposure to my embryo/fetus?

The occurrence and severity of health effects caused by ionizing radiation are dependent upon the typeand total dose of radiation received, as well as the time period over which the exposure was received. SeeRegulatory Guide 8.29, “Instruction Concerning Risks from Occupational Exposure” (Ref. 3), for moreinformation. The main concern is embryo/fetal susceptibility to the harmful effects of radiation such as cancer.

6. Are there any risks of genetic defects?

Although radiation injury has been induced experimentally in rodents and insects, and in theexperiments was transmitted and became manifest as hereditary disorders in their offspring, radiation has not beenidentified as a cause of such effect in humans. Therefore, the risk of genetic effects attributable to radiationexposure is speculative. For example, no genetic effects have been documented in any of the Japanese atomicbomb survivors, their children, or their grandchildren.

7. What if I decide that I do not want any radiation exposure at all during my pregnancy?

You may ask your employer for a job that does not involve any exposure at all to occupationalradiation dose, but your employer is not obligated to provide you with a job involving no radiation exposure. Evenif you receive no occupational exposure at all, your embryo/fetus will receive some radiation dose (on average75 mrem (0.75 mSv)) during your pregnancy from natural background radiation.

The NRC has reviewed the available scientific literature and concluded that the 0.5 rem (5 mSv) limitprovides an adequate margin of protection for the embryo/fetus. This dose limit reflects the desire to limit the totallifetime risk of leukemia and other cancers. If this dose limit is exceeded, the total lifetime risk of cancer to theembryo/fetus may increase incrementally. However, the decision on what level of risk to accept is yours. Moredetailed information on potential risk to the embryo/fetus from radiation exposure can be found in References2-10.

8. What effect will formally declaring my pregnancy have on my job status?

Only the licensee can tell you what effect a written declaration of pregnancy will have on your jobstatus. As part of your radiation safety training, the licensee should tell you the company's policies with respectto the job status of declared pregnant women. In addition, before you declare your pregnancy, you may wantto talk to your supervisor or your radiation safety officer and ask what a declaration of pregnancy would meanspecifically for you and your job status.

In many cases you can continue in your present job with no change and still meet the dose limit forthe embryo/fetus. For example, most commercial power reactor workers (approximately 93%) receive, in 12months, occupational radiation doses that are less than 0.5 rem (5 mSv) (Ref. 11). The licensee may alsoconsider the likelihood of increased radiation exposures from accidents and abnormal events before making adecision to allow you to continue in your present job.


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If your current work might cause the dose to your embryo/fetus to exceed 0.5 rem (5 mSv), thelicensee has various options. It is possible that the licensee can and will make a reasonable accommodation thatwill allow you to continue performing your current job, for example, by having another qualified employee do asmall part of the job that accounts for some of your radiation exposure.

9. What information must I provide in my written declaration of pregnancy?

You should provide, in writing, your name, a declaration that you are pregnant, the estimated dateof conception (only the month and year need be given), and the date that you give the letter to the licensee. Aform letter that you can use is included at the end of these questions and answers. You may use that letter, usea form letter the licensee has provided to you, or write your own letter.

10. To declare my pregnancy, do I have to have documented medical proof that I am pregnant?NRC regulations do not require that you provide medical proof of your pregnancy. However, NRC

regulations do not preclude the licensee from requesting medical documentation of your pregnancy, especially ifa change in your duties is necessary in order to comply with the 0.5 rem (5 mSv) dose limit.

11. Can I tell the licensee orally rather than in writing that I am pregnant?No. The regulations require that the declaration must be in writing.

12. If I have not declared my pregnancy in writing, but the licensee suspects that I am pregnant, do thelower dose limits apply?

No. The lower dose limits for pregnant women apply only if you have declared your pregnancy inwriting. The United States Supreme Court has ruled (in United Automobile Workers International Union v.Johnson Controls, Inc., 1991) that “Decisions about the welfare of future children must be left to the parents whoconceive, bear, support, and raise them rather than to the employers who hire those parents” (Reference 7). TheSupreme Court also ruled that your employer may not restrict you from a specific job “because of concerns aboutthe next generation.” Thus, the lower limits apply only if you choose to declare your pregnancy in writing.

13. If I am planning to become pregnant but am not yet pregnant and I inform the licensee of that inwriting, do the lower dose limits apply?

No. The requirement for lower limits applies only if you declare in writing that you are alreadypregnant.

14. What if I have a miscarriage or find out that I am not pregnant?

If you have declared your pregnancy in writing, you should promptly inform the licensee in writing thatyou are no longer pregnant. However, if you have not formally declared your pregnancy in writing, you need notinform the licensee of your nonpregnant status.

15. How long is the lower dose limit in effect?The dose to the embryo/fetus must be limited until you withdraw your declaration in writing or you


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inform the licensee in writing that you are no longer pregnant. If the declaration is not withdrawn, the writtendeclaration may be considered expired one year after submission.

16. If I have declared my pregnancy in writing, can I revoke my declaration of pregnancy even if I amstill pregnant?

Yes, you may. The choice is entirely yours. If you revoke your declaration of pregnancy, the lowerdose limit for the embryo/fetus no longer applies.

17. What if I work under contract at a licensed facility?The regulations state that you should formally declare your pregnancy to the licensee in writing. The

licensee has the responsibility to limit the dose to the embryo/fetus.

18. Where can I get additional information?The references to this Appendix contain helpful information, especially Reference 3, NRC's

Regulatory Guide 8.29, “Instruction Concerning Risks from Occupational Radiation Exposure,” for generalinformation on radiation risks. The licensee should be able to give this document to you.

For information on legal aspects, see Reference 7, “The Rock and the Hard Place: Employer Liabilityto Fertile or Pregnant Employees and Their Unborn Children—What Can the Employer Do?” which is an articlein the journal Radiation Protection Management.

You may telephone the NRC Headquarters at (301) 415-7000. Legal questions should be directedto the Office of the General Counsel, and technical questions should be directed to the Division of Industrial andMedical Nuclear Safety.

You may also telephone the NRC Regional Offices at the following numbers: Region I, (610)337-5000; Region II, (404) 562-4400; Region III, (630) 829-9500; and Region IV, (817) 860-8100. Legalquestions should be directed to the Regional Counsel, and technical questions should be directed to the Divisionof Nuclear Materials Safety.


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1Single copies of regulatory guides, both active and draft, and draft NUREG documents may be obtained freeof charge by writing the Reproduction and Distribution Services Section, OCIO, USNRC, Washington, DC20555-0001, or by fax to (301)415-2289, or by email to <[email protected]>. Active guidesmay also be purchased from the National Technical Information Service on a standing order basis. Details onthis service may be obtained by writing NTIS, 5285 Port Royal Road, Springfield, VA 22161. Copies of activeand draft guides are available for inspection or copying for a fee from the NRC Public Document Room at 2120L Street NW., Washington, DC; the PDR's mailing address is Mail Stop LL-6, Washington, DC 20555;telephone (202)634-3273; fax (202)634-3343.

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REFERENCES FOR APPENDIX

1. National Council on Radiation Protection and Measurements, Limitation of Exposure to IonizingRadiation, NCRP Report No. 116, Bethesda, MD, 1993.

2. International Commission on Radiological Protection, 1990 Recommendations of the InternationalCommission on Radiological Protection, ICRP Publication 60, Ann. ICRP 21: No. 1-3, Pergamon Press,Oxford, UK, 1991.

3. USNRC, “Instruction Concerning Risks from Occupational Radiation Exposure,” Regulatory Guide 8.29,Revision 1, February 1996.11 (Electronically available at www.nrc.gov/NRC/RG/index.html)

4. Committee on the Biological Effects of Ionizing Radiations, National Research Council, Health Effects ofExposure to Low Levels of Ionizing Radiation (BEIR V), National Academy Press, Washington, DC,1990.

5. United Nations Scientific Committee on the Effects of Atomic Radiation, Sources and Effects of IonizingRadiation, United Nations, New York, 1993.

6. R. Doll and R. Wakeford, “Risk of Childhood Cancer from Fetal Irradiation,” The British Journal ofRadiology, 70, 130-139, 1997.

7. David Wiedis, Donald E. Jose, and Timm O. Phoebe, “The Rock and the Hard Place: Employer Liabilityto Fertile or Pregnant Employees and Their Unborn Children—What Can the Employer Do?” RadiationProtection Management, 11, 41-49, January/February 1994.

8. National Council on Radiation Protection and Measurements, Considerations Regarding the UnintendedRadiation Exposure of the Embryo, Fetus, or Nursing Child, NCRP Commentary No. 9, Bethesda,MD, 1994.

9. National Council on Radiation Protection and Measurements, Risk Estimates for Radiation Protection,NCRP Report No. 115, Bethesda, MD, 1993.


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2Copies are available at current rates from the U.S. Government Printing Office, P.O. Box 37082, Washington,DC 20402-9328 (telephone (202)512-1800); or from the National Technical Information Service by writingNTIS at 5285 Port Royal Road, Springfield, VA 22161. Copies are available for inspection or copying for afee from the NRC Public Document Room at 2120 L Street NW., Washington, DC; the PDR's mailing addressis Mail Stop LL-6, Washington, DC 20555; telephone (202)634-3273; fax (202)634-3343.

8.13-8.13-10

10. National Radiological Protection Board, Advice on Exposure to Ionising Radiation During Pregnancy,National Radiological Protection Board, Chilton, Didcot, UK, 1998.

11. M.L. Thomas and D. Hagemeyer, “Occupational Radiation Exposure at Commercial Nuclear PowerReactors and Other Facilities, 1996,” Twenty-Ninth Annual Report, NUREG-0713, Vol. 18, USNRC,1998.22


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(Your signature)

(Your name printed)

(Date)

FORM LETTER FOR DECLARING PREGNANCY

This form letter is provided for your convenience. To make your written declaration ofpregnancy, you may fill in the blanks in this form letter, you may use a form letter the licensee has providedto you, or you may write your own letter.

DECLARATION OF PREGNANCY

To:

In accordance with the NRC's regulations at 10 CFR 20.1208, “Dose to an Embryo/Fetus,” Iam declaring that I am pregnant. I believe I became pregnant in (only the month and yearneed be provided).

I understand the radiation dose to my embryo/fetus during my entire pregnancy will not be allowedto exceed 0.5 rem (5 millisievert) (unless that dose has already been exceeded between the time ofconception and submitting this letter). I also understand that meeting the lower dose limit may require achange in job or job responsibilities during my pregnancy.


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REGULATORY ANALYSIS

A separate regulatory analysis was not prepared for thisregulatory guide. A regulatory analysis prepared for 10 CFR Part 20,“Standards for Protection Against Radiation” (56 FR 23360), providesthe regulatory basis for this guide and examines the costs and benefits ofthe rule as implemented by the guide. A copy of the “RegulatoryAnalysis for the Revision of 10 CFR Part 20” (PNL-6712, November1988) is available for inspection and copying for a fee at the NRC PublicDocument Room, 2120 L Street NW, Washington, DC, as an enclosureto Part 20 (56 FR 23360).

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