Display Related Directives to this directive.

Approved: 7-09-99

APPENDIX A
Technical Basis and Considerations
for 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.)
TABLE OF CONTENTS

TECHNICAL BASIS AND CONSIDERATIONS

1.0 INTRODUCTION. . . . . . . . . . . . . . . . . . . . . . . .1

2.0 BACKGROUND. . . . . . . . . . . . . . . . . . . . . . . . .2

3.0 ORDER REVISION TEAM ORGANIZATION. . . . . . . . . . . . . .3
3.1 Order Revision Team . . . . . . . . . . . . . . .3
3.2 Executive Committee . . . . . . . . . . . . . . .4
3.3 Senior Review Panel . . . . . . . . . . . . . . .4

4.0 ORDER REVISION PROCESS. . . . . . . . . . . . . . . . . . .7
4.1 Identification of Radioactive Waste Management Functions and Activities7
4.2 Assessment of the Hazards . . . . . . . . . . . .8
4.3 Requirements Analysis. . . . . . . . . . . . . . . . 13

5.0 OTHER CONSIDERATIONS. . . . . . . . . . . . . . . . . . . 17
5.1 Protection of the Public. . . . . . . . . . . . 17
5.2 Protection of the Workforce . . . . . . . . . . 17
5.3 As Low as Reasonably Achievable (ALARA) . . . . 17
5.4 Defense-in-depth . . . . . . . . . . . . . . . . . . 18
5.5 Protection of the Environment . . . . . . . . . 18
5.6 Compliance. . . . . . . . . . . . . . . . . . . 18
5.7 Authorization Basis . . . . . . . . . . . . . . 18
5.8 Cost-Effectiveness. . . . . . . . . . . . . . . 18
5.9 Voluntary Consensus Standards. . . . . . . . . . . . 19
5.10 Waste Minimization . . . . . . . . . . . . . . . . . 19
5.11 Property and Facility Protection . . . . . . . . . . 19
5.12 Timely Disposal of Waste . . . . . . . . . . . . . . 20
5.13 Waste Characterization. . . . . . . . . . . . . 20

6.0 REQUIREMENT DOCUMENTATION AND TECHNICAL BASIS . . . . . . 20
6.1 Order Writing Process . . . . . . . . . . . . . 20
6.2 Documentation of Technical Basis Crosswalk . . . . . 20

BASIS FOR REGULATION OF RADIOACTIVE WASTE. . . . . . . . . . . 40
Chapter I - General Requirements and Responsibilities . . 43

BASIS FOR REGULATION OF HIGH-LEVEL WASTE . . . . . . . . . . . 72
Chapter II - High-Level Waste Requirements. . . . . . . . 74

BASIS FOR REGULATION OF TRANSURANIC WASTE. . . . . . . . . . .114
Chapter III - Transuranic Waste Requirements. . . . . . .117

BASIS FOR REGULATION OF LOW-LEVEL WASTE. . . . . . . . . . . .150
Chapter IV - Low-Level Waste Requirements . . . . . . . .158

CROSSWALK TABLES . . . . . . . . . . . . . . . . . . Attachment 1 TECHNICAL BASIS AND CONSIDERATIONS

1.0 INTRODUCTION

This section outlines and summarizes the methodology used by the Department of Energy in
revising its Order on radioactive waste management. The purpose of this appendix is to establish
the technical basis of the order revision process and of each of the requirements included in the
revised radioactive waste management order. The Department of Energy revised the Order on
radioactive waste management for several reasons:

After thorough technical reviews and analyses, both the Department of Energy and
the Defense Nuclear Facilities Safety Board concluded that the existing Order,
5820.2A, did not adequately address the Department's radioactive waste management
and disposal practices.

There have been significant advances in radioactive waste management practices and
changes within the Department of Energy since the Order was issued in 1988.

Risk based and performance-based requirements are a prudent and necessary
component of DOE's new directives system.

Opportunities for stakeholder involvement, a key element of DOE decision making,
needed to be provided.

The technical basis for the Department's radioactive waste management requirements
and guidance needed to be documented.

The revised Order, designated DOE O 435.1, establishes the requirements for management of
radioactive waste consistent with the Department's Atomic Energy Act responsibilities to provide
for radiological protection from DOE operations. The scope of DOE O 435.1 includes: (1) high-level waste, including closure of high-level waste tank systems and management of associated
incidental wastes; (2) transuranic waste, including safe treatment, storage, and characterization/
certification to support disposal at the Waste Isolation Pilot Plant; and (3) low-level waste, with
attention to disposal and the impacts of interacting source terms on projected public dose. The
revised Order does not contain requirements for the decontamination or decommissioning of
radioactively contaminated facilities. Those requirements are incorporated in a revision of DOE
O 430.1A, Life-Cycle Asset Management. Additionally, the requirements for the management of
spent nuclear fuel are not contained in this Order. The hazards analysis performed to identify
requirements for high-level waste did not address the functions associated with management of
spent nuclear fuel. Thus the requirements contained in DOE M 435.1-1 do not apply to this
DOE-managed spent nuclear fuel.

2.0 BACKGROUND

DOE 5820.2A, Radioactive Waste Management, was issued by the Department of Energy in
September 1988. As early as 1990, the Department began analyzing, assessing, and reviewing
the implementability of the Order on radioactive waste management, 5820.2A. Most DOE
Orders are scheduled for review every two years to determine whether they should be continued,
revised, or canceled. The policy of the Department of Energy is to use a consistent and effective
management system for the development, communication, implementation, and periodic review
of its Orders. Objectives in revising a DOE Order include providing more effective program
direction, accountability, and performance assurance. In 1991, the Department initiated efforts to
revise DOE 5820.2A.

During this initial revision effort, the Defense Nuclear Facilities Safety Board (DNFSB) also
began examining low-level waste management within the defense nuclear complex, including the
Department's low-level management program and practices in terms of its past, present, and
future operations. In September 1994, the DNFSB issued Recommendation 94-2, Conformance
with Safety Standards at Department of Energy Low-Level Nuclear Waste and Disposal Sites,
which identified problems with the Department's radioactive waste management specific to low-level waste.

The DNFSB's findings, as reported to DOE in Recommendation 94-2, were that: (1) DOE had
not kept pace with the evolution of commercial practices for waste disposal; (2) that six years
after the issuance of DOE 5820.2A, the performance assessment process had not been completed
for any of DOE's low-level waste disposal facilities; (3) that the performance assessments
excluded waste buried prior to September 1988 and interacting source terms; (4) that there was
considerable uncertainty in the DOE projections of low-level waste volumes; (5) that DOE
needed additional requirements standards, or guidance on LLW Management; and (6) that DOE
needed to improve its modeling and predictive capability for assessing radionuclide migration,
enhancing stability of buried waste forms, deterring intrusion, and inhibiting migration of
radionuclides.

In May 1995, a revision to 5820.2A (draft DOE 5820.2B) was issued for review by DOE and the
DNFSB staff. The draft revised DOE 5820.2B was an extensive, detailed set of requirements.
However, the relationship of the requirements to guidance within the Order and the technical
basis for each was not clear. When distributed for review, the draft revision drew 1,500
comments from within DOE and the Defense Nuclear Facilities Safety Board. DNFSB staff
identified 41 significant safety concerns and eight additional observations which they determined
could adversely affect the safety of DOE's management of its radioactive waste and/or which
conflicted with commitments made by DOE in response to other DNFSB Recommendations,
including 94-2. Based on the DNFSB's concerns and those raised by the numerous comments on
the draft Order, a significant number of issues were raised internally within DOE. As a result,
the Office of Environmental Management (EM) committed to a new approach to revising the
radioactive waste management Order, and also committed to issuing a draft of the revised Order.

DOE objectives in revising the Order included: (1) incorporate DOE commitments in response
to 94-2 and other DNFSB Recommendations into the Order; (2) develop a clear and sound
technical basis for the requirements and guidance; (3) incorporate considerations of risk,
including the processes being developed under DOE's Integrated Safety Management System; (4)
develop less prescriptive and more performance-based requirements; (5) address stakeholder
concerns; and (6) address other emerging considerations, such as the movement toward external
regulation, legislation requiring the adoption of industry consensus standards, and DOE's
ongoing efforts to delegate decision-making and managerial controls from Headquarters to the
Field Office level.

The Department's approach for revising the Order on radioactive waste management involved:

Undertaking a systematic review of DOE's radioactive waste management activities
to identify and evaluate the functions and activities necessary to manage radioactive
waste effectively;

Assessing the hazards posed by performing the functions and activities;

Identifying the regulatory requirements and guidance to mitigate identified hazards
and manage waste effectively; and

Establishing and documenting the technical basis for the requirements and guidance.

The revised DOE radioactive Waste Management Order, as DOE O 435.1, with its
accompanying Contractor Requirements Document, Manual, and Guidance Documents governs
the management of DOE's radioactive wastes: high-level waste, transuranic waste, low-level
waste, and the radioactive component of mixed waste. The process of developing these
documents recorded the technical basis for the general requirements common to all radioactive
waste, and the waste-type specific requirements. The overall Order revision process is
summarized below. Functions maps, crosswalk tables, and technical bases for waste type
specific requirements are included in this Appendix.

3.0 ORDER REVISION TEAM ORGANIZATION

3.1 Order Revision Team

DOE drew on the technical expertise of its Headquarters and Field staff and contractors to assist
in the analysis radioactive of waste management functions and development of requirements.
Four subteams were formed, one to address each waste type, and one to address the Order's
general requirements. The revision of the Order relied on a broad spectrum of relevant talent
within and beyond DOE. Many of the team members who contributed to the response to the
DNFSB Recommendation 94-2 on low-level waste were recruited for this effort because of their
extensive experience in the operation and regulation of radioactive waste management activities.
The expertise of the DOE National Program Managers for radioactive waste types were tapped.
Also, representatives from each DOE site assisted through frequent participation via conference
calls, meetings, workshops, and document reviews.

The Organization Chart in Figure 4-1 reflects both the structure of the Order Revision Team and
the relationships among the Team, the Executive Committee, line management, and the Senior
Review Panel.

3.2 Executive Committee

The Executive Committee provided direction on major policy issues and ensured that all
programmatic issues regarding the Order revision were addressed in an integrated fashion. The
Committee consist upper level management representatives from the following DOE
Environmental Management offices: Office of the Assistant Secretary (EM-1); Office of the
Principal Deputy Assistant Secretary (EM-2); Office of Safety and Health (EM-4); Office of
Management and Evaluation (EM-10); Office of Planning, Policy and Budget (EM-20); Office of
Waste Management (EM-30); Office of Environmental Restoration (EM-40); Office of Science
and Technology (EM-50); Office of Nuclear Material and Facility Stabilization (EM-60); and
Office of Site Operations (EM-70).

3.3 Senior Review Panel

A Senior Review Panel was established to review and provide independent technical advice and
comment on the technical issues, analytical approaches, conclusions, and other activities
performed for revising of the Order. The Panel consisted of top-level experts from outside DOE
in the field of radioactive waste management. The expertise of the Senior Review Panel and the
perspectives of each member is shown in Table 3-1.
Figure 3-1: DOE Low-Level Waste (LLW) Management Essential Requirements Senior Review Panel Members

NAME
HIGHLIGHTS OF EXPERIENCE
STRENGTH

Paul L. Ziemer, Ph.D, CHP
Chairman
(317) 494-1435
(317) 496-1377 Fax
Adviser to DOE LLW Advisory Committee 1971;
Former DOE Assistant Secretary for Environment, Safety and Health (EH);
Member of the National Academy Science (NAS) BIER VI Committee
Dean of School of Health Sciences, Purdue University;
Past President of Health Physics Society.
Representation of professional and academic views;
Familiarity with DOE practices, Order development &
implementation, and political sensitivity;
Established relations with DNFSB, EH, NAS, and others.

Dade Moeller, Ph.D., CHP, P.E.
(919) 633-3352
(919) 633-3352 Fax
Former Chairman of NRC's Advisory Committee on Nuclear Waste (ACNW);
Led DOE/Office Waste Management Disposal Site Working Group Senior Review Board.
Familiarity with Office of Waste Management;
Experience with radiological performance assessments;
Familiarity with NRC views and practices.

William A. Mills, Ph.D.
(301) 774-0975
Former Senior Science/Policy Advisor to the Committee on Interagency Coordination on
Radiation Research and Policy Coordination;
Retired Public Health Service;
Formerly with the Environmental Protection Agency and the Nuclear Regulatory Commission
Past-President of the Health Physics Society
Representation of professional views;
Familiarity with NRC policies and regulations;
Familiarity with DOE practices.
Familiarity with EPA policies and regulations;

Mary Birch, P.E., CHP
803 831-3310
803 831-344 Fax
Currently Engineering Supervisor, Duke Power Company
Former Regulatory and Licensing Manager, U.S. DOE Civilian Radioactive Waste Management
System Management and Operating Contractor
Former Licensing Manager, Duke Engineering Services
Former Technical System Manager, Radiation Protection,
Duke Power Company
Former Technical System Manager, Radioactive Waste Management Function, Duke Power
Company
Former Member of the North Carolina Governor's Waste Management Board
Chaired the Electric Power Research Institute Advisory Committee on Below Regulatory Concern
Familiarity with NRC policies and regulations;
Familiarity with DOE practices;
Familiarity with EPA policies and regulations;
Familiarity with State Waste Management Issues;
Extensive knowledge and understanding of commercial waste
management practices.

Robert Bernero
301 926-3844
301 926-1368 Fax

Currently acting as a nuclear safety consultant on projects involving spent nuclear fuel and
radioactive waste management
Served as a member of the Commission of Inquiry for an International Review of Swedish
Nuclear Regulatory Activities to examine the effectiveness of Swedish regulations for nuclear
reactor safety, radiation protection and waste management
Former Director NRC's Office of Nuclear Material Safeguards and Security
Former NRC Division Director for boiling water reactor licensing, reactor systems safety, and
radiological safety
Former NRC Division Director in Research for probablistic risk analysis and the analysis of
severe reactor accidents
Representation of professional views;
Familiarity with NRC policies and regulations;
Familiarity with DOE practices.

4.0 ORDER REVISION PROCESS

The Order on radioactive waste management was revised using the following process which
included the use of work and documents which were completed under a number of ongoing
efforts, which supported the requirements and objectives of the Order revision task. The process
included the following five steps:

1) Identification of radioactive waste management functions and activities based on
standard systems engineering approaches.

2) Assessment of the hazards posed by performing the functions and activities.

3) Assessment of existing requirements (e.g., DOE directives, NRC regulations, EPA
standards and international standards) for possible use and development of preferred
language for the revised Order.

4) Development of requirements to address significant hazards and the technical basis
for each requirement.

5) Solicitation of wide review and comment and resolution of comments.

This approach also corresponds to the grouping of activities used in DOE's Integrated Safety
Management System (ISMS). This system establishes a logical process for integrating risk into
all of DOE's activities and was used as the foundation for the next steps in the Order revision
process. As noted, the ISMS outlines a simple and logical process for understanding and
mitigating risks. Under this process, the development of work processes should include the
following five steps: (1) identifying the functions (tasks) that must be performed to complete the
work; (2) conducting a safety and hazards analysis of those functions; (3) identifying mitigating
measures and controls based on that analysis; (4) applying the controls and implementing a
periodic reassessment of the activities, and (5) providing for a feedback to revising the work
processes as necessary. As described above, this analytical approach has been incorporated into
the core of DOE's effort to revise the radioactive waste management Order, and represents the
overall philosophical approach and major steps of this effort.

4.1 Identification of Radioactive Waste Management Functions and Activities

The identification of the functions associated with the management of each of the waste types
was based on standard systems engineering approaches. These functions provided the
framework for analysis of the tasks involved in radioactive waste management throughout the
rest of the Order revision process. The identification of the functions associated with the
management of low-level waste was performed as part of DOE's response to the DNFSB
Recommendation 94-2. This effort was documented in the Low-Level Waste Systems
Description Document (reference). The other waste type team members used this approach as a
model for developing function maps for high-level and transuranic waste management activities.
The use of this systems engineering approach resulted in a consistent approach across the
specific waste types. The function maps for each of the waste types are included. The functions
were grouped into three basic categories: those associated with planning (formulate the
program); those involving performance of work tasks (execute the program); and those which
provided for review of activities and feedback (evaluate the program).

4.2 Assessment of the Hazards

Following the development of the function maps for each of the waste types, a Safety and
Hazards Analysis Workshop was conducted. The workshop was attended by both DOE
Headquarters and Field Element staff and support was provided by contractor personnel. At the
workshop, the waste-type teams formed breakout groups and using the functional maps for all of
the waste types discussed their respective functional maps to identify any omissions or
inconsistencies. After the functional maps were finalized the teams identified and documented
the activities that occur in each of the functions. Once the task descriptions were completed, they
were used to conduct a qualitative hazards and safety analysis. Through this analysis, scenarios
were developed for each task of a radioactive waste management function to identify events that
could result in an exposure to a worker or the public, a release of radioactivity to the
environment, or an impact on disposal facility performance. Potentially affected receptors were
then identified for each scenario, and the likelihood and consequences of the postulated exposure
or release was qualitatively estimated. Next, the likelihood of occurrence and consequences were
used to determine risk. The last step involved identifying the weakness or condition in the work
performance and managerial structures which lead to the risk and developing mitigation options
to address these weaknesses or conditions. This identification of weaknesses and conditions and
associated mitigation options became part of the foundation for writing the technical basis for
each of the requirements in the Order, Contractor Requirement Document, and Manual. This
information was used to document the need for the final requirement. A diagram of the steps in
the Safety and Hazards Analysis Process is presented in Figure 4.2. Each of the steps in the
Safety and Hazards Analysis Process are discussed in greater detail in the following section.

The methodology for predictive hazard evaluation of the radioactive waste management system
(Safety and Hazards Analysis Process) was used to identify system weaknesses and/or
conditions, qualitatively estimate risks, and develop mitigation options associated with each of
the functions of the radioactive waste management system. This analysis focused on the
radiological hazards associated with the management of radioactive waste. The analysis was
conducted from a complex-wide perspective using a generic facility concept that drew on
site/facility specific knowledge as a basis. This information was then evaluated to provide the
basis for identifying and developing the requirements and implementing guidance needed to
safely manage radioactive waste from a radiological perspective. The Safety and Hazards
Analysis Process was performed on the low-level, high-level, and transuranic waste management
systems described in each waste-type functions map. To the extent appropriate, existing systems
engineering functional analysis maps were used as a starting point. The Safety and Hazards
Analysis Process involved 11 steps. A flow diagram of the 11 steps is presented in Figure 4-2.
The steps are as follows:

1. Operationalize the Function. Define and describe the physical activities associated
with each function to be performed in managing each waste type.

2. Identifying Initiating Event Categories. Initiating events are those in the chain of
events that could affect the function as described in step 1. Initiating events were
classified as either:

Natural Events (e.g., flood, earthquake, freezing temperatures, electrical storm);

Natural Processes/Passage of Time (e.g., corrosion, erosion, aging material,
intrusion of plants/animals);

Equipment Malfunctions (e.g., instrument/sensor malfunction, process equipment
malfunction);

External Events (e.g., fire, loss of utilities, high velocity impact); or

Human/Information Errors (e.g., communication error, operator error,
documentation error, inadvertent intrusion by humans).

3. Identify Follow-on Event Categories. Follow-on events are those which could affect
the function as described in step 1, and were classified as:

Structural Failure (e.g., building collapse, containment failure),

Infrastructure Failure (e.g., loss of water or water pipe break, loss of power or
electrical surge),

Equipment Failure (e.g., instrument/sensor malfunction, process equipment
malfunction),

Human Error (e.g., communication error, operator error), Method/Information Failure (e.g., documentation error), or

Other.

These categories reflect the first line of defense in preventing an initiating event from
leading to exposure of a receptor.

4. Develop Relevant Scenarios. Sub-Team members developed one or more scenarios
for each follow-on event category identified in step 3 that could reasonably lead to an
exposure of a receptor (defined as workers, public, the environment, and disposal
facility performance). The number of scenarios developed was determined by the
need to address all of the activities identified in step 1. The scenarios were also used
in step 10 as the basis for identifying the weaknesses and/or conditions that might
exist in each scenario. The weaknesses and conditions identified were then used to
focus the development of mitigation options.

5. Determine Which Receptors are Affected in Each Scenario. The scenarios developed
may not have led to impacts to all four of the receptors. This step provided an
opportunity for assessing which receptors were impacted under each scenario.
Determining that a receptor was not impacted by a scenario eliminated the need to
further evaluate that scenario/receptor combination.

6. Estimate Likelihood of Occurrence for Each Scenario. The frequency with which a
scenario was expected to occur then was estimated using a set of ranges and the
professional judgment of waste-type team members. The likelihood of occurrence
was not meant to be a deterministic calculation, but a qualitative evaluation using
experience or information on probabilities previously known or calculated (e.g.,
safety analysis evaluations). The likelihood of occurrence was used as one of the
inputs to determine the receptor-specific qualitative risk in step 8. To determine the
likelihood of the occurrence of such a scenario, each waste-type team used the
process adapted from "Risks and the Risk Debate: Searching for Common Ground
"The First Step,'" Volume 1, June 1995, and successfully employed in the Complex-Wide Review of DOE's Low-Level waste Management ES&H Vulnerabilities. The
likelihoods of occurrence fall into categories of time:

< 1 year indicates a scenario whose consequence already exists or is expected to
occur with a frequency of at least once per year;

1 - 10 years indicates a scenario whose consequence is expected less frequently
than once per year, but more frequently than once every 10 years;

10 - 100 years indicates a scenario whose consequence is expected less frequently
than once every 10 years, but more frequently than once every 100 year); and

> 100 years indicates a scenario whose consequence is unlikely to occur within
the operating life of a facility, but is not completely precluded from occurring.

7. Estimate the Receptor-Specific Consequences for Each Scenario. The consequences
for each scenario/receptor combination was estimated using broadly defined ranges of
effects, allowing waste-type team members to use their professional judgement and
experience. Again, information on consequences previously known or calculated
(e.g., safety analysis evaluations) was applied. This information was a key input to
the qualitative risk evaluation in step 8. To determine the consequences to the
receptor, each waste-type team adapted the system from the "Risks and the Risk
Debate: Searching for Common Ground "The First Step". Consequences are
receptor specific:

Injury/loss of life for workers;

Exposure/loss of life for the public;

Damage for the environment; and

Impact for the disposal facility performance.

8. Apply the Likelihood and Consequences to the Risk Matrix for Each Receptor and
Aggregate the Impacts. The likelihood of occurrence (from step 6) and estimated
consequence (from step 7) for each scenario was used in this step as the basis for
qualitatively estimating the risk to a receptor through the standard risk matrices
developed for each receptor type. This information along with the information from
steps 4 through 7, was used to develop the mitigation options.

9. Aggregate Impacts by Follow-on Event Category. The risks for scenario/receptor
combinations were then tabulated by follow-on event category to provide a relative
measure of the potential risk associated with each category of follow-on events.

10. Analyze Scenarios to Identify Weaknesses and/or Conditions and Develop Mitigation
Options. The scenarios developed in step 4 were analyzed to identify the weaknesses
and/or conditions that were assumed in the operations or managerial structure of each
scenario. The weaknesses and conditions identified were then used to help focus the
development of mitigation options. Using the results of steps 4 through 9, the waste-type team members developed mitigation measures that would address the
weaknesses and/or conditions and that could reduce the likelihood of occurrence
and/or consequences of an event. The information from steps 4 through 9 also were
used to focus the development of the mitigation activities in the context of the
scenarios. These mitigation options served as the basis for identification and
development of the requirements and the implementing guidance for the safe
management of radioactive waste.

11. Rank the Mitigation Options to Focus on the Development of the Most Effective
Requirements. The tabulated risks for each scenario/receptor combination were used
as the basis for ranking mitigation options for effectiveness in addressing safe
management of radioactive waste. This ranking served as an input to the decision of
which potential requirements and/or implementing guidance would be most effective
in safely managing radioactive waste.

4.3 Requirements Analysis

Once the weaknesses and conditions and mitigation options to address these weaknesses or
conditions were developed, existing requirements were evaluated to identify those which
addresses the mitigation options. This was accomplished during the Requirements Analysis
Workshop. The workshop was attended by both DOE Headquarters and Field Element staff and
support was provided by contractor personnel. At the workshop the waste type teams formed
breakout groups and using the weakness and conditions and associated mitigation options
identified by all the waste types at the previous workshop they evaluated their own to identify
any omissions or inconsistencies. Following this the weaknesses and conditions and associated
mitigation options were finalized for each of the waste type. The process of searching through
existing requirements to identify those that would address these weaknesses and conditions
began. This effort was facilitated by the identification of potentially applicable requirement
sources before the workshop. These sources were then readily available for the team members.
This resulted in the inclusion of over 100 DOE directives (orders, manuals, guides, and policies)
and other agency requirements and guides (EPA and NRC requirements and other national,
international, and industry consensus standards).

The evaluation involved a determination of whether the requirement addressed the weakness or
condition. If yes, did it adequately address the weakness or condition? If yes, it was adopted for
use. If no, could it be modified to adequately address the weakness or condition? If yes, it was
modified and adopted for use. If no, a requirement was written and adopted for use. To ensure a
complete evaluation, checklists were prepared for each function which included a list of DOE
directives and other requirements that might apply that were required to reviewed. If more than
one requirement was identified which would address a weakness or condition, they were
evaluated and the most appropriate one or a if necessary a hybrid using one or more of the
requirements was adopted for use. This evaluation, modification, writing, and adoption for use
process became part of the foundation for writing the technical basis for each of the requirements
in the final Order, Contractor Requirement Document, and Manual. This information was used
to describe the source of the language used in the final requirement. The following describes the
Requirements Analysis and each of its steps in more detail. A flow diagram of the steps in the
Requirements Analysis, which includes decisions on which document is most appropriate for
each requirement is depicted in Figure 5-1. The steps are as follows:

1) Operationalize Functions

For each waste type, the functions were listed along with the definition of the function
and phrases representing the operationalization of the function. An example is high-level waste function 1.3.1.1.1.2 Characterize Site for Storage Facility: Recognize
facility-specific characteristics and gather and review technical data from candidate
sites.

2) Identify Needed Requirement Areas

For the function being analyzed, the list of items for which requirements were needed
was included. This comprised a list of weaknesses and conditions from the Safety
and Hazards Analysis process and a list of the vulnerabilities from the low-level
waste Complex-Wide Review and similar evaluations of transuranic and high-level
waste which have been identified.

3) Identified Existing and External Requirement Sources

For each function, the appropriate requirements were listed from sources that are or
could be requirements for the safe and effective implementation of the function for
managing radioactive waste. Each requirement was then linked to any weaknesses,
conditions, or vulnerability which it could potentially address. Requirement sources
included:

DOE 5820.2A, Radioactive Waste Management and other DOE directives;

Applicable Federal requirements (e.g., 40 CFR Part 190);

A set of proposed multi-function requirements;

Other Federal requirements (e.g., 10 CFR Part 61);

International standards (if appropriate); and

National standards and practices (if appropriate).

4) Evaluate Adequacy of Requirements

Each of the requirements compiled in Step 2 was evaluated to determine its adequacy
in providing for safe management of radioactive waste for the function being
analyzed. This evaluation was based on an analysis of the requirement against the
following considerations:

Does the requirement support an upper-level requirement?

Does the requirement address an activity of the function as defined in the function
definition and operationalization?

Does the requirement address a weakness or condition identified through the
Safety and Hazards Analysis process?

Does the requirement address a vulnerability identified through the Complex-Wide Review for low-level and mixed low-level wastes or other assessments for
transuranic or high-level wastes?

Does the requirement address the guiding principles for establishment of specific
requirements to support the upper-level requirements?

Does the requirement describe a best management practice or a proven site-specific method?

The requirements were evaluated in the following Order. First, any proposed multi-function requirements and other applicable Federal requirements and DOE directives
were evaluated. Then requirements potentially applicable from DOE 5820.2A,
Radioactive Waste Management, were evaluated. Finally, requirements from other
non-applicable sources (similar U.S. Nuclear Regulatory Commission, U.S.
Environmental Protection Agency regulations, and national standards), followed by
any international information were evaluated.

5) Identification of Additional Requirements

When the preceding steps in the requirements analysis were completed, the lists of
vulnerabilities and weaknesses or conditions, and the list of operationalized functions
were examined to identify if any additional requirements were needed. Similarly, the
proposed requirements listed were examined to see if additional requirements were
needed in order to effectively implement the waste management functions of each
waste type.

5.0 OTHER CONSIDERATIONS

The following areas of consideration were identified as concepts and values to be incorporated
in and reflected throughout the revised radioactive waste management order.

5.1 Protection of the Public

Radioactive waste management activities at DOE sites including design, construction, operation,
decontamination, disposal, closure, and post-closure activities shall be conducted and shown to
assure adequate protection of the public from exposure to radioactive materials during both
normal operations and during reasonably foreseen off-normal events. Adequate radiation
protection is defined by the exposure limits set forth in 10 CFR Part 834. In addition, the DOE
Nuclear Safety Policy defines safety goals that are expressed in terms of public risk of accidental
fatality and fatal cancer incidence. The risk of prompt fatality to average individual due to an
accident in the vicinity of a DOE facility is to be less than 0.1% of the sum of prompt fatalities
due to other accidents to which members of the public are generally exposed. The risk of cancer
fatality that might result from operations at a DOE site should not exceed 0.1% of the sum of all
cancer fatality risks to the public resulting from all other causes [SEN-35-91].

5.2 Protection of the Workforce

Radioactive waste management activities at DOE sites including design, construction, operation,
decontamination, disposal, closure, and post-closure activities, shall be conducted and shown to
protect the workforce from hazards to a level commensurate with comparable, safe industrial
facilities and shall meet the requirements of the Occupational Safety and Health Act (OSHA)
requirements 29 CFR Part 1910 and 29 CFR Part 1926 [DOE O 440.1A]. Facilities shall be
designed, operated, decontaminated, and closed to limit radiation exposures to the workforce
during normal operations and during reasonably foreseen off-normal events to levels below
limits set forth in 10 CFR Part 835 as supplemented by DOE Notice 441.1

5.3 As Low as Reasonably Achievable (ALARA)

Radioactive waste management activities at DOE sites including design, construction, operation,
decontamination, disposal, closure, and post-closure activities shall be analyzed to show and
shall be conducted in manners such that radiation exposures of the public, the workforce, and
environment are kept as low as reasonably achievable (ALARA). ALARA is the approach to
radiation protection to manage and control exposures, taking into account social, technical,
economic, practical and policy considerations. ALARA does not identify a dose limit but is
instead a process which has the objective of attaining doses as far below the applicable limits as
can be reasonably achieved. [10 CFR 835.1001 and 10 CFR 835.1002]

5.4 Defense-in-depth

The safety strategy for radioactive waste management activities at DOE sites shall be based on
defense-in-depth. In this context, defense-in-depth is the practice of using systems of equipment
and systems of procedures in a structure of mutual re-enforcement to avoid exposures of the
public, the workforce, and the environment to nuclear radiation [DNFSB/TECH-6]. A graded
approach based on risk shall be utilized to comply with the requirement [10 CFR 830.3 and
10 CFR 830.7].

5.5 Protection of the Environment

Radioactive waste management activities at DOE sites including design, construction, operation,
decontamination, disposal, closure, and post closure activities shall be conducted to meet
statutory limits and shown to minimize contamination of the environment in a cost-effective
manner and to limit exposure of aquatic animals to levels below the limits specified in 10 CFR
Part 834. Contamination of land by DOE activities shall be limited to avoid permanently
restricting land from beneficial use [Atomic Energy Act of 1954, as amended; Executive Order
11514].

5.6 Compliance

Radioactive waste management activities at DOE sites including design, construction, operation,
decontamination, disposal, closure, and post-closure activities shall be compliant with applicable
Federal, State, and local laws and regulations, as well as Compliance Orders [10 CFR Part 820].
These activities shall also comply with applicable Executive Orders, DOE's Strategic Plan, and
DOE Policies [SEN-15-90; DOE Policy P 251.1].

5.7 Authorization Basis

Radioactive waste management activities at DOE sites shall have an authorization basis. "The
authorization basis establishes the safety envelop for a facility operation or activity and defines
what will have to be done to control safety of the operation [or activity]. The authorization basis
includes the hazards analysis, the definition of administrative and engineering controls to prevent
and mitigate hazards, and the associated technical and operation limits. The type of safety
documents that will constitute the authorization basis will vary with the hazard and complexity
of the operation or activity." [DOE O 425.1A; DOE 5480.21; DOE 5480.22; DOE 5480.23]

5.8 Cost-Effectiveness

Quantified estimates of life-cycle cost of proposed activities and alternatives. Life-cycle cost shall include capital investment, acceptance testing, operations,
maintenance, decontamination, decommissioning, disposal, closure and post-closure
activities.

Quantified estimates of the benefits of proposed activities and alternatives. The
benefits shall include waste minimization, increments in the expected radiation dose
to the public, the workforce, and the contamination of the environment, land use, and
timely disposal of waste. The conversion of benefits to monetary values for use in
comparisons to cost shall have a defensible and documented basis. Estimates of costs
and benefits shall include the time cost of capital and quantification of uncertainties.
Selection among alternatives shall minimize life-cycle costs and investment risk
while maximizing the net benefit for the timely disposition of wastes without
compromising the protection of the public, the workforce, and the environment, nor
the compliance with applicable laws and regulations [SEN-35-91 Section 1;
Executive Order 12780 (1991)].

5.9 Voluntary Consensus Standards

Radioactive waste management activities at DOE sites including design, construction, operation,
decontamination, disposal, closure, and post-closure activities shall be conducted in conformance
with applicable technical standards that are developed or adapted by voluntary consensus
standard bodies to the extent that these standards are appropriate and practical [Public Law 104-113; SEN-35-91, Section 2, Paragraphs 1 and 2; DOE Policy 251.1].

5.10 Waste Minimization

Radioactive waste management activities at DOE sites including design, construction, operation,
decontamination, disposal, closure, and post-closure activities shall minimize the waste quantity,
volume, and toxicity to an extent technically and economically practical.

5.11 Property and Facility Protection

Radioactive waste management activities at DOE sites including design, construction, operation,
decontamination, disposal, closure, and post-closure activities shall be conducted in manners that
minimize the threats to DOE property [Atomic Energy Act of 1954, as amended, Executive Order
13101, Greening the Government through Waste Prevention, Recycling, and Federal
Acquisition].

5.12 Timely Disposal of Waste

Radioactive waste management activities at DOE sites shall be prioritized to minimize with
respect to life-cycle cost the time integral of risk of radiation exposure to the public and the
workforce, as well as the time integral of the risk of environmental contamination.

5.13 Waste Characterization

Radioactive waste on DOE sites shall be characterized sufficiently to assure compliance with
other requirements including those concerning limitations on radiation doses to the public and
the workforce, possible degradation of the environmental quality, and the cost-effective
management of radioactive waste, as well as to assure compliance with the waste acceptance
criteria both on the site and at the eventual waste disposal site.

6.0 REQUIREMENT DOCUMENTATION AND TECHNICAL BASIS

6.1 Order Writing Process

The general requirements and waste-type teams took the requirements that resulted from
applying the guiding principles and began to organize then into the draft outline of the Order and
Manual. Once all of the requirements had been place into the appropriate section of the draft
outline it was reviewed and modified to eliminate redundancies, provide for better flow and
logic, identification of requirements common to all waste types (these requirements were then
evaluated for possible inclusion in the General Requirements section), and other changes
associated with consistency and wording selection. Once each of the individual waste-type
chapters was completed the chapters were reviewed collectively for consistency and continuity
and further revised to address suggested changes. Finally, the draft was sent out for a
Department-wide review.

6.2 Documentation of Technical Basis Crosswalk

During the entire Order revision process, information needed to develop the technical basis for
each of the requirements was identified and generated. The Safety and Hazards Analysis
provided the technical basis for why the requirements are important and necessary for the safe
management of radioactive waste. The Requirements Analysis provided the technical basis for
the source and, in some cases, the wording of the requirements. The application of the guiding
principles for generating requirements provided the technical basis for the wording of the
requirements and, in the case of some of general requirements, also provided the technical basis
for the need and source of the requirements. The following sections provide a discussion of the
approaches for the management of radioactive waste, high-level waste, transuranic waste, and
low-level waste.

Additionally, a crosswalk of the requirements from DOE 5820.2A, Radioactive Waste
Management, to Draft DOE O 435.1, Radioactive Waste Management, was conducted and the
technical basis for each of the requirements is included for general requirements and the
requirements for high-level waste management, transuranic waste management, and low-level
waste management. The technical basis provides crosswalk tables (Attachment 1) depicting the
revised 435.1 requirements, the 5820.2A requirements, and the technical basis for the revised
requirements.

The technical basis for the revised requirement includes:

The driver for the requirement (Safety and Hazard Analysis, Requirements Analysis,
complex-wide review, etc.).

The weakness/condition or vulnerability which the requirement addresses.

The origin or source of the requirement.

Other information (e.g., the requirement addresses other considerations as identified
in Section 5.0, such as provides defense in depth, addresses ALARA, etc.).

Functions Maps

BASIS FOR REGULATION OF RADIOACTIVE WASTE

The revised Order, designated DOE O 435.1, Radioactive Waste Management, establishes the
requirements for management of radioactive waste consistent with the Department's Atomic
Energy Act of 1954, as amended, responsibilities to provide for radiological protection from
DOE operations. The scope of DOE O 435.1 includes: (1) high-level waste, including closure of
high-level waste tank systems and management of associated incidental wastes; (2) transuranic
waste, including safe treatment, storage, and characterization/certification to support disposal at
the Waste Isolation Pilot Plant; and (3) low-level waste, with attention to disposal and the
impacts of interacting source terms on projected public dose. The revised Order does not contain
requirements for the management of the decontamination or decommissioning of radioactively
contaminated facilities. Those requirements are incorporated in a revision of DOE O 430.1, Life-Cycle Asset Management. Additionally, the requirements for the management of spent nuclear
fuel are not contained in this Order. The hazards analysis performed to identify requirements for
high-level waste did not address the functions associated with management of spent nuclear fuel.
Thus the requirements contained in DOE M 435.1-1 do not apply to this DOE-managed spent
nuclear fuel.

Risk

The focus of the Radioactive Waste Management Order revision effort provided numerous
challenges and opportunities to DOE for addressing risk. These opportunities and challenges
operated at several different levels. As sources for understanding the overall scope of risk
throughout the DOE complex and its operations, the DOE Risk Report to Congress and the
findings of the Complex-Wide Review on low-level waste implemented under Defense Nuclear
Facilities Safety Board (DNFSB) Recommendation 94-2 were invaluable. Through these
sources, DOE was able to conceptualize both the breadth and causes of the major risks within
DOE's operations at the complex-wide and site-specific managerial levels.

DOE's Integrated Safety Management System (ISMS) establishes a logical process for integrating
consideration of risk into all of DOE's planning and activities, and provides a uniform and
common process for thinking about the problems of risk and developing solutions. In particular,
the ISMS dictates a simple but logical process for understanding and mitigating risks. Under
ISMS, the development of work processes follows a simple five-step approach: (1) identify the
functions that must be performed to complete the work; (2) conduct a safety and hazards analysis
of those functions; (3) develop the appropriate mitigating measures and controls based on that
analysis; (4) apply the controls and implement a periodic reassessment of the activities, and (5)
provide for a feedback to revising the work processes as necessary. This analytical approach has
been incorporated into the heart of DOE's effort to revise the Radioactive Waste Management
Order and represents the overall philosophical approach and major steps of this effort.

Performance-Based Requirements

One of the factors that contributed heavily to the shaping of the efforts to revise DOE's
radioactive waste management requirements is the emphasis on performance-based requirements.
Through the Department's system for revising and issuing directives there has been a strong
movement away from detailed prescriptive requirements toward higher-level and more
performance-based requirements. The implementation of performance-based requirements
requires methods of measurement or demonstration in order to determine effective
implementation and/or compliance. Such requirements are difficult to implement if the
requirements are not clearly written, complete guidance is not provided, or the technical basis of
the requirements is not known or understood. A particular challenge to this effort, therefore, was
to develop not only the appropriate level of performance-based requirements, but to also develop
the appropriate level of associated guidance and technical basis. Notably, these key elements of
an effective performance-based requirements system have also been some of the key areas of
failure with DOE's past requirements, especially with regard to DOE's radioactive waste
management requirements.

When both the goals of performance-based and risk-based requirements are considered, an
approach is necessary, which if developed and used properly, can provide the avenue for
implementing such requirements effectively. One method of achieving this balance and allowing
for a graded approach in the application of the requirements is to implement the requirements at
the site level through the development of operation-specific authorization basis documentation.
Under the concept of authorization basis documentation, each site-specific waste management
operation develops its own vehicle for demonstrating methods of compliance, documenting
implementation-level procedures and requirements, and providing the baseline for measurement
of performance. The authorization basis is developed based on site-specific conditions and the
particular risks and performance needs for the facility, and is approved by the cognizant DOE
manager.

An example of such authorization basis documentation is the process that DOE currently uses for
developing Safety Analysis Reports (SARs) and authorizing facilities to operate. Under this
approach, each operation or facility is required to analyze the key hazards of the facility's
operations and processes, describe them, develop the controls to mitigate the hazards and the
technical basis for such, and provide an overall framework for the operation of the facility.
When authorized, the facility then operates to the procedures and operational envelope identified
in the authorization basis documentation. Events or occurrences which deviate from the
authorization basis trigger re-evaluation and development of additional work process and
requirements as necessary.

The requirements developed under the General Requirements Chapter of DOE M 435.1-1
provide the umbrella which incorporates the considerations of risk, performance, and
authorization basis documentation into DOE's radioactive waste management system. The
technical basis and crosswalk tables presented in this document address both the waste-type
specific requirements and the general requirements of DOE M 435.1-1, and where appropriate,
references across chapters of the Manual have been included. CHAPTER I

GENERAL REQUIREMENTS AND RESPONSIBILITIES

1. REQUIREMENTS

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.

Basis:

Functions Evaluated. This requirement derives from the analysis of almost all functions for all
three radioactive waste types.

Safety and Hazard Analyses. The requirement addresses the need for there to always be a DOE
manager with direct responsibility for ensuring activities are conducted in a fashion that protects
the public, workers, and the environment. This requirement specifically addresses several
weaknesses and conditions associated with lack of management and lack of documentation of
decisions.

Requirements Analysis. New requirement derived for the Manual.

Other Considerations. The requirement implements a best management practice in place at
most Departmental levels, and is included to emphasize the importance of accountability for
ensuring radioactive waste management activities conducted by the Department are done so
safely.

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.

Basis:

Functions Evaluated. This requirement derives from the analysis of most Execute functions for
all three radioactive waste types.

Safety and Hazard Analyses. This requirement derives from the vetting process used in the
safety and hazards analyses. Mitigating activities were identified to control the weaknesses and
conditions identified, and in many cases, better guidance was recognized as the most effective
mitigating action, especially in cases where there was a longstanding requirement that was
considered sufficient. The preparation of effective implementation guidance for all requirements
was indicated as a result of the safety and hazards analyses.

Requirements Analysis. The requirement partially derives from the evaluation of DOE O
251.1A, Directives System, DOE M 251.1-1A, Directives System Manual, and its implementation
guidance.

Other Considerations. The use of guidance to explain the intention of requirements, along with
acceptable ways of meeting the requirements, is a well developed regulatory method used by the
NRC. The use of guidance as described in the requirement implements this best management
practice for DOE management of radioactive waste. Also, some of the acceptable ways for
meeting requirements included in the guidance are there due to the vetting process used in
development of performance-based requirements. The source of these acceptable methods is
often another requirements document (e.g., WIPP Waste Acceptance Criteria). They may
represent the only acceptable way to meet the requirement right now, but the level of specificity
is not appropriate for the Manual and the activities to which it applies. The requirement includes
the need to document the use of alternative methods, and a rationale if one is used.

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.

Basis:

Functions Evaluated. This requirement derives from the analysis of the top level functions for
all three waste types: Formulate, Execute, and Evaluate.

Safety and Hazard Analyses. The safety and hazards analyses conducted for determining the
essential requirements for radioactive waste management assumed that all radioactive waste was
either high-level waste, transuranic waste, or low-level waste, based on the definitions assumed
for the three waste types (The definitions in DOE 5820.2A were assumed). Special case waste,
non-defense transuranic waste, and other wastes that have been management problems in the past
were included in the analysis for the purposes of determining technical requirements needed to
manage them, and the essential requirements included in the manual are believed to be sufficient
for managing all of the Department's radioactive waste as one of the three waste types.

Requirements Analysis. New requirement derived for the Manual.

Other Considerations. Because of the special needs of management of mixed low-level waste,
the Department has established and manages a mixed low-level waste program independent of
the low-level waste management program. The requirement includes consideration of the
effectiveness of this program by recognizing that all DOE radioactive waste could be managed
within one of these four programs.

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.

Basis:

Functions Evaluated. This requirement derives from the analysis of functions in all three waste
types associated with siting, designing, and constructing new waste management facilities. It
also partially derives from the analysis of the Develop the program functions for all three waste
types

Safety and Hazard Analyses. The requirement partially addresses some weaknesses and
conditions associated with poor siting of facilities, and inadequate site characterization data. The
requirement also partially addresses the need to involve stakeholders in decision making, a need
identified in some of the program development requirements.

Requirements Analysis. The requirement is essentially equivalent to and updates the reference
in DOE 5820.2A, 6.10. to DOE 5440.1C, National Environmental Policy Act.

Other Considerations. None.

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.

Basis:

Functions Evaluated. This requirement derives from the analysis of all Execute functions for
all three radioactive waste types.

Safety and Hazard Analyses. During the safety and hazard analysis, numerous weaknesses and
conditions and needs for controls for radioactive waste management were identified as
potentially covered by requirements or DOE directives already in place. Some examples of these
weaknesses and conditions are safety documentation, personal protective equipment, and effluent
monitoring. The safety and hazards analysis identified the controls and mitigating actions
included in these other requirements and directives.

Requirements Analysis. The requirements and directives identified in the safety and hazard
analyses that contained necessary mitigating actions and controls were evaluated for their
adequacy in addressing the weaknesses and conditions identified for radioactive waste
management. Many of these requirements and directives were found to provide controls that
were essential to the protection of the public, workers, and the environment. These are listed
below to ensure that the requirements they invoke are followed for radioactive waste
management facilities. The directives that are listed under this requirement represent those that
addressed weaknesses and conditions that; were associated with high hazard scenarios, were
associated with numerous accident scenarios, or are known to be significant in management of
one of the radioactive waste types. More discussion appears about the specific weaknesses and
conditions addressed by the requirement or directive in the following sections. The requirement
also imposes the Department's Integrated Safety Management System as required under DOE P
45.4, Safety Management System Policy. This ensures that if any of these essential requirements
and directives are modified or waived, that the hazard associated with the requirement is being
adequately controlled.

Other Considerations. The requirement includes allowing waivers or modifications to
requirements in these directives through any of the accepted processes for doing so within the
Department. This is included to implement the Department's integrated safety management
system. The principle allows that alternative requirements are acceptable if a similar process as
the one followed in developing the Order demonstrates the controls are the correct set for the
situation.

E. Requirements of Other Regulations and DOE Directives.

(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.

Basis:

Functions Evaluated. This requirement derives from the analysis of the Evaluate top-level
function for all three waste types.

Safety and Hazard Analyses. The requirement addresses the need to perform evaluations of the
performance of radioactive waste management facilities in protecting the public, workers, and
the environment, and improving performance in critical activities if indicated.

Requirements Analysis. Analysis of DOE O 210.1, Performance Indicators and Analysis of
Operations Information, indicates that it provides the essential requirements necessary for
radioactive waste management facilities to implement an effective analysis of operations
information.

Other Considerations. None.

E. Requirements of Other Regulations and DOE Directives.

(2) Classified Waste. Radioactive waste for 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.

Basis:

Functions Evaluated. This requirement derives from the analysis of the Execute functions for
all three waste types.

Safety and Hazard Analyses. The safety and hazards analyses assumed that classified waste
was included in the radioactive wastes for which essential requirements were being developed.

Requirements Analysis. Analysis of DOE 5632.1C, Protection and Control of Safeguards and
Security Interests, and DOE 5633.3B, Control and Accountability of Nuclear Materials,
indicate that they provide the essential requirements necessary for the national security
protections needed for management of classified radioactive waste at DOE waste management
facilities.

Other Considerations. None.

E. Requirements of Other Regulations and DOE Directives.

(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.

Basis:

Functions Evaluated. This requirement derives from the analysis of the Execute functions for
all three waste types.

Safety and Hazard Analyses. The requirement addresses the need for adequate procedures to
be developed and implemented for all radioactive waste management operations and activities
important to protection of the public, workers, and the environment. Weaknesses and conditions
associated with lack of or poor procedures were identified repeatedly in the safety and hazards
analysis.

Requirements Analysis. Analysis of DOE 5480.19, Conduct of Operations Requirement for
DOE Facilities, indicates that it provides the essential requirements necessary for effective
development of procedures and other conduct of operations at DOE radioactive waste
management facilities. Meeting of these requirements is emphasized by this DOE M 435.1-1
requirement because the weaknesses and conditions associated with poor or lack of procedures
was repeatedly identified as potentially contributing to management problems with radioactive
waste.

Other Considerations. None.

E. Requirements of Other Regulations and DOE Directives.

(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.

Basis:

Functions Evaluated. This requirement derives from the analysis of the Execute functions for
all three waste types.

Safety and Hazard Analyses. The requirement addresses the need for criticality to be
considered in the management of wastes containing fissile or fissionable materials. Potentially
catastrophic consequences were identified in the safety and hazard analyses for storage,
treatment, and disposal scenarios involving weaknesses involving criticality concerns.

Requirements Analysis. Analysis of DOE O 420.1, Facility Safety, indicates that it provides
the essential requirements necessary for an effective criticality safety program at DOE
radioactive waste management facilities. Meeting of these requirements is emphasized by this
DOE M 435.1-1 requirement because of the potential for large consequences indicated in the
safety and hazards analyses if criticality safety programs are not carefully adhered to.

Other Considerations. The requirement is included for emphasis based partially on comments
of the Senior Review Panel on draft versions of the Manual.

E. Requirements of Other Regulations and DOE Directives.

(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.

Basis:

Functions Evaluated. This requirement derives from the analysis of the Execute functions for
all three waste types.

Safety and Hazard Analyses. The requirement addresses the need for adequate emergency
management to respond to accident scenarios and potentially hazardous situations involving
radioactive waste management. The need for emergency management was identified as a very
important mitigating action for situations involving high hazard activities, especially weaknesses
and conditions associated with storage of high-level waste, and treatment and pre-treatment of
high-level waste, and transportation of all wastes.

Requirements Analysis. Analysis of DOE O 151.1, Comprehensive Emergency Management
System indicates that it provides the essential requirements necessary for development of an
effective emergency management program for DOE that will include radioactive waste
management facilities, operations, and activities. Meeting of these requirements is emphasized
by this DOE M 435.1-1 requirement to ensure that the high hazard activities involved in the
management of some radioactive wastes has the necessary mitigating activities to ensure
protection of the public, workers, and the environment.

Other Considerations. None.

E. Requirements of Other Regulations and DOE Directives.

(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 Health Reporting, and DOE O 232.1A,
Occurrence Reporting and Processing of Operations Information.

Basis:

Functions Evaluated. This requirement derives from the analysis of all of the Execute functions
and the Evaluate the program functions for all three radioactive waste types.

Safety and Hazard Analyses. The requirement addresses the need to provide reporting of
environmental monitoring and operational data for radioactive waste management operations and
activities to ensure the protection of the public, workers, and the environment continues to meet
regulatory and stakeholder requirements. The requirement also addresses the need to implement
an effective feedback system within an integrated safety management system to effectively
evaluate radioactive waste management facilities, operations, and activities.

Requirements Analysis. The requirement is essentially equivalent to and updates the reference
in DOE 5820.2A, 6. References to the environmental monitoring order which has been canceled,
DOE 5484.1, and the occurrence reporting order which has been canceled, DOE O 231.1,
Environment, Safety, and Health Reporting, and DOE O 232.1A, Occurrence Reporting and
Processing of Operations Information were evaluated and found to be adequate in implementing
environmental monitoring reporting requirements and occurrence reporting requirements for
radioactive waste management. This is included to implement the Department's integrated
safety management system, as invoked in the introductory requirement to this section of the
Manual, Requirements of Other Regulations and DOE Directives.

Other Considerations. None.

E. Requirements of Other Regulations and DOE Directives.

(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 the Environment.

Basis:

Functions Evaluated. This requirement derives from the analysis of all of the Execute functions
for all three radioactive waste types.

Safety and Hazard Analyses. The requirement addresses the need to provide monitoring of
radioactive waste management operations and activities to ensure the protection of the public,
workers, and the environment continues to meet regulatory and stakeholder requirements. The
requirement also partially addresses the need to involve stakeholders in decision making, a need
identified in some of the program development requirements.

Requirements Analysis. The requirement is essentially equivalent to and updates the reference
in DOE 5820.2A, 6. References to several environmental compliance orders which have been
canceled that required environmental and effluent monitoring. DOE 5400.1, General
Environmental Protection; and DOE 5400.5, Radiation Protection of the Public and
Environment were evaluated and found to be adequate in implementing environmental
monitoring requirements for radioactive waste management facilities. (Some additional
monitoring requirements appear in the waste type chapters where specific waste management
situations warrant.)

Other Considerations. None.

E. Requirements of Other Regulations and DOE Directives.

(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 O 5480.21, Unreviewed
Safety Questions, DOE 5480.22, Technical Safety Requirements, and DOE
5480.23, Nuclear Safety Analysis Reports.

Basis:

Functions Evaluated. This requirement derives from the analysis of the Execute functions for
constructing a new facility for all three radioactive waste types.

Safety and Hazard Analyses. The requirement addresses the need for the analysis of the
specific hazards associated with a specific radioactive waste management facility, operation, or
activity to be considered in the determination of whether the public, workers, and environment
are adequately protected. Poor or lack of hazard analysis has been identified repeatedly by the
Defense Nuclear Facilities Safety Board as a weakness requiring correction for many
Departmental programs.

Requirements Analysis. DOE O 425.1A, Startup and Restart of Nuclear Facilities,
DOE O 5480.21, Unreviewed Safety Questions, DOE 5480.22, Technical Safety Requirements,
and DOE 5480.23, Nuclear Safety Analysis Reports contain the Department's requirements for
implementing appropriate safety and hazards documentation for those facilities which warrant it.
The requirement is emphasized here because of the potential for large consequences indicated in
the safety and hazards analyses if this process is carefully adhered to.

Other Considerations. The requirement is included to implement one of the top-level
requirements established for the Order revision, the use of the authorization basis concept. It was
recognized during the development of essential requirements that some radioactive waste
management facilities activities, and operations already function under the authorization basis
system established in the Directives that are invoked by this requirement. This situation is
addressed in the guidance on DOE M 435.1-1 under the General Requirement for a radioactive
waste management basis.

E. Requirements of Other Regulations and DOE Directives.

(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.

Basis:

Functions Evaluated. This requirement derives from the analysis of almost all functions for all
three radioactive waste types.

Safety and Hazard Analyses. Several effective mitigating actions were identified in the safety
and hazard analyses that were assumed to be potentially covered by the implementation of a
couple of newer DOE directives. These mitigating activities included improved planning for
waste management activities, operations, and facilities, better maintenance of radioactive waste
management facilities, equipment, and assets, and a configuration management process for
controlling changes to facilities, activities, and requirements important to protection of the
public, workers, and the environment. Numerous weaknesses and conditions in many functions
were addressed by one of these mitigating actions.

Requirements Analysis. DOE O 430.1A, Life-Cycle Asset Management, and DOE 4330.4B,
Maintenance Management Program, were evaluated and found to be adequate in implementing
improved life-cycle asset planning, project management, configuration control, and maintenance
for radioactive waste management. Implementation of DOE O 430.1A essentially updates the
reference in DOE 5820.2A, 6. References, to the canceled DOE Orders, DOE 4700.1 Project
Management System, and DOE 4300.1B, Real Property and Site Development Planning. (Some
additional life-cycle planning requirements appear in the waste type chapters where specific
waste management situations warrant.)

Other Considerations. None.

E. Requirements of Other Regulations and DOE Directives.

(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.

Basis:

Functions Evaluated. This requirement derives from the analysis of almost all functions for all
three radioactive waste types.

Safety and Hazard Analyses. Mixed waste was included in the radioactive wastes that required
management in the safety and hazard analyses for all three waste types. Needs for specific
controls and specific weaknesses and conditions, if any, were addressed for the management of
mixed waste. It was determined that, with a few exceptions, the hazardous constituents were
probably sufficiently controlled by any hazardous waste requirements in place.

Requirements Analysis. The requirement implements the longstanding Department policy,
reflected in the requirement DOE O 435.1, 4.b.(4) that radioactive waste management facilities,
operations, and activities will comply with all applicable Federal, State, and local laws and
regulations. This is consistent with and essentially continues the DOE 5820.2A Policy O.5,
references to 10 CFR Part 962, in DOE 5820.2A, 6. References.

Other Considerations. None.

E. Requirements of Other Regulations and DOE Directives.

(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.

Basis:

Functions Evaluated. This requirement derives from the analysis of all Execute functions in all
three radioactive waste type analyses that involve transport of radioactive waste to another
facility. The requirement also derives from the packaging functions in the treatment, storage,
and disposal functions for all three waste types.

Safety and Hazard Analyses. The requirement addresses the need to provide adequate controls
on the packaging of radioactive waste, and transportation of radioactive waste management from
facility to facility, to ensure the protection of the public, workers, and the environment.
Transportation of radioactive waste has long been recognized as one of the most hazardous
activities associated with radioactive waste management, and also, the activity is conducted with
regularity, increasing the chances of a mishap. The requirement also addresses the weaknesses
and conditions associated with poorly packaged radioactive waste, leaking waste packages,
repackaging of waste, waste that must be returned to the generator, and waste that does not
contribute to the performance of a disposal facility. The requirement also partially addresses the
need to consider stakeholders in development of requirements or in decision making, a need
identified in some of the program development requirements.

Requirements Analysis. The requirement is essentially equivalent to and updates the references
in DOE 5820.2A, 6. References to several Departmental directives on transportation which have
been canceled. DOE O 460.1A, Packaging and Transportation Safety, and DOE O 460.2,
Departmental Materials Transportation and Packaging Management were evaluated and found
to be adequate in implementing packaging and transportation requirements for radioactive waste.
(Some additional packaging and transportation requirements appear in the waste type chapters
where specific waste management situations warrant.)

Other Considerations. None.

E. Requirements of Other Regulations and DOE Directives.

(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.

Basis:

Functions Evaluated. This requirement derives from the analysis of most of the Execute
functions of all three waste types.

Safety and Hazard Analyses. The requirement addresses the need for radioactive waste
management facilities, operations, and activities that are important to protection of the public,
workers, and the environment to adhere to a controlled process for contracting, production,
record keeping, auditing, labeling, and other elements that are addressed in quality assurance
programs implemented in nuclear facilities. The requirement addresses the weaknesses and
conditions of poor quality materials, workmanship, documentation, training, and evaluations.

Requirements Analysis. This requirement implements requirements promulgated since DOE
5820.2A, 6. References, referred to DOE 5700.6B, Quality Assurance. 10 CFR 830.120, Quality
Assurance Requirements and Responsibilities, and DOE O 414.1, Quality Assurance, provide
Departmental approved quality assurance programs and processes adequate for radioactive waste
management. They are emphasized in DOE M 435.1-1 because adherence to the requirements in
Quality Assurance Programs was identified as an extremely effective mitigating factor for many
weaknesses and conditions identified in the safety and hazard analyses .

Other Considerations. Following the requirements of the quality assurance directives also
addresses the needs for conducting effective evaluations of radioactive waste management
facilities, operations, and activities which were identified in the analysis of the Evaluate
functions for all three waste types.

E. Requirements of Other Regulations and DOE Directives.

(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.

Basis:

Functions Evaluated. This requirement derives from the analysis of all of the Execute functions
for all three radioactive waste types.

Safety and Hazard Analyses. The requirement addresses the need to provide the protection of
the public, workers, and the environment from radioactive waste management operations and
activities.

Requirements Analysis. The requirement is essentially equivalent to and updates the DOE
5820.2A, 6. References to several environmental compliance orders which have been canceled
that required protection of the workers, public, and the environment for radioactive waste
management operations and activities. These requirements are also consistent with the Policy of
DOE 5820.2A contained in that Order at paragraph 5. 10 CFR Part 835, Occupational Radiation
Protection, and DOE 5400.5, Radiation Protection of the Public and Environment are the
fundamental Departmental directives that provide these protection requirements. This
requirement implements three of the top-level requirements of the Department for providing
controls on the management of radioactive waste, and also implements in the Manual, the
fundamental requirements of DOE O 435.1, O.4, Requirements.

Other Considerations. None.

E. Requirements of Other Regulations and DOE Directives.

(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.

Basis:

Functions Evaluated. This requirement derives from the analysis of almost all of the functions
of all three waste types.

Safety and Hazard Analyses. The requirement addresses the need for radioactive waste
management facilities, operations, and activities to provide effective record keeping on
information and data are important to protection of the public, workers, and the environment.
The requirement addresses significant weaknesses and conditions associated with poor or lack of
effective record keeping in storage, treatment, and disposal of waste. Particular concerns were
identified when waste was left in storage longer than anticipated, during any transfers of waste
and information, and for long-term considerations such as disposal.

Requirements Analysis. This requirement implements requirements promulgated since DOE
5820.2A, 6. References, referred to DOE 5700.6B, Quality Assurance. DOE O 200.1,
Information Management Program, and DOE O 414.1, Quality Assurance, were evaluated and
found to provide adequate record keeping controls for radioactive waste management. The
requirement specifically calls out record keeping for the activities of generation, storage,
treatment, transportation, and disposal because some significant consequences were identified if
record keeping was not sufficient, and because poor record keeping practices had already
contributed to known problems in the complex.

Other Considerations. This general requirement contains additional requirements beyond a
reference to another DOE directive or a requirement due to consolidation of some similar
requirements in the individual waste type chapters, and in response to comments on draft
versions of the Manual.

E. Requirements of Other Regulations and DOE Directives.

(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.

Basis:

Functions Evaluated. This requirement derives from the analysis of the Develop the program
functions for low-level waste management.

Safety and Hazard Analyses. The requirement addresses the need to recognize that some low-level waste contains so little radioactivity that it is more appropriate to manage it without regard
for its radioactive content, and still provide adequate protection to the public, workers, and the
environment.

Requirements Analysis. The requirement is a new requirement that further implements policies
established by the Office of Environment and Health for release of property containing residual
radioactive material, including waste. Guidance for the policy, implemented under DOE 5440.5,
entitled Application of DOE 5400.5 Requirements for Release and Control of Property
Containing Residual Radioactive Material, is the source of the requirement statement. The
Order and guidance are considered sufficient to implement a program and process for managing
some radioactive waste without regard to its radioactivity.

Other Considerations. This requirement addresses the upper level criterion of achieving cost-effective operations for radioactive waste management. The final wording of the requirement is
consistent with the policy direction of the Office of Environment and Health.

E. Requirements of Other Regulations and DOE Directives.

(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 materials control and accountability, where applicable; and shall be
consistent with DOE O 470.1, Safeguards and Security Program.

Basis:

Functions Evaluated. This requirement derives from the analysis of the Execute functions for
all three waste types.

Safety and Hazard Analyses. The requirement addresses the need for adequate security and
safeguards of special nuclear material to be implemented and conducted for all radioactive waste
management operations and activities. Weaknesses and conditions associated with lack of or
poor security and safeguards were identified repeatedly in the safety and hazards analysis

Requirements Analysis. Analysis of DOE O 470.1, Safeguards and Security Program,
indicates that the essential requirements necessary for effective deployment of safeguards and
security at DOE radioactive waste management facilities are in that directive. Meeting these
requirements is emphasized by this DOE M 435.1-1 requirement because the weaknesses and
conditions associated with poor or lack of security and safeguards for special nuclear material
were repeatedly identified as potentially contributing to management problems with radioactive
waste.

Other Considerations. None.

E. Requirements of Other Regulations and DOE Directives.

(17) Safety Management System. Radioactive waste management facilities,
operations, and activities shall incorporate the principles of integrated 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.

Basis:

Functions Evaluated. This requirement derives from the analysis of the Evaluate functions for
all three waste types.

Safety and Hazard Analyses. The requirement addresses the need for the Department's
integrated Safety Management System's policies and procedures to be implemented for all
radioactive waste management facilities, operations, and activities. Weaknesses and conditions
associated with lack of or poor oversight and evaluations of radioactive waste management
functions were identified repeatedly in the safety and hazards analysis. The need for systematic
evaluation of radioactive waste management programs, facilities, and operations was identified
during development of the Implementation Plan in response to Defense Nuclear Facilities Safety
Board Recommendation 94-2, and is included as a commitment to the Board in that document.

Requirements Analysis. During the requirements analysis, the Department's integrated Safety
Management System was still in a developmental stage, and the benefits of full implementation
of it were not recognized. Even though some elements of the system were used in the
development of the Order and Manual, the original set of requirements did not include a citation
for radioactive waste management facilities, operations, and activities to follow the Safety
Management System requirements (see Other Considerations). Only a few requirements were
cited in the Manual concerning evaluations of programs, facilities, operations, and activities and
how to utilize the results of evaluations for improvement.

Other Considerations. In response to comments on the draft versions of the Order and Manual
by DOE-EH, the citation for following the Department's integrated Safety Management System
was added. Effective evaluations and oversight of radioactive waste management facilities,
operations, and activities will result from following the Safety Management System Directives.
Improvements from feedback systems, such as internal safety audits, will result from full
implementation of the Safety Management System.

E. Requirements of Other Regulations and DOE Directives.

(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.

Basis:

Functions Evaluated. This requirement derives from the analysis of the Execute function for
constructing new facilities in all three radioactive waste type analyses.

Safety and Hazard Analyses. The requirement addresses the need to provide adequate site
characteristics to the facility design process, and for adequately designing the facility to address
protection of the public, workers, and the environment. The requirement addresses numerous
weaknesses and conditions associated with problems that could potentially develop from poor
design, especially in terms of processing waste in treatment, and in the need for long-term
performance of a disposal facility. The requirement partially addresses some scenarios in the
safety and hazards analyses that have high consequences associated with an accident involving
the facility.

Requirements Analysis. The requirement is essentially equivalent to and updates the references
in DOE 5820.2A, 6. References to DOE 6430.1A, which is canceled. DOE O 420.1, Facility
Safety, and DOE O 430.1A, Life-Cycle Asset Management were evaluated and found to be
mostly adequate in implementing site evaluation and facility design requirements for radioactive
waste management facilities. However, some weaknesses and conditions significant to
management of radioactive waste are not specifically addressed in these two Orders. They are
still invoked because they do address a large number of weaknesses and conditions, and also
establish administrative and program elements that are necessary to control site evaluation and
facility design. To address the specific weaknesses and conditions not addressed in the two
Orders, additional site evaluation and facility design requirements appear in the waste type
chapters where specific waste management situations warrant.

Other Considerations. None.

E. Requirements of Other Regulations and DOE Directives.

(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.

Basis:

Functions Evaluated. This requirement derives from the analysis of the Execute functions for
all three waste types.

Safety and Hazard Analyses. The requirement addresses the need for adequate training and
qualification of personnel to be implemented and conducted for all radioactive waste
management operations and activities important to protection of the public, workers, and the
environment. Weaknesses and conditions associated with lack of or poor training and personnel
qualifications were identified repeatedly in the safety and hazards analysis

Requirements Analysis. Analysis of DOE O 360.1, Training, and DOE 5480.20A, Personnel
Selection, Qualification, and Training Requirements for DOE Nuclear Facilities, indicates that
they provide the essential requirements necessary for effective development of training
procedures and programs and qualification of personnel procedures at DOE radioactive waste
management facilities. Meeting these requirements is emphasized by this DOE M 435.1-1
requirement because the weaknesses and conditions associated with poor or lack of training and
qualification of personnel was repeatedly identified as potentially contributing to management
problems with radioactive waste.

Other Considerations. None.

E. Requirements of Other Regulations and DOE Directives.

(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 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.

Basis:

Functions Evaluated. This requirement derives from the analysis of specific functions
identified in the analysis of all three waste types for minimization of waste generation.

Safety and Hazard Analyses. The safety and hazard analyses identified that waste
minimization, pollution prevention, and where appropriate, volume reduction, were effective
mitigating actions against many of the hazards associated with radioactive waste management.

Requirements Analysis. The requirement is consistent with the policy implemented at DOE
5820.2A, paragraph 5. The existence of several executive level positions that are called out in
the requirement provided the necessary controls that were needed to flow down to appropriate
waste minimization techniques at the actual activity level, and were found to be sufficient.

Other Considerations. Implementation of waste minimization and pollution prevention was
one of the top-level principles formulating the basic requirements for the Order and Manual.

E. Requirements of Other Regulations and DOE Directives.

(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.

Basis:

Functions Evaluated. This requirement derives from the analysis of all of the Execute functions
for all three radioactive waste types.

Safety and Hazard Analyses. The requirement addresses the need to provide the protection of
the workers from radioactive waste management operations and activities that involve hazards
not solely associated with the radioactive characteristic of material being used, but which are
required to be conducted. Because of the need to provide protection from the radioactive hazard,
workers may be subjected to other hazards, such as working in confined spaces, or with complex
machinery, that involve their own hazards for which workers must be protected.

Requirements Analysis. The requirement is consistent with the Policy of DOE 5820.2A
contained in that Order at paragraph 5. for protecting workers. DOE O 440.1A, Worker
Protection Management for DOE Federal and Contractor Employees is the Departmental
directive that provides the basic protection requirements for workers. This requirement
implements the top-level requirement of the Department for providing controls on the
management of radioactive waste, and also implements in the Manual, the requirements of DOE
O 435.1, O.4 Requirements, paragraph (3), Protect the work force.

Other Considerations. None.

2. RESPONSIBILITIES

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.

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.

(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.

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.

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.

(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.

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.

(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.

Basis:

Functions Evaluated. Generally the Responsibilities do not derive from the analysis of
radioactive waste management functions. The specific responsibilities reflected in the above
requirements are derived from the analysis of the top-level functions of Develop, Execute, and
Evaluate the Program evaluated for all three radioactive waste management types.

Safety and Hazard Analyses. Generally, the Responsibilities do not derive from the safety and
hazards analyses of radioactive waste management. These requirements address the Low-Level
Waste Complex-Wide Review Vulnerabilities on Waste Forecasting, Disposal Facility Capacity,
and Approval of Radiological Performance Assessments for low-level waste disposal facilities.
The responsibility concerning changes to regulations did derive from the safety and hazards
analyses. Existing regulations and directives were found to provide controls which mitigated
weakness and conditions identified during the safety and hazards analysis, so any changes in
these existing regulations need to be analyzed for their impact on the safety of radioactive waste
management activities.

Requirements Analysis. These requirements are essentially equivalent to the assignments of
Responsibilities in DOE 5820.2A. The specific responsibilities reflect updates to the
responsibilities in DOE 5820.2A to reflect the current organizations, revisions to remove any
responsibility discussions of organizations that do not implement any essential radioactive waste
management functions or requirements, the implementation of the principle of a radioactive
waste management basis for operating a facility, and the implementation of the majority of
radioactive waste management functions integral to protecting the public, the workers, and the
environment by DOE field operations. Commitments made in response to Defense Nuclear
Facilities Safety Board Recommendation 94-2 provide the basis for the review and approval of
performance assessments and composite analyses, and the issuance of a disposal authorization
statement (see Other Considerations). The low-level waste chapter technical basis contains
additional discussions about these requirements.

Other Considerations. The final wording and the elements that appear in the Responsibilities
section result from achieving consistency between waste type chapters and from responses to
comments on the draft versions of the Manual. The specific discussions on the review panel for
low-level waste disposal facilities' performance assessments and composite analyses are
included in response to comments made by the Defense Nuclear Facilities Safety Board so that
DOE M 435.1-1 would be consistent with commitments made and review methods implemented
in response to Recommendation
94-2.

2. RESPONSIBILITIES

F. Field Element Managers. Field Element Managers are responsible for:

(1) Site-Wide Radioactive Waste Management Programs. Developing,
documenting, implementing, and maintaining a Site-Wide Radioactive
Waste Management Program. The Program shall use a systematic
approach for planning, executing, and evaluating the site-wide
management of radioactive waste in a manner that supports the
Complex-Wide Radioactive Waste Management Programs and ensures
that the requirements of DOE O 435.1, Radioactive Waste Management,
and this Manual are met.

(2) Radioactive Waste Management Basis. Ensuring a radioactive waste
management basis is developed and maintained for each DOE
radioactive waste management facility, operation, and activity; and
ensuring review and approval of the basis before operations begin. The
Radioactive Waste Management Basis shall:

(a) Reference or define the conditions under which the facility may
operate based on the radioactive waste management
documentation;

(b) Include the applicable elements identified in the specific waste-type
chapters of this Manual; and

(3) Waste Minimization and Pollution Prevention. Ensuring
implementation of waste minimization and pollution prevention
programs.

(4) Approval of Exemptions for Use of Non-DOE Facilities. DOE
radioactive waste shall be treated, stored, and in the case of low-level
waste, disposed of at the site where the waste is generated, if practical; or
at another DOE facility. If DOE capabilities are not practical or cost
effective, exemptions may be approved to allow use of non-DOE facilities
for the storage, treatment, or disposal of DOE radioactive waste based
on the following requirements:

(a) Such non-DOE facilities shall:

1. Comply with applicable Federal, State, and local
requirements;

2. Have the necessary permit(s), license(s), and approval(s) for
the specific waste(s); and

3. Be determined by the Field Element Manager to be
acceptable based on a review conducted annually by DOE.

(b) Exemptions for the use of non-DOE facilities shall be documented
to be cost effective and in the best interest of DOE, including
consideration of alternatives for on-site disposal, an alternative
DOE site, and available non-DOE facilities; consideration of life-cycle cost and potential liability; and protection of public health
and the environment.

(d) Appropriate National Environmental Policy Act (NEPA) review
must be completed. For actions taken under the Comprehensive
Environmental Response, Compensation, and Liability Act
(CERCLA), it is DOE's policy to incorporate NEPA values into the
CERCLA documentation.

(e) Headquarters shall be notified of any exemption allowing use of a
non-DOE facility and the Office of the Assistant Secretary for
Environment, Safety and Health (EH-1) shall be consulted prior to
the exemption being executed.

(f) Host States and State Compacts where non-DOE facilities are
located shall be consulted prior to approval of an exemption to use
such facilities and notified prior to shipments being made.

(5) Environmental Restoration, Decommissioning, and Other Cleanup
Waste. Ensuring the management and disposal of radioactive waste
resulting from environmental restoration activities, including
decommissioning, meet the substantive requirements of DOE O 435.1,
Radioactive Waste Management, and this Manual. Environmental
restoration activities using the CERCLA process (in accordance with
Executive Order 12580) may demonstrate compliance with the
substantive requirements of DOE O 435.1, Radioactive Waste
Management, and this Manual (including the Performance Assessment
and performance objectives, as well as the Composite Analysis) through
the CERCLA process. However, compliance with all substantive
requirements of DOE O 435.1 not met through the CERCLA process
must be demonstrated. Environmental restoration activities which will
result in the off-site management and disposal of radioactive waste must
meet the applicable requirements of DOE O 435.1, Radioactive Waste
Management, and this Manual for the management and disposal of those
off-site wastes. Field Elements performing environmental restoration
activities involving development and management of radioactive waste
disposal facilities under the CERCLA process shall:

(a) Submit certification to the Deputy Assistant Secretary for
Environmental Restoration that compliance with the substantive
requirements of DOE O 435.1 have been met through application
of the CERCLA process; and

(b) Submit the decision document, such as the Record of Decision, or
any other document that serves as the authorization to dispose, to
the Deputy Assistant Secretary for Environmental Restoration for
approval.

(6) Radioactive Waste Acceptance Requirements. Ensuring development,
review, approval, and implementation of the radioactive waste
acceptance requirements for facilities that receive waste for storage,
treatment, or disposal. Radioactive waste acceptance requirements shall
establish the facility's requirements for the receipt, evaluation, and
acceptance of waste.

(7) Radioactive Waste Generator Requirements. Ensuring development,
review, approval, and implementation of a program for waste generation
planning, characterization, certification, and transfer. This program
shall address characterization of waste, preparation of waste for
transfer, certification that waste meets the receiving facility's radioactive
waste acceptance requirements, and transfer of waste.

(8) Closure Plans. Ensuring development, review, approval, and
implementation of closure plans for radioactive waste management
facilities in accordance with the applicable requirements in the waste-type chapters of this Manual.

(9) Defense-In-Depth. Ensuring defense-in-depth principles are
incorporated where potential uncertainties or vulnerabilities warrant
their use when reviewing and approving radioactive waste management
activities and documents. These principles advocate the use of multiple
levels of engineered and administrative controls to provide protection to
the public, workers, and the environment.

(10) Oversight. Ensuring oversight of radioactive waste management
facilities, operations, and activities is conducted. Oversight shall ensure
radioactive waste management program activities are conducted in
accordance with a radioactive waste management basis and meet the
requirements of DOE O 435.1, Radioactive Waste Management, and this
Manual.

(11) Training and Qualification. Ensuring a training and qualification
program is implemented for designated radioactive waste management
program personnel, and the training is commensurate with job duties
and responsibilities. Only those personnel who have been trained and
qualified shall design or operate safety (safety class and safety
significant) structures, systems, and components.

(12) As Low As Reasonably Achievable (ALARA). Ensuring ALARA
principles for radiation protection are incorporated when reviewing and
approving radioactive waste management activities.

(13) Storage. Ensuring all radioactive waste is stored in a manner that
protects the public, workers, and the environment in accordance with a
radioactive waste management basis, and that the integrity of waste
storage is maintained for the expected time of storage and does not
compromise meeting the disposal performance objectives for protection
of the public and environment when the waste is disposed.

(14) Treatment. Ensuring all radioactive waste requiring treatment is
treated in a manner that protects the public, workers, and the
environment and in accordance with a radioactive waste management
basis.

(15) Disposal. Ensuring radioactive waste is disposed in a manner that
protects the public, workers, and the environment and in accordance
with a radioactive waste management basis. Reviewing specific
transuranic or low-level waste documentation including the performance
assessment and composite analysis, or appropriate CERCLA
documentation, prior to forwarding them to Headquarters for approval,
and obtaining and ensuring the facility is operated in accordance with
the disposal authorization statement. Conducting performance
assessment and composite analysis maintenance.

(16) Monitoring. Ensuring monitoring is conducted for all radioactive waste
management facilities as required. Ensuring that disposal facilities are
monitored, as appropriate, for compliance with conditions of the
disposal authorization statement.

(17) Material and Waste Declassification and Waste Management. Ensuring,
to the extent practical, radioactive material and waste generated under a
program that is classified for national security reasons is declassified or
rendered suitable for unclassified radioactive waste management.

(18) Waste Incidental to Reprocessing. Ensuring that waste incidental to
reprocessing determinations are made by either the "citation" or
"evaluation" process described in Chapter II of this Manual. Ensuring
consultation and coordination with the Office of Environmental
Management for waste determined to be incidental to reprocessing
through the "evaluation" process.

(19) Waste With No Identified Path to Disposal. Ensuring a process is
developed and implemented for identifying the generation of radioactive
waste with no identified path to disposal, and reviewing and approving
conditions under which radioactive waste with no identified path to
disposal may be generated. Headquarters shall be notified of the
decisions to generate a waste with no identified path to disposal.

(20) Corrective Actions. Ensuring a process exists for proposing,
reviewing, approving, and implementing corrective actions when
necessary to ensure that the requirements of DOE O 435.1, Radioactive
Waste Management, and this Manual are met, and to address
conditions that are not protective of the public, workers, or the
environment. The process shall allow workers, through the
appropriate level of management, to stop or curtail work when they
discover conditions that pose an imminent danger or other serious
hazard to workers or the public, or are not protective of the
environment.

Basis:

Functions Evaluated. Generally the Responsibilities for the Field Element Manager do not
derive from the analysis of any specific radioactive waste management functions. However, the
specific responsibility of the Field Element Manager to develop and implement a site-wide
radioactive waste management program is derived from the analysis of the top-level functions of
Develop, Execute, and Evaluate the Program evaluated for all three radioactive waste
management types.

Safety and Hazard Analyses. Generally, the Responsibilities do not derive from the safety and
hazards analyses of radioactive waste management. These requirements do address the
Complex-Wide Review Vulnerabilities on Waste Forecasting, Disposal Facility Capacity,
Storage of Low-Level Waste, Waste Characterization, and No Path Forward Waste.

Requirements Analysis. These requirements are basically equivalent to the assignment of
Responsibilities in DOE 5820.2A to the heads of field organizations. These specific
responsibilities reflect updates to the responsibilities in DOE 5820.2A to reflect the current
facilities, functions, operations, organizations, and activities associated with radioactive waste
management, the implementation of the principle of a radioactive waste management basis for
operating a facility, and the implementation of the majority of radioactive waste management
functions integral to protecting the public, the workers, and the environment by DOE field
operations. Commitments made in response to Defense Nuclear Facilities Safety Board
Recommendation 94-2 provide the basis for several specific Field Element Manager
responsibilities. The language for some of these is derived from the DNFSB 94-2 deliverable,
"Revised Interim Policy on Regulatory Structure for Low-Level Radioactive Waste Management
and Disposal," (letter from A. Alm, July 31, 1996), and the DNFSB 94-2 deliverable, "Guidance
for Complying with DOE 5820.2A, Radioactive Waste Management, for Onsite Management
and Disposal of Low-Level Waste (LLW) Resulting from Environmental Restoration Activities."
Language for the use of non-DOE facilities requirement is derived from, "Delegation of
Authority to Grant Exemptions to Department of Energy Order 5820.2A to Allow for the Use of
Commercial Facilities for Disposal of Department of Energy Low-Level Waste."

Other Considerations. Implementation of waste minimization and pollution preventi