DOE G 441.1-1C Chg 1 (Admin Chg), Radiation Protection Programs Guide for Use with Title 10, Code of Federal Regulations, Part 835, Occupational Radiation Protection

AVAILABLE ONLINE AT: INITIATED BY: www.directives.doe.gov Office of Health, Safety and Security DOE G 441.1-1C 05-19-08 Chg 1 07-08-11 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 DOE G 441.1-1C i 5-19-08 TABLE OF CONTENTS RADIATION PROTECTION PROGRAMS .............................................................. 1 1.0 PURPOSE AND APPLICABILITY ...................................................................... 1 1.1 USE OF CONSENSUS STANDARDS ...................................................... 2 1.2 ACRONYMS .............................................................................................. 3 2.0 DEFINITIONS ......................................................................................................... 6 3.0 RADIATION PROTECTION PROGRAMS ...................................................... 16 3.1 Implementation Guidance ......................................................................... 17 3.2 Organization and Administration .............................................................. 18 3.2.0 Administrative Processes .............................................................. 19 3.2.1 Radiological Control Organization ............................................... 20 3.2.2 Education, Training, and Skills ..................................................... 20 3.2.3 Internal Audit and Self Assessment .............................................. 22 3.2.4Radioactive Material Transportation Exclusion................................23 3.3 RPP Functional Elements ......................................................................... 24 Appendix 3.A Preparation, Review, and Approval of RPPs.................................. 26 4.0 ALARA ................................................................................................................... 39 4.1 Implementation Guidance ......................................................................... 39 4.2 ALARA Programs .................................................................................... 40 4.2.0 Formal Plans and Measures .......................................................... 40 4.2.1 Policy and Management Commitment.......................................... 41 4.2.2 ALARA Training .......................................................................... 41 4.2.3 Plans and Procedures .................................................................... 42 4.2.4 Internal Assessments/Audits ......................................................... 42 4.2.5 ALARA Design Review ............................................................... 42 4.2.6 Radiological Work/Experiment Administration and Planning ..... 46 4.2.6.0 Job/Task/Experiment Reviews....................................... 46 4.2.6.1 Consideration of Non-radiological Hazards .................. 47 4.3 Records ..................................................................................................... 48

5.0 INTERNAL DOSIMETRY PROGRAM ............................................................. 49 5.1 Implementation Guidance ......................................................................... 50 5.2 Program Management and Administration ............................................... 51 5.2.0 General Requirements ................................................................... 52 5.2.1 Organization, Staffing, and Facilities ........................................... 52 5.2.1.0 Organization ................................................................... 52 5.2.1.1 Staffing ........................................................................... 53 5.2.1.2 Facilities and Resources ................................................. 53 5.2.2 Technical Basis Document ............................................................ 53 5.2.3 Internal Dosimetry Procedures Manual ........................................ 54 5.2.4 Quality Assurance ......................................................................... 54 5.3 Air Monitoring and Contamination Control Programs ............................. 54 5.3.0 Air Monitoring When There Is No Practical Radiobioassay Method... ...................................... 55 5.3.1 Recourse for Technology Shortfall (DIL<MDA) ......................... 55 DOE G 441.1-1C ii 5-19-08 5.4 Individual Monitoring Program ................................................................ 56 5.4.0 Establishing the Need for Individual Monitoring ......................... 56 5.4.1 Investigation Levels/Derived Investigation Levels ...................... 57 5.4.2 Minimum Detectable Amount (MDA).......................................... 57 5.4.3 Frequency of Measurement........................................................... 58 5.4.4 Detection and Confirmation of Intakes ......................................... 58 5.4.5 Internal Dose Management ........................................................... 59 5.4.6 Planned Special Exposures ........................................................... 59 5.4.7 Medical Response ......................................................................... 60 5.5 Internal Dose Evaluation........................................................................... 60 5.5.0 Required Dose Calculations .......................................................... 60 5.5.1 Interpretation of Radiobioassay Data ............................................ 61 5.5.2 Evaluation of Internal Dose from Radiobioassay and Air Monitoring Data ............................................................................ 61 5.5.3 Periodic Reevaluation of Internal Dose ........................................ 61 5.6 Recordkeeping and Reporting................................................................... 62 6.0 EXTERNAL DOSIMETRY PROGRAM............................................................ 65 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 ................................................. 70 6.2.2 Technical Basis Document ............................................................ 70 6.2.3 Procedures ..................................................................................... 71 6.2.4 Quality Assurance ......................................................................... 71 6.3 Area Monitoring Program ......................................................................... 71 6.3.0 Monitoring Instruments and Devices ............................................ 72 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 Whole Body Monitoring ................................................... 76 6.4.1.1 Lens of the Eye Monitoring .............................................. 76 6.4.1.2 Skin and Extremity Monitoring ....................................... 77 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 .............................. 79 6.4.3 Nuclear Accident Dosimetry ......................................................... 79 6.4.4 Planned Special Exposures ........................................................... 80 6.4.5 Personal Protective Equipment ..................................................... 80 DOE G 441.1-1C iii 5-19-08 6.5 External Dose Evaluation ......................................................................... 80 6.5.0 Required Dose Calculations .......................................................... 80 6.5.1 Special Considerations .................................................................. 82 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 ............................................................................ 87 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 ...................................... 90 7.3.2 Area Posting .................................................................................. 90 7.3.2.0 Radiological Conditions................................................. 90 7.3.2.1 Operational Status .......................................................... 90 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 ......................................... 92 7.4.0.0 Shielding ........................................................................... 93 7.4.0.1 Access Control and Safety Devices ............................... 93 7.4.0.2 Interlocks........................................................................... 94 7.4.0.3 Device Controls ................................................................ 95 7.4.0.4 Run-Safe and Emergency Shutdown Devices ............... 95 7.4.0.5 Monitoring Instruments .................................................... 96 7.4.1 Guidance for Specific RGD Installations ..................................... 96 7.4.1.0 Accelerators ................................................................... 96 7.4.1.1 Electron Devices that Generate X-Rays Incidentally ....... 96 7.4.1.2 Cabinet X-Ray Systems ................................................. 97 8.0 EVALUATION AND CONTROL OF RADIATION DOSE TO THE EMBRYO/FETUS.................................................................................................. 98 8.1 Implementation Guidance ......................................................................... 98 8.2 Declaration of Pregnancy/Withdrawal of Declaration .............................. 98 8.3 Work Restrictions Following Declarations of Pregnancy ........................ 99 8.4 Counseling .............................................................................................. 101 8.5 Dose Determination and Monitoring Methods ....................................... 101 8.5.0 Dose Determination .................................................................... 101 8.5.1 Monitoring Methods ................................................................... 103 8.6 Training ................................................................................................... 103 8.7 Record -Keeping and Reporting ............................................................. 103 DOE G 441.1-1C iv 5-19-08 Appendix 8.A Declaration of Pregnancy Form ............... ……………………….104 Appendix 8.B Withdrawal of Pregnancy Declaration Form .................................. 105 Appendix 8.C Embryo/Fetal Equivalent Dose Record Form ................................ 106 9.0 PORTABLE MONITORING INSTRUMENT CALIBRATION ................... 107 9.1 Implementation Guidance ....................................................................... 108 9.2 Instrument Selection ............................................................................... 108 9.2.0 Type Testing ............................................................................... 109 9.2.1 Acceptance Testing ..................................................................... 109

9.3 Instrument Calibration ............................................................................ 109 9.4 Operability Tests ..................................................................................... 110 9.5 Maintenance ............................................................................................ 110 9.6 Calibration Equipment/Calibration Quality ............................................ 110 9.7 Laboratory Documentation ..................................................................... 111 9.7.0 Laboratory Protocol .................................................................... 111 9.7.1 Laboratory Records ..................................................................... 111 9.7.2 Instrument Calibration Records .................................................. 111 9.7.3 Instrument Location .................................................................... 112 9.8 Laboratory and Staff ............................................................................... 112 9.8.0 Laboratory ................................................................................... 112 98.1 Calibration Staff Qualifications .................................................. 112 9.8.2 Calibration Staff Training ........................................................... 113 9.9 Assessments ............................................................................................ 113 10.0 AIR MONITORING ............................................................................................ 114 10.1 Implementation Guidance ....................................................................... 114 10.2 Determining the Needs for Air Monitoring ............................................ 115 10.2.0 Exposure Assessment.................................................................. 116 10.2.0.0 Type and Frequency of Bioassay ............................. 116 10.2.0.1 Estimation of Dose ................................................... 117 10.2.1 Personnel Protection ................................................................... 118 10.2.1.0 Need for Posting .......................................................... 118 10.2.1.1 Effectiveness of Engineered Controls ...................... 118 10.2.1.2 Proper Respiratory Protective Equipment ............... 118 10.2.2 Early Warning ............................................................................. 119 10.3 Placement of Air Sampling and Real-Time Air Monitoring Equipment ..................................................................... 120 10.3.0 Locations of Release Points and Individuals .............................. 120 10.3.1 Purpose of Sample ...................................................................... 121 10.3.2 Room Air Flow Patterns ............................................................. 121 10.4 Air Sampling Equipment……………… ....... ………………………… 122 10.4.0 Breathing Zone Air Monitoring .................................................. 122 10.4.1 Source-Specific Air Sampling .................................................... 122 10.4.2 Grab Sampling ............................................................................ 123 10.4.3 Operability Checks...................................................................... 123 10.5 Real-Time Air Monitoring Equipment ................................................... 123

10.5.0 Instrument Selection ................................................................... 123 DOE G 441.1-1C v 5-19-08 10.5.1 Alarm Set Points ......................................................................... 124 10.5.2 Alarm Capabilities ...................................................................... 124 10.5.3 Operability Checks...................................................................... 124 10.6 Sample Analysis and Data Review ......................................................... 125 10.7 Quality Control and Quality Assurance .................................................. 125 10.7.0 Sample Identification, Handling, and Storage ............................ 126 10.7.1 Air Sampling and Real-Time Air Monitoring Equipment .......... 126 10.7.2 Counting Room Equipment ........................................................ 127 10.7.3 Audits.... ………………………....... …………………………...127 10.7.4 Recordkeeping ............................................................................ 127 10.8 Administrative Controls .......................................................................... 127 10.8.0 Technical Basis Document ......................................................... 127 10.8.1 Written Procedures...................................................................... 128 11.0 RADIOACTIVE CONTAMINATION CONTROL ......................................... 129 11.1 Implementation Guidance ....................................................................... 130 11.2 Contamination Control Program Management ....................................... 130 11.3 Engineered Controls................................................................................ 131 11.4 Administrative Control ........................................................................... 133 11.4.0 Work Authorizations ................................................................... 133 11.4.1 Access Control ............................................................................ 134 11.4.1.0 Entry Controls .......................................................... 134 11.4.1.1 Egress Controls ........................................................ 135 11.4.1.2 Posting and Labeling................................................ 136 11.4.2 Areas of Fixed Contamination .................................................... 136 11.4.3 Conduct of Radiological Work ................................................... 137 11.4.4 Personnel and Material Decontamination ................................... 137 11.4.4.0 Skin and Clothing Contamination ............................ 137 11.4.4.1 Wound Contamination ............................................. 138 11.4.4.2 Material and Area Decontamination ........................ 138 11.5 Contamination Monitoring...................................................................... 138 11.5.0 Contamination Control Values ................................................... 139 11.5.1 Monitoring .................................................................................. 140 11.5.2 Control of Material and Equipment ............................................ 142 11.5.3 Portal Monitors, Laundry Monitors, and Tool Monitors ............ 145 12.0 POSTING AND LABELING FOR RADIOLOGICAL CONTROL .............. 146 12.1 Implementation Guidance ....................................................................... 146

12.2 General .................................................................................................... 146 12.2.0 Design...... ................ ...................................................................148 12.2.1 Content.. ...... ……………………………………………………148 12.2.2 Visibility ..................................................................................... 149 12.2.3 Conditions ................................................................................... 150 12.2.4 Accessibility ................................................................................ 150 12.2.5 Boundaries and Barriers .............................................................. 152 12.3 Controlled Areas ..................................................................................... 152 12.4 Posting for Control of Exposure to External Radiation .......................... 152 DOE G 441.1-1C vi 5-19-08 12.5 Posting for Control of Contamination..................................................... 153 12.5.0 Removable and Airborne Radioactive Contamination ............... 153 12.5.1 Areas of Fixed Contamination .................................................... 154 12.6 Radioactive Material Posting .................................................................. 154 12.7 Exceptions from Posting Requirements .................................................. 156 12.8 Radioactive Material Labeling ................................................................ 157 12.8.0 Radioactive Material Labeling .................................................... 157 12.8.1 Exceptions from Labeling Requirements .................................... 158 Appendix 12.A – Standard Radiation Warning Trefoil ......................................... 160 13.0 OCCUPATIONAL RADIATION PROTECTION RECORD-KEEPING AND REPORTING....................................................... 161 13.1 Implementation Guidance ....................................................................... 161 13.2 Records to be Generated and Maintained ............................................... 162 13.2.0 Individual Monitoring and Dose Records ................................... 162 13.2.0.0 Internal Doses .......................................................... 163 13.2.0.1 External Doses ......................................................... 165 13.2.0.2 Summation of Internal and External Doses ............. 165 13.2.0.3 Lifetime Occupational Dose .................................... 166 13.2.0.4 Non-Uniform Exposure to the Skin ......................... 167 13.2.0.5 Planned Special Exposures (PSEs) .......................... 168 13.2.0.6 Doses Resulting from Emergency or Accidental Exposures .......................................... 168 13.2.0.7 Records of Embryo/Fetus Dose and Declared Pregnant Workers .............................. 169 13.2.0.8 Individual Monitoring Program Records ................. 169 13.2.0.9 Equipment Capabilities ............................................ 170 13.2.1 Monitoring and Workplace Records ........................................... 170 13.2.1.1 Work Authorizations ................................................ 172 13.2.1.2 Area and Material/Equipment Monitoring Records ................................................. 172 13.2.1.3 Airborne Radioactivity Monitoring Records ........... 173 13.2.1.4 Records of Releases of Materials

and Equipment from Radiological Areas ................. 174 13.2.2 Administrative Records .............................................................. 174 13.2.2.0 Radiation Safety Training ........................................ 174 13.2.2.1 ALARA Records ...................................................... 176 13.2.2.2 Facility Design ......................................................... 177 13.2.2.3 Entry and Access Control Records .......................... 177 13.2.2.4 Sealed Radioactive Sources ..................................... 177 13.2.2.5 Radiation Protection Program, Policies and Procedures.. .................................................. ............178 13.2.2.6 Audits and Programmatic Reviews .......................... 178 13.2.2.7 Posting and Labeling................................................ 178 DOE G 441.1-1C vii 5-19-08 13.2.2.8 Calibration, Functional Tests, and Maintenance Records .................................................................... 179 13.3 Reports .................................................................................................... 179 13.3.0 Reports to Individuals ................................................................. 179 13.3.0.0 Records Requested by Monitored Individuals ......... 180 13.3.0.1 Termination Dose Reports ....................................... 180 13.3.0.2 Reports to DOE ........................................................ 181 13.3.1 Reports of Planned Special Exposures ....................................... 181 13.4 Privacy Act Considerations..................................................................... 181 13.4.0 Informing Individuals ................................................................. 182 13.4.1 Identifying Individuals ................................................................ 182 13.4.2 Requesting Correction or Amendment of a Record .................... 182 13.4.3 Responding to Requests .............................................................. 182 13.4.4 Accounting for Disclosures......................................................... 182 13.5 Record – Keeping Standards ................................................................... 183 14.0 RADIATION SAFETY TRAINING .................................................................. 184 14.1 Implementation Guidance ....................................................................... 184 14.1.0 General Information .................................................................... 184 14.2 Determination of Required Training ....................................................... 185 14.3 Training Course Content ......................................................................... 186 14.4 Facility-Specific Materials ...................................................................... 189 14.5 Conduct of Radiation Safety Training .................................................... 189 14.6 Completion of Radiation Safety Training ............................................... 190 14.7 Periodic Radiation Safety Training ......................................................... 192 14.8 Use of Escorts in Lieu of Training .......................................................... 193 14.9 Refresher Training .................................................................................. 193 14.10 Other Training Programs ........................................................................ 193

14.11 Training Effectiveness Evaluations ........................................................ 194 15.0 SEALED RADIOACTIVE SOURCE ACCOUNTABILITY AND CONTROL........................................................... 195 15.1 Implementation Guidance ....................................................................... 195 15.2 Organization and Responsibilities .......................................................... 196 15.3 Receipt .................................................................................................... 197 15.4 Labeling and Storage .............................................................................. 198 15.5 Inventory ................................................................................................. 199 15.6 Leak Testing............................................................................................ 200 15.7 Handling and Disposal ............................................................................ 202 Appendix 15.A Example Individual Accountable Sealed Radioactive Source Form ............................................................ 203 Appendix 15.B – Example Sealed Radioactive Source Accountability Form ............................................................................... 205 16.0 TECHNICAL TABLES FOR OCCUPATIONAL RADIATION PROTECTION ............................................................................. 206 DOE G 441.1-1C viii 5-19-08 Appendix A ............................................................................................................ 206 Derived Air Concentrations (DAC) For Controlling Radiation Exposure To Workers At DOE Facilities ................................ 206 Appendix B ............................................................................................................ 263 Reserved .................................................................................................. 263 Appendix C ............................................................................................................ 265 Derived Air Concentration (DAC) For Workers From External Exposure During Immersion in a Cloud of Airborne Radioactive Material ............................................... 265 Appendix D ............................................................................................................ 267 Surface Contamination Values ................................................................ 267 Appendix E ............................................................................................................ 269 Values For Establishing Sealed Radioactive Source Accountability And Radioactive Material Posting And Labeling Requirements ....................................................... 269 Appendix F............................................................................................................. 272 Radiation Weighting Factors ................................................................... 272 Appendix G ............................................................................................................ 273 Tissue Weighting Factors ........................................................................ 273 REFERENCES ................................................................................................................. 275 DOE G 441.1-1C 1 5-19-08 RADIATION PROTECTION PROGRAMS 1.0 PURPOSE AND APPLICABILITY

In March 2007 the U.S. Department of Energy (DOE) published an updated implementation Guide which discussed acceptable methods for ensuring that the functional elements of radiological activities will be managed and administered in accordance with Title 10, Code of Federal Regulations (CFR), Part 835, Occupational Radiation Protection (DOE 2007a), hereinafter referred to as 10 CFR 835. The March 2007 Guide was part of DOE’s efforts to eliminate redundant requirements and guidance and compiled the guidance previously provided in a set of 13 Implementation Guides. On June 8, 2007, the DOE published an amendment to 10 CFR 835. This Guide reflects the June 8, 2007, amendment to 10 CFR 835 and continues to provide cross-references to other Guides, DOE-STD-1098-2008, RADIOLOGICAL CONTROL (DOE 2008a), hereinafter referred to as the RCS, DOE directives, and industry consensus standards that provide detailed guidance for implementing specific requirements in 10 CFR 835. DOE is in the process of updating all of its guidance documents for occupational radiation protection to reflect the 2007 amendment to 10 CFR 835. This Guide is one of the first documents to be updated, and as such, the cross-references to other DOE guidance documents will change as additional updated guidance documents are finalized. The references to other DOE guidance documents, which are scheduled to be updated, will include the notation “Use the revised version, reflecting the 2007 amendment to 10 CFR 835, when available.” 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 251.1C, Departmental Directives Program Manual, (DOE 2009a) 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 DOE G 441.1-1C 2 5-19-08 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 2007b). 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 is written to be consistent with following non-governmental national consensus 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 DOE G 441.1-1C 3 5-19-08 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 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 The following are the acronyms frequently used in this document. AEC U.S. Atomic Energy Commission ALARA Low As Is Reasonably Achievable ALI 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 CED Committed Effective Dose CFR Code of Federal Regulations http://webstore.ansi.org/ansidocstore/product.asp?sku=N322%2D1997 http://webstore.ansi.org/ansidocstore/product.asp?sku=N322%2D1997 http://webstore.ansi.org/ansidocstore/product.asp?sku=N322%2D1997 DOE G 441.1-1C 4 5-19-08 CSO Cognizant Secretarial Officer CTED Cumulative Total Effective Dose 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 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 DOE G 441.1-1C 5 5-19-08 SLAC Stanford Linear Accelerator Center TED Total Effective Dose 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 441.1-1C 6 5-19-08 2.0 DEFINITIONS Terms from 10 CFR 835 are used consistent with their regulatory definition. 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. This is 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. This is 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." DOE G 441.1-1C 7 5-19-08 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 1998A), or DOE STD-1112-98, THE DEPARTMENT OF ENERGY LABORATORY ACCREDITATION PROGRAM FOR RADIOBIOASSAY (DOE 1998b). 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, DOE G 441.1-1C 8 5-19-08 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. 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. DOE G 441.1-1C 9 5-19-08 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 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. 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 DOE G 441.1-1C 10 5-19-08 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. 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 DOE G 441.1-1C 11 5-19-08 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 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: DOE G 441.1-1C 12 5-19-08 (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. 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. DOE G 441.1-1C 13 5-19-08

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 441.1-1C 15 5-19-08 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 441.1-1C 16 5-19-08 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 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 DOE, typically 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 involving occupational exposure to ionizing radiation. 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 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. DOE G 441.1-1C 17 5-19-08 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/HealthSafety/WSHP/radiation/tpp.html). In addition, this Guide provides acceptable methods for achieving compliance with a variety of technical and administrative requirements. 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; DOE G 441.1-1C 18 5-19-08 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. 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. DOE G 441.1-1C 19 5-19-08 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 (DOE 1996). 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; – 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 DOE G 441.1-1C 20 5-19-08 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 in DOE O 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 G 441.1-1C 21 5-19-08 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 O 426.2, Personnel Selection, Training, Qualification, and Ceftification Requirements for DOE Nuclear Facilities (DOE 2010a). 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-1107-2007, Chg 1. KNOWLEDGE, SKILLS AND ABILITIES FOR KEY RADIATION POSITIONS AT DOE FACILITIES (DOE 2007g). This document supplements the requirements discussed above by synthesizing guidance from several source documents into a single reference. DOE STD-1107-2007 describes the level of knowledge, skills, and abilities for personnel in key radiation protection involved with DOE activities. The approach taken in DOE STD-1107-2007 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 O 426.2 and DOE STD-1107-2007 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 STD-1107-2007 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 G 441.1-1C 22 5-19-08 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-1130-2008; RADIOLOGICAL WORKER (RW) TRAINING MATERIALS; APPENDIX A, RADIOLOGICAL CONTROL TRAINING FOR SUPERVISORS. (DOE 2008c) DOE-HDBK-1145-2008; RADIOLOGICAL SAFETY TRAINING FOR PLUTONIUM FACILITIES (DOE 2008d) DOE-HDBK-1141-2008; RADIOLOGICAL ASSESSOR TRAINING (DOE 2008e) DOE-HDBK-1129-2008; TRITIUM SAFE HANDLING AND STORAGE(DOE 2008f) DOE-HDBK-1106-2008, RADIOLOGICAL WORKER TRAINING; Appendix B: RADIOLOGICAL CONTAMINATION CONTROL TRAINING FOR LABORATORY RESEARCH (DOE 2008g) DOE-HDBK-1108-2002; RADIOLOGICAL SAFETY TRAINING FOR ACCELERATOR FACILITIES (DOE 20025b) DOE-HDBK-1130-2008, RADIOLOGICAL WORKER (RW) TRAINING MATERIALS; Appendix C: RADIOLOGICAL SAFETY TRAINING FOR RADIATION-PRODUCING (X-RAY) DEVICES (DOE 2008h) DOE-HDBK 1110-2008, ALARA TRAINING FOR TECHNICAL SUPPORT PERSONNEL (DOE 2008b) DOE-HDBK-1113-2008, RADIOLOGICAL SAFETY TRAINING FOR URANIUM FACILITIES (DOE 2008i) DOE-HDBK-1122-2009, RADIOLOGICAL CONTROL TECHNICIAN TRAINING (DOE 2009a) 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 http://www.eh.doe.gov/radiation/RST/rct3/rct-web-cover.htm DOE G 441.1-1C 23 5-19-08 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 or mechanism 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. Internal audits should be conducted by individuals who are organizationally independent from the organizations responsible for developing and implementing the RPP. 3.2.4 Radioactive Material Transportation Exclusion 10 CFR part 835 excludes radioactive material transportation not performed by DOE or a DOE contractor (10 CFR 835.1(b)(7)). The intent is to exclude from 10 CFR part 835 transportation by the U. S. Postal Service or a commercial carrier, such as FedEx or UPS, which transport radioactive material as part of their normal operations. A company or subsidiary of a corporation that operates a DOE facility would not be considered a commercial carrier - even if such an organization transports radioactive material as part of its contractual agreement with DOE. Activities related to transportation such as the preparation of material or packaging for transportation, storage of material awaiting transportation, or application of markings and labels required for transportation is not included in the exclusion (See 10 CFR 835.2, Definitions, Radioactive material transportation). Subparts F (Entry Control Program) and G (Posting and Labeling) do not apply to radioactive material transportation conducted by a DOE individual or DOE contractor, when the radioactive material is under the continuous observation and control of an individual who is knowledgeable of and implements required exposure control measures or when conducted in accordance with Department of Transportation regulations or DOE orders that govern such movements (10 CFR 835.1(d)). This does not affect the application of requirements to radioactive material transportation in the other subparts of 10 CFR part 835. In accordance with the definition of “radioactive material transportation,” the exclusion applies while the material is in the process of undergoing movement, including nominal stoppages such as for traffic considerations or refueling activities. DOE G 441.1-1C 24 5-19-08 Occupational doses received as a result of radioactive material transportation performed by other than the DOE or a DOE contractor, shall be considered to the extent practicable when determining compliance with the occupational dose limits (10 CFR 835.1(c)). Occupational doses received by DOE or DOE contractor employees while conducting radioactive material transportation shall be considered when determining compliance with the occupational dose limits.

3.3 RPP Functional Elements This section identifies the programmatic functional elements of a comprehensive RPP. For each element, the following table identifies the applicable regulatory provisions, contractual requirements, and recommended guidance document(s) which are useful in achieving compliance with these provisions. DOE G 441.1-1C 25 5-19-08 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-1098-2008, 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 151.1-1C, 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 441.1-1C 26 5-19-08 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 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,” “Site 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; and (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 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 is clearly communicated. DOE approval of the RPP will constitute agreement with applicability statements contained therein. DOE G 441.1-1C 27 5-19-08 Applicability statements may not be used to provide relief where the requirements are clearly stated to be applicable in 10 CFR 835. Relief from 10 CFR 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 835. For example, the DOE General Counsel responded to a question concerning what activities are intended to be included within the scope of the 10 CFR 835.1(b)(3) exclusion. In response, General Counsel Ruling 95-1 stated "This exclusion is drafted narrowly to cover only those activities necessary to prevent an accidental or unauthorized nuclear detonation (that is, where the component parts of a nuclear weapon have been assembled in a manner such that a nuclear detonation could take place)." There are potential situations where a DOE protective force individual could receive an exposure to ionizing radiation in excess of the 10 CFR 835 limits (or be in noncompliance with other 10 CFR 835 provisions) as a result of emergency actions taken to protect nuclear or other material from theft or diversion. Per General Counsel Ruling 95-1, these situations would not be included within the scope of the 10 CFR 835.1(b)(3) exclusion. However, these situations, if conducted as part of an emergency response to a threat to nuclear or other material, would likely fall within the scope of 10 CFR 835.3(d) which states that "Nothing in this part shall be construed as limiting actions that may be necessary to protect health and safety." 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 835. The use of guides and technical standards is not required; however, it is encouraged for the following reasons: DOE G 441.1-1C 28 5-19-08 (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. 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 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 DOE G 441.1-1C 29 5-19-08 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 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. DOE G 441.1-1C 30 5-19-08 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 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 an 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 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.A 4 below for additional submittal requirements for final RPPs. 3.A 3. REVIEW AND APPROVAL OF RPPs DOE G 441.1-1C 31 5-19-08 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 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 of 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 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. 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 DOE G 441.1-1C 32 5-19-08 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. 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. DOE G 441.1-1C 33 5-19-08 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 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. DOE G 441.1-1C 34 5-19-08 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 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)]. 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 DOE G 441.1-1C 35 5-19-08 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 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 835. 3.A 3.1.6.6 RPPs which are not Approved by Final Date Per 10 CFR 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 implementation of 10 CFR 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 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. DOE G 441.1-1C 36 5-19-08 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) to 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 the 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 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 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 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; DOE G 441.1-1C 37 5-19-08 (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. 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 DOE G 441.1-1C 38 5-19-08 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 835 is cited to indicate the basis for statements containing the 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 441.1-1C 39 5-19-08 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 as far below the current regulatory occupational dose limits as reasonably achievable. 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 engineered 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 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 DOE G 441.1-1C 40 5-19-08 engineered controls; administrative controls may be used as supplemental features and for specific activities where engineered controls 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 engineered controls and optimization methods during work procedure development to assure that the 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; DOE G 441.1-1C 41 5-19-08 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 (DOE 1996), 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. 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

DOE G 441.1-1C 42 5-19-08 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 1110-2008, ALARA TRAINING FOR TECHNICAL SUPPORT PERSONNEL (DOE 2008b). 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. 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 engineered controls (e.g., confinement, ventilation, remote handling, and shielding); administrative controls shall be incorporated only as supplemental methods and for specific activities where engineered controls are demonstrated to be impractical (10 CFR 835.1001). 10 CFR 835.1003 further requires that during routine operations, the combination of engineered controls 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. Engineered controls 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 DOE G 441.1-1C 43 5-19-08 use of designs and materials that facilitate operations, maintenance, and other activities. They may also include controls (e.g., temporary shielding, confinement and ventilation systems) that are typically used to facilitate short-term or emergent operations when the installed engineered controls do not provide the desired level of protection. In addition to the engineered controls,

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 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 O 458.1; Radiation Protection of the Public and the Environment (DOE 2011a); – DOE P 441.1; Department of Energy Radiological Health and Safety Policy (DOE 1996) DOE G 441.1-1C 44 5-19-08 – DOE O 420.2B, Safety of Accelerator Facilities (DOE 2004a); – DOE 5480.30, Nuclear Reactor Safety Design Criteria (DOE 1993); – DOE O 420.1B, Facility Safety (DOE 2005d); – DOE O 413.3B, Program and Project Management for the Acquisition of Capital Assets (DOE 2010b); – DOE O 435.1, Radioactive Waste Management (DOE 2001b); 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 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; DOE G 441.1-1C 45 5-19-08 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 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 is 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 DOE G 441.1-1C 46 5-19-08 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 engineered 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 and appropriate radiological judgment should be used to develop numerical criteria and/or trigger points for determining when a formal ALARA review of planned radiological work activities is required. Once conducted, the completed ALARA review should be incorporated into the written authorizations for the work activity.

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 DOE G 441.1-1C 47 5-19-08 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, 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, -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 should 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. DOE G 441.1-1C 48 5-19-08 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 2006) provides requirements for worker safety and health. The worker safety and health program must integrate the 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 441.1-1C 49 5-19-08 5.0 INTERNAL DOSIMETRY PROGRAM In the 2007 amendment to 10 CFR 835 DOE changed most of the dosimetric terms used in 10 CFR 835 to reflect the recommendations for assessing dose and associated terminology from ICRP Publication 60, 1990 Recommendations of the ICRP on Radiological Protection (ICRP 1991), and ICRP Publication 68, Dose Coefficients for Intakes of Radionuclides by Workers (ICRP 1995). DOE made this change mainly because these recommendations are based on updated scientific models and more accurately reflect the occupational doses to workers than the models currently used by DOE. During the rulemaking process DOE received a comment that, under certain circumstances, when an individual conducts multiple activities involving both activities under 10 CFR 835.1(b)(1) and excluded activities (e.g., activities involving NRC licensed activities) it is ambiguous as to how the rule would be applied when using different dose coefficients and weighting factors to calculate the total effective dose for the worker from both activities. DOE agreed that guidance was needed for this provision. In the preamble for the final rule DOE stated that for the purpose of compliance with 10 CFR 835.1(b)(1) and (c), DOE considers the following terms to be equivalent:

Dosimetric Term as Defined by Excluded Activity Cognizant Regulator DOE Amended Dosimetric Term Committed effective dose equivalent Committed effective dose Committed dose equivalent Committed equivalent dose Cumulative total effective dose equivalent Cumulative total effective dose Deep dose equivalent Equivalent dose to the whole body Dose equivalent Equivalent dose Effective dose equivalent Effective dose Lens of the eye dose equivalent Equivalent dose to the lens of the eye Quality factor Radiation weighting factor Shallow dose equivalent Equivalent dose to the skin or Equivalent dose to any extremity Weighting factor Tissue weighting factor Total effective dose equivalent Total effective dose DOE G 441.1-1C 50 5-19-08 Accordingly, for the purpose of compliance with the requirement in 10 CFR 835.1(c) for the inclusion of doses from excluded activities in determining compliance with the limits, DOE considers it acceptable to sum the equivalent dosimetric terms (per the above table) without further adjustment. DOE recognizes that, for some situations, such as evaluation of uranium intakes, this approach will overestimate radiation doses from excluded activities as compared to those assessed using ICRP 60 values. For other situations, such as the evaluation of certain neutron exposures or for intakes of selected radionuclides, this approach may underestimate radiation doses from excluded activities as compared to those assessed using ICRP 60 values. In cases where doses from excluded activities are expected to have been over estimated, no additional activities above the standard radiological controls are required because this dose estimate is unlikely to have resulted in a dose less than that estimated using ICRP 60 methods. Regarding cases where doses from excluded activities are expected to have been underestimated, a review of doses over the past several recent years, from both DOE and NRC, indicated very few examples where individuals had neutron exposures or significant intakes of those radionuclides which could underestimate radiation doses from excluded activities as compared to those assessed using ICRP 60 values. Accordingly, the differences in assessing these intakes or neutron doses between DOE (ICRP 60) and excluded activities would infrequently result in doses challenging limits had they been entirely assessed using ICRP 60 values. Use of Administrative Control Levels, per the RCS, should be adequate to address concerns regarding these situations. See Section 6.0.1, “Protection and Operational Quantities” for a discussion on the use of protection and operational quantities. 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 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; and 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 DOE G 441.1-1C 51 5-19-08 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-1121-2008, INTERNAL DOSIMETRY (DOE 2008j) 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; 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 DOE G 441.1-1C 52 5-19-08 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 ACCREDITATION PROGRAM ADMINISTRATION (DOE 1998a). 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 DOE G 441.1-1C 53 5-19-08 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 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-1107-2007, Chg 1, KNOWLEDGE, SKILLS, AND ABILITIES FOR KEY RADIATION PROTECTION POSITIONS AT DOE FACILITIES (DOE 2007g). 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 414.1D, Quality Assurance (DOE 2011), 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 DOE G 441.1-1C 54 5-19-08 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. 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-1121-2008. 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-1121-2008, 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. DOE G 441.1-1C 55 5-19-08 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. 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-1121-2008, 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, nasal smears) to trigger early special radiobioassay monitoring; enhance personal contamination monitoring (e.g., clothing, skin) to trigger special radiobioassay monitoring; DOE G 441.1-1C 56 5-19-08 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 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 for radionuclides with a stochastic ALI. 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-1121-2008, 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-1121-2008 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. 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 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 pregnant women, and confirmatory radiobioassay are covered in DOE G 441.1-1C 57 5-19-08 DOE-STD-1121-2008, 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. 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 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-1121-2008, 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-1121-2008, 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 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 DOE G 441.1-1C 58 5-19-08 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-1121-2008 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? 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

DOE G 441.1-1C 59 5-19-08 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, material type, 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) committed effective dose 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. 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. 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-1121-2008, 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

DOE G 441.1-1C 60 5-19-08 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-1121-2008, 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-1121-2008. NCRP Report No. 84 is an additional suggested reference. 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. In the 2007 amendment to 10 CFR 835, section 835.702(b) was modified and a provision was added regarding the recording of internal dose (committed effective dose or committed equivalent dose). The provision allows for not recording of any positive monitoring result estimated to correspond to an individual receiving less than 0.01 rem (0.1 mSv) committed effective dose. Typically, this would be for very sensitive bioassay protocols or for radionuclides which are easy to detect at very low doses (e.g., routine tritium bioassay). The bioassay or air monitoring result used to make the estimate shall be maintained in accordance with 10 CFR 835.703(b) and the unrecorded internal dose estimated for any individual in a year shall not exceed the applicable monitoring threshold at 10 CFR 835.402(c). 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. The schedule and frequency of long-term special radiobioassay measurements to evaluate the committed effective dose 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 committed effective dose and the likelihood of the individual receiving additional intakes. DOE G 441.1-1C 61 5-19-08 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-1121-2008, Section 7. Radiobioassay data should be interpreted in accordance with the applicable portions of this DOE technical standard. Evaluations of committed effective dose 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 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. 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. DOE G 441.1-1C 62 5-19-08 Evaluations for general employees with prior confirmed intakes should be revised when information demonstrates a change in the currently evaluated committed effective dose 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 committed effective dose 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. An acceptable approach would be for DOE sites to update their dosimetry program to reflect the amended 10 CFR 835 tissue and radiation weighting factors, and to assess doses using the updated factors at some predetermined time. It is not expected that DOE sites recalculate all previously completed dose estimates performed at that site. Note the Department did not require recalculation of previous internal doses resulting from uranium intakes when it granted a DOE contractor an exemption from those requirements in 10 CFR 835 requiring the use of the specified tissue weighting factors, thus, permitting the use of the tissue weighting factors in ICRP 60 when calculating internal doses from uranium.

DOE does not encourage routine recalculation of internal doses in response to changes in internal dosimetry methodologies such as biokinetic models, tissue weighting factors, or improved bioassay techniques after a final dose estimate has been completed and recorded. Internal doses calculated using technically sound and defensible methods available at the time of the dose estimate are an acceptable way to meet the Department’s expectations for internal dose monitoring and compliance with occupational exposure dose limits promulgated in 10 CFR 835. However, in the process of updating methodologies it is recommended that DOE sites should maintain close communication with cognizant DOE personnel. DOE recognizes there may be unique situations in which a DOE site may consider or be directed to reevaluate an internal dose estimate. Examples of such situations are a response to litigation, determination that an internal dose has been incorrectly estimated, or availability of new bioassay data. In such cases the decision to recalculate a final internal dose estimate should be made on a case-by-case basis and consider: The magnitude of the expected change, Programmatic costs, Impact on compliance with dose limits, Documentation of the recalculated result in official records, and Communication of the recalculated dose to current and former workers. To ensure compliance with record-keeping provisions of 10 CFR 835 subpart H, the technical basis and results of determinations to recalculate a completed internal dose assessment should be documented in official site records. 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-1121-2008, Section 9. Record-keeping and DOE G 441.1-1C 63 5-19-08 reporting of internal doses and related information should be in accordance with these DOE documents. DOE G 441.1-1C 65 5-19-08 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. 6.0.1 Protection and Operational Quantities The ICRP Publication 60 dosimetric quantities adopted in 10 CFR 835 have been designated by ICRP as “protection quantities” that are intended for defining and calculating the numerical limits and action levels used in radiation protection standards such as 10 CFR 835. Protection quantities provide a way to relate the magnitude of a radiation exposure to the risk of a health effect th