DOE G 450.1-2, Implementation Guide for Integrating Environmental Management Systems into Integrated Safety Management Systems

AVAILABLE ONLINE AT: INITIATED BY: http://www.directives.doe.gov Office of Environment, Safety and Health DOE G 450.1-2 8-20-04 Implementation Guide for Integrating Environmental Management Systems into Integrated Safety Management Systems [This Guide describes suggested nonmandatory approaches for meeting requirements. Guides are not requirements documents and are not to be construed as requirements in any audit or appraisal for compliance with the parent Policy, Order, Notice, or Manual.] U.S. Department of Energy Washington, D.C. 20585 NOT MEASUREMENT SENSITIVE DOE G 450.1-2 i (and ii) 8-20-04 Preface PREFACE DOE G 450.1-2, Implementation Guide for Integrating Environmental Management Systems into Integrated Safety Management Systems, is the second guidance document in a series of Guides issued to provide suggested approaches for meeting the requirements of DOE O 450.1. DOE O 450.1 requires DOE elements to establish an Environmental Management System (EMS) that is integrated into DOE’s Integrated Safety Management System (ISMS). DOE G 450.1-1, Implementation Guide for Use with DOE O 450.1, Environmental Protection Program, which was issued February 18, 2004, provides an overview of the integration process. DOE G 450.1-2 provides detailed guidance relating to integrating EMSs into a site’s ISMS. DOE G 450.1-2 iii 8-20-04 Contents CONTENTS ACRONYMS AND ABBREVIATIONS ...................................................................................... ix INTRODUCTION .......................................................................................................................... 1 Purpose ...................................................................................................................................... 1 Applicability and Scope ............................................................................................................ 1 Use of Guidance ........................................................................................................................ 1 Overview ................................................................................................................................... 1 CHAPTER I. PHASE I—PLANNING AND ASPECTS IDENTIFICATION Step 1 Identifying Environmental Aspects ................................................................................. I-1 1.1 TASK 1: Identify and List the Organization’s Activities, Products, and Services and Their Interactions With the Environment (Environmental Aspects) ........................................................................................................................... I-1 1.1.1 Starting Task 1 ................................................................................................................. I-2 1.1.2 Environmental Aspects Identification ............................................................................. I-2 1.1.3 Approaches for Identifying Activities, Products, and Services and their Interactions with the Environment .................................................................................. I-3 1.2 TASK 2: Identify How Each Environmental Aspect Impacts the Environment .................................................................................................................... I-5

1.2.1 Understanding the Aspect Impact Analysis .................................................................... I-5 1.2.2 Approach to Characterizing Environmental Impacts ...................................................... I-7 1.2.3 Documenting Positive Impacts ........................................................................................ I-7 Step 2 Determining Significant Aspects ..................................................................................... I-9 2.1 TASK 3: Identify All Environmental Aspects That Are Regulated, Have Regulatory Implications, or Are Required by DOE Directive ........................................ I-9 2.1.1 Identifying Environmental Aspects with Regulatory Consequences ............................ I-10 2.1.2 Specific Environmental Interactions ............................................................................. I-13 2.1.3 Pollution Prevention ..................................................................................................... I-13 2.1.4 Clean Air Act General Conformity ............................................................................... I-14 2.1.5 Watershed Approach for Surface-Water Protection ...................................................... I-15 2.1.6 Site-Wide Approach for Ground Water Protection ....................................................... I-15 2.1.7 Natural Resources—Biota ............................................................................................. I-16 2.1.8 Wildland Fire Management Program ............................................................................ I-18 2.1.9 Cultural Resources Management Program .................................................................... I-18 2.1.10 Long-Term Stewardship Program ................................................................................. I-18 2.1.11 Preoperational Characterization and Assessment and Effluent and Surveillance Monitoring ................................................................................................ I-19 2.1.12 Environmental Quality Systems .................................................................................... I-21 iv DOE G 450.1-2 8-20-04 Contents CONTENTS (continued) 2.2 TASK 4: Determine Significance Based on Environmental and Organizational Consideration ........................................................................................ I-22 2.2.1 “Significance” in the NEPA and ISMS/EMS Context .................................................. I-23 2.2.2 Criteria for Scoring Likelihood of Occurrence ............................................................. I-23 2.2.3 Criteria for Scoring Environmental Consequences of Impacts ..................................... I-24 2.2.4 Criteria for Scoring Mission Consequences .................................................................. I-25 2.2.5 Determination of Overall Impact Score ........................................................................ I-25 Step 3 Setting Objectives and Targets ...................................................................................... I-29 3.1 TASK 5: Develop Objectives and Targets To Address Significant Aspects .......................................................................................................................... I-29 3.1.1 Defining Objectives and Targets ................................................................................... I-30 3.1.2 Approach to Setting Objectives and Targets ................................................................. I-31

3.2 TASK 6: Formalize Environmental Objectives and Targets And Develop The Environmental Management Plan .......................................................................... I-32 CHAPTER II. PHASE II—IMPLEMENTATION AND OPERATION Step 4 Integrated Safety Management System/Environmental Management System Documentation ...............................................................................................................II-1 4.1 TASK 7: Updating the Integrated Safety Management System/Environmental Management System Description .............................................II-1 4.1.1 Background.....................................................................................................................II-2 4.1.2 Documenting Environmental Management System Elements .......................................II-2 4.2 TASK 8: Developing an Environmental Management System Roadmap ....................II-2 4.2.1 Background.....................................................................................................................II-2 4.2.2 EMS Roadmap Template ...............................................................................................II-3 Step 5 Developing Environmental Management Programs ......................................................II-3 5.1 TASK 9: Create Environmental Management Programs ..............................................II-3 5.1.1 Create Environmental Management Programs ...............................................................II-4 5.2 TASK 10: Document Environmental Management Programs ......................................II-5 5.3 TASK 11: Approve the Environmental Management Programs ...................................II-5 5.3.1 Review and Approval .....................................................................................................II-6 5.3.2 Placement of Completed Environmental Management Program Documents ......................................................................................................................II-6 DOE G 450.1-2 v 8-20-04 Contents CONTENTS (continued) Step 6 Developing Operational Controls ...................................................................................II-6 6.1 TASK 12: Specify Operational Controls .......................................................................II-6 6.1.1 Specifying Operational Controls ....................................................................................II-7 6.2 TASK 13: Approve Operational Controls .....................................................................II-8 6.2.1 Review and Approval .....................................................................................................II-8 6.2.2 Placement of Completed Operational Controls ..............................................................II-8 Step 7 Develop Integrated Safety Management System/Environmental Management System Procedures .........................................................................................................II-9 7.1 TASK 14: Establish Integrated Safety Management System/ Environmental Management System Procedures ...........................................................II-9 7.1.1 Integrated Safety Management System/Environmental Management System Procedures........................................................................................................II-11

7.1.2 The Role of Integrated Safety Management System/Environmental Management System Procedures ..................................................................................II-11 7.1.3 Keeping Procedures Simple .........................................................................................II-11 7.2 TASK 15: Documenting Integrated Safety Management System/Environmental Management System Procedures ............................................II-11 7.2.1 Integrated Safety Management System /Environmental Management System Procedures........................................................................................................II-11 7.2.2 Implementing Integrated Safety Management System/Environmental Management System Procedures .................................................................................II-12 7.3 TASK 16: Approve Integrated Safety Management System/ Environmental Management System Procedures .........................................................II-12 7.3.1 Review and Approval ...................................................................................................II-13 7.4 TASK 17: Implement Integrated Safety Management System/ Environmental Management System Procedures .........................................................II-13 7.4.1 Background...................................................................................................................II-13 7.4.2 Training ........................................................................................................................II-13 7.4.3 Responsibility for Maintaining Records .......................................................................II-14 7.4.4 Maintaining Procedures ................................................................................................II-14 7.4.5 Accessibility .................................................................................................................II-14 CHAPTER III. PHASE III—CHECKING AND CORRECTIVE ACTION Step 8 Establish the ISMS/EMS Assessment Program ........................................................... III-1 8.1 TASK 18: Establish the ISMS/EMS Assessment Program ......................................... III-1 vi DOE G 450.1-2 8-20-04 Contents CONTENTS (continued) 8.1.1 Background and Purpose .............................................................................................. III-2 8.1.2 The Assessment Program ............................................................................................. III-2 8.1.3 Assessment Concepts ................................................................................................... III-3 8.2 TASK 19: Plan the Assessment ................................................................................... III-6 8.2.1 Basic Principles ............................................................................................................ III-6 8.2.2 Conducting the Assessment .......................................................................................... III-7 8.3 TASK 20: Conduct On-Site Assessment Activities .................................................... III-7 CHAPTER IV. PHASE IV—MANAGEMENT REVIEW AND SYSTEM MAINTENANCE Step 9 Develop the Management Review Process .................................................................. IV-1 9.1 TASK 21: Prepare for the Management Review ......................................................... IV-1

9.1.1 Background................................................................................................................... IV-2 9.1.2 Importance of Senior Management Involvement in the Management Review .......................................................................................................................... IV-3 9.1.3 Coordinating the Management Review ........................................................................ IV-3 9.1.4 Management Review Participants ................................................................................ IV-3 9.2 TASK 22: Conduct the Management Review ............................................................. IV-4 9.2.1 Background................................................................................................................... IV-4 9.2.2 Decisions Made in the Management Review ............................................................... IV-5 9.2.3 Documenting the Management Review ....................................................................... IV-6 9.2.4 Followup to the Management Review .......................................................................... IV-7 Step 10 Develop a Plan to Keep the ISMS/EMS Updated ........................................................ IV-7 10.1 TASK 23: Keeping the ISMS/EMS Updated .............................................................. IV-8 10.1.1 Background................................................................................................................... IV-8 10.1.2 Environmental Aspects ................................................................................................. IV-8 10.1.3 Legal and Other Requirements ..................................................................................... IV-9 10.1.4 Objectives and Targets ................................................................................................. IV-9 10.1.5 Environmental Management Programs ........................................................................ IV-9 10.1.6 Training ...................................................................................................................... IV-10 10.1.7 Operational Controls .................................................................................................. IV-10 10.1.8 Resources for the Environmental Management System ............................................. IV-10 10.1.9 Occurrence Identification and Corrective Actions ..................................................... IV-10 10.1.10 Developing a Formal Maintenance Schedule ............................................................. IV-11 DOE G 450.1-2 vii (and viii) 8-20-04 Contents APPENDIXES A. ADDITIONAL GUIDANCE DOCUMENTS B. EMS ROADMAP TEMPLATES C. ASSESSMENTS D. GLOSSARY E. REFERENCES TABLES 1. Example of Listing Environmental Aspects and Activities/ Products/Services ................................................................................................................. I-6 2. Example of Listing Environmental Impacts ........................................................................ I-8 3. Regulatory and Other Requirements Related to Environmental Aspects .......................... I-11 4. Assigning a Regulatory Score to Aspects .......................................................................... I-12 5. Sample Criteria for Scoring the Likelihood of Occurrence ............................................... I-24 6. Sample Criteria for Scoring Environmental Consequences on DOE Sites ........................ I-26 7. Sample Criteria for Scoring Mission Consequences for DOE Sites .................................. I-26 8. Determination of Significance Based on Environmental and

Organizational Considerations ........................................................................................... I-28 8a. Rank of Overall Significance Based on Environmental and Organizational Considerations ........................................................................................... I-29 9. Overview of Objectives, Targets, Required Resources, and Management Approval Status.................................................................................................................. I-33 10. Sample Portion of the Assessment Questionnaire .......................................................... III-14 11. Sample ISMS/EMS Corrective Action Report Template ............................................... III-16 12. Example. Suggested Schedule for Maintaining and Updating Required and Important Selected Elements of the ISMS/EMS...................................................... IV-12 FIGURES 1. Sample assessment program ............................................................................................. III-4 2. ISMS/EMS assessment process flow chart ....................................................................... III-9 3. Identifying legal and other requirements and new activities, products, and services that are incorporated into the ISMS/EMS .................................................. IV-13 DOE G 450.1-2 ix (and x) 8-20-04 Acronyms and Abbreviations ACRONYMS AND ABBREVIATIONS ANSI American National Standards Institute ASER Annual Site Environmental Reports ASQ American Society of Quality CAR Corrective Action Report CCE continuing core expectation CERCLA Comprehensive Environmental Response, Compensation, and Liability Act CRD Contractor Requirements Document CRMP Cultural Resources Management Plan D & D decontamination and decommissioning DOE U.S. Department of Energy EIS Environmental Impact Statement EMP environmental management program EPA U.S. Environmental Protection Agency EMS Environmental Management System ES&H Environment, Safety and Health ISMS Integrated Safety Management System ISO International Standards Organization LTS long-term stewardship MSDS material safety data sheets NAAQS national ambient air quality standards NEPA National Environmental Policy Act NNSA National Nuclear Security Administration ODS ozone-depleting substance QA quality assurance QC quality control QMP Quality Management Plan QS Quality System UFP-QAPP Uniform Federal Policy for Quality Assurance Project Plan UFP-QS Uniform Federal Policy for Implementing Environmental Quality Systems UST underground storage tank DOE G 450.1-2 1 8-20-04 Introduction INTRODUCTION Purpose This document provides discretionary guidance for implementing the requirements of Department of Energy (DOE) Order (O) 450.1, Environmental Protection Program, dated 1-15-03. DOE O 450.1 requires implementation of sound stewardship practices that are protective of the air, water, land, cultural and ecological resources impacted by DOE operations, and by which DOE meets or exceeds compliance with applicable environmental, public health and resource protection laws, regulations and DOE requirements in a cost-effective way. This objective is to be accomplished by implementing Environmental Management Systems (EMSs) as part of existing Integrated Safety Management Systems (ISMSs) established pursuant to DOE P 450.4, Safety Management System Policy, dated 10-25-96, at DOE facilities. This Guide provides suggested approaches for meeting the requirements of DOE O 450.1.

Applicability and Scope This Guide is for use by all DOE elements, including the National Nuclear Security Administration (NNSA) and contractors required to implement DOE O 450.1. Use of Guidance DOE Guides are not requirements documents and may not be construed as requirements in any audit or assessment of compliance with the associated Policy, Order, Notice, or Manual. The information in this Guide will be useful for the implementation of DOE O 450.1. This Guide provides information on acceptable methods and alternatives for meeting the requirements of DOE O 450.1. Overview DOE O 450.1 requires DOE elements to establish an EMS that is integrated into a DOE site’s ISMS. The integration of an EMS into an ISMS (hereinafter referred to as ISMS/EMS) provides a unified strategy for the management of resources; the control and attenuation of risks; and the establishment and achievement of the organization’s environment, safety and health goals. The ISMS/EMS should be viewed as an enhancement of ISMS that adds those EMS elements not previously included in the ISMS. The guidance contained in this document recognizes that many DOE sites have already implemented ISMSs and should, therefore, have most if not all of the elements of an EMS already in place. This document focuses on providing guidance to assist DOE sites in identifying those missing EMS elements and integrating them into the site’s ISMS. This Guide is organized around the following four phases of establishing an EMS:  Phase I, Planning and Aspects Identification;  Phase II, Implementation and Operation;  Phase III, Checking and Corrective Action; and  Phase IV, Management Review and System Maintenance. 2 DOE G 450.1-2 8-20-04 Introduction Chapter I, Phase I, Planning and Aspects Identification, provides guidance on how to identify environmental aspects associated with site activities, products and services, and determine the significance of impacts associated with these aspects. Chapter II, Phase II, Implementation and Operation, provides guidance on how to document an EMS through the use of the site’s ISMS description. Chapter II also provides guidance on how to develop or modify existing environmental management programs and how to develop operational controls and procedures. Chapter III, Phase III, Checking and Corrective Action, provides guidance on conducting an internal assessment program. Chapter IV, Phase IV, Management Review and System Maintenance, provides guidance on conducting a management review and ensuring that the ISMS/EMS remains current. The following matrix is a roadmap to the entire ISMS/EMS integration process. D O E G 450.1-2 3 (and 4) 8-20-04 Introduction PHASE STEP TASK I. Planning and Aspects Identification 1. Identifying Environmental Aspects 1. Identify and List the Organization’s Activities, Products & Services and Their Interactions With the Environment (environmental aspects). 2. Identify How Each Environmental Aspect Impacts the Environment 2. Determining Significant Aspects 3.Identify Environmental Aspects that are regulated, have regulatory implications, or are required by DOE directive 4. Determine Significance Based On Environmental and Organizational Considerations 3. Setting objectives and targets 5. Develop objectives and targets to address significant aspects 6. Formalize Environmental Objectives and Targets II. Implementation and Operation 4. Integrated Safety Management System/Environmental Management System Documentation

7. Update the Integrated Safety Management System/Environmental Management System Description 8. Develop an Environmental Management System Roadmap 5. Developing Environmental Management Programs 9. Create Environmental Management Programs 10.Document Environmental Management Programs 11.Approve Environmental Management Programs 6. Developing Operational Controls 12. Specify Operational Controls 13. Approve Operational Controls 7. Develop Integrated Safety Management System/Environmental Management System Procedures 14. Establish Integrated Safety Management System/Environmental Management System Procedures 15. Document Integrated Safety Management System/Environmental Management System Procedures 16. Approve Integrated Safety Management System/Environmental Management System Procedures 17. Implement Integrated Safety Management System/Environmental Management System Procedures III. Checking and Corrective Action 8. Establish the ISMS/EMS Assessment Program 9. Develop the Management Review Process 18. Establish the ISMS/EMS Assessment Program 19. Plan the Assessment 20. Conduct On-Site Assessment Activities 21. Prepare for the Management Review 22. Conduct the Management Review IV. Management Review and System Maintenance 10. Develop a Plan to Keep the ISMS/EMS Updated 23. Keep the ISMS/EMS Updated CHAPTER I. PHASE I—PLANNING AND ASPECTS IDENTIFICATION DOE G 450.1-2 I-1 8-20-04 Phase I Step 1 Identifying Environmental Aspects Step 1 Step 2 Step 3 Step 4 Step 5 Step 6 Step 7 Step 8 Step 9 Step10 Phase I Phase II Phase III Phase IV Your current loc ation on the ISMS/EMS Integration Road Map You are here 1.1 TASK 1: IDENTIFY AND LIST THE ORGANIZATION’S ACTIVITIES, PRODUCTS, AND SERVICES AND THEIR INTERACTIONS WITH THE ENVIRONMENT (ENVIRONMENTAL ASPECTS) References This task fulfills DOE Order requirements listed below.  The ISMS/EMS includes policies [and] procedures to identify activities with significant environmental impacts [DOE O 450.1 §4.a. (2)].  The ISMS/EMS provides for the systematic planning of programs for public health and environmental protection [DOE O 450.1 §4.a. (1) (a)].  The ISMS/EMS provides for the systematic planning of programs for pollution prevention [DOE O 450.1 §4.a. (1) (b)]. The provisions in this task relate to established requirements of the following ISMS element.  ISMS Core Function 2, “Analyze the Hazards: Hazards associated with the work are identified, analyzed and categorized.” Task 1. Identify and list the organization’s activities, products, and services and their interactions with the environment (environmental aspects). Task 2. Identify how each environmental aspect impacts the environment. I-2 DOE G 450.1-2 8-20-04 Phase I 1.1.1 Starting Task 1 The first step in developing the ISMS/EMS is to identify how the organization might impact the environment. In EMS terms, this is known as identifying the environmental aspects of an organization’s existing, as well as new or proposed activities, products, and services. These cover all the possibilities for an organization to influence the environment, both positive and negative. Several approaches may be used to identify environmental aspects are described below. To understand these approaches, individuals must first have a working knowledge of the terms activities, products, and services and environmental aspects and know how they relate to a DOE site. Activities

Activities offer the greatest possibilities for DOE sites to influence the environment. Activities may include those that generate waste (radioactive, hazardous, solid waste), such as construction of waste management units or equipment maintenance, or general administrative activities that use resources, including energy, paper, water, or natural resources. Products DOE sites do not, on the whole, make products in the conventional manufacturing sense. The aspects identification methodology will, therefore, place greater emphasis on activities and services typically associated with DOE operations. However, policies and/or procedural documents may have tangible environmental implications when sites implement them. For example, the institutional control policy (DOE P 454.1, Use of Institutional Controls) provides a mechanism designed to appropriately limit access to or uses of land, facilities and other real and personal properties to protect cultural and natural resources, which can have tangible environmental implications when put into practice. These policies/procedures may therefore be considered products by organizations that are determining their impacts on the environment. Services DOE sites may include several organizations that provide services to other site operations. For example, services may include waste treatment, waste pickup, and technical support services. These services should be considered when determining how a site interacts with the environment. 1.1.2 Environmental Aspects Identification Environmental aspects are the attributes of a site’s activities, products, and services that can interact with the environment. In other words, in most cases, an environmental aspect signifies the possibility of an environmental impact, whether good or bad. It is recognized that sites within the DOE complex have differences that determine how they would approach environmental aspects identification. The process of identifying activities, products, and services may be accomplished using a variety of techniques. For example, DOE sites that have implemented ISMS/EMSs have already identified their various activities, products, and services. In small organizations, individuals may be able to name all of the activities, products, and services at the site. This is unlikely to be the case at the larger DOE DOE G 450.1-2 I-3 8-20-04 Phase I sites, given their size and complexity. Large DOE sites should conduct the analysis at the lowest work activity level and then consolidate the data into the site-wide analysis. A site conducting near term closure activities may have most of the elements of the ISMS/EMS available or completed. For example, identification of significant environmental aspects and impacts may have been identified in the Remedial Investigation/Feasibility Study (RI/FS) process under CERCLA. Environmental Impact Statements conducted pursuant to the National Environmental Policy Act (NEPA) may also yield important information. Sites in the near term closure phase should consider how well environment was integrated in their existing ISMS and use a graded approach to supplement their existing ISMS. Section 1.1.3 contains some commonly used approaches to identify activities, products, and services within an organizational unit.

When starting the environmental aspects identification, it is important to note that many parallels exist between safety management and environmental management. For example, using a ladder in the workplace could result in a worker injury. Therefore, a possible fall is the safety hazard of a ladder in the workplace in the same way that a possible spill is an environmental aspect of waste transportation. In other words, in most cases, an environmental aspect is the equivalent of a safety hazard. 1.1.3 Approaches for Identifying Activities, Products, and Services and their Interactions with the Environment This guidance describes three approaches that may be used to identify activities, products, and services and can also be used to identify the environmental aspects. In some cases, it may be possible to identify activities, products, and services and their associated environmental aspects at the same time to avoid duplication and increase efficiency. In other cases, it is necessary to first identify all of the activities, products, and services, and then determine what the environmental aspects are. The three approaches are—  brainstorming,  physical walk-through, and  employee input. Approach 1––Brainstorming The site ISMS/EMS team (see Section 7 of DOE G 450.1-1 for a discussion of how to establish a site ISMS/EMS team) and other individuals with relevant knowledge participate in a brainstorming session. Brainstorming is extremely effective when participants have a detailed understanding of the site’s activities, products, and services and their environmental aspects. Typically an organization assembles an ISMS/EMS team at the site. This group meets and lists all the activities products and services that occur on the site. In many cases, brainstorming can be supplemented and structured by using site documents and records to direct the group. Common examples are regulatory documents, National Environmental Policy Act (NEPA) documents, compliance agreements, and the Annual Site Environmental Reports (ASERs). Brainstorming may be inadequate by itself, so sites can use additional approaches, such as the physical walk-through and employee input for further exploration. I-4 DOE G 450.1-2 8-20-04 Phase I Approach 2––Physical Walk-Through This technique involves an actual walk-through of all areas and functions of the organization. Seeing these different areas and operations serves as a visual trigger to identify possible interactions with the environment. It is most effective to have the ISMS/EMS team conduct the walk-through of all areas and operations of the site to ensure that the analysis includes all possible sources. The team should have a detailed understanding of the activities and operations in a particular location. It should also be familiar with the potential environmental issues of various operations and activities. It may be useful to provide a checklist of potential environmental aspects that may prompt the ISMS/EMS team to recognize such aspects. The Team can develop these types of checklists in a brainstorming exercise, like that described above. The walk-through should ensure the inspection and consideration of all areas and operations. This effort requires sufficient time for the completion of a thorough survey of the entire site. The team should consider if there are areas on-site considered “sensitive” or that may have classified operations. The checklist developed to identify potential environmental aspects should follow all applicable DOE directives and policies re: sensitive or classified areas.

Approach 3––Employee Input No other individuals are likely to be as familiar with a particular area of the site as the employees who work there. It can be particularly useful, therefore, to engage employees in the process of identifying activities, products, and services that could result in an environmental aspect. An added benefit of soliciting employee input is that it begins the process of raising employee awareness, involvement, and eventually ownership of practices that avoid waste and environmental degradation. To be useful, employee input needs to be structured, thus enabling its proper evaluation. A questionnaire or survey instrument can be an effective tool for capturing employee input. Following are examples of appropriate questions to ask on a questionnaire.  Do activities in your work area—  use chemicals, radiological sources, or other hazardous substances?  use appreciable amounts of materials or natural resources?  discharge to air, soil, water, and/or sewers?  produce solid waste (e.g., scrap, refuse)?  consume large amounts of electrical energy or fuels?  consume large amounts of water?  Is the site prepared for any accident or emergency?  Does the site have adequate training and/or experience to avoid, prevent, or mitigate potential environmental consequences? DOE G 450.1-2 I-5 8-20-04 Phase I  Are there activities that involve the use of material safety data sheets (MSDS)?  Do any other conditions or attributes of the activity/product/service pose a risk to the environment or to health and safety? Environmental aspects identified should be listed against the activity with which they are associated (see Table 1). Table 1 provides some examples of typical environmental aspects at DOE sites. These examples illustrate how the environmental aspects are paired with the activities, products, and services that cause them. 1.2 TASK 2: IDENTIFY HOW EACH ENVIRONMENTAL ASPECT IMPACTS THE ENVIRONMENT Reference The provisions in this task relate to established requirements of the following ISMS element.  ISMS Core Function 2, “Analyze the Hazards: Hazards associated with the work are identified, analyzed and categorized.” Task 2 involves the identification of the potential environmental impacts of an environmental aspect. A potential environmental impact is defined by its likelihood of occurrence and the likely consequences if it does occur. When the potential environmental impacts have been identified, their descriptions should be recorded alongside the activity and aspect with which they are associated. To assist in the identification of potential impacts, Table 2 lists some sample environmental impacts. The description of environmental impacts should include as much detail as possible, including the identification of pollutants. 1.2.1 Understanding the Aspect Impact Analysis Aspect impact analysis identifies the significant aspects (i.e., interactions with the environment) that site management should address to prevent or control activities thereby reducing the site’s risk to the environment. There is no single correct approach to aspect identification and impact analysis. Differences in structures and missions will lead organizations to adopt different approaches. Whenever possible, aspect impact analysis should rely on existing site information from documents such as Environmental Impact Statements (EISs), permit applications, ASERs, and ISMS documents. I-6 DOE G 450.1-2 8-20-04

Phase I Table 1. Example of Listing Environmental Aspects and Activities/Products/Services ENVIRONMENTAL ASPECT ACTIVITIES/PRODUCTS/SERVICES Air Emissions  Using and Storing Chemicals  Constructing or Modifying Facilities, Processes, or Equipment  Deactivating, Decommissioning, Dismantling or Closing Facilities, Equipment, and Processes  Maintaining, Servicing, or Repairing Refrigeration and Air Conditioning Equipment  Constructing Hazardous Waste Units  Closing Waste Management Units  Combusting fuel for heat, power or electricity Disturbance of Cultural and Historic Resources  Constructing or Modifying Facilities, Processes, or Equipment  Conducting Open Burning  Constructing or Modifying Aboveground and Underground Storage Tanks (USTs) Releases to Wastewater System and Ground Water  Deactivating, Decommissioning, Dismantling, or Closing Facilities, Equipment, and Processes  Conducting Research and Development  Leaks, Spills, and Releases from Waste Management Activities  Closing Waste Management Units Medical Waste Generation, Management, and Disposal  Conducting Research and Development Radioactive Waste Generation, Management, and Disposal  Preparing Buildings or Facilities for Transfer to Surplus, Inactive Facility Status or Decontamination and Decommissioning ( D & D)  Leaks, Spills, and Releases from Waste Management Activities  Closing Waste Management Units  Conducting Research and Development  Disposition of Excess Materials  Treating, Storing, Disposing of Waste  Cleanup of Legacy Waste Sites DOE G 450.1-2 I-7 8-20-04 Phase I 1.2.2 Approach to Characterizing Environmental Impacts As discussed previously, the potential environmental impact of an aspect is defined by the likelihood of that aspect occurring and the likely consequences to the environment, mission, and/or community when it does occur. Although it is possible to determine these characteristics in a technically rigorous manner, including the use of decision trees, modeling, and studies of toxicological parameters, this level of rigor is rarely necessary and is often impractical for purposes of identifying how an environmental aspect affects the environment. In most cases, individuals with experience at a DOE site should be able to assign a realistic likelihood and consequence to potential environmental impacts. In many cases, sites can use the experiences of other organizations or sites regarding similar activities and similar circumstances, and the environmental aspects and impacts are likely to be comparable. Quantification of potential environmental impacts, where possible, will facilitate the determination of significance. Entries in the “impacts” column of Table 2 should be as descriptive as possible; for example, instead of simply listing a potential spill impact as “soil contamination,” it would be more useful to describe the impact as “soil contamination––biohazards.” This fuller description, when available, will greatly facilitate the proper determination of the impact’s significance. 1.2.3 Documenting Positive Impacts

For purposes of this Guide, an environmental impact is “any change to the environment, whether adverse or beneficial, wholly or partially resulting from an organization’s activities, products, or services.” Although the aspect/impact analysis is inherently geared toward identifying risks and, essentially, the degree of negative impact, it can also identify those positive impacts on the environment that are a result of existing programs or activities. Examples of positive impacts include protecting wetlands with buffer strips and maintaining wooded areas to protect species and habitat diversity. Positive impacts should be identified in the aspect/impact analysis because the aspects that create them may be incorporated into environmental management programs (EMPs) and systematically managed. As an example, a site may voluntarily decide to let a 50-foot buffer strip grow alongside a stream. This action can have positive impacts on the environment such as reduced storm-water flow, sediment loading, etc. A proactive program may need ongoing management to maintain the buffer strip. When characterizing impacts as “positive,” it is important that the impact actually improve the quality of the environment and is not just the result of minimizing a negative impact. For example, cleaning up a site that has contaminated the soil is not a positive impact; it is simply mitigating a negative impact (contamination). I-8 DOE G 450.1-2 8-20-04 Phase I Table 2. Example of Listing Environmental Impacts ENVIRONMENTAL ASPECT ACTIVITIES/PRODUCTS/SERVICES POTENTIAL IMPACTS Air Emissions  Using and Storing Chemicals  Constructing or Modifying Facilities, Processes, or Equipment  Deactivating, Decommissioning, Dismantling or Closing Facilities, Equipment, and Processes  Maintaining, Servicing, or Repairing Refrigeration and Air Conditioning Equipment  Constructing Hazardous Waste Units  Closing Waste Management Units  Combusting fuel for heat, power, or electricity General reduction in air quality and potential human, ecological, and habitat effects in the locality affecting all media and biota. Disturbance of Cultural and Historical Resources  Constructing or Modifying Facilities, Processes, or Equipment  Conducting Open Burning  Constructing or Modifying Aboveground and Underground Storage Tanks Ecological damage, damage of culturally and historically significant artifacts. Releases to Wastewater System and Ground Water  Deactivating, Decommissioning, Dismantling or Closing Facilities, Equipment, and Processes  Conducting Research and Development  Leaks, Spills, and Releases from Waste Management Activities  Closing Waste Management Units Runoff to local surface waters with species, habitat, biota, and fisheries impact. Leaching to ground water aquifer of hazardous wastes. Medical Waste Generation, Management, and Disposal  Conducting Research and Development Ecological damage, contamination of air, water, and soil with biohazards, impact to human health and biota, waste generation. Radioactive Waste Generation, Management, and Disposal  Preparing Buildings or Facilities for Transfer to Surplus, Inactive Facility Status or D & D  Leaks, Spills, and Releases from Waste Management Activities  Closing Waste Management Units  Conducting Research and Development  Disposing of Excess Materials  Treating, Storing, Disposing of Waste  Cleanup of Legacy Waste Sites

Ecological damage, contamination of air, water, and soil with radiological contaminants, impact to human health and biota, waste generation. DOE G 450.1-2 I-9 8-20-04 Phase I Step 2 Determining Significant Aspects 2.1 TASK 3: IDENTIFY ALL ENVIRONMENTAL ASPECTS THAT ARE REGULATED, HAVE REGULATORY IMPLICATIONS, OR ARE REQUIRED BY DOE DIRECTIVE References This task fulfills several DOE Order requirements listed below.  The ISMS/EMS provides for the systematic planning of programs for compliance with applicable requirements [DOE O 450.1 §4.a. (1) (c)].  The ISMS/EMS includes (if applicable) conformity of DOE proposed actions with State Implementation Plans to attain and maintain national ambient air quality standards [DOE O 450.1 §4.b. (1) (a)].  The ISMS/EMS includes (if applicable) implementation of a watershed approach for surface-water protection [DOE O 450.1 §4.b. (1) (b)].  The ISMS/EMS includes (if applicable) implementation of a sitewide approach for ground water protection [DOE O 450.1 §4.b. (1) (c)].  The ISMS/EMS includes (if applicable) protection of other natural resources, including biota [DOE O 450.1 §4.b. (1) (d)].  The ISMS/EMS includes (if applicable) protection of site resources from wildland and operational fires [DOE O 450.1 §4.b. (1) (e)].  The ISMS/EMS includes (if applicable) protection of cultural resources [DOE O 450.1 §4.b. (1) (f)].  The ISMS/EMS promotes the long-term stewardship of a site’s natural and cultural resources throughout its operational, closure, and post-closure life cycle [DOE O 450.1 §4.b. (2)]. Task 3. Identify all environmental aspects that are regulated, have regulatory implications or are required by DOE Directive. Task 4. Determine significance based on environmental and organizational considerations. I-10 DOE G 450.1-2 8-20-04 Phase I  The ISMS/EMS provides for reduction or elimination of the generation of waste, the release of pollutants to the environment, and the use of Class I ozone-depleting substances (ODS) through source reduction, reuse, segregation, and recycling and by procuring recycled-content materials and environmentally preferable products and services [DOE O 450.1 §4.b.(3)].  The ISMS/EMS ensures the early identification of, and appropriate response to, potential adverse environmental impacts associated with DOE operations, including, as appropriate, preoperational characterization and assessment and effluent and surveillance monitoring [DOE O 450.1 §4.b.(4)].  The ISMS/EMS includes environmental monitoring, as appropriate, to support the site’s ISMS, to detect, characterize, and respond to releases from DOE activities; assess impacts and estimate dispersal patterns in the environment; characterize the pathways of exposure to members of the public; characterize the exposures and doses to individuals and to the population; and to evaluate the potential impacts to the biota in the vicinity of the DOE activity [DOE O 450.1 § 5.d. (14)].  The ISMS/EMS ensures the implementation of the analytical work supporting environmental monitoring, using a consistent system for collecting, assessing, and documenting environmental data of known and documented quality [DOE O 450.1 § 5.d. (15)(a)].  The ISMS/EMS ensures the implementation of the analytical work supporting environmental monitoring, using a validated and consistent approach for sampling and analyzing radionuclide samples to ensure laboratory data meet program-specific needs and requirements within the framework of a performance-based approach for analytical laboratory work [DOE O 450.1§5.d.(15)(b)].

 The ISMS/EMS ensures the implementation of the analytical work supporting environmental monitoring, using an integrated sampling approach to avoid duplicative data collection [DOE O 450.1 §5.d. (15) (c)]. The provisions in this task relate to established requirements of the following ISMS elements.  ISMS Core Function 3, “Develop and Implement Hazard Controls: Applicable standards and requirements are identified.”  ISMS Principle 5, “Identification of [Environment, Safety and Health] Standards and Requirements. Before work is performed, the associated hazards shall be evaluated and an agreed-upon set of [environment, safety and health] standards and requirements shall be established . . . .” 2.1.1 Identifying Environmental Aspects with Regulatory Consequences Under Task 3 a DOE site should identify of all activities, products, or services whose aspects have regulatory implications. Because of the ramifications that regulatory violations might have for a site, it is important that all aspects with regulatory implications be managed through the DOE G 450.1-2 I-11 8-20-04 Phase I ISMS/EMS. Site environmental and legal personnel should help determine those legal requirements that apply to environmental aspects on DOE sites. The site ISMS/EMS team and other parties that the team believes can contribute (e.g., the site regulatory experts) should list all environmental aspects whose activities, products, or services are subject to regulation, or other requirements as shown in Table 4. Table 3, below, includes a recommended approach rating the regulatory and requirements status of a particular environmental aspect. The appropriate value should be entered beside the corresponding impact in Table 4. Table 3. Regulatory and Other Requirements Related to Environmental Aspects Scale of Regulatory and Other Requirements 5 = Regulated––Mandated by Federal, host nation, State, or local government agency statutes, laws, or regulations, Executive Orders and DOE regulations or required by DOE directives (Automatically Significant) 4 = Regulated in the Future––Not currently mandated by a government agency, but under proposal 3 = Site Best Management Practice (i.e., not DOE-wide but mandated by site management) 0= No applicable regulatory requirement The ISMS/EMS team may use a variety of techniques to identify regulated aspects. In some cases, a brainstorming exercise similar to that conducted when identifying aspects may be effective. A search of existing documents such as environmental permits and compliance agreements may be helpful in identifying regulated activities. In this case, it is usually important to include a member of the legal staff to be confident of the regulatory implications of each possible aspect. In other cases, the responsible environmental expert for that issue may be able to review each aspect within his or her area of expertise and provide the ISMS/EMS team with the necessary regulatory information. Any of these or other methods is suitable as long as it provides a high degree of certainty regarding the regulatory implications of environmental aspects. In Task 3, all aspects with regulatory and policy implications should be identified and assigned a value of “5” using the rating system shown in Table 3. In practical terms, those assigned a value of “5” should be considered significant environmental aspects. As a result, when an organization identifies its significant environmental aspects, those that are regulated or governed by external regulation; Executive Orders (i.e., E.O. 13148, Greening the Government Through Leadership in Environmental Management); or Departmental directives (e.g., DOE O 450.1 or DOE P 450.4) will be automatically designated as significant aspects.

Aspects that will be regulated in the future are assigned a value of “4,” and site best management practices assigned a value of “3.” Although these aspects may be considered minor, they should be documented when assigning a score. If there is no applicable requirement, a value of “0” should be assigned. I-12 D O E G 450.1-2 8-20-04 P hase I Table 4. Assigning a Regulatory Score to Aspects Env. Aspect Activities/Products/Services Potential Impacts Reg. Score Air Emissions Using and Storing Chem. Products and Chem. Hazardous Agents General reduction in air quality, and potential human, ecological, and habitat effects in the locality, spreading over a large footprint affecting all media and biota. Noncompliance with applicable laws/regulations. 5 Constructing or Modifying Facilities, Processes, or Equipment Deactivating, Decommissioning, Dismantling, or Closing Facilities, Equipment, and Processes Maintaining, Servicing, or Repairing Refrigeration and Air Conditioning Equipment Constructing Hazardous Waste Units Combusting fuel for heat, power, or electricity Closing Waste Management Units Disturbance of Cultural and Historical Resource Constructing or Modifying Facilities, Processes, or Equipment Ecological damage, damage of cultural and historically significant artifacts. Noncompliance with applicable laws/regulations. 5 Conducting Open Burning Constructing or Modifying Aboveground and Underground Storage Tanks Releases to Wastewater System and Ground Water Deactivating, Decommissioning, Dismantling, or Closing Facilities, Equipment, and Processes Runoff to local rivers and streams with species, habitat, and fisheries impacts. Leaching to ground water (aquifers) and biota of hazardous wastes. Noncompliance with applicable laws/regulations 5 Conducting Research and Development Leaks, Spills, and Releases Closing Waste Management Units Medical Waste Generation Management, and Disposal Conducting Research and Development Ecological damage, contamination of air, water, and soil with biohazards impact to human health and biota, and waste generation. Noncompliance with applicable laws/regulations. 5 Radioactive Waste Generation Management and Disposal Preparing Buildings or Facilities for Transfer to Surplus, Inactive Facility Status or D & D Ecological damage, contamination of air, water, and soil with radiological contaminants, impact to human health and biota, and waste generation. Noncompliance with applicable laws/regulations. 5 Releases, leaks, spills or unusual operating conditions from USTs Closing Waste Management Units Conducting Research and Development Disposition of Excess Materials Clean up of Legacy Waste Sites Treating, Storing and Disposing of Waste DOE G 450.1-2 I-13 8-20-04 Phase I 2.1.2 Specific Environmental Interactions After listing all activities, products, and services (see example Table 1) and identifying their associated environmental aspects, sites should consider specific environmental interactions and impacts and develop measurable objectives and targets (see Section 3.1). Through this process, sites should consider pollution prevention opportunities. DOE O 450.1 §4.b. (1), (2), (3), and (4) require consideration for inclusion, as applicable.  Conformity of DOE proposed actions with State Implementation Plans to attain national ambient air quality standards;  Implementation of watershed approach for surface-water protection;  Implementation of site-wide approach for ground water protection;

 Protection of other natural resources, including biota;  Protection of site resources from wildland and operational fires;  Protection of cultural resources;  Promotion of long-term stewardship of a site’s natural and cultural resources;  Reduction or elimination of the generation of waste, the release of pollutants to the environment, and the use of Class I ozone-depleting substances (ODS) through source reduction, reuse, segregation, and recycling and by procuring recycled-content materials and environmentally preferable products and services;  Ensure the early identification of and appropriate response to, potential adverse environmental impacts associated with DOE operations, including, as appropriate, preoperational characterization and assessment, and effluent and surveillance monitoring. 2.1.3 Pollution Prevention Pollution prevention is not a stand-alone program; rather it is incorporated into the day-to-day operations at DOE sites. DOE O 450.1 §4 a.(1)(b) requires that all DOE elements ensure that site ISMSs include an EMS that provides for the systematic planning, integrated execution, and evaluation of programs for pollution prevention. DOE O 450.1 §4.b.(3) requires that as part of integrating EMSs into site ISMSs, DOE elements must reduce or eliminate the generation of waste, the release of pollutants to the environment, and the use of Class I ODSs through source reduction, reuse, segregation, and recycling and by procuring recycled-content materials and environmentally preferable products and services. DOE O 450.1 §5.d. (6) requires sites to conduct Pollution Prevention Opportunity Assessments (PPOA) and implement cost effective pollution prevention solutions. A PPOA is an appraisal of a process, activity, or operation to identify and evaluate potential pollution prevention opportunities (see Appendix D, Glossary). Pollution prevention opportunities should be considered before setting your site’s objective and targets. For example, specific pollution I-14 DOE G 450.1-2 8-20-04 Phase I prevention goals were set forth in a Secretary of Energy Memorandum issued in 1999.1 Site- specific goals that contribute to these existing pollution prevention goals can be a site’s environmental objective for reducing or eliminating a certain impact (i.e., waste generation or discharge). A target could be a schedule for conducting a PPOA to identify pollution prevention solutions for achieving the objective. Subsequent guidance regarding incorporating pollution prevention elements into the site’s ISMS/EMS will be provided in the future. 2.1.4 Clean Air Act General Conformity Under Section 176(c)(1) of the Clean Air Act (and the Environmental Protection Agency’s implementing regulations at 40 CFR Part 93, or State or local agency implementing regulations), a Federal agency is prohibited from carrying out or providing financial assistance for any activity that does not conform to State efforts to attain or maintain compliance with the national ambient air quality standards (NAAQS) for the criteria pollutants (i.e., ozone, nitrogen dioxide, sulfur oxides, particulate matter, carbon monoxide, and lead). If there are air emissions of criteria pollutants of concern for a proposed DOE action in a nonattainment or maintenance area,2 the general conformity regulations require that an analysis of these emissions of pollutants of concern be carried out prior to the initiation of the proposed action, preferably in conjunction with the NEPA compliance process. This analysis is not required for proposed DOE actions that would cause air emissions to occur in attainment areas (i.e., areas complying with all NAAQS).

After the site has identified activities, products and services related to general conformity requirements and how they interact with the ambient air environment, the ISMS/EMS team may determine the impacts (and their significance) caused by emission of criteria air pollutants for the planned DOE action in nonattainment and maintenance areas. Examples of potential impacts include—  deterioration of air quality,  possible greater health hazards to the public due to the DOE action, and  noncompliance with conformity regulations. Sites may evaluate environmental impacts by comprehensively estimating criteria pollutant emissions from proposed DOE actions. If estimated emissions are greater than either of two conformity de minimis emission levels, the emissions associated with the proposed DOE action are considered to be of significance, and a more detailed “conformity determination” is needed. An example of an environmental objective for conformity is to go beyond compliance with all conformity regulatory requirements. Examples of targets are to ensure that all organizations on the site are responsible for proposed DOE actions in nonattainment and maintenance areas, and 1 Secretary of Energy Memorandum, “Pollution Prevention and Energy Efficiency Leadership Goals for Fiscal Year 2000 and Beyond,” November 12, 1999. 2 Nonattainment areas are areas not meeting one or more NAAQS, and maintenance areas are former nonattainment areas now in attainment, with an approved maintenance plan to stay in attainment. DOE G 450.1-2 I-15 8-20-04 Phase I conduct PPOAs to identify pollution prevention solutions such as reductions in the use of chemicals that produce criteria pollutants. Appendix A contains a list of additional guidance materials. 2.1.5 Watershed Approach for Surface-Water Protection A watershed is defined as a geographic area of land and water within the confines of a drainage divide and the total area above a given point of a water body that contributes flow to that point. Aspects that impact surface water include, but are not limited to, waste generation and discharge to the watershed, spills from raw material storage, construction and maintenance, fresh water and energy consumption, solid waste generation and disposal, and radiation. Examples of potential impacts include—  reduction of fresh water supply,  soil erosion,  reduction in the number of flora and fauna, and  degradation of water quality. An example of an environmental objective for watershed management might be the use of a consistent, science-based, approach to watershed assessments. A target might be to restore some wetlands within the watershed. Appendix A contains a list of additional guidance materials. 2.1.6 Site-Wide Approach for Ground Water Protection After the site has identified activities, products and services that could impact ground water quality, the site may determine the impacts (and their significance) caused by such actions. Since ground water can be affected by any operating facility or activity, the ISMS/EMS should provide a framework whereby all efforts to protect ground water are integrated, including, but not limited to, the following:  integration of active remediation of contaminated ground water with prevention of future ground water contamination,  integration of compliance with external and internal regulatory requirements,  integration of ongoing program activities and facilities with site-wide landlord responsibilities, and

 integration of all ground water and vadose zone monitoring activities. Using the systems approach to ground water protection allows for flexibility in the long term and should address current needs, be able to adapt to changes over time, and serve as a repository for historic ground water activities, documents, and data. The site-wide approach can also address the needs for long-term protection; including surveillance and maintenance (see Section 2.1.11). Current needs are determined by specific requirements included in applicable permits and I-16 DOE G 450.1-2 8-20-04 Phase I compliance agreements. Long-term needs are determined by the sources of potential future releases that will remain at the site after DOE operations cease and the completion of active remediation. The site-wide ground water protection approach should be tailored to each DOE site’s unique physical setting, history, current mission, and local or regional cultural characteristics. There are, however, certain objectives that are common to all DOE sites, and that should be reflected in each site ISMS/EMS. Examples of objectives for ground water protection include the following.  Develop a strategy for controlling existing contamination and pursuing site-wide pollution prevention goals for preventing future contamination.  Establish and maintain a process for identifying possible future sources of contamination.  Ensure that all external and internal regulatory requirements are met.  Maintain documentation of all measures used for monitoring the ground water and vadose zone.  Maintain a consolidated system for documenting the quality of ambient ground water and vadose zone conditions and reporting the results of ground water and vadose zone monitoring.  Maintain a process of program review and evaluation that includes regular evaluation of technical improvements and cost-effective technologies. Targets may be set to—  ensure compliance with applicable regulatory requirements,  identify and document possible future sources of contamination,  prevent contamination, and  ensure dates for completing PPOAs are set. Guidance regarding ground water surveillance and monitoring may be found in DOG G 450.1-6, Ground Water Surveillance Monitoring Implementation Guide for Use with DOE O 450.1, Environmental Protection Program. Appendix A contains a list of additional guidance materials. 2.1.7 Natural Resources—Biota Biota is defined as the plant and animal life in a particular region. After the site has identified activities, products, and services related to interactions with biota, the site may then determine the impacts (and their significance) caused by such actions. When determining the environmental impacts to biota, sites should use evaluation methods that consider— DOE G 450.1-2 I-17 8-20-04 Phase I  site-related physical, chemical, and radiological hazards;  routes of exposure to biota from these hazards or sources;  potential for harm or reduction in biota populations;  actual or potential habitat loss that could directly or indirectly impact biota populations;  noncompliance with permits, limits and standards; and  associated costs and schedule impacts to site operations, decontamination and decommissioning, and property and land transfer as a result of impacts to biota or noncompliance with biota protection requirements.

Guidance for evaluating potential radiological impacts to biota is provided in the DOE Technical Standard, A Graded Approach for Evaluating Radiological Doses to Aquatic and Terrestrial Biota (DOE-STD-1153-2002). Sites should consider other requirements, standards, and guidance for protection of biota as appropriate (see Appendix A). Examples of objectives for biota may include the following.  Demonstrate to DOE, local regulators, and stakeholders that radioactive discharges and residual radioactive contamination on site lands does not impact biota.  Determine that there are no significant impacts to biota associated with site activities and their associated environmental aspects. Examples of targets for biota may include the following.  Conduct biota dose evaluations for 80 percent of site operable units, facilities, or other defined evaluation areas within a specific timeframe and document the results of these biota dose evaluations in the site’s ASER.  Determine if additional monitoring is needed or if the existing sampling program (e.g., locations and frequencies) needs refinement or augmentation.  Promote awareness of biota protection activities to local regulators and stakeholders.  Provide evidence that potential impacts to biota have been evaluated through a systems approach considering all relevant site activities and associated environmental aspects, and that any significant impacts to biota are identified and being addressed in the site EMS.  Develop procedures for evaluating radiation doses to biota and needed monitoring are in place.  Develop procedures for addressing noncompliance with permits, standards, and limits for biota protection are in place.  Provide evidence that biota evaluation and protection activities are going beyond reactive compliance, and are fostering continuous improvement. Appendix A contains a list of additional guidance materials. I-18 DOE G 450.1-2 8-20-04 Phase I 2.1.8 Wildland Fire Management Program Existing wildland fire management programs should be adopted into the site’s ISMS/EMS where appropriate. Most sites’ wildland fire management programs are already institutionalized (for example, emergency preparedness and response, roles and responsibilities, and training). This should facilitate inclusion of environmental aspects related to wildland fires in a site’s ISMS/EMS. Guidance regarding incorporation of wildland fire considerations in the site’s management system is available in DOE G 450.1-4, Implementation Guide, Wildland Fire Management Program for Use with DOE O 450.1, Environmental Protection Program. Appendix A contains a list of additional guidance materials. 2.1.9 Cultural Resources Management Program Existing cultural resources management programs should be adopted into a site’s ISMS/EMS where appropriate. Guidance regarding incorporating cultural resources elements into the site’s ISMS/EMS, are available in draft DOE G 450.1-3, Environmental Guidelines for Development of Cultural Resource Management Plans-Update. This guidance document provides guidelines to organizations responsible for the development of a Cultural Resources Management Plan (CRMP). As with all guidance, each site should consider individual needs and tailor the elements of the CRMP for incorporation into the site’s ISMS/EMS. Appendix A contains a list of additional guidance materials. 2.1.10 Long-Term Stewardship Program

DOE O 450.1 §4.b. (2) requires that, as part of integrating EMSs into site ISMSs, DOE elements must promote the long-term stewardship (LTS) of a site’s natural and cultural resources throughout its operational, closure, and post-closure life cycle. LTS is a Department-wide responsibility and a component of all aspects of Departmental decision making. One effective and efficient way to implement the sound stewardship practices sought by DOE is by weaving pollution prevention technologies, practices, and policies into the EMS continuous cycle of planning, implementing, evaluating, and improving the organizations environmental performance. The following should be considered when setting objectives and targets:  approaches to avoid, delay, or reduce the frequency or impact of harmful exposures to hazardous substances remaining after DOE cleanup projects and other operations are completed;  approaches to ensure sustainable design, construction, and operation of new facilities and avoid creating waste and contamination problems that will require long-term stewardship; and  approaches to ensure the use of improved technologies and institutional structures to improve reliability and reduce the costs of long-term stewardship. Setting objectives and targets for LTS may require the ISMS/EMS team to interact with stakeholders and State, local, and tribal governments. Each site should consider its individual needs and tailor the elements of the LTS program into the site ISMS/EMS. DOE G 450.1-2 I-19 8-20-04 Phase I 2.1.11 Preoperational Characterization and Assessment and Effluent and Surveillance Monitoring DOE O 450.1 § 4.b. (4) requires that as part of integrating EMSs into site ISMSs, DOE elements must ensure the early identification of, and appropriate response to, potential adverse environmental impacts associated with DOE operations, including, as appropriate, preoperational characterization and assessment and effluent and surveillance monitoring. The ISMS/EMS should include adequate monitoring of environmental media to detect releases from facilities and operations, and to evaluate the impact of these releases on the general public and environmental resources. Specific monitoring elements include the following:  monitoring effluents from discharge points and air emissions from existing sources to ensure regulatory compliance and to assess potential impacts on the public and on the environment,  preoperational monitoring to provide an adequate baseline of environmental conditions for new facilities or operations,  meteorological monitoring to provide accurate environmental transport parameters for assessing potential exposure and dose, and  using environmental surveillance (air, ground, surface water, vadose zone) to detect potential releases at the earliest possible time to ensure appropriate response. Sites should conduct all environmental monitoring in an integrated fashion to ensure that the environmental stewardship responsibilities are met in a cost-effective manner. To achieve a fully integrated environmental monitoring program, the design of monitoring networks should meet site-wide needs for environmental measurements and facility- and area-specific surveillance monitoring needs. The environmental monitoring networks should be—  designed to provide specific data on environmental conditions to ensure that facilities and operations are managed to have minimal impact on the environment;

 reevaluated by periodic assessment of the potential impact on the environment of each facility and operating program at the site;  optimized regularly to ensure the provision of adequate data, given changing conditions over time, and that data produced by the networks are not duplicative or unnecessary; and  designed to serve as the basis for long-term environmental stewardship monitoring for the period of time following cessation of active DOE operations. Each DOE site will address monitoring differently and may tailor the monitoring program in response to unique site conditions. The following elements should be included in each site’s environmental monitoring program: I-20 DOE G 450.1-2 8-20-04 Phase I  sampling and analysis plan;  surveillance or detection monitoring network;  contingency plan that includes specific actions to be taken by specific individuals or organizations to take in response to certain monitoring results;  site-wide vulnerability assessment process to identify priority areas for surveillance monitoring;  site-wide subsurface characterization process for ground water and vadose zone monitoring;  prioritization system, based on vulnerability assessments, to determine the focus of surveillance monitoring and for estimating the site-wide surveillance monitoring program budget;  integrated site-wide monitoring data management and reporting system;  monitoring system maintenance plan;  well abandonment monitoring and closure procedures for ground water monitoring;  detailed Quality Assurance/Quality Control (QA/QC) procedures designed for the specific data needs of the users of the results of each monitoring network; and  external peer review process for assisting in periodic program performance assessments. To ensure that the adequacy and utility of the site-wide environmental monitoring networks are maintained over time, each site’s monitoring program should include a process for periodic review and evaluation. The following criteria should be used in any periodic review of environmental monitoring program performance.  The network provides sufficient quantitative data of appropriate quality for environmental resources management.  The network provides sufficient quantitative data of appropriate quality for regulatory compliance, to include assessments of potential doses to the public.  The program includes descriptions of each facility-specific and area-specific network, linking anticipated monitoring results with the stated purpose of the network’s design and the needs of the users of the data.  The program maintains documentation of current size, scope, and technical specifications of each network, as well as historical data on the network’s design and operations.  The program includes processes that ensure periodic evaluation of the network’s efficiency and cost-effectiveness for continuous improvement.  The program ensures that data provided by the network meet the site’s needs. DOE G 450.1-2 I-21 8-20-04 Phase I  The program provides processes for periodic review of alternative and innovative monitoring methods.  The program includes regular analyses of long-term trends in environmental data quality.  The program includes processes to ensure that environmental data quality is comparable across environmental media, and the consistent gathering and reporting of data over time. 2.1.12 Environmental Quality Systems

DOE O 450.1 §5(d) (15) requires DOE elements to ensure that the analytical work supporting environmental monitoring is implemented using—  a consistent system for collecting, assessing, and documenting environmental data of known and documented quality;  a validated and consistent approach for sampling and analysis of radionuclide samples to ensure laboratory data meet program-specific needs and requirements within the framework of a performance-based approach for analytical laboratory work; and  an integrated sampling approach to avoid duplicative data collection. The Uniform Federal Policy for Implementing Environmental Quality Systems (UFP-QS) offers an implementation tool for meeting this requirement. The UFP-QS is based on the American National Standards Institute/American Society for Quality Control E-4 (ANSI/ASQC E4, 1994). The Quality System (QS) is a structured and documented management system (to be integrated into the site ISMS/EMS) that provides recommendations to Federal agencies for documenting and implementing a quality system for the management of environmental data collection and use. It ensures that data used to support environmental decisions are of adequate quality and usability for the intended purpose. The overall goal of this consensus system is simple: sound decisions must be based on sound documented data. The QS is documented, at the organizational level, in a Quality Management Plan (QMP). The QMP details information by which the organization will manage, plan, implement, assess, and continually improve the activities involved in environmental data collection and use3. At the project level the QS is documented in a Uniform Federal Policy for Quality Assurance Project Plan (UFP-QAPP).4 3 American National Standards Institute and American Society for Quality Control E-4 (ANSI/ASQC E4-1994) was selected as the basis for the intergovernmental quality system because it is a national standard that specifically addresses environmental data collection and use and environmental technology. Part A, Management Systems, describes the quality management elements needed for managing environmental programs effectively. These include: management and organization, quality system and description, personnel qualification and training, procurement of items and services, documents and records, computer hardware and software, planning, implementation of work processes, assessment and response, and quality improvement. 4 ANSI/ASQC E-4 Part B, “Collection and Evaluation of Environmental Data.” It addresses project-specific requirements needed to plan, implement, and assess environmental data operations, including the collection, handling, analysis, and evaluation of environmental-related data. Such data include: chemical, biological, toxicological, and radiological data. I-22 DOE G 450.1-2 8-20-04 Phase I The objectives of the UFP-QS are to—  provide essential elements of a quality system for management of environmental data collection and use;  provide a framework to Federal agencies for documenting and implementing an acceptable intergovernmental quality system based on an approved standard, (ANSI/ASQC E-4 1994, Part A); and,  provide guidance to document, assess, and improve existing quality systems. The following are examples of targets.  Consolidating site-wide data collection across projects, programs, and media; enhancing knowledge communication; and using a graded approach to optimize and conserve valuable resources.

 Establishing a process to maintain a link among systematic planning, implementation, and assessment stages of environmental data collection to ensure that the data produced meet their intended purposes and are documented and defensible.  Establishing a validated and consistent approach for sampling and analysis of radionuclide samples to ensure laboratory data meet program-specific needs and requirements within the framework of a performance-based approach for analytical laboratory work. Appendix A contains additional guidance materials. 2.2 TASK 4: DETERMINE SIGNIFICANCE BASED ON ENVIRONMENTAL AND ORGANIZATIONAL CONSIDERATION Reference This task fulfills the DOE Order requirement listed below.  All DOE elements must ensure that the site ISMS include an EMS that does the following: Includes policies, procedures, and training to identify activities with significant environmental impacts; to manage, control, and mitigate the impacts of these activities; and to assess performance and implement corrective actions where needed [DOE O 450.1 § 4.a.(2)]. The provisions in this task relate to established requirements of the following ISMS element.  ISMS Core Function 2, “Analyze the Hazards: Hazards associated with the work are identified, analyzed and categorized.” There is no scientific test for determining “significance”; as such, the term is used in a subjective and flexible manner. It is ultimately up to the site to determine what constitutes significance. DOE G 450.1-2 I-23 8-20-04 Phase I However, this task attempts to provide criteria for that determination that are both applicable and relevant to DOE site operations. Numerous factors influence whether an environmental aspect is a significant environmental aspect. To identify the organization’s significant environmental aspects, the site must consider these factors systematically and appropriately as described in the following sections to protect the environment and support the organization’s environmental policy and mission priorities. 2.2.1 “Significance” in the NEPA and ISMS/EMS Context There are similarities and differences in the basis for determining significance in the context of the ISMS/EMS and NEPA. The criteria for “likelihood” and “environmental consequence” used to identify significant environmental aspects in an ISMS/EMS are consistent with the criteria for assessing potential significance in NEPA, even though their application may be different in the two processes. The criteria for “mission consequence” may not factor into a determination of significant impacts under NEPA, however, there are instances where the Department’s NEPA documents do consider potential mission impact. When identifying significant environmental aspects in ISMS/EMS planning, staff members should be aware whether those aspects have been addressed through the NEPA process and whether they are identifying information that might trigger the need for a NEPA review or that should be part of an otherwise planned NEPA review. Conversely, the NEPA process may identify aspects that are significant for the site’s ISMS/EMS, or may resolve such significant aspects (e.g., through mitigation commitments).

Another situation in which the relationship is important is when evaluating new proposals. In the NEPA context, the significance of potential environmental impacts is most relevant when evaluating a proposed major Federal action. The ISMS/EMS should account for this by encouraging an awareness of NEPA requirements and existing NEPA documentation during the assessment of environmental aspects for new proposals. In many circumstances, some environmental aspects would be significant for both NEPA and EMS, while in others they might be significant for one but not the other. 2.2.2 Criteria for Scoring Likelihood of Occurrence One of the factors in scoring the significance of an aspect is the likelihood that its impact will occur. In this Guide, we use likelihood to score both the environmental consequence and the mission consequence of environmental impacts. Both the environmental and mission consequences are multiplied by the likelihood that the impact will occur for a given aspect. For example, surface-water contamination is an impact of the aspect hazardous materials spills (i.e., spills are an interaction with the environment). To determine the significance of these spills, it is important to understand the probability that spills will occur and the probability that contamination (i.e., impact) will occur. If contamination will never occur because no work occurs outdoors, then hazardous materials spills will not be significant for surface-water contamination. However, if indoor spills occur often and are flushed into the storm sewer system, then that hazardous materials spill may be designated significant on the basis of the likelihood of surface-water contamination. I-24 DOE G 450.1-2 8-20-04 Phase I Providing an estimate of the likelihood of an impact occurring helps to select the aspects that are the most significant to the environment and to the organization’s mission. Table 5 provides a rating system for assigning the relative likelihood that an impact will occur for a given aspect (e.g., the chance of contamination occurring while managing waste). The assigned value should be entered into the Likelihood column of Table 8 in Section 2.2.5. Table 5. Sample Criteria for Scoring the Likelihood of Occurrence Estimated chance that the impact will occur (e.g., contamination of surface water) for a given aspect (e.g., a hazardous material spill) for a given time period Likelihood Score Very Frequently 5 Frequently 4 Occasionally 3 Infrequently 2 Rarely 1 Likelihood indicates the chance that an impact will occur. Therefore, it is important to obtain information from experienced facility personnel with experience in site activities, who provides an indication of the chance that the aspect will occur (e.g., a spill when filling tanks) and from individuals who can provide a rough estimate of the chance that the impact will occur (e.g., surface-water contamination) if the spill happens. These estimates are likely to be based on subjective experience. When available, the ISMS/EMS team should give preference in its estimates to records that show objective data of actual occurrences. 2.2.3 Criteria for Scoring Environmental Consequences of Impacts

After the likelihood of an impact has been determined, the next step is to determine the relative environmental consequence of the impact. For example, if two hazardous materials spills, (A) and (B), occur during an organization’s operations with equal frequency, they may be equally significant on the basis of likelihood. However, if (A) is volatile and evaporates almost immediately (i.e., becoming inert) and (B) is soluble and highly persistent (i.e., will stay in the environment for many years), the two spills have difference consequences for the environment. In this case, the site may designate spill (B) as significant based on the consequence of its impact to the environment (i.e., it is soluble and highly persistent and therefore greater risk of contamination). Table 6 provides an approach for scoring the consequence of the environmental impacts of each aspect. The second column of Table 6 provides a few common characteristics that the site should consider when making this determination. The two main factors are the proximity of that aspect to sensitive receptors and the severity of harm that the aspect’s impact can cause to the environment. The importance the site places on these various characteristics depends on site conditions and priorities. The resulting score that is generated for a particular aspect should be transferred to the environmental score column in Table 8. DOE G 450.1-2 I-25 8-20-04 Phase I 2.2.4 Criteria for Scoring Mission Consequences The second type of consequence that needs to be evaluated to determine overall significance is the consequence of a potential environmental impact for the continued accomplishment of the site’s mission. This consideration will help ensure that a site’s ISMS/EMS is mission focused and that it sets priorities not just on the basis of potential environmental impact, but also on the basis of impact on core DOE missions. DOE’s overarching mission is to advance the national economic and energy security of the United States to promote scientific and technological innovation in support of that mission; and to ensure the environmental cleanup of the national nuclear weapons complex. Further, one of the four strategic goals is to protect the environment by providing a responsible resolution to the environmental legacy of the Cold War and by providing for the permanent disposal of the Nation’s high-level radioactive waste. Table 7 provides an approach that can be used to determine the level of mission impact that an adverse environmental impact could have. For example, if a cleanup activity for the removal of contaminated soils required by the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA) uncovers cultural/historical artifacts, and work cannot proceed until after the removal of the artifacts in an appropriate manner, then the mission of removing contaminated soil is delayed past a scheduled milestone. Therefore this activity should be considered a significant mission consequence (score of 5). As discussed above, the likelihood that an impact will occur is also used when scoring the mission impact. The criteria in Table 7 are applied to a given potential environmental impact that is present in an activity, product or service. To apply the criteria in Table 7, ask the following question: If this potential environmental impact were to actually occur in this activity, what would be the probable mission consequences (from among those listed in Table 7)?

2.2.5 Determination of Overall Impact Score Once each aspect has been evaluated for regulatory status, likelihood of impact, environmental consequence, and mission consequence, the ISMS/EMS team can then score it for overall significance through use of the following equation. Significance Score = (Likelihood x Env. Consequence) + (Likelihood x Mission Consequence) + Regulatory Status . I-26 DOE G 450.1-2 8-20-04 Phase I Table 6. Sample Criteria for Scoring Environmental Consequences on DOE Sites Environmental Consequence Scale Environmental Consequence Considerations These general characteristics should be taken into account when determining the environmental consequences of an aspect. 5 = Severe/ Catastrophic– Very harmful or potentially fatal; great effort to correct and recover 4 = Serious– Harmful but not potentially fatal, difficult to correct but recoverable 3 = Moderate– Somewhat harmful; correctable 2 = Mild–Little potential for harm; correctable 1 = Insignificant– Trivial harm/ consequence; easily correctable Toxicity/Hazard: The relative toxicity of the consequence (including attributes such as exposure pathway in the environment, mobility of a compound in the environment, persistence or bioaccumulation). Quantity: Generally the size of the consequence (quantity of site scrap generated, gallons of water consumed) produced/used per year. Duration: The length of time that the consequence will be felt by affected entities (noise impacts are generally short term, whereas contamination of an aquifer with lead or radioactive material generally creates a long-term impact). Geographic Boundaries: Reflects the size of the physical area in which the consequence occurs (a 10-gallon diesel fuel spill may affect a few cubic feet of soil, whereas contamination of a local river with sediment or pollutants may impact the ecosystem of an entire watershed). Proximity of Consequence to People or Sensitive Environmental Receptors: The closeness of an impact to sensitive environmental receptors such as those listed below. Cultural resources [threatens (mild or moderate), disturbs/damages (serious), or destroys (severe) historic properties, cultural landscapes, cultural items, archaeological resources, Indian sacred sites, cemeteries]. Biota [threatens (mild or moderate), alters (moderate or serious), or destroys (severe) sensitive natural and ecological resources such as wetlands, threatened and endangered species, critical habitats, sole-source aquifers, etc.]. People [poses acute or chronic (serious or moderate) or temporary (mild or moderate) risks to human health because of the impact’s proximity to schools, public stakeholders, employees, hospitals, housing, recreational areas, drinking water]. Table 7. Sample Criteria for Scoring Mission Consequences for DOE Sites Mission Impact Scale 5 = Loss of ability to accomplish mission (Automatically Significant) 4 = Mission restrictions/impacts 3 = Moderate mission restrictions/impacts 2 = Minor mission restrictions/impacts 1 = Insignificant mission restrictions/impacts 0 = No mission restrictions/impacts The ISMS/EMS team then decides on the overall impact score threshold above which an aspect is to be considered a significant environmental aspect. For example, the selected numerical DOE G 450.1-2 I-27 8-20-04 Phase I

threshold indicating significance in Table 8 was a score above 30 (therefore, impacts scoring 30 and below are not significant on the basis of their overall impact scores). The team determines the establishment of this cutoff value based on site considerations that should account for resources, risks, mission impact and priorities. This overall score also serves as a useful factor for allocating resources in the EMPs. In general, the higher the score, the more opportunity and incentive for improvement. In other words, a higher overall score generally represents a higher payback potential in terms of lowering risks. The three tests below are the recommended criteria for determining significance on DOE sites. The highlighted fields in Table 8 indicate significance.  Overall impact score above some site-selected threshold value (Overall Score column, Table 8)  Mission impact score of “5” (Mission Score column, Table 8)  Regulatory status score of “5” (Reg. Score column, Table 8) Table 8a illustrates how the site could rank environmental aspects for overall significance based on environmental and organizational considerations. As discussed previously, our examples use a score greater than 30 as the threshold for determining significance. With an overall score of 45, radioactive waste generation has the highest score. When allocating resources in the EMP, this environmental aspect would receive the highest priority. I-28 D O E G 450.1-2 8-20-04 P hase I Table 8. Determination of Significance Based on Environmental and Organizational Considerations Env. Aspect Activities/ Products/Services Potential Impacts R eg . S co re E n vi ro n m en ta l S co re M is si on S co re L ik el ih oo d S co re O ve ra ll S co re Significance based on 1. overall score>30 2. reg. Score 3. mission score Air Emissions Using and Storing Chem. Products and Chem. Hazardous Agents General reduction in air quality, and potential human, ecological, and habitat effects in the locality, spreading over a large footprint affecting all media and biota. Noncompliance with applicable laws/regulations. 5 4 3 3 26 Significant on: Reg. Score Constructing or Modifying Facilities, Processes, or Equipment Deactivating, Decommissioning, Dismantling, or Closing Facilities, Equipment, and Processes Maintaining, Servicing or Repairing Refrigeration and Air Conditioning Equipment Constructing Hazardous Waste Units Combusting fuel for heat, power or electricity Closing Waste Management Units Disturbance of Cultural and Historical Resources Constructing or Modifying Facilities, Processes, or Equipment Ecological damage, damage of culturally and historically significant artifacts. Noncompliance with applicable laws/regulations. 5 3 3 2 17 Significant on: Reg. Score Conducting Open Burning Constructing or Modifying Aboveground and Underground Storage Tanks Releases to Wastewater System and Ground Water Deactivating, Decommissioning, Dismantling, or Closing Facilities, Equipment, and Processes Runoff to local rivers and streams with species, habitat, and fisheries impacts. Leaching to ground water (aquifers) and biota. Noncompliance with applicable laws/regulations. 5 4 3 4 33 Significant on: Reg. Score Overall Score Conducting Research and Development Leaks, Spills, and Releases Closing Waste Management Units Medical Waste Generation, Management and Disposal Conducting Research and Development

Ecological damage, contamination of air, water and soil with biohazards, impacts to human health and biota, waste generation Noncompliance with applicable laws/regulations. 5 4 4 1 13 Significant on: Reg. Score Radioactive waste generation Preparing Buildings or Facilities for Transfer to Surplus, Inactive Facility Status or D & D Ecological damage, contamination of air, water and soil with radiological material, impacts to human health and biota, waste generation. Noncompliance with applicable laws/regulations. 5 5 5 4 45 Significant on: Reg. Score Mission Score Overall Score Releases, leaks, spills or unusual operating conditions from USTs Closing Waste Management Units Conducting Research and Development Disposition of Excess Materials Cleanup of Legacy Waste Sites Treating, Storing and Disposing of Waste DOE G 450.1-2 I-29 8-20-04 Phase I Table 8a. Rank of Overall Significance Based on Environmental and Organizational Considerations Environmental Aspect Significance based on overall score Overall Score Rank as a significant environmental impact Air Emissions Significant on: Regulatory Score 26 3 Disturbance of Cultural/Historical Resources Significant on: Regulatory Score 17 4 Releases to Wastewater System and Ground Water Significant on: Regulatory Score Overall Score 33 2 Medical Waste Generation, Management and Disposal Significant on: Regulatory Score 13 5 Radioactive Waste Generation, Management and Disposal Significant on: Regulatory Score Mission Score Overall Score 45 1 Step 3 Setting Objectives and Targets Step 1 Step 2 Step 4 Step 5 Step 6 Step 7 Step 8 Step 9 Step 10 Phase I Phase II Phase III Phase IV Your current location on the ISMS/EMS Integration Road Map You are here Step 3 3.1 TASK 5: DEVELOP OBJECTIVES AND TARGETS TO ADDRESS SIGNIFICANT ASPECTS References This task fulfills several DOE Order requirements listed below.  The ISMS/EMS includes measurable environmental goals, objectives, and targets [DOE O 450.1 §4.a.(3)]. Task 5. Develop objectives and targets to address significant aspects. Task 6. Formalize environmental objectives and targets and develop the Environmental Management Program . I-30 DOE G 450.1-2 8-20-04 Phase I  The ISMS/EMS includes site-specific goals that contribute to the accomplishment of DOE pollution prevention and energy efficiency goals [DOE O 450.1 §5.c.(3)].  Contractor ES&H performance objectives, performance measures, and commitments include appropriate environmental elements based on the environmental risks, impacts of activities at the site and established Departmental pollution prevention/energy efficiency goals [DOE O 450.1 §5.d.(17)]. The provisions in this task relate to established requirements of the following DOE Policies and Department of Energy Acquisition Regulations (DEAR).  DOE P 450.5, “The Departments and contractors’ line organizations (a) Work together to develop ES&H performance objectives, measures, and expectations, . . . as well as performance goals and objectives of the [Environment, Safety and Health] Management System elements.”  DOE P 450.5, “A robust, rigorous, and credible contractor self-assessment program linked to the DOE [Environment, Safety and Health] Management System is in place, which includes elements that address . . . performance measures and performance indicators . . . .”

 DEAR clause 970.5223-1(d), “The [ISM] System shall describe how the contractor will establish, document, and implement [environment, safety and health] performance objectives, performance measures, and commitments . . . . The System shall also describe how the contractor will measure system effectiveness.”  DEAR clause 970.5223-1(e), “On an annual basis, the contractor shall review and update . . . its [environment, safety and health] performance objectives, performance measures, and commitments . . . .” Task 5 sets forth the approach for setting objectives and targets for the significant environmental aspects. It is through the achievement of these objectives and targets that an organization addresses its significant aspects, including its compliance, mission, and environmental risks. To be confident that the objectives and targets will be effective in addressing the significant environmental aspects, it is important that they be systematically established and periodically reviewed and reconsidered within the management review process. 3.1.1 Defining Objectives and Targets Setting objectives and targets requires a clear understanding of the exact meaning of these terms. The following paragraphs explain how the ISMS/EMS team might apply the terms in an EMS. EMS Objectives Objectives describe the organization’s goals for environmental performance. The organization should set measurable (and if possible quantifiable) objectives. Some objectives are quantifiable, while others that cannot be quantified may still be measured quantitatively. For example, the organization may set an objective to reduce pesticide usage by 4 percent in the first year. Such a quantified objective is possible because the organization is aware of its previous pesticide usage and thus has a baseline against which it can measure improvement. DOE G 450.1-2 I-31 8-20-04 Phase I An objective to develop a plan to reduce the use of hazardous chemicals by 20 percent through the use of less hazardous substitutes is measurable even if it is not quantifiable. Another common example of this relates to compliance. If the organization has achieved compliance with a regulatory requirement, it may set its objective to maintain compliance. The key when setting objectives is to ensure that they are measurable whether or not they are quantifiable. EMS Targets Targets are specific and measurable immediate steps that the organization can achieve in terms of obtaining the objectives. When the organization has set objectives, it may break them down into more specific subordinate targets. For example, an objective may be to reduce pesticide use by 20 percent in 2 years. Targets for this objective may include reductions of pesticide usage by 10 percent in grounds maintenance and by 10 percent in facility pest control. When the objective is not quantified, targets can be used to provide performance measures by setting dates for completion of specific tasks. For example, if the objective is to develop a plan to reduce the use of hazardous chemicals by 20 percent through the use of less hazardous substitutes, the targets may define the completion date for this plan, (i.e., within 1 year). 3.1.2 Approach to Setting Objectives and Targets

The ISMS/EMS team should consider a variety of factors when setting objectives and targets to ensure that the objectives and targets are feasible and achievable. The following paragraphs describe some well-recognized factors. However, there may be other factors specific to the organization that the team should consider. These include any items that the ISMS/EMS team believes may influence the effectiveness of the objectives and targets. The pollution prevention possibilities for a given aspect should be considered before setting objectives and targets. Considerations for setting objectives and targets include the following.  Applicability of regulatory requirements, Executive Orders, and DOE Orders.  Applicability of pollution prevention opportunities.  Views of interested parties, such as employees, neighbors, environmental groups, and customers.  Financial, operational, and technological options available and feasible for the organization.  Organizational mission and need for continued operations.  Direction and commitments described in the organization’s environmental policy. Setting Objectives and Targets In addition, the ISMS/EMS team should consider measurability and timeframes when setting objectives and targets. Whenever possible, the ISMS/EMS team should set objectives and targets in quantitative terms, with specific timeframes for accomplishment, to facilitate performance monitoring and trends analysis. However, while measurability should normally be specified, quantification is not a requirement. In some cases, quantification may not be possible because there is no baseline against which to measure performance of the environmental aspect. I-32 DOE G 450.1-2 8-20-04 Phase I In these cases, the first cycle of measurements will serve as a baseline against which to compare future performance. Estimated resource requirements may be set for each objective and target. These resources include financial requirements, time needed, and manpower resources needed for achieving the objectives and targets. The ISMS/EMS team should list all of the objectives with detailed descriptions, including all of the targets that make up each objective and a detailed resource estimate and justification. This information is necessary for assessing the ISMS/EMS. In addition, the ISMS/EMS team should maintain a summary table to track progress toward developing objectives and targets and to keep as a record after the objectives and targets are formalized. Table 9 is an example of this type of summary table. 3.2 TASK 6: FORMALIZE ENVIRONMENTAL OBJECTIVES AND TARGETS AND DEVELOP THE ENVIRONMENTAL MANAGEMENT PROGRAM The final task in Phase I is to formalize the organization’s objectives and targets. The primary decision makers (management) in the organization must agree on the objectives and targets before they can be formalized. Management must review the detailed descriptions of the objectives, the resource estimates, and any other related information necessary for it to authorize implementation of programs for achieving the objectives and targets (see Table 9). Once management has authorized the use of resources and the development of programs to achieve objectives and targets, the organization can proceed to accomplish those aims through development of an Environmental Management Plan. The organization creates the EMP for achieving the objectives and targets set for significant environmental aspects. These new, modified, or existing EMPs should clearly describe any additional actions and tasks needed to achieve the objectives and targets for the EMS elements. For additional guidance on EMPs, see Section 5.1.1 of this Guide.

D O E G 450.1-2 I-33 (and I-34) 8-20-04 P hase I Table 9. Overview of Objectives, Targets, Required Resources, and Management Approval Status Env. Aspect Activities/ Products/Services Potential Impacts Significance based 1 overall score>30 2 reg. score 3 mission score Objective Target R es ou rc e (F T E ) A p p ro va l Air Emissions Using and Storing Chem. Products and Chem. Hazardous Agents General reduction in air quality, and potential human, ecological, and habitat effects in the locality, spreading over a large footprint affecting all media and biota. Noncompliance with applicable laws/regulations. Significant on: Reg. Score Reduce air emissions Reduce number of violations for non compliance Conduct PPOA in a 1st quarter of FY. Report results in 3rd quarter of FY, set new target to implement P2 solution by 4th quarter of the second year 0.75 yes Constructing or Modifying Facilities, Processes, or Equipment Deactivating, Decommissioning, Dismantling, or Closing Facilities, Equipment, and Processes Maintaining, Servicing or Repairing Refrigeration and Air Conditioning Equipment Constructing Hazardous Waste Units Combusting fuel for heat, power or electricity Closing Waste Management Units Disturbance of Cultural Historical Resources Constructing or Modifying Facilities, Processes, or Equipment Ecological damage, damage of culturally and historically significant artifacts. Noncompliance with applicable laws/regulations. Significant on: Reg. Score Ensure that cultural and historical preservation training is available to waste management staff Have training program in place within 9 months 0.5 yes Conducting Open Burning Constructing or Modifying Aboveground and Underground Storage Tanks Releases to Wastewater System and Ground Water Deactivating, Decommissioning, Dismantling, or Closing Facilities, Equipment, and Processes Runoff to local rivers and streams with species, habitat, and fisheries impacts. Leaching to ground water (aquifers) and biota. Noncompliance with applicable laws/regulations. Significant on: Reg. Score Overall Score Conduct PPOA of all activities and processes that produce discharges and identify opportunities to eliminate or reduce discharges. Conduct PPOA in 1st quarter of FY. Report results in 3rd quarter of FY, set new target to implement P2 solutions by 4th quarter of second year. 2.0 yes Conducting Research and Development Leaks, Spills, and Releases Medical Waste Generation, Management and Disposal Conducting Research and Development Ecological damage, contamination of air, water, and soil with biohazards, impact to human health and biota, waste generation. Noncompliance with applicable laws/regs. Significant on: Reg. Score Analyze ways to reduce waste generation & maintain full reg. compliance Reduce waste generation by 5% in 2 years. 0.5 yes Radioactive waste generation Closing Waste Management Units Waste storage and disposal; harm to the environ. impact to human health and biota; solid waste generation. Noncompliance with applicable laws/regs. Significant on: Reg. Score Mission Score Overall Score Analyze ways to reduce waste generation Achieve full regulatory compliance Reduce waste generation by 5% in 2 years. Develop program to achieve full compliance within 2 years 3.0 yes Treating, Storing, Disposal of Waste Releases, Leaks, Spills, Releases from Waste Management Activities Disposition of Excess Materials CHAPTER II. PHASE II—IMPLEMENTATION

AND OPERATION DOE G 450.1-2 II-1 8-20-04 Phase II Step 4 Integrated Safety Management System/ Environmental Management System Documentation Step 1 Step 2 Step 5 Step 6 Step 7 Step 8 Step 9 Step 10 Phase I Phase II Phase III Phase IV Your current location on the ISMS/EMS Integration Road Map You are here Step 3 Step 4 4.1 TASK 7: UPDATING THE INTEGRATED SAFETY MANAGEMENT SYSTEM/ENVIRONMENTAL MANAGEMENT SYSTEM DESCRIPTION References This task provides guidance on how to meet the requirements listed below.  The Contractor Requirements Document (CRD) attached to DOE O 450.1 specifies that one of the requirements of the Order is to “update approved ISMS descriptions as necessary to include EMS requirements of this CRD. The provisions in this task relate to established requirements of the following Integrated Safety Management System (ISMS) elements.  DEAR clause 970.5223-1(e), “The contractor shall submit to the contracting officer documentation of its [ISM] System for review and approval.”  ISM Guiding Principle 7, “Operations Authorization. The conditions and requirements to be satisfied for operations to be initiated and conducted shall be clearly established and agreed upon.” Task 7. Updating the Integrated Safety Management System/ Environmental Management System Description Task 8. Developing an Environmental Management System Roadmap II-2 DOE G 450.1-2 8-20-04 Phase II ISMS Description A tool that describes an organization’s approach to integrating ES&H requirements into conducting its work and helps to maintain and manage all information and documents relating to its ISMS/EMS. 4.1.1 Background DEAR 970.5223-1 requires that the ISMS be documented, and many DOE sites have already met this requirement through the use of an ISMS description, which the contractor prepares and DOE approves. Generally, the ISMS description identifies existing policies, procedures, and manuals of practice used when performing work. In addition, many contractors have found it beneficial to provide details on the overall ISMS philosophy or vision, the implementation mechanisms, and the contractor’s approach to integrating Environment, Safety and Health requirements into the processes for planning and conducting work at the site to effectively protect the workers, the public, and the environment. Most contractors have organized their ISMS descriptions to reflect the core functions and guiding principles of ISMS. Section 5.d. (2) of DOE O 450.1 requires the ISMS description to be updated, as necessary, to include the Environmental Management System (EMS) elements required by the Order. In many cases, sites with existing ISMSs are likely to have already addressed these EMS elements in their ISMS descriptions. 4.1.2 Documenting Environmental Management System Elements Appendix B contains a list of the EMS elements required by DOE O 450.1 that the ISMS description should include. A gap analysis (see DOE G 450.1-1 for a discussion of conducting a gap analysis) can determine which EMS elements required by DOE O 450.1 are already included in the site’s existing ISMS description. The elements of an EMS and the ISMS core functions and guiding principles are very similar (see DOE G 450.1-1 for a discussion of the similarities between ISMS and EMS). Because of this compatibility between the two systems, updating the ISMS description should be straightforward. For example, if a site’s gap analysis uncovered the need to conduct an environmental aspects analysis, and the site conducted such an analysis, then the contractor should update the ISMS description to include a description of this analysis. Since analyzing environmental aspects is very similar to the “analyze the hazards” concept in ISMS, that part of the description should include a discussion of the environmental aspects analysis.

4.2 TASK 8: DEVELOPING AN ENVIRONMENTAL MANAGEMENT SYSTEM ROADMAP 4.2.1 Background It may be useful for sites to develop a document that lists all the EMS elements required by DOE O 450.1 and describes their location in the ISMS description. This document can act as a checklist of EMS requirements, and allows an auditor or other interested party to quickly determine where all EMS elements are located or referenced in the ISMS description. For example, this checklist might be useful to the Office of Independent Oversight and Performance Assurance, which under the DOE O 450.1 has the responsibility to evaluate the effectiveness of DOE Headquarters and Field implementation of the requirements of the Order. (DOE O 450.1 § 5.e.) This checklist is referred to as the “EMS Roadmap.” DOE G 450.1-2 II-3 8-20-04 Phase II 4.2.2 EMS Roadmap Template Appendix B contains a complete EMS Roadmap template and an example illustrating the use of this template. Although this template is not a requirement of the Order, when the site has fully integrated the EMS Elements into its ISMS, it should be able to provide references for all the DOE O 450.1 requirements. Step 5 Developing Environmental Management Programs Step 1 Step 2 Step 6 Step 7 Step 8 Step 9 Step 10 Phase I Phase II Phase III Phase IV Your current location on the ISMS/EMS Integration Road Map You are here Step 3 Step 4 Step 5 5.1 TASK 9: CREATE ENVIRONMENTAL MANAGEMENT PROGRAMS References This task provides guidance on how to meet the DOE O 450.1 requirements listed below.  The ISMS/EMS includes policies [and] procedures to manage, control, and mitigate the potential impacts of site activities with significant environmental impacts [DOE O 450.1 §4.a. (2)].  The ISMS/EMS includes (if applicable) conformity of DOE proposed actions with State Implementation Plans to attain and maintain national ambient air quality standards [DOE O 450.1 §4.b. (1)(a)]. Task 9. Create environmental management programs Task 10. Document environmental management programs Task 11. Approve environmental management programs II-4 DOE G 450.1-2 8-20-04 Phase II Environmental Management Program An environmental management program is created to achieve goals, objectives, and targets set for significant environmental aspects.  The ISMS/EMS includes (if applicable) implementation of a watershed approach for surface-water protection [DOE O 450.1 §4.b. (1)(b)].  The ISMS/EMS includes (if applicable) implementation of a site-wide approach for ground water protection [DOE O 450.1 §4.b. (1)(c)].  The ISMS/EMS includes (if applicable) protection of other natural resources, including biota [DOE O 450.1 §4.b. (1)(d)].  The ISMS/EMS includes development and implementation of cost-effective pollution prevention programs that use life-cycle assessment concepts and practices in determining program return-on-investment [DOE O 450.1 §5.c. (4)].  The ISMS/EMS includes (if applicable) protection of cultural resources [DOE O 450.1 §4.b. (1)(f)].  The ISMS/EMS includes (if applicable) protection of site resources from wildland and operational fires [DOE O 450.1 §4.b. (1)(e)].  The ISMS/EMS provides for reduction or elimination of: the generation of waste, the release of pollutants to the environment, and the use of Class I ozone-depleting substances (ODS), through source reduction, reuse, segregation, and recycling and by procuring recycled-content materials and environmentally preferable products and services [DOE O 450.1 §4.b. (3)].

 The ISMS/EMS promotes the long-term stewardship of a site’s natural and cultural resources throughout its operational, closure, and post-closure life cycle [DOE O 450.1 §4.b. (2)]. The provisions in this task relate to established requirements of the following ISMS elements.  ISM Guiding Principle 6, “Hazard Controls Tailored to Work Being Performed. Administrative and engineering controls to prevent and mitigate hazards shall be tailored to the work being performed and associated hazards.”  Environmental management programs—environmental management programs [a subset of management programs (MP) in the ISMS/EMS] address the environmental goals, objectives, and targets set for significant environmental aspects. 5.1.1 Create Environmental Management Programs At this point, the ISMS/EMS team should have identified the organization’s significant environmental aspects and established new or modified goals, objectives and targets based on the Chapter 1, Phase I guidance. The next task is to develop Environmental Management Programs (EMPs) to achieve these goals, objectives and targets. Sites may approach the creation of EMPs from different perspectives. They may DOE G 450.1-2 II-5 8-20-04 Phase II develop one for each significant environmental aspect (identified in Chapter 1, Phase I); they may develop one for each objective and target; they may develop them for activities that contain significant environmental aspects; and they may even develop them for facilities with many significant environmental aspects. Wherever possible, sites should use existing ISMS programs to address the EMS goals, objectives and targets. If there is no suitable program under the ISMS, then the team should create new EMPs for that purpose. Whatever approach sites use should suit their operations and make best use of existing programs. EMPs should cover all EMS goals, objectives and targets set for significant environmental aspects and should include the allocation of organizational resources, the assignment of environmental management program responsibilities for tasks, and the specification of timelines for actions that are to be taken. It is also useful to document other EMS elements in the EMP such as employee training, operational controls, performance indicators, and relevant legal requirements. 5.2 TASK 10: DOCUMENT ENVIRONMENTAL MANAGEMENT PROGRAMS The site should formally document its EMP. The EMP template, contained in Appendix B, is an optional approach for structuring the documentation of an EMP. A DOE site developed and used the template contained in Appendix B. Although many sites already have well-documented management programs, this template is useful for those sites that do not have written programs; those sites that have documented programs but would like to compare these programs against an alternative approach; and those sites that have formal documented programs for most of their goals, objectives, and targets but need to address some new ones related to the EMS elements. 5.3 TASK 11: APPROVE ENVIRONMENTAL MANAGEMENT PROGRAMS Reference This task provides guidance on how to meet the DOE Order requirements listed below.  DOE Operations/Field/Site Office Managers must “ensure that contractors with approved ISMS descriptions update the ISMS description as necessary, to include the EMS requirements of this Order.” [DOE O 450.1 § 5.d. (2)] The provisions in this task relate to established requirements of the following ISMS element.

 DOE P 450.4, “Responsibilities must be clearly defined in documents appropriate to the activity. For each management mechanism employed to satisfy [an environment, safety, and health] management principle or function, the associated approval authority needs to be established. The review and approval levels may vary commensurate with the type of work and the hazards involved.” II-6 DOE G 450.1-2 8-20-04 Phase II 5.3.1 Review and Approval Once completed, the EMPs should be presented to appropriate management for review and approval. The ISMS/EMS team should incorporate management’s comments before gaining final approval. Management’s approval should be obtained before individuals are trained, new activities designated, and resources expended. 5.3.2 Placement of Completed Environmental Management Program Documents The ISMS/EMS description should reference the EMPs, after their approval. Step 6 Developing Operational Controls Step 1 Step 2 Step 7 Step 8 Step 9 Step 10 Phase I Phase II Phase III Phase IV Your current location on the ISMS/EMS Integration Road Map You are here Step 3 Step 4 Step 5 Step 6 6.1 TASK 12: SPECIFY OPERATIONAL CONTROLS References This task provides guidance on how to meet the DOE Order requirements listed below.  The ISMS/EMS includes procedures to manage, control, and mitigate the potential impacts of site activities with significant environmental impacts [DOE O 450.1 §4.a.(2)].  The ISMS/EMS includes training to identify activities with significant environmental impacts [DOE O 450.1 §4.a.(2)]. Task 12. Specify Operational controls Task 13. Approve Operational controls DOE G 450.1-2 II-7 8-20-04 Phase II  The ISMS/EMS includes training to manage, control, and mitigate the potential impacts of site activities with significant environmental impacts [DOE O 450.1 §4.a.(2)].  The ISMS/EMS includes training to assess performance and implement corrective actions where needed [DOE O 450.1 §4.a.(2)].  The ISMS/EMS provides for obtaining, as appropriate, community advice relevant to aspects of “Greening the Government” Executive Orders, through new or existing outreach programs [DOE O 450.1 §5.d.(3)]. The provisions in this task relate to established requirements of the following ISMS elements.  ISM Core Function 3, “Develop and Implement Hazard Controls: . . . controls to prevent/mitigate hazards are identified, the [environment, safety and health] envelope is established, and controls are implemented.”  ISM Core Function 4, “Perform Work within Controls.” 6.1.1 Specifying Operational Controls As mentioned in Step 5, operational controls are an important element for managing EMS goals, objectives, and targets. Operational controls are applied to specific activities or processes managed by the EMP and can fall into two categories: (1) engineering controls and (2) administrative controls. Engineering controls intervene mechanically to avoid a potential incident. A simple example is using a funnel to reduce the chance of oil spills. Administrative controls include procedural approaches to activities, such as training employees on the procedure for filling fuel tanks. Frequently, sites use administrative and engineering controls in combination, in which case the procedure incorporates the funnel as one of the mechanical controls workers are to follow when filling fuel tanks. The ISMS/EMS should reference these operational controls.

Sites should apply operational controls to the activities, products, and services that give rise to significant environmental aspects. For example, energy use may have been designated as a significant environmental aspect. One of the activities that could cause this aspect may be office work. While it may not be feasible to set operational controls for office work as a whole, individual operational controls can be set for each contributing source such as computers, the office kitchen, and office heating, all of which are component parts of office work. Sites implement operational controls as integral parts of the EMPs. Another example is an objective to reduce hazardous waste produced by a laboratory. In this case, the site could apply operational controls to specific tasks, processes, or analytical techniques. Wherever possible, sites should use existing operational controls to control the occurrence of specific aspects identified in Phase I. However, it is possible that sites will need to develop new operational controls to address specific operations and activities that have significant environmental aspects as identified in Phase I. The ISMS/EMS description should reference these new operational controls. The operational control template, provided in Appendix B, is an approach that many organizations have used effectively to document their operational controls. II-8 DOE G 450.1-2 8-20-04 Phase II 6.2 TASK 13: APPROVE OPERATIONAL CONTROLS Reference This task provides guidance on how to meet the DOE Order requirements listed below.  DOE Operations/Field/Site Office Manager’s must “ensure that contractors with approved ISMS descriptions update the ISMS description as necessary, to include the EMS requirements of this Order.” [DOE O 450.1 §5.d.(2)] The provisions in this task relate to established requirements of the following ISMS element.  DOE P 450.4, “Responsibilities must be clearly defined in documents appropriate to the activity. For each management mechanism employed to satisfy [an environment, safety and health] management principle or function, the associated approval authority needs to be established. The review and approval levels may vary commensurate with the type of work and the hazards involved.” 6.2.1 Review and Approval Once completed, an operational control should be sent to appropriate management for review and approval. The ISMS/EMS team should incorporate management’s comments before gaining its approval. The team should obtain management’s approval before individual training, designation of new activities, and resource expenditures occur. 6.2.2 Placement of Completed Operational Controls The ISMS/EMS description should reference operational controls after their approval. DOE G 450.1-2 II-9 8-20-04 Phase II Step 7 Develop Integrated Safety Management System/Environmental Management System Procedures Step 1 Step 2 Step 8 Step 9 Step 10 Phase I Phase II Phase III Phase IV Your current location on the ISMS/EMS Integration Road Map You are here Step 3 Step 4 Step 5 Step 6 Step 7 7.1 TASK 14: ESTABLISH INTEGRATED SAFETY MANAGEMENT SYSTEM/ ENVIRONMENTAL MANAGEMENT SYSTEM PROCEDURES References This task provides guidance on how to meet the DOE Order requirements listed below.  The ISMS/EMS includes policies, procedures to assess performance [DOE O 450.1 §4.a.(2)].  Contractor ES&H self-assessment programs within the framework of DOE P 450.5 are established and continue to be effective [DOE O 450.1 §5.d.(16)].

Task 14. Establish Integrated Safety Management System/Environmental Management System procedures Task 15. Document Integrated Safety Management System/Environmental Management System procedure templates Task 16. Approve Integrated Safety Management System/Environmental Management System procedures Task 17. Implement Integrated Safety Management System/Environmental Management procedures II-10 DOE G 450.1-2 8-20-04 Phase II  The ISMS/EMS ensures the early identification of, and appropriate response to, potential adverse environmental impacts associated with DOE operations, including, as appropriate, preoperational characterization and assessment and effluent and surveillance monitoring [DOE O 450.1 §4.b.(4)].  The ISMS/EMS provides for the conduct of environmental monitoring, as appropriate, to support the site’s ISMS, to detect, characterize, and respond to releases from DOE activities [DOE O 450.1 §5.d.(14)].  The ISMS/EMS provides for the conduct of environmental monitoring, as appropriate, to assess impacts, to estimate dispersal patterns in the environment, to characterize the pathways of exposure to members of the public, and to characterize the exposures and doses to individuals, and to the population [DOE O 450.1 §5.d.(14)].  The ISMS/EMS provides for the conduct of environmental monitoring, as appropriate, to evaluate the potential impacts to the biota in the vicinity of the DOE activity [DOE O 450.1 §5.d.(14)].  The ISMS/EMS provides for the implementation of the analytical work supporting environmental monitoring using a consistent system for collecting, assessing, and documenting environmental data of known and documented quality [DOE O 450.1 §5.d.(15)(a)].  The ISMS/EMS provides for the implementation of the analytical work supporting environmental monitoring using a validated and consistent approach for sampling and analysis of radionuclide samples to ensure laboratory data meet program-specific needs and requirements within the framework of a performance-based approach for analytical laboratory work [DOE O 450.1 §5.d.(15)(b)].  The ISMS/EMS provides for the implementation of the analytical work supporting environmental monitoring using an integrated sampling approach to avoid duplicative data collection [DOE O 450.1 §5.d.(15)(c)]. The provisions in this task relate to established requirements of the following ISMS elements.  DOE P 450.4, “[Environment, Safety and Health] Mechanisms define how the core [environment, safety and health] management functions are performed. The mechanisms may vary from facility to facility and from activity to activity based on the hazards and the work being performed and may include: contractor policies, procedures and documents . . . established to implement [environment, safety and health] management . . . .”  ISM Core Function 3, “Develop and Implement Hazard Controls: . . . controls to prevent/mitigate hazards are identified, the [environment, safety and health] envelope is established, and controls are implemented.”  ISM Core Function 4, “Perform Work within Controls.” DOE G 450.1-2 II-11 8-20-04 Phase II 7.1.1 Integrated Safety Management System/Environmental Management System Procedures Standard operating procedures are an essential element of any management system. Sites should document these procedures, as well as other procedures that are repeatedly carried out in the ISMS/EMS. By documenting all procedures, sites improve the likelihood that they are carried out consistently and reliably. Table 10 of Appendix B lists all the procedures required by DOE O 450.1, as well as the procedures that are recommended. Sites should consider documenting all these procedures.

7.1.2 The Role of Integrated Safety Management System/Environmental Management System Procedures Standard Operating Procedures include two types of procedures: (1) those that directly address environmental issues, such as the procedure for identifying environmental aspects, the procedure for identifying legal and other requirements and the procedure for setting goals, objectives, and targets, and (2) those that are administrative, such as record keeping and document control. Many DOE sites may already have most of these procedures. Standard operating procedures enable information to flow to individuals at the relevant functions and levels of the organization. This provides them with the knowledge and expertise to manage the day-to-day environmental impacts of their work activities and to support the organization’s ISMS/EMS goals, objectives and targets. ISMS/EMS procedures also promote reliable and appropriate information flows that allow the execution of emergency response plans, the checking of system status and progress, the correction of nonconformances, the upgrading of training levels and competence, the implementation of programs and operational controls to achieve goals, objectives and targets, and the proper involvement and intervention of the organization’s appropriate management. The EMS procedures discussed here can be used to help maintain the effectiveness of the EMS elements within an ISMS/EMS over the long-term. 7.1.3 Keeping Procedures Simple ISMS/EMS procedures should be simple to implement and execute on an ongoing basis. The major goal of achieving reliability in the management of environmental, safety and health (ES&H) exposures can be jeopardized by complicated or unnecessarily prescriptive procedures. This is particularly important in using the ISMS/EMS to integrate ES&H programs into the organization’s total operations and not just those of the ES&H staff. 7.2 TASK 15: DOCUMENT INTEGRATED SAFETY MANAGEMENT SYSTEM/ENVIRONMENTAL MANAGEMENT SYSTEM PROCEDURES 7.2.1 Integrated Safety Management System /Environmental Management System Procedures In many cases, DOE sites will already have the majority of these procedures in place, including records management, document control, emergency preparedness and response, and training as part of the ISMS or as part of the site general management system. Usually it is possible to incorporate the appropriate EMS requirements directly into these existing procedures. II-12 DOE G 450.1-2 8-20-04 Phase II Therefore, ISMS/EMS teams should identify potentially applicable existing procedures wherever possible and then use them as the basis for satisfying any additional EMS requirements. If there is no existing procedure, the site should develop a new procedure to fulfill the requirement of the ISMS/EMS. 7.2.2 Implementing Integrated Safety Management System/Environmental Management System Procedures

The ISMS/EMS team should coordinate the preparation of the ISMS/EMS procedures. The task of drafting new procedures or revising existing ones will fall either to the environmental staff or to functional staff members responsible for that particular activity in the organization. For example, the administrative staff at the site may modify records management and document control procedures to conform to the expanded ISMS/EMS requirements. Responsibility for modifying the emergency preparedness and response procedure may be a task for the emergency response and occupational health and safety staff with input from the environmental staff on the potential environmental consequences and the proper manner to respond to them. On the other hand, those assigned to environmental duties are more likely to write the environmental aspects identification procedure. Planning and coordinating the responsibilities for drafting the ISMS/EMS procedures constitute a major effort. Sites should designate an individual to serve as the ISMS/EMS coordinator to coordinate the procedure drafting process. He or she should ensure that, to the greatest extent possible, such procedures do not duplicate existing site or ISMS procedures. The goal, rather, is to promote the total integration of EMS elements into the ISMS/EMS. All employees have some role to play in the implementation of ISMS/EMS. This is because all job functions within the organization are likely to have the opportunity to interact with the ISMS/EMS at some point. Therefore, all employees should be able to implement those procedures that specifically apply to their job functions. 7.3 TASK 16: APPROVE INTEGRATED SAFETY MANAGEMENT SYSTEM/ ENVIRONMENTAL MANAGEMENT SYSTEM PROCEDURES References This task fulfills the DOE Order requirements listed below.  The ISMS/EMS provides for the evaluation of programs for compliance with applicable requirements [DOE O 450.1 §4.a. (1)(c)].  The ISMS/EMS provides for the evaluation of programs for public health and environmental protection [DOE O 450.1 §4.a. (1)(a)].  The ISMS/EMS provides for the evaluation of programs for pollution prevention [DOE O 450.1 §4.a. (1)(b)].  The assessment of ISMS/EMS implementation is a component of the implementation of DOE P 450.5 Line Environment, Safety and Health Oversight (DOE O 450.1 §5.b.). DOE G 450.1-2 II-13 8-20-04 Phase II  The ISMS/EMS includes policies and procedures to implement corrective actions where needed [DOE O 450.1 §4.a. (2)]. The provisions in this task relate to established requirements of the following ISMS element.  DOE P 450.4, “Responsibilities must be clearly defined in documents appropriate to the activity. For each management mechanism employed to satisfy [an environment, safety and health] management principle or function, the associated approval authority needs to be established. The review and approval levels may vary commensurate with the type of work and the hazards involved.” 7.3.1 Review and Approval It is essential that appropriate management review and approve new or adapted procedures. Once the ISMS/EMS procedures are complete, the ISMS/EMS team should provide them to appropriate management for review, and incorporate management’s comments before obtaining final approval. The procedures must be approved by management before it is implemented at the site. 7.4 TASK 17: IMPLEMENT INTEGRATED SAFETY MANAGEMENT SYSTEM /ENVIRONMENTAL MANAGEMENT SYSTEM PROCEDURES

References The provisions in this task relate to established requirements of the following ISMS elements.  ISM Core Function 4, “Perform Work within Controls.”  ISM Guiding Principle 3, “Competence Commensurate with Responsibilities. Personnel shall possess the experience, knowledge, skills, and abilities that are necessary to discharge their responsibilities.” 7.4.1 Background The site should implement ISMS/EMS procedures at all levels and functions and integrate the procedures into the existing site system, so all site employees can follow them. Procedures should reflect, therefore, actions occurring on the ground at the site. It is also essential that all employees in the organization be able to easily follow the procedures that apply to their job functions. 7.4.2 Training Training is an important part of the implementation of the ISMS/EMS procedures. The site should make all employees aware of the procedures through general awareness training, which should detail, in particular, any changes made to existing procedures. II-14 DOE G 450.1-2 8-20-04 Phase II 7.4.3 Responsibility for Maintaining Records The implementation of procedures creates records in the ISMS/EMS. These include training records, audit reports, minutes of meetings, records of equipment calibration, reports of compliance status, lists of aspects and legal requirements, communication memorandums, measurements of outcomes, and so on. Each procedure should specify the basis for producing such records. At the time of implementation, all appropriate personnel must be aware of who is responsible for creating, managing, labeling, collecting, and storing these records. 7.4.4 Maintaining Procedures Over time, it will be necessary to make changes to the procedures as employees identify elements for improvement or new record needs are identified as site operations evolve. In particular, it is likely that many changes will be necessary soon after the initial implementation of procedures. The first time a procedure is used often reveals many areas for its improvement. Following this initial modification, the site should update procedures periodically as operations and systems evolve. This is part of the continual improvement process of the ISMS/EMS. As these updates occur, the ISMS/EMS coordinator should ensure—  procedures are controlled in accordance with the site’s document control procedure and only the latest approved version of each procedure is in circulation for use by employees,  the revision date is displayed on each procedure, and  employees are aware of any changes and have access to the latest authorized versions. 7.4.5 Accessibility Because the purpose of procedures is to standardize common activities that occur in the ISMS/EMS to ensure their performance to the same high standard, employees should have easy access to the procedures. The accessibility of a procedure to employees is the result of several factors described below. Physical Accessibility The ISMS/EMS relies heavily on the participation and contributions of line functions. Physical accessibility ensures that employees can obtain the procedures they are supposed to be following. Physical accessibility is more than merely permitting the retrieval of a document from a file drawer; it requires that access to the document be convenient, immediate, and encouraged.

Employees need to know that documents exist and their locations, and that they have ready and easy access to them. This may necessitate posters at work sites that point to the location of applicable procedures and that encourage workers to retrieve them. Conceptual Access Employees must also have conceptual access to the specific requirements contained in procedures. This means that, in addition to being able to locate the procedures, they must be able to understand the concepts contained within them. Procedures should be simple and easy to follow for their primary users. DOE G 450.1-2 II-15 (and II-16) 8-20-04 Phase II Operational Access Operational access concerns whether employees can realistically apply the procedure in a real situation. The question to answer here is whether the procedural requirements consider the work area conditions and culture, and whether employees can apply them under those conditions. The internal ISMS/EMS assessment and employee feedback will eventually answer this question. CHAPTER III. PHASE III—CHECKING AND CORRECTIVE ACTION DOE G 450.1-2 III-1 8-20-04 Phase III Step 8 Establishing the ISMS/EMS Assessment Program Step 1 Step 2 Step 9 Step 10 Phase I Phase II Phase III Phase IV Your current location on the ISMS/EMS Integration Road Map You are here Step 3 Step 4 Step 5 Step 6 Step 7 Step 8 8.1 TASK 18: ESTABLISH THE ISMS/EMS ASSESSMENT PROGRAM References This task fulfills requirements in several DOE Directives listed below.  The Integrated Safety Management System/Environmental Management System (ISMS/EMS) provides for the evaluation of programs for public health and environmental protection, pollution prevention, and compliance with applicable requirements [DOE O 450.1 §4.a.(1)].  Contractor ES&H self-assessment programs within the framework of U.S. Department of Energy (DOE) P 450.5 are established and continue to be effective [DOE O 450.1 §5.d.(16)(c)].  The ISMS/EMS includes policies and procedures to assess performance and implement corrective actions where needed [DOE O 450.1 (4.a.(2)]. The provisions in this task also relate to requirements in the following ISMS elements.  ISM Core Function 5, “Provide Feedback and Continuous Improvement: . . . line and independent oversight is conducted . . . .” Task 18. Establish the ISMS/EMS Assessment Program Task 19. Plan the Assessment Task 20. Conduct On-Site Assessment Activities III-2 DOE G 450.1-2 8-20-04 Phase III  DOE P 450.5, “A robust, rigorous, and credible contractor self-assessment program linked to the DOE [Environment, Safety and Health] Management System is in place, which includes elements that address . . . line and independent evaluations.”  DOE P 450.5, DOE field elements conduct “a periodic, value-added appraisal of sufficient frequency and duration to confirm the contractor’s [safe and environmentally sound] performance of work and the effectiveness of the [contractor’s] self-assessment program.”  DOE G 450.4-1B, Chapter III, discusses assessing an ISMS, and Chapter IV discusses maintaining and sustaining an approved ISMS. 8.1.1 Background and Purpose Self-assessment activities range from informal, to formal and structured. The purpose of this section of the Guide is to provide guidance on conducting formal self-assessments. Normally an organization with an appropriate degree of independence from the activity being reviewed conducts these assessments.

The assessment described here (referred to as assessment or ISMS/EMS assessment) is a structured, formal self-assessment used to evaluate a site’s ISMS/EMS. For example, some DOE sites have already established Internal Independent Review Boards that conduct these types of assessments of the site’s ISMS. These existing programs should be used to satisfy the DOE O 450.1 requirement that a site’s ISMS/EMS include policies and procedures to assess performance and implement corrective actions. 8.1.2 The Assessment Program DOE P 450.5, Line Environment, Safety and Health Oversight requires a robust, rigorous and credible contractor E,S & H assessment program linked to the organization’s ISMS that addresses the following: 1. Performance measures and performance indicators. 2. Line evaluations and independent evaluations. 3. Compliance with applicable requirements. 4. Data collection, analysis, and corrective actions. 5. Feedback and performance improvement. As an effective contractor assessment program is established, DOE field elements have oversight functions. Further clarification can be found in Section 2 of DOE P 450.5. Conducting an assessment is not a one-time activity. To ensure that assessments are conducted in an organized fashion with regularity, efficiency, and effectiveness, sites should have an “Assessment Program.” The ongoing activities associated with providing for, preparing for, and carrying out the assessments makes up the site’s Assessment Program. The Assessment Program should also include the establishment of assessment procedures, protocols, and criteria that verify the DOE G 450.1-2 III-3 8-20-04 Phase III effectiveness of both the individual elements of the system and of the system in its entirety (see Figure 1). The Assessment Program should comprise the site’s provisions and arrangements for ongoing assessments as well as its systematic approach for preparing for and planning each ISMS/EMS assessment. Other elements of the Assessment Program should include—  communicating the Assessment Program to relevant parties;  coordinating and scheduling assessments and other assessment program activities;  establishing and maintaining a process for the initial training of the assessment team and for the ongoing evaluation of its training needs;  ensuring the selection of assessment teams;  providing necessary resources to the assessment teams;  ensuring the conduct of assessments in accordance with the Assessment Program;  ensuring the control of records of the assessment activities;  ensuring review and approval of assessment reports, and ensuring their distribution to the site being assessed and other specified parties; and  ensuring assessment followup, when applicable. 8.1.3 Assessment Concepts The ISMS/EMS assessments should be carried out in order to determine whether or not the ISMS/EMS conforms to requirements established by DOE O 450.1 and whether the site has properly implemented and maintained its ISMS/EMS. Based on the review of information gathered during the assessment and the management review, the organization should consider actions or changes to the ISMS/EMS system such as the following.  Corrective actions for functional environment, safety, and health program integration issues.  Corrective actions to improve ISMS/EMS implementation and effectiveness.  Performance measures for the next year.  Any changes required in the assessment focus or criteria.

 Any changes, if required, to an ISMS/EMS description document.  Impacts of any changes in laws, regulations, and directives.  Any changes to the level of resources applied to the ISMS/EMS. III-4 DOE G 450.1-2 8-20-04 Phase III START Figure 1. Sample assessment program. Establish and continually improve the program  Objectives and scope  Responsibilities  Resources  Procedures Implement the program  Selecting competent assessment teams  Directing assessment activities  Recording Monitor and review the program  Identifying opportunities for improvement Provide necessary resources Conduct assessment activities Improve the ISMS/EMS program A C T P L A N D O C H E C K DOE G 450.1-2 III-5 8-20-04 Phase III An ISMS/EMS Assessment is not—  An ISO audit  A self-declaration evaluation  A regulatory compliance assessment  A performance check  The management review The organization should determine whether the ISMS/EMS system and performance objectives, performance measures, and commitments require modification, update, or revision in the scheduled review and approval process. (See DOE G 450.4.-1B.) The ISMS/EMS assessment is a review of system implementation and system strength. It should provide senior management with information concerning the ISMS/EMS and enable managers to identify priority areas for improvement. Information gained from the ISMS/EMS assessment should be reviewed during the management review described in Phase IV. It may be helpful to clarify the meaning and intent of the ISMS/EMS assessment by stating what it is and what it is not.  The ISMS/EMS assessment is a documented process that provides a snapshot view of the ISMS/EMS status at a point in time from which the organization can continue to improve.  It is more than a walk-through (that may or may not be documented) by various individuals within an organization. It is a formal process that uses established criteria for conducting the assessment and individuals within the organization who are trained to conduct the assessments.  It is not primarily a regulatory compliance assessment, so it need not verify the organization’s compliance with applicable laws and regulations. It can, however, make use of information on the compliance status of the organization to ascertain whether the management system is succeeding in addressing compliance and performance goals the organization has set.  It is not, by itself, a performance check to ascertain whether the site is meeting performance goals or making progress toward meeting them. As with compliance, the assessment team may use information on whether the site is meeting performance goals or progressing to evaluate whether the system needs further improvement in certain areas to ensure progress towards meeting certain performance goals. The assessment team should use information on both performance attainments and compliance as indicators of whether the elements of the ISMS/EMS require improvement.  It is not a management review since that is a distinct and separate item of the ISMS/EMS that the organization’s management conducts (see Phase IV). The ISMS/EMS assessment should not duplicate or obviate management’s determination of the suitability, adequacy, and effectiveness of the ISMS/EMS. The ISMS/EMS assessment should, however, determine whether the process established for the management review is sufficiently rigorous to allow the organization’s management to make the determinations of suitability, adequacy, and effectiveness.

III-6 DOE G 450.1-2 8-20-04 Phase III 8.2 TASK 19: PLAN THE ASSESSMENT References This task fulfills requirements in several DOE directives listed below.  The ISMS/EMS provides for the evaluation of programs for public health and environmental protection, pollution prevention, and compliance with applicable requirements [DOE O 450.1 §4.a.(1)].  Contractor ES&H self-assessment programs within the framework of DOE P 450.5 are established and continue to be effective [DOE O 450.1 §5.d.(16)].  The ISMS/EMS includes policies and procedures to assess performance and implement corrective actions where needed [DOE O 450.1 (4.a.(2)]. The provisions in this task also relate to requirements in the following ISMS elements.  ISMS Core Function 5, “Provide Feedback and Continuous Improvement: . . . line and independent oversight is conducted . . . .”  DOE P 450.5, “A robust, rigorous, and credible contractor self-assessment program linked to the DOE [Environment, Safety and Health] Management System is in place, which includes elements that address . . . line and independent evaluations.”  DOE P 450.5, DOE field elements conduct “a periodic, value-added appraisal of sufficient frequency and duration to confirm the contractor’s [safe and environmentally sound] performance of work and the effectiveness of the [contractor’s] self-assessment program.”  DOE G 450.4-1B, Chapter III on assessing ISMSs and Chapter IV on maintaining and sustaining approved ISMSs. Section 8.2.1 discusses audit principles that are relevant and appropriate for ISMS/EMS assessments (see Figure 2). Also included are best-practice descriptions of the implementation of these principles. While it is likely that sites already use many of these principles and practices in their assessments, the discussion below aims to provide additional insights and opportunities for sites to enhance or adapt their existing assessment programs. 8.2.1 Basic Principles The same principles used in the auditing arena are applicable to conducting an assessment. A number of auditing principles ensure that assessments are effective and reliable so as to support management policies and to provide data that personnel can use to improve performance. Adherence to these principles also ensures that assessment team members working independently from one another can reach relevant and consistent assessment conclusions. DOE G 450.1-2 III-7 8-20-04 Phase III The following are two key principles of auditing.  Impartiality—This is the basis for maintaining objectivity of the assessment conclusions. (Assessment team members should be independent of the activity being assessed and be free from bias and conflict of interest. Assessment team members should maintain an objective state of mind throughout the assessment process to ensure that the assessment findings and conclusions will be based only on the collected evidence.)  Evidence-based approach—This is the method for reaching reliable and reproducible assessment conclusions in a systematic assessment process. 8.2.2 Conducting the Assessment Planning Typically, the assessment process should proceed in stages, including preparation, communication, coordination, execution, documentation, and closure. Figure 2, ISMS/EMS assessment process flow chart, illustrates this process. The assessment team may also use existing site assessment processes to accomplish this task.

1. Initiating the assessment plan—The site should assemble an assessment team to develop a plan to conduct the assessment. Initially, the team should ensure that it has all the information necessary to write the plan. It can use a checklist to ensure the availability of the necessary information for the assessment plan. (See sample ISMS/EMS Internal Assessment Preparation Checklist, Appendix C). 2. Completing the assessment plan—Appendix C, provides a sample assessment plan, including instructions regarding how to complete the plan. This or a similar form can help in the planning of an assessment. 8.3 TASK 20: CONDUCT ON-SITE ASSESSMENT ACTIVITIES References This task fulfills requirements in several DOE Directives listed below.  The ISMS/EMS provides for the evaluation of programs for public health and environmental protection, pollution prevention, and compliance with applicable requirements [DOE O 450.1 §4.a.(1)].  Contractor ES&H self-assessment programs within the framework of DOE P 450.5 are established and continue to be effective [DOE O 450.1 §5.d.(16)].  The ISMS/EMS includes policies and procedures to assess performance and implement corrective actions where needed [DOE O 450.1 (§4.a.(2)]. III-8 DOE G 450.1-2 8-20-04 Phase III The provisions in this task also relate to requirements in the following ISMS elements.  ISM Core Function 5, “Provide Feedback and Continuous Improvement: . . . line and independent oversight is conducted . . . .”  DOE P 450.5, “A robust, rigorous, and credible contractor self-assessment program linked to the DOE [Environment, Safety and Health] Management System is in place, which includes elements that address . . . line and independent evaluations.”  DOE P 450.5, “A robust, rigorous, and credible contractor self-assessment program linked to the DOE [Environment, Safety and Health] Management System is in place, which includes elements that address . . . compliance with applicable requirements . . . .”  DOE P 450.5, DOE field elements conduct “a periodic, value-added appraisal of sufficient frequency and duration to confirm the contractor’s [safe and environmentally sound] performance of work and the effectiveness of the [contractor’s] self-assessment program.”  DOE G 450.4-1B, Chapter III, on assessing ISMSs, and Chapter IV, on maintaining and sustaining approved ISMSs. Having completed preparations for the assessment, the assessment team should be ready to conduct the assessment. The team does the assessment primarily through the analyses of documentation and by observing and interviewing employees. The planning phase of the assessment should have identified areas for priority, appropriate staff to be interviewed, and records to be analyzed. The assessment team should communicate these requirements to the organization being assessed prior to the initial meeting so that documents, records, employees to be interviewed, and any required safety items can be available in a timely and convenient manner. The tasks below describe an approach and key stages for conducting on-site assessments. The team can also use existing site assessment processes to accomplish this task. 1. Conduct opening meeting. The assessment team should conduct an opening meeting with appropriate management of the organization it is assessing (e.g., the ISMS/EMS coordinator, facility manager, and other staff if necessary). The following should be included in the opening meeting.

 Proper introductions (initiate an attendance record).  Review of the scope, objectives, and assessment plan and agreement on the timetable.  Short summary of the methods and procedures that will be used.  Establishment of the official communication link between the team and management of the organization to be assessed.  Confirmation that the resources and facilities needed by the team are available.  Confirmation of the time and date of the closing meeting (request that the organization’s senior management be present). DOE G 450.1-2 III-9 8-20-04 Phase III Preparing for On site Audit Activities Preparation of work documents Audit team-work assignments Preparing the audit plan Initiating the Audit  Appointing the audit team leader  Definition of objectives, scope and criteria  Determination of the feasibility of the audit  Establishing the audit team  Initial contact with the auditee  On-site Audit Activities  Conducting opening meeting  Collecting and verifying information  Generate audit findings  Communicating during the audit  Preparing audit conclusions  Conducting closing meeting Prepare for On-Site Activities  Prepare the plan  Make Team assignments  Prepare work documents Reporting on the Audit Audit report preparation Report approval and distribution Retention of documents Audit Completion Audit Follow - up Initiate the Assessment  Appoint the team leader  Define objectives, scope and criteria  Determine feasibility  Establish team  Initiate contact with organization On-Site Activities  Conduct opening meeting  Collect and verify information  Making findings  Communicate during the assessment  Prepare conclusions  Conduct closing meeting    Reporting Assessment report preparation Report approval and distribution Retention of documents Completion Follow-up Review relevant ISMS/EMS documents and records and determine their adequacy Document Review Plan Assessment On-Site Activities Complete Assessment  Encouragement of the active participation of the organization’s personnel during the assessment.  Review of relevant site safety and emergency procedures the team will follow during the assessment. 2. Collect information. Assessment team members collect information in any of three ways: by reviewing documents and records, by interviewing employees, and by observing employees and systems in operation. Figure 2. ISMS/EMS assessment process flow chart. III-10 DOE G 450.1-2 8-20-04 Phase III 3. Assess observations against criteria. Appendix C contains an example of the assessment criteria used by a DOE facility. A sample portion of the Assessment Questionnaire is provided in Table 10. The assessment team can use this questionnaire to determine—  apparent root causes of system failures (for example, inadequate training may be the root cause for repeated failure of an operational control),  areas that conform and have best practices, and  areas where further improvements can be made. 4. Verify against the assessment criteria. 4.1 Findings—The assessment team must classify each of the findings either during the assessment or at its completion (see example in Table 10). The team can classify findings in any way that the assessed organization finds convenient. For example, findings may fall into four classifications.  A = In Conformance  B = Critical: Omission of an ISMS/EMS requirement or failure to implement an EMS Element of the ISMS/EMS.

 C = Serious: A significant number of minor nonconformances against any one ISMS/EMS requirement.  D = Minor: A single nonconformance of a system requirement. 4.2 Recommendations—In addition to findings, the assessment team may identify areas where improvements could be made but that do not warrant a finding (see example in Table 10). Such improvements might include—  alternative approaches that are recognized as best in class,  approaches that enhance organizational mission, and  approaches that reduce cost. 4.3 Comments—The assessment team may include comments in connection with findings, best practices, and opportunities to improve (see example in Table 10). 5. Prepare Assessment Summary Report. In preparation for the assessment’s closing meeting, the assessment team should prepare a Findings and Summary Report that may include—  A summary of the assessment (overall, areas of strength, areas of weakness) and recommendations and  A list of all the findings, including— DOE G 450.1-2 III-11 8-20-04 Phase III  the finding category,  finding description, and  finding location. An Assessment Findings Summary Table and sample ISMS/EMS Assessment Summary Report Template in Appendix C identify options for presenting the summary report and findings. 6. Prepare Corrective Action Report. The assessment team may also prepare a Corrective Action Report (CAR) as shown in Table 11 for each finding. These CARs, if developed, should be delivered to the assessed organization during the closing meeting. 7. Conduct closing meeting. A closing meeting should be conducted to complete the assessment to allow the assessment team members and the assessed organization to exchange information and lessons learned as well as to agree on followup actions to address findings. Closeout meetings may include the following—  a discussion by the team leader of his/her overall impression of the assessment,  a presentation that explains that the assessment team’s findings are based on a sampling of evidence,  a presentation by each assessment team member of his/her individual findings and recommendations,  distribution of copies of the CARs to the assessed organization’s management,  an opportunity for the assessed organization’s representatives to ask questions regarding findings and recommendations,  an explanation of the how the team will conduct the visit to check on corrective and preventive action progress,  a discussion that explains to whom the team will forward draft assessment reports, and  a discussion between the assessment team and the assessed organization regarding the findings. 8. Prepare final assessment report. The assessment report is the official record of the assessment that the team should provide to the assessed organization’s senior management. It is a key source of information on the general health of the ISMS/EMS and should be an important part of the subsequent management review. Following a specified time period (e.g., a week), during which time corrective actions and associated CARs (see Table 11) can be generated, the assessment team should deliver the final assessment report. This report should identify all findings, including those that III-12 DOE G 450.1-2 8-20-04 Phase III the organization has corrected, as well as best practices, opportunities to improve, and any recommendations or comments. In most cases, final assessment reports can be very similar to summary reports, except that they represent a formal record of the assessment outcomes.

The assessment team leader is usually responsible for the preparation and contents of the assessment report, which should provide a complete, accurate, concise, and clear record of the assessment and may include or refer to the following:  assessment objectives;  assessment scope, particularly the identification of the organizational and functional units or processes assessed and the time period covered;  identification of the assessment team leader and members;  dates and places where the on-site assessment activities were conducted;  assessment criteria;  assessment findings;  assessment conclusions;  assessment plan;  summary of the assessment process, including uncertainty and/or obstacles encountered that can decrease the reliability of the assessment conclusions;  confirmation that the assessment objectives have been accomplished within the assessment scope in accordance with the assessment plan;  areas not covered, although within the assessment scope;  unresolved, diverging opinions between the assessment team and the assessed organization;  recommendations for improvement, if specified in the assessment objectives;  agreed-to followup action plans, if any;  statement of the confidential nature of the contents; and  distribution list for the assessment report. 9. Conduct corrective actions. Following the closeout meeting, the assessed unit should correct all findings and complete a corrective action report similar to that shown in Table 11. This corrective action report contains fields where the unit can describe actions it took to address the findings, including— DOE G 450.1-2 III-13 8-20-04 Phase III  root cause analysis,  interim actions,  corrective actions, and  preventative actions. III-14 DOE G 450.1-2 8-20-04 Phase III Table 10. Sample Portion of the Assessment Questionnaire [The following table contains a portion of the ISMS/EMS Assessment Questionnaire, which lists system requirements and root causes of nonconformances in the organization’s system (the full questionnaire is included in Appendix C).] Questions to address implementation of system requirements and root causes of existing nonconformances Finding Best practice Improvement opportunities Comment/evidence System Requirements: Does the organization have an ES&H Policy? A Does the policy reflect the organization’s values? A Does the policy provide a framework for setting and reviewing environmental objectives and targets at all levels within the organization? A Does the policy include a commitment to the prevention of pollution? A Does the policy include commitments to continual improvement and compliance with relevant laws and other requirements applicable to the organization? C Policy does not explicitly demand continual improvement but does describe the principle for it. Is the policy appropriate to the nature, scale, and environmental impacts of the organization’s activities, products or services? A Is the policy communicated to all employees and made available to the public? C X Policy not widely displayed. General employees were unfamiliar with it and did not apply it to daily activities. Is it clear that the policy has senior management’s endorsement and commitment? A 2. Questions to determine root causes for existing nonconformities Was senior management involved in crafting the policy? X Meeting minutes show that management was principally involved in crafting the policy

Are there any obvious inconsistencies between the policy commitments and organizational practices? Do employees believe that management is sincere in its commitment to the ISMS/EMS? X Employees did not believe that management understands that application of the policy is important Does management believe that systematic environmental, safety and health management will improve the quality and success of this organization? Is there evidence that sufficient resources have been allocated to the ISMS/EMS implementation over a sustained period? DOE G 450.1-2 III-15 8-20-04 Phase III Findings may fall into four classifications according to their seriousness. The classifications are as follows. A = In Conformance. B = Critical: Omission of an ISMS/EMS requirement or failure to implement an EMS Element of the ISMS/EMS. C = Serious: A significant number of minor nonconformances against any one system requirement. D = Minor: A single nonconformance of a system requirement. X = Indicates where a best practice or improvement opportunity was found. III-16 DOE G 450.1-2 8-20-04 Phase III Table 11. Sample ISMS/EMS Corrective Action Report Template (This is a sample of the CAR report template included in Appendix C.) Sample ISMS/EMS Corrective Action Report (CAR) Facility Name: Laboratory X Activity Number: (2) laboratory Assessment Date: 04/08/03 - 04/10/03 Finding Number:4 Finding No. Category A: Category B: X Category C: Finding: OLaboratory personnel are not aware of and not using operational controls for carrying waste. These include the use of trolleys for high loads or for multiple containers Cause Analysis: Employees could not remember having received training on any laboratory ISMS/EMS operational controls. Therefore, itt is likely that a lack of training is the root cause of this finding. Interim Actions: N/A Corrective Actions: All laboratory staff have been trained on ISMS/EMS procedures and operational controls which apply to them. Preventative Actions: The training program has been expanded to provide mandatory ISMS/EMS laboratory training to all new staff and also provides refresher training on a yearly basis. Action Due Date: 04/25/03 ISMS/EMS Coordinator:Ima Leader Environmental Manager Approval:Max Headroom Date Closed: 04/25/03 EMS Assessor Verification: Joe Assessor Date: 04/30/03 CHAPTER IV. PHASE IV—MANAGEMENT REVIEW AND SYSTEM MAINTENANCE DOE G 450.1-2 IV-1 8-20-04 Phase IV Step 9 Develop the Management Review Process Step 1 Step 2 Step 10 Phase I Phase II Phase III Phase IV Your current location on the ISMS/EMS Integration Road Map You are here Step 3 Step 4 Step 5 Step 6 Step 7 Step 8 Step 9 9.1 TASK 21: PREPARE FOR THE MANAGEMENT REVIEW References This task fulfills several DOE Order requirements listed below.  The Integrated Safety Management System/Environmental Management System (ISMS/EMS) provides for the evaluation of programs for public health and environmental protection, pollution prevention, and compliance with applicable requirements [DOE O 450.1 §4.a.(1)].  The ISMS/EMS includes policies and procedures to assess performance and implement corrective actions where needed [DOE O 450.1 §4.a.(2)].  The ISMS/EMS includes annual reviews and updates (when appropriate) of the site’s measurable environmental goals, objectives, and targets [DOE O 450.1 §4.a.(3)].  ISMS/EMS implementation is assessed as a component of the implementation of DOE P 450.5, Line Environment, Safety and Health Oversight (DOE O 450.1 §5.b.).

 Contractor ES&H performance objectives, performance measures, and commitments are reviewed through the annual ISM review process [established pursuant to DEAR 970.5223-1 (e)] [DOE O 450.1 §5.d.(17)]. The provisions in this task relate to established requirements of the following ISMS element.  DOE G 450.4-1B states that the annual ISMS review “is the integration of numerous system-related activities in a manner that assists management in assuring that work is performed . . . in a manner that protects the public, workers, and environment from harm” (p. 92). Task 21. Prepare for the management review Task 22. Conduct the management review IV-2 DOE G 450.1-2 8-20-04 Phase IV Goals for the management review include— Highlighting Management Commitment  Promote management involvement in the ISMS/EMS.  Provide management re-emphasis of ISMS/EMS objectives and allocation of resources. Decision Making—on suitability, adequacy, and effectiveness. Decisions could include—  Set new objectives and targets.  Better align objectives and targets with environmental policy.  Change the methods by which objectives and targets are achieved.  Recommit human, fiscal, and/or technological resources.  Promote continual improvement. 9.1.1 Background When applied to a site’s ISMS/EMS, the term “Management Review” refers to the periodic evaluation of the ISMS/EMS by senior management (i.e., managers who have the authority to make decisions for the site or facility). This review completes the ISMS/EMS plan-do-check-act cycle and allows management to ascertain whether the ISMS/EMS continues to be suitable, adequate, and effective for its intended purposes. The management review is not the same as the assessment process discussed in Phase III. However, senior managers conducting the management review should consider the results of the site’s assessment. For DOE sites, the concepts and principles of the management review are already addressed by many areas of the ISMS developed under DOE P 450.4, particularly the requirement for an annual review of ISMS performance. For example, the management review aligns with ISMS core principle 5 for feedback and improvement; specifically, that sites “should have a process for management to consider and dispose of recommendations for improvement.” DEAR, 48 CFR 970.5223-1 (d) and (e) also contain provisions for a review which specify that, “dates for submittal, discussions and revisions to the system will be established by the contracting officer . . . . On an annual basis, the contractor shall review and update, for DOE approval, its safety performance objectives, performance measures, and commitments.” This task further reinforces the current requirement that “for the purpose of this clause, safety encompasses the environment . . . including pollution prevention and waste minimization.” The management review, therefore, should serve to identify any gaps or enhancement opportunities for the existing ISMS as well as for the integrated ISMS/EMS. The primary goal of management review should be to ensure that the ISMS/EMS continues to be suitable, adequate, and effective for its intended purposes. The review accomplishes this by involving the members of the organization who have the authority to make needed changes to ensure the effectiveness of the system. The very first management review is usually conducted soon after the completion of corrective actions that follow the first assessment. Subsequent reviews are conducted on a scheduled basis or sooner if circumstances warrant management’s attention. Other important purposes of the management review are to—

 ensure that senior management stays involved in the ISMS/EMS;  give the ISMS/EMS visibility within the organization; and  allow senior management to set the environmental, safety, and health ethic for the organization and give guidance and direction for continual improvement of the system. DOE G 450.1-2 IV-3 8-20-04 Phase IV 9.1.2 Importance of Senior Management Involvement in the Management Review During the management review, senior managers should assess whether they are satisfied with the outcomes of the ISMS/EMS and whether they should make midcourse adjustments to bring the system back on track. In short, the management review process allows senior managers of the organization to—  assess the existing ISMS/EMS,  evaluate whether changes are necessary, and  give direction and/or resources for any actions necessary to make the changes. The importance of senior management involvement in the ISMS/EMS extends beyond the ability to authorize resources for continual improvement. The management review is an opportunity for the active and visible involvement of senior management in the ISMS/EMS and, thereby invigorates employee involvement and commitment through their leadership. 9.1.3 Coordinating the Management Review The periodic ISMS/EMS management review should include the assessment of an appropriate amount of information relating to the performance of the ISMS/EMS. For example, management should review all continuing core expectations (CCEs) described by DOE G 450.1-1B for both safety and environment. The ISMS/EMS coordinator should organize, schedule, and manage the management review. He or she should collect, analyze, and assemble pertinent information to present managers with the current status of ISMS/EMS. The ISMS/EMS coordinator should ensure that—  the review meeting date is set,  all the necessary managers are able to participate in the review,  there is coordination among those presenting information during the review,  the minutes of the review have management approval,  management reaches decisions on whether to update the ISMS/EMS to maintain its effectiveness and compliance with DOE O 450.1 and DOE P 450.4,  specific management decisions regarding actions, including allocation or reallocation of resources as a result of the review, begin, and  there is proper execution of decisions, including specific actions and resource allocations authorized by management, following the review. 9.1.4 Management Review Participants Participants in the management review should include the senior management (e.g., site managers, facility managers), the ISMS/EMS coordinator, appropriate members of the IV-4 DOE G 450.1-2 8-20-04 Phase IV ISMS/EMS team, P2 managers, and other individuals with ISMS/EMS responsibilities (e.g., internal assessors, other ISMS/EMS representatives). 9.2 TASK 22: CONDUCT THE MANAGEMENT REVIEW References This task fulfills several DOE Order requirements listed below.  The ISMS/EMS provides for the evaluation of programs for public health and environmental protection, pollution prevention, and compliance with applicable requirements [DOE O 450.1 §4.a.(1)].  The ISMS/EMS includes policies and procedures to assess performance [DOE O 450.1 §4.a.(2)].  The ISMS/EMS includes annual reviews and updates (when appropriate) of the site’s measurable environmental goals, objectives, and targets [DOE O 450.1 §4.a.(3)].

 ISMS/EMS implementation is assessed as a component of the implementation of DOE P 450.5, Line Environment, Safety and Health Oversight (DOE O 450.1 §5.b.).  Contractor ES&H performance objectives, performance measures, and commitments are reviewed through the annual ISM review process [established pursuant to DEAR 970.5223-1 (e)] [DOE O 450.1 §5.d.(17)]. The provisions in this task relate to established requirements of the following ISMS element.  DOE G 450.4-1B states that the annual ISMS review “is the integration of numerous system-related activities in a manner that assists management in assuring that work is performed . . . in a manner that protects the public, workers, and environment from harm” (p. 92). 9.2.1 Background In addition to fulfilling the requirements set forth in DEAR Clause 970.5223-1 that require contractors to update their environment, safety and health (ES&H) performance objectives, measures, and commitments on an annual basis, the management review is an opportunity for management to confirm that it is satisfied with the performance of the ISMS/EMS. This includes the achievement of goals set for the ISMS/EMS, and its alignment with the organization’s mission and commitments. In effect, management should ask whether the ISMS/EMS continues to be suitable, adequate, and effective for the DOE site in question. Senior managers should be given all relevant information to enable them to make accurate and sound judgments regarding ISMS/EMS implementation. All information needed to assess the conformance of the ISMS/EMS with DOE P 450.4 and DOE O 450.1, as well as any other objectives set by the site should be collected, consolidated, analyzed, and communicated. As discussed above, this is typically one of the responsibilities of the ISMS/EMS coordinator (or DOE G 450.1-2 IV-5 8-20-04 Phase IV individual who leads the ISMS/EMS team). Information for the management reviews may come from the following sources.  Assessments DOE P 450.5 and DOE O 414.1B require a rigorous and credible contractor assessment program with elements that address performance measures and indicators, line and independent evaluations, compliance with applicable requirements, data collection, analysis and corrective actions, and feedback and performance improvement. These assessments should cover ISMS and EMS elements alike and are a key source of information for the management review. Detailed discussion of the role of the assessments for maintaining the effectiveness and legitimacy of the ISMS/EMS was covered earlier in Phase III.  Monitoring and measurement results Data collected through ongoing system monitoring and measurement, including ISMS/EMS programs, processes, activities, and controls, are another key source of information for the management review. This information relates to the achievement of objectives and targets, the status of operational controls, the maintenance of regulatory compliance, and other parameters that are overseen to ensure that the ISMS/EMS remains effective.  Occurrence reports Information contained in occurrence reports, especially the root causes of an incident, are a good source of information for the management review.  Corrective actions Actions taken to correct deficiencies in the ISMS/EMS are a rich source of information on the day-to-day health of the ISMS/EMS. The data available from this source include—  the status of training (both awareness training and competence training);

 the currency of regulatory and other requirements in the ISMS/EMS;  the identification of new significant aspects;  the implementation of new environmental management programs (EMPs);  compliance with the schedule for internal ISMS/EMS assessments; and  the assignment of responsibility and accountability for ISMS/EMS implementation, etc. 9.2.2 Decisions Made in the Management Review Senior management should make specific decisions during the management review or immediately thereafter. They may wish to consider the following questions.  Is the ISMS/EMS still suitable, adequate, and effective for the organization? IV-6 DOE G 450.1-2 8-20-04 Phase IV Actions or changes that could result from the management review  Develop corrective actions to improve system implementation and effectiveness  Set performance measures and commitments for next year  Make changes to criteria for conducting assessments  Make changes, if required, to the ISMS description document  Account for and integrate any changes to laws, regulations, and directives  Based on an assessment of these three characteristics, does the ISMS/EMS need changes?  If it needs changes (see box below), what actions and what resources are needed for those changes?  Who should be directed to oversee the implementation of those changes?  When does management want an update on the status and effect of the changes? Suitability: Refers to the nature of the ISMS/EMS and whether it continues to be appropriate to the organization. For example, if a site’s mission changes, as in the case of a site moving to closure status, then many of the programs and procedures established for ongoing operation may no longer be suitable to control risks under the site’s new mission. Other approaches to the ISMS/EMS relevant to this area would need to be considered. Adequacy: Refers to the sufficiency of the arrangements for the ISMS/EMS. For example, if the resources allocated to management programs are not sufficient to achieve the objectives and targets set for them, then the ISMS/EMS may have inadequate support. If new employees do not receive timely awareness or competence training before they begin their assigned tasks, then the ISMS/EMS is inadequate with respect to the training element. Effectiveness: Refers to the system’s progress in accomplishing the objectives and targets set for the ISMS/EMS. If progress is slower than expected or if operational controls fail more often than is expected or acceptable, then the system may be ineffective for its intended purposes. Because the organization sets its own objectives and targets, analyzing an ISMS/EMS’s effectiveness should help management evaluate success in achieving its own objectives and targets. In other words, effectiveness is a relative term depending on what the organization sets out for itself. The only exception to this is regulatory compliance. If the organization fails to maintain regulatory compliance, management may consider the ISMS/EMS ineffective regardless of whether other objectives and targets are being achieved. 9.2.3 Documenting the Management Review The annual review and update of the ISMS/EMS should be documented. DOE G 450.4 describes this documentation in detail. The following are some of the documentation requirements, including those in DOE O 450.1.  Contractor’s performance against the previous year’s safety and environmental commitments. DOE G 450.1-2 IV-7 8-20-04

Phase IV  Contractor’s commitments designed to achieve safety and environmental performance objectives and measures for the upcoming fiscal year.  Commitment of resources necessary to meet environment, safety and health program minimum requirements. In addition to documenting the above outcomes of the annual management review process, other details of the review, including the following, should be recorded.  Names and functions of all participants.  Copies of the presentations and other information.  Decisions on the system’s suitability, adequacy, and effectiveness.  Decisions on changes desired for the system.  Management directions for actions to be taken and resources to be applied.  Expected timeline for achieving changes and the date of any future review. 9.2.4 Followup to the Management Review Implementation of the changes identified in the management review should occur as directed. Management should clearly assign responsibility for coordinating updates or implementation of new programs. Following the management review, management should ensure that there are sufficient resources to carry out revisions to the ISMS/EMS. Ensuring that there are sufficient resources aligns closely with ISMS guiding principle 4 “balanced priorities,” also provided for in sections (d) and (e) of DEAR Clause 970.5223-1. Identification of resources necessary for environment, safety and health programs should be a part of the DOE annual budget guidance and direction. Step 10 Develop a Plan to Keep the ISMS/EMS Updated Step 1 Step 2 Phase I Phase II Phase III Phase IV Your current location on the ISMS/EMS Integration Road Map You are here Step 3 Step 4 Step 5 Step 6 Step 7 Step 8 Step 9 Step 10 Task 23. Keeping the ISMS/EMS updated IV-8 DOE G 450.1-2 8-20-04 Phase IV 10.1 TASK 23: KEEPING THE ISMS/EMS UPDATED References The provisions in this task relate to established requirements of the following ISMS elements.  DOE P 450.5, “A robust, rigorous, and credible contractor self-assessment program linked to the DOE [Environment, Safety and Health] Management System is in place, which includes elements that address . . . data collection, analysis, and corrective actions; [and] continuous feedback and performance improvement.”  DOE P 450.5, “The Department’s and contractors’ line organizations … work together to develop a high level of performance assurance which results in improved environment, safety and health performance.”  DOE G 450.4-1B, Chapter IV, on keeping approved ISMSs effective through continuous improvement actions. 10.1.1 Background Changes in regulations, site mission, site operations, budget allocations, or customer needs will all cause changes in activities and operations, which in turn may have safety and environmental consequences. In some cases, it is sufficient to update the ISMS/EMS annually to remain current and relevant to the site. However, other changes such as regulatory amendments or new operations can occur at any time during the year and will precipitate the need for continual updates to the ISMS/EMS. In particular DEAR, 48 CFR 970.5215-3, requires 1) compliance with applicable laws, regulations, and DOE Directives; 2) implementation of and adherence to the contractor’s Safety Management System; and 3) accomplishment of annual contractor environment, safety and health performance commitments. The suggestions below describe how the organization can update the ISMS/EMS to remain relevant to the organization. (Keeping the ISMS/EMS updated is also discussed in Step 9, above, under Management Review).

10.1.2 Environmental Aspects DOE O 450.1 section 4.a(2) states that the ISMS/EMS includes policies and procedures to identify activities with significant environmental impacts. Most sites probably address this requirement under the ISMS Core Function 3, to identify and analyze hazards, which include environmental hazards also referred to as environmental aspects (see Phase I). The organization should periodically revise the procedure by which it identifies its environmental aspects and sets improvement objectives for those that are significant to reflect change in regulations, mission focus, and site operations. One approach to meet the need to maintain updated environmental aspects and safety hazards is to execute the procedure for Identifying Significant Environmental Aspects and Safety Hazards on a periodic basis. Another potential practice is to update the list of significant environmental aspects on an ongoing basis by subjecting each new activity, product, or service to an up-front evaluation to ascertain whether it includes an environmental aspect and whether that aspect meets a significance threshold that makes it a significant environmental aspect. This approach will keep the ISMS/EMS up-to-date and relevant, and will allow the organization to address significant environmental aspects as they occur. DOE G 450.1-2 IV-9 8-20-04 Phase IV 10.1.3 Legal and Other Requirements DOE O 450.1 §4.a.(1) requires the ISMS/EMS provide for the systematic planning of programs for compliance with applicable requirements. This recognizes that as State and Federal regulations change, it is critical that sites update their programs and procedures for compliance. Requirements are not necessarily just laws and regulations. DOE Orders and policies, industry standards, and EPA Performance Track requirements should also be considered. Phase II of this Guide discusses the development of a formal procedure for identifying legal and other requirements based on the existing site procedure. This procedure should ensure that there is ongoing monitoring of new legal and other requirements, as well as assessment of new activities, products, and services to evaluate whether any legal requirements apply to them. This approach captures applicable information when there is a new requirement or the organization initiates a new activity, product, or service. In addition to addressing legal and other requirements on an ongoing basis, it is useful to conduct periodic reviews of the organization’s requirements to determine if any new requirements apply and if any of those being addressed are out of date. This periodic assessment can occur in conjunction with the management review. 10.1.4 Objectives and Targets A fundamental element of the ISMS/EMS is the establishment of “measurable environmental goals, objectives, and targets” [DOE O 450.1 §4.a.(3)]. These objectives and targets will not remain static. The site may want to update its existing objectives and targets because it has been accomplished them and desires new ones, or because management directs changes based on the results of the management review, or because new regulations, operations, or changing site mission re