This book is included in the Medical Specialties, Veterinary Medicine & Emergency Situations section.
US ARMY CORPS OF ENGINEERS ENGINEERING MANUAL
ENVIRONMENTAL QUALITY
1. Purpose
The overall objective of this manual is to provide risk assessors with the recommended
basic/minimum requirements for developing scopes of work, evaluating Architect-Engineer (A-E) prepared human
health risk assessments, and documenting risk management options associated with Hazardous, Toxic, and
Radioactive Waste (HTRW) investigations, studies, and designs consistent with principles of good science in
defining the quality of risk assessments. This EM is intended for use by U.S. Army Corps of Engineers (USACE)
Project Managers, technical personnel, and contractor personnel.
2. Applicability.
This EM applies to all HQUSACE elements and USACE commands responsible for HTRW projects.
3. References.
References are listed in Appendix A.
4. Distribution.
Approved for public release, distribution is unlimited.
5. Discussion.
This manual is intended to provide USACE risk assessors and contractor personnel with
supplemental guidance for performance and evaluation of risk assessments 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. It is not intended to replace the accepted guidance
by the USEPA (e.g., Risk Assessment Guidance for Superfund, Human Health Evaluation Manual), but should be
used in conjunction with that document. Additional information provided by this manual concerns presentation of
the risk assessment results for use in risk management and decision-making, concerns focusing on the decisions, and
criteria needed for decisions. Both risk and nonrisk factors are presented for consideration by the risk managers.
FOR THE COMMANDER: Albert J. Genetti, Jr.
Major General, USA
Chief of Staff
This manual supersedes EM 200-I-4, Volume I, dated 30 June 1995.
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 PLANNING FOR AN HHRA 2.1 INTRODUCTION 2.1.1 Purpose of the HHRA 2.1.2 Objectives of the HHRA 2.1.3 Minimum Requirements 2.1.4 Technical Requirements 2.1.5 Technical Basis 2.1.6 Planning and Problem Identification 2.2 PLANNING CONSIDERATIONS 2.2.1 Coordinating HHRA and ERA Planning 2.2.2 Coordination with Natural Resource Trustees 2.2.3 RAGS, Part D: Standardized Planning, Reporting, and Review of Superfund Risk Assessments 2.2.4 The HTRW TPP Process 2.3 ESTABLISHING THE LEVEL OF EFFORT 2.3.1 Preliminary Risk Screening; PA/SI 2.3.2 HHRA; RI 2.3.3 Risk-Based Analysis of Remedial Alternatives; FS 2.3.4 Short-Term Risks Associated With Construction Chapter 3.0 EVALUATING THE SCREENING-LEVEL HHRA 3.1 INTRODUCTION 3.2 SCREENING-LEVEL HHRAs 3.2.1 Chemical Data Collection and Review 3.2.2 Exposure Assessment 3.2.3 Health-Based Screening Levels 3.2.4 Risk Screening 3.2.5 Characterization of Uncertainty Chapter 4.0 EVALUATING THE BASELINE HHRA 4.1 INTRODUCTION 4.2.1 Historical Data Review 4.2.2 Guidance 4.2.3 Evaluation of Data Quality 4.3 SELECTION OF COPCs 4.3.1 Objectives 4.3.2 General Considerations 4.3.3 Selection Criteria/Methodology 4.3.4 Presentation of COPCs 4.4 EXPOSURE ASSESSMENT 4.4.1 Refinement of the CSM 4.4.2 Characterization of the Exposure Setting 4.4.3 Identification of Exposure Pathways and Intake Routes 4.4.4 Identification of Potential Receptor Populations 4.4.5 Quantitation of Exposure (Intake or Dose) 4.5 TOXICITY ASSESSMENT 4.5.1 Objectives 4.5.2 Derivation of Toxicity Values 4.5.3 Toxicity Assessment for Carcinogenic Effects 4.5.4 Toxicity Assessment For Non-carcinogenic Effects 4.5.5 Sources of Toxicity Values 4.5.6 Use of Toxicity Values 4.5.7 Special Chemicals 4.6 RISK CHARACTERIZATION 4.6.1 Objective 4.6.2 Methodology 4.7 EVALUATION OF UNCERTAINTIES AND LIMITATIONS 4.7.1 Objective 4.7.2 Sources of Uncertainty 4.7.3 Evaluation of Uncertainty Chapter 5.0 EVALUATING THE HHRA OF REMEDIAL ALTERNATIVES 5.1 INTRODUCTION 5.2 DEVELOPMENT OF RGs 5.3 EVALUATION OF LONG-TERM RISKS 5.3.1 Comparative Risk Assessment of Remedial Alternatives 5.3.2 Risk Reduction 5.3.3 Residual Risk 5.4 SHORT-TERM RISKS ASSOCIATED WITH REMEDIATION Chapter 6.0 RISK MANAGEMENT - INFORMATION NEEDED FOR DECISION-MAKING 6.1 INTRODUCTION 6.2 DETERMINING REQUIREMENTS FOR ACTION 6.2.1 PA/SI and RFA 6.2.2 RI/RFI 6.2.3 FS/CMS and RD/RA 6.2.4 Non-Risk Issues or Criteria as Determining Factors for Actions 6.3 DESIGN CONSIDERATIONS 6.3.1 Potential Risk Mitigation Measures 6.3.2 Risk Management; Degree of Protectiveness Appendix A. References A-1 Appendix B. Acronyms B-1End of Preview.
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