DOE G 441.1-1B, Radiation Protection Programs Guide

DOE G 441.1-1B 3-1-07 RADIATION PROTECTION PROGRAMS GUIDE for Use with Title 10, Code of Federal Regulations, Part 835, Occupational Radiation Protection [This Guide describes nonmandatory approaches for meeting requirements. Guides are not requirements documents and are not to be construed as requirements in any audit or appraisal for compliance with the parent Rule, Policy, Order, Notice, or Manual.] Department of Energy Office of Health, Safety and Security NOT MEASUREMENT SENSITIVE DOE G 441.1-1B i 3-1-07 TABLE OF CONTENTS RADIATION PROTECTION PROGRAMS.................................................................... 1 1.0 PURPOSE AND APPLICABILITY ...................................................................... 1 1.1 USE OF CONSENSUS STANDARDS................................................................... 2 1.2 ACRONYMS............................................................................................................ 4 2.0 DEFINITIONS ......................................................................................................... 7 3.0 RADIATION PROTECTION PROGRAMS...................................................... 17 3.1 Implementation Guidance......................................................................... 18 3.2 Organization and Administration.............................................................. 20 3.2.0 Administrative Processes .............................................................. 20 3.2.1 Radiological Control Organization ............................................... 21 3.2.2 Education, Training, and Skills..................................................... 22 3.2.3 Internal Audit and Self Assessment.............................................. 24 3.3 RPP Functional Elements ......................................................................... 25 4.0 ALARA ................................................................................................................... 41 4.1 Implementation Guidance..................................................................................... 41 4.2 ALARA Programs ................................................................................................. 42 4.2.0 Formal Plans and Measures .......................................................... 42 4.2.1 Policy and Management Commitment.......................................... 43 4.2.2 ALARA Training .......................................................................... 44 4.2.3 Plans and Procedures .................................................................. 44 4.2.4 Internal Assessments/Audits........................................................ 44 4.2.5 ALARA Design Review ............................................................. 45 4.2.6 Radiological Work/Experiment Administration and Planning ... 48 4.2.6.0 Job/Task/Experiment Reviews....................................... 49 4.2.6.1 Consideration of Non-radiological Hazards .................. 50 4.3 Records ................................................................................................... 51 5.0 INTERNAL DOSIMETRY PROGRAM............................................................ 53 5.1 Implementation Guidance....................................................................... 53 5.2 Program Management and Administration............................................. 54

5.2.0 General Requirements................................................................. 54 5.2.1 Organization, Staffing, and Facilities.......................................... 55 5.2.1.0 Organization................................................................... 55 5.2.1.1 Staffing........................................................................... 55 5.2.1.2 Facilities and Resources................................................. 56 5.2.2 Technical Basis Document........................................................... 56 5.2.3 Internal Dosimetry Procedures Manual ....................................... 57 5.2.4 Quality Assurance ....................................................................... 57 5.3 Air Monitoring and Contamination Control Programs ............................ 57 5.3.0 Air Monitoring When There Is No Practical Radiobioassay Method .......................................................................................... 58 5.3.1 Recourse for Technology Shortfall (DIL<MDA) ........................ 58 5.4 Individual Monitoring Program ............................................................... 59 5.4.0 Establishing the Need for Individual Monitoring ........................ 59 ii DOE G 441.1-1B 3-1-07 5.4.1 Investigation Levels/Derived Investigation Levels ..................... 60 5.4.2 Minimum Detectable Amount (MDA)......................................... 60 5.4.3 Frequency of Measurement.......................................................... 61 5.4.4 Detection and Confirmation of Intakes........................................ 61 5.4.5 Internal Dose Management .......................................................... 63 5.4.6 Planned Special Exposures .......................................................... 63 5.4.7 Medical Response ........................................................................ 63 5.5 Internal Dose Evaluation.......................................................................... 63 5.5.0 Required Dose Calculations......................................................... 63 5.5.1 Interpretation of Radiobioassay Data........................................... 64 5.5.2 Evaluation of Internal Dose from Radiobioassay and Air Monitoring Data............................................................................ 64 5.5.3 Periodic Reevaluation of Internal Dose ....................................... 65 5.6 Recordkeeping and Reporting................................................................. 65 6.0 EXTERNAL DOSIMETRY PROGRAM........................................................... 67 6.1 Implementation Guidance........................................................................ 67 6.2 Program Management and Administration .............................................. 68 6.2.0 General Requirements.................................................................. 68 6.2.1 Organization, Staffing, And Facilities ......................................... 69 6.2.1.0 Organization................................................................... 69 6.2.1.1 Staffing........................................................................... 69 6.2.1.2 Facilities and Resources................................................. 69 6.2.2 Technical Basis Document........................................................... 69 6.2.3 Procedures.................................................................................... 70 6.2.4 Quality Assurance ........................................................................ 71

6.3 Area Monitoring Program........................................................................ 71 6.3.0 Monitoring Instruments and Devices........................................... 71 6.3.1 Performance of Area Radiation Monitoring ................................ 72 6.3.2 Allowance for Physical Characteristics ....................................... 73 6.3.3 Recourse for Technology Shortfall .............................................. 73 6.4 Individual Monitoring Program ............................................................... 73 6.4.0 Establishing the Need for Individual Monitoring ........................ 73 6.4.1 Routine Monitoring of Individual External Doses....................... 75 6.4.1.0 Deep Dose Monitoring................................................... 75 6.4.1.1 Lens of the Eye Monitoring ............................................. 75 6.4.1.2 Skin and Extremity Monitoring ..................................... 76 6.4.1.3 Embryo/Fetal Monitoring ................................................ 77 6.4.1.4 Non-Uniform Radiation Fields ......................................... 77 6.4.1.5 Supplemental Dosimeters ................................................ 78 6.4.2 Lost, Damaged, or Contaminated Dosimeters ............................. 78 6.4.3 Nuclear Accident Dosimetry....................................................... 78 6.4.4 Planned Special Exposures .......................................................... 79 6.4.5 Personal Protective Equipment .................................................... 79 6.5 External Dose Evaluation ........................................................................ 80 6.5.0 Required Dose Calculations......................................................... 80 DOE G 441.1-1B iii 3-1-07 6.5.1 Special Considerations................................................................. 81 6.6 Recordkeeping and Reporting.................................................................. 83 7.0 RADIATION GENERATING DEVICES .......................................................... 85 7.1 Implementation Guidance........................................................................ 85 7.2 Administrative Organization and Controls .............................................. 86 7.2.0 Contractor Management............................................................... 86 7.2.1 RGD Custodian............................................................................ 86 7.2.2 RGD Operator.............................................................................. 87 7.2.3 Qualified Expert........................................................................... 88 7.2.4 Radiological Control Manager..................................................... 88 7.2.5 Radiological Control Organization .............................................. 88 7.3 Development of Site-Specific Documents............................................... 89 7.3.0 Radiological Monitoring............................................................. 89 7.3.1 Sealed Radioactive Source Leak Testing..................................... 91 7.3.2 Area Posting................................................................................ 91 7.3.2.0 Radiological Conditions................................................. 91 7.3.2.1 Operational Status.......................................................... 91 7.3.2.2 Maintenance Status .......................................................... 91

7.3.3 Training........................................................................................ 92 7.3.4 Records ........................................................................................ 92 7.4 Engineered Safety Controls ..................................................................... 92 7.4.0 Shielding, Controls, & Safety Devices ........................................ 93 7.4.0.0 Shielding .......................................................................... 93 7.4.0.1 Access Control and Safety Devices ............................... 93 7.4.0.2 Interlocks......................................................................... 93 7.4.0.3 Device Controls .............................................................. 94 7.4.0.4 Run-Safe and Emergency Shutdown Devices ............... 94 7.4.0.5 Monitoring Instruments .................................................. 95 7.4.1 Guidance for Specific RGD Installations .................................... 95 7.4.1.0 Accelerators ................................................................... 95 7.4.1.1 Electron Devices that Generate X-Rays Incidentally ..... 96 7.4.1.2 Cabinet X-Ray Systems ................................................. 96 8.1 Implementation Guidance....................................................................... 97 8.2 Declaration of Pregnancy/Withdrawal of Declaration............................ 97 8.3 Work Restrictions Following Declarations of Pregnancy ...................... 99 8.4 Counseling ............................................................................................ 100 8.5 Dose Determination and Monitoring Methods ..................................... 101 8.5.0 Dose Determination ................................................................... 101 8.5.1 Monitoring Methods .................................................................. 102 8.6 Training................................................................................................. 102 8.7 Record -Keeping and Reporting ........................................................... 102 Appendix 8.B ......................................................................................................... 105 Withdrawal of Pregnancy Declaration Form ......................................................... 105 Appendix 8.C ......................................................................................................... 107 Embryo/Fetal Dose Equivalent Record Form........................................................ 107 iv DOE G 441.1-1B 3-1-07 9.0 PORTABLE MONITORING INSTRUMENT CALIBRATION .................. 109 9.1 Implementation Guidance...................................................................... 110 9.2 Instrument Selection .............................................................................. 111 9.2.0 Type Testing .............................................................................. 111 9.2.1 Acceptance Testing.................................................................... 111 9.3 Instrument Calibration ........................................................................... 111 9.4 Operability Tests.................................................................................... 112 9.5 Maintenance........................................................................................... 112 9.6 Calibration Equipment/Calibration Quality........................................... 112 9.7 Laboratory Documentation .................................................................... 113

9.7.0 Laboratory Protocol ................................................................... 113 9.7.1 Laboratory Records.................................................................... 113 9.7.2 Instrument Calibration Records ................................................. 113 9.7.3 Instrument Location ................................................................... 113 9.8 Laboratory and Staff ............................................................................. 114 9.8.0 Laboratory.................................................................................. 114 98.1 Calibration Staff Qualifications ................................................ 114 9.8.2 Calibration Staff Training .......................................................... 115 9.9 Assessments .......................................................................................... 115 10.0 AIR MONITORING........................................................................................... 117 10.1 Implementation Guidance..................................................................... 117 10.2 Determining the Needs for Air Monitoring ........................................... 119 10.2.0 Exposure Assessment.................................................................. 119 10.2.0.0 Type and Frequency of Bioassay............................. 119 10.2.0.1 Estimation of Dose................................................... 120 10.2.1 Personnel Protection .................................................................. 121 10.2.1.0 Need for Posting .......................................................... 121 10.2.1.1 Effectiveness of Physical Design Features and Engineering Controls ................................................... 121 10.2.1.2 Proper Respiratory Protective Equipment ............... 122 10.2.2 Early Warning............................................................................ 122 10.3 Placement of Air Sampling and Real-Time Air Monitoring Equipment ................................................................................................................. 123 10.3.0 Locations of Release Points and Individuals ............................. 124 10.3.1 Purpose of Sample ..................................................................... 124 10.3.2 Room Air Flow Patterns ............................................................ 125 10.4.0 Breathing Zone Air Monitoring ................................................. 125 10.4.1 Source-Specific Air Sampling .................................................... 126 10.4.2 Grab Sampling ........................................................................... 126 10.4.3 Operability Checks..................................................................... 126 10.5 Real-Time Air Monitoring Equipment .................................................. 127 10.5.0 Instrument Selection .................................................................. 127 10.5.1 Alarm Set Points ........................................................................ 127 10.5.2 Alarm Capabilities ..................................................................... 127 10.5.3 Operability Checks..................................................................... 128 DOE G 441.1-1B v 3-1-07 10.6 Sample Analysis and Data Review....................................................... 128 10.7 Quality Control and Quality Assurance................................................ 129

10.7.0 Sample Identification, Handling, and Storage ........................... 129 10.7.1 Air Sampling and Real-Time Air Monitoring Equipment ......... 130 10.7.2 Counting Room Equipment ....................................................... 130 10.7.3 Audits......................................................................................... 131 10.7.4 Recordkeeping ........................................................................... 131 10.8 Administrative Controls........................................................................ 131 10.8.0 Technical Basis Document ........................................................ 131 10.8.1 Written Procedures..................................................................... 132 11.0 RADIOACTIVE CONTAMINATION CONTROL........................................ 133 11.1 Implementation Guidance...................................................................... 134 11.2 Contamination Control Program Management...................................... 135 11.3 Physical Design Features ...................................................................... 135 11.4 Administrative Control .......................................................................... 138 11.4.0 Work Authorizations.................................................................. 138 11.4.1 Access Control ........................................................................... 138 11.4.1.0 Entry Controls.......................................................... 138 11.4.1.1 Egress Controls ........................................................ 139 11.4.1.2 Posting and Labeling................................................ 141 11.4.2 Areas of Fixed Contamination ................................................... 141 11.4.3 Conduct of Radiological Work .................................................. 141 11.4.4 Personnel and Material Decontamination.................................. 142 11.4.4.0 Skin and Clothing Contamination............................ 142 11.4.4.1 Wound Contamination ............................................. 143 11.4.4.2 Material and Area Decontamination........................ 143 11.5 Contamination Monitoring ................................................................... 143 11.5.0 Contamination Control Values .................................................. 143 11.5.1 Monitoring ................................................................................. 145 11.5.2 Control of Material and Equipment ........................................... 147 11.5.3 Portal Monitors, Laundry Monitors, and Tool Monitors ........... 149 12.0 POSTING AND LABELING FOR RADIOLOGICAL CONTROL............. 151 12.1 Implementation Guidance...................................................................... 151 12.2 General.................................................................................................. 151 12.2.0 Design ........................................................................................ 152 12.2.1 Content....................................................................................... 153 12.2.2 Visibility .................................................................................... 154 12.2.3 Conditions .................................................................................. 155 12.2.4 Accessibility............................................................................... 155 12.2.5 Boundaries and Barriers............................................................. 156

12.3 Controlled Areas ................................................................................... 157 12.4 Posting for Control of Exposure to External Radiation ......................... 157 12.5 Posting for Control of Contamination................................................... 158 12.5.0 Removable and Airborne Radioactive Contamination .............. 158 12.5.1 Areas of Fixed Contamination ................................................... 159 vi DOE G 441.1-1B 3-1-07 12.6 Radioactive Material Posting................................................................. 159 12.7 Exceptions from Posting Requirements................................................ 161 12.8 Radioactive Material Labeling............................................................... 162 12.8.0 Radioactive Material Labeling................................................... 162 12.8.1 Exceptions from Labeling Requirements................................... 163 Appendix 12.A – Standard Radiation Warning Trefoil ......................................... 165 13.0 OCCUPATIONAL RADIATION PROTECTION RECORD- KEEPING AND REPORTING ......................................................................... 167 13.1 Implementation Guidance..................................................................... 167 13.2 Records to be Generated and Maintained .............................................. 168 13.2.0 Individual Monitoring and Dose Records.................................. 168 13.2.0.0 Internal Doses .......................................................... 169 13.2.0.1 External Doses ......................................................... 170 13.2.0.2 Summation of Internal and External Doses ............. 171 13.2.0.3 Lifetime Occupational Dose .................................... 171 13.2.0.4 Non-Uniform Exposure to the Skin ......................... 172 13.2.0.5 Planned Special Exposures (PSEs) .......................... 172 13.2.0.6 Doses Resulting from Emergency or Accidental Exposures................................................... 172 13.2.0.7 Records of Embryo/Fetus Dose and Declared Pregnant Workers........................................................................ 172 13.2.0.8 Individual Monitoring Program Records ................. 173 13.2.0.9 Equipment Capabilities............................................ 174 13.2.1 Monitoring and Workplace Records.......................................... 174 13.2.1.1 Work Authorizations................................................ 175 13.2.1.2 Area and Material/Equipment Monitoring Records 176 13.2.1.3 Airborne Radioactivity Monitoring Records ........... 177 13.2.1.4 Records of Releases of Materials and Equipment from Radiological Areas ........................... 178 13.2.2 Administrative Records ............................................................. 178 13.2.2.0 Radiation Safety Training ........................................ 179 13.2.2.1 ALARA Records...................................................... 180 13.2.2.2 Facility Design ......................................................... 181 13.2.2.3 Entry and Access Control Records .......................... 181 13.2.2.4 Sealed Radioactive Sources ..................................... 182 13.2.2.5 Radiation Protection Program,

Policies and Procedures .............................................. 182 13.2.2.6 Audits and Programmatic Reviews.......................... 183 13.2.2.7 Posting and Labeling................................................ 183 13.2.2.8 Calibration, Functional Tests, and Maintenance Records ........................................................................ 183 13.3 Reports .................................................................................................. 184 13.3.0 Reports to Individuals ................................................................ 184 DOE G 441.1-1B vii (and viii) 3-1-07 13.3.0.0 Records Requested by Monitored Individuals......... 184 13.3.0.1 Termination Dose Reports ....................................... 185 13.3.0.2 Reports to DOE........................................................ 185 13.3.1 Reports of Planned Special Exposures ...................................... 185 13.4 Privacy Act Considerations................................................................... 186 13.4.0 Informing Individuals ................................................................ 186 13.4.1 Identifying Individuals............................................................... 186 13.4.2 Requesting Correction or Amendment of a Record................... 187 13.4.3 Responding to Requests............................................................. 187 13.4.4 Accounting for Disclosures........................................................ 187 13.5 Record – Keeping Standards................................................................. 187 14.0 RADIATION SAFETY TRAINING................................................................. 189 14.1 Implementation Guidance..................................................................... 189 14.1.0 General Information................................................................... 189 14.2 Determination of Required Training....................................................... 190 14.3 Training Course Content..................................................................... 192 14.4 Facility-Specific Materials.................................................................. 193 14.5 Conduct of Radiation Safety Training ................................................ 194 14.6 Completion of Radiation Safety Training........................................... 195 14.7 Periodic Radiation Safety Training..................................................... 196 14.8 Use of Escorts in Lieu of Training.......................................................... 197 14.9 Refresher Training ................................................................................. 198 14.10 Other Training Programs ....................................................................... 198 14.11 Training Effectiveness Evaluations ....................................................... 198 15.0 SEALED RADIOACTIVE SOURCE ACCOUNTABILITY AND CONTROL................................................................................................. 199 15.1 Implementation Guidance...................................................................... 199 15.2 Organization and Responsibilities ......................................................... 200 15.3 Receipt ................................................................................................... 201 15.4 Labeling and Storage ............................................................................. 201 15.5 Inventory ................................................................................................ 203 15.6 Leak Testing........................................................................................... 204 15.7 Handling and Disposal........................................................................... 206 Appendix 15.A Example Individual Accountable Sealed

Radioactive Source Form........................................................................ 209 Appendix 15.B – Example Sealed Radioactive Source Accountability Form....... 210 DOE G 441.1-1B 1 3-1-07 RADIATION PROTECTION PROGRAMS 1.0 PURPOSE AND APPLICABILITY In 1999 the U.S. Department of Energy (DOE) published a set of 13 Implementation Guides for use with Title 10, Code of Federal Regulations (CFR), Part 835, Occupational Radiation Protection (DOE 1998a), hereinafter referred to as 10 CFR 835. That series of guides discussed acceptable methods for ensuring that the functional elements of radiological activities will be managed and administered in accordance with 10 CFR 835. As part of DOE’s efforts to consolidate redundant requirements and guidance, this Guide is a compilation of the guidance provided in the set of 13 Implementation Guides and continues to provide cross-references to other Guides, DOE-STD-1098-99, RADIOLOGICAL CONTROL (DOE 1999a), hereinafter referred to as the RCS, DOE directives, and industry consensus standards that provide detailed guidance for implementing specific requirements in 10 CFR 835. Accordingly, this Guide cancels and supersedes the following guides: • DOE G 441.1-1A, Management and Administration of Radiation Protection Programs Guide, dated 10-20-03 • DOE G 441.1-2, Occupational ALARA Program Guide, dated 3-17-99 • DOE G 441.1-3A, Internal Dosimetry Program Guide, dated 6-11-05 • DOE G 441.1-4A, External Dosimetry Program Guide, dated 6-11-05 • DOE G 441.1-5, Radiation-Generating Devices Guide, dated 4-15-99 • DOE G 441.1-6, Evaluation and Control of Radiation Dose to the Embryo/Fetus Guide, dated 4-29-99 • DOE G 441.1-7, Portable Monitoring Instrument Calibration Guide, dated 6-17-99 • DOE G 441.1-8, Air Monitoring Guide, dated 3-17-99 • DOE G 441.1-9, Radioactive Contamination Control Guide, 6-17-99 • DOE G 441.1-10, Posting and Labeling for Radiological Control Guide, dated 5-24-99 • DOE G 441.1-11, Occupational Radiation Protection Record-Keeping and Reporting Guide, dated 5-20-99 • DOE G 441.1-12, Radiation Safety Training Guide, dated 3-17-99 • DOE G 441.1-13, Radioactive Sealed Source Accountability Guide, dated 4-15-99 2 DOE G 441.1-1B 3-1-07 This Guide provides guidance with respect to implementing the provisions of all the functional areas contained in 10 CFR 835. These are listed in Chapter 3 of this Guide. Specific regulatory citations are provided in the body of the Guide. This Guide amplifies the regulatory requirements of 10 CFR 835 and provides explanations and examples of the basic requirements for implementing the requirements of 10 CFR 835. The requirements of 10 CFR 835 are enforceable under the provisions of Sections 223(c) and 234A of the Atomic Energy Act of 1954, as amended (AEC 1954). This Guide was developed consistent with DOE M 251.1-1B, Departmental Directives Program Manual, (DOE 2006a) which states that guides: (1) Provide preferred, nonmandatory, supplemental information about acceptable methods for implementing requirements, including lessons learned, suggested practices, instructions, and suggested performance measures; (2) Do not impose requirements but may quote requirements if the sources are adequately cited; and (3) Provide alternate methods that may be used if it can be demonstrated that they provide an equivalent or better level of performance.

Except for requirements established by a regulation, contract, or administrative means, the provisions in this Guide are DOE's views on acceptable methods of program implementation and are not mandatory. Conformance with this Guide will, however, create an inference of compliance with the related regulatory requirements. Alternate methods that are demonstrated to provide an equivalent or better level of protection are acceptable. DOE encourages its contractors to go beyond the minimum regulatory requirements and to pursue excellence in their programs. The word "shall" is used in this Guide in reference to requirements from 10 CFR 835. Compliance with 10 CFR 835 is mandatory except to the extent an exemption has been granted pursuant to 10 CFR 820, Procedural Rules for DOE Nuclear Activities (DOE 1997a). The words "should" and "may" are used to denote optional program recommendations and allowable alternatives, respectively. This Guide may be used by all DOE activities that are subject to the requirements of 10 CFR 835. The Administrator of the National Nuclear Security Administration (NNSA) will assure that NNSA employees and contractors comply with their respective responsibilities under this Guide. 1.1 USE OF CONSENSUS STANDARDS As discussed in the Department of Energy's Radiological Health and Safety Policy DOE P 441.1, (DOE 1996), DOE has established a system of regulatory policy and guidance reflective of national and international radiation protection standards and recommendations. Consistent with this policy, this Guide endorses the use of several national and international recommendations and standards, including several from the International Commission on Radiological Protection, the National Council on Radiation Protection and Measurements, the American National Standards Institute. In regards to national consensus standards, to the extent possible, this guidance document endorses and DOE G 441.1-1B 3 3-1-07 is written to be consistent with following non-governmental national consensus standard standards for radiation protection: • ANSI N13.3, Dosimetry for Criticality Accidents • ANSI N43.3-1993, General Radiation Safety -Installations Using Non-Medical X-Ray and Sealed Gamma-Ray Sources, Energies up to 10 MeV • ANSI N323A-1997, American National Standard Radiation Protection Instrumentation Test and Calibration, Portable Survey Instruments • ANSI N13.5-R1989, American National Standard Performance Specifications for Direct Reading and Indirect Reading Pocket Dosimeters • ANSI N42.17A-1989, Performance Specifications for Health Physics Instrumentation - Portable Instrumentation for Use in Normal Environmental Conditions • ANSI N42.17C-1989, Performance Specifications for Health Physics Instrumentation - Portable Instrumentation for Use in Extreme Environmental Conditions • ANSI N42.17B, Performance Specifications for Health Physics Instrumentation - Occupational Airborne Radioactivity Monitoring Instrumentation • ANSI N2.1-1971(R1989), Radiation Symbol • ANSI N13.27, Performance Specifications for Pocket-sized Alarming Dosimeter/Ratemeters • ANSI Z88.2-1992, Practices for Respiratory Protection • ANSI/HPS N13.30-1996, Performance Criteria for Radiobioassay • ANSI/HPS N13.41-1997, Criteria for Performing Multiple Dosimetry • ANSI/HPS N43.6-1997, Sealed Radioactive Sources Classification • ANSI /HPS N13.6-1999, Practice for Occupational Radiation Exposure Records Systems

• ANSI/HPS N43.2-2001, Radiation Safety for X-Ray Diffraction and Fluorescence Analysis Equipment • ANSI/HPS N13.49-2001, Performance and Documentation of Radiological Surveys 4 DOE G 441.1-1B 3-1-07 • ANSI/HPS N43.5-2005, Radiological Safety Standard for the Design of Radiographic and Fluoroscopic Industrial X-Ray Equipment • ANSI/NCSL Z540-1-1994, American National Standard for Calibration - Calibration Laboratories and Measuring and Test Equipment -General Requirements • ANSI N322, American National Standard Inspection, Test, Construction, and Performance Requirements for Direct Reading Electrostatic/Electroscope Type Dosimeters • ANSI N320, American National Standard Performance Specifications for Reactor Emergency Radiological Monitoring Instrumentation 1.2 ACRONYMS AEC U.S. Atomic Energy Commission ALARA Low As Is Reasonably Achievable AL Annual Limit on Intake ANS American Nuclear Society ANSI American National Standards Institute BEIR Biological Effects of Ionizing Radiations BRH Bureau of Radiological Health BZ Breathing Zone CAM Continuous Air Monitor CEDE Committed Effective Dose Equivalent CFR Code of Federal Regulations CSO Cognizant Secretarial Officer CTEDE Cumulative Total Effective Dose Equivalent DAC Derived Air Concentration DIL Derived Investigation Level DL Decision Level DOE Department of Energy DOE G DOE Guide DOE O DOE Order DOE P DOE Policy DOELAP Department of Energy Laboratory Accreditation Program DOE-STD DOE Standard DPM Disintegrations per Minute EPA Environmental Protection Agency FOIA Freedom of Information Act DOE G 441.1-1B 5 (and 6) 3-1-07 FR Federal Register GERT General Employee Radiological Training HEPA High Efficiency Particulate Air (filter) HPS Health Physics Society ICRP International Commission on Radiological Protection ICRU International Commission on Radiation Units and Measurements IL Investigation Level ISO International Organization for Standardization MDA Minimum Detectable Amount/Activity NCRP National Council on Radiation Protection and Measurements NCSL National Conference of Standards Laboratories NIST National Institute of Standards and Technologies NRC Nuclear Regulatory Commission PNL Pacific Northwest Laboratory PSE Planned Special Exposure PSO Program Secretarial Office RCO Radiological Control Organization RCS DOE-STD-1098-99, RADIOLOGICAL CONTROL RCT Radiological Control Technician RGD Radiation-Generating Device RMA Radioactive Material Area RPP Radiation Protection Program RWP Radiological Work Permit RWT Radiological Worker Training SLAC Stanford Linear Accelerator Center TEDE Total Effective Dose Equivalent TLD Thermo Luminescent Dosimeter TWD Technical Work Document UNSCEAR United Nations Scientific Committee on the Effects of Atomic Radiation USLW United States Law Week DOE G 441.1-1B 7 3-1-07 2.0 DEFINITIONS Acceptance testing: Evaluation or measurement of performance characteristics to verify that certain stated specifications and contractual requirements are met. Air monitoring: Actions to detect and quantify airborne radiological conditions by the collection of an air sample and the subsequent analysis, either in real-time or offline laboratory analysis, of the amount and type of radioactive material present in the atmosphere. Air sampling: A form of air monitoring in which an air sample is collected and analyzed at a later time, sometimes referred to as retrospective air monitoring.

ALARA committee: The multi-disciplined forum that reviews and advises management on improving progress towards minimizing radiation dose and radiological releases. ALARA design review: A systematic review to ensure that ALARA considerations are evaluated, incorporated if reasonable, and documented for the design of new facilities and modifications to existing facilities that involve the potential for exposure to ionizing radiation. ALARA job/task/experiment review: A systematic pre- and post-job review of high-dose and potentially high-dose activities to ensure that ALARA controls are planned, evaluated, implemented where reasonable, and documented. Alarm set point: The count rate or concentration at which a real-time air monitor will alarm, usually set to correspond to a specific airborne radioactive material concentration averaged over time (e.g., DAC-hour alarm equivalent) by calculating the sample buildup rate on the collection medium. Alpha (α): The probability (not to be confused with an alpha particle) of a Type I error or false positive. Also called the false positive probability. Analyte: The particular radionuclide to be determined in a sample of interest. Baseline bioassay: An appropriate bioassay measurement obtained from a radiobioassay program participant prior to beginning or resuming work with radioactive material. Beta (β): The probability (not to be confused with a beta particle) of a Type II error or false negative. Also called the non-detection probability. Boundary identifier: A hazard identifier that is used to define the boundary of an area. Boundary: The line that defines the transition from one specified area to another. Breathing zone air monitoring: A form of air monitoring that is used to detect and quantify the radiological conditions of air from the general volume of air breathed by the individual, usually at a height of 1 to 2 meters. See "personal air monitoring." 8 DOE G 441.1-1B 3-1-07 Cabinet X-ray system: An X-ray system with the X-ray tube installed in an enclosure (hereinafter termed "cabinet") which, independently of existing architectural structures except the floor on which it may be placed, is intended to contain at least that portion of a material being irradiated, provide radiation attenuation, and exclude individuals from its interior during generation of X-radiation. Included are all the X-ray systems designed primarily for inspection of carry-on baggage at airline, railroad, and bus terminals, and in similar facilities. An X-ray tube used within a shielded part of a building or X-ray equipment which may temporarily or occasionally incorporate portable shielding is not considered a cabinet X-ray system. Challenge examination: An examination administered to ascertain the knowledge of a worker with respect to radiation safety and provide an exception to the required training. Check source: A radioactive source, not necessarily calibrated, that is used to confirm the continuing satisfactory operation of an instrument. Confirmed intake: An intake confirmed by follow-up radiobioassay, by association with a known incident, or by investigation. Contaminated area: Any area meeting the definition of “contamination area,” “high contamination area,” or “airborne radioactivity area” provided in 10 CFR 835.2(a). Continuous air monitor (CAM): An instrument that continuously samples and measures the levels of airborne radioactive material on a "real-time" basis and has alarm capabilities at preset alarm set points.

Decision level (Lc): The amount of a count (Lc or L′c) as final instrument measurement of a quantity of analyte (Dc or D′c) at or above which a decision is made that the analyte is definitely present. Derived investigation level (DIL): A value of a radiobioassay or air monitoring measurement that indicates an intake resulting in a dose exceeding an Investigation Level (IL). Detector: A device or component designed to produce a quantifiable response to ionizing radiation, normally measured electronically. Direct (in vivo) radiobioassay: The measurement of radioactive material in the human body utilizing instrumentation that detects radiation emitted from the radioactive material in the body. DOELAP: The Department of Energy Laboratory Accreditation Program. This program defines a set of reference performance tests and provides a description of the minimum levels of acceptable performance for personnel dosimetry systems and radiobioassay programs under either DOE STD-1111-98, THE DEPARTMENT OF ENERGY LABORATORY ACCREDITATION PROGRAM ADMINISTRATION (DOE 1998b), or DOE G 441.1-1B 9 3-1-07 DOE STD-1112-98, THE DEPARTMENT OF ENERGY LABORATORY ACCREDITATION PROGRAM FOR RADIOBIOASSAY (DOE 1998c). Dose assessment: The process of determining radiological dose and uncertainty included in the dose estimate, through the use of exposure scenarios, bioassay results, monitoring data, source term information, and pathway analysis. Elimination: The biological removal of a radionuclide from the body by excretion, perspiration, exhalation, secretion (e.g., breast milk), exfoliation (sloughing of dead tissue), or excision. Embryo/fetus: A developing human organism from conception until birth. Escort: An individual with the prerequisite training necessary for unescorted access to the area(s) where the escort activities will be performed and who is authorized to accompany and ensure the safety of individuals who lack such training. Evaluation: The process of arriving at a value for intake or dose that uses, among other inputs, measurement results. Excretion: The biological removal of a radionuclide from the body via one or more excretion pathways: urine and feces. Exempt sealed radioactive source: A sealed radioactive source that does not meet the accountability criteria established in the definition of the term “accountable sealed radioactive source” provided in 10 CFR 835.2(a). Exposure: The general condition of being subjected to ionizing radiation, such as by proximity to external sources of ionizing radiation or through intake of radioactive material into the body. In this document, exposure does not refer to the radiological physics concept of charge liberated per unit mass of air. False negative: A Type II (β) error, that is, concluding that analyte is not present when in fact it is. False positive: A Type I (α) error, that is, concluding that there is analyte present when it is not. Fixed contamination: Radioactive material that cannot be readily removed from surfaces by nondestructive means, such as casual contact, wiping, or brushing. Fixed-location sampler: An air sampler located at a fixed location in the workplace. Frisk or frisking: Process of monitoring individuals or surfaces for contamination by directly scanning the surface with a suitable radiation detector. 10 DOE G 441.1-1B 3-1-07 Functional tests: Tests (often qualitative) to determine that an instrument is operational and capable of performing its intended function. Such tests may include, for example, battery check, zero setting, or source response checks.

Geotropism: A change in an instrument's reading as its orientation changes, due to gravitational effects. Gestation period: The time from conception to birth; usually 40 weeks or approximately 9 months. Grab sampling: A single sample removed from the air over a short time interval, typically a few minutes for high volume air samplers and less than one hour for low volume air samplers. Hot particles: Small, discrete, highly radioactive particles that can cause extremely high dose rates to a localized area. Indirect (in vitro) radiobioassay: The measurement or analysis of radionuclides in excreta or other biological samples removed from the body. Instrument (radiation detection): A complete system consisting of one or more subassemblies (e.g., detector, readout, etc.) designed to quantify one or more characteristics of ionizing radiation or radioactive material. Intake: The amount of radionuclide taken into the body by inhalation, absorption through intact skin, injection, ingestion, or through wounds. Depending on the radionuclide involved, intakes may be reported in mass (e.g., μg, mg), activity (e.g., μCi, Bq), or potential alpha energy (e.g., MeV, J) units. Interlock: A device for precluding access to an area of radiation hazard by either preventing entry or by automatically removing the hazard. One example is an electro-mechanical control mechanism that interrupts the beam of ionizing radiation or shuts down the radiation installation whenever the interlock is challenged. Internal audits: Reviews and evaluations of the content and implementation of the documented radiation protection program conducted by an organization neither responsible nor accountable for developing program content or implementing the program. Investigation level (IL): The value of the committed effective dose equivalent from an intake(s) of a radioactive material by a worker at or above which, for regulatory purposes, is regarded as sufficiently important to justify further investigation Irradiator: Any gamma- or neutron-emitting sealed radioactive material that has the potential to create a radiation level exceeding 500 rads (5 grays) in 1 hour at 1 meter and is operated within the requirements of an RGD installation. DOE G 441.1-1B 11 3-1-07 Minimum detectable amount (MDA): The smallest amount (activity or mass) of an analyte in a sample that will be detected with a probability, β, of non-detection (Type II error) while accepting a probability, α, of erroneously deciding that a positive (non-zero) quantity of analyte is present in an appropriate blank sample (Type I error). The MDA is computed using the same value of α as used for the Lc. The MDA depends on both α and β. Measurement results are compared to the Lc, not the MDA; the MDA is used to determine whether a program has adequate detection capability. The MDA will be greater than or equal to the Lc. Modification: Any alteration of the shielding configuration, device or installation operating practices, or the replacement of the original RGD (or component part thereof) with another that has not been previously evaluated, inspected, monitored, and documented by the radiological control organization. This definition also includes the collocation of additional or multiple unevaluated RGDs within a previously evaluated installation. Normal operation: Operation under conditions as recommended by the manufacturer of the RGD with recommended shielding and barriers in place, and as specified in the operating procedures and requirements for the RGD installation.

Occupied (occupiable) area: An area or location that may be physically accessible by individuals (or body parts thereof) while a radiation-generating device is in operation. Off-normal operation: An event or condition that adversely affects, potentially affects, or indicates degradation in the safety, security, environmental, or health-protection performance or operation of an RGD installation. Optimization methodology: A documented methodology which describes how the factors affecting a protection decision, i.e., social, technical, economic, practical, and public policy, are assigned values to compare detriment and benefits. Performance demonstration: A demonstration by a student of the skills required to perform certain designated activities. Performance tests: Tests performed periodically over the life of an instrument to verify that it continues to meet operational requirements. Examples of performance tests are response time and geotropism. Personal air monitoring: A form of breathing zone air monitoring that involves the sampling of air in the immediate vicinity (typically within one foot) of an individual’s nose and mouth, usually by a portable sampling pump and collection tube (e.g., a lapel sampler) worn on the body. Physical barrier: A bounding physical obstruction that prevents unimpeded access to an area. Portable air sampler: An air sampler designed to be moved from area to area. 12 DOE G 441.1-1B 3-1-07 Portable monitoring instrument: An instrument intended to be operated while being carried by an individual. Qualified expert: An individual having the knowledge, training, and recognition of such by management to measure ionizing radiation, to evaluate safety techniques, to design RGD installations, and to provide advice on radiation protection requirements. Radiation protection program (RPP): The documented program, approved by DOE, including, but not limited to, the plans, schedules, and other measures developed and implemented to achieve and ensure continuing compliance with 10 CFR 835 and to apply the as low as is reasonably achievable (ALARA) process to occupational dose. Radiation-generating device (RGD): Collective term for devices which produce ionizing radiation, including, certain sealed radioactive sources, small particle accelerators used for single purpose applications which produce ionizing radiation (e.g., radiography), and electron generating devices that produce X-rays incidentally. Radiography: Examination of the structure of materials by nondestructive methods, using a RGD. Radiological control organization (RCO): An organization responsible for radiation protection activities. Radiological engineer: An individual who is responsible for providing technical support and assistance to supervisors, planners, schedulers, principal investigators, and design engineers to reduce occupational doses and the spread of radioactive materials. Radiological work permit (RWP): The document that identifies radiological conditions, establishes worker protection and monitoring requirements, and contains specific approvals for radiological work activities. The RWP serves as an administrative process for planning and controlling radiological work and informing the worker of the radiological conditions. Radon: Unless otherwise specified, the isotope 222Rn. Real time air monitor: An instrument that measures the levels of airborne radioactive material on a "real-time" basis.

Refresher training: Periodic (usually annual) training that provides current information on changes to radiation protection policies and procedures or changes in facility conditions, or to promote awareness of infrequently encountered radiological safety matters. Removable contamination: Radioactive material that can be removed from surfaces by nondestructive means, such as casual contact, wiping, or brushing. Representative air sampling: The sampling of airborne radioactive material in a manner such that the sample collected closely approximates both the amount of activity DOE G 441.1-1B 13 3-1-07 and the physical and chemical properties (e.g., particle size and solubility) of the contaminant to which the individuals may be exposed. Retention: The amount of material which, after being taken into the body by inhalation, ingestion, entry through an open wound, or absorption through the skin, exists in the whole body, a compartment, an organ, or a tissue at a specified time. RGD Custodian: An individual who is trained and designated to maintain cognizance over accountability control of radiation-generating devices assigned to him or her. RGD installation: The sum of the radiation source (e.g., sealed radioactive material or x-ray tube), the associated equipment and component items, and the space in which they are operated. Five types of installations are defined as follows: (1) Shielded installations are those designed to use the room-within-a-room concept to limit access to the RGD beam and to place more emphasis on distance as opposed to shielding for radiation protection and include shielded, exempt shielded, and cabinet x-ray installations; (2) Unattended installations are those designed for a specific purpose and that do not require personnel in attendance for operation and include unattended gauge and other unattended installations; (3) Open installations are those designed to accommodate a specimen that is so large as to make an exempt shielded installation impractical; (4) X-ray diffraction & fluorescence analysis equipment, including both open and closed beam installations; and (5) Incidental, including devices that emit low levels of ionizing radiation as a byproduct of their normal function, such as electron beam welders, electronic microscopes, and pulse generators. RGD Operator: An individual who is trained and deemed qualified to use a radiation-generating device. Routine radiobioassay monitoring: Any radiobioassay measurement made on a predetermined, periodic schedule, to establish whether a worker has had any intake of radioactive material since previous radiobioassay measurements. Source custodian: An individual who is trained and designated to maintain cognizance over accountability and control of assigned sealed radioactive sources. Source response check: A functional test that includes the observation of the response of an instrument to a check source. 14 DOE G 441.1-1B 3-1-07 Source user: An individual who is trained and authorized to use sealed radioactive sources. Source-specific air sampling: Collection of an air sample near an actual or likely release point. Special radiobioassay monitoring: Any radiobioassay measurement that is required for confirmation of a suspected intake of radionuclides, or is required for follow-up evaluation of confirmed intakes. State-of-the-art: The most advanced technology that is commercially available and successfully field tested.

Technical work document (TWD): A term used to generically identify formally approved documents that direct work, such as procedures, work packages, or job or research plans. TWDs provide radiological and ALARA controls applicable to the task. Technology shortfall: A technology shortfall for routine radiobioassay exists when the derived investigation level (DIL) for a well-designed and appropriate routine radiobioassay program, using current or state-of-the-art methods and equipment, is less than the minimum detectable amount/activity of the routine monitoring method (e.g., the DIL is less than the MDA). Termination radiobioassay: A radiobioassay measurement performed for the purpose of documenting the retention of radioactive materials in the body due to occupational exposure either upon termination of employment or upon the cessation of potential exposure to a specific nuclide. Test: A procedure whereby an instrument, component, or circuit is evaluated against certain criteria for satisfactory operation. Thoron: Unless otherwise specified, the isotope 220Rn. Traceability: The ability to show, through documentation, that a particular instrument or radiation source has been calibrated using either the national standard or a transfer standard in a chain or echelon of calibrations, ultimately leading to a comparison with the national standard. Type test: An initial test of one or more production instruments made to a specific design to show that the design meets certain specifications. Type I error: Incorrectly concluding from a result that there is analyte present; the probability (α) of a Type I error is usually taken as 0.05. The decision level is determined on the basis of an acceptable level of Type I errors. Type II error: Incorrectly concluding from a result that there is no analyte present; its probability (β) is usually taken as 0.05. DOE G 441.1-1B 15 (and 16) 3-1-07 Uniform exposure: Hypothetical radiation field in which the fluence and its angular and energy distributions are the same throughout the volume of interest. Useful beam: That part of the primary and secondary radiation beam that passes through the aperture, cone, or other device used for collimation. DOE G 441.1-1B 17 3-1-07 3.0 RADIATION PROTECTION PROGRAMS 10 CFR 835 establishes specific requirements for the development, content, revision, and approval of the documented RPP for a DOE activity. These requirements include identifying existing and/or anticipated operational tasks and formal plans and measures for maintaining occupational radiation doses ALARA. Guidance provided in this Guide, in combination with the provisions of site radiological control manuals developed and implemented consistent with guidance provided by the RCS for those regulatory provisions not addressed by the this Guide, provide reasonable assurance that a site RPP will meet the requirements of 10 CFR 835. The RPP for a specific DOE activity is approved by the cognizant DOE Headquarters Program Office. The RPP is intended to provide DOE reasonable assurance that the DOE activity will be conducted in compliance with the provisions of 10 CFR 835. The RPP also satisfies the requirement for an Implementation Plan found in other DOE directives. Guidance concerning the specific documentation required for DOE approval of RPPs as required in 10 CFR 835.101(f), (g), and (h) is provided in Appendix 3.A, PREPARATION, REVIEW AND APPROVAL OF RADIATION PROTECTION PROGRAMS. Appendix 3.A is based on guidance which previously was provided in DOE-STD-1082-94, PREPARATION, REVIEW, AND APPROVAL OF IMPLEMENTATION PLANS FOR NUCLEAR SAFETY REQUIREMENTS. Guidance is also provided by the cognizant DOE Headquarters Program Office.

Program Offices will also provide guidance should DOE need to direct or make modifications to an RPP as provided under 10 CFR 835.101(b). 10 CFR 835 permits changes, additions, or updates to an RPP to become effective without prior DOE approval only if the changes do not decrease the effectiveness of the RPP and the RPP, as changed, continues to meet the requirements of the rule. Proposed changes that decrease the effectiveness of the RPP shall not be implemented without submittal to and approval by DOE [10 CFR 835.101(h)]. Guidance regarding the process for submitting and approving changes will be provided by the appropriate DOE Headquarters Program Office. The RPP is the basis for implementing operational radiation protection program requirements for a DOE activity. A combination of various methods which can be used to achieve regulatory compliance is discussed in this Guide. DOE recognizes that many of the requirements of 10 CFR 835 are not new. Equivalent requirements were previously promulgated in DOE Orders and the DOE Radiological Control Manual, which were implemented under contractual obligations for most DOE activities. Therefore, much of the RPP documentation required to ensure compliance with 10 CFR 835 has already been developed to ensure compliance with contractually-imposed radiation protection standards. DOE recognizes that significant effort was expended in upgrading radiation protection of the work force and does not intend for its contractors to expend significant additional effort to develop and implement a separate, redundant program to satisfy the RPP requirements of 10 CFR 835. The RPP should rely on existing documents, such as the site radiological control manual, contractual agreements, procedures, and memoranda, to effectively administer and 18 DOE G 441.1-1B 3-1-07 manage regulatory commitments. However, the completeness of these existing documents should be verified to ensure that all 10 CFR 835 requirements are satisfied. This chapter of this Guide provides guidance on the management and administrative aspects of the RPP to achieve and maintain compliance with specific requirements in 10 CFR 835. Internal audits of the radiation protection program, including examination of program content and implementation, shall be conducted through a process that ensures that all functional elements of the program are reviewed no less frequently than every 36 months (10 CFR 835.102). This Guide discusses the role of an internal audit program in effectively managing and administering an RPP that complies with 10 CFR 835. These internal audits may also be incorporated into quality assurance programs developed under 10 CFR 830 Subpart A, Quality Assurance Requirements (DOE 2001a) and/or DOE Order 414.1C, Quality Assurance (DOE 2005a). Functional elements of a comprehensive RPP are identified and discussed throughout Section 3.2 of this Guide. The specific functional elements for a DOE activity will depend upon the types of radiological work being performed and the radiological hazards present. Other functional elements necessary for an integrated worker health and safety program are not addressed in this Guide, but should be integrated with a radiological control program. These other functional elements include: respiratory protection, radioactive material shipment and receipt, radioactive waste management, and emergency response. 3.1 Implementation Guidance

The approved RPP details how a DOE activity shall be in compliance with 10 CFR 835 and should identify the functional elements appropriate for that activity. Additional documentation should be developed and maintained to supplement the approved RPP to demonstrate that an RPP can be effectively managed and administered to achieve compliance with 10 CFR 835. This documentation typically includes a site radiological control manual developed to the guidance contained in the RCS, as well as detailed implementing procedures, appropriate management policy statements, and technical basis documentation. While this documentation need not be part of the RPP, it should be clearly linked to the compliance commitments contained in the RPP. DOE has developed technical guidance to support effective implementation of programs to ensure compliance with 10 CFR 835. The RCS was developed to provide detailed guidance on and best practices for line management implementation of DOE's radiation protection requirements. DOE has also developed a set of technical standards and handbooks addressing radiation protection issues, such as training, internal dosimetry, or plutonium operations. Additionally, DOE has developed a set of Radiological Control Technical Positions (RCTPs). The RCTPs provide acceptable approaches to implementing specific provisions, or otherwise address specific issues, of the Rule (available at http://www.hss.energy.gov/radiation). In addition, this Guide provides acceptable methods for achieving compliance with a variety of technical and administrative requirements. DOE G 441.1-1B 19 3-1-07 RPP changes may be implemented without prior DOE approval only if the RPP continues to meet 10 CFR 835 requirements and the changes do not reduce program effectiveness [10 CFR 835.101(h)]. Due to the wide range of activities subject to 10 CFR 835 and the variety of methods used by these activities to ensure compliance, no specific criteria exist by which DOE may predetermine whether an RPP change results in a reduction in program effectiveness. Factors that should be considered include the impact of the proposed change(s) on: • radiological conditions in occupied areas; • individual and collective doses; • worker awareness of radiological conditions and controls; • management oversight and control of routine and non-routine radiological work activities; • sufficiency of area and personnel monitoring programs; • completeness and irretrievability of records; • radiological control performance indicators; • adherence to consensus standards; and • other factors that ensure full implementation of the RPP. Documentation of the rationale applied to RPP changes implemented without prior DOE approval should be retained for future reference and demonstration of compliance. The terms "likely" and "potential" have been used judiciously throughout the rule to allow the use of professional judgment and experience in making decisions in specific circumstances and provide the flexibility necessary to implement the regulatory requirements under a broad range of activities. The technical bases and other considerations should be documented when professional judgment is exercised. This documentation should provide sufficient detail to permit individuals who are responsible for implementing and assessing the RPP to clearly understand how regulatory compliance is achieved and maintained. The RCS, Guides, and other DOE technical standards and handbooks are designed to facilitate development and implementation of a comprehensive RPP commensurate with the radiological hazards associated with the DOE activity. In addition, consensus standards, such as those developed by the American National Standards Institute (ANSI) and the Health Physics Society (HPS), may provide additional guidance concerning technical issues not specifically addressed by the Guides, RCS, DOE technical standards, or other DOE guidance documents.

20 DOE G 441.1-1B 3-1-07 3.2 Organization and Administration The RPP shall include plans, schedules, and other measures for achieving compliance with 10 CFR 835 [10 CFR 835.101(f)]. Plans should include establishing the organization and administration of the RPP to ensure that the program is effectively implementing appropriate measures that ensure regulatory compliance can be achieved and sustained. The authority and responsibility for radiation protection should originate at the highest levels of line management and should be emphasized throughout the organization. Ultimately, workers should be aware of their individual responsibilities for radiation protection. Programmatic documentation should be developed to document the organizational and administrative aspects of the RPP. 3.2.0 Administrative Processes The degree of formality and scope of the associated administrative processes should be commensurate with the radiological hazards encountered and complexity of the associated control measures. More rigorous administrative processes should be implemented for more complex or hazardous DOE activities. Administrative processes should include a hierarchy of documents that clearly and unambiguously delineate management policies, requirements, expectations, and objectives for the RPP. This documentation should typically include the following: • Policy statement: The policy statement should articulate management’s commitment to conduct radiological operations in a manner that will ensure the health and safety of all its employees, contractors, and the general public. This policy statement should be patterned after DOE P 441.1, Department of Energy Radiological Health and Safety Policy. • Site-specific radiological control manual or handbook: This document should be issued and endorsed by senior management for a DOE activity. This manual or handbook should address all functional elements of the RPP for the DOE activity. • Procedures: These documents should provide detailed instructions for implementing various functional elements of the RPP. Responsibilities and actions required of management and workers should be clearly and unambiguously stated. Written procedures shall be developed and implemented as necessary to ensure compliance with 10 CFR 835, commensurate with the radiological hazards created by the activity and consistent with the education, training, and skills of the individuals exposed to those hazards (10 CFR 835.104). It is not necessary for written procedures to be developed and implemented for all of the requirements of 10 CFR 835. Written procedures should be developed and employed under the following circumstances: – Worker health and safety are directly affected; DOE G 441.1-1B 21 3-1-07 – the expected outcome for the process or operation requires that a specific method be followed; – the process or operation is infrequently used and competence training cannot assure adequate implementation; or – to document the approved method to implement specific processes or operations. In evaluating the need for written procedures, consideration shall be given to the level and extent of the radiological hazards, the complexity of the measures required to achieve compliance, and the education, training and skills of the individuals who must implement those measures (10 CFR 835.104). Under such a regimen, a low hazard activity employing a stable staff of highly educated and skilled workers having demonstrated an advanced knowledge of radiation protection principles and practices could have fewer and less detailed procedures than a higher hazard activity employing a transient workforce with less knowledge of radiation protection practices and principles. This Guide provides additional guidance regarding specific procedural aspects of the RPP.

• Technical basis documents: Document decisions and approaches used to achieve regulatory compliance, such as those decisions where professional judgment has been exercised. The document should include supporting analyses and justifications sufficient to demonstrate that regulatory compliance can be achieved and maintained. This Guide contains specific recommendations for documenting the technical basis for various RPP functional elements. 10 CFR 835 specifies the frequency for performing certain activities. Internal audits shall be conducted on a 36 month cycle (10 CFR 835.102); radiation safety training shall be conducted every twenty four months [10 CFR 835.901(e)]; and accountable sealed radioactive sources shall be inventoried and leak tested every six months [10 CFR 835.1202(a) and (b)]. DOE expects that those entities responsible for ensuring compliance with the rule will undertake those measures necessary to perform the required activities within the prescribed time frame (e.g., if a sealed radioactive source is leak tested on January 15, DOE would expect the subsequent leak test to be performed on or before July 15 of the same year). 10 CFR 835.3(e) allows a grace period of up to 30 days when operational or scheduling considerations preclude adherence to the required schedule (e.g., the leak test could be performed no later than August 14 of the same year). If the provisions of 10 CFR 835.3(e) are exercised, documentation of the schedule deviation should be developed and include a discussion of the specific activity involved and the reason for the schedule deviation. Schedule extensions beyond the 30 day grace period can only be granted through the regulatory exemption process under 10 CFR 820.62. 3.2.1 Radiological Control Organization A radiological control organization should be established to support line managers and workers. To function effectively and be consistent, as necessary, with the requirements 22 DOE G 441.1-1B 3-1-07 in DOE Order 226.1, Implementation of Department of Energy Oversight Policy (DOE 2005b) the radiological control organization should be independent of the line organizational element responsible for production, operation, or research activities, and should have an equivalent reporting level. Radiological control organization function is discussed in detail in the RCS. Other organizational schemes that allow effective compliance with the standards set forth in 10 CFR 835 should be considered to address site- or facility-specific needs. 3.2.2 Education, Training, and Skills Individuals responsible for developing and implementing measures necessary for ensuring compliance with the requirements of 10 CFR 835 shall have the appropriate education, training and skills to discharge these responsibilities (10 CFR 835.103). These individuals can include technical and management personnel within the radiological control organization, independent assessors, and line managers responsible for radiological work activities. In addition, 10 CFR 830.122(b), Quality Assurance Criteria, specifies that nuclear facility personnel shall be trained and qualified to ensure they are capable of performing their assigned work.

DOE previously issued requirements and guidance with regard to education, training, and skills for many categories of personnel, including individuals responsible for developing and implementing measures necessary for ensuring compliance with the requirements of 10 CFR 835. Some of these requirements are addressed in DOE 5480.20A, Ch. 1, Personnel Selection, Qualification, and Training Requirements for DOE Nuclear Facilities (DOE 2001b). This order establishes training and qualification requirements for technical professionals and management personnel operating defense nuclear facilities. While these requirements are not mandatory for all DOE facilities, this information may be useful for all DOE facilities in developing training programs and standards for the education, training, and skills appropriate for personnel to achieve compliance with the requirements of 10 CFR 835.103 and 10 CFR 830.122(b). Key radiation protection positions are identified in DOE STD-1107-97, KNOWLEDGE, SKILLS AND ABILITIES FOR KEY RADIATION POSITIONS AT DOE FACILITIES (DOE 1997b). This document supplements the requirements discussed above by synthesizing guidance from several source documents into a single reference. DOE STD-1107-97 describes the level of knowledge, skills, and abilities for personnel in key radiation protection involved with DOE activities. The approach taken in DOE STD-1107-97 reinforces the DOE’s emphasis on establishing a system of criteria for key radiation protection positions that reflects the increasing levels of education, training, and skills needed for positions of increasing responsibility. The information contained in this standard should be strongly considered when evaluating the education, training, and skills of personnel in key radiation protection positions. The standards in DOE 5480.20A and DOE STD-1107-97 are based on DOE, Nuclear Regulatory Commission, and related industry standards and provide an acceptable method for achieving compliance with the requirements of 10 CFR 835.103. DOE G 441.1-1B 23 3-1-07 DOE STD-1107-97 includes radiological control technicians (RCTs) in the list of key radiation protection positions. While 10 CFR 835 does not establish specific requirements for RCT training, DOE considers the typical job functions associated with RCTs to be critical in implementing an acceptable RPP. These typical job functions include: prescribing and implementing radiological work controls, performing radiological monitoring, responding to radiological incidents, or evaluating radiological conditions in the workplace. Individuals performing these functions shall meet the provisions of 10 CFR 835.103. Chapter 6, Part 4, of the RCS discusses the essential elements of RCT training and qualification, including qualification standards, oral examination boards, and continuing training. In support of these elements, DOE has developed and maintains the core course for RCTs. DOE considers the DOE-developed core course for RCTs, augmented with site specific training, an acceptable level of training for individuals performing the typical job functions associated with RCTs. As is the case with using any of the DOE-developed training courses, sites need to evaluate the individual’s job functions and ensure the adequacy of the training provided.

To ensure that the work performed by RCTs receives the appropriate level of review and evaluation, it is important that RCT Supervisors receive a higher level of training and maintain a higher level of knowledge than those expected of RCTs. Chapter 6, Part 4 of the RCS also provides guidance on the essential elements of RCT Supervisor training and qualification, including continuing training and oral examination boards. DOE developed and implemented core courses to enhance the content of training provided to general employees, radiological workers, and radiological control technicians across the DOE complex and bring these core training programs up to a standard consistent with the commercial industry. The use of the core courses is not mandatory. However, these courses should strongly be considered as a basis for developing and implementing radiation safety and radiological control technician training programs. Additional guidance regarding compliance with the Subpart J requirements is provided in Chapter 14 of this Guide. DOE has also sponsored development of additional training courses and guidance. DOE strongly encourages its operating entities to implement these courses and guidance. These courses and guidance, when augmented with site specific information and appropriately revised to reflect the most current regulatory requirements, provide acceptable approaches for providing radiation safety training or training for individuals responsible for developing and implementing measures necessary for ensuring compliance with the rule. These courses include: • DOE-HDBK-1143-2001; RADIOLOGICAL CONTROL TRAINING FOR SUPERVISORS (DOE 2001c) • DOE-HDBK-1145-2001; RADIOLOGICAL SAFETY TRAINING FOR PLUTONIUM FACILITIES (DOE 2001d) • DOE-HDBK-1141-2001;RADIOLOGICAL ASSESSOR TRAINING (DOE 2001e) 24 DOE G 441.1-1B 3-1-07 • DOE-HDBK-1105-2002; RADIOLOGICAL SAFETY TRAINING FOR TRITIUM FACILITIES (DOE 2002a) • DOE-HDBK-1106-97; RADIOLOGICAL CONTAMINATION CONTROL TRAINING FOR LABORATORY RESEARCH (DOE 1997c) • DOE-HDBK-1108-2002; RADIOLOGICAL SAFETY TRAINING FOR ACCELERATOR FACILITIES (DOE 2002b) • DOE-HDBK-1109-97; RADIOLOGICAL SAFETY TRAINING FOR RADIATION-PRODUCING (X-RAY) DEVICES (DOE 1997d) • DOE-HDBK 1110-97; ALARA TRAINING FOR TECHNICAL SUPPORT PERSONNEL (DOE 1997e) • DOE-HDBK-1113-98 RADIOLOGICAL SAFETY TRAINING FOR URANIUM FACILITIES (DOE 1998d) • DOE-HDBK-1122-99 Radiological Control Technician Training (DOE 1999b) 3.2.3 Internal Audit and Self Assessment Internal audits and self assessments are two of the numerous checks and balances needed in an effective RPP. Internal audits of the RPP, including examination of program content and implementation, shall be conducted through a process that ensures that all functional elements of the program are reviewed no less frequently than every 36 months (10 CFR 835.102). The RCS discusses how assessments, including internal audits, provide independent feedback to senior line managers concerning the implementation of the RPP. An audit plan should be developed that identifies the functional elements of the RPP and the schedule for review to ensure that over a 36 month period, all of the functional elements are reviewed. Internal audits should be conducted on a continuing basis. DOE cautions against conducting a single comprehensive internal audit of the entire RPP once every three years. DOE does not believe that such an approach is effective in assuring that a DOE activity will be conducted in conformance with its approved RPP. DOE recommends that, at a minimum, an annual, broad scope audit of the program be conducted. Under this approach, the audit plan would identify each functional element to be reviewed during the annual audit and ensure that all functional elements would be reviewed during a 36 month cycle. Thus, the RPP is under continuing review and deficiencies can be identified and corrected in a timely manner.

The functional elements of a comprehensive RPP are discussed in this Guide. All of these functional elements may not be applicable to a specific DOE activity, but should be selected based upon the type of radiological work being performed and the radiological hazards encountered. DOE G 441.1-1B 25 (and 26) 3-1-07 Internal audits should be conducted by individuals who are organizationally independent from the organizations responsible for developing and implementing the RPP. 3.3 RPP Functional Elements This section identifies the programmatic functional elements of a comprehensive RPP. For each element, the table below identifies the applicable regulatory provisions, contractual requirements, and recommended guidance document(s) which are useful in achieving compliance with these provisions. Functional Element Regulatory Provision Contractual/Guidance Document 1. Organization and Administration 10 CFR 835, Subpart B Chapter 3.0 of this Guide 2. ALARA Program 10 CFR 835.101(c), Subpart K Chapter 4.0 of this Guide. 3. External Dosimetry Program 10 CFR 835.401 (a), 402(a), (b) Chapter 6.0 of this Guide. 4. Internal Dosimetry Program 10 CFR 835.401(a), 402(c), (d) Chapter 5.0 of this Guide. 5. Area Monitoring and Control a. Area Radiation Monitoring 10 CFR 835.401(a) Chapter 6.0 of this Guide. b. Airborne Radioactivity Monitoring 10 CFR 835.209, 401(a), 403 Chapter 10.0 of this Guide. c. Contamination Monitoring and Control 10 CFR 835.401(a), Subpart L Chapter 11.0 of this Guide. d. Instrument Calibration and Maintenance 10 CFR 835.401(b) Chapter 9.0 of this Guide. 6. Radiological Controls a. Radiological Work Planning 10 CFR 835.501(d), 1001(b), 1003 DOE-STD-1098-99, RADIOLOGICAL CONTROL b. Entry and Exit Controls 10 CFR 835, Subpart F Chapter 7.0 of this Guide. c. Radiological Work Controls 10 CFR 835, Subpart F, 1003 Chapter 7.0 of this Guide. d. Posting and Labeling 10 CFR 835, Subpart G Chapter 12.0 of this Guide. e. Release of Materials and Equipment 10 CFR 835.1101 Chapter 11.0 of this Guide. f. Sealed Radioactive Source Accountability and Control 10 CFR 835, Subpart M Chapter 15.0 of this Guide. 7. Emergency Exposure Situations 10 CFR 835.1301, 1302 DOE O 151.1-1, Comprehensive Emergency Management System (DOE 2005c) 8. Nuclear Accident Dosimetry 10 CFR 835.1304 Chapter 6.0 of this Guide. 9. Records 10 CFR 835, Subpart H Chapter 13.0 of this Guide. 10. Reports to Individuals 10 CFR 835, Subpart I Chapter 13.0 of this Guide. 11. Radiation Safety Training 10 CFR 835, Subpart J Chapter 14.0 of this Guide. 12. Limits for the Embryo/Fetus 10 CFR 835, Subpart C Chapter 8.0 of this Guide. DOE G 441.1-1B 27 3-1-07 Appendix 3.A PREPARATION, REVIEW, AND APPROVAL OF RADIATION PROTECTION PROGRAMS 3.A 1. PREPARATION OF RPPs The RPPs detail how the site, facility, or activity has met or will meet the requirements of 10 CFR Part 835. The format for the RPP is not specified. This flexibility will permit the RPP submitting organizations to take advantage of pre-existing documents. The following sections describe the minimum content expected in RPPs. Note: The term “Operations Office” is used throughout this document. Where it is used, the term “Field Office” or the term “Area Office,” as appropriate, should be substituted where there is no Operations Office. 3.A 1.1 RPP SUMMARY Each RPP should contain a summary section in the front to allow DOE management and reviewers to quickly assess the more significant information contained in the RPP. The summary should identify the following minimum information:

(1) Any requests for exemptions contained in the RPP; (2) The total additional funding required to meet the commitments of the RPP and the expected sources of funding by fiscal year; (3) Any significant new programs or activities needed to meet the requirements; (4) Any significant impacts to other programs or activities not included in the RPP; (5) Any constraints to implementing the RPP; (6) Those areas where there is currently full compliance with the requirements. 3.A 1.2 GENERAL INFORMATION The RPP should include general information which: (1) identifies that the RPP addresses the requirements of 10 CFR Part 835; (2) identifies whether the RPP is the initial submittal or a revision; (3) identifies the facilities or activities, missions, and organizations involved; and (4) briefly discusses the content and format of the RPP. 3.A 1.3 APPLICABILITY OF REGULATORY REQUIREMENTS The RPP should identify the specific facilities or activities covered by the RPP. Any determination that a specific requirement is not applicable to the facilities or activities addressed in the RPP should be documented in the RPP to ensure that the determination 28 DOE G 441.1-1B 3-1-07 is clearly communicated. DOE approval of the RPP will constitute agreement with applicability statements contained therein. Applicability statements may not be used to provide relief where the requirements are clearly stated to be applicable in 10 CFR Part 835. Relief from 10 CFR Part 835 can only be granted by an approved exemption granted in accordance with 10 CFR Part 820, Subpart E as discussed in Section 3.A 1.8 of this technical document. The information provided in the plan should clearly identify which of the following three categories applies to each requirement for a given facility, site, or activity: (1) The requirement is applicable and the RPP defines the actions and schedules for compliance; (2) The requirement is applicable and an exemption is being requested; or (3) The requirement is not applicable for the reasons documented in the RPP. The RPP should also identify any requirements that are only partially applicable, the limits of the applicability, and the reasons for the limitation. Individuals should contact the appropriate Operations Office to assist with any needed clarification of applicability statements. The Operations Office should contact the Office of Health and Safety for any needed technical clarifications or the Office of the General Counsel for legal interpretations of 10 CFR Part 835. 3.A 1.4 GUIDES AND TECHNICAL STANDARDS The RPP should identify the guides and technical standards that are to be adopted as the means to meet 10 CFR Part 835. The use of guides and technical standards is not required; however, it is encouraged for the following reasons: (1) The use of previously approved methodologies will streamline the review and approval process; and (2) The use of guides and technical standards will enhance the consistent and successful implementation of requirements across the DOE complex. The implementing organization should consider methods and guidance from guides and technical standards when developing the RPPs; however, alternative methods that achieve equivalent or better results are acceptable. When an implementing organization identifies an alternate way to implement the requirements, a reasonable opportunity will always be provided to demonstrate compliance with the requirements using the alternate method. Demonstration of compliance does not require an organization to address the differences between the alternate method and the method in the guide or technical standard unless the comparison is necessary to demonstrate acceptability.

DOE G 441.1-1B 29 3-1-07 When guides or technical standards are used, the RPP should indicate if they are adopted in their entirety or adopted with exceptions. The exceptions, if any, should be specifically noted. Methodologies and guidance that are adopted with exceptions will be reviewed on a case-by-case basis. The adopted guides and technical standards should be listed either by: (1) Including a list of applicable guides and technical standards in the RPP, or (2) Incorporating a list of guides and technical standards by reference. Commitments in an RPP to meet all or parts of guides and technical standards are enforceable as part of the RPP. 3.A 1.5 RESOURCE ASSESSMENT New RPPs should contain an estimate of the additional life cycle costs to implement 10 CFR Part 835. Revised RPPs may contain an estimate of the change in life cycle costs associated with the revision, if the change in life cycle cost is significant. The goals of this element of the RPP are as follows: (1) to communicate the expected new costs of implementation to DOE management for the purposes of budget planning and prioritization; (2) to identify the need to explore more cost effective means of achieving compliance; and (3) to identify cases where exemptions should be requested on the basis of insufficient benefit versus the expected implementation costs. Identification of required resources should also serve to open a dialogue between DOE and the RPP submitting organization on adjusting costs and activities to the available resources. When performing the assessments, the estimator should consider monetary costs, as well as non-monetary resource considerations such as the limited availability of special job capabilities (e.g., health physicists). The assessment should (1) be guided by available quantitative and qualitative information; (2) reflect the current status of plant conditions, configurations, and processes; (3) consider the availability of materials and resources; and (4) consider any other information that is relevant to the radiation protection requirements. RPP submitting organizations should seek to achieve the broadest consistency in the methods used to evaluate the resource requirements so that the assumptions, evaluations, and results of the assessment can be objectively compared with the equivalent parameters of other resource assessments. This will assist DOE and RPP activity management to determine priorities for the use of funding. All assumptions and estimates should be made using the best available knowledge and information. After evaluating the resource impacts, consideration should be given if a more cost-effective means of achieving the intent of the requirement is available. As a minimum, the use of more cost-effective methods of compliance, or exemptions (see 30 DOE G 441.1-1B 3-1-07 section 3.A 3.1.6.7 of this attachment), should be considered whenever the resource expenditures necessary to meet a requirement are not commensurate with the expected safety improvements. One of the criteria for granting an exemption to a nuclear safety requirements is that the requirement results in resource impacts which are not justified by safety improvements. In the past DOE has granted exemptions on this basis for such topics as radiological postings and recording tritium intakes, see http://www.eh.doe.gov/whs/rhmwp/exemption.html. There should be limited effort used to develop the resource assessments to only that level of detail necessary to achieve the goals of the assessment as stated above.

3.A 1.6 PRIORITIZATION The RPP should include a discussion of the prioritization process used to integrate the proposed activities into a facility or site schedule of activities. The prioritization process is to be used to develop the proposed schedules and should be sufficiently flexible to accommodate changes at later dates. The prioritization process should consider available information from safety analyses and other sources and give primary attention to controlling and reducing risks to the public; the environment, and the workers to an acceptable level. It should also consider other factors such as mission needs, outage schedules, and external regulations. The prioritization process should be selected in consultation with the applicable DOE Operations Office and Program Offices to ensure that the prioritization of efforts meets DOE expectations. The prioritization schedule should tie budgets to schedules. 3.A 1.7 MILESTONES AND SCHEDULES Per 10 CFR 835.101(f), the RPP must identify proposed milestones with achievable schedules developed in accordance with the prioritization process identified in the RPP (see Section 3.A 1.6 above). In developing the schedules, consider the resources available to support the work, as well as any major work reductions or schedule changes in other areas that will be required in order to meet the proposed schedules. The RPP should identify major impacts to activities or commitments outside the scope of the RPP that will be caused by the proposed additional activities. Schedules should be developed using the best information available with any assumptions on availability of resources (monetary or non-monetary) clearly stated. The milestones and schedules will be enforceable commitments upon approval of the RPP. Schedule commitments should be firm commitments and consequently, should not be listed as contingent on funding. Thus, it is essential that line program representatives participate in the review and approval of RPPs that involve additional funding needs. Following approval of the RPPs, DOE has a responsibility to provide appropriate funding to support the RPP schedules, the RPPs should be revised to reflect the new schedules DOE G 441.1-1B 31 3-1-07 supported by funding (provided any schedules specifically prescribed in the DOE requirements documents are met or schedule exemptions are approved). Such revisions should be submitted to DOE for review and approval. Alternatively, RPP developers may consider requesting an exemption for unfunded activities, if the criteria for granting an exemption are met (see Section 3.A 1.8 of this attachment). 3A 1.8 EXEMPTIONS Exemptions are to be requested whenever relief is sought from applicable DOE requirement. The RPP should clearly identify any exemptions that have been approved or are being requested from the subject requirements. The organization conducting RPP activities may submit requests for exemptions as part of the RPP provided that they relate to the same requirements. Requests for exemption that are submitted as part of the RPP should be identified in the RPP summary for early recognition. Early identification of exemption requests is important because they may need to follow a separate review and approval process. The provisions for requesting and granting exemptions to rules are stated in 10 CFR Part 820, Subpart E, Exemption-Relief. 3.A 2 SUBMITTAL OF RPPS

Per 10 CFR 835.101, RPPs must be submitted to the designated DOE point-of-contact within the schedule specified in 10 CFR Part 835. Normally, the RPP is submitted to a point-of-contact located in a DOE Operations Office. The Operations Office point-of-contact should date stamp the receipt of the RPP. Contact the Operations Office point-of-contact in advance of the submittal date to determine the number of copies to be submitted. Documents that are incorporated by reference should be submitted with the RPP unless other arrangements are made with the Operations Office point-of-contact. In addition, if the RPP is not a stand-alone document (able to be reviewed independent of other documents), contact the Operations Office point-of-contact prior to submittal of the RPP to discuss which supporting documents are to be transmitted with the RPP or made available for onsite review. Also see section 3.4 below for additional submittal requirements for final RPPs. 3.A 3. REVIEW AND APPROVAL OF RPPs 3.A 3.1 REVIEW AND APPROVAL PROTOCOL The Department’s protocol for review and approval of RPPs is described below. The protocol defines the roles, interfaces, and responsibilities of Department organizations 32 DOE G 441.1-1B 3-1-07 with respect to review and approval of RPPs. Organizations who prepare the RPPs and the DOE organizations responsible for review and approval of the RPPs should have a shared vision of what should be in the completed RPPs before submission f the RPP to DOE. In order to ensure this shared vision and the development of successful RPPs, early and continual dialogue between the RPP submitting organization and the Review Team is essential. This dialogue should begin well before the RPP is submitted to DOE. The process described below was built on the lessons learned in similar efforts and was designed to facilitate that dialogue. Because review and approval of the RPPs will often involve multiple Departmental organizations, the review and approval process should provide for coordination, consistency of review, and resolution of issues among those offices. In addition, the review and approval process should address both the technical adequacy of the proposed RPPs and the programmatic responsibilities (i.e., funding and mission). These responsibilities will require additional coordination within the Department as they may reside in different organizations. The review and approval process should be sufficiently flexible to accommodate the subjects addressed by 10 CFR Part 835 and adequately structured to permit efficient completion of the review and approval within the 180 days [See 10 CFR 835.101.(i)]. Table 1, at the end of this attachment, provides recommended time periods to meet this 180-day requirement. In the review and approval process, the Operations Office should be responsible for coordination between the RPP submitting organization and the Department’s Headquarters staff. This focused interface will ensure consistency in the information provided to the RPP submitting organization and allow interaction with a single point-of-contact. In addition, the Operations Office should be responsible for coordinating PSO (Program Secretarial Officer) approvals. It should be noted that this attachment contains a detailed protocol. However, individual steps may be modified to or eliminated, based on local conditions, as long as the process involves appropriate review and approval. For example, approval authority may have been delegated to the Manager of the Field Element (or lower), which would obviate the need for specific PSO approval

A RPP Review Team should be formed for each RPP to conduct the review of the RPP. The Review Team members should include DOE Headquarters and Field Operations personnel with technical expertise and coordinating responsibility for program decisions (e.g., funding, schedule). Operations Office personnel should serve as points-of-contact and Review Team Leaders for RPP reviews applicable to their sites. Individual participation in Review Team activities will vary in level of effort and time frame based on review and approval needs. The Operations Office point-of-contact plays a key role in coordinating all RPP review and approval activities between DOE Headquarters and the RPP submitting organization. DOE G 441.1-1B 33 3-1-07 The process for the development, review, and approval of RPPs is discussed below. The provisions of 10 CFR 835.101(i) state that “an initial RPP or an update shall be considered approved 180 days after its submission unless rejected by DOE at an earlier date.” See Table 1 for a typical schedule of activities to meet this provision. 3.A 3.1.1 Identifications of Responsible Review Staff 3.A 3.1.1.1 Points-of-Contact Each Operations Office Manager should identify a point-of-contact for the RPP. The Operations Office point-of-contact should be the primary interface for all activities associated with the development, submittal, review, and approval of the RPPs. The Operations Office point-of-contact should also be the Review Team Leader. The Review Team Leader should coordinate assignment of Review Team members with the PSOs and the Operations Office. 3.A 3.1.1.2 RPP Review Teams As discussed in the previous paragraph, the Operations Office point-of-contact should normally be the Review Team Leader. The Operations Office Manager may provide additional team members and technical assistance as necessary. In addition, each affected PSO should identify the Program Office representatives for each Review Team to the Review Team Leaders. The PSO may assign multiple reviewers to a single site or a single reviewer. 3.A 3.1.2. Review Planning 3.A 3.1.2.1 RPP Guide Each responsible PSO should prepare an RPP Guide that defines DOE’s specific technical and programmatic expectations for the RPPs internal to their organization. The guide should include the following types of information: (1) criteria and/or checklists of items to be considered during the review, (2) approaches to key issues, (3) direction on use of existing RPPs and approvals, (4) review and approval authorities, and (5) specific issues relating to Headquarters or Operations Office review responsibilities. The guide should be as brief as possible, should be user friendly, and should not repeat general guidance available in other guidance documents such as this attachment. The PSO should provide assistance and/or training to the Review Teams on the use of the guide. 3.A 3.1.2.2 Implementation Action Plan For each RPP, the Review Team Group should prepare an Implementation Action Plan that defines the Review Team activities, priorities, and schedule. A copy of the plan should be provided for information. 34 DOE G 441.1-1B 3-1-07 3.A 3.1.2.3 Responsibility and Interface Matrix The PSO should prepare and maintain a matrix that identifies the Review Team Leader, Review Team members, and DOE programmatic and technical contacts for each RPP. 3.A 3.1.3 Meetings, Conference Calls, and Status Reports 3.A3.1.3.1 Initial Site Meeting

The Review Team should meet with the RPP submitting organization at the earliest feasible date to discuss the basic expectations for implementation of the DOE requirements document and to discuss any issues that might impact the timely and acceptable completion of the RPP. Issues to be discussed should include (1) how to best use existing plans or other information in developing the RPP; (2) potential exemptions; (3) plans and schedules for ongoing interactions; and (4) funding sources for new activities identified as necessary to come into compliance. The Operations Office point-of-contact has primary responsibility for planning and coordinating this meeting. 3.A 3.1.3.2 Status Meetings Periodic status meetings should be held with the RPP submitting organization to fully discuss all elements of the proposed RPPs that could affect the acceptability of the RPPs. 3.A3.1.3.3 Periodic Conference Calls The Operations Office point-of-contact should coordinate regular conference calls with the RPP submitting organization and the Program Offices to address and resolve issues as they arise. As necessary, site or headquarters meetings should be held to resolve difficult issues. The Operations Office point-of-contact has primary responsibility for coordinating phone conferences, as well as necessary meetings to resolve issues. 3.A 3.1.4 Submittal and Distribution of RPPs As discussed in Section3.A 2 of this attachment, RPPs should be submitted directly to the Operation Office point-of-contact. The Operations Office point-of-contact should transmit a copy of the RPP to the Review Team members and a copy of the transmittal memorandum to the affected PSOs within four working days of the receipt of the RPP. The transmittal memorandum should identify the required date for completing the review. 3.A 3.1.5 Review 3.A 3.1.5.1 Review to Review Teams RPPs should be reviewed by an integrated Review Team with Program and Operations Office representatives, as discussed in Section3.A 3.1.1.2 above. Program Office team members and their contacts should, as a minimum, participate in the review of issues involving funding, missions, schedules, priorities, and exemptions. The Review Team DOE G 441.1-1B 35 3-1-07 Leader should facilitate resolution of unique or difficult issues not addressed in the RPP Guide. Review Team members should assist the RPP submitting organization in clearly understanding what actions or changes are necessary to result in an acceptable RPP. DOE comments and feedback should be routed through the Review Team Leader to ensure consistent feedback. The Review Team Leader should also be responsible for resolving conflicts prior to communication with the RPP submitter. All reviewers should expedite their reviews to allow closure on an acceptable RPP as early as possible. 3.A 3.1.5.2 Delegated Approval Authority for RPPs The PSO may delegate the authority to approve specific RPPs. Any such delegation should be provided in writing to the designee and documented in the Functions, Responsibilities, and Authorities (FRA) document for that organization. Wherever the authority to approve an RPP has been delegated to the Operations Office by all of the affected PSOs, the Operations Office may choose to have the Review Team consist entirely of Operations Office personnel provided any technical and programmatic requirements can be handled by the designated team. Per 10 CFR Part 820, Subpart E, the authority to approve exemptions to 10 CFR Part 835 cannot be delegated.

3.A 3.1.6 Approval 3.A 3.1.6.1 Approval Recommendations by the Review Team The Review Team Leader is responsible for ensuring that the Operation’s Office Manager receives the Review Team’s final recommendation for approval within 145 days after receipt of the RPP. That recommendation should either endorse acceptance of the RPP as submitted (or changed through negotiations during the review process) or, if issues cannot be resolved, provide recommendations regarding specific additional commitments or changes to be incorporated in the RPP. 3.A 3.1.6.2 Operations Office Review of the Review Team Recommendations The Operations Office Manager, or equivalent, should review the recommendation of the Review Team and either endorse the recommendation or provide specific recommendations for an acceptable RPP. The Operations Office Manager is responsible for ensuring that the PSO receives the recommendations of the Review Team along with any recommendations from the Operations Office no later than 159 days after receipt of the RPP [with information copy to the affected CSOs [Cognizant Secretarial Officer)]. 36 DOE G 441.1-1B 3-1-07 In some cases involving multiple PSOs, approval authority may be delegated by one or more PSOs, but not all PSOs. In such cases, the Operations Office Manager should coordinate the remaining approvals with the PSOs. For cases in which the approval authority has been delegated by all affected PSOs to the Operations Office Manager, the Operations Office Manager should skip to step 3.A 3.1.6.4 Approval Letter, below. 3.A 3.1.6.3 PSO Approval Memorandum In order to ensure the Operations Office has a week to transmit the approval or disapproval of the RPP before it becomes automatically effective 180 days after receipt of the RPP by DOE, each affected PSO should indicate approval or disapproval of the RPP in a memorandum to the Operations Office within 173 days of receipt of the RPP by DOE. 3.A 3.1.6.4 Approval Letter The Operations Office Manager should transmit the approval memorandum by letter to the RPP submitting organization no later than 180 days after receipt of the RPP by DOE. 3.A 3.1.6.5 Imposition of RPPs The Review Team will endeavor to resolve any issues identified during the review process. If conflicts exist which cannot be resolved, the Department may exercise its authority [see 10 CFR Part 835.101(b)] to modify proposed RPPs to include those actions and schedules that the Department finds appropriate for achieving full compliance in a reasonable and timely manner. In such cases, the PSO approval memorandum should be replaced with a memorandum imposing a revised RPP. The revised RPP should be transmitted to the RPP submitting organization by the Operations Office Manager. The RPPs may be renegotiated at a later date, but until it is replaced by another approved RPP, it will be the enforceable basis for implementation of 10 CFR Part 835. 3.A 3.1.6.6 RPPs which are not Approved by Final Date Per 10 CFR Part 835.101(I), RPPs which are not approved within the approval period specified in the DOE requirements document should be considered to be approved unless another RPP is imposed by the Department. These RPPs may be renegotiated at a later date, but until they are replaced by another approved RPP, they will be the enforceable basis for implement of 10 CFR Part 835. 3.A3.1.6.7 Approval of RPPs Containing Exemption Requests

RPPs may contain requests for exemptions. When they do, the requests may be granted in the approval memorandum for the RPP, provided that all of the requirements for processing exemptions are met, including the approval of the DOE Headquarters official DOE G 441.1-1B 37 3-1-07 designated by 10 CFR Part 820 Subpart E. When exemptions are approved as part of an RPP, the approval document should state how the provisions of 10 CFR Part 820, Subpart E were met. Alternatively, exemptions may be approved separately and referenced in the RPP approval letter. Upon submittal of the RPPs, the Review Team Leader should determine if any exemption requests submitted in the RPPs need to be reviewed and approved separate from the RPPs. Where separate review and approval is necessary, the Review Team Leader should alert the PSO Review Team representatives to initiate a separate and expeditious review of the exemption requests. The provision in 10 CFR 835.101(i) that states that RPPs are considered approved 180 days after submission, does not apply to exemptions. Approval of an RPP pending granting of an exemption does not constitute or imply approval of the exemptions contained therein. 3.A 3.2 DISTRIBUTION OF COPIES OF THE FINAL RPP The Operations Office Manager should be responsible for distributing approved RPPs (if changed from the originally submitted RPP), the Office of the Docketing Clerk (in the Office of Price Anderson Enforcement), and to the affected PSOs. Copies of approved RPPs transmitted to the Office of Docketing Clerk should include both a hard copy and an electronic copy. As required by 10 CFR Part 820, the Office of Docketing Clerk will maintain a file of enforceable actions based upon rule violations and noncompliance with RPPs. 3.A 3.3 REVIEW RESPONSIBILITIES The Review Team should determine if the RPP provides an acceptable method to meet 10 CFR Part 835. The Review Team should also determine if the RPP adequately addresses the elements discussed in Section 3.A 1 of this attachment (Preparation of RPPs). RPP submitting organizations are encouraged to use the methodologies contained in this Guide for implementation of 10 CFR Part 835 where they are reasonable and economical; however, one may elect to propose an alternate way to meet the requirements. In cases where an alternate method is proposed, the Review Team should evaluate the proposed method to ensure that it will be adequate to meet the requirements and provide a comparable level of safety. The Review Team should verify that the RPP provides sufficient detail to permit DOE to measure the progress towards meeting the DOE requirements. The Review Team should also ensure that (1) the projected budget and schedule information contained in the RPP is reasonable and consistent with the funding projects, (2) the prioritization of efforts meets the DOE expectations, (3) the proposed milestones 38 DOE G 441.1-1B 3-1-07 and schedules will meet DOE needs, (4) the applicability of the requirements is correctly identified, and (5) the compensatory actions are acceptable. The Review Team should expect to see significant variations in the level of detail and size of individual RPPs because of the diversity of types, sizes, and missions of DOE facilities. In order to facilitate timely reviews and agreements on complex RPPs, the members of the Review Team should visit the site and/or facility and have frequent communication during both the preparation and the review of the RPP.

3.A 3.4 APPROVAL RESPONSIBILITIES DOE approval of the RPP constitutes acceptance by the PSO that: (1) The proposed activities represent an acceptable method to meet the requirements; (2) The resources identified in the RPP are necessary and sufficient to ensure completion of the activities contained in the RPP and are expected to be available to support the proposed schedules; (3) The proposed milestones and schedules are acceptable; (4) The applicability of the requirements is correctly identified; and (5) The identified compensatory actions are acceptable. 3A 4. REVISIONS TO RPPs The RPPs will probably need to be revised and updated during the life cycle of the site, facility, or activity. Approved RPPs should be revised as needed to reflect the addition or deletion of other work at a facility or other factors that affect the ability to meet the approved schedule, such as prospective changes in the level of funding or assumptions regarding the availability of materials and other resources. The provisions in 10 CFR 835.101(h) contain conditions under which RPPs may be revised without prior approval from DOE. In such cases, submit the revised RPP to DOE within 30 days of the effective date of the RPP. All other changes to RPPs should be reviewed and approved by DOE prior to the effective date of the change. Revised RPPs should be submitted in a timely manner for DOE approval (at least 180 days before the change is to be effective), along with justification for the revision. As noted previously, proposed revisions will be considered approved 180 days after submittal to DOE, unless they are approved or rejected by DOE. The changes to the RPP should be clearly indicated (e.g., sidebars) to facilitate timely review. Revised RPPs are to be submitted to DOE in the manner described in this section and reviewed and approved in the manner described in section 3.A.3 above. DOE G 441.1-1B 39 (and 40) 3-1-07 Any changes to RPPs which will result in a requirement not being met, require an approved exemption. 3.A 5. EXTENSIONS TO THE SUBMITTAL SCHEDULE FOR RPPS Extensions to the schedule for submitting an RPP will generally require an exemption processed in accordance with 10 CFR Part 820, Subpart E, and approved by the Secretarial Officer responsible for environment, safety and health matters (i.e., the Chief Health, Safety and Security Officer). 3.A 6. IMPLEMENTATION TRACKING Following approval of the RPP and during the implementation process, the DOE Operations Office should oversee progress in meeting the commitments in the RPP (for example, schedules, milestones, and costs) and maintain a dialogue on any problems that arise. 3.A 7. INCORPORATION BY REFERENCE The RPP submitting organization may choose to incorporate information into the RPP by referencing all or selected portions of other documents. In such cases, the portions of the referenced documents that are incorporated into the RPP are also subject to the provisions of this Guide and attachment. However there are situations when a citation or reference is used to indicate the origin of some of the text in a document. For example, in this Guide, 10 CFR Part 835 is cited to indicate the basis for statements containing word “should” or “shall” (i.e., requirements). Consequently, the RPP submitting organization should clearly indicate which documents (or portions of documents) are considered part of the RPP commitments. The RPP submittal should maintain a file of all documents incorporated by reference and should make non-DOE documents available to DOE upon their request. See also section 3.A 1.2 above for submittal criteria.

Table 1. TYPICAL SCHEDULE FOR REVIEW AND APPROVAL OF RPPS Submittal of RPP to Operations Office 0 days Operations Office send RPP to Review Team/PSOs/Environment, Safety and Health 4 days Review Team sends recommendation to Operations Office Manager 145 days Operations Office Manager sends recommendation to PSO* 159 days PSO Approval to Operations Office* 173 days Operations Office Manager issues approval/disapproval to RPP submitting organization 180 days *If approval authority not delegated to the Operations Office by the PSO. DOE G 441.1-1B 41 3-1-07 4.0 ALARA In promulgating 10 CFR 835, DOE considered alternatives to reduce the risk from radiation exposure to workers that included retaining the current occupational dose limits, reducing these limits, and emphasizing efforts to maintain occupational doses As Low As is Reasonably Achievable (ALARA). After considering public comments on this issue, DOE elected to emphasize the ALARA process to maintain occupational dose for DOE and contractor employees well below the current regulatory occupational dose limits. Adopting the ALARA process in DOE occupational radiation protection regulations also provides consistency with recommendations provided in the President’s Radiation Protection Guidance to Federal Agencies For Occupational Exposure (EPA 1987), which endorsed the ALARA process. The importance of the ALARA concept was further stressed in DOE P 441.1, DOE Radiological Health -and Safety Policy (DOE 1996), which states: It is the policy of the Department of Energy to conduct its radiological operations in a manner that ensures the health and safety of all its employees, contractors, and the general public. In achieving this objective, the Department shall ensure that radiation exposures to its workers and the public and releases of radioactivity to the environment are maintained below regulatory limits and deliberate efforts are taken to further reduce exposures and releases as low as reasonably achievable. The Department is fully committed to implementing a radiological control program of the highest quality that consistently reflects this policy. 10 CFR 835 requires formal plans and measures for maintaining occupational exposures ALARA as part of the documented radiation protection program (RPP). Measures include incorporating ALARA considerations into the design of new facilities and modifications of existing facilities, as well as activities that pose the potential for significant occupational dose. Additionally, administrative controls are addressed as measures which supplement physical design features and controls and are integrated into the work planning process. Record keeping and training requirements related to ALARA are also specified. This chapter of this Guide discusses acceptable methods for implementing the ALARA process provisions in 10 CFR 835. Due to the complex nature of many DOE activities, a combination of radiological and non-radiological hazards may be encountered. Identification of non-radiological hazards is critical to the ALARA process, because efforts to apply the ALARA process may inadvertently increase risks from non-radiological hazards. An integrated safety management approach that optimizes worker protection from all hazards should be considered in the ALARA process for a given DOE activity. 4.1 Implementation Guidance Subpart B of 10 CFR 835 requires that a DOE activity shall be conducted in compliance with an RPP approved by DOE [10 CFR 835.101(a)]. The content of the RPP shall be

42 DOE G 441.1-1B 3-1-07 commensurate with the nature of the activities performed and shall include formal plans and measures for applying the ALARA process to occupational exposure [10 CFR 835.101(c)]. Subpart K of the rule provides requirements for design and control for maintaining radiation exposures ALARA. The primary methods used for maintaining radiation exposures ALARA in controlled areas shall be physical design features; administrative controls may be used as supplemental features and for specific activities where physical design features are impractical [10 CFR 835.1001(a) and (b)]. The rule specifies objectives for design of new facilities or modifications to existing facilities (10 CFR 835.1002) and the integration of work controls during routine operations (10 CFR 835.1003). Additionally, the rule requires documentation of the actions taken to maintain occupational exposures ALARA, including actions required by the RPP, as well as facility design and control actions [10 CFR 835.704(b)]. Guidance on complying with the training requirements of 10 CFR 835.103 and 835.901 is provided in Chapters 3 and 14 of this Guide. This chapter provides the basic guidelines for conducting an occupational ALARA program. It includes the requirements and guidance for developing, implementing, documenting, and providing feedback and lessons learned for improving the program to reduce individual doses to levels that are ALARA. 4.2 ALARA Programs 4.2.0 Formal Plans and Measures The method of implementing an ALARA program is highly dependent on the complexity and magnitude of potential radiological hazards associated with the DOE activity. The elements of an effective ALARA program should be identified in a formal ALARA plan or procedure. The RPP shall clearly identify the ALARA plans and measures employed by the DOE activity [10 CFR 835.101(c)]. The degree of formality and the level of detail contained in these plans and measures and other pertinent documentation should be commensurate with the magnitude of the radiological hazard associated with the DOE activity. A DOE activity with higher collective dose and/or potential for significant occupational doses should have more detailed ALARA documentation than an activity with low collective doses and/or potential for significant occupational doses. ALARA plans and measures should address the following elements at a level commensurate with the radiological hazards associated with the DOE activity: • Policy and Management Commitment: Establish commitment and participation of all line management and all levels of the work force; • ALARA Training: Require ALARA training for all employees, including managers involved with any aspect of radiological operations. Guidance is provided in Chapters 4 and 14 of this Guide and the RCS; • Plans and Procedures: Consider administrative and engineering controls and optimization methods during work procedure development to assure that the DOE G 441.1-1B 43 3-1-07 ALARA process is fully integrated into the development of operational/experimental plans, procedures, and protocols. Document formal plans and measures for applying the ALARA process to occupational doses; • Internal Assessments/Audits: Conduct comprehensive internal reviews, audits, and evaluations periodically and report the results to the highest levels of site management. Guidance is provided in Chapter 3;

• ALARA Design Review: Ensure the integration of appropriate methods and considerations during the design phase to maintain occupational exposures ALARA during subsequent construction, modification, and operation of the equipment or facility; • Radiological Work/Experiment Administration and Planning: Implement controls and use optimization methods to assure that occupational dose is maintained ALARA for routine and special operations or experiments; and • Records: Maintain documents that demonstrate compliance and that the program is adequately carried out. Guidance is provided in Chapter 13. 4.2.1 Policy and Management Commitment Management commitment to ALARA, consistent with the DOE Radiological Health and Safety Policy, is a critical element in ensuring a successful ALARA program. This commitment should take the form of a formal, written, policy statement from a high level of corporate management, generally the senior site executive or company officer responsible for radiological activities that cause the exposures. This commitment should hold all levels of management and individual workers responsible for adhering to the company's ALARA policy. If appropriate, union leadership endorsement of the ALARA policy should be considered. Senior site and line management should demonstrate their support of the ALARA program through direct communication, instruction, inspection of the workplace, and actions including: • management decisions that place ALARA considerations before cost or schedule considerations (in accordance with numerical criteria; see section 4.2.5 below); • encouragement of and praise for workers who identify ALARA solutions; • support of the ALARA Committee; and • publication of ALARA success stories. All site personnel should be made aware of management's commitment to ALARA and radiological workers should be instructed on their responsibility to comply. 44 DOE G 441.1-1B 3-1-07 Management’s ALARA commitment statement should be periodically updated and reaffirmed. 4.2.2 ALARA Training Specialized ALARA training should be developed for personnel who plan, prepare, schedule, estimate, or engineer jobs that have the potential for significant radiological consequences. The purpose of training these personnel in ALARA concepts and techniques is to empower them to include ALARA considerations in the early phases of job planning and engineering. This training should provide the basics of ALARA concepts and the use of ALARA related equipment such as containment devices, shielding, ventilation, and special tools. Topics such as radiological waste minimization, application of decontamination efforts, and basic contingency planning for mitigation of accidental spills and releases may also be appropriate. DOE has developed specialized training material for these types of positions in DOE HDBK 1110-97, ALARA TRAINING FOR TECHNICAL SUPPORT PERSONNEL (DOE 1997e). Discipline-specific ALARA training may be appropriate for some organizations including: operations, maintenance, engineering, production, and construction (craft workers). Chapter 3 provides additional guidance with respect to training for such individuals under 10 CFR 835.103. Mock-up training may be appropriate for craft workers and others to prepare them for unique and/or high dose jobs. 4.2.3 Plans and Procedures

10 CFR 835.101(c) requires that the content of each RPP be commensurate with the nature of the activities performed and include formal plans and measures for applying the ALARA process to occupational exposures. The RPP (approved by facility management and DOE) and supporting procedures (approved by facility management) should describe the organization, responsibilities, and method of operation of the ALARA program. These documents should be reviewed and updated according to an established schedule. Chapter 3 provides additional guidance with respect to procedures required under 10 CFR 835.104. 4.2.4 Internal Assessments/Audits 10 CFR 835.102 requires that internal audits of the RPP be conducted such that all functional elements are reviewed no less frequently than every 36 months and shall include program content and implementation. The ALARA program is one of these functional elements. Chapter 3 provides detailed guidance concerning internal audits. Management's responsibilities for reviewing, auditing, and evaluating the ALARA program should be clearly documented. The occupational ALARA program should be evaluated by an individual(s) or members of the ALARA Committee with no direct responsibility for implementing the program. DOE G 441.1-1B 45 3-1-07 4.2.5 ALARA Design Review 10 CFR 835.1001 requires that measures be taken to maintain radiation exposures in controlled areas ALARA. The primary method used shall be physical design features (e.g., confinement, ventilation, remote handling, and shielding); administrative controls shall be incorporated only as supplemental methods and for specific activities where physical design features are demonstrated to be impractical (10 CFR 835.1001). 10 CFR 835.1003 further requires that during routine operations, the combination of design features and administrative controls shall provide that the anticipated occupational dose to general employees does not exceed regulatory limits and that the ALARA process is utilized for personnel exposures to ionizing radiation. Physical design features typically include features that are used to control the work environment, such as permanent structures, systems, and controls, including shielding, filtered ventilation systems, remote controls, containment devices, and the use of designs and materials that facilitate operations, maintenance, and other activities. Physical design features may also include engineering controls (e.g., temporary shielding, confinement and ventilation systems) that are typically used to facilitate short-term or emergent operations when the installed physical design features do not provide the desired level of protection. In addition to the physical design features, initial consideration should be given to elimination or substitution of the hazards where feasible and appropriate. This could include use of non-radioactive material or sources. Administrative controls typically include controls that are implemented by the individual at the work site, including written procedures, technical work documents, work authorizations, and other controls that are used to guide individual actions in a manner that will facilitate implementation of the ALARA process.

DOE has an approved set of directives concerning radiological design criteria for the design, construction, operation, and decommissioning phases of its nuclear facilities. (See list below.) The appropriate ALARA design features should be incorporated into modifications of existing facilities and/or equipment and designs of new facilities and/or equipment as early as possible in the engineering and design process. From early in the design phase and throughout the project, a radiological engineer or representative of the radiation protection staff should be assigned to the design team. This individual should ensure that reasonable radiological considerations have been integrated into the design, construction procedures, proposed operating procedures, and plans for decommissioning. Numerical criteria (e.g., dollars per rem avoided) developed for site ALARA decisions should be used to determine those design features that are reasonable. An individual with expertise in radiation protection, preferably from the site staff, but at least familiar with the site program, should perform an independent ALARA design review that includes the following elements: • review the general configuration of the facility and/or equipment, considering traffic patterns, location of radiation areas, location and size of changing rooms, adequacy of personnel decontamination facilities, location of fixed monitoring 46 DOE G 441.1-1B 3-1-07 equipment, and adequacy of space for anticipated operations, maintenance, production, research, and decommissioning. Facility design and selection of materials shall include features that facilitate operations, maintenance, decontamination, and decommissioning [10 CFR 835.1002(d)]. The RCS provides additional guidance; • verify that radiological design criteria are consistent with applicable federal/state regulations, recognized standards and guides, and with the following DOE directives relating to radiological safety in design: – 10 CFR 835; – DOE 5400.5; Radiation Protection of the Public and the Environment (DOE 1993a); – DOE P 441.1; Department of Energy Radiological Health and Safety Policy – DOE O 420.2B, Safety of Accelerator Facilities (DOE 2004a); – DOE 5480.30, Nuclear Reactor Safety Design Criteria (DOE 1993b); – DOE O 420.1B, Facility Safety (DOE 2005d); – DOE O 413.3A, Program and Project Management for the Acquisition of Capital Assets (DOE 2006b); – DOE 435.1, Radioactive Waste Management (DOE 2001f); and – the RCS. • verify that the design of the confinement and ventilation systems provides the required level of protection from airborne contamination, giving particular attention to patterns of air flow and to the locations of air inlets, penetrations, and exhausts. Releases of radioactive material to the workplace atmosphere should be avoided under normal operating conditions and inhalation of such materials by workers should be controlled to the extent reasonably achievable; • evaluate and confirm the adequacy of specific control devices for reducing occupational doses, including shielding, hoods, glove boxes, containments, interlocks, barricades, shielded cells, decontamination features, and remote operations. External sources of radiation in areas of continuous occupational occupancy (2,000 hours/year) shall be maintained below an average of 0.5 millirem (0.005 mSv) per hour and as far below this average as is reasonably achievable. For areas where occupancy differs from the above, external dose

DOE G 441.1-1B 47 3-1-07 rates should be ALARA and should be maintained at a rate so as not to exceed 20% of the limits in 10 CFR 835.202; • verify that the design will be able to maintain personnel entry control for each radiological area, commensurate with existing or potential radiological hazards within the area, by using one or more of the methods listed in 10 CFR 835.501; • verify that each entrance or each access point to high and very high radiation areas will have the control features required by 10 CFR 835.502; and • assess the adequacy of planned radiological monitoring and nuclear criticality safety instrumentation and determine whether the proposed instrumentation is appropriate for the expected types, levels, and energies of the radiation(s) to be encountered, and whether it has sufficient redundancy and capability for operation under normal operating conditions and during emergencies [10 CFR 835.401(b)]. The ALARA design review should have six discrete phases: • dose assessment; • review of projected radiological conditions against the trigger points or numerical criteria established by management to initiate a review (e.g., creation of a new radiation source or an increase in the dose rates from an existing source that causes increased projected facility lifetime collective dose of greater than 5,000 millirem (50 mSv) or annual collective dose of 1,000 millirem (10 mSv), from operations, maintenance, production, research, inspection and decommissioning activities); • identification of the applicable radiological design criteria; • review of similar facilities, designs, and processes to assist in the selection of optimum ALARA design features and less costly alternatives using approved numerical criteria; and, • incorporation and documentation in the design package of features to reduce the: exposure of personnel; spread of radioactive contamination; release of radioactive effluent; and creation of radioactive waste; and • post-construction review of effectiveness of ALARA engineering features to provide feedback to the design engineers and help refine the design process. The ALARA design review should be conducted and documented in accordance with an approved procedure and the design review package should be readily retrievable. Detailed radiological design considerations are discussed in 48 DOE G 441.1-1B 3-1-07 PNL-6577, Health Physics Good Practices for Reducing Radiation Exposures to as Low as Reasonably Achievable (ALARA) (PNL 1988a). Optimization Methodology Optimization methods are required to assure that occupational exposure is maintained ALARA in developing and justifying facility designs or modifications and physical controls. Optimization methodology provides the technical and managerial basis for setting numerical criteria for ALARA decisions in the design of facilities, development or review of work processes, and the design/purchase of special tools and equipment. Selection of an appropriate cost benefit factor for reducing occupational dose involves a judgment of the relative value of dose, normally in terms of dollars per rem avoided. Additionally, guidance on optimization methodology will also provide the basis for selection of trigger points or collective dose values (facility lifetime, facility annual, job lifetime, one time job, etc.) above which an ALARA design review or job review is appropriate. Numerical criteria for ALARA decision making should include radioactive waste volume, radioactive effluent, contamination levels, and airborne radioactivity levels. Optimization methodology has led to a multi-attribute analysis technique which discussed extensively in ICRP Publication 37, Cost-Benefit Analysis in Optimization of Radiation Protection (ICRP 1982) and ICRP Publication 55, Optimization and Decision-making in Radiological Protection (ICRP 1990).

At sites with significant collective dose, formally documented optimization methodologies should be developed for ALARA reviews and decisions on implementation of ALARA efforts should be developed. This may be on a site- or facility-specific basis. Application of optimization methodologies to the ALARA process should lead to consistent, rational, repeatable decisions as to which ALARA efforts are justifiable. The level of effort involved in documenting ALARA decisions should be commensurate with the potential dose savings to be realized. A detailed evaluation need not be made if its cost, including the cost of documentation, outweighs the potential value of the benefits. The procedure used to evaluate the "appropriateness" of dose-reduction and contamination minimization decisions should be maintained. The RCS and PNL-6577 provide additional guidance on optimization methodologies. 4.2.6 Radiological Work/Experiment Administration and Planning 10 CFR 835.1003 requires that during routine operations, the combination of design and administrative controls shall provide that the anticipated occupational dose to general employees shall not exceed the limits established in 10 CFR 835.202 and that the ALARA process is utilized for personnel exposures to ionizing radiation. Additionally, 10 CFR 835.501(d) requires written authorizations to control entry into and perform work within radiological areas. Often, these written authorizations take the form of radiological work permits (RWP) or technical work documents (TWD) associated with jobs or experiments. These written authorizations provide a convenient mechanism to integrate ALARA review of work tasks if the requirement for ALARA review is embodied in the written authorization. Optimization methodologies should be used to develop trigger points or numerical criteria be developed for conducting ALARA reviews DOE G 441.1-1B 49 3-1-07 of job tasks. These criteria should be incorporated into the written authorization to require ALARA review when appropriate. The RCS provides detailed guidance on the development and use of RWPs and TWDs. 4.2.6.0 Job/Task/Experiment Reviews A formal ALARA job/task/experiment review should be performed for work or experiments with the potential to exceed the established numerical radiological criteria. The following are examples of criteria that should trigger a formal ALARA review. • the estimated individual or collective dose is greater than pre-established criteria. • the predicted concentrations of airborne radioactivity could exceed pre-established criteria (such as 100 times the DAC values provided in 10 CFR 835 Appendices A and C). • there is potential for significant radiological exposures. • the removable contamination in work areas could exceed pre-established criteria (such as 100 times the values provided in 10 CFR 835 Appendix D). • individuals will enter areas where exposure rates could exceed pre-established criteria [such as 1 rem/hour (0.01 Sv/hr)]. The ALARA job/task/experiment review should encompass three discrete phases: (1) pre-job planning and dose assessment; (2) specification and implementation of ALARA controls and dose tracking; and (3) post-job review. Pre-job Planning and Dose Assessment Pre-job planning should include an estimate of the collective dose resulting from the job/task/experiment and a determination regarding whether the numerical criteria for an ALARA job/task/experiment review will be exceeded. The estimates may be based on actual or historical radiological monitoring results. If a review is required, the next

step is to identify appropriate ALARA controls and alternatives. This should include an assessment of the cost of controls against numerical criteria. ALARA Controls During the work or experiment, periodic inspections should be made to ensure that ALARA controls are being implemented and are effective. Typical ALARA controls implemented in the field include: appropriate use of shielding and personal protective equipment (including respiratory protection devices), monitoring of stay times, minimization of time in radiological areas, maximizing distances from radioactive sources, and effective use of mock-up training and pre-job briefings. In addition, 50 DOE G 441.1-1B 3-1-07 individual and collective doses should be tracked and periodically compared to the dose estimates to determine if intervention is needed. Post-Job Review Criteria should be established to trigger a formal post-job review. Examples include: • an actual collective dose equivalent of 5 person-rem or greater, • actual doses outside the range of 25% of pre-job estimates, • use of the stop radiological work authority, • issuance of a radiological occurrence/deficiency report, or • identification of significant lessons learned. The post-job review should compare the actual person-hours and person-rem with the estimates, evaluate the effectiveness and cost of the ALARA controls, document the lessons learned, and make recommendations on ways to control dose and contamination for similar activities. The ALARA review should be documented and records should be readily retrievable. In the special case of an ALARA review for a planned special exposure, additional requirements are described under 10 CFR 835.204. 4.2.6.1 Consideration of Non-radiological Hazards The work planning process should integrate the consideration of other industrial, physical, and chemical hazards that an individual may encounter. Efforts to maintain worker doses ALARA should ensure that the risk of personnel injury from other hazards is not disproportionately increased. The ALARA process must consider the impact of other occupational hazards when optimizing worker radiation dose. For example: • excessive protective clothing to control personnel contamination events may lead to heat stress situations. • respiratory protective devices used to reduce intakes of radionuclides may impair visual acuity and communications capabilities between workers. • protective clothing to protect workers from chemical hazards may slow work down leading to increased worker dose. An integrated approach during the work planning process will ensure that all occupational hazards are appropriately considered and the ALARA process is followed. 10 CFR 851, Worker Safety and Health Program (DOE 2006c) provides requirements for worker safety and health. The worker safety and health program must integrate the DOE G 441.1-1B 51 (and 52) 3-1-07 Rule’s requirements with other site worker protection activities and the integrated safety management system (ISMS) [851.11(a)(3)(ii)]. Coordination should be established, maintained, and documented among worker safety and health technical disciplines and other safety and health organizations (e.g., radiation control) at a site to ensure successful implementation of the worker safety and health program.

Additional information concerning DOE expectations for integrating safety management can be found in Department of Energy Acquisition Regulations (DEAR) clause 48 CFR 970.5223-1, Integration of Environment, Safety and Health into Work Planning and Execution. This states that “the contractor will manage and perform work in accordance with a documented Safety Management System (System).” DOE G 440.1-8, Implementation Guide for Use with Title 10 code of Federal Regulations Part 851 (DOE 2006d) provides guidance for establishing and implementing an ISMS program. 4.3 Records Actions taken to maintain occupational exposures ALARA shall be documented and retained [10 CFR 835.701(a) and 835.704(b)]. Administrative controls discussed in this Guide should include the systematic generation and retention of those auditable records and reports that document major actions considered or taken to attain and maintain occupational doses and the spread of radioactive contamination ALARA. The RCS and Chapter 13 provide detailed guidance on record-keeping. All documents and legal records used to demonstrate compliance with ALARA program requirements should be reviewed and approved by supervisory or line management. DOE G 441.1-1B 53 3-1-07 5.0 INTERNAL DOSIMETRY PROGRAM Radiation protection programs for limiting intakes of radioactive material are based on the DOE policy of controlling radioactive material at the source. It is nonetheless recognized that low-level, chronic, or intermittent occupational exposures to some materials may be difficult to avoid due to the types of material handled or processed, their chemical or physical forms, and the nature of operations, and that incidents may cause unplanned releases of radioactive material. 10 CFR 835.402(c) requires internal dosimetry programs (including routine radiobioassay programs) be conducted for radiological workers, declared pregnant workers, occupationally exposed minors, and members of the public entering controlled areas who are likely to receive intakes that exceed specified levels for committed effective dose equivalent in a year. An internal dosimetry program generally consists of three elements: • An air monitoring program, using a combination of real-time, fixed, and portable devices, as appropriate; • an individual monitoring program, using direct and/or indirect radiobioassay, and personal breathing zone (BZ) air monitoring, as appropriate; • a dose evaluation program that evaluates the data collected by the air and individual monitoring programs to determine the magnitude of individual doses. 5.1 Implementation Guidance This section provides guidance for establishing and conducting internal dosimetry programs for individuals who have the potential for intakes of radioactive materials. It includes guidance for design and implementation of the radiobioassay program, and guidance for evaluating, recording, reporting, and managing internal doses. Additional technical guidance is provided in DOE-STD-1121-2003, INTERNAL DOSIMETRY (DOE 2003) and the National Council on Radiation Protection and Measurements (NCRP) Report No. 87, Use of Radiobioassay Procedures for Assessment of Internal Radionuclide Deposition (NCRP 1987a). An acceptable internal dosimetry program includes the following features: • adequate staff with appropriate technical training; • internal dosimetry technical basis documentation providing scientific information and other rationale explaining essential elements of the internal dosimetry program to support dose evaluation methods;

• written policies and procedures covering essential steps in the activities used to determine worker internal dose; • criteria and methods for implementing an appropriate air monitoring program; 54 DOE G 441.1-1B 3-1-07 • defined criteria for identifying workers who need to participate in the individual monitoring program; • appropriate radiobioassay measurement methods and frequencies; • methods for control, accountability, and safe handling of samples; • appropriate dosimetric models and default parameters for evaluating internal dose; • timely analysis of radiobioassay samples and measurements, transmission of results, dose evaluation, and recommendations to operations management; • adequate detection capability and quality of radiobioassay measurements; • defined criteria and actions for identifying individuals with suspected intakes, based on workplace measurements and radiobioassay measurements; • appropriate action level guidelines; • defined program to report internal doses to workers, management, and DOE; • historical records of radiobioassay measurement results and dose evaluations; • historical records of the program, and changes in the program over time; and a quality assurance program covering essential steps in the activities that determine worker internal dose. 5.2 Program Management and Administration 5.2.0 General Requirements The internal dosimetry program shall be adequate to demonstrate compliance with the dose limits established in Subpart C of 10 CFR 835 [10 CFR 835.402(d)]. In addition, radiobioassay programs implemented to demonstrate compliance with the requirements in 10 CFR 835.402(c) (individual monitoring thresholds) shall be: • accredited or excepted from accreditation in accordance with the DOELAP for Radiobioassay [10 CFR 835.402(d)(1)]; or • determined by the Secretarial Officer responsible for environment, safety and health matters (i.e., the Chief Health, Safety and Security Officer) to have performance substantially equivalent to that of programs accredited under DOELAP for radiobioassay [10 CFR 835.402(d)(2)]. Guidance for achieving accreditation or exception from accreditation under DOELAP is provided in DOE-STD-1111-98, DEPARTMENT OF ENERGY LABORATORY DOE G 441.1-1B 55 3-1-07 ACCREDITATION PROGRAM ADMINISTRATION (DOE 1998b). Requests for other program determinations will be considered by DOE on a case-by-case basis. The provision requiring accreditation for radiobioassay programs implemented to demonstrate compliance with 10 CFR 835.402(c) does not reflect an intent to provide a lesser degree of protection to individuals unlikely to receive doses exceeding the regulatory monitoring thresholds, nor does it express a desire to establish two separate radiobioassay programs (i.e., an accredited program for individuals likely to exceed the regulatory monitoring thresholds and a non-accredited program for individuals who are unlikely to exceed these thresholds). Rather, those individuals who are unlikely to exceed the regulatory monitoring thresholds are provided an adequate degree of protection by the various engineering and administrative controls that limit their internal doses. Implementation of a comprehensive air monitoring program in accordance with 10 CFR 835.401 and 403 verifies the effectiveness of these controls. When an accredited radiobioassay program already exists and management of any given facility chooses to provide monitoring for those individuals who are unlikely to exceed the regulatory monitoring threshold, consideration should be given to using the accredited program. This will obviate the need to implement two radiobioassay programs, one accredited and the other not. In addition, it will avoid giving workers who are not required to be monitored the impression that they are being provided a lesser degree of protection. However, this does not imply that the monitoring program for those unlikely to exceed the monitoring threshold must be accredited.

Sections 401 through 403 of 10 CFR 835 establish specific monitoring requirements for areas and individuals. 10 CFR 835 also establishes requirements for maintaining individual monitoring records (10 CFR 835.702) and reporting radiation doses to individuals (10 CFR 835.801). 5.2.1 Organization, Staffing, and Facilities 5.2.1.0 Organization The internal dosimetry program should be administered by the radiological control organization under the leadership of the radiological control manager. The internal dosimetry program should have a designated leader with demonstrated expertise in internal dose evaluation. When elements of the internal dosimetry program are performed by one or more subcontractors, the radiological control organization should establish an arrangement of contractual standards and assessments that ensure that subcontractors meet all applicable requirements in 10 CFR 835, the documented Radiation Protection Program (RPP), DOELAP standards, and the internal dosimetry technical basis document. 5.2.1.1 Staffing The radiological control organization management should ensure that the internal dosimetry program is adequately staffed to carry out its functions. The analysis of workplace and radiobioassay measurement data and the evaluation of internal dose 56 DOE G 441.1-1B 3-1-07 involve complex evaluation and professional judgment. Personnel with responsibility for internal dose evaluation should have the necessary expertise and skill, based on appropriate education and training in conjunction with practical experience, to perform their assigned duties. Additional guidance on education, skills, and training is provided in Chapter 3. It is important that internal dosimetry specialists be capable of recognizing conditions warranting follow-up radiobioassay and dose evaluation. Personnel should be familiar with the relevant internal dosimetry literature and the recommendations of national and international scientific organizations with regard to internal dose evaluation. Management of the radiological control organization should establish minimum requirements for those staff who evaluate internal doses. These requirements should include both experience and education requirements. Suggested educational background and formal training needed for internal dosimetry program key positions are listed in DOE-STD-1107-97, KNOWLEDGE, SKILLS, AND ABILITIES FOR KEY RADIATION PROTECTION POSITIONS AT DOE FACILITIES (DOE 1997b). Members of the internal dosimetry staff should meet these requirements, or the staff should have access to individuals with the required background (perhaps through interdepartmental agreements or contracted services). It is not necessary for all personnel on the staff to have expertise in all of the listed subject areas. 5.2.1.2 Facilities and Resources Computational facilities and software tools used by internal dosimetry personnel should be adequate for performing calculations required for the evaluation of dose from radionuclides in the body. A library of handbooks, reference materials, scientific publications, and other resources pertaining to internal dosimetry should be readily available. Suggested reference materials are included in the reference chapter of this Guide. DOE O 414.1C, Quality Assurance (DOE 2005a), establishes quality process requirements to be implemented under a QA program (QAP) for the control of suspect/counterfeit items (S/CIs), safety issue corrective actions, and safety software.

5.2.2 Technical Basis Document Internal dosimetry technical basis documentation should be developed and should include technical methods, supporting evidence, and reference information used to provide the technical foundation for the internal Dosimetry program. The internal dosimetry technical basis documentation should provide the approach to evaluating internal doses from radiobioassay data, and for situations in which there is no practical radiobioassay, from representative air monitoring or other appropriate data. The technical basis documentation should address all of the topics listed under Section 3.1 of DOE-STD-1121-2003. The technical basis documentation should be reviewed periodically and updated as necessary to ensure that the scientific bases are appropriate for current conditions. The technical basis documentation should be controlled and retained as a radiation protection program record. DOE G 441.1-1B 57 3-1-07 5.2.3 Internal Dosimetry Procedures Manual 10 CFR 835 requires that written procedures be developed and implemented as necessary to ensure compliance, commensurate with the radiological hazards created by the activity and consistent with the education, training, and skills of the individuals exposed to those hazards (10 CFR 835.104). Essential elements of the internal dosimetry program should be addressed in written procedures. These procedures should be consistent with 10 CFR 835, the DOELAP standard, and technical basis documentation. Detailed guidance on topics that should be addressed in the internal dosimetry procedures manual are discussed in Section 3.2 of DOE-STD-1121-2003. Additional guidance on written procedures is provided in Chapter 3 of this Guide. 5.2.4 Quality Assurance Quality Assurance for internal dosimetry programs is addressed in DOE-STD-1121-2003, Section 11. Quality assurance in support of internal dosimetry programs should be conducted in accordance with this DOE standard. The internal dosimetry program should be included as a functional element subject to the internal audit requirements of 10 CFR 835.102. Chapter 3 provides guidance on internal audit programs. External peer-review by qualified individuals, on a periodic basis, is also recommended. 5.3 Air Monitoring and Contamination Control Programs The objectives of an air monitoring program are to verify the integrity of radioactive material containment, detect the release of radioactive materials from some routine operations, detect inadvertent releases of those materials in the workplace, evaluate and provide the basis for modification to containment systems, provide a basis for the design of radiobioassay programs, and verify that selected groups do not need to participate in a radiobioassay program. Air monitoring programs and internal dosimetry programs are complimentary. The air monitoring program provides an indication of the effectiveness of engineering and administrative controls in preventing or minimizing worker intakes and the internal dosimetry program provides verification of the adequacy of these controls in preventing or minimizing worker intakes.

The air monitoring and contamination control programs supplement the individual monitoring program by providing a prospective assessment of radiological conditions, facilitating decisions regarding postings, access controls, work authorizations, and individual monitoring, and providing back-up data for use in individual dose evaluations. Because of the need to evaluate individual internal doses from intakes of radioactive material from uncontained sources, airborne radioactive material, and surface contamination, the air monitoring and contamination control programs should include methods for assessing the degree of hazard arising from each of these hazards to which individuals may be exposed. Guidance for implementing contamination control and air monitoring programs is provided in Chapters 10 and 11 of this Guide. 58 DOE G 441.1-1B 3-1-07 In most cases the air monitoring program is used to supplement and validate the individual monitoring program. However, in the case when there is no practical radiobioassay method or when there is a technology shortfall (e.g., the DIL is less than the MDA) the air monitoring program may be the basis for the determination of internal doses. These two cases are discussed below. 5.3.0 Air Monitoring When There Is No Practical Radiobioassay Method In situations where no radiobioassay method is available for the radionuclides in question, and no radiobioassay program, either routine or special, can show compliance with 10 CFR 835, personal (BZ) air monitoring may be used for demonstrating compliance with 10 CFR 835. BZ air monitoring is part of the Individual Monitoring Program which is detailed below. However, other fixed or portable monitoring instruments that provide either real-time (such as continuous air monitors) or retrospective (such as grab sampling which is analyzed at some time after the sample is collected) may be required when BZ monitoring data is not available or to supplement or validate the BZ data if it is available. Radionuclides with short half-lives, including the short-lived decay products of 222Rn (“radon” decay products 218Po, 214Pb, 214Bi, and 214Po) and 220Rn (“thoron” primary decay products 212Pb and 212Bi) are examples of radionuclides where intakes cannot be determined through radiobioassay and must be determined from personal air monitoring. For detailed information on non-background exposures to radon and thoron, see DOE-STD-1121-2003, Section 4.5. Monitoring programs for Radon and Thoron should be in accordance with the DOE standard. 5.3.1 Recourse for Technology Shortfall (DIL<MDA) DILs for reasonable and practical routine radiobioassay programs may be significantly less than the achievable MDA for certain radionuclides, such as plutonium. Since a technology shortfall for routine radiobioassay exists, the facility should consider the following actions (note that some of these suggested actions fall under the category of individual as opposed to area monitoring, but for completeness they are all listed below): • enhance contamination and air monitoring and the use of indicators (e.g., unexpected glove or surface contamination, increase in airborne radioactive material contamination) to trigger early special radiobioassay monitoring; • enhance personal contamination monitoring (e.g., clothing, skin, nasal smears) to trigger special radiobioassay monitoring; • use the best practicable radiobioassay monitoring methods;

• implement enhanced design, operation, controls, and personnel protection equipment and procedures to minimize intakes; • implement supplementary air monitoring; and DOE G 441.1-1B 59 3-1-07 • document and justify the planned supplementary approach in the facility's internal dosimetry technical basis documentation. When air monitoring data are used, each worker's stay times (in hours) and the average concentration (in DACs) to which the worker is exposed should be multiplied to yield exposures to airborne radioactive materials in units of DAC-hours. Forty (40) DAC-hours corresponds to 0.1 rem (0.001 Sv) committed effective dose equivalent for radionuclides with stochastic Annual Limits on Intake. A technology shortfall for routine radiobioassay should not be sufficient cause for failing to place individuals on a minimum or best-available radiobioassay program. Refer to DOE-STD-1121-2003, Section 4.4.4, for a discussion and examples of technology shortfalls and suggested methods to handle such situations. 5.4 Individual Monitoring Program Individual monitoring programs should be designed in accordance with Section 4 of DOE-STD-1121-2003 and should: • provide for investigation of suspected intakes; • provide data for evaluating internal dose; and • provide results that are adequate to demonstrate compliance with the radiation dose limits given in 10 CFR 835. The primary methods of routine and special worker radiobioassay are direct (in vivo) radiobioassay and indirect (in vitro) radiobioassay. International Commission on Radiological Protection (ICRP) Publication 54, Individual Monitoring for Intakes of Radionuclides by Workers: Design and Interpretation (ICRP 1989) as well as the previously referenced NCRP Report No. 87 are suggested supplementary references for individual monitoring program design. In situations where there is no practical radiobioassay, representative air monitoring (e.g. breathing zone (BZ) air monitoring) is the preferred measurement method on which to base dose evaluations. Additional guidance on air monitoring programs may be found in Chapter 10 of this Guide. 5.4.0 Establishing the Need for Individual Monitoring Radiological workers who could likely receive intakes resulting in 0.1 rem (0.001 Sv) or more committed effective dose equivalent in a year shall participate in an internal dose evaluation program [10CFR 835.402(c)(1)]. Declared pregnant workers, occupationally exposed minors, and members of the public are also required, under specific conditions [see 10 CFR 835.402(c)] to participate in internal dosimetry programs. Criteria for participation in individual monitoring programs which include baseline radiobioassay, routine radiobioassay and/or air sampling, Radon and thoron monitoring, special radiobioassay, and termination or task-ending radiobioassay, radiobioassay for declared 60 DOE G 441.1-1B 3-1-07 pregnant women, and confirmatory radiobioassay are covered in DOE-STD-1121-2003, Section 5. This section of the technical standard also discusses timely receipt of radiobioassay results. Participation in individual monitoring programs for internal dosimetry should be in accordance with the DOE technical standard. ICRP Publication 54 is also a recommended reference.

Situations may arise where a decision is made to monitor radiological workers who are not likely to receive intakes that exceed 0.1 rem (0.001 Sv) committed effective dose equivalent in a year. Such monitoring may be useful for demonstrating compliance with 10 CFR 835.401(a) or established for other purposes. The internal dosimetry program documentation should clearly identify those individuals or groups of individuals being monitored for such purposes. 5.4.1 Investigation Levels/Derived Investigation Levels Refer to DOE-STD-1121-2003, Sections 4.3 and 4.4 for a discussion of and reference levels for Investigation Levels (ILs) and Derived Investigation Levels (DILs). Programs should be designed in accordance with this technical standard. Refer to DOE-STD-1121-2003, Section 4.4.1 for a discussion of factors affecting the DIL. Additionally, section 4.4.2 provides guidance for calculating the DIL for a given sample frequency, Section 4.4.3 discusses factors affecting the DIL for air sampling, and Section 4.4.4 deals with supplementing routine radiobioassay programs when DIL< MDA (technology shortfall). Programs should be designed in accordance with this technical standard. 5.4.2 Minimum Detectable Amount (MDA) The internal dosimetry program staff should determine the minimum detectable amount (MDA) for each radiobioassay and BZ air monitoring method for each radionuclide present. The MDAs should be documented in procedures and their statistical bases given in the internal dosimetry technical basis documentation. ANSI Standard N13.30-1996, Performance Criteria for Radiobioassay, (ANSI/HPS 1996) provides extensive guidance on the calculation of MDAs. As MDAs are affected by various aspects involved with individual monitoring methods, procedures should contain descriptions of the method(s) of individual monitoring measurements (e.g., urinalysis, fecal analysis, in vivo counting, BZ air monitoring), analytical methodology (e.g., chemical separation followed by alpha counting), and measurement parameters (e.g., counting time or instrument efficiency) to be used in each component of the individual monitoring program. Several other factors affect the method of radiobioassay used and its associated MDA. They include: • the possible need for improved detection capability to assess individual dose during the special radiobioassay following an intake requiring internal dose DOE G 441.1-1B 61 3-1-07 evaluation, due to diminishing amounts of material in compartments as time goes on; • the need for improved precision and accuracy if residual retention and excretion from prior intakes interferes with the detection of additional intakes in subsequent years; • timeliness of results needed to manage individuals and keep subsequent intakes low enough to avoid exceeding dose limits; • convenience to the affected individuals; • costs, including lost production time while individuals are participating in the radiobioassay program; and • the impact of the method of radiobioassay on the frequency of radiobioassay measurements. Where practicable, the method of individual monitoring, analytical methodology, and measurement parameters should result in an MDA less than the corresponding DIL for all radionuclides to which an individual might be exposed. The methods of radiobioassay and air monitoring measurements, their MDAs, and their accuracies should be specified in the internal dosimetry technical basis documentation, along with a rationale or justification for the methods chosen.

5.4.3 Frequency of Measurement The routine radiobioassay measurement frequency depends on the radiobioassay measurement method and associated MDA. The frequency should be chosen so that it is unlikely that intakes by an individual in a year will result in doses exceeding one IL without detection. 5.4.4 Detection and Confirmation of Intakes Section 6 of DOE-STD-1121-2003 provides acceptable methods for detecting and confirming intakes through workplace monitoring and radiobioassay. Statistical methods for confirming that an intake has occurred are also discussed. Decisions regarding the detection and confirmation of suspected occupational intakes of radioactive material should be based on answers to the following questions: • Can it be concluded reliably that the analyte is present in the measured sample (>Lc)? • Is the measurement result unexpected? In other words, is the result beyond the range of values that would be expected due to environmental “background” sources or due to previously recognized intakes? 62 DOE G 441.1-1B 3-1-07 • Is the intake (and resulting dose) implied by the measurement significant enough (e.g., greater than the IL) to warrant follow-up measurements or investigation? If the answer to all these questions is “yes”, then follow-up measurements or investigation is warranted. Internal dosimetry programs should establish appropriate and technically-based decision criteria to assist in answering these questions. Such decision criteria should be included in the technical basis document for the site or facility. The proper decision criteria for the first question is the Lc which is a purely statistical concept based on an acceptable probability of “false positive” conclusions. The Lc for radiobioassay and air sample measurements should be set by considering the acceptable rate of false positives, the cost and consequences of false positives, and the dosimetric consequences of false negatives. The analytical laboratory Lc should be based on a reagent blank. Radiobioassay results above the Lc may be expected in the absence of a new intake due to normal statistical fluctuations, non-occupational or environmental sources, or prior confirmed intakes. In the case of environmental sources of interference (e.g., uranium in urine) an “occupational decision level” should be established, above which the measurement result is concluded to be statistically significant and above the range of values that would normally be expected from environmental sources of the radionuclide. In the case of prior confirmed intakes, an individual-specific “occupational decision level” should be established, which takes into account the expected contribution from the prior intakes. Finally, for each route of intake, measurement type, and radioactive material of interest (taking into account particle size, inhalation class, etc.), time-dependent DILs should be established. Such DILs are based solely on dosimetric considerations, and typically correspond to an implied intake (and corresponding dose) of 1 investigation level, i.e., 0.1 rem. This Guide has adopted the value of 0.1 rem (0.001 Sv) CEDE as the value which, for regulatory purposes, is regarded as sufficiently important to justify further investigation. However, a site or facility may wish to establish lower follow-up levels for ALARA purposes.

If the measurement result is statistically significant, unexpected, and dosimetrically significant, then follow-up measurements and/or an investigation should be done to attempt to confirm or rule out the intake. An intake should be considered to be confirmed if the three criteria above are satisfied and the measurement result is associated with a known incident, or appropriate follow-up measurements meet the three criteria above, or follow-up investigation indicates that an intake has occurred. Refer to DOE-STD-1121-2003, Section 6, for additional information on the detection and confirmation of intakes. Table 3 addresses reference levels for interpreting or responding to intake monitoring results. Program elements which address the detection and confirmation of intakes of radionuclides should be in accordance with the DOE technical standard. ANSI N13.30-1996 and ICRP Publication 54 are suggested references. Additionally, NCRP Report No. 84, General Concepts for the Dosimetry of Internally Deposited Radionuclides (NCRP 1985) and ICRP Publication 30, Limits for Intakes of Radionuclides by Workers (ICRP 1979), may be useful references. DOE G 441.1-1B 63 3-1-07 5.4.5 Internal Dose Management Internal dose management, which includes routine radiological worker dose management, management of dose from previous intakes (work restrictions), control of dose to the embryo/fetus, control of dose to minors and students, dose limitation, interface with the external dosimetry program, lifetime dose control, accidental dose control, and internal dose control after an incident, is covered in DOE-STD-1121-2003, Section 8. Individual programs should be in accordance with the DOE technical standard. 5.4.6 Planned Special Exposures Planned special exposures are included in an individual’s occupational dose record, but shall not be considered when determining compliance with the occupational dose limits of 10 CFR 835 [10CFR 835.204(a)]. In order to maintain separate records of doses resulting from planned special exposures and routine occupational exposures, dosimetry adequate to measure the potential doses and appropriate for the work to be performed and specific radiological circumstances should be provided for the planned special exposure. 5.4.7 Medical Response Medical response is addressed in DOE-STD-1121-2003, Section 10. The standard addresses situations where internal dosimetry actions and medical treatment occur simultaneously, the role of the health physicist in medical treatment, when to treat, how to treat, the impact of therapy on dosimetry, and the counseling of workers. Medical response should be handled in accordance with the DOE technical standard. 5.5 Internal Dose Evaluation 10 CFR 835 requires internal dose evaluation programs for assessing intakes of radionuclides and for maintaining adequate worker exposure records. Technical details and extensive references for internal dose evaluation are given in DOE-STD-1121-2003. ICRP Publications 30 and 54, NCRP Report No. 84, and ANSI N13.30 are additional suggested references. 5.5.0 Required Dose Calculations Internal doses should be evaluated for all confirmed intakes, as defined in Section 5.3.5 of this Guide. For intakes confirmed with radiobioassay results below the DIL, no further investigation or follow-up radiobioassay are indicated. For intakes confirmed with radiobioassay results above the DIL or exposures greater than 40 DAC-hours, follow-up radiobioassay (if practical) and investigation should be performed.

The extent of the investigation and the number and frequency of special radiobioassay measurements following a suspected or confirmed intake should be determined and documented on an individual, case-specific basis, taking into account the potential magnitude of the intake, the effective clearance half-time, the health of the worker, and the number of measurements needed to evaluate the internal dose. 64 DOE G 441.1-1B 3-1-07 The schedule and frequency of long-term special radiobioassay measurements to evaluate the CEDE to an individual who has had an intake resulting in a dose in excess of one IL should depend on the expected magnitude of the CEDE and the likelihood of the individual receiving additional intakes. While the investigation should be tailored to the specific individual and exposure circumstances, the trigger levels and preliminary actions to be taken for exposures to the different radionuclides encountered at the facility should be documented in the internal dosimetry technical basis documentation and procedures. 5.5.1 Interpretation of Radiobioassay Data Technical details on the interpretation of radiobioassay data including the use of biokinetic models are given in DOE-STD-1121-2003, Section 7. Radiobioassay data should be interpreted in accordance with the applicable portions of this DOE technical standard. Evaluations of CEDE from a specific intake should account for expected values of radiobioassay measurements from prior confirmed intakes. 5.5.2 Evaluation of Internal Dose from Radiobioassay and Air Monitoring Data Methods for evaluating the various doses from intakes should be specified in the internal dosimetry technical basis documentation. The methods should be based on recommendations, consistent with DOE requirements, given in ICRP Publications, NCRP Reports, and ANSI standards which embody improvements and updates of the science of internal dosimetry. Other methods may be used provided they are documented and justified in the procedures and/or internal dosimetry technical basis documentation. In the calculation of internal doses less than one IL, default parameters may be used. These parameters (e.g., intake date, deposition fractions, retention functions, organ masses, and absorption fractions) should be based on the recommendations of the ICRP, NCRP, other relevant technical references, or facility-specific factors as documented in the internal dosimetry technical basis documentation. If the initial evaluation of an intake indicates a dose in excess of 10 times an IL, individual-specific and facility-specific factors should be used when more appropriate parameters are expected to change the dose calculations by a factor of 1.5 or more (ICRP Publication 54, paragraph 74). Between 1 and 10 times the IL, either default parameters or individual- and facility-specific parameters may be used, as deemed appropriate and documented by the internal dosimetry staff. The basis for determining which individual-specific and facility-specific factors are expected to change the dose calculations by a factor of 1.5 or more should be documented in the internal dosimetry technical basis documentation. Determination of individual retention patterns for a worker requires participation in the special radiobioassay program and may require temporary work restriction or reassignment to prevent subsequent intakes from confounding the dose evaluation. DOE G 441.1-1B 65 (and 66) 3-1-07 5.5.3 Periodic Reevaluation of Internal Dose

In the case of certain well-retained radionuclides (e.g., plutonium), long-term follow-up and reevaluation of doses may be required. The internal contribution to lifetime occupational dose should continue to be reevaluated as further radiobioassay results and improved methods for evaluating internal dose become available. Evaluations for general employees with prior confirmed intakes should be revised when information demonstrates a change in the currently evaluated CEDE of 0.5 rem (0.005 Sv) or a factor of 1.5 of the previously assigned dose for that intake, whichever is higher. In cases where intakes are detected or confirmed in a year subsequent to the year of the intake, the CEDE should be attributed to the known or assumed year of the intake, and all records and reports for that year should be amended as appropriate. 5.6 Recordkeeping and Reporting Requirements and guidance for recording and reporting internal doses and related information are provided in Chapter 14 and DOE-STD-1121-2003, Section 9. Record-keeping and reporting of internal doses and related information should be in accordance with these DOE documents. DOE G 441.1-1B 67 3-1-07 6.0 EXTERNAL DOSIMETRY PROGRAM Due to the types of material handled or processed, low-level, chronic occupational exposures to external ionizing radiation are difficult to avoid, necessitating an external dosimetry program at most DOE and DOE-contractor facilities that use, handle, or store radioactive materials. An external dosimetry program generally consists of three elements: • an area monitoring program, using an array of fixed and portable devices, as appropriate; • an individual monitoring program, using personnel dosimeters; and • a dose evaluation program that evaluates the data collected by the area and individual monitoring programs to determine the magnitude of individual doses. 6.1 Implementation Guidance This chapter provides guidance for establishing and conducting an external dosimetry program for individuals who are likely to be exposed to external sources of ionizing radiation. Conduct of an external dosimetry program involves determining area and individual monitoring methods and frequencies, distributing and controlling monitoring devices, and evaluating external doses. This chapter also addresses program organization, administration, staffing, and training. An external dosimetry program should include the following features: • adequate staff provided with appropriate technical training; • a technical basis document that explains each program element; • procedures that address each step in the activities that determine external dose; • criteria and methods for implementing the area monitoring program; • criteria and methods for identifying individuals who require individual monitoring; • appropriate personnel dosimeter measurement methods and frequencies; • methods for control, accountability, and safe handling of dosimeters; • appropriate dosimetric models and default parameters for evaluating external dose; • timely analysis of personnel dosimeter measurements and transmission of results, dose evaluation, and recommendations to monitored individuals, management, and DOE, as appropriate; 68 DOE G 441.1-1B 3-1-07 • historical records of the external dosimetry program, procedures, and results; and • a quality assurance (QA) program that covers all steps in the activities that determine individual external dose. 6.2 Program Management and Administration

6.2.0 General Requirements The external dosimetry program implemented to demonstrate compliance with 10 CFR 835.402(a) shall be adequate to demonstrate compliance with the dose limits established in Subpart C of 10 CFR 835 [10 CFR 835.402(b)] and shall be: • accredited by the DOE Laboratory Accreditation Program (DOELAP); or • excepted from DOELAP accreditation in accordance with the DOELAP standards; or • determined by the Secretarial Officer responsible for environment, safety and health to have performance substantially equivalent to that of programs accredited under the DOE Laboratory Accreditation Program for Personnel Dosimetry [10 CFR 835.402(b)]. Guidance for achieving accreditation or exception from accreditation under the DOELAP Program is provided in DOE-STD-1111-98. DOE will consider requests for other program approvals on a case-by-case basis. The specification of accreditation requirements only for programs implemented to demonstrate compliance with 10 CFR 835.402(a) does not reflect an intent to provide a lesser degree of protection to individuals unlikely to receive doses exceeding the regulatory monitoring thresholds, nor does it reflect DOE’s intent for it’s contractors to establish two separate individual monitoring programs (i.e., an accredited program for individuals likely to exceed the regulatory monitoring thresholds and a non-accredited programs for individuals who are unlikely to exceed these thresholds). Rather, those individuals who are unlikely to exceed the regulatory monitoring thresholds are provided an adequate degree of protection by the various engineering and administrative controls that limit their doses. Implementation of a comprehensive area monitoring program verifies the effectiveness of these controls. When an accredited dosimeter program already exists and management of any given facility chooses to provide monitoring for those individuals who are unlikely to exceed the regulatory monitoring threshold, consideration should be given to using the accredited program. This will obviate the need to implement two dosimeter programs, one accredited and the other not. In addition, it will avoid giving workers who are not required to be monitored the impression that they are being provided a lesser degree of protection. However, this does not imply that the monitoring program for those unlikely to exceed the monitoring threshold must be accredited. DOE G 441.1-1B 69 3-1-07 Sections 401 - 403 of 10 CFR 835 establish specific monitoring requirements for areas and individuals. 10 CFR 835 also establishes requirements for preserving dosimetric records and reporting external radiation doses to individuals. 6.2.1 Organization, Staffing, And Facilities 6.2.1.0 Organization The external dosimetry program should be administered by the radiological control organization under the leadership of the radiological control manager. When elements of the external dosimetry program are performed by a subcontractor, the radiological control organization should establish contractual standards and assessments that ensure the subcontractor meets all applicable requirements in 10 CFR 835, the documented radiation protection program (RPP), DOELAP standards, and the technical basis document. 6.2.1.1 Staffing

Management should maintain an adequate staff with the necessary expertise and skill to implement the external dosimetry program. For staff members responsible for evaluating external doses, management should establish minimum qualification standards that include both experience and education requirements. Additional guidance on education, skills, and training is provided in Chapter 3 and DOE STD-1107-97, KNOWLEDGE, SKILLS, AND ABILITIES FOR KEY RADIATION PROTECTION POSITIONS AT DOE FACILITIES (DOE 1997b). Personnel should be familiar, at a level commensurate with their assigned responsibilities, with relevant external dosimetry literature and related recommendations of national and international scientific organizations. 6.2.1.2 Facilities and Resources Computational facilities and software tools used by external dosimetry personnel should be adequate for performing calculations required for dose evaluation. A library of handbooks, reference materials, scientific publications, applicable regulations and guidance documents should be readily available. 6.2.2 Technical Basis Document A technical basis document should be developed for the external dosimetry program to provide (or provide reference to) the regulatory, scientific, and technical foundation of the program. The technical basis document should include: • the methods used for evaluating external doses from workplace and individual monitoring data and the technical basis for those methods; • justification of categories selected for participation in and exception from DOELAP personnel dosimeter performance testing; 70 DOE G 441.1-1B 3-1-07 • QA procedures for dosimeters that are outside of the DOELAP testing protocol, as appropriate; • the physical characteristics of external radiation to be monitored, methods for calculating external doses, methods for documenting calculations, dose evaluation quality assurance, and procedures for recording and reporting external dose results; • the methodology used in determining the dose of record when multiple dosimeters are used and when dosimeters are relocated; • individual monitoring methods, their lower limits of detectability, and monitoring intervals, along with a rationale or justification for the methods and intervals chosen; • calibration models, parameters, assumptions, and default values used in dosimetric modeling and evaluation; and • statistical methods for evaluating dosimeter data, using appropriate controls, identifying above-background values, and analyzing trends. The technical basis document should be reviewed periodically and updated as necessary to ensure that it remains appropriate for current conditions. The technical basis document should be handled as a controlled document and retained as an RPP record. 6.2.3 Procedures 10 CFR 835 requires that written procedures be developed and implemented as necessary to ensure compliance, commensurate with the radiological hazards created by the activity and consistent with the education, training, and skills of the individuals exposed to those hazards (10 CFR 835.104). All functions of the external dosimetry program should be specified in written procedures that provide for appropriate quality control and QA measures. The procedures should be consistent with 10 CFR 835, the DOELAP technical standards, and the technical basis document. In summary, the procedures should provide the following information: • methods and requirements for measuring, evaluating, and recording external dose;

• methods for consistent collection of workplace and personnel monitoring data, its evaluation, documentation of results, and records maintenance; • components and reporting structure of the external dosimetry program; • responsibilities of line management and members of the dose evaluation group; and DOE G 441.1-1B 71 3-1-07 • elements of the area monitoring program that are germane to external dose determination. Additional guidance on written procedures is provided in Chapter 3. 6.2.4 Quality Assurance Internal audits shall be conducted such that all functional elements are reviewed no less frequently than every 36 months and shall include program content and implementation (10 CFR 835.102). External peer-review by qualified individuals, on a periodic basis, is also recommended. See Chapter 3 for further information on internal audits. 6.3 Area Monitoring Program The area monitoring program supplements the individual monitoring program by providing a prospective assessment of radiological conditions, thus facilitating decisions regarding postings, access controls, work authorizations, and individual monitoring, and providing back-up data for use in individual dose evaluations. Because of the need to evaluate individual external doses (prospectively and retrospectively) from contained sources, airborne radioactive material, and surface contamination, the area monitoring program should include methods for assessing the degree of hazard arising from each of these hazards to which individuals may be exposed. Guidance for implementing surface contamination and airborne radioactivity monitoring programs is provided in Chapters 10 and 11. Guidance for implementing area monitoring for other external sources of radiation is provided below. For each element of the area monitoring program, additional guidance is provided in Chapter 5 of the RCS. 6.3.0 Monitoring Instruments and Devices External radiation monitoring instruments and devices include both fixed and portable instruments that provide real-time indication of radiation levels and passive monitoring devices (such as TLDs and radio-sensitive film) that provide a retrospective indication of radiological conditions. Guidance on portable instrument selection, calibration, and checking for operability is provided in Chapter 9. While Chapter 9 addresses portable instruments, many of the concepts and practices discussed in Chapter 9, and in the referenced consensus standards, may be applicable to fixed instruments. Although fixed instruments provide the advantage of continuous operation with little or no attention, their application is limited by their lack of mobility. Fixed instruments should be used to monitor areas and installations: • having a known and relatively predictable operation where little variation in the radiological hazards is expected; • where monitoring of an access point (and possible provision of an alarm function) is desirable to warn individuals of hazards in the area; 72 DOE G 441.1-1B 3-1-07 • where it is desirable to continuously monitor an area to detect changes in radiological conditions, possibly as a result of an unplanned change in process functions; • where continuous monitoring and alarm functions are necessary to prevent unplanned exposures; and • as necessary to provide input into interlocks, control devices, and alarm systems that are dependent upon or that control the operation being monitored

Portable instruments are most appropriate for use in performing prospective monitoring for the purposes of work planning, radiological condition verification, facility integrity verification, and operational assessments. The quality and utility of the data provided by portable instruments are highly dependent upon the knowledge and skills of the user. Because of these important applications and significant vulnerabilities, portable instruments should be used only by trained individuals (such as specifically-trained radiological workers and radiological control technicians). Passive monitoring devices (e.g., area monitoring TLDs) should be placed in areas surrounding radiological areas to verify that doses in these areas do not exceed the individual monitoring threshold. Passive monitoring devices should be placed where they will be exposed to radiation fields similar to those affecting individuals frequenting the area, but should be protected from loss or vandalism. The use of passive monitoring devices to characterize radiation fields as a part of pre-job planning should also be considered. 6.3.1 Performance of Area Radiation Monitoring 10 CFR 835 defines radiation and high radiation areas in terms of the radiation levels at a distance of 30 centimeters from the source or from any surface penetrated by the radiation. Similarly, 10 CFR 835 defines very high radiation areas in terms of the radiation levels at a distance of 100 centimeters. Therefore, area radiation monitoring should be performed at th