DOE G 435.1-1 Chapter 1, General Responsibilities and Requirements

DOE G 435.1-1 Approved: 7-09-99 IMPLEMENTATION GUIDE for use with DOE M 435.1-1 U.S. DEPARTMENT OF ENERGY Distribution: Initiated By: All Departmental Elements Office of Environmental Management (This page intentionally left blank.) DOE G 435.1-1 i 7-09-99 Introduction IMPLEMENTATION GUIDE FOR USE WITH DOE M 435.1-1, RADIOACTIVE WASTE MANAGEMENT MANUAL INTRODUCTION This guide was developed to aid in implementing the requirements of DOE M 435.1-1, Radioactive Waste Management Manual. The guide has the same format as the Manual and is divided into four chapters. Chapter I, General Requirements and Responsibilities Chapter II, High-Level Waste Requirements Chapter III, Transuranic Waste Requirements Chapter IV, Low-Level Waste Requirements The material presented in this guide provides suggestions and acceptable ways of implementing DOE M 435.1-1 and should not be viewed as additional or mandatory requirements. The objective of the guide is to ensure that responsible individuals understand what is necessary and acceptable for implementing the requirements of DOE M 435.1-1. For each requirement in DOE M 435.1-1, the guide provides: C The objective of the requirement; C Discussion of the technical, management, and administrative aspects covered by the requirement; C Principles, practices, and methods for implementing the requirement, including examples; C Performance measures for evaluating implementation of the requirement; and C Supplemental references which may be consulted for more detailed information related to the requirement. The guide aids in understanding what is necessary to attain compliance, facilitates effective and efficient implementation of the requirements, and offers acceptable ways to implement the requirement. As noted, the guide provides suggestions and acceptable ways of implementing the requirements, and is not mandatory. Provisions in the guide should not be construed as requirements. The approaches presented in the guidance are not the only acceptable ways of complying with any given requirement. Alternate methods that satisfy the requirements of DOE O 435.1 and DOE M 435.1-1 also are acceptable. A rationale and basis for the approaches identified in the guide has been provided and no further basis is required to implement the approaches outlined in the guide. Any implementation method selected must ensure an adequate level of safety commensurate with the hazards associated with the work. The implementation method selected must be consistent with the radioactive waste management basis. ii DOE G 435.1-1 7-09-99 Introduction Situation-specific attributes and application of the graded approach should always be considered in applying the information contained in this guide. Activities with greater potential consequences or hazards may require more rigor or effort to implement the requirements of DOE M 435.1-1, Radioactive Waste Management Manual. Wherever possible, existing processes, programs, and documentation should be considered as possible routes to complying with the requirements of DOE M 435.1-1. Existing processes and programs generally provide mechanisms for demonstrating compliance and providing auditable records which will also meet the requirements of DOE M 435.1-1. Therefore, it should not be necessary to repeat or recreate programs into which the DOE M 435.1-1 requirements can be integrated.

Chapter I, General Requirements and Responsibilities, provides guidance on DOE management responsibilities and requirements that are applicable to the management of all DOE radioactive waste types. Chapter II, High-Level Waste Requirements; Chapter III, Transuranic Waste Requirements; and Chapter IV, Low-Level Waste Requirements, provide guidance on waste-type specific requirements to be used in conjunction with the guidance on General Requirements and Responsibilities. Other requirements and DOE directives are referenced in DOE M 435.1-1, Radioactive Waste Management Manual, because their applicability to radioactive waste management facilities, operations, and activities was identified through a hazards analysis as necessary for protection of workers, the public, or the environment. It is understood and expected that requirements of this Manual may be satisfied by compliance with other requirements. Paragraph (4) of the Introduction to the Radioactive Waste Management Manual, DOE M 435.1- 1, states that any of the requirements in the Manual may be waived or modified through application of a DOE-approved requirements tailoring process, such as the “Necessary and Sufficient Closure Process” in DOE P 450.3 and DOE M 450.3-1 and DOE P 450.4, Safety Management System Policy, the applicable or relevant and appropriate requirements identification process for actions taken pursuant to the Department’s CERCLA authorities, or by an exemption processed in accordance with the requirements of DOE M 251.1-1A, Directives System Manual. The series of manuals and implementation guides under DOE P 450.4 contain requirements and guidance for implementing the evaluation processes mentioned above that would allow a waiver or modification to any of the individual DOE M 435.1-1 requirements. Chapter VII of DOE M 251.1-1A provides the requirements, including roles and responsibilities, for exempting a DOE site or facility from any of the DOE M 435.1-1 requirements. When the exemption process of DOE M 251.1-1A is used, the policies of the integrated Safety Management System must still be followed, and the overall effect of modifications and exemptions to individual requirements should be evaluated and a determination made that they are DOE G 435.1-1 iii 7-09-99 Introduction not detrimental to the objectives of DOE O 435.1 and DOE M 435.1-1 for the protection of the public, workers, and the environment. Paragraph (4) of the Introduction to the Radioactive Waste Management Manual, DOE M 435.1- 1, also states that all DOE entities shall be in compliance with this directive within one year of issuance. Compliance is defined as implementing the requirements or an approved implementation or corrective action plan. If compliance cannot be achieved within one year, the Field Element Manager must request approval from the cognizant Program Secretarial Officer to extend the compliance date to no later than October 1, 2001. The purpose of this requirement is to encourage DOE sites and programs to implement the requirements of the Order and Manual as soon as possible, to ensure that a plan is developed for implementing requirements that will take longer than one year to implement, and to ensure that the cognizant Program Secretarial Officer is aware of those requirements for which compliance cannot be achieved in one year. Field Elements need to evaluate the state of readiness of facilities, operations, and activities under their authority for compliance with the revised radioactive waste management requirements, and invoke a systematic process for achieving full implementation as soon as possible.

Implementation or corrective action plans establish a commitment and strategy for how sites will implement the requirements by October 1, 2001, and should include objectives and milestones, including dates, for implementing the requirements on a site or facility basis. Example 1: A site implementation plan addresses the requirement for Radioactive Waste Management Basis (RWMB) in one of two ways. For facilities with an existing Authorization Basis, the strategy for implementing the RWMB requirement is to review the Authorization Basis to determine whether it sufficiently covers the requirements needed for a RWMB, then issue a blanket RWMB for those facilities. For facilities which do not have an Authorization Basis, implementation of the RWMB will follow implementation of Waste Acceptance Requirements (for facilities receiving waste) and Waste Generator Requirements (for facilities generating waste). Example 2: A site develops an implementation plan for section III.L.(1)(b) “Vents or other mechanisms....” The site has 1,000 drums of transuranic waste in storage. Two hundred drums have been prepared to the Waste Acceptance Criteria for the Waste Isolation Pilot Plant (WIPP WAC) including having filter vents installed. Of the remaining 800 drums which are not vented, 500 drums are stored in air support storage buildings awaiting certification, and 300 drums are retrievably stored in earthen-covered berms. The site prepares an implementation plan for this requirement which summarizes how the remaining 800 drums will meet the requirement based on existing plans for management of this waste. The plan states that the 500 drums in the air support storage buildings are scheduled to be prepared to WIPP WAC during the following two years. Filter vents will be installed during the certification process. The site has plans to begin iv DOE G 435.1-1 7-09-99 Introduction retrieving the bermed waste in five years. Filter vents will be installed on the drums as they are removed from the berms. The implementation plan shows the schedule and notes that although the requirement will be implemented outside of the three year implementation period, the requirement allow for vents to be installed on existing waste in storage as soon as practical (i.e., the next time the waste is actively managed). DOE G 435.1-1 v 7-09-99 TABLE OF CONTENTS CHAPTER I - GENERAL REQUIREMENTS AND RESPONSIBILITIES . . . . . . . . . . . . . I-1 1. REQUIREMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I-1 A. Delegation of Authority . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I-1 B. Use of Guidance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I-3 C. Radioactive Waste Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I-7 D. Analysis of Environmental Impacts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I-13 E. Requirements of Other Regulations and DOE Directives . . . . . . . . . . . . . . . . I-15

(1) Analysis of Operations Information . . . . . . . . . . . . . . . . . . . . . . . . . . I-17 (2) Classified Waste . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I-18 (3) Conduct of Operations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I-18 (4) Criticality Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I-19 (5) Emergency Management Program . . . . . . . . . . . . . . . . . . . . . . . . . . . I-19 (6) Environmental and Occurrence Reporting . . . . . . . . . . . . . . . . . . . . . I-19 (7) Environmental Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I-20 (8) Hazard Analysis Documentation and Authorization Basis . . . . . . . . . I-21 (9) Life-Cycle Asset Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I-22 (10) Mixed Waste . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I-23 (11) Packaging and Transportation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I-23 (12) Quality Assurance Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I-24 (13) Radiation Protection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I-24 (14) Records Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I-25 (15) Release of Waste Containing Residual Radioactive Material . . . . . . . I-26 (16) Safeguards and Security . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I-27 (17) Safety Management System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I-27 (18) Site-Evaluation and Facility Design . . . . . . . . . . . . . . . . . . . . . . . . . . I-28 (19) Training and Qualification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I-29 (20) Waste Minimization and Pollution Prevention . . . . . . . . . . . . . . . . . . I-29 (21) Worker Protection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I-30 2. RESPONSIBILITIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I-32 A. Program Secretarial Officers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I-32 B. Assistant Secretary for Environmental Management . . . . . . . . . . . . . . . . . . . I-35 (1) Complex-Wide Radioactive Waste Management Programs . . . . . . . . I-35 (2) Changes to Regulations and DOE Directives . . . . . . . . . . . . . . . . . . . I-39 C. Assistant Secretary for Environment, Safety, and Health . . . . . . . . . . . . . . . . I-42 D. Deputy Assistant Secretary for Waste Management . . . . . . . . . . . . . . . . . . . I-43 (1) Complex-Wide Radioactive Waste Management Program Plans . . . . I-44 (2) Waste Management Data System . . . . . . . . . . . . . . . . . . . . . . . . . . . I-53 vi DOE G 435.1-1 7-09-99 TABLE OF CONTENTS (cont.) vi DOE G 435.1-1 7-09-99 E. Deputy Assistant Secretaries for Waste Management and Environmental Restoration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I-55 (1) Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I-55 (2) Site Closure Plans . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I-65

F. Field Element Managers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I-72 (1) Site-Wide Radioactive Waste Management Programs . . . . . . . . . . . . I-72 (2) Radioactive Waste Management Basis . . . . . . . . . . . . . . . . . . . . . . . I-84 (3) Waste Minimization and Pollution Prevention . . . . . . . . . . . . . . . . . I-101 (4) Approval of Exemptions for Use of Non-DOE Facilities . . . . . . . . . I-103 (5) Environmental Restoration, Decommissioning, and Other Cleanup Waste . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I-111 (6) Radioactive Waste Acceptance Requirements . . . . . . . . . . . . . . . . . I-128 (7) Radioactive Waste Generator Requirements . . . . . . . . . . . . . . . . . . I-134 (8) Closure Plans . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I-141 (9) Defense-In-Depth . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I-146 (10) Oversight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I-148 (11) Training and Qualification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I-151 (12) As Low As Reasonably Achievable (ALARA) . . . . . . . . . . . . . . . . . I-153 (13) Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I-156 (14) Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I-159 (15) Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I-161 (16) Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I-166 (17) Material and Waste Declassification for Waste Management . . . . . . I-170 (18) Waste Incidental to Reprocessing . . . . . . . . . . . . . . . . . . . . . . . . . . I-174 (19) Waste with No Identified Path to Disposal . . . . . . . . . . . . . . . . . . . I-179 (20) Corrective Actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I-188 G. All Personnel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I-190 (1) Problem Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I-190 (2) Shutdown or Curtailment of Activities . . . . . . . . . . . . . . . . . . . . . . I-191 CHAPTER II - HIGH-LEVEL WASTE REQUIREMENTS . . . . . . . . . . . . . . . . . . . . . . . . . II-1 A. Definition of High-Level Waste . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II-1 B. Waste Incidental to Reprocessing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II-13 (1) Citation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II-13 (2) Evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II-13 C. Management of Specific Wastes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II-34 (1) Mixed High-Level Waste . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II-34 (2) TSCA-Regulated Waste . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II-34 D. Complex-Wide High-Level Waste Management Program . . . . . . . . . . . . . . . II-38 DOE G 435.1-1 vii 7-09-99 TABLE OF CONTENTS (cont.)

E. Site-Wide High-Level Waste Management Program . . . . . . . . . . . . . . . . . . . II-39 F. Radioactive Waste Management Basis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II-43 (1) Generators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II-43 (2) Pretreatment and Treatment Facilities . . . . . . . . . . . . . . . . . . . . . . . . II-43 (3) Storage Facilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II-43 G. Quality Assurance Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II-48 (1) Product Quality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II-48 (2) Audits and Assessments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II-48 H. Contingency Actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II-51 (1) Contingency Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II-51 (2) Transfer Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II-51 I. Corrective Actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II-56 (1) Order Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II-56 (2) Operations Curtailment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II-58 J. Waste Acceptance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II-61 (1) Technical and Administrative . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II-61 (2) Evaluation and Acceptance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II-68 K. Waste Generation Planning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II-72 (1) Life-Cycle Planning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II-72 (2) Waste With No Identified Path to Disposal . . . . . . . . . . . . . . . . . . . . II-72 L. Waste Characterization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II-78 (1) Data Quality Objectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II-85 (2) Minimum Waste Characterization . . . . . . . . . . . . . . . . . . . . . . . . . . . II-90 (3) Hazardous Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II-93 M. Waste Certification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II-94 (1) Certification Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II-99 (2) Certification Before Transfer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II-103 (3) Maintaining Certification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II-104 N. Waste Transfer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II-107 (1) Authorization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II-107 (2) Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II-109 (3) Records and Transfer Reporting . . . . . . . . . . . . . . . . . . . . . . . . . . . II-112 O. Packaging and Transportation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II-116 (1) Canistered Waste Form . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II-116

P. Site Evaluation and Facility Design . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II-123 (1) Site Evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II-123 (2) Facility Design . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II-128 Q. Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II-164 (1) Operation of Confinement Systems . . . . . . . . . . . . . . . . . . . . . . . . . II-164 (2) Structural Integrity Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II-166 viii DOE G 435.1-1 7-09-99 TABLE OF CONTENTS (cont.) viii DOE G 435.1-1 7-09-99 (3) Canistered Waste Form Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . II-175 R. Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II-178 S. Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II-180 T. Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II-186 U. Closure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II-191 (1) Decommissioning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II-191 (2) CERCLA Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II-191 (3) Closure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II-191 V. Specific Operations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II-207 (1) Operation of Lifting Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II-207 (2) Operation of Facilities for Receipt and Retrieval of High-Level Waste . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . II-208 CHAPTER III - TRANSURANIC WASTE REQUIREMENTS . . . . . . . . . . . . . . . . . . . . . III-1 A. Definition of Transuranic Waste . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III-1 B. Management of Specific Wastes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III-7 (1) Mixed Transuranic Waste . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III-7 (2) TSCA-Regulated Waste . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III-7 (3) Pre-1970 Transuranic Waste . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III-7 C. Complex-Wide Transuranic Waste Management Program . . . . . . . . . . . . . . III-13 D. Radioactive Waste Management Basis . . . . . . . . . . . . . . . . . . . . . . . . . . . . III-14 (1) Generators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III-14 (2) Treatment Facilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III-14 (3) Storage Facilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III-14 (4) Disposal Facilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III-14 E. Contingency Actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III-20 (1) Contingency Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III-20 (2) Transfer Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III-20

F. Corrective Actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III-24 (1) Order Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III-24 (2) Operations Curtailment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III-26 G. Waste Acceptance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III-29 (1) Technical and Administrative . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III-29 (2) Evaluation and Acceptance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III-39 H. Waste Generation Planning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III-43 (1) Life-Cycle Planning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III-43 (2) Waste With No Identified Path to Disposal . . . . . . . . . . . . . . . . . . . III-47 I. Waste Characterization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III-54 (1) Data Quality Objectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III-60 DOE G 435.1-1 ix 7-09-99 TABLE OF CONTENTS (cont.) (2) Minimum Waste Characterization . . . . . . . . . . . . . . . . . . . . . . . . . . III-64 J. Waste Certification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III-69 (1) Certification Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III-74 (2) Certification Before Transfer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III-77 (3) Maintaining Certification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III-79 K. Waste Transfer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III-84 (1) Authorization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III-87 (2) Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III-90 L. Packaging and Transportation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III-95 (1) Packaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III-95 (2) Transportation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III-105 M. Site Evaluation and Facility Design . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III-109 (1) Site Evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III-109 (2) Facility Design . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III-113 N. Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III-130 (1) Storage Prohibitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III-130 (2) Storage Integrity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III-131 (3) Container Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III-133 (4) Retrievable Earthen-Covered Storage . . . . . . . . . . . . . . . . . . . . . . III-137 O. Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III-142 P. Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III-145 Q. Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III-150

(1) All Waste Facilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III-150 (2) Stored Wastes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . III-152 (3) Liquid Waste Storage Facilities . . . . . . . . . . . . . . . . . . . . . . . . . . . III-154 CHAPTER IV - LOW-LEVEL WASTE REQUIREMENTS . . . . . . . . . . . . . . . . . . . . . . . . IV-1 A. Definition of Low-Level Waste . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV-1 B. Management of Specific Wastes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV-7 (1) Mixed Low-Level Waste . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV-7 (2) TSCA-Regulated Waste . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV-7 (3) Accelerator-Produced Waste . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV-7 (4) 11e.(2) and Naturally Occurring Radioactive Material . . . . . . . . . . . . IV-7 C. Complex-Wide Low-Level Waste Management Program . . . . . . . . . . . . . . IV-15 D. Radioactive Waste Management Basis . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV-18 (1) Generators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV-18 (2) Treatment Facilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV-18 (3) Storage Facilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV-18 (4) Disposal Facilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV-18 x DOE G 435.1-1 7-09-99 TABLE OF CONTENTS (cont.) x DOE G 435.1-1 7-09-99 E. Contingency Actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV-23 (1) Contingency Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV-23 (2) Transfer Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV-23 F. Corrective Actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV-28 (1) Order Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV-28 (2) Operations Curtailment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV-32 G. Waste Acceptance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV-35 (1) Technical and Administrative . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV-35 (2) Evaluation and Acceptance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV-49 H. Waste Generation Planning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV-53 (1) Life-Cycle Planning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV-53 (2) Waste With No Identified Path to Disposal . . . . . . . . . . . . . . . . . . . IV-58 I. Waste Characterization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV-70 (1) Data Quality Objectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV-76 (2) Minimum Waste Characterization . . . . . . . . . . . . . . . . . . . . . . . . . . IV-80 J. Waste Certification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV-84 (1) Certification Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV-89 (2) Certification Before Transfer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV-92 (3) Maintaining Certification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV-93

K. Waste Transfer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV-97 (1) Authorization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV-100 (2) Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV-103 L. Packaging and Transportation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV-108 (1) Packaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV-108 (2) Transportation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV-114 M. Site Evaluation and Facility Design . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV-118 (1) Site Evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV-118 (2) Low-Level Waste Treatment and Storage Facility Design . . . . . . . IV-134 (3) Low-Level Waste Disposal Facility Design . . . . . . . . . . . . . . . . . . IV-151 N. Storage and Staging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV-161 (1) Storage Prohibitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV-161 (2) Storage Limit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV-162 (3) Storage Integrity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV-168 (4) Waste Characterization for Storage . . . . . . . . . . . . . . . . . . . . . . . . IV-170 (5) Container Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV-173 (6) Storage Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV-176 (7) Staging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV-178 O. Treatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV-181 P. Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV-185 (1) Performance Objectives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV-185 DOE G 435.1-1 xi (and xii) 7-09-99 TABLE OF CONTENTS (cont.) Introduction (2) Performance Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV-188 (3) Composite Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV-199 (4) Performance Assessment and Composite Analysis Maintenance . . . IV-202 (5) Disposal Authorization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV-206 (6) Disposal Facility Operations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV-210 (7) Alternate Requirements for Low-Level Waste Disposal Facility Design and Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV-219 Q. Closure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV-222 (1) Disposal Facility Closure Plans . . . . . . . . . . . . . . . . . . . . . . . . . . . IV-222 (2) Disposal Facility Closure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV-232 R. Monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV-238 (1) All Waste Facilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV-238 (2) Liquid Waste Storage Facilities . . . . . . . . . . . . . . . . . . . . . . . . . . . IV-241 (3) Disposal Facilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IV-244

APPENDIX A – TECHNICAL BASIS FOR DOE O 435.1 . . . . . . . . . . . . . . . . . . . . . . . . . . A-1 (This page intentionally left blank.) Chapter I General Responsibilities and Requirements IMPLEMENTATION GUIDE for use with DOE M 435.1-1 (This page intentionally left blank.) DOE G 435.1-1 I-1 7-09-99 Chapter I - General Requirements and Responsibilities I. 1.A. Delegation of Authority. Managers charged with responsibilities within this Manual may delegate authority for these tasks to another manager. All delegations of authority shall be documented. Objective: The objective of this requirement is to provide DOE managers with the needed flexibility in managing programs while retaining DOE responsibility and ensuring traceability of authority. Discussion: Delegation of authority is authorizing another DOE manager to perform the task for the manager who has been assigned the responsibility in a DOE Directive. The responsibility for ensuring that the task is performed remains with the DOE manager charged with the responsibility in the DOE Directive. Requiring that delegation be to another DOE manager retains the elements of DOE responsibility, accountability, and attention. DOE attention provides a mechanism for assigning resources necessary for successful execution of the task. Requiring documentation ensures the traceability of authority. The delegation of authority can be made to any DOE manager at any level by the DOE manager charged with the responsibility in DOE M 435.1-1. Any managers who fall in the management chain between the manager who has been assigned the responsibility in DOE M 435.1-1 and the manager who is charged the responsibility for the task have no responsibility for the task themselves but should be notified of the delegation by a copy of the memorandum of record. The delegation of authority can be revoked at any time and delegated to a different DOE manager by the DOE manager charged with the responsibility in DOE M 435.1-1. The manager delegated the authority for a task may further delegate this authority to another manager but must notify the DOE manager charged with the responsibility of this re-delegation, with a copy to other managers, as appropriate for their information. The performance of tasks by other DOE staff or contractors can be assigned by the DOE manager with the authority to perform a task without affecting the delegation of authority. The manager charged with the responsibility in DOE M 435.1-1 needs to ensure the delegation of authority is successful. This can be achieved by periodically discussing the task with the manager to whom the authority was delegated, or requiring a written report from that manager describing how the task is being implemented. The delegation of authority can be indefinite or for a specific time period, but the selected time period should be clearly identified in the documentation of the delegation of authority. The documentation of the delegation of authority can be accomplished by a memorandum of record which should be maintained as an auditable record. The documentation of the delegation of I-2 DOE G 435.1-1 7-09-99 Chapter I - General Requirements and Responsibilities authority should clearly describe the authority being delegated; identify any terminating condition(s) or a termination date of the delegation, as appropriate; identify the DOE manager to whom authority is being delegated; contain a mechanism for acknowledgment of receipt; and be managed as an auditable record as long as the delegation is in effect. A delegation of authority that contains these elements should be considered complete and meets the Manual requirement.

Example: The Field Element Manager is assigned responsibility in DOE M 435.1-1 for ensuring development of, review, approval, and implementation of closure plans for low- level waste disposal facilities. The Field Element Manager delegates authority for these responsibilities to the DOE Radioactive Waste Manager at the site in a memorandum. The Radioactive Waste Manager does not report directly to the Field Element Manager but is two levels removed in the management chain. The memorandum states that the Radioactive Waste Manager is responsible for ensuring development of, review, approval, and implementation of closure plans for all of the site’s low-level waste disposal facilities. The memorandum establishes the effective date as the date that the Radioactive Waste Manager acknowledges receipt of the memorandum and states that this delegation is in effect until revoked by the Field Element Manager. The manager who falls in the management chain between the manager charged with the responsibility and the one who is delegated the authority is copied in the memorandum. The memorandum is identified as a quality assurance record that must be maintained in accordance with the Quality Assurance Program’s record keeping requirements. Delegations of authority should be reviewed whenever a change in DOE management takes place (e.g., there is a reorganization or a manager leaves). These reviews should evaluate the status of the delegation of authority to establish its continued validity over time or under the changed circumstances. Compliance with this requirement is demonstrated if all DOE managers who have been delegated authority for DOE M 435.1-1 have documentation that describes the authority being delegated, identifies the time period for the delegation, and contains an acknowledgment of the receipt of the delegation of authority. This documentation must be maintained as an auditable record. Supplemental References: 1. DOE, 1997. Manual of Safety Management Functions, Responsibilities, and Authorities, DOE M 411.1-1, U.S. Department of Energy, Washington, D.C., October 8, 1997. DOE G 435.1-1 I-3 7-09-99 Chapter I - General Requirements and Responsibilities I. 1.B. Use of Guidance. Additional information supporting the requirements in this Manual is contained in the Implementation Guide for use with DOE M 435.1-1, Radioactive Waste Management Manual. This Guide, DOE G 435.1-1, Implementation Guide for DOE M 435.1-1, shall be reviewed when implementing the requirements of this Manual. The Guide provides additional information and acceptable methods for meeting the requirements. Other methods may be used but must ensure an adequate level of safety commensurate with the hazards associated with the work and be consistent with the radioactive waste management basis. Objective: The objective of this requirement is to ensure that individuals responsible for DOE radioactive waste management operations, facilities, and activities understand what is necessary and acceptable for implementing the requirements of DOE O 435.1, Radioactive Waste Management, and DOE M 435.1-1, Radioactive Waste Management Manual. By understanding the objective of these requirements, individuals responsible for managing radioactive waste should be able to take the appropriate action even in situations not previously discussed in the requirements. Discussion:

The Implementation Guide for DOE M 435.1-1, DOE G 435.1-1, serves as a tool to assist personnel in gaining a comprehensive understanding of how to implement DOE O 435.1 and DOE M 435.1-1 requirements. Guidance for each requirement discusses the technical, management, and administrative aspects of the requirement and identifies acceptable principles, practices, and methods for implementing the requirement. Performance measures for evaluating acceptable implementation of each requirement are also presented. The guidance also includes examples to help illustrate concepts being discussed. These examples are based on hypothetical situations and should not be used as the basis for adapting specific technical standards. Users need to evaluate real situations to identify the hazards which need to be managed and establish the appropriate technical standards. The guide, in many cases, also provides a list of supplemental references that may benefit the individuals responsible for implementing DOE O 435.1 and DOE M 435.1-1. The referenced documents may, in some instances, be regularly updated. Users are responsible for ensuring that the most current versions of these documents are available to affected workers and are referenced as appropriate. Although the requirements in DOE M 435.1-1 were prepared to be as clear and concise as possible, they may be interpreted differently among users. The guidance provides contextual information and explanation to aid users in understanding the purpose and intent of the requirements. Reviewing the guidance can facilitate use of more consistent approaches to I-4 DOE G 435.1-1 7-09-99 Chapter I - General Requirements and Responsibilities implementing the requirements throughout the complex and prevent over or under-interpretation of the requirements. The information is intended to facilitate understanding of intent, scope of application, graded application, degree of effort, and, if possible, measurable standards. The guide also serves as the mechanism for further elaboration and emphasis on concepts which are important to consider in the implementation of requirements, and describes acceptable ways of implementing the requirements. The guidance describes situation-specific considerations and application of the graded approach and necessary and sufficient processes, which can be considered in applying the requirements. In addition, many requirements of DOE M 435.1-1 can be met with existing processes, programs, and documentation. Although DOE M 435.1-1 stipulates that the guidance must be reviewed, this does not mean that all personnel are responsible for reviewing all guidance. The intent of the requirement is that personnel responsible for performing particular work processes are accountable for correctly understanding and interpreting the DOE M 435.1-1 requirements that apply to the work they perform. For example, those personnel who are responsible for translating specific DOE M 435.1-1 requirements into controlling documents and operating procedures at the sites should understand how to effectively and efficiently implement them.

Example: Site Z has constructed a new facility for storing transuranic waste. Facility personnel responsible for preparing the waste acceptance criteria read DOE O 435.1 and DOE M 435.1-1 to identify relevant requirements. Based on their review, they determine that they need to review the General Requirements and Responsibilities guidance for Radioactive Waste Management Basis, Radioactive Waste Acceptance Requirements, Radioactive Waste Generator Requirements, Training and Qualification, Storage, and Waste Declassification. They also read guidance corresponding the Transuranic Waste Requirement for Definition of Transuranic Waste, Management of Specific Wastes, Radioactive Waste Management Basis, Contingency Actions, Waste Acceptance, Waste Certification, Waste Transfer, Packaging and Transportation, and Storage. The review reminds the storage facility personnel of other sources of information which need to be considered in developing the waste acceptance criteria, including the safety analysis, the Waste Acceptance Criteria for the Waste Isolation Pilot Plant, and the DOE directives addressing safeguards and securities, records management, and the Safety Management System. Equipped with all of these resources, waste acceptance criteria that provide for safe receipt and storage of transuranic waste are developed. The guide aids in understanding what is necessary to attain compliance, facilitates effective and efficient implementation of the requirements, and offers acceptable ways to implement the requirement. Guidance documents, including technical standards, can assist in implementing requirements. This guide is intending to provide useful information and methodologies on how a DOE G 435.1-1 I-5 7-09-99 Chapter I - General Requirements and Responsibilities requirement might be implemented. The guidance includes background information regarding the intent of the requirement and its technical underpinnings. Unlike the requirements specifically set forth in a rule or Order, the provisions in guidance documents are not mandatory. Failure to follow a guidance document does not in itself indicate noncompliance with a specific requirement – a finding of noncompliance must be based on a failure to satisfy the requirement. The guidance provided in implementation guides and standards referenced therein are considered acceptable methods to satisfy requirements. The approaches presented in the guidance are not the only acceptable ways of complying with any given requirement. Alternative methods that satisfy the requirements of DOE O 435.1 and DOE M 435.1-1, are also acceptable. Any implementation method selected must ensure that an adequate level of safety commensurate with the identified hazards associated with work is achieved and be consistent with the radioactive waste management basis. Generally it is expected that site documents (e.g., program plans, procedures, waste acceptance criteria) will provide documentation showing that a requirement is being met consistent with the guidance. However, personnel can employ alternative methods that may be more appropriate for specific situations. To the extent that a unique or different approach other than that addressed in the guidance does not otherwise have a documented rationale or basis, it will be necessary to create one. Documentation should identify the alternative method and should include a technically defensible reason for using the alternative approach. The Integrated Safety Management standards identification processes already have safeguards to address the adequacy of standards and these should be the processes used for making and documenting any such decisions.

Compliance with this requirement is demonstrated by key individuals being familiar with the intent of DOE M 435.1-1 requirements based on their review of the guidance, and sites meeting DOE M 435.1-1 requirements by establishing processes described in the guidance. Sites meeting DOE M 435.1-1 requirements in a way different than described in the guidance will be able to demonstrate that an adequate level of safety commensurate with the hazards associated with the work is being maintained, that the method is consistent with the radioactive waste management basis, and if necessary, documentation of the rationale for the alternative approach. Supplemental References: 1. DOE, 1998. Directives System and Directives System Manual, DOE O 251.1A and DOE M 251.1-1A, U.S. Department of Energy, January 30, 1998. 2. DOE, 1995. Performance Indicators and Analysis of Operations Information, DOE O 210.1, U.S. Department of Energy, Washington, D.C., September 27, 1995. I-6 DOE G 435.1-1 7-09-99 Chapter I - General Requirements and Responsibilities 3. DOE, 1995. Environment, Safety, and Health Policy for the Department of Energy Complex, DOE P 450.1, U.S. Department of Energy, Washington, D.C., June 15, 1995. 4. DOE, 1996. Identifying, Implementing and Complying with ES&H Requirements, DOE P 450.2A, U.S. Department of Energy, Washington, D.C., May 15, 1996. DOE G 435.1-1 I-7 7-09-99 Chapter I - General Requirements and Responsibilities I. 1.C. Radioactive Waste Management. All radioactive waste subject to DOE O 435.1, Radioactive Waste Management, and the requirements of this Manual shall be managed as high-level waste, transuranic waste, low-level waste, or mixed low-level waste. Objective: The objective of this requirement is to ensure that all DOE radioactive waste is managed as one of the established waste types, and to eliminate the creation of other waste categories or the management of radioactive waste outside of the requirements established in DOE M 435.1-1. It is also the objective of this requirement to ensure that the radioactive waste is managed safely and effectively within the established programs for high-level waste, transuranic waste, low-level waste, or mixed low-level waste. Discussion: The DOE system for management of radioactive waste has evolved over the last several years into four complex-wide program areas. The first three correspond to the radioactive waste types identified in DOE O 435.1: high-level waste, transuranic waste, and low-level waste. The fourth program, for management of mixed low-level waste, evolved separately from the low-level waste management program due to the hazardous portion of the waste also being subject to the Resource Conservation and Recovery Act (RCRA). Mixed low-level waste, being a subset of low-level waste, must be managed in accordance with the low-level waste requirements of DOE M 435.1-1 and the applicable requirements of RCRA. The evolution of the management of high-level waste and transuranic waste, based on the driving statutes for their management, has not resulted in separate programs for mixed high-level or mixed transuranic waste. Rather, the programs for those waste types address the combined programmatic planning aspects of storage, treatment, and disposal of mixed and non-mixed waste varieties of those waste types.

Management of wastes containing radioactivity that do not meet the definitions of the radioactive waste types in DOE O 435.1 and DOE M 435.1-1 (i.e., 11e.[2] byproduct material, residual radioactive material as defined in the Uranium Mill Tailings Radiation Control Act [UMTRCA], or naturally occurring radioactive material [NORM]) should continue to be managed under the provisions of the UMTRCA, 40 CFR Part 192, or DOE 5400.5, Radiation Protection of the Public and the Environment, as applicable. However, DOE M 435.1-1 allows for small quantities of these wastes to be managed in accordance with Chapter IV, Low-Level Waste Requirements (see the Guidance on DOE M 435.1-1, Section IV.B). Waste in quantities too large for acceptance at DOE low-level waste disposal sites shall be managed according to the requirements I-8 DOE G 435.1-1 7-09-99 Chapter I - General Requirements and Responsibilities of 40 CFR Part 192, and disposed of at specially designated DOE sites or tailing disposal sites established under the Uranium Mill Tailings Radiation Control Act of 1978. During the development of the requirements in DOE M 435.1-1, a safety and hazards analysis was performed to identify operational activities which presented potential hazards that needed to be mitigated. The analysis was conducted on the waste types that have been established through federal legislation and regulation, i.e., high-level, transuranic, low-level, and mixed low-level waste. In order to ensure that the public, workers, and the environment are protected in the course of radioactive waste management, any waste managed by the Department, pursuant to DOE M 435.1-1, must be identified as one of these waste types and managed within the appropriate program. For many years some sites have identified as special case waste that would otherwise meet the definition of high-level, transuranic, or low-level waste. This term was initially used for any waste that did not have a disposition path and evolved to encompass waste which needed special attention. This requirement is intended to preclude the categorization of a radioactive waste as a special-case waste or something other than high-level, transuranic, low- level, or mixed low-level waste, and avoid potential problems associated with the waste not being recognized by and managed within one of the existing waste type programs discussed above. Table I-1.C provides examples of different waste streams and how they could be categorized by waste type and by waste management program. Table I-1.C. Examples of Waste Type and Program Identification Previous Designation or Description of Waste DOE O 435.1 Designation Management Program DOE Equivalent to GTCC Low-Level Waste LLW or MLLW Surplus Sealed Sources with No Potential Reuse Low-Level Waste or Transuranic Waste LLW or TRU Special Performance Assessment Required (SPAR) Low-Level Waste or Transuranic Waste LLW, MLLW, or TRU Waste Samples from Control Runs of DWPF High-Level Waste or HLW Waste Incidental to Reprocessing if determined to be so LLW, MLLW, or TRU Example: A site with a low-level waste disposal facility has waste that has been accumulating in storage over the last 20 years. The waste is contaminated with less than 100 nCi/g (3700 Bq/g) of transuranic radionuclides so it does not meet the definition of DOE G 435.1-1 I-9 7-09-99 Chapter I - General Requirements and Responsibilities

transuranic waste. Even though the transuranic radionuclide concentration is less than 100 nCi/g (3700 Bq/g), the low-level waste disposal facility performance assessment does not project that the waste can be disposed with a reasonable expectation of meeting the disposal performance measures. Rather than categorize the waste as a special case, performance assessment-limited waste, the site correctly categorizes the waste as a low-level waste and includes it as such in the site radioactive waste management program. Since it is included as a low-level waste and there is not an identified path to disposal, plans will be developed for resolving conditions which prevent its disposal, and its existence will be reported to Headquarters for consideration in complex-wide planning. This requirement mandating the management of all radioactive wastes as one of the waste types is not intended to force a presumption about the hazards of managing a waste, nor to automatically define the management steps to be followed based on the categorization of a radioactive waste. Instead, it is intended to promote safe management and timely disposal by ensuring that all wastes subject to DOE O 435.1, including legacy waste and various wastes traditionally called special case wastes, are managed within one of the four existing waste programs. The hazards associated with the waste should still be the most important factor in determining the appropriate management steps for the waste. Therefore, it would be appropriate, for example, to manage all remote-handled waste in one location, even if some of it has been categorized as transuranic waste and some as low-level waste, as long as the waste containers are distinctly marked and segregated, if necessary to deter cross-contamination. Example 1: The Defense Waste Processing Facility has a piece of failed equipment that is contaminated as a result of high-level waste operations. Site personnel characterize the failed equipment to determine the radioactive species and inventories. By applying the “waste incidental to reprocessing” process described in DOE M 435.1-1, Chapter II, High-Level Waste Requirements, site personnel determine that the failed equipment is low-level waste because it meets the evaluation criteria of Section II.B and can be disposed of in the onsite low-level waste disposal facility. Example 2: A site has a waste known to be contaminated with transuranic radionuclides that has been accumulating in storage over the last 20 years. Because a method for disposing of the waste has not been determined, the waste has been called a special case waste. Site management determines that the waste meets the definition of transuranic waste. This categorization does not mean that the waste will necessarily be disposed of at WIPP. However, it establishes the program in which the waste will be managed and also the Manual requirements for managing the waste. Site management must ensure that the waste is appropriately managed as a transuranic waste, considering the hazards of managing it, and managed to achieve disposal in an appropriate waste disposal facility. I-10 DOE G 435.1-1 7-09-99 Chapter I - General Requirements and Responsibilities If a legacy waste is not characterized and the waste type is not known, then the organization responsible for the waste should: C decide the program under which the waste should be managed; C identify whether there is a path forward for disposition of the waste;

C delineate any issues associated with further management steps, including whether it requires further characterization; C provide plans for accomplishing the steps needed to achieve disposal; and C include this information in the documentation of the Site-Wide Radioactive Waste Management Program. Example: A piece of equipment remaining from certain processes no longer conducted at the site is in storage at Building 400. The equipment has been declared waste, but is not fully characterized. It has lead shielding which is known to be contaminated, and based on the processes it was used for, is called mixed low-level waste. It is included in the FY 1999 Site-Wide Radioactive Waste Management Program documentation as mixed low-level waste without a path forward for disposal, and management steps are described to fully characterize the equipment to confirm the waste type designation and to begin an options analysis for treatment and disposal. (Note: Documentation in this case is the information in the update to the Site’s FFCA Treatment Plan.) Figure 1 provides a logic diagram to assist in determining the proper waste type and the appropriate program for managing wastes. Guidance for each waste type chapter should also be consulted for more detailed information about characterization of specific wastes or waste streams. As noted above, any waste managed by the Department, pursuant to DOE M 435.1-1, must be identified as high-level, transuranic, low-level, or mixed low-level waste, and managed within the appropriate program. For many years some sites have identified as special case waste that would otherwise meet the definition of high-level, transuranic, or low-level waste. This term was initially used for any waste that did not have a disposition path and evolved to encompass waste which needed special attention. Special case waste designations should not be used, nor should separate systems and/or management programs be established outside the existing radioactive waste programs. The Assistant Secretary for Environmental Management is responsible for developing and maintaining complex-wide programs for managing the three radioactive waste types (DOE M 435.1-1, Section I.2.B.(1)). Guidance on that requirement discusses the important elements to be included in a waste type management program. The guidance also explains how DOE G 435.1-1 I-11 7-09-99 Chapter I - General Requirements and Responsibilities this responsibility can be met through the existing four waste type specific programs. Specific guidance for the mixed low-level waste management program, which supplements the guidance on General Requirements, is provided in the guidance for a complex-wide low-level waste program, DOE M 435.1-1, Section IV.C. Compliance with this requirement is met by demonstrating that all radioactive wastes are correctly categorized as high-level waste, transuranic waste, low-level waste, or mixed low-level waste, and that all waste and waste streams are managed under one of the four existing waste type specific management programs. For waste that is not adequately characterized, the Site-Wide Radioactive Waste Management Program documentation should detail the plans for management of this waste under one of the four programs and should include a step for confirming the waste type categorization. Supplemental References: 1. Resource Conservation and Recovery Act of 1976, as amended, October 21, 1986.

2. NRC, 1969. “Proposed Rule Making, 10 CFR Part 50 Licensing of Production and Utilization Facilities,” Federal Register, Vol. 34, No. 8712, U.S. Nuclear Regulatory Commission, Washington, D.C., June 3, 1969. 3. Nuclear Waste Policy Act of 1982, as amended, January 7, 1983. 4. Low-Level Radioactive Waste Policy Amendments Act of 1985, as amended, January 15, 1986. 5. Waste Isolation Pilot Plant Land Withdrawal Act of 1992, as amended, October 30, 1992. 6. EPA. Identification and Listing of Hazardous Waste, 40 CFR Part 261, U.S. Environmental Protection Agency, Washington, D.C. 7. DOE, 1990. Radiation Protection of the Public and the Environment, DOE 5400.5, U.S. Department of Energy, Washington, D.C., February 8, 1990. 8. Uranium Mill Tailings Radiation Control Act, as amended, 42 U.S.C. 7901 et seq., 1978. I-12 DOE G 435.1-1 7-09-99 Chapter I - General Requirements and Responsibilities Figure 1 Logic Diagram for Waste-Type/Program DOE G 435.1-1 I-13 7-09-99 Chapter I - General Requirements and Responsibilities I. 1.D. Analysis of Environmental Impacts. Existing and proposed radioactive waste management facilities, operations, and activities shall meet the requirements of 10 CFR Part 1021, National Environmental Policy Act Implementing Procedures; and DOE O 451.1A, National Environmental Policy Act Compliance Program. All reasonable alternatives shall be considered, as appropriate. Nothing in this Order is meant to restrict consideration of alternatives to proposed actions. Objective: The objective of this requirement is to ensure the protection of the public, workers, and the environment in the management of radioactive waste, and in particular, compliance with the requirements of the National Environmental Policy Act. Discussion: The safety and hazards analysis indicated that comprehensive evaluation and documentation of alternatives to radioactive waste management operations and activities was one way of ensuring that risks associated with the management of radioactive waste were understood, and avoided if possible. Additionally, compliance with the requirements of the National Environmental Policy Act (NEPA) is required for all Departmental actions. The requirements analysis concluded that the current set of requirements invoked by 10 CFR Part 1021, National Environmental Policy Act Implementing Procedures, and DOE O 451.1A, National Environmental Policy Act Compliance Program, adequately addressed the controls which were needed to effect such a program. Under 10 CFR Part 1021, the Department adopts in full the regulations for implementing the National Environmental Policy Act published by the Council on Environmental Quality (CEQ) at 40 CFR Parts 1500 through 1508. 10 CFR Part 1021 lays out the procedures DOE decision making must follow and the general requirements for implementing the CEQ requirements for Department of Energy projects. In accordance with these requirements, the Department must review all actions to determine the significance of potential environmental impacts and, as appropriate, prepare environmental assessments and environmental impact statements; prepare, analyze, and consider alternatives; and provide for public participation in the Department’s decision making processes.

DOE’s Office of Environment, Safety, and Health (EH) has published extensive guidance on implementation of CEQ regulations and performing required NEPA analysis for DOE projects in a two volume set entitled, National Environmental Policy Act Compliance Guide. This guidance contains all the relevant sections of laws, and all Executive Orders, DOE policies, and policies from other governmental agencies that need to be considered in complying with NEPA I-14 DOE G 435.1-1 7-09-99 Chapter I - General Requirements and Responsibilities requirements for DOE projects, including those involving radioactive waste management facilities, operations, and activities. No additional guidance on complying with NEPA requirements or to evaluate radioactive waste management facilities, operations, and activities is needed. Supplemental References: 1. DOE. National Environmental Policy Act Implementing Procedures, 10 CFR Part 1021, U.S. Department of Energy, Washington, D.C. 2. CEQ. Regulations for Implementing the Procedural Provisions of the National Environmental Policy Act, 40 CFR Parts 1500-1508, Council on Environmental Quality, Executive Office of the President, Washington, D.C. 3. DOE, 1998. National Environmental Policy Act Compliance Guide, Volumes I and II, U.S. Department of Energy, Washington, D.C., August 1998. DOE G 435.1-1 I-15 7-09-99 Chapter I - General Requirements and Responsibilities I. 1.E. Requirements of Other Regulations and DOE Directives. The following requirements and DOE directives are required for all DOE radioactive waste management facilities, operations, and activities as applicable. Any of the requirements for the following Departmental directives may be waived or modified through application of a DOE-approved requirements tailoring process, such as the “Necessary and Sufficient Closure Process” in DOE P 450.3 and DOE M 450.3-1 and DOE P 450.4, Safety Management System Policy, or by an exemption processed in accordance with the requirements of that directive or DOE M 251.1- 1A, Directives System Manual. Objective: The objective of this requirement is to ensure the protection of the public, workers, and the environment in the management of radioactive waste through the implementation of controls required in other regulations and DOE Directives. Discussion: The safety and hazards analysis conducted during development of DOE O 435.1 and DOE M 435.1-1 was a comprehensive analysis which evaluated all functions of radioactive waste management from generation to post-closure of disposal facilities, and which considered potential impacts on the public, workers, and the environment. The analysis identified numerous weaknesses and conditions requiring controls that are addressed in other existing DOE directives or Federal regulations. During the requirements analysis, these directives and regulations were evaluated to determine if they adequately address the weaknesses and conditions identified in the safety and hazards analysis. It was determined that many of the directives and regulations include all of the controls necessary. Rather than repeating or paraphrasing existing requirements within DOE O 435.1 and DOE M 435.1-1, the current requirement invokes the controls of those directives and regulations in order to provide full regulation of the activities undertaken in the management of radioactive waste.

In the case of a few of the directives and regulations evaluated, certain controls were considered too generic to adequately address the specific needs in management of radioactive waste, but most of the controls were found to be adequate. Also, in the case of a few of the directives and regulations, emphasis on certain important requirements in them was considered necessary to ensure adequate protection of the public, workers, and the environment. In both of these cases, the current requirement invokes the controls of the existing directive or regulation, and additional requirements are added in DOE M 435.1-1. The need for additional controls is included in the guidance discussions addressing each of the existing directives or regulations which has been invoked. I-16 DOE G 435.1-1 7-09-99 Chapter I - General Requirements and Responsibilities The safety and hazard analysis conducted in support of the DOE O 435.1 and DOE M 435.1-1 requirements was conducted using generalized assumptions and generic facilities. It is recognized that this may have resulted in the directives list in this Section containing one or more directives that do not apply to certain facilities. This list is not meant to force a facility to comply with those directives, rather, the facility should continue to comply with only the applicable directives. Example: Facility A is not a nuclear facility or activity. Therefore, the requirements of DOE O 420.1 and other nuclear safety orders are not being followed at Facility A. No additional requirements are invoked to replace these requirements, nor is there any implication that a provision of DOE M 435.1-1 is being violated. It is expected that the responsibilities which are assigned in these directives and regulations will be adhered to, as well as the requirements for processing exemptions and other administrative requirements. It is also expected that any implementation guidance which already exists for the other directives or regulations will be followed. The guidance discussions that follow include specific implementation guidance for radioactive waste management facilities which augments whatever implementation guidance already exists. Waivers, Modifications, and Exemptions. Because the comprehensive safety and hazards analysis is the basis for inclusion of the controls of the other existing DOE directives and regulations in DOE M 435.1-1, the controls should be met to ensure the public, workers, and the environment are protected. However, since the safety and hazards analysis was conducted using generic scenarios for radioactive waste management, it is recognized that facility-specific requirements may be different. There are structured processes through which the requirements of DOE directives invoked in this section of DOE M 435.1-1 may be determined to be unnecessary or satisfied through application of some other requirement. See DOE P 450.3 and DOE M 450.3-1 on Necessary and Sufficient Closure Process. Also, an exemption may be requested and granted for DOE requirements which can be demonstrated to be unnecessary for protection of the public, workers, or the environment. Consistent with the guidance implementing the Safety Management System Policy, DOE P 450.4, this requirement does not allow exemptions from regulations or other requirements which are mandated by law. Regulatory relief from these regulations and requirements must be obtained by the contractor. See DOE M 450.3-1 and 48 CFR 970.5204- 7(8).

The process that is used to justify a requirement as unnecessary or adequately addressed (e.g., “Necessary and Sufficient Closure Process” in DOE P 450.3 and DOE M 450.3-1 and DOE P 450.4, Safety Management System Policy) should be documented in accordance with the requirements and guidance of that process. If an exemption is used to demonstrate a requirement does not need to be met, the exemption should be documented in accordance with the process and requirements in the directive from which an exemption is being requested. If the subject directive does not have requirements for exemptions, then the requirements for exemptions in DOE M DOE G 435.1-1 I-17 7-09-99 Chapter I - General Requirements and Responsibilities 251.1-1A, Directives System Manual, should be followed. Additionally, the documentation should be managed as an auditable record as long as the requirement is considered unnecessary or an exemption is in effect. Documentation that identifies a requirement as being unnecessary or adequately addressed, through the use of an accepted process and which meets the requirements of that process, should be considered complete and in compliance with the DOE M 435.1-1 requirement. Each of the regulations and DOE directives invoked by the current requirement is identified below, and a discussion follows that includes information on why the regulation or directive is specifically identified in DOE M 435.1-1. Also, where needed, information on implementing the regulation or directive at DOE radioactive waste management facilities, operations, and activities is included, as well as references to other guidance sections that discuss the implementation of requirements in these regulations or directives. I. 1.E.(1) Analysis of Operations Information. Data that measure the environment, safety, and health performance of radioactive waste management facilities, operations, and activities shall be identified, collected, and analyzed as required by DOE O 210.1, Performance Indicators and Analysis of Operations Information. Discussion: The functional and requirements analyses conducted in development of DOE O 435.1 and DOE M 435.1-1 concluded that an effective system for identification, monitoring, and analysis of important data and measurements of environment, safety, and health performance was an effective measure for identifying potential issues before they begin to propagate throughout the system or begin to present themselves at other facilities in the complex. The Complex-Wide and Site-Wide Radioactive Waste Management Programs required by DOE M 435.1-1 should include such a feedback mechanism as part of the evaluation process. The requirements analysis indicated that the programs in compliance with DOE O 210.1, Performance Indicators and Analysis of Operations Information, were sufficient for effecting this type of program for radioactive waste management. The program should track and analyze appropriate measures of radioactive waste management performance in order to identify potential problems requiring technical or management attention before the safety of workers, the public, or the environment, is threatened. More guidance on an effective feedback mechanism for radioactive waste management programs can be found in guidance on DOE M 435.1-1, Sections I.2.B.(1) and I.2.F.(1). The Implementation Plan for Defense Nuclear Facilities Safety Board Recommendation 98-1, Department of Energy Plan to Address and Resolve Safety Issues Identified by Internal Independent Oversight, March 10, 1999, contains additional guidance for feedback and tracking systems.

I-18 DOE G 435.1-1 7-09-99 Chapter I - General Requirements and Responsibilities I. 1.E.(2) Classified Waste. Radioactive waste to which access has been limited for national security reasons and cannot be declassified shall be managed in accordance with the requirements of DOE 5632.1C, Protection and Control of Safeguards and Security Interests, and DOE 5633.3B, Control and Accountability of Nuclear Materials. Discussion: During the safety and hazards analysis, no significant risks were identified concerning the management of DOE classified waste. However, the requirements analysis did conclude that any classified radioactive waste should continue to be managed appropriately, and if this meant that its classified status must be maintained, then the current requirements invoked by the Department for protecting and controlling classified materials were sufficient. On the other hand, the requirements analysis also concluded that, if possible, the management of waste as classified should be continued only if necessary. Therefore, DOE M 435.1-1 contains a requirement to declassify or render suitable for unclassified radioactive waste management to the extent practical (DOE M 435.1-1, Section I.2.F.(17)) so it can be managed efficiently with other like wastes, which would help ensure consistency of controls and probably be less expensive. Guidance is provided on DOE M 435.1-1, Section I.2.F.(17) for making as much radioactive waste as practical suitable for unclassified management, thereby minimizing the amount that must continue to be managed as classified waste. I. 1.E.(3) Conduct of Operations. Radioactive waste management facilities, operations, and activities shall be conducted in a manner based on consideration of the associated hazards. Waste management facilities, operations, and activities shall meet the requirements of DOE 5480.19, Conduct of Operations Requirement for DOE Facilities. Discussion: The safety and hazard analysis indicated that many weaknesses and conditions which could lead to potential radiation exposures and environmental contamination could be prevented through effective analysis of functions being conducted in management of waste and establishment of procedures to control the activities that would lead to the desired results. These types of required controls are already implemented by compliance with DOE 5480.19, Conduct of Operations Requirement for DOE Facilities, and this requirement serves to emphasize the continued importance of effective conduct of operations as a protective measure, especially in light of some of the complex activities that are needed in radioactive waste management. No additional guidance is provided here for implementing these requirements for radioactive waste management facilities, operations, or activities. DOE G 435.1-1 I-19 7-09-99 Chapter I - General Requirements and Responsibilities I. 1.E.(4) Criticality Safety. Radioactive waste management facilities, operations, and activities shall be covered by a criticality safety program in accordance with DOE O 420.1, Facility Safety. Discussion: The safety and hazard analysis identified that situations which could lead to criticality were a particularly high-risk aspect of radioactive waste management because the consequences of a rare event of this type could be catastrophic. The Department already requires a criticality safety program in compliance with DOE O 420.1, Facility Safety. This DOE M 435.1-1 requirement serves to emphasize that a criticality program in accordance with DOE O 420.1 must be in place for radioactive waste management facilities, operations, and activities for which criticality is an important consideration. No additional guidance is provided here for implementing these requirements for radioactive waste management facilities, operations, or activities.

I. 1.E.(5) Emergency Management Program. Radioactive waste management facilities, operations, and activities shall maintain an emergency management program in accordance with DOE O 151.1, Comprehensive Emergency Management System. Discussion: The safety and hazards analysis identified that an emergency management program which institutes precautions against potential situations which could lead to worker and public radiation exposures, and which can effectively respond to emergencies is a mitigating measure that should be in place for all radioactive waste management facilities, operations, and activities. The requirements analysis indicated that the programs required to be in compliance with DOE O 151.1, Comprehensive Emergency Management System, would be sufficient. The safety and hazard analysis also revealed a few weaknesses and conditions concerning radioactive waste management that required special emphasis due to the consequences of accidents involving liquid radioactive waste. Therefore, additional requirements for contingency actions for radioactive waste management facilities, operations, and activities are found in each of the waste type chapters, and implementation guidance on the requirements (DOE M 435.1-1, Sections II.H, III.E, and IV.E) should be consulted for discussions on meeting those requirements by incorporating actions into the existing emergency response programs of DOE O 151.1. I. 1.E.(6) Environmental and Occurrence Reporting. Radioactive waste management facilities, operations, and activities shall meet the reporting requirements of DOE O 231.1, Environment, Safety and I-20 DOE G 435.1-1 7-09-99 Chapter I - General Requirements and Responsibilities Health Reporting, and DOE O 232.1A, Occurrence Reporting and Processing of Operations Information. Discussion: The functional and requirements analyses conducted in development of DOE O 435.1 and DOE M 435.1-1 concluded that a system for monitoring and reporting important environmental data and occurrences of certain actions or off normal events was an effective measure for mitigating radioactive waste management problems. Reporting is especially important for identifying potential issues before they propagate through the system or for identifying problems and issues before they present themselves at other facilities in the complex. The requirements analysis indicated that the programs already in place in compliance with DOE O 231.1, Environment, Safety, and Health Reporting, and DOE O 232.1A, Occurrence Reporting and Processing of Operations Information, were sufficient for effecting this type of program for radioactive waste management. The Complex-Wide and Site-Wide Radioactive Waste Management Programs should incorporate these feedback mechanism as part of the evaluation process. More guidance on effective feedback mechanisms for radioactive waste management programs can be found in guidance on DOE M 435.1-1, Sections I.2.B.(1) and I.2.F.(1). I. 1.E.(7) Environmental Monitoring. Radioactive waste management facilities, operations, and activities shall meet the environmental monitoring requirements of DOE 5400.1, General Environmental Protection Program, and DOE 5400.5, Radiation Protection of the Public and Environment. Discussion:

The safety and hazard analysis identified that monitoring for releases of radiation and radioactive material to the environment was an especially important mitigating factor for potential weaknesses and conditions in radioactive waste management. The requirements analysis concluded that the environmental monitoring programs and plans, as required by DOE 5400.1, General Environmental Protection Program; and DOE 5400.5, Radiation Protection of the Public and Environment, implemented monitoring that would address the kinds of concerns evaluated in the analysis. However, monitoring of disposed radioactive waste, because it must remain effective for a long time period following cessation of operations, presents a unique challenge. Additional monitoring of low-level waste disposal facilities is addressed in DOE M 435.1-1, Section IV.R. Implementation guidance for those requirements should be consulted for information on DOE G 435.1-1 I-21 7-09-99 Chapter I - General Requirements and Responsibilities incorporating additional low-level waste disposal facility performance monitoring into the environmental monitoring program and plans already required to be in compliance with the subject DOE Orders on environmental monitoring. I. 1.E.(8) Hazard Analysis Documentation and Authorization Basis. Radioactive waste management facilities, operations, and activities shall implement DOE Standards, DOE-STD-1027-92, Hazard Categorization and Accident Analysis Techniques for Compliance with DOE 5480.23, Nuclear Safety Analysis Reports, and/or DOE-EM-STD- 5502-94, DOE Limited Standard: Hazard Baseline Documentation, and shall, as applicable, prepare and maintain hazard analysis documentation and an authorization basis as required by DOE O 425.1A, Startup and Restart of Nuclear Facilities, DOE 5480.21, Unreviewed Safety Questions, DOE 5480.22, Technical Safety Requirements, and DOE 5480.23, Nuclear Safety Analysis Reports. Discussion: The safety and hazard analysis that was conducted in development of DOE O 435.1 and DOE M 435.1-1 considered a generic or composite facility, operation, or activity in determining the risks associated with management of radioactive waste. During the analysis, it was recognized that for an actual facility, operation, or activity, the real risks posed could be different than those used in development of the set of requirements in the Manual. This requirement was included to ensure that, where appropriate, hazard analysis and documentation was prepared for actual facilities in accordance with the established DOE directives covered, so that if any more severe risks did exist with any radioactive waste management facilities, operations, or activities, then appropriate controls would be developed to mitigate them. Guidance that discusses the authorization basis that may be developed in implementing DOE O 425.1A, Startup and Restart of Nuclear Facilities, DOE 5480.21, Unreviewed Safety Questions, DOE 5480.22, Technical Safety Requirements, and DOE 5480.23, Nuclear Safety Analysis Reports, appears in discussions of the radioactive waste management basis requirement, DOE M 435.1-1, Section I.2.F.(2).

Supporting the implementation of the DOE Orders are two DOE Standards: DOE-STD-1027-92, Hazard Categorization and Accident Analysis Techniques for Compliance with DOE Order 5480.23, Nuclear Safety Analysis Reports, and DOE-EM-STD-5502-94, DOE Limited Standard: Hazard Baseline Documentation. The first Standard establishes guidance for the preparation and review of hazard categorization and accident analyses techniques as required in DOE 5480.23 and therefore, applies only to nuclear facilities, i.e., Hazard Category facilities/operations 1, 2, and 3. The second is a DOE-EM Limited Standard that establishes uniform Office of Environmental Management guidance on hazard baseline documents that identify and control radiological and I-22 DOE G 435.1-1 7-09-99 Chapter I - General Requirements and Responsibilities non-radiological hazards for all Office of Environmental Management facilities including nuclear, radiological, non-nuclear, and industrial. Supplemental References: 1. DOE, 1992. Hazard Categorization and Accident Analysis Techniques for Compliance with DOE Order 5480.23, Nuclear Safety Analysis Reports, DOE-STD-1027-92, U.S. Department of Energy, Washington, D.C., December 1992. 2. DOE, 1994. DOE Limited Standard: Hazard Baseline Documentation, DOE-EM-STD- 5502-94, U.S. Department of Energy, Washington, D.C., August 1994. I. 1.E.(9) Life-Cycle Asset Management. Planning, acquisition, operation, maintenance, and disposition of radioactive waste management facilities shall be in accordance with DOE O 430.1A, Life-Cycle Asset Management, and DOE 4330.4B, Maintenance Management Program, including a configuration management process to ensure the integrity of physical assets and systems. Corporate physical asset databases shall be maintained as complete, current inventories of physical assets and systems to allow reliable analysis of existing and potential hazards to the public and workers. Discussion: The hazards analysis and requirements analysis conducted in development of DOE O 435.1 and DOE M 435.1-1 indicated that effective planning throughout the entire life of a facility or process, coupled with a maintenance program to maintain facilities and systems in proper working order, and configuration management to orderly track changes and decisions made in the life of a facility or operation, were effective ways to avoid problems in management of radioactive waste. DOE O 430.1A, Life-Cycle Asset Management, provides for the kind of planning and configuration management envisioned by the development process, and is cited in this requirement for emphasis. Likewise, the maintenance process required by DOE 4330.4B, Maintenance Management Program, would achieve adequate maintenance for radioactive waste management facilities, operations, and activities, and is also cited for emphasis. The guidance for the following requirements should be consulted for incorporation of aspects of implementation of the process and programs required by these Orders into radioactive waste management facilities, operations, and activities: DOE M 435.1-1, Section II.P.(2); Section III. M.(2); and Section IV.M.(2). However, both the safety and hazards and the requirements analyses indicated that some of the specific weaknesses and conditions which could be experienced with management of radioactive DOE G 435.1-1 I-23 7-09-99 Chapter I - General Requirements and Responsibilities

waste are not covered by the planning required by DOE O 430.1A, Life-Cycle Asset Management. Specific weaknesses identified that were not adequately addressed by DOE O 430.1A requirements dealt with planning and facility closure when waste streams requiring additional management or which had no path to disposal were involved. An emphasis on life- cycle planning for cradle-to-grave management of waste streams from facilities, operations, and activities was thought to cover these weaknesses and conditions that need controlling in the management of radioactive waste. Therefore, the concept of life-cycle planning for waste streams is introduced in DOE O 435.1 and DOE M 435.1-1. The incorporation of life-cycle planning for radioactive waste is discussed in guidance for the Complex-Wide and Site-Wide Radioactive Waste Management Programs (DOE M 435.1-1, Sections I.2.B.(1) and I.2.F.(1)), and the Radioactive Waste Generator Requirements (DOE M 435.1-1, Section I.2.F.(7)). I. 1.E.(10) Mixed Waste. Radioactive waste that contains both source, special nuclear, or by-product material subject to the Atomic Energy Act of 1954, as amended, and a hazardous component is also subject to the Resource Conservation and Recovery Act (RCRA), as amended. Discussion: The potential additional risks posed by mixed radioactive waste due to the hazardous constituents involved, and the complexities of managing mixed radioactive waste, have been recognized for years. This requirement acknowledges the regulation of the hazardous constituents of mixed radioactive wastes in accordance with the Resource Conservation and Recovery Act (RCRA), as amended or in accordance with state hazardous waste regulations promulgated under RCRA authority. Each of the waste type chapters in DOE M 435.1-1 contains additional requirements for mixed radioactive wastes. Guidance for those additional requirements (DOE M 435.1-1, Sections II.C, III.B, and IV.B.(1)) should be consulted to find discussions on management of radioactive mixed waste under DOE O 435.1. Also, implementation guidance on the Department’s management of mixed low-level waste is in the guidance on the Complex-Wide Low-Level Waste Management Program requirement, DOE M 435.1-1, Section IV.C. I. 1.E.(11) Packaging and Transportation. Radioactive waste shall be packaged and transported in accordance with DOE O 460.1A, Packaging and Transportation Safety, and DOE O 460.2, Departmental Materials Transportation and Packaging Management. Discussion: The Department of Transportation maintains regulations covering the transportation of radioactive materials, and DOE will continue to meet these requirements for all applicable transportation situations. This requirement emphasizes the need to continue to meet DOE O I-24 DOE G 435.1-1 7-09-99 Chapter I - General Requirements and Responsibilities 460.1A, Packaging and Transportation Safety, and DOE O 460.2, Departmental Materials Transportation and Packaging Management, for all transportation of radioactive waste. However, the safety and hazard analysis revealed weaknesses and conditions concerning packaging of radioactive waste and waste containers that are not sufficiently covered in the existing transportation regulations because of the long time frames radioactive waste needs to be managed compared with the short time radioactive waste is in transport. Therefore, additional requirements for packaging and transportation of radioactive waste are found in each of the waste type chapters, and guidance for the requirements (DOE M 435.1-1, Sections II.O, III.L, and IV.L) should be consulted for discussions on meeting those requirements.

I. 1.E.(12) Quality Assurance Program. Radioactive waste management facilities, operations, and activities shall develop and maintain a quality assurance program that meets the requirements of 10 CFR 830.120, Quality Assurance Requirements, and DOE O 414.1, Quality Assurance, as applicable. Discussion: The safety and hazards analysis indicated that a strong quality assurance program is appropriate because of the risks posed by the management of DOE’s radioactive waste. The analysis of requirements concluded that most of the requirements already imposed for quality assurance programs in 10 CFR 830.120, Quality Assurance Requirements and Responsibilities, and DOE O 414.1, Quality Assurance, would establish a sufficient program to maintain the quality of products and processes needed for radioactive waste management. Some specific additional quality assurance program requirements are invoked for high-level waste management in DOE M 435.1- 1, Section II.G, and the guidance for those requirements should be consulted to determine how they can be implemented within the quality assurance programs already in place as a result of compliance with 10 CFR 830.120 and DOE O 414.1. I. 1.E.(13) Radiation Protection. Radioactive waste management facilities, operations, and activities shall meet the requirements of 10 CFR Part 835, Occupational Radiation Protection, and DOE 5400.5, Radiation Protection of the Public and the Environment. Discussion: The protection of humans and the environment from the dangers of radiation due to radioactive waste management facilities, operations, and activities is a fundamental requirement of the revised DOE O 435.1, Radioactive Waste Management, and is invoked in DOE O 435.1, Section 4, Requirements. This DOE M 435.1-1 requirement emphasizes the need to ensure that the requirements of 10 CFR Part 835, Occupational Radiation Protection, and DOE 5400.5, DOE G 435.1-1 I-25 7-09-99 Chapter I - General Requirements and Responsibilities Radiation Protection of the Public and the Environment, are met for radioactive waste management facilities, operations, and activities. An important element of these DOE directives is the As Low As Reasonably Achievable (ALARA) process. The Manual contains a specific requirement for the Field Element Manager to ensure that the ALARA principles are incorporated for radioactive waste management facilities, operations, and activities. The guidance on that Manual requirement (DOE M 435.1-1, Section I.2.F.(12)) should be consulted for additional information in implementing the ALARA principles for activities covered by this Manual. I. 1.E.(14) Records Management. Radioactive waste management facilities, operations, and activities shall develop and maintain a record-keeping system, as required by DOE O 200.1, Information Management Program, and DOE O 414.1, Quality Assurance. Records shall be established and maintained for radioactive waste generated, treated, stored, transported, or disposed. To the extent possible, records prepared in response to other requirements may be used to satisfy the documentation requirements of this Manual. Additional records may be required to satisfy the regulations applicable to the hazardous waste components of mixed waste. Discussion:

The safety and hazards analysis demonstrated that management of information important to understanding the risks posed by radioactive waste and the needs for establishing controls was an important control in and of itself. This mitigating factor showed up in many places in the analysis, and the requirements analysis indicated that DOE O 200.1, Information Management Program, and DOE O 414.1, Quality Assurance, provided for the necessary programmatic considerations in establishing effective records and information management. However, some of the specific controls which were thought necessary for managing the technical adequacy and accuracy needed for radioactive waste records, especially considering the magnitude of consequences that could be involved and the long time frames associated with disposal of waste, are not specific enough in these two orders. Thus, there are specific references in many places in all three waste type chapters to establishing a particular kind of record, what the record may be used for, and some indication of the time the record must be kept. These additional considerations are then discussed in the guidance that explains that requirement in detail. It is intended that the programmatic recordkeeping requirements of the particular site will incorporate the necessary changes and accommodations to implement the intent of the DOE M 435.1-1 recordkeeping requirement. I-26 DOE G 435.1-1 7-09-99 Chapter I - General Requirements and Responsibilities Records for Waste Generated, Treated, Stored, Transported, and Disposed. The requirement states that records shall be established for radioactive waste generated, treated, stored, transported, or disposed. The intention of this part of the requirement is to emphasize that records should be kept throughout the entire life-cycle of the waste, including after it is disposed. To that end, there are specific requirements for recordkeeping in waste certification, waste transfer, high-level waste disposal, low-level waste storage, and radioactive waste management basis sections of DOE M 435.1-1. Site- or facility-specific recordkeeping requirements for any radioactive waste management functions that are deemed necessary in addition to the requirements called out in DOE M 435.1-1 should be established in order to maintain the information important to protection of the public, workers, and the environment. Use of Other Documentation Requirements. It is possible that documentation required by other DOE directives, regulations, or site- or facility-specific requirements may contain all the necessary information needed and be maintained adequately for radioactive waste management recordkeeping. To the extent practical, any other recordkeeping requirements that are already being complied with should be used, or modified if appropriate, to meet the recordkeeping requirements of DOE M 435.1-1. It is not intended that duplicate or additional recordkeeping be established to meet DOE M 435.1-1 requirements where sufficient recordkeeping already exists. Mixed Waste Documentation Requirements. Additional recordkeeping and records management requirements may be needed for radioactive mixed waste to comply with Federal and/or State hazardous waste requirements. This part of the requirement stands as a reminder that the hazardous waste records requirements must still be complied with regardless of the records management requirements for the radioactive contaminants being addressed in DOE M 435.1-1. Unless it is agreed to by the appropriate regulators for the hazardous component of mixed waste, the recordkeeping requirements of DOE M 435.1-1 do not necessarily achieve compliance with the separate requirements for the hazardous component of the waste.

I. 1.E.(15) Release of Waste Containing Residual Radioactive Material. The process for determining and documenting that waste is suitable to be released and managed without regard to its radioactive content shall be in accordance with the criteria and requirements in DOE 5400.5, Radiation Protection of the Public and the Environment. Discussion: The requirements analysis indicated that controls for the management of radioactive waste in DOE M 435.1-1 may not be necessary for wastes that may have low concentrations of residual radioactive material. Consistent with DOE 5400.5, Radiation Protection of the Public and the Environment, this requirement allows the determination of waste streams that may be managed without regard to their radioactivity. The current requirements in DOE 5400.5, Radiation DOE G 435.1-1 I-27 7-09-99 Chapter I - General Requirements and Responsibilities Protection of the Public and the Environment, along with implementation guidance established by the Office of Environment, Safety, and Health, for making and documenting these determinations should be consulted for appropriately managing waste streams without regard to their radioactive content. I. 1.E.(16) Safeguards and Security. Appropriate features shall be incorporated into the design and operation of radioactive waste management facilities, operations, and activities to prevent unauthorized access and operations, and for purposes of nuclear material control and accountability, where applicable; and shall be consistent with DOE O 470.1, Safeguards and Security Program. Discussion: The requirements analysis concluded that the current requirements delineated in DOE O 470.1, Safeguards and Security Program, adequately provide for the safeguarding of classified information and material as well as security for radioactive waste management facilities, operations, and activities. Therefore, DOE O 470.1 is cited in DOE M 435.1-1 for emphasis. No additional implementation guidance is considered necessary to address any special needs of the required programs due to the management of radioactive waste. I.1.E.(17) Safety Management System. Radioactive waste management facilities, operations, and activities shall incorporate the principles of safety management as described in DOE P 450.4, Safety Management System Policy, and DOE P 450.5, Line Environment, Safety and Health Oversight, and meet the requirements of the safety management systems sections of 48 CFR Chapter 9, Department of Energy Acquisition Regulations and DOE M 411.1-1, Manual of Safety Management Functions, Responsibilities, and Authorities. Discussion: DOE P 450.4, Safety Management System Policy, establishes the Department’s policy that a formal, organized process shall be used for planning, performing, assessing, and improving the safe conduct of work. DOE P 450.5, Line Environment, Safety and Health Oversight, establishes the Department’s policies that line management conduct environment, safety and health line oversight in a cost-effective, coordinated, integrated, and efficient manner that is seamless to contractors and that value is placed on the Department's line managers and contractors working together to identify and ensure resolution of environment, safety and health concerns. In keeping with this Departmental policy, the principles of integrated safety management were embodied in the technical analyses and processes used to determine the essential requirements of the DOE

I-28 DOE G 435.1-1 7-09-99 Chapter I - General Requirements and Responsibilities Order and Manual on radioactive waste management. The core functions for implementing these principles are (1) define the scope of work; (2) analyze the hazards; (3) develop and implement hazard controls; (4) perform work within the controls; and (5) provide feedback and continuous improvement. Requirements for these policies are set forth in Chapter 9 of Title 48, the Department of Energy Acquisition Regulations, and in DOE M 411.1-1, Manual of Safety Management Functions, Responsibilities, and Authorities. These requirement sets are invoked in DOE M 435.1-1 not only because of the flowdown of the Departmental policies, but also because the implementation of the policies in the Order and Manual were done through evaluating generic situations on a complex-wide basis. The actual implementation of the policies for radioactive waste management facilities, operations, and activities is required on an actual site- and facility-specific basis. Guidance for implementation of a compliant integrated safety management system is found in DOE G 450.4-1A, Safety Management System Guide. No additional guidance is needed for implementing a system for radioactive waste management facilities, operations, and activities. I. 1.E.(18) Site-Evaluation and Facility Design. New radioactive waste management facilities, operations, and activities shall be sited and designed in accordance with DOE O 420.1, Facility Safety, and DOE O 430.1A, Life-Cycle Asset Management. Discussion: The safety and hazards analysis demonstrated that the selection and evaluation of a suitable site plus an appropriate facility design that considered the characteristics of the site chosen were effective mitigation measures to prevent potential problems with the management of radioactive waste, especially when the long-time frames required for effective management of disposed waste are considered. The provisions of DOE O 420.1, Facility Safety, and DOE O 430.1A, Life-Cycle Asset Management, were evaluated and found to be adequate in providing the necessary controls in radioactive waste management. In addition to these Orders, refer to the DOE Handbook, DOE-HDBK-1132-99, Design Considerations. This Handbook includes information and considerations for the design of systems typical to nuclear facilities, design considerations specific to various types of special facilities, and information useful to various design disciplines. The Handbook specifically includes design considerations for confinement systems and radiation protection and effluent monitoring systems as well as good practices and design principles that should be considered in specific design disciplines. The DOE M 435.1-1 waste-type chapters contain specific requirements to supplement DOE O 420.1 and DOE O 430.1A for radioactive waste management facilities. DOE M 435.1-1 (Sections II.P, III.M, and IV.M) contains detailed additional requirements for both site evaluation and facility design. DOE G 435.1-1 I-29 7-09-99 Chapter I - General Requirements and Responsibilities

The intent of the specific facility design requirements in each waste type chapter is to have them applied to all radioactive waste management facilities, both existing and new. However, it is recognized that in some cases it may not be practical, or possible, to apply these requirements to existing facilities or operations. In such cases a graded application of the requirement, or an exemption to the requirement, may be warranted. Use of a graded application or exemption to the requirements may be due to limited programmatic usage, a short service life, or other reasons that make long-term, capital intensive upgrades unreasonable. The guidance for the DOE M 435.1-1 waste type specific facility design requirements contain discussions for conducting adequate facility designs for radioactive waste management facilities, operations, and activities and additional discussions on the application of a graded approach to achieving compliance with the requirements. I. 1.E.(19) Training and Qualification. A training and qualification program shall be implemented for radioactive waste management program personnel, and shall meet the requirements of DOE O 360.1, Training, and DOE 5480.20A, Personnel Selection, Qualification, and Training Requirements for DOE Nuclear Facilities. Discussion: The safety and hazards analysis indicated that an effective mitigating measure for a large number of weaknesses and conditions that could arise in management of radioactive waste was an effective program for qualification and training of personnel. The requirements analysis indicated that DOE’s current programs implementing DOE O 360.1, Training, and DOE 5480.20A, Personnel Selection, Qualification, and Training Requirements for DOE Nuclear Facilities were adequate in establishing effective radioactive waste management personnel qualification and training programs. It is expected that some changes, additions, or improvements to the existing radioactive waste management personnel qualification and training programs would be needed to train personnel on the new and revised requirements of DOE O 435.1 and DOE M 435.1-1. The Field Element Manager is assigned a specific responsibility in DOE M 435.1-1, Section I.2.F.(11) to ensure that this training and re-qualification is reflective of each individuals specific job responsibilities and the changes and improvements made to the radioactive waste management Order. Guidance on DOE M 435.1-1, Section I.2.F.(11) should be consulted for more discussion about the implementation of a radioactive waste management qualification and training program. I. 1.E.(20) Waste Minimization and Pollution Prevention. Waste minimization and pollution prevention shall be implemented for radioactive waste management facilities, operations, and activities to meet the requirements of Executive Order 12856, Federal Compliance with I-30 DOE G 435.1-1 7-09-99 Chapter I - General Requirements and Responsibilities Right-to-Know Laws and Pollution Prevention Requirements, and Executive Order 13101, Greening the Government through Waste Prevention, Recycling, and Federal Acquisition, and DOE 5400.1, General Environmental Protection Program. Discussion:

The safety and hazards analysis indicated that an effective mitigating measure in management of radioactive waste was to avoid potential weaknesses and conditions through minimization of waste. The requirements analysis indicated that DOE’s current programs implementing Executive Order 12856, Federal Compliance with Right-to-Know Laws and Pollution Prevention Requirements and Responsibilities, and Executive Order 13101, Greening the Government through Waste Prevention, Recycling, and Federal Acquisition, and DOE 5400.1, General Environmental Protection Program, were adequate in establishing effective waste minimization programs. In addressing this subject, the NRC endorsed EPA’s Guidance to Hazardous Waste Generators on the Elements of a Waste Minimization Program (59 FR 31114). This guidance should be reviewed for applicability to site waste minimization issues, and establishing a waste minimization program. For emphasis, the Field Element Manager is assigned a specific responsibility in DOE M 435.1-1, Section I.2.F.(3) to ensure that a waste minimization program is fully implemented. I. 1.E.(21) Worker Protection. Radioactive waste management facilities, operations, and activities shall meet the requirements of DOE O 440.1A, Worker Protection Management for DOE Federal and Contractor Employees. Discussion: The safety and hazards analysis indicated that many risks were posed by the management of radioactive waste that were related to non-radioactive characteristics of the waste, and/or by activities that would need to be carried out on the waste regardless of its radioactive content. A few examples of these activities are: conducting activities in tight spaces, handling of heavy, unstable packages, and operation of forklifts. The requirements analysis concluded that the requirements of DOE O 440.1A, Worker Protection Management for DOE Federal and Contractor Employees adequately covered these risks and should be cited in DOE M 435.1-1 for completeness. DOE O 440.1A invokes external Occupational Safety and Health Administration requirements (e.g., 29 CFR Part 1910, Occupational Safety and Health Standards) for both DOE Federal and contractor personnel, along with several industrial and consensus standards for safe workplaces, such as the American Society of Mechanical Engineers’ Boiler and Pressure Vessel Safety Code, and the National Fire Protection Association’s Electrical Safety Requirements for DOE G 435.1-1 I-31 7-09-99 Chapter I - General Requirements and Responsibilities Employee Workplaces. No additional implementation guidance is needed for implementing DOE O 440.1A for radioactive waste management facilities, operations, or activities. Supplemental References: 1. DOE. Nuclear Safety Management, Quality Assurance Requirements, 10 CFR 830.120, U.S. Department of Energy, Washington, D.C. 2. DOE, 1995. Facility Safety, DOE O 420.1, U.S. Department of Energy, Washington, D.C., October 13, 1995. I-32 DOE G 435.1-1 7-09-99 Chapter I - General Requirements and Responsibilities I. 2.A. Program Secretarial Officers. Program Secretarial Officers with radioactive waste management facilities, operations, or activities are responsible within their respective programs for ensuring that the Field Element Managers meet the requirements of DOE O 435.1, Radioactive Waste Management, and this Manual. Objective: The objective of this requirement is to ensure DOE Headquarters management attention and oversight of Field Offices’ management of radioactive waste.

Discussion: This requirement applies to any Program Secretarial Officer (PSO) that has responsibility for facilities, operations, or activities involving the management of radioactive waste. PSOs should be cognizant of Field radioactive waste management activities under their purview and provide appropriate oversight of Field Element Manager’s implementation of DOE O 435.1 and DOE M 435.1-1. A key to successful compliance with any DOE Directive is oversight. This is particularly true of directives which, like DOE O 435.1 and DOE M 435.1-1, have performance-oriented requirements that call for review and approval of site- or facility-specific implementation of procedures and other controls to ensure the requirements are being met. Oversight is defined (DOE M 435.1-1, Attachment 2) as: The responsibility and authority assigned to line management to assess the adequacy of DOE and contractor performance. Independent Oversight refers to the responsibility and authority assigned to the Assistant Secretary for Environment, Safety, and Health to independently assess the adequacy of DOE and contractor performance. The DOE complex has initiated the integrated Safety Management System under Secretarial policies DOE P 450.4, Safety Management System Policy, DOE P 450.5, Line Environment, Safety, and Health Oversight, and DOE P 411.1, Safety Management Functions, Responsibilities, and Authorities Policy. These policies are invoked by DOE M 435.1-1, I.1.E.(17) for the purposes of emphasis and clarity. DOE P 450.4 provides the overall goals and objectives of the DOE integrated Safety Management System. Core function No. 5, “Provide Feedback and Continuous Improvement,” calls for a system of evaluations and reporting in order to continuously improve in achieving the goals and requirements for safety and protection of the environment. DOE P 450.5 explains that line management has the responsibility for oversight of DOE G 435.1-1 I-33 7-09-99 Chapter I - General Requirements and Responsibilities DOE facilities, operations, and activities, including those involving management of radioactive waste. It is expected that the revised requirements of DOE O 435.1 and DOE M 435.1-1 will be incorporated into contractor self-assessments established under the integrated Safety Management System, and incorporated into the Field Office oversight of the contractor programs, as appropriate. Similarly, under the Safety Management System policies, PSOs have the responsibility to monitor the Field Office oversight and participate in Field Office oversight functions, as appropriate. Likewise, under the Safety Management Systems policies, the Assistant Secretary for Environment, Safety, and Health (EH-1) has the responsibility to assess the adequacy of Field Office and contractor performance, and it is expected that the revised DOE O 435.1 and DOE M 435.1-1 requirements will be assimilated into the Assistant Secretary for Environment, Safety, and Health’s programs for independent oversight at his/her discretion. Example: The Assistant Secretary for Defense Programs (DP-1) has been delegated the responsibility for waste management at the Kansas City Plant. He has delegated the authority for this responsibility to DP-24, the Office of Site Operations. DP-24 directs personnel in his organization to conduct an annual evaluation at the Kansas City Plant during which they assess the site’s implementation of DOE O 435.1 and DOE M 435.1-1. DP-24 is advised of any non-compliance issues and in turn advises DP-1 of these issues.

Compliance with this requirement is demonstrated by appropriate incorporation of DOE O 435.1 and DOE M 435.1-1 requirements within the functions, responsibilities, authorities, and requirements explained in the set of Safety Management System directives. This results in thorough and effective oversight of radioactive waste management facilities, operations, and activities, and assurance that the public, workers, and the environment are protected from the hazards associated with management of radioactive waste. Supplemental References: 1. DOE, 1997. Safety Management Functions, Responsibilities, and Authorities Policy, DOE P 411.1, U.S. Department of Energy, Washington, D.C., January 28, 1997. 2. DOE, 1996. Safety Management System Policy, DOE P 450.4, U.S. Department of Energy, Washington, D.C., October 15, 1996. 3. DOE, 1997. Line Environment, Safety and Health Oversight, DOE P 450.5, U.S. Department of Energy, Washington, D.C., June 26, 1997. 4. DOE, 1997. Manual of Safety Management Functions, Responsibilities, and Authorities, DOE M 411.1-1, U.S. Department of Energy, Washington, D.C., October 8, 1997. I-34 DOE G 435.1-1 7-09-99 Chapter I - General Requirements and Responsibilities 5. DOE, 1992. Environmental Audit Program Guidance, DOE/EH-0232, U.S. Department of Energy, Washington, D.C., January 1992. 6. DOE. Performance Objective and Criteria for Conducting DOE Environmental Audits, DOE/EH-0229, U.S. Department of Energy, Washington, D.C. DOE G 435.1-1 I-35 7-09-99 Chapter I - General Requirements and Responsibilities I. 2.B. Assistant Secretary for Environmental Management. The Assistant Secretary for Environmental Management is responsible for: (1) Complex-Wide Radioactive Waste Management Programs. Establishing and maintaining integrated Complex-Wide Radioactive Waste Management Programs for high-level, transuranic, low-level, and mixed low-level waste. These programs shall use a systematic approach to planning, execution, and evaluation to ensure that waste generation, storage, treatment, and disposal needs are met and coordinated across the DOE complex. Objective: The objective of this requirement is to ensure development of complex-wide programs that result in the safe and efficient management of all DOE high-level, transuranic, low-level, and mixed low- level waste. The programs are to ensure coordination among DOE sites and among Headquarters program offices. Such programs provide Headquarters and Field personnel a common basis for carrying out the radioactive waste management programs’ missions. Discussion: The Department is responsible for managing radioactive waste in a manner that is protective of the public, workers, and the environment. To accomplish this in the most efficient manner, and to make the best use of resources, programs for managing the various waste types need to be coordinated among Headquarters Program Offices and among the DOE sites. Radioactive waste subject to the Radioactive Waste Management Order (DOE O 435.1) and the Manual (DOE M 435.1-1) is to be managed within one of four waste-type programs in accordance with the Radioactive Waste Management requirement of the Manual (DOE M 435.1-1, Section I.1.C). The complex-wide programs must respond to current needs affecting the safe, effective, and efficient management of waste. The complex-wide programs should provide a vision of the final disposition of each waste type for the complex, yet need to be responsive to the issues that arise at individual DOE sites.

The Assistant Secretary for Environmental Management is assigned responsibility for maintaining programs for managing each waste type to ensure that there is a focal point for managing the wastes and ensuring integration across the complex. Integration across the complex involves coordinating treatment, storage, and disposal to allow the needs of one site to be met by capabilities at another site, if practical. To that end, activities at individual DOE sites should support the complex-wide program by providing data needed for complex-wide planning (e.g., waste inventories and projections, facility capacities) and by budgeting for and executing site activities that lead to accomplishing complex-wide program goals. Conversely, the complex-wide I-36 DOE G 435.1-1 7-09-99 Chapter I - General Requirements and Responsibilities program should also be supportive of the site programs by establishing realistic goals and resolving complex-wide issues (e.g., disposal configurations, equity issues, certain issues affecting waste with no path to disposal), and should be developed with cognizance of individual site constraints (e.g., agreements with State or local governments, compliance orders). In addition to ensuring integration across the complex, assigning the Assistant Secretary for Environmental Management responsibility for program development and maintenance also provides a focal point for coordination across all Headquarters Program Offices. Thus, regardless of whether other Headquarters program offices (e.g., Defense Programs, Science) have responsibility for various waste management activities, the Assistant Secretary for Environmental Management is responsible for ensuring that activities are coordinated within the waste type programs. The requirement calls for a program for each waste type. This is consistent with the way DOE manages the radioactive waste types and allows the focus of the program to be on the characteristics and/or legal and regulatory requirements specific to the waste type. For example, the regulatory constraints on disposal vary among the waste types. DOE plans to dispose of high- level waste in a geologic repository so the end point objective of the high-level waste program is to convert the waste into a form that meets the waste acceptance criteria for the repository. Federal legislation provides for the disposal of defense transuranic waste in a geologic repository, separate from the spent nuclear fuel/high-level waste repository. Waste characteristics and the need to coordinate transportation to the repository provides the common basis for having a transuranic waste management program. The Department’s policy and regulatory authority for onsite disposal of low-level waste establishes the underlying basis for addressing this waste within a program; and in part, because of the overlay of external requirements, mixed low-level waste is addressed within a separate program. Although individual programs for the waste types are established at the complex-wide level, separate programs for each waste type are not required at the DOE sites. Rather, the site programs are to be developed in a manner that the Field Element Manager deems appropriate, as long as the site programs support the individual complex-wide programs (see guidance for Site-Wide Waste Management Program).

A systematic approach for managing each waste type should provide all of the organizations involved in the program with a common framework within which they can discharge their responsibilities. The program framework should identify the overall mission of the program, the key program participants, participants roles, and expected accomplishments. The top-level functions of the program are planning or formulation, execution, and evaluation. The planning function identifies the organizations or sites responsible for implementing the strategies and activities directed at accomplishing the program mission. Under the execution function of the program, each organization performs the work for which it is responsible. For example, site DOE G 435.1-1 I-37 7-09-99 Chapter I - General Requirements and Responsibilities personnel would perform the activities associated with storing, treating, and disposing of waste and Headquarters personnel would perform the necessary coordination, data collection and analysis, and further complex-wide planning. The evaluation function provides the means of improving the program by learning from the experience gained through execution of the program. Each of these functions is discussed in more detail below. Planning. A systematic approach to planning involves identifying and defining those aspects of the program necessary for the sites to execute their individual responsibilities. The planning should be consistent with DOE policies, other programs, and controlling or higher level documents that specify DOE policy or direction. Example: The waste type programs need to be consistent with the overall plan for clean up of DOE sites developed under the auspices of the Assistant Secretary for Environmental Management. The Assistant Secretary’s plan is a higher level document establishing policy and direction for environmental restoration and waste management activities in the Department. The complex-wide program for each waste type should be defined in terms of scope, mission, goals and objectives, priorities, and interfaces. As used here, the term scope means the boundaries of the program, such as the waste and the waste management facilities and activities that are included in the program. The mission, and goals and objectives provide program participants a common view of what the program is intended to accomplish in the short and long term. The priorities address the order of importance of the goals, objectives and activities to be accomplished. A priority may be based on the need to complete a fairly minor activity in order to support a subsequent activity. The interfaces describe where and how the program interactions occur, both within the program and with other organizations and facilities outside of the program. A key interface for each waste type program is the interaction with the other waste type programs since there are occasions when waste exits one program and enters another programs (e.g., see guidance on Waste Incidental to Reprocessing). In order to ensure that waste management needs will be met (e.g., sufficient waste storage capacity), it is necessary to have data on inventories of waste and estimates of future waste receipts to compare with current and projected facility capacities. These data provide the basis for determining the strategy for meeting current and future waste management needs. A strategy for meeting waste management needs may include constructing new facilities (permanent or mobile), using commercial facilities or capabilities, coordinating among DOE sites, or combinations of these and other actions. The Assistant Secretary also needs to ensure that National Environmental Policy Act (NEPA) analyses are performed to support policy-making and configuration decisions.

I-38 DOE G 435.1-1 7-09-99 Chapter I - General Requirements and Responsibilities Lastly, the planning function includes developing and submitting a budget request to implement the planned program activities. Depending on organizational responsibilities assigned at Headquarters, the Assistant Secretary for Environmental Management may not be responsible for funding all waste management activities. However, in exercising the responsibility assigned by this requirement, the Assistant Secretary should be cognizant of the funding for waste management being requested by other Program Offices to ensure that waste management activities are integrated. In performing budget planning, it is necessary to plan for events far enough into the future to allow sufficient lead time for the Federal funding process. Generally, this requires identifying major expenditures two or three years in advance. Implementation of the program planning activities may be provided for by existing actions undertaken by or on behalf of the Assistant Secretary for Environmental Management. To the extent the planning function is already met by ongoing activities (e.g., the annual budget submittal, existing waste type program plans), no additional effort is required to fulfill this responsibility. Execution. Execution of the waste management programs involves those activities taken to implement planning. At the complex-wide level, execution will involve performing the studies and analyses that form the basis for resolving issues and conducting future planning. At the site level, execution includes the generation, storage, treatment, and disposal of waste. In addition, program execution includes data collection and documentation associated with waste management activities, as well as construction and procurement activities necessary to provide future waste management capabilities. Evaluation. An important part of a systematic approach to the waste management programs is evaluating the work accomplished during the execution phase. Progress should be measured against programmatic goals established during the planning phase. In addition, success should be measured against parameters established to evaluate protection of the public, workers, and the environment. The evaluation should include the following elements: Performance Measures. Metrics should be used in evaluating performance against program, and environmental, health, and safety goals should be selected and agreed to by Headquarters and the field; Performance Data. Performance data should be collected from across the complex to enable evaluation of performance relative to the measures selected above; Performance Evaluation and Reporting. Collected data should be reduced into a form that allows it to be analyzed against the metrics and to allow it to be interpreted and evaluated for performance and trends; and DOE G 435.1-1 I-39 7-09-99 Chapter I - General Requirements and Responsibilities Feedback. Information should be provided for use in the planning process and for use by the sites in improving performance. Feedback should be in the form of recommendations for potential changes to program policies, goals, priorities, strategies, or interfaces. Additionally, feedback may include recommendations on methods to improve protection of the environment, and human health and safety, either through top-level management actions (e.g., administration of contractor award fees) or working level management actions (e.g, changes to site operating practices and/or procedures).

The process of planning, execution, and evaluation is iterative. The lessons learned from the activities undertaken during one fiscal year, or changes in the assumptions on which the program strategy was based, will require revising the program planning. This in turn will affect the execution of the program, and therefore the performance measures that will be included in the evaluation step. Compliance with this requirement is demonstrated if complex-wide waste type programs exist for high-level, transuranic, low-level, and mixed low-level waste. These programs should result in safe and efficient management of all DOE radioactive waste and ensure coordination among DOE sites and programs. Supplemental References: 1. DOE, 1997. Safety Management Functions, Responsibilities, and Authorities Policy, DOE P 411.1, U.S. Department of Energy, Washington, D.C., January 28, 1997. 2. DOE, 1997. Manual of Safety Management Functions, Responsibilities, and Authorities, DOE M 411.1-1, U.S. Department of Energy, Washington, D.C., October 8, 1997. 3. DOE, 1996. DOE Low-Level Waste System Description Document, U.S. Department of Energy, Office of Environmental Management, September 1996. I. 2.B.(2) Changes to Regulations and DOE Directives. Ensuring changes to regulations and DOE directives are reviewed and, when necessary, incorporated into revisions of this Manual to ensure the basis for safe radioactive waste management facilities, operations, and activities is maintained. I-40 DOE G 435.1-1 7-09-99 Chapter I - General Requirements and Responsibilities Objective: The objective of this requirement is to ensure that changes to pertinent regulations and other DOE directives are evaluated and incorporated into revisions to radioactive waste management directives to keep current with new information and practices. Discussion: The Assistant Secretary for Environmental Management is responsible for ensuring changes to regulations and DOE directives are reviewed and evaluated for their impact on safe radioactive waste management. The results of the review should be used to assess the need to revise DOE O 435.1, Radioactive Waste Management and the associated Manual and Contractor Requirements Documents. When warranted, these documents are to be revised to ensure protection of workers, the public, and the environment. New information leads to changes in regulations and other DOE directives, and practices used in the management of radioactive waste. This information and the changes should be evaluated and, when appropriate, incorporated into revisions of DOE O 435.1, Radioactive Waste Management, or DOE M 435.1-1, Radioactive Waste Management Manual, so that DOE radioactive waste management requirements and practices are consistent with requirements and practices within DOE and in commercial radioactive waste management. If the review of a change in a regulation or directive leads to the potential need for a revision, the determination of the need and rationale for a revision should be documented. The documentation should be maintained as an auditable record as long as the directive is in effect.

Example: The DOE directive on environmental and occurrence reporting is revised and a new version issued. The Order and associated documents are reviewed and primarily administrative requirements (e.g., the way DOE does business) are changed. A review of the technical basis document does not reveal any reliance on the administrative requirements of the revised order for protection of workers, the public, or the environment. Therefore, the results of the review lead to the conclusion that there is no need to revise DOE O 435.1, Radioactive Waste Management. This conclusion is documented and maintained as a quality assurance record. Additionally, however, a change to a technical requirement which was relied upon to address a weakness or condition associated with radioactive waste management is assessed to determine impact on the protection of workers, the public, and the environment. A significant impact is identified that warrants a revision to the requirements of DOE M 435.1-1. The method of effecting the revision (change page, memorandum, order revision, etc.) should be documented and managed as a quality assurance record. DOE G 435.1-1 I-41 7-09-99 Chapter I - General Requirements and Responsibilities Compliance with this requirement is demonstrated by the existence of a systematic process of reviewing new and proposed directives and regulations for their impact on the basis for safe management of DOE radioactive waste. Documented conclusions from the reviews provide evidence that the process is being implemented. Supplemental References: None. I-42 DOE G 435.1-1 7-09-99 Chapter I - General Requirements and Responsibilities I. 2.C. Assistant Secretary for Environment, Safety, and Health. The Assistant Secretary for Environment, Safety and Health is responsible for providing an independent overview of DOE radioactive waste management and decommissioning programs to determine compliance with DOE environment, safety, and health requirements and applicable Environmental Protection Agency (EPA) and state regulations, including: (1) Advising the Secretary of the status of Departmental compliance with the requirements of DOE O 435.1, this Manual, and applicable provisions of other DOE Orders. (2) Conducting independent appraisals and audits of DOE waste management programs. (3) Reviewing site Waste Management Plans with regard to compliance with DOE environment, safety, and health requirements. Objective: The objective of this requirement is to ensure that the existing role of the Office of Environment, Safety and Health for providing independent oversight is maintained and understood. Discussion: The role of the Assistant Secretary for Environment, Safety and Health is to conduct independent oversight of DOE activities, including radioactive waste management. The purpose of this oversight is to determine compliance of DOE Headquarters and Field Element programs with DOE Environment, Safety and Health regulations and applicable EPA and state regulations. During the development of DOE M 435.1-1, it was recognized that explicit inclusion of this statement within the General Requirements and Responsibilities Chapter would serve to clarify this role. The inclusion of this requirement/responsibility is not expected to change any current reporting, oversight, or compliance arrangements within the Department, rather it further clarifies existing roles and responsibilities. DOE G 435.1-1 I-43 7-09-99

Chapter I - General Requirements and Responsibilities Supplemental References: 1. DOE, 1997. Manual of Safety Management Functions, Responsibilities, and Authorities, DOE M 411.1-1, U.S. Department of Energy, Washington, D.C., October 8, 1997. 2. DOE, 1988. General Environmental Protection Program, DOE 5400.1, U.S. Department of Energy, Washington, D.C., November 9, 1988. 3. DOE, 1990. Radiation Protection of the Public and the Environment, DOE 5400.5, U.S. Department of Energy, Washington, D.C., February 8, 1990. I-44 DOE G 435.1-1 7-09-99 Chapter I - General Requirements and Responsibilities I. 2.D. Deputy Assistant Secretary for Waste Management. The Deputy Assistant Secretary for Waste Management is responsible for: (1) Complex-Wide Radioactive Waste Management Program Plans. Developing, implementing, and maintaining integrated Complex-Wide Radioactive Waste Management Program Plans for high-level, transuranic, low-level, and mixed low-level waste. Each plan shall, at the DOE complex-wide level, describe the functional elements, organizations, responsibilities, and activities that comprise the system needed to store, treat, and dispose of radioactive waste in a manner that is protective of the public, workers, and the environment. In addition, the plans shall: (a) Present a waste management strategy that integrates waste projections and life-cycle waste management planning into complex- wide facility configuration decisions; and (b) Describe the approach to research and technology development being pursued to improve safety and/or efficiency in managing radioactive waste. Objective: The objective of this requirement is to ensure that complex-wide plans provide an overarching strategy for making and implementing waste management decisions. The overarching strategy provides site personnel a framework within which they can formulate and execute plans for managing wastes at the individual sites. Discussion: The Radioactive Waste Management Manual, DOE M 435.1-1, Section I.2.B.(1), assigns the Assistant Secretary for Environmental Management responsibility for establishing and maintaining complex-wide management programs for each waste type. This responsibility is fulfilled through the planning, execution, and evaluation of these programs. The current requirement assigns the responsibility for a complex-wide program plan for each waste type to the Deputy Assistant Secretary for Waste Management. These plans are to provide a clear picture of the waste type program and its direction, and serve as a mechanism for documenting most of the planning functions of the programs. Although assigned to the Deputy Assistant Secretary, the development of these plans is a cooperative and iterative effort with the site representatives and other affected programs. Whereas the Field Element Managers are to develop and implement site DOE G 435.1-1 I-45 7-09-99 Chapter I - General Requirements and Responsibilities programs that support the complex-wide plan, the complex-wide plan should be developed based on the inventory, facility status, constraints, and needs of the individual sites. Definition of Waste Management Program. The following topics are to be addressed in the waste type program plans to define the program in a manner that conveys the extent and intent of the program. Mission. The program plans should provide a succinct statement of the overall purpose of the program. The mission statement should reflect the expectation to safely manage each waste type throughout all stages of waste management and should reflect disposal of waste as part of the mission.

Example: The Low-Level Waste Management Program mission statement states - The mission of the Department of Energy Low-Level Waste Management Program is to develop, implement, and coordinate a nationally integrated program for low-level waste treatment, storage, and disposal that uses a combination of Federal and private facilities to meet the needs of waste generators while fully protecting workers, the public, and the environment. Safety of operations and timely disposal of waste are high priorities for the Department. Goals, Objectives, and Milestones. A key element of the complex-wide waste type program plans is the identification of program goals, objectives, and major milestones. Goals to be defined in the program plans may be general and apply to the complex as a whole, or they may be site-specific goals, based on input from the field, that are major events for the program (e.g., opening the Waste Isolation Pilot Plant). One of the complex-wide goals that should be defined in the plans is the expected end-state for the waste type. That is, the end of the life-cycle for the particular waste type should be one of the long-term goals of the program. The complex-wide goals should be specific, long- term measures of the waste type program’s progress, and the goals should be challenging, yet achievable. To support the periodic assessment of the program’s progress, the goals should be measurable. Objectives should be established as interim measures of progress towards meeting the program goals. The objectives may be established as complex-level objectives, or may reflect key events at individual sites that are significant to measuring progress in the program. Milestones are more specific events, e.g., decision points, completion of specific studies or analyses, or operation of specific facilities, which have a date of completion associated with them. Milestones are to be established in support of the goals and/or objectives. As with the goals and objectives, milestones may be established for activities being addressed I-46 DOE G 435.1-1 7-09-99 Chapter I - General Requirements and Responsibilities at the complex-wide level, or may represent major activities that are to be completed at a specific site consistent with site programs (see DOE M 435.1-1, Section I.2.F.(1)). The following examples shows program goals, supported by objectives, and specific milestones. Example 1: Goal: Convert Environmental Management high-level waste to a form that can be accepted by the Office of Civilian Radioactive Waste Management. Objective: Vitrify all of the high-level liquid waste at the Savannah River Site. Milestone: Produce 250 canisters of vitrified Savannah River Site high-level waste in conformance with Environmental Management Waste Acceptance Product Specification during FY 1999. Example 2: Goal: Provide for disposal of all transuranic waste. Objective: Dispose of defense transuranic waste at the Waste Isolation Pilot Plant. Milestone: Begin disposal operations at the Waste Isolation Pilot Plant by September 1998. Milestone: Remove all packaged transuranic waste from the Rocky Flats Environmental Technology Site by December 2XXX. Priorities. The complex-wide program should establish priorities which are then reflected in the goals and objectives of the program. The priorities for the program may be influenced by a number of different factors, including legal commitments or agreements, predecessor-successor relationships of related program activities, timing of the availability of a technology or facility, and funding considerations.

Example 1: A prioritization of activities in the high-level waste management program has resulted in a decision to construct and start operation of vitrification facilities at the Savannah River Site and the West Valley Demonstration Project, followed by facilities at Hanford and the Idaho National Engineering and Environmental Laboratory. These priorities are based on availability of funding and the stage of technology development and readiness at these sites. DOE G 435.1-1 I-47 7-09-99 Chapter I - General Requirements and Responsibilities Example 2: An example of prioritization for the Transuranic Waste Management Program would be deciding to open the transportation corridors through New Mexico, Colorado, Wyoming, Utah, and Idaho prior to opening corridors through eastern states. This priority is based on the sites that are expected to ship waste to the Waste Isolation Pilot Plant first. Boundaries and Interfaces. The program plans should clearly define the boundaries or scope of the program and describe the internal and external interfaces which must be managed. The complex-wide plans should define what is within the program boundary, including a general description of the wastes to be managed. Part of defining the boundaries or scope in the waste type program plans includes identifying the internal interfaces. The internal interfaces include the interactions among organizations or activities that have different funding sources, but are part of the DOE waste management (e.g., high-level, transuranic, low-level, or mixed low-level waste) programs. Internal interfaces are defined through the identification of organizations and responsibilities discussed in a following subsection. Interfaces external to a waste type program should also be defined in the program plan. The interfaces exist between waste type programs, with generators, and with external entities. First, interfaces between waste type programs need to account for transfers of waste between the programs. Transfer may be necessary to accommodate waste that changes from one waste type to another (e.g., as a result of assay or a waste incidental to reprocessing determination), or from generating a waste as a result of managing another waste type (e.g., high-level waste treatment generates a secondary low-level waste stream). An important outcome of identifying interfaces with other waste type programs is ensuring that all waste (subject to DOE O 435.1) under the Department of Energy’s purview is being managed within one of the waste type programs. Example: Pretreatment of high-level waste at the Savannah River Site results in a high-volume stream of salt solution. Through application of the waste incidental to reprocessing process, a determination is made that the salt solution should be managed as low-level waste. The high-level and low-level waste programs establish an interface that ensures that the waste is safely managed according to the appropriate set of requirements. Second, each of the programs needs to identify interfaces with the generators of each waste type. The program plan should document the sources of waste that the program will manage. Whereas some waste is generated by activities within the program, waste is also generated by the Environmental Restoration Program, Defense Programs, Science Programs, and Nuclear Energy Programs. I-48 DOE G 435.1-1 7-09-99 Chapter I - General Requirements and Responsibilities

Third, the program plan should document interfaces with organizations external to the Department of Energy. This could include external regulatory agencies (Federal or State) as well as commercial facilities. Constraints. The program plans should discuss significant constraints on the planning and execution of each waste type program. As used here, the term constraints has a broad meaning including program assumptions, Departmental policies which direct or restrict certain waste management actions, external regulations, etc. Key assumptions that may impact planning at the complex-wide level include major policies, current and out-year program funding, expected programmatic or activity decisions, and expected contract awards. Example: A key assumption affecting the management of low-level waste is that the six currently operating low-level waste disposal facilities will continue to operate for the next two years. Therefore, there would be no significant changes to existing generator- disposal facility relationships. Organization and Responsibilities. The organizational and functional responsibilities of the participants in the complex-wide waste type programs, and their interrelationships, should be described in the program plans. This description should include the identification of the organizations within both the Headquarters and Field organizations, and a discussion of their respective roles in formulating, executing, and evaluating the waste type programs. The plan should include organization and interface charts that define the roles, responsibilities, and authorities for each of the major program participants, as well as required lines of communication. Example: For the Low-Level Waste Management Program, the Program Plan identifies the entity responsible for supporting the Deputy Assistant Secretaries for Waste Management and Environmental Restoration in the review and evaluation of disposal facility performance assessments and composite analyses. Integrated Program Strategy. The program plan provides a description and basis for the strategy being pursued to fulfill the program mission and meet the program goals. The strategy addresses the life-cycle management of waste from generation and generation reduction through the plans and approaches for effecting disposal of waste. The strategy also needs to recognize that part of the life-cycle management of the waste may include continued safe storage of legacy waste pending the ability to dispose of it. The strategy needs to be consistent with the assumptions described earlier and should be developed considering the following elements: • Technical and programmatic issues; • Waste projections; • Life-cycle waste management planning; DOE G 435.1-1 I-49 7-09-99 Chapter I - General Requirements and Responsibilities • Waste minimization and pollution prevention; • Research and development; and • Implementation of DOE O 435.1. Technical and Programmatic Issues. Major issues that impact the safe management of waste, including regulatory issues; expected changes in Federal, State or local statutes; and major technical issues should be discussed in the plan. Among the issues included in the plan should be problems identified by the sites that would best be addressed at a complex-wide level (e.g., resolving certain issues that result in waste with no path to disposal). Examples of these types of problems are issues that need to be negotiated at the Federal level (with Headquarters of another Federal agency or Congress) or issues that occur at multiple sites that would benefit by a common resolution. In addition to identifying the issues, the plan should describe proposed solutions or steps towards resolving them (e.g., obtaining data, completing studies).

Example 1: A major issue that should be addressed at the complex-wide level for transuranic waste management is the disposition of non-defense transuranic waste. There is currently no path to disposal for non-defense transuranic waste. The plan should address the development of information and other steps necessary to support resolution of the issue. Example 2: In the high-level waste management program, a key technical and regulatory issue is the high-level waste tank closure process. The plan identifies technical issues that need to be resolved, such as appropriate methods to solidify and stabilize residues that remain in the tank, and regulatory issues such as the waste categorization of the tanks. The activities and schedule for resolving these issues is identified in the plan. Waste Projections. The waste projections element of the programs plans should identify the minimum data requirements that must be included in waste projections, a consistent projections methodology, data quality objectives, and evaluation of data uncertainties, maintenance of data quality, and a periodic review and assessment of waste projections data quality. The collection of waste projections data should be focused on promoting the safe and efficient life-cycle management of waste. Therefore, data collection is an element in ensuring that sufficient storage, treatment, and disposal capacity will be available to handle current and future wastes. Example: Projections of low-level waste volumes are necessary to ensure that sufficient disposal capacity will be available, either within DOE and/or at commercially-operated facilities. Therefore, the types of information that would be needed include the volumes of waste that would be generated in different time periods, and the inventories and/or I-50 DOE G 435.1-1 7-09-99 Chapter I - General Requirements and Responsibilities concentrations of key radionuclides. Through a cooperative effort among personnel from the complex-wide program, the generating sites, and DOE disposal sites, a determination is made as to what actions are necessary to ensure adequate waste disposal capacity. Life-cycle Waste Management Planning. At the complex-wide level, personnel working on the program plan should consider the management needs for all of the waste included in the program when mapping out a strategy. In so doing, personnel developing the strategy should consider the volumes and characteristics of waste in storage and those projected to be generated. The availability of waste management facilities to safely and expeditiously manage the types and amounts of waste should be considered in developing the program strategy. For much of the waste, management through its entire life cycle will be possible using existing or planned facilities. The strategy for these types of waste should then focus on actions to improve efficiency and safety in effecting disposal. If appropriate, the strategy should consider the use of non-DOE facilities for meeting waste management needs. Example 1: In the Transuranic Waste Management Program, a strategy is developed that calls for the use of mobile equipment for certifying waste at small generator sites. Use of the equipment results in program cost savings by avoiding the construction of facilities for waste certification at multiple sites. Program efficiency is also achieved by being able to coordinate the schedule for the mobile equipment with the schedule for shipping waste to WIPP.

Example 2: Use of non-DOE facilities to help meet waste management needs occurs in the management of mixed low-level waste for disposal where DOE capabilities do not currently exist. A commercial facility that has the necessary radioactive materials license and RCRA permit provides disposal of mixed low-level waste which cannot currently be transferred to a DOE site for disposal. The use of the commercial facility is determined to be in the best interest of DOE and an exemption has been approved. The DOE strategy to allow disposal of small volumes of mixed low-level waste at a commercial facility promotes compliance with agreements and external regulations at the individual DOE sites, and reduces the costs and risks associated with storage. The strategy should also account for managing the wastes that do not have an apparent path to disposal. The complex-wide plan should provide sufficient information that site personnel can use to determine whether activities being taken at the complex-wide level address the issues that prevent disposal or whether the site should take individual actions to resolve the issues. DOE G 435.1-1 I-51 7-09-99 Chapter I - General Requirements and Responsibilities Example: For transuranic waste that currently cannot be disposed at WIPP, a strategy might be to address the issues preventing disposal of the waste. In this case, personnel with non-defense wastes that could otherwise meet the WIPP waste acceptance criteria would rely on the efforts being taken by Headquarters to resolve the issue. Waste Minimization and Pollution Prevention. The complex-wide plan should acknowledge the role that waste minimization and pollution prevention play in the management of radioactive waste. The plan should reference any applicable pollution prevention program plans which address commitments concerning the particular waste type. Example: The program plan for low-level waste or mixed low-level waste references the Pollution Prevention Program Plan that documents a Secretarial commitment to reduce the generation rates for the waste types by 50 percent by the end of 1999 (compared to the 1993 generation rates). This commitment is then translated into a program goal for the low-level waste and mixed low-level waste programs. Research and Development (R&D) Activities. The complex-wide plan should address the research and development being done to address multi-site issues related to disposal and other waste management issues. This provides a basis for the sites to determine what issues need to be addressed at the site level. Example: In the Transuranic Waste Management Program, research is being performed to re-evaluate the potential for generation of explosive gases in transuranic waste containers. If the research concludes that gases are not generated in closed transuranic waste containers, the need for sampling and/or venting prior to placement into the TRUPACT II could be eliminated for transportation. This research being undertaken by a central organization may benefit all shippers of transuranic waste. Implementation of DOE O 435.1. The program plan should consider the time and cost of implementing the Radioactive Waste Management Order, DOE O 435.1 and the supporting Manual, DOE M 435.1-1 when establishing program goals and objectives. In the near term, the complex-wide strategy must include attaining compliance with the Order as one of its goals. Individual objectives may address significant facilities at individual sites.

Example: Completion of a performance assessment and composite analysis for low-level waste disposal facilities, and issuance of a Disposal Authorization Statements, are appropriate key objectives for inclusion in the Low-Level Waste Management Program Plan. These are required to comply with DOE M 435.1-1 and are significant to the overall low-level waste management program. I-52 DOE G 435.1-1 7-09-99 Chapter I - General Requirements and Responsibilities The program plan also provides a mechanism for documenting means by which the program progress and compliance can be evaluated. The plan should indicate the types of evaluations that are going to take place and at what level in the organizational structure they will occur. The evaluation and oversight responsibilities should include a clear delineation between the roles of Headquarters, Field, and contractor organizations. Periodic evaluations of program activities will provide the basis for determining progress toward achieving the program goals and provide the feedback necessary to improve performance of the waste-type programs. Examples of evaluation and oversight activities include: • Contractor self-assessments; • Field oversight assessments; • Progress Tracking System reporting; and • Quarterly Management Reviews. Compliance with this requirement is demonstrated if a program plan is developed for each of the waste types specified in DOE M 435.1-1. The program plans should convey the overall purpose (end-point) of the program, the responsibilities for accomplishing different program activities, and a strategy that reflects the uncertainties and constraints that affect management of the specific waste type. Supplemental References: 1. CAO, 1997. The National TRU Waste Management Plan, Revision 1, DOE/NTP-96- 1204, U.S. Department of Energy, Carlsbad Area Office, Carlsbad, NM, December 18, 1997. 2. DOE, 1997. DOE Low-Level Waste Program Management Plan, Revision 0, DOE/LLW/PMP-001, U.S. Department of Energy, Washington, D.C., March 1997. DOE G 435.1-1 I-53 7-09-99 Chapter I - General Requirements and Responsibilities I. 2.D. Deputy Assistant Secretary for Waste Management. The Deputy Assistant Secretary for Waste Management is responsible for: (2) Waste Management Data System. Establishing and maintaining a system to compile waste generation projection data and other information concerning radioactive waste management facilities, operations, and activities across the complex. Objective: The objective of this requirement is to ensure information and data concerning the management of radioactive waste is collected and compiled at the DOE complex level. Compilation of waste management information promotes safe management of radioactive waste by supporting the integration and optimization activities, and life-cycle waste management planning across the DOE complex. Discussion: To effectively manage radioactive waste, the Department is dependent on information and data which describe its waste, both previously generated and projected, as well as the facilities and systems used to manage the waste. In the development of DOE O 435.1 and DOE M 435.1-1, collecting and managing this information was determined to be an important function for the safe and effective management of radioactive waste. The information and data are generated and developed as a result of site-specific compliance with various requirements including DOE M 435.1-1.

The "waste management data system" is a general description used to describe systems and processes needed to collect, compile, and report information in a uniform and consistent manner. The specific mechanisms for collecting the data and information will vary based on changes in management approach and implementation methodology. However, the information and data that are to be managed originate from many diverse sources so consistent reporting is important. The data must be collected and reported in a manner that makes them useful to the complex-wide waste-type programs and plans required by DOE M 435.1-1, Sections I.2.B and I.2.D. For instance, information on waste with no path to disposal needs to be included in the data system to allow evaluations which could lead to common solutions that would benefit multiple sites. Also, data need to be collected to support the evaluation phase of waste management by depicting progress made in the program. The development and documentation of data requirements are to be completed for all information to be collected from the field. Use of data requirements ensures consistency and provides a basis I-54 DOE G 435.1-1 7-09-99 Chapter I - General Requirements and Responsibilities for accurate reporting. Data requirements describe the information requested, why it's requested, and how to report it. Information and data will generally be collected for each DOE site in the complex. Typically, the following information and data for high-level waste, transuranic waste, low-level waste, and mixed low-level waste are to be included in the waste management data system: • Quantities of past, current, and projected waste, by waste type and year; • Waste characteristics; • Waste management life-cycle plans, including final disposition and no path to disposal information; • Facility and operational information including capacities; and • Barriers to disposition and technology needs. Example: Information on DOE field waste management activities is provided to DOE- HQ through the "Accelerating Cleanup: Paths to Closure" reporting process using various systems and tools. The information is used to generate a DOE report that includes disposition maps used to help depict the waste management life cycle and any barriers that may exist for final waste stream disposition. Compliance with this requirement is demonstrated by the existence of systems and processes for the collection and management of complex-wide information about DOE radioactive waste. The data systems should be updated on a routine basis, and support capacity and facility planning, resource and budget planning, integration and efficiency efforts, and lessons learned. Supplemental References: 1. DOE, 1998. Accelerating Cleanup: Paths to Closure, DOE/EM-0362, U.S. Department of Energy, Washington, D.C., June 1998. 2. DOE, 1996. Low-Level Waste Projection Program Guide, U.S. Department of Energy, Office of Environmental Management, Washington, D.C., December 18, 1996. DOE G 435.1-1 I-55 7-09-99 Chapter I - General Requirements and Responsibilities I. 2.E. Deputy Assistant Secretaries for Waste Management and Environmental Restoration. The Deputy Assistant Secretary for Waste Management and the Deputy Assistant Secretary for Environmental Restoration are responsible for:

(1) Disposal. Reviewing and approving, along with EH-1, transuranic waste disposal facility performance assessments and other disposal documents as required in waste specific chapters for which DOE is responsible for making compliance determinations. Reviewing and approving performance assessments and composite analyses, or appropriate CERCLA documentation, for low-level waste disposal facilities, and issuing disposal authorization statements. (a) The Deputy Assistant Secretaries shall establish a review panel consisting of DOE personnel to review low-level waste disposal facility performance assessments and composite analyses, review appropriate CERCLA documentation, recommend low-level waste disposal facility compliance determinations to the Deputy Assistant Secretaries, and develop disposal authorization statements. (b) The Deputy Assistant Secretaries shall issue disposal authorization statements containing conditions that low-level waste disposal facilities must meet in order to operate with an approved radioactive waste management basis. Objective: The objective of this requirement is to ensure that the evaluations conducted in the performance assessment for a transuranic waste disposal facility, and in the performance assessment (or appropriate CERCLA documentation) and composite analysis (or appropriate CERCLA documentation) for a low-level waste disposal facility, are found by DOE to be technically adequate, logical, complete, and defensible for establishing the controls on disposal of waste for protection of the public and the environment into the future. The evaluations and controls should result in a reasonable expectation that the standards of 40 CFR Part 191 will be met at the transuranic waste disposal facility or in a reasonable expectation that the performance objectives of Chapter IV of DOE M 435.1-1 will be met at the low-level waste disposal facility. I-56 DOE G 435.1-1 7-09-99 Chapter I - General Requirements and Responsibilities Discussion: During the development of the requirements of DOE O 435.1 and DOE M 435.1-1, the safety and hazard analyses indicated that disposal is a critical activity requiring controls. Disposal is the final waste management function performed, yet the potential hazards from disposed radioactive waste will continue far into the future. Thus, there are specific requirements for the protection of the public, workers, and environment that are critical to maintaining safe and effective disposal of radioactive waste. Analyses conducted in a performance assessment for a transuranic and a low- level waste disposal facility (or appropriate CERCLA documentation for a low-level waste disposal facility), and the composite analysis (or appropriate CERCLA documentation) for a low- level waste disposal facility, are critical in determining the nature and extent of the controls that need to be put in place at the facility being evaluated. The review and approval of these evaluations is extremely important for management of transuranic and low-level waste to ensure it is being conducted safely and effectively. Therefore, the review and approval of these evaluations are assigned as the responsibility of senior management within the Office of Environmental Management.

The requirement states that it is the responsibility of the Deputy Assistant Secretaries for Waste Management and Environmental Restoration, within their respective programs, to review and approve certain radiological assessments for transuranic and low-level waste disposal facilities and to issue the disposal authorization statement based on the reviews. The discussions that follow provide guidance on the requirement for review and approval of the documents and issuance of the disposal authorization statement. The discussion begins with an explanation for excluding certain waste disposal from the DOE M 435.1-1, Section I.2.E. Disposal of Transuranic Waste at WIPP and High-Level Waste. Requirement 4.d of DOE O 435.1 identifies WIPP and facilities and operations licensed by the Nuclear Regulatory Commission (NRC) or an Agreement State as having special requirements that supplement, or in many cases, replace requirements in DOE O 435.1 and DOE M 435.1-1. Requirement 4.d of the Order effectively ties the protection of the public, workers, and the environment--the major objective of DOE O 435.1--to key external legal drivers and regulations that achieve these goals at certain facilities managing DOE radioactive waste. Key among the facilities currently under external regulation for public, worker, and environmental protection are WIPP (certified by EPA), the proposed high-level waste repository (regulated by the NRC), and commercial waste treatment and disposal facilities utilized by DOE (regulated by the NRC or Agreement States) for treatment and disposal of low-level and mixed low-level waste. A DOE facility for the disposal of commercial (NRC licensed) Greater-than-class C (GTCC) low-level waste will also be regulated by the NRC, as specified in 10 CFR Part 61, Section 61.55 (a)(2)(IV) (see additional discussion on commercial (NRC licensed) GTCC in the guidance on the Complex-Wide Low-Level Waste Management Program (DOE G 435.1-1, Section IV.C)). DOE G 435.1-1 I-57 7-09-99 Chapter I - General Requirements and Responsibilities One effect of this requirement is that the design, construction, operation, closure, analysis of, licensing, permitting, and regulation of disposal of DOE transuranic waste at WIPP, and high-level waste at a proposed geologic repository, are evaluated and controlled by regulations and requirements outside of the DOE directives system. Based on the safety and hazard and requirements analyses conducted in the development of DOE O 435.1, and the review and approval of permitting and licensing documentation by other government organizations, it was concluded that there is no need to repeat any specific requirements from these external regulations within DOE M 435.1-1, or to define new requirements for disposal. Example: The NRC requirements for siting, design, facility performance, package design, quality assurance, and training and certification of operators for a high-level waste disposal repository are found in 10 CFR Part 60, Disposal of High-Level Radioactive Wastes in Geologic Repositories. No additional disposal requirements were determined to be necessary for inclusion in Chapter II of DOE M 435.1-1. The only requirements for disposal found in DOE M 435.1-1, Chapter II, High-Level Waste Requirements, and DOE M 435.1-1, Chapter III, Transuranic Waste Requirements, for disposal at WIPP, reference the regulatory drivers that have created the external requirements for disposal of these wastes. Guidance for Chapters II and III contains additional discussions concerning these drivers, and the disposal of high-level waste and transuranic waste.

Disposal of Transuranic Waste (not at WIPP). In cases where the Department disposes of transuranic waste in a facility other than WIPP (e.g., Greater Confinement Disposal at the Nevada Test Site), the Department is responsible for determining compliance with 40 CFR Part 191 and issuing a disposal authorization statement. Therefore, the requirement includes the responsibility for reviewing and approving performance assessments for a transuranic waste disposal facility for which DOE must make a compliance determination (i.e., other than WIPP). The Deputy Assistant Secretary for Waste Management and the Deputy Assistant Secretary for Environmental Restoration, along with EH-1, are responsible for reviewing and approving performance assessments for transuranic disposal facilities other than WIPP. A process similar to that described below for reviewing and approving low-level waste disposal facility performance assessments will be required. In developing the review criteria, DOE staff should evaluate the following: • General provisions including purpose, scope, definitions, conditions of approval, and alternative provisions; • Compliance certification including completeness and accuracy of submissions and reference materials; I-58 DOE G 435.1-1 7-09-99 Chapter I - General Requirements and Responsibilities • General requirements addressing inspections, quality assurance, models and computer codes, waste characterization, future state assumptions, expert judgment, and peer review; • Containment requirements considering application of release limits, scope of performance assessments, consideration of drilling events in performance assessments, and results of performance assessments; • Assurance requirements including active and passive institutional controls, monitoring, engineered barriers, and consideration of natural resources; and • Individual and groundwater protection requirements considering the protected individual, exposure pathways, underground sources of drinking water, and the scope and results of the performance assessment. Example: The Field Element Manager of a site with a small amount of transuranic waste that cannot be accepted for disposal at the Waste Isolation Pilot Plant confers with Headquarters and decides to construct a small transuranic waste disposal facility. The Manager directs the preparation of a performance assessment that provides a reasonable expectation of meeting the performance measures in 40 CFR Part 191 for the onsite facility. Since the facility is not WIPP, following approval at the site, the performance assessment is submitted to Headquarters for approval. The Deputy Assistant Secretary for Waste Management assigns the task of establishing criteria and conducting a review to a staff member. The staff member assembles a review team of technically qualified DOE and contractor staff. The team develops criteria for the review based on the Department’s criteria for review of low-level waste disposal facility performance assessments. Upon completing its review, the team provides a recommendation to the Deputy Assistant Secretary who makes a final determination and documents it in a memorandum to the Field Element Manager. Since 40 CFR Part 191 defines performance assessment, the contents of a performance assessment, and requirements for compliance, the transuranic waste chapter only contains reference to the 40 CFR Part 191 standards. Guidance on the transuranic waste disposal requirements in Section III.P of this document should be consulted for additional discussion.

Disposal of Low-Level Waste. Although some of DOE’s low-level waste is disposed at commercial facilities, much of it is still disposed at DOE-owned and operated low-level waste disposal facilities. The Department meets its responsibilities under the Atomic Energy Act of 1954, as amended, by providing the requirements for protection of the public, workers, and the environment for its low-level waste disposal facilities in DOE O 435.1 and DOE M 435.1-1. Meeting the low-level waste disposal requirements remains a responsibility of DOE managers at DOE G 435.1-1 I-59 7-09-99 Chapter I - General Requirements and Responsibilities Headquarters and in the Field. DOE M 435.1-1, Chapter IV, Low-Level Waste Requirements, includes the detailed low-level waste disposal requirements. At the Headquarters level, the Deputy Assistant Secretaries for Waste Management and Environmental Restoration are responsible for reviewing and approving the performance assessments and composite analyses (or reviewing appropriate CERCLA documentation) for low-level waste disposal facilities and for issuing disposal authorization statements. For purposes of DOE O 435.1 and DOE M 435.1-1, the term “appropriate CERCLA documentation” means the written materials prepared to demonstrate compliance with the substantive requirements of DOE M 435.1-1 for low-level waste disposal facilities managed under CERCLA. Specifically included in such written materials are crosswalks between CERCLA requirements and DOE M 435.1-1 requirements which are used as the basis for issuance of a disposal authorization by the Deputy Assistant Secretary for Environmental Restoration. Low-Level Waste Performance Assessment and Composite Analysis Reviews. Performance assessments are conducted to demonstrate that there is a reasonable expectation that low-level waste disposed of at a DOE facility will not result in exceeding low-level waste disposal facility performance objectives contained in DOE M 435.1-1, Chapter IV, Low-Level Waste Requirements, and related performance measures associated with protection of the public from disposed low-level waste. Composite analyses are conducted as a planning tool to analyze the interaction of other radioactive source terms at a site along with the low-level waste disposal facility to minimize the likelihood that current low-level waste disposal activities will result in the need for future corrective or remedial actions, and to protect the public and environment, consistent with Departmental limits on total allowable public doses of radiation from all sources. Performance assessments and composite analyses are reviewed to determine that they are complete, comprehensive, reflective of site- and facility-specific conditions, are supported by appropriate rationale, and therefore, are defensible. These reviews are performed to provide the information to the Deputy Assistant Secretary for Waste Management or the Deputy Assistant Secretary for Environmental Restoration to conclude there is a reasonable expectation that the disposal performance objectives of Chapter IV will be met and will continue to be met.

Review Panel. The Deputy Assistant Secretaries for Waste Management and Environmental Restoration must formally establish a panel or group to review performance assessments and composite analyses. At the time of issuance of DOE O 435.1 and DOE M 435.1-1, the Low- Level Waste Disposal Facility Federal Review Group was established by the Deputy Assistant Secretaries for Waste Management and Environmental Restoration to manage the reviews of low- level waste disposal facilities prepared in accordance with DOE 5820.2A and DNFSB 94-2 commitments and make recommendations regarding performance assessment and composite analysis approvals and issuance of disposal authorization statements. The Low-Level Waste Disposal Facility Federal Review Group has been guided by the Department of Energy LLW Disposal Facility Federal Review Group Performance Assessment and Composite Analysis I-60 DOE G 435.1-1 7-09-99 Chapter I - General Requirements and Responsibilities Review Guidance Manual, Revision 0. Following issuance of DOE O 435.1, Revision 0 of the Low-Level Waste Disposal Facility Federal Review Group Manual will be revised to reflect any new guidance for reviews and approvals of performance assessments and composite analyses in accordance with DOE O 435.1 and DOE M 435.1-1 and will be issued as a DOE G 435.1-1 guide. The Low-Level Waste Disposal Facility Federal Review Group reports its findings on performance assessment and composite analysis reviews directly to the Deputy Assistant Secretaries. Example: The Brown Site Low-Level Waste Disposal Facility Composite Analysis is submitted to Headquarters by the Field Element Manager for review. The Deputy Assistant Secretaries for Waste Management and Environmental Restoration convene the Low-Level Waste Disposal Facility Federal Review Group, who in turn selects a Team Leader to form the Brown Site Review Team to evaluate the Brown Site composite analysis against the Review Guide. The Low-Level Waste Disposal Facility Federal Review Group prepares a report based on the Brown Site Team review and submits their findings to the Deputy Assistant Secretary, Office of Waste Management. Based on the Low-Level Waste Disposal Facility Federal Review Group’s findings, the Deputy Assistant Secretary makes a decision on approval of the composite analysis. Performance Assessments and Composite Analysis Approvals & Issuance of Disposal Authorization Statement. A review of a performance assessment and/or composite analysis performed by the Low-Level Waste Disposal Facility Federal Review Group or a similar review panel produces a report in the form of a compliance evaluation that is transmitted to the appropriate Deputy Assistant Secretary. The report recommends whether the disposal facility operations are to be approved, approved with conditions, or disapproved. The Review Guide contains detailed guidance on the compliance evaluation and approval recommendation.

The Deputy Assistant Secretary is responsible for issuing a disposal authorization statement in accordance with DOE M 435.1-1, Section IV.P.(5). The disposal authorization statement provides Headquarters approval of the performance assessment and/or composite analysis, and includes conditions deemed necessary for long-term protection of the public and the environment from the low-level waste disposal facility. In this fashion, the disposal authorization statement should be viewed as analogous to a license for a low-level waste disposal facility that would be issued by the U.S. Nuclear Regulatory Commission or an Agreement State. The disposal authorization statement will be issued to the Field Element Manager responsible for the disposal facility. The Field Element Manager must consider any conditions in the disposal authorization statement that are to be incorporated into the radioactive waste management basis (see DOE M 435.1-1, Section IV.D.(4)) for the facility. Additional detailed guidance on disposal authorization statements can be found in the guidance on DOE M 435.1-1, Chapter IV, Low-Level Waste Requirements. DOE G 435.1-1 I-61 7-09-99 Chapter I - General Requirements and Responsibilities Example: The Deputy Assistant Secretary for Waste Management and the Deputy Assistant Secretary for Environmental Restoration jointly issue the Disposal Authorization Statement Concerning Operation of the Brown Site Low-Level Waste Disposal Facility to the Field Element Manager. The Statement refers to the compliance evaluation prepared by the Brown Site Composite Analysis Review Team, which contains six conditions that must be implemented at the facility in order for operations to continue safely in accordance with the performance objectives. The compliance evaluation was reviewed by the Low-Level Waste Disposal Facility Federal Review Group, which transmitted its recommendation for approval with conditions, those conditions and a draft disposal authorization statement to the Deputy Assistant Secretaries. CERCLA Documentation. As discussed in guidance for DOE M 435.1-1, Section I.2.F.(5), Environmental Restoration, Decommissioning and Other Cleanup Waste, environmental restoration remedies involving the development and management of radioactive waste disposal facilities under the CERCLA process are to meet the substantive requirements of DOE O 435.1. The original guidance on this topic was articulated in: 1) Policy for Demonstrating Compliance with DOE 5820.2A for Onsite Management and Disposal of Environmental Restoration Low- Level Waste under the Comprehensive Environmental Response, Compensation, and Liability Act, May 31, 1996 (DOE, 1996); and 2) Guidance for Complying With DOE 5820.2A, Radioactive Waste Management, for Onsite Management and Disposal of Low-Level Waste (LLW) from Environmental Restoration Activities (Alm, 1997). The major concepts of these policies are: C The CERCLA requirements and DOE M 435.1-1 requirements include significant overlap in their substantive requirements given both are designed to ensure safe management and disposal of waste; C The CERCLA process is to be used to comply with the requirements of DOE M 435.1-1 for environmental restoration actions; C The substantive requirements of DOE M 435.1-1 should be directly incorporated into the CERCLA process to the extent practical and consistent with site-specific technical and regulatory issues; and

C The Department must demonstrate compliance with the substantive requirements of DOE M 435.1-1 to fulfill its responsibilities under the Atomic Energy Act of 1954, as amended. When a proposed environmental restoration response at DOE sites on the National Priorities List (NPL) involves the development and management of a radioactive waste management facility, the CERCLA process will be used to assess the performance of the disposal facility. Subject to final I-62 DOE G 435.1-1 7-09-99 Chapter I - General Requirements and Responsibilities regulatory approval, the CERCLA process is expected to incorporate the substantive requirements of DOE M 435.1-1 as described in this section. For sites not on the NPL, DOE may initiate a response action in accordance with CERCLA under the authority assigned by Executive Order 12580, Superfund Implementation. In this case, if the remedy under consideration involves the development and management of a radioactive waste disposal facility, then the requirements of DOE M 435.1-1 are to be incorporated into the CERCLA documentation as described in this section, as appropriate, subject to final regulatory approval. There may be situations at non-NPL sites where DOE chooses to implement a remedy using its authority under the Atomic Energy Act of 1954, as amended, in which case the procedural requirements of DOE M 435.1-1 would also apply. When consideration is being given to a cleanup response that requires development and management of a radioactive waste disposal facility under CERCLA, in most cases an analysis satisfying the requirement for a performance assessment will be prepared as part of the project- specific CERCLA document. The analysis is often contained in the Feasibility Study and is prepared in accordance with the National Contingency Plan (40 CFR Part 300). In some cases, an analysis will be performed which includes an evaluation of all interactive sources near the proposed disposal facility, as suggested in EPA’s Risk Assessment Guidance for Superfund: Human Health Evaluation Manual, Part A, Interim Final. This analysis would essentially be equivalent to a composite analysis. If the CERCLA analysis does not include evaluation of all interactive sources at the proposed radioactive waste disposal facility, then a separate composite analysis is to be prepared. This separate analysis may be incorporated into the CERCLA process, including review by the regulatory agencies and stakeholders, or it may be handled as a document that is reviewed by the Low-Level Waste Disposal Facility Federal Review Group (LFRG) established under the authority of DOE M 435.1-1. To fulfill DOE’s responsibilities under the Atomic Energy Act of 1954, as amended, the Department must demonstrate compliance with the substantive requirements of DOE M 435.1-1 for low-level waste disposal facilities managed under CERCLA. A crosswalk between the CERCLA and the DOE M 435.1-1 requirements needs to be prepared and reviewed as described below when the cleanup action involves development and management of a radioactive waste disposal facility. It is not necessary to prepare a crosswalk to demonstrate compliance with DOE M 435.1-1 requirements for environmental restoration activities that do not involve development and management of a radioactive waste disposal facility.

The appropriate CERCLA documentation is to be submitted by the Field Element Manager to the Deputy Assistant Secretary for Environmental Restoration. For purposes of DOE O 435.1 and DOE M 435.1-1, the term “appropriate CERCLA documentation” means the written materials prepared to demonstrate compliance with the substantive requirements of DOE M 435.1-1 for low-level waste disposal facilities managed under CERCLA. Specifically included in such written materials are crosswalks between CERCLA requirements and DOE M 435.1-1 requirements DOE G 435.1-1 I-63 7-09-99 Chapter I - General Requirements and Responsibilities which are used as the basis for issuance of a disposal authorization by the Deputy Assistant Secretary for Environmental Restoration. Based on the appropriate CERCLA documentation, the Field Element Manager certifies that compliance with the substantive requirements of DOE M 435.1-1 has been achieved through application of the CERCLA process. Any other analyses that have not been incorporated into the CERCLA process require a separate review. The Deputy Assistant Secretary may assign the LFRG the task of reviewing the information submitted by the Field Element Manager. In this instance, the documents would be reviewed against the criteria set forth in the guidance entitled Department of Energy LLW Disposal Facility Federal Review Group Performance Assessment and Composite Analysis Review Guidance Manual (the Review Guide). Based on the content of the crosswalk, the LFRG will determine whether it needs to review the detailed analysis. The Low-Level Waste Disposal Facility Federal Review Group will report its conclusions from this review to the Deputy Assistant Secretary for Environmental Restoration. The Deputy Assistant Secretary for Environmental Restoration will use this information as the basis for deciding whether to issue a disposal authorization based on DOE’s responsibilities under the Atomic Energy Act of 1954, as amended. The disposal authorization statement does not impact the decision documented in the CERCLA Record of Decision on whether to build a facility because this decision is made through the CERCLA process. The disposal authorization statement specifies the limits and conditions on design, construction, operation, and closure of the radioactive waste disposal facility. The disposal authorization statement could be included as part of the Record of Decision. If this is the case, then the guidance on disposal authorization (Chapter IV) should be followed during the development of the ROD on CERCLA radioactive waste disposal facilities, to the extent practical. However, it should be understood that compliance with requirements of a law (e.g., CERCLA) does not release DOE of compliance with another law (e.g., Atomic Energy Act of 1954, as amended). DOE must determine that whatever actions are taken, Atomic Energy Act requirements are met. Example: The remedial action on Operable Unit 34 at Site Q considers construction and operation of a facility for onsite low-level waste disposal. The CERCLA RI/FS contains analyses equivalent to the performance assessment and composite analysis required in DOE M 435.1-1. The site prepares a crosswalk between the CERCLA NCP and DOE M 435.1-1 requirements that demonstrates that the RI/FS documents contain the substantive requirements of DOE M 435.1-1. The Low-Level Waste Disposal Facility Federal Review Group evaluates the crosswalk and, if necessary, selected supporting documentation against the guidance and criteria in the Review Guide, and presents their conclusions to the Deputy Assistant Secretary for Environmental Restoration. Based on the evaluation and conclusions, the Deputy Assistant Secretary for Environmental Restoration decides whether to issue a Disposal Authorization.

I-64 DOE G 435.1-1 7-09-99 Chapter I - General Requirements and Responsibilities Demonstrating Compliance. Compliance with this requirement is demonstrated by: C Establishment of qualified panels to conduct reviews of performance assessments, composite analyses, and, as requested, appropriate CERCLA documentation for environmental restoration activities involving the development and management of a radioactive waste disposal facility; C Performance of the reviews by the panels and use of the results that leads to a decision on operations and long-term protectiveness of a low-level waste disposal facility, or compliance with 40 CFR Part 191 for a transuranic waste disposal facility; and C Documentation of such decisions for low-level waste disposal facilities in a disposal authorization statement issued by the appropriate Deputy Assistant Secretary (for Waste Management or for Environmental Restoration) to the cognizant Field Element Manager. The disposal authorization statement contains conditions that the disposal facility must meet in order to operate under an approved radioactive waste management basis. For environmental restoration activities, if the CERCLA Record of Decision is to serve as the disposal authorization statement, it must include the same information as stated above, or the disposal authorization statement can be issued separately. Supplemental References: 1. DOE, 1999. Format and Content Guide for U.S. Department of Energy Low-Level Waste Disposal Facility Performance Assessments and Composite Analyses (in preparation), DOE G 435.1-1, U.S. Department of Energy, Washington, D.C., 1999. 2. DOE, 1999. Review Guide for U.S. Department of Energy Low-Level Waste Disposal Facility Performance Assessments and Composite Analyses (in preparation), DOE G 435.1-2, U.S. Department of Energy, Washington, D.C., 1999. 3. DOE, 1999. Maintenance Guide for U.S. Department of Energy Low-Level Waste Disposal Facility Performance Assessments and Composite Analyses. (in preparation), DOE G 435.1-3, U.S. Department of Energy, Washington, D.C., 1999. 4. EPA, 1985. “Final Rule; Environmental Standards for the Management and Disposal of Spent Nuclear Fuel, High-Level and Transuranic Radioactive Wastes,” Federal Register, Vol. 50, No. 182, U.S. Environmental Protection Agency, Washington, D.C., September 19, 1985. DOE G 435.1-1 I-65 7-09-99 Chapter I - General Requirements and Responsibilities 5. EPA, 1989. Risk Assessment Guidance for Superfund, Vol. 1, Human Health Evaluation Manual (Part A), Interim Final, EPA/540/1-89/002, U.S. Environmental Protection Agency, Washington, D.C., December 1989. 6. EPA, 1993. “Final Rule; Environmental Radiation Protection Standards for the Management and Disposal of Spent Nuclear Fuel, High-Level and Transuranic Radioactive Wastes,” Federal Register, Vol. 58, No. 242, U.S. Environmental Protection Agency, Washington, D.C., December 20, 1993. 7. DOE 1996. Interim Format and Content Guide, and Standard Review Plan for U.S. Department of Energy Low-Level Waste Disposal Facility Performance Assessments, U.S. Department of Energy, Washington, D.C., October 1996. 8. DOE 1996. Interim Review Process and Criteria for Department of Energy Low-Level Waste Disposal Facilities Composite Analyses, U.S. Department of Energy, Washington, D.C., November 1, 1996. 9. DOE, 1996. Interim Guidance for a Composite Analysis of the Impact of Interacting Source Terms on the Radiological Protection of the Public from Department of Energy Low-Level Waste Disposal Facilities, U.S. Department of Energy, Washington, D.C., October 1996.

10. DOE, 1998. Department of Energy LLW Disposal Facility Federal Review Group, Performance Assessment and Composite Analysis Review Guidance Manual, Revision 0, U.S. Department of Energy, Washington, D.C., September 1998. I.2.E.(2) Site Closure Plans. Reviewing and approving closure plans and other closure documentation for deactivated high-level waste facilities/sites and issuing authorization for closure activities to proceed. Objective: The objective of this requirement is to ensure that closure activities for deactivated high-level waste facilities/sites do not proceed prior to the review/approval of the site closure plans . Discussion: The scope of the requirement, and this guidance, applies only to deactivated high-level waste closure plans, and other closure documents, e.g., CERCLA documentation, developed in accordance with the requirements of DOE M 435.1-1, Chapter II.U., Closure. The requirement I-66 DOE G 435.1-1 7-09-99 Chapter I - General Requirements and Responsibilities does not apply to the Decommissioning path documentation required by Section II.U. The documentation and review/approval requirements for this path are defined in DOE O 430.1A and DOE 5400.5 and are not repeated in this guidance. This requirement is to be impleme