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EM 200-1-4 Risk Assessment Handbook Vol. 2
Environmental Evaluation

By The US Army Corps of Engineers 
99 pages 1999

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This book is included in the Medical Specialties, Veterinary Medicine & Emergency Situations section.

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US ARMY CORPS OF ENGINEERS ENGINEERING MANUAL
ENVIRONMENTAL QUALITY


1. Purpose The overall objective of this manual is to provide U.S. Army Corps of Engineers (USACE) Hazardous, Toxic, and Radioactive Waste (HTRW) managers and technical proponents with the recommended basic/minimum requirements for planning, evaluating, and conducting ecological risk assessments, consistent with USACE principles of good science and in defining expected quality and goals of the overall program.

2. Applicability. This manual applies to ecological risk assessment aspects for all USACE HTRW investigations, studies, and designs under the Department of Defense, Defense Environmental Restoration Program (DERP), Base Realignment and Closure (BRAC), U.S. Environmental Protection Agency (EPA) Superfund Program, Civil Works, and Work for Others. EM 200-1-4, Risk Assessment Handbook, Volume I: Human Health Evaluation, provides guidance on human health risk assessments performed for all HTRW projects.

3. General. Chapter 1 of this manual presents the purpose, scope, concept, and policy considerations, and the use of risk assessment in HTRW programs. It provides a description of the USACE HTRW program, the quality required for performance of ecological risk assessment, and an understanding of how risk assessments serve management decision needs. Relevant Federal statutes/regulations, agency guidance and directives and state requirements are also highlighted in this chapter. Chapter 2 presents the major scoping and project planning elements under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) as amended by the Superfund Amendments and Reauthorization Act (SARA) of 1986, and the Resource Conservation and Recovery Act (RCRA) as amended by the Hazardous and Solid Waste Amendments (HSWA) of 1984. Particular emphasis is placed on the early development of an Ecological Conceptual Site Model (ECSM). utilizing the data quality objectives planning process presented in EM 200-1-2, Technical Project Planning Guidance for HTRW Data Quality Design, to identify data needs and optimize data collection efforts. Chapters 3 through 8 are intended to provide the risk assessor with the minimum content expected to be included in an ecological risk assessment to adequately serve site decision requirements. They summarize the key components of a Screening Ecological Risk Assessment (Chapter 3), the four tiers employed for Baseline Ecological Risk Assessments (Chapters 4, 5, 6, and 7), and Ecological Risk Assessment of Remedial Alternatives (Chapter 8). These chapters stress the importance of properly identifying the receptors and chemicals of concern and a thorough understanding of the dynamics of interrelationships of multiple receptors and pathways in the development/refinement of an ECSM before embarking on estimating exposure point concentrations. They also highlight the need for characterizing site hazard or risk objectively and realistically to satisfy the regulatory requirement of protection of the environment. Chapter 9 concerns presentation of the risk assessment results for use in risk management and decision-making, focusing on the decisions and criteria needed for making those decisions. Both risk and nonrisk factors are presented for consideration by the manager. This chapter emphasizes the need for balancing protection of the environment with other project constraints based on the level of confidence and uncertainty in the risk assessment results. Risk results are used for evaluating the need for a removal action, interim corrective measures, or remediation, and to provide the decision criteria and rationale for the selection of remedial alternatives, if required for site closeout. The chapter concludes that the HTRW project team has the responsibility to present risk information as management options to the customer, documenting the uncertainty and rationale.

FOR THE COMMANDER: Robert H. GGriffin
Colonel, Corps of Engineers
Chief of Staff

This handbook will be reviewed on an annual basis for revisions, and updates issued accordingly.

Chapter 1.0 INTRODUCTION 
	1.1 PURPOSE AND SCOPE
		1.1.1 Objectives
		1.1.2 Scope
		1.1.3 Intended Audience and Use
		1.1.4 Contents of the Handbook
	1.2 USACE ROLE IN THE HTRW PROGRAM
		1.2.1 DERP
		1.2.2 BRAC
		1.2.3 Others
		1.2.4 HTRW Program Organization
	1.3 OVERVIEW OF HTRW RESPONSE PROCESS
		1.3.1 CERCLA Process
		1.3.2 RCRA Corrective Action Process
		1.3.3 Functional Equivalency of the CERCLA and RCRA Processes
		1.3.4 Role of Risk Assessment in the HTRW Process
	1.4 CONCEPT OF RISK ASSESSMENT AND GOOD SCIENCE
		1.4.1 Basic Concepts
		1.4.2 Risk Assessment as Decision Criteria in the HTRW Program
	1.5 POLICY CONSIDERATIONS AND RISK MANAGEMENT
		1.5.1 Relationship Between Policy Considerations and Risk
		1.5.2 USACE Policy Considerations
		1.5.3 EPA Headquarters, Regional and State Policies
		1.5.4 Risk-Based Management Decisions for Site Actions
	1.6 REGULATORY DIRECTIVES AND GUIDANCE
		1.6.1 EOs and Federal Statutes/Regulations
		1.6.2 DOD Directives
		1.6.3 EPA Headquarters and Regional Guidance
		1.6.4 State Requirements/Guidance
		1.6.5 Others
	1.7 FEDERAL FACILITY AGREEMENT
		1.7.1 Basis for Interim Remedial Action (IRA) Alternatives
		1.7.2 Requirements for RI/RFI and FS/CMS
		1.7.3 Expedited Cleanup Process
		1.7.4 Units Excluded from the Agreement
Chapter 2.0 Ecological Risk Assessment Scoping Considerations
	2.1 INTRODUCTION
	2.2 SCOPING CONSIDERATIONS
		2.2.1 Objectives of the Ecological Risk Assessment
		2.2.2 Definition of Ecological Risk Assessment
		2.2.3 Planning for an ERA
		2.2.4 The HTRW Policy and TPP Process
		2.2.5 The HTRW TPP Process
		2.2.6 Approaches to the conduct of an ERA
		2.2.7 Establishing the Level of Effort
	2.3 INTRODUCTION TO THE ERA PROCESS
	2.4 INTRODUCTION TO THE FOUR-TIERED APPROACH	
Chapter 3.0 EVALUATING THE SCREENING ECOLOGICAL RISK ASSESSMENT
	3.1 INTRODUCTION
	3.2 PROBLEM FORMULATION
		3.2.1 Chemical Data Collection and Review
		3.2.2 Ecological Conceptual Site Model
		3.2.3 Problem Formulation Summary
	3.3 EXPOSURE AND EFFECTS ANALYSIS	
		3.3.1 Exposure Characterization
		3.3.2 Effects Characterization	
	3.4 PRELIMINARY RISK and UNCERTAINTY CHARACTERIZATION	
Chapter 4.0 EVALUATING THE TIER-1 BASELINE ECOLOGICAL RISK ASSESSMENT
	4.1 INTRODUCTION
	4.2 PROBLEM FORMULATION
		4.2.1 Ecological Site Description
		4.2.2 Chemical Data Collection and Review
		4.2.3 Selection of Preliminary Chemicals of Ecological Concern
		4.2.4 Selection of Key Receptors
		4.2.5 Ecological Endpoints Identification
		4.2.6 Ecological Conceptual Site Model
	4.3 ANALYSIS PHASE - EXPOSURE CHARACTERIZATION
		4.3.1 Exposure Setting Characterization 
		4.3.2 Exposure Analysis
		4.3.3 Exposure Profiles
	4.4 ANALYSIS PHASE - ECOLOGICAL EFFECTS CHARACTERIZATION
		4.4.1 Objectives
		4.4.2 Sources of Literature Benchmark Values
		4.4.3 Selection of Literature Benchmark Values
		4.4.4 Development of Reference Toxicity Values
		4.4.5 Additional Considerations in Developing RTVs
		4.4.6 Special Chemicals
	4.5 RISK CHARACTERIZATION
		4.5.1 Risk Estimation
		4.5.2 Characterization of Uncertainty
		4.5.3 Risk Description
Chapter 5.0 EVALUATING THE TIER-II BASELINE ECOLOGICAL RISK ASSESSMENT
	5.1 INTRODUCTION
	5.2 PROBLEM FORMULATION
		5.2.1 Field Studies
		5.2.2 Laboratory Studies
	5.3 DATA COLLECTION and ANALYSIS
	5.4 REVISION OF THE TIER 1 ERA
Chapter 6.0 EVALUATING THE TIER-III BASELINE ECOLOGICAL RISK ASSESSMENT
	6.1 INTRODUCTION
	6.2 PROBLEM FORMULATION
		6.2.1 Field Studies
		6.2.2 Modeling Studies
		6.2.3 Laboratory Studies
	6.3 DATA COLLECTION and ANALYSIS
	6.4 REVISION OF THE TIER II ERA
Chapter 7.0 EVALUATING THE TIER-IV BASELINE ECOLOGICAL RISK ASSESSMENT
	7.1 INTRODUCTION
	7.2 PROBLEM FORMULATION
		7.2.1 Field Studies
		7.2.2 Ecosystem Modeling Studies
		7.2.3 Laboratory Analysis
	7.3 DATA COLLECTION and ANALYSIS
	7.4 REVISION OF THE TIER III ERA
Chapter 8.0 EVALUATING THE ECOLOGICAL RISK ASSESSMENT OF REMEDIAL ALTERNATIVES
	8.1 INTRODUCTION
	8.2 DEVELOPMENT OF REMEDIATION ALTERNATIVES
	8.3 COMPARATIVE RISK ASSESSMENT OF REMEDIAL ALTERNATIVES
	8.4 OTHER APPLICATIONS OF ERAs
Chapter 9.0 RISK MANAGEMENT - INFORMATION NEEDED FOR DECISION MAKING
	9.1 INTRODUCTION
	9.2 DETERMINING REQUIREMENTS FOR ACTION
		9.2.1 PA/SI and RFA
		9.2.2 RI/RFI
		9.2.3 FS/CMS and RD/RA
		9.2.4 Nonrisk Issues or Criteria as Determining Factors for Actions
	9.3 DESIGN CONSIDERATIONS
		9.3.1 Potential Risk Mitigation Measures
		9.3.2 Risk Management: Degree of Protectiveness

Glossary
Exhibits
Appendix A. References 
Appendix B. Information Sources for ERA
Appendix C. Framework
Appendix D. HTRW Technical Project Planning Process
Appendix E. Monte Carlo Analysis
Appendix F. Ecotoxicity Profiles for Munitions Compounds
Appendix G. Benchmark Studies
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