Archives of Directives

Archive

DOE G 441.1-1A, Management and Administration of Radiation Protection Programs Guide for use with Title 10, Code of Federal Regulations, Part 835, Occupational Radiation Protection

Functional areas: Work Processes

This Guide discusses acceptable methods for ensuring that radiological activities will be managed and administered in accordance with a documented radiation protection program that complies with U.S. DOE requirements specified in Title 10 CFR Part 835, Occupational Radiation Protection. Cancels DOE G 441.1-1. Canceled by DOE G 441.1-1B.
g4411-1a.pdf229.90KB
Version history and related documents
Document text

Text extracted from the attached file. Refer to the original document for the authoritative version.

Section 1

DOE G 441.1-1A 11-4-03 E R R A T A S H E E T The Office of Primary Interest has identified minor errors in DOE G 441.1-1A, Management and Administration of Radiation Protection Programs Guide for Use with Title 10, Code of Federal Regulations, Part 835, Occupational Radiation Protection, dated 10-20-03. This Errata Sheet transmits the following minor errors: C Page ii, delete the acronym “RCCC” and the words “Radiological Control Coordinating Committee.” C In Attachment 2, paragraph 3.1.6.2, the words “RCCC (Radiological Control Coordinating Committee)” should be changed to “PSO.” The changes are reflected in this Guide. This Errata Sheet must remain with DOE G 441.1-1A. DOE G 441.1-1A 10-20-03 MANAGEMENT AND ADMINISTRATION OF RADIATION PROTECTION PROGRAMS GUIDE for use with Title 10, Code of Federal Regulations, Part 835, Occupational Radiation Protection [This Guide describes suggested 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 Policy, Order, Notice, or Manual.] Assistant Secretary for Environment, Safety and Health (THIS PAGE INTENTIONALLY LEFT BLANK) DOE G 441.1-1A i 10-20-03 CONTENTS PAGE 1. PURPOSE AND APPLICABILITY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 2. DEFINITIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 3. DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 4. IMPLEMENTATION GUIDANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 4.1 ORGANIZATION AND ADMINISTRATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 4.1.1 Administrative Processes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 4.1.2 Radiological Control Organization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 4.1.3 Education, Training, and Skills . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 4.1.4 Internal Audit and Self Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 4.2 RPP FUNCTIONAL ELEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 5. REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 6. ATTACHMENT 1: Requests for Changes 7. ATTACHMENT 2: Preparation, Review, and Approval of Radiation Protection Programs ii DOE G 441.1-1A 10-20-03 ACRONYMS RPP radiation protection program DOE Department of Energy CFR Code of Federal Regulations RCS DOE-STD-1098-99, RADIOLOGICAL CONTROL PSO Program Secretarial Office CSO Cognizant Secretarial Officer AEA Atomic Energy Act AEC Atomic Energy Commission ALARA As Low as Reasonably Achievable FRA Functions, Responsibilities, and Authorities DOE G 441.1-1A 1 10-20-03 MANAGEMENT AND ADMINISTRATION OF RADIATION PROTECTION PROGRAMS

Section 2

1. PURPOSE AND APPLICABILITY This Guide discusses acceptable methods for ensuring that radiological activities will be managed and administered in accordance with a documented radiation protection program (RPP) that complies with U.S. Department of Energy (DOE) requirements specified in Title 10 of the Code of Federal Regulations (CFR), Part 835, Occupational Radiation Protection (DOE 1998a), hereinafter referred to as 10 CFR 835. This Guide provides cross-references to other Guides, DOE-STD-1098-99, RADIOLOGICAL CONTROL (DOE 1999a), hereinafter referred to as the RCS, DOE directives, and industry consensus standards that provide detailed guidance for implementing specific requirements in 10 CFR 835. This Guide provides guidance and is focused primarily with respect to implementing the provisions for management and administration of RPPs contained in Subpart B of 10 CFR 835. 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 managing and administering a documented RPP. 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). Except for requirements established by a regulation, contract, or administrative means, the provisions in this Guide are DOE's views on acceptable methods of program implementation and are not mandatory. Conformance with this Guide will, however, create an inference of compliance with the related regulatory requirements. Alternate methods that are demonstrated to provide an equivalent or better level of protection are acceptable. DOE encourages its contractors to go beyond the minimum regulatory requirements and to pursue excellence in their programs. The word "shall" is used in this Guide to designate requirements from 10 CFR 835. Compliance with 10 CFR 835 is mandatory except to the extent an exemption has been granted pursuant to 10 CFR 820, Procedural Rules for DOE Nuclear Activities (DOE 1997a). The words "should" and "may" are used to denote optional program recommendations and allowable alternatives, respectively. This Guide is applicable to all DOE activities that are subject to the requirements of 10 CFR 835. The RPP requirements may include DOE Program and Field Offices as well as contractors . 2 DOE G 441.1-1A 10-20-03 2. DEFINITIONS Terms defined in 10 CFR 835 are used in this Guide consistent with their regulatory definitions. 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. Radiation or ionizing radiation: Alpha particles, beta particles, gamma rays, X-rays, neutrons, high-speed electrons, high-speed protons, and other particles capable of producing ions. Radiation as used in this Guide does not include non-ionizing radiation, such as radio-, or micro-waves, or visible, infrared, or ultraviolet light. 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.

Section 3

Radiological: Involving radiation or radioactive materials. DOE G 441.1-1A 3 10-20-03 3. DISCUSSION 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 the DOE G 441.1 series of Guides, in combination with the provisions of site radiological control manuals developed and implemented consistent with guidance provided by the RCS for those regulatory provisions not addressed by the these Guides, provide reasonable assurance that a site RPP will meet the requirements of 10 CFR 835. The RPP for a specific DOE activity is approved by the cognizant DOE Headquarters Program Office. The RPP is intended to provide DOE reasonable assurance that the DOE activity will be conducted in compliance with the provisions of 10 CFR 835. The RPP also satisfies the requirement for an Implementation Plan found in other DOE directives. Guidance for DOE Program and Field Offices concerning the specific documentation required for DOE approval of RPPs as required in 10 CFR 835.101(f), (g), and (h) is provided in Attachment 2, PREPARATION, REVIEW AND APPROVAL OF RADIATION PROTECTION PROGRAMS. Attachment 2 is based on guidance which previously was provided in DOE-STD-1082-94, PREPARATION, REVIEW, AND APPROVAL OF IMPLEMENTATION PLANS FOR NUCLEAR SAFETY REQUIREMENTS. Guidance is also provided by the cognizant DOE Headquarters Program Office. Program Offices will also provide guidance should DOE need to direct or make modifications to an RPP as provided under 10 CFR 835.101(b). 10 CFR 835 permits changes, additions, or updates to an RPP to become effective without prior DOE approval only if the changes do not decrease the effectiveness of the RPP and the RPP, as changed, continues to meet the requirements of the rule. Proposed changes that decrease the effectiveness of the RPP shall not be implemented without submittal to and approval by DOE (10 CFR 835.101(h)). Guidance regarding the process for submitting and approving changes will be provided by the appropriate DOE Headquarters Program Office. The RPP is the basis for implementing operational radiation protection program requirements for a DOE activity. A combination of various methods which can be used to achieve regulatory compliance is discussed in this Guide. DOE recognizes that many of the requirements of 10 CFR 835 are not new. Equivalent requirements were previously promulgated in DOE Orders and the DOE Radiological Control Manual, which were implemented under contractual obligations for most DOE activities. Therefore, much of the RPP documentation required to ensure compliance with 10 CFR 835 has already been developed to ensure compliance with contractually-imposed radiation protection standards. DOE recognizes that significant effort was expended in upgrading radiation protection of the work force and does not intend for its contractors to expend significant additional effort to develop and implement a separate, redundant program to satisfy the RPP requirements of 10 CFR 835. The RPP should rely on existing documents, such as the site radiological control manual, contractual agreements, procedures, and memoranda, to effectively administer and manage regulatory commitments. However, the completeness of these existing documents should be verified to ensure that all 10 CFR 835 requirements are satisfied. 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.

Section 4

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 O 414.1A, Ch. 1, QUALITY ASSURANCE (DOE 2001b). Functional elements of a comprehensive RPP are identified and discussed throughout Section IV of this Guide. The specific functional elements for a DOE activity will depend upon the types of radiological work being performed and 4 DOE G 441.1-1A 10-20-03 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. DOE G 441.1-1A 5 10-20-03 4. IMPLEMENTATION GUIDANCE The approved RPP ensures that a DOE activity will 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. The DOE 441.1 series of Guides provide 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; • 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 retrievability of records; • radiological control performance indicators; • adherence to consensus standards; and • other factors that ensure full implementation of the RPP.

Section 5

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 judgement 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 judgement 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 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 6 DOE G 441.1-1A 10-20-03 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, or other DOE technical standards. 4.1 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. 4.1.1 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.

Section 6

• 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. DOE G 441.1-1A 7 10-20-03 In evaluating the need for written procedures, consideration shall be given to the level and extent of the radiological hazards, the complexity of the measures required to achieve compliance, and the education, training and skills of the individuals who must implement those measures (10 CFR 835.104). Under such a regimen, a low hazard activity employing a stable staff of highly educated and skilled workers having demonstrated an advanced knowledge of radiation protection principles and practices could have fewer and less detailed procedures than a higher hazard activity employing a transient workforce with less knowledge of radiation protection practices and principles. The series of Guides written for 10 CFR 835 (DOE G 441.1 series) provide 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 judgement has been exercised. The document should include supporting analyses and justifications sufficient to demonstrate that regulatory compliance can be achieved and maintained. The 441.1 series of Guides contain 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.

Section 7

4.1.2 Radiological Control Organization A radiological control organization should be established to support line managers and workers. To function effectively, 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. 4.1.3 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 8 DOE G 441.1-1A 10-20-03 activities. In addition, 10 CFR 830.122(b), Quality Assurance Criteria, specifies that nuclear facility personnel shall be trained and qualified to ensure they are capable of performing their assigned work. DOE previously issued requirements and guidance with regard to education, training, and skills for many categories of personnel, including individuals responsible for developing and implementing measures necessary for ensuring compliance with the requirements of 10 CFR 835. Some of these requirements are addressed in DOE 5480.20A, Ch. 1, PERSONNEL SELECTION, QUALIFICATION, AND TRAINING REQUIREMENTS FOR DOE NUCLEAR FACILITIES (DOE 2001c). 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 education, training, and skills requirements of 10 CFR 835.103 and 10 CFR 830.122(b). Key radiation protection positions are identified in DOE STD-1107-97, KNOWLEDGE, SKILLS AND ABILITIES FOR KEY RADIATION POSITIONS AT DOE FACILITIES (DOE 1997b). This document supplements the requirements discussed above by synthesizing guidance from several source documents into a single reference. DOE STD-1107-97 describes the level of knowledge, skills, and abilities for personnel in key radiation protection involved with DOE activities. The approach taken in DOE STD-1107-97 reinforces the DOE’s emphasis on establishing a system of criteria for key radiation protection positions that reflects the increasing levels of education, training, and skills needed for positions of increasing responsibility. The information contained in this standard should be strongly considered when evaluating the education, training, and skills of personnel in key radiation protection positions. The standards in DOE 5480.20A and DOE STD-1107-97 are based on DOE, Nuclear Regulatory Commission, and related industry standards and provide an acceptable method for achieving compliance with the education, training, and skills requirements of 10 CFR 835.103.

Section 8

DOE STD-1107-97 includes radiological control technicians (RCTs) in the list of key radiation protection positions. While 10 CFR 835 does not establish specific requirements for RCT training, DOE considers the typical job functions associated with RCTs to be critical in implementing an acceptable RPP. These typical job functions include: prescribing and implementing radiological work controls, performing radiological monitoring, responding to radiological incidents, or evaluating radiological conditions in the workplace. Individuals performing these functions shall meet the provisions of 10 CFR 835.103. Chapter 6, Part 4, of the RCS discusses the essential elements of RCT training and qualification, including qualification standards, oral examination boards, and continuing training. In support of these elements, DOE has developed and maintains the core course for RCTs, DOE-HDBK-1122-99, RADIOLOGICAL CONTROL TECHNICIAN TRAINING (DOE 1999b). DOE considers the DOE-developed core course for RCTs, augmented with site specific training, an acceptable level of training for individuals performing the typical job functions associated with RCTs. As is the case with using any of the DOE- developed training courses, sites need to evaluate the individual’s job functions and ensure the adequacy of the training provided. To ensure that the work performed by RCTs receives the appropriate level of review and evaluation, it is important that RCT Supervisors receive a higher level of training and maintain a higher level of knowledge than those expected of RCTs. Chapter 6, Part 4 of the RCS also provides guidance on the essential elements of RCT Supervisor training and qualification, including continuing training and oral examination boards. DOE developed and implemented core courses to enhance the content of training provided to general employees, radiological workers, and radiological control technicians across the DOE complex and bring these core training programs up to a standard consistent with the commercial industry. The use of the core courses is not mandatory. However, these courses should strongly be considered as a basis for developing and implementing radiation safety and radiological control technician training programs. Additional guidance regarding compliance with the Subpart J requirements is provided in DOE G-441.1-12, RADIATION SAFETY TRAINING (DOE 1999c). DOE G 441.1-1A 9 10-20-03 DOE has also sponsored development of additional training courses and guidance. DOE strongly encourages its operating entities to implement these courses and guidance. These courses and guidance, when augmented with site specific information and appropriately revised to reflect the most current regulatory requirements, provide acceptable approaches for providing radiation safety training or training for individuals responsible for developing and implementing measures necessary for ensuring compliance with the rule. These courses include: DOE-HDBK-1143-2001- RADIOLOGICAL CONTROL TRAINING FOR SUPERVISORS (DOE 2001d) DOE-HDBK-1145-2001- RADIOLOGICAL SAFETY TRAINING FOR PLUTONIUM FACILITIES (DOE 2001e) DOE-HDBK-1141-2001-RADIOLOGICAL ASSESSOR TRAINING (DOE 2001f) DOE-HDBK-1105-2002 - RADIOLOGICAL SAFETY TRAINING FOR TRITIUM FACILITIES (DOE 2002a) DOE-HDBK-1106-97 - RADIOLOGICAL CONTAMINATION CONTROL TRAINING FOR LABORATORY RESEARCH (DOE 1997c) DOE-HDBK-1108-2002 - RADIOLOGICAL SAFETY TRAINING FOR ACCELERATOR FACILITIES (DOE 2002b) DOE-HDBK-1109-97 - RADIOLOGICAL SAFETY TRAINING FOR RADIATION-PRODUCING (X-RAY) DEVICES (DOE 1997d) DOE-HDBK 1110-97 - ALARA TRAINING FOR TECHNICAL SUPPORT PERSONNEL (DOE 1997e) DOE-HDBK-1113-98 - RADIOLOGICAL SAFETY TRAINING FOR URANIUM FACILITIES (DOE 1998b)

Section 9

4.1.4 Internal Audit and Self Assessment Internal audits and self assessments are two of the numerous checks and balances needed in an effective RPP. Internal audits of the RPP, including examination of program content and implementation, shall be conducted through a process that ensures that all functional elements of the program are reviewed no less frequently than every 36 months (10 CFR 835.102). The RCS discusses how assessments, including internal audits, provide independent feedback to senior line managers concerning the implementation of the RPP. An audit plan should be developed that identifies the functional elements of the RPP and the schedule for review to ensure that over a 36 month period, all of the functional elements are reviewed. Internal audits should be conducted on a continuing basis. DOE cautions against conducting a single comprehensive internal audit of the entire RPP once every three years. DOE does not believe that such an approach is effective in assuring that a DOE activity will be conducted in conformance with its approved RPP. DOE recommends that, at a minimum, an annual, broad scope audit of the program be conducted. Under this approach, the audit plan would identify each functional element to be reviewed during the annual audit and ensure that all functional elements would be reviewed during a 36 month cycle. Thus, the RPP is under continuing review and deficiencies can be identified and corrected in a timely manner. The functional elements of a comprehensive RPP are discussed in this Guide. All of these functional elements may not be applicable to a specific DOE activity, but should be selected based upon the type of radiological work being performed and the radiological hazards encountered. Internal audits should be conducted by individuals who are organizationally independent from the organizations responsible for developing and implementing the RPP. 10 DOE G 441.1-1A 10-20-03 4.2 RPP FUNCTIONAL ELEMENTS This section identifies the programmatic functional elements of a comprehensive RPP. For each element, the table below identifies the applicable regulatory provisions and recommended guidance document(s) which is useful in achieving compliance with these provisions. Functional Element Regulatory Provision Guidance Document 1. Organization and Administration 10 CFR 835, Subpart B Section 4.1 of this Guide 2. ALARA Program 10 CFR 835.101(c), Subpart K DOE G 441.1-2, OCCUPATIONAL ALARA PROGRAM GUIDE (DOE 1999d) 3. External Dosimetry Program 10 CFR 835.401 (a), 402(a), (b) DOE G 441.1-4, EXTERNAL DOSIMETRY PROGRAM GUIDE (DOE 1999e) 4. Internal Dosimetry Program 10 CFR 835.401(a), 402(c), (d) DOE G 441.1-3, INTERNAL DOSIMETRY PROGRAM GUIDE (DOE 1999f) 5. Area Monitoring and Control a. Area Radiation Monitoring 10 CFR 835.401(a) DOE G 441.1-4, EXTERNAL DOSIMETRY PROGRAM GUIDE b. Airborne Radioactivity Monitoring 10 CFR 835.209, 401(a), 403 DOE G 441.1-3, INTERNAL DOSIMETRY PROGRAM GUIDE DOE G 441.1-8, AIR MONITORING GUIDE (DOE 1999g) c. Contamination Monitoring and Control 10 CFR 835.401(a), Subpart L DOE G 441.1-9, RADIOACTIVE CONTAMINATION CONTROL GUIDE (DOE 1999h) d. Instrument Calibration and Maintenance 10 CFR 835.401(b) DOE G 441.1-7, PORTABLE MONITORING INSTRUMENT CALIBRATION GUIDE (DOE 1999i) 6. Radiological Controls a. Radiological Work Planning 10 CFR 835.501(d), 1001(b), 1003 DOE-STD-1098-99, RADIOLOGICAL CONTROL

Section 10

b. Entry and Exit Controls 10 CFR 835, Subpart F DOE-STD-1098-99, RADIOLOGICAL CONTROL DOE G 441.1-5, RADIATION- GENERATING DEVICES GUIDE (DOE 1999j) DOE G 441.1-1A 11 10-20-03 Functional Element Regulatory Provision Guidance Document c. Radiological Work Controls 10 CFR 835, Subpart F, 1003 DOE-STD-1098-99, RADIOLOGICAL CONTROL DOE G 441.1-5, RADIATION- GENERATING DEVICES GUIDE d. Posting and Labeling 10 CFR 835, Subpart G DOE G 441.1-10, POSTING AND LABELING FOR RADIOLOGICAL CONTROL GUIDE (DOE 1998j) e. Release of Materials and Equipment 10 CFR 835.1101 DOE G 441.1-9, RADIOACTIVE CONTAMINATION CONTROL GUIDE f. Sealed Radioactive Source Accountability and Control 10 CFR 835, Subpart M DOE G 441.1-13, SEALED RADIOACTIVE SOURCE ACCOUNTABILITY AND CONTROL GUIDE (DOE 1999l) 7. Emergency Exposure Situations 10 CFR 835.1301, 1302 DOE O 151.1A, COMPREHENSIVE EMERGENCY MANAGEMENT SYSTEM (DOE 2000) 8. Nuclear Accident Dosimetry 10 CFR 835.1304 DOE G 441.1-4, EXTERNAL DOSIMETRY PROGRAM GUIDE 9. Records 10 CFR 835, Subpart H DOE G 441.1-11, OCCUPATIONAL RADIATION PROTECTION RECORD-KEEPING AND REPORTING GUIDE (DOE 1999m) 10. Reports to Individuals 10 CFR 835, Subpart I DOE G 441.1-11, OCCUPATIONAL RADIATION PROTECTION RECORD-KEEPING AND REPORTING GUIDE DOE O 232.1A, OCCURRENCE REPORTING AND PROCESSING OF OPERATIONS INFORMATION (DOE 1997f) 11. Radiation Safety Training 10 CFR 835, Subpart J DOE G 441.1-12, RADIATION SAFETY TRAINING GUIDE 12. Limits for the Embryo/Fetus 10 CFR 835, Subpart C DOE G 441.1-6, EVALUATION AND CONTROL OF RADIATION DOSE TO THE EMBRYO/FETUS GUIDE (DOE 1999n) 12 DOE G 441.1-1A 10-20-03 5. REFERENCES AEC (Atomic Energy Commission) 1954. U.S. Atomic Energy Act of 1954, as amended. Public Law 83-703 (68 Stat. 919), Title 42 U.S.C., Section 2011. DOE 1996. DOE P 441.1, DEPARTMENT OF ENERGY RADIOLOGICAL HEALTH AND SAFETY POLICY. Washington, D.C. DOE 1997a. 10 CFR 820, U. S. Department of Energy. Procedural Rules for DOE Nuclear Activities. 62 FR 52479 Federal Register, Vol. 62, No. 195, dated 10-8-97. Washington, D.C. DOE 1997b. DOE STD-1107-97, KNOWLEDGE, SKILLS, AND ABILITIES FOR KEY RADIATION PROTECTION POSITIONS AT DOE FACILITIES. Washington, D.C. DOE 1997c. DOE-HDBK-1106-97, RADIOLOGICAL CONTAMINATION CONTROL TRAINING FOR LABORATORY RESEARCH. Washington, D.C. DOE 1997d. DOE-HDBK-1109-97, RADIOLOGICAL SAFETY TRAINING FOR RADIATION-PRODUCING (X-RAY) DEVICES. Washington, D.C. DOE 1997e. DOE-HDBK-1110-97, ALARA TRAINING FOR TECHNICAL SUPPORT PERSONNEL. Washington, D.C. DOE 1997f. DOE O 232.1A, OCCURRENCE REPORTING AND PROCESSING OF OPERATIONS INFORMATION. Washington, D.C. DOE 1998a. 10 CFR 835, U.S. Department of Energy, Occupational Radiation Protection. 63 FR 59662, Federal Register, Vol. 63, No. 213, dated 11-4-98. Washington, D.C. DOE 1998b. DOE-HDBK-1113-98, RADIOLOGICAL SAFETY TRAINING FOR URANIUM FACILITIES. Washington, D.C. DOE 1999a. DOE-STD-1098-99, RADIOLOGICAL CONTROL. Washington, D.C. DOE 1999b. DOE-HDBK-1122-99, RADIOLOGICAL CONTROL TECHNICIAN TRAINING. Washington, D.C. DOE 1999c. DOE G 441.1-12, RADIATION SAFETY TRAINING GUIDE. Washington, D.C. DOE 1999d. DOE G 441.1-2, OCCUPATIONAL ALARA PROGRAM GUIDE. Washington, D.C. DOE 1999e. DOE G 441.1-4, EXTERNAL DOSIMETRY PROGRAM GUIDE. Washington, D.C. DOE 1999f. DOE G 441.1-3, INTERNAL DOSIMETRY PROGRAM GUIDE. Washington, D.C. DOE 1999g. DOE G 441.1-8, AIR MONITORING GUIDE. Washington, D.C.

Section 11

DOE 1999h. DOE G 441.1-9, RADIOACTIVE CONTAMINATION CONTROL GUIDE. Washington, D.C. DOE 1999i. DOE G 441.1-7, PORTABLE MONITORING INSTRUMENT CALIBRATION GUIDE. Washington, D.C. DOE G 441.1-1A 13 (and 14) 10-20-03 DOE 1999j. DOE G 441.1-5, RADIATION-GENERATING DEVICES GUIDE. Washington, D.C. DOE 1999k. DOE G 441.1-10, POSTING AND LABELING FOR RADIOLOGICAL CONTROL GUIDE. Washington, D.C. DOE 1999l. DOE G 441.1-13, SEALED RADIOACTIVE SOURCE ACCOUNTABILITY AND CONTROL GUIDE. Washington, D.C. DOE 1999m. DOE G 441.1-11, OCCUPATIONAL RADIATION PROTECTION RECORD-KEEPING AND REPORTING GUIDE. Washington, D.C. DOE 1999n. DOE G 441.1-6, EVALUATION AND CONTROL OF RADIATION DOSE TO THE EMBRYO/FETUS GUIDE. Washington, D. C. DOE 2000. DOE O 151.1A, COMPREHENSIVE EMERGENCY MANAGEMENT SYSTEM. Washington, D.C. DOE 2001a. 10 CFR 830 Subpart A, U.S. Department of Energy, Quality Assurance Requirements. 66 FR 1810, Federal Register, Vol. 66, No. 7, dated 1-10-2001. Washington, D.C. DOE 2001b. DOE O 414.1, Ch.1, QUALITY ASSURANCE. Washington, D.C. DOE 2001c. DOE 5480.20A. Ch. 1, PERSONNEL SELECTION, QUALIFICATION, AND TRAINING REQUIREMENTS FOR DOE NUCLEAR FACILITIES. Washington, D.C. DOE 2001d. DOE-HDBK-1143-2001, RADIOLOGICAL CONTROL TRAINING FOR SUPERVISORS. Washington, D.C. DOE 2001e. DOE-HDBK-2001, RADIOLOGICAL SAFETY TRAINING FOR PLUTONIUM FACILITIES. Washington, D.C. DOE 2001f. DOE-HDBK-2001, RADIOLOGICAL ASSESSOR TRAINING. Washington, D.C. DOE 2002a. DOE-HDBK-1105-2002, RADIOLOGICAL SAFETY TRAINING FOR TRITIUM FACILITIES. Washington, D.C. DOE 2002b. DOE-HDBK-1108-2002, RADIOLOGICAL SAFETY TRAINING FOR ACCELERATOR FACILITIES. Washington, D.C. DOE G 441.1-1A Attachment 1 10-20-03 Page 1 (and 2) UNITED STATES DEPARTMENT OF ENERGY Office of Worker Protection Policy and Programs (EH-52/270CC) 1000 Independence Avenue, SW, Washington, DC 20585-0270 Request for Changes to MANAGEMENT AND ADMINISTRATION OF RADIATION PROTECTION PROGRAMS GUIDE (Use Multiple Pages as Necessary) Page No. ___________ Section No. _________ Paragraph No. ____________ ___________________________________________________ Facility Requesting Change ___________________________________________________ Contact Person ___________________________________________________ Telephone Number - Fax Number Description of Change Request: _________________________________________________________________________________ _________________________________________________________________________________ _________________________________________________________________________________ _________________________________________________________________________________ Suggested Specific Word Changes: _________________________________________________________________________________ _________________________________________________________________________________ _________________________________________________________________________________ _________________________________________________________________________________ EH-52 Technical Staff Contact: Peter O’Connell (301) 903-5641 DOE G 441.1-1A Attachment 2 10-20-03 Page 1 PREPARATION, REVIEW, AND APPROVAL OF RADIATION PROTECTION PROGRAMS 1. PREPARATION OF RPPS The RPPs detail how the site, facility, or activity has met or will meet the requirements of 10 CFR Part 835. The format for the RPP is not specified. This flexibility will permit the RPP submitting organizations to take advantage of pre-existing documents. The following sections describe the minimum content expected in RPPs.

Section 12

Note: The term “Operations Office” is used throughout this document. Where it is used, the term “Field Office” or the term “Area Office,” as appropriate, should be substituted where there is no Operations Office. 1.1 RPP SUMMARY Each RPP should contain a summary section in the front to allow DOE management and reviewers to quickly assess the more significant information contained in the RPP. The summary should identify the following minimum information: (1) Any requests for exemptions contained in the RPP; (2) The total additional funding required to meet the commitments of the RPP and the expected sources of funding by fiscal year; (3) Any significant new programs or activities needed to meet the requirements; (4) Any significant impacts to other programs or activities not included in the RPP; (5) Any constraints to implementing the RPP; (6) Those areas where there is currently full compliance with the requirements. 1.2 GENERAL INFORMATION The RPP should include general information which: (1) identifies that the RPP addresses the requirements of 10 CFR Part 835; (2) identifies whether the RPP is the initial submittal or a revision; (3) identifies the facilities or activities, missions, and organizations involved; and (4) briefly discusses the content and format of the RPP. 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. Applicability statements may not be used to provide relief where the requirements are clearly stated to be applicable in 10 CFR Part 835. Relief from 10 CFR Part 835 can only be granted by an approved exemption granted in accordance with 10 CFR Part 820, Subpart E as discussed in Section 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. Attachment 2 DOE G 441.1-1A Page 2 10-20-03 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 Environment, Safety and Health for any needed technical clarifications or the Office of General Counsel for legal interpretations of 10 CFR Part 835. 1.4 GUIDES AND TECHNICAL STANDARDS The RPP should identify the guides and technical standards that are to be adopted as the means to meet 10 CFR Part 835. The use of guides and technical standards is not required; however, it is encouraged for the following reasons: (1) The use of previously approved methodologies will streamline the review and approval process; and (2) The use of guides and technical standards will enhance the consistent and successful implementation of

Section 13

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. 1.5 RESOURCE ASSESSMENT New RPPs should contain an estimate of the additional life cycle costs to implement 10 CFR Part 835. Revised RPPs may contain an estimate of the change in life cycle costs associated with the revision, if the change in life cycle cost is significant. The goals of this element of the RPP are as follows: (1) to communicate the expected new costs of implementation to DOE management for the purposes of budget planning and prioritization; (2) to identify the need to explore more cost effective means of achieving compliance; and (3) to identify cases where exemptions should be requested on the basis of insufficient benefit versus the expected implementation costs. Identification of required resources should also serve to open a dialogue between DOE and the RPP submitting organization on adjusting costs and activities to the available resources. When performing the assessments, the estimator should consider monetary costs, as well as non-monetary resource considerations such as the limited availability of special job capabilities (e.g., health physicists). The assessment should (1) be guided by available quantitative and qualitative information; (2) reflect the current status of plant conditions, configurations, and processes; (3) consider the availability of materials and resources; and (4) consider any other information that is relevant to the radiation protection requirements. RPP submitting organizations should seek to achieve the broadest consistency in the methods used to evaluate the resource requirements so that the assumptions, evaluations, and results of the assessment can be objectively DOE G 441.1-1A Attachment 2 10-20-03 Page 3 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.

Section 14

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 3.1.6.7 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. 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. 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 1.6 above). In developing the schedules, consider the resources available to support the work, as well as any major work reductions or schedule changes in other areas that will be required in order to meet the proposed schedules. The RPP should identify major impacts to activities or commitments outside the scope of the RPP that will be caused by the proposed additional activities. Schedules should be developed using the best information available with any assumptions on availability of resources (monetary or non-monetary) clearly stated. The milestones and schedules will be enforceable commitments upon approval of the RPP. Schedule commitments should be firm commitments and consequently, should not be listed as contingent on funding. Thus, it is essential that line program representatives participate in the review and approval of RPPs that involve additional funding needs. Following approval of the RPPs, DOE has a responsibility to provide appropriate funding to support the RPP schedules, the RPPs should be revised to reflect the new schedules 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 1.8 of this attachment).

Section 15

Attachment 2 DOE G 441.1-1A Page 4 10-20-03 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. 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. 2. SUBMITTAL OF RPPS Per 10 CFR 835.101, RPPs must be submitted to the designated DOE point-of-contact within the schedule specified in 10 CFR Part 835. Normally, the RPP is submitted to a point-of-contact located in a DOE Operations Office. The Operations Office point-of-contact should date stamp the receipt of the RPP. Contact the Operations Office point-of-contact in advance of the submittal date to determine the number of copies to be submitted. Documents that are incorporated by reference should be submitted with the RPP unless other arrangements are made with the Operations Office point-of-contact. In addition, if the RPP is not a stand-alone document (able to be reviewed independent of other documents), contact the Operations Office point-of-contact prior to submittal of the RPP to discuss which supporting documents are to be transmitted with the RPP or made available for onsite review. Also see section 3.2 below for additional submittal requirements for final RPPs. 3. REVIEW AND APPROVAL OF RPPS 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 f the RPP to DOE. In order to ensure this shared vision and the development of successful RPPs, early and continual dialogue between the RPP submitting organization and the Review Team is essential. This dialogue should begin well before the RPP is submitted to DOE. The process described below was built on the lessons learned in similar efforts and was designed to facilitate that dialogue. Because review and approval of the RPPs will often involve multiple Departmental organizations, the review and approval process should provide for coordination, consistency of review, and resolution of issues among those offices. In addition, the review and approval process should address both the technical adequacy of the proposed RPPs and the programmatic responsibilities (i.e., funding and mission). These responsibilities will require additional coordination within the Department as they may reside in different organizations. The review and approval process should be sufficiently flexible to accommodate the subjects addressed by 10 CFR Part 835 and adequately structured to permit efficient completion of the review and approval within the 180 days (See 10 CFR 835.101.(i)). Table 1, at the end of this attachment, provides recommended time periods to meet this 180-day requirement.

Section 16

DOE G 441.1-1A Attachment 2 10-20-03 Page 5 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 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. 3.1.1 Identifications of Responsible Review Staff 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 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. 3.1.1.2 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. 3.1.2. Review Planning 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.

Section 17

Attachment 2 DOE G 441.1-1A Page 6 10-20-03 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. 3.1.2.3 Responsibility and Interface Matrix The PSO should prepare and maintain a matrix that identifies the Review Team Leader, Review Team members, and DOE programmatic and technical contacts for each RPP. 3.1.3 Meetings, Conference Calls, and Status Reports 3.1.3.1 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. 3.1.3.2 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. 3.1.3.3 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. 3.1.4 Submittal and Distribution of RPPs As discussed in Section 4 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. 3.1.5 Review 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 Section 3.1.2.1 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 441.1-1A Attachment 2 10-20-03 Page 7 All reviewers should expedite their reviews to allow closure on an acceptable RPP as early as possible. 3.1.5.2 Delegated Approval Authority for RPPs

Section 18

The PSO may delegate the authority to approve specific RPPs. Any such delegation should be provided in writing to the designee and documented in the Functions, Responsibilities, and Authorities (FRA) document for that organization. Wherever the authority to approve an RPP has been delegated to the Operations Office by all of the affected PSOs, the Operations Office may choose to have the Review Team consist entirely of Operations Office personnel provided any technical and programmatic requirements can be handled by the designated team. Per 10 CFR Part 820, Subpart E, the authority to approve exemptions to 10 CFR Part 835 cannot be delegated. 3.1.6 Approval 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. 3.1.6.2 Operations Office Review of the Review Team Recommendations The Operations Office Manager 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 3.1.6.4 Approval Letter, below. 3.1.6.3 PSO Approval Memorandum In order to ensure the Operations Office has a week to transmit the approval or disapproval of the RPP before it becomes automatically effective 180 days after receipt of the RPP by DOE, each affected PSO should indicate approval or disapproval of the RPP in a memorandum to the Operations Office within 173 days of receipt of the RPP by DOE. 3.1.6.4 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. 3.1.6.5 Imposition of RPPs The Review Team will endeavor to resolve any issues identified during the review process. If conflicts exist which cannot be resolved, the Department may exercise its authority (see 10 CFR Part 835.101(b)) to modify proposed Attachment 2 DOE G 441.1-1A Page 8 10-20-03 RPPs to include those actions and schedules that the Department finds appropriate for achieving full compliance in a reasonable and timely manner. In such cases, the PSO approval memorandum should be replaced with a memorandum imposing a revised RPP. The revised RPP should be transmitted to the RPP submitting organization by the Operations Office Manager. The RPPs may be renegotiated at a later date, but until it is replaced by another approved RPP, it will be the enforceable basis for implementation of 10 CFR Part 835.

Section 19

3.1.6.6 RPPs which are not Approved by Final Date Per 10 CFR Part 835.101(I), RPPs which are not approved within the approval period specified in the DOE requirements document should be considered to be approved unless another RPP is imposed by the Department. These RPPs may be renegotiated at a later date, but until they are replaced by another approved RPP, they will be the enforceable basis for implement of 10 CFR Part 835. 3.1.6.7 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. Approval of an RPP pending granting of an exemption does not constitute or imply approval of the exemptions contained therein. 3.2 DISTRIBUTION OF COPIES OF THE FINAL RPP The Operations Office Manager should be responsible for distributing approved RPPs (if changed from the originally submitted RPP), the Office of the Docketing Clerk (in the Office of Price Anderson Enforcement in the Office of Environment, Safety and Health), and to the affected PSOs. Copies of approved RPPs transmitted to the Office of Docketing Clerk should include both a hard copy and an electronic copy. As required by 10 CFR Part 820, the Office of Docketing Clerk will maintain a file of enforceable actions based upon rule violations and noncompliance with RPPs. 3.3 REVIEW RESPONSIBILITIES The Review Team should determine if the RPP provides an acceptable method to meet 10 CFR Part 835. The Review Team should also determine if the RPP adequately addresses the elements discussed in Section 3 of this attachment (Preparation of RPPs). RPP submitting organizations are encouraged to use the methodologies contained in the DOE G 441.1 series of guides for implementation of 10 CFR Part 835 where they are reasonable and economical; however, one may elect to propose an alternate way to meet the requirements. In cases where an alternate method is proposed, the Review Team should evaluate the proposed method to ensure that it will be adequate to meet the requirements and provide a comparable level of safety. The Review Team should verify that the RPP provides sufficient detail to permit DOE to measure the progress towards meeting the DOE requirements. DOE G 441.1-1A Attachment 2 10-20-03 Page 9 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.

Section 20

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. 3.4 APPROVAL RESPONSIBILITIES DOE approval of the RPP constitutes acceptance by the PSO that: (1) The proposed activities represent an acceptable method to meet the requirements; (2) The resources identified in the RPP are necessary and sufficient to ensure completion of the activities contained in the RPP and are expected to be available to support the proposed schedules; (3) The proposed milestones and schedules are acceptable; (4) The applicability of the requirements is correctly identified; and (5) The identified compensatory actions are acceptable. 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 section 4 above and reviewed and approved in the manner described in section 3 above. Any changes to RPPs which will result in a requirement not being met, require an approved exemption. 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 Assistant Secretary of EH Assistant Secretary for Environment, Safety and Health. 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. Attachment 2 DOE G 441.1-1A Page 10 10-20-03 7. INCORPORATION BY REFERENCE The RPP submitting organization may choose to incorporate information into the RPP by referencing all or selected portions of other documents. In such cases, the portions of the referenced documents that are incorporated into the RPP are also subject to the provisions of this guide and attachment.

Section 21

However there are situations when a citation or reference is used to indicate the origin of some of the text in a document. For example, in this guide, 10 CFR Part 835 is cited to indicate the basis for statements containing word “should” or “shall” (i.e. requirements). Consequently, the RPP submitting organization should clearly indicate which documents (or portions of documents) are considered part of the RPP commitments. The RPP submittal should maintain a file of all documents incorporated by reference and should make these documents available to DOE upon their request. See also section 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. Errata Sheet Cover Contents Acronyms Purpose and Applicability Definitions Discussion Implementation Guidance References Attachment 1 - Request for Changes Attachment 2 - Preparation, Review, and Approval of Radiation Protection Programs

Something wrong with this record? Tell us