Public Health Assessment
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`GUIDANCE MANUAL
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`(Update)
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`January 2005
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`U.S. Department of Health and Human Services
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`Public Health Service
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`Agency for Toxic Substances and Disease Registry
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`Atlanta, Georgia
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`Coalition for Affordable Drugs IV LLC – Exhibit 1010
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`

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`Public Health Assessment Guidance Manual (Update)
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`Disclaimer
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`Any mention of trade names or commercial products is for identification only and does not
`constitute endorsement or recommendation by the Agency for Toxic Substances and Disease
`Registry, the Public Health Service, or the U.S. Department of Health and Human Services.
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`

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`Public Health Assessment Guidance Manual (Update)
`Foreword
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`In the United States and its territories, thousands of abandoned industrial and commercial
`facilities and hazardous waste disposal sites exist. Some of these sites may have the potential to
`adversely affect public health. The mission of the Agency for Toxic Substances and Disease
`Registry (ATSDR) is to serve the public by using the best science, taking responsive public
`health actions and providing trusted health information to prevent harmful exposures and
`disease related to toxic substances. The ATSDR public health assessment process serves as a
`mechanism to help ATSDR sort through the many hazardous waste sites in its jurisdiction and
`determine when, where, and for whom, public health actions should be taken. Through this
`process, ATSDR finds out whether people living near or at a hazardous waste site are being
`exposed to toxic substances, whether that exposure is harmful, and what must be done to stop or
`reduce any exposure.
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`This manual is a revision of ATSDR=s 1992 Public Health Assessment Guidance Manual. The
`revised manual builds upon the process described in the 1992 manual and draws from the lessons
`learned through conducting public health assessments for nearly two decades. More detailed
`guidance on many of the procedures used to identify hazards and needed public health actions is
`presented in the manual. New information and techniques that reflect advances in science and
`technology, including tools and resources available to health assessors, are also presented.
`Advancements in geographical information systems, computational modeling techniques,
`exposure investigation approaches, and toxicologic knowledge, for example, enable a more
`sophisticated analysis of environmental data and exposures than was previously possible.
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`The manual emphasizes a team approach and the importance of careful planning, coordination of
`scientific analyses, and communication throughout the public health assessment process.
`ATSDR recognizes that effective collection, analysis, interpretation, and dissemination of public
`health assessment information often requires the cooperation and coordination of multi(cid:173)
`disciplinary teams of scientists, health communication specialists, health educators, and/or
`medical professionals. Good communication with other governmental agencies, tribes, the
`community, and other stakeholders is critical and integral to the process.
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`This Public Health Assessment Guidance Manual is just one tool available to the health
`assessment team. It is not intended to supplant the professional judgment or discretion of the
`health assessor (or public health assessment team) in compiling and analyzing data, drawing
`conclusions, and making pubic health recommendations. Instead, the manual is intended to serve
`as a uniform tool to help discriminate and prevent poor professional judgement calls, and to
`provide a logical approach to the team in evaluating the public health implications of hazardous
`waste sites, while still allowing the health assessor to develop new approaches to the process and
`apply the most current and appropriate science and methodology. The public health assessment
`process adapts to changing scientific technology and public health procedures to remain
`dynamic.
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`

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`Public Health Assessment Guidance Manual (Update)
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`ATSDR is committed to updating the manual as new technical information becomes available.
`The agency welcomes comments from users of the manual.
`
`William Cibulas, Jr., Ph.D.
`Director
`Division of Health Assessment and
`Consultation/ATSDR
`Captain, U.S.P.H.S.
`
`Henry Falk, M.D., M.P.H
`Director
`National Center for Environmental
`Health (NCEH)/ATSDR
`Rear Admiral, U.S.P.H.S. (Retired)
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`

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`Public Health Assessment Guidance Manual (Update)
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`Table of Contents
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`Chapter 1: Introduction ...................................................................................................... 1-1
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`1.1 ATSDR’s Mandate and Mission ................................................................................ 1-1
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`1.2
`The Public Health Assessment Process...................................................................... 1-3
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`1.3
`Purpose of This Guidance Manual ............................................................................. 1-5
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`1.4 Organization of the Guidance Manual ....................................................................... 1-6
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`Chapter 2: Public Health Assessment Overview............................................................... 2-1
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`2.1 What Is a Public Health Assessment? ........................................................................ 2-1
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`2.1.1 Definition and Purpose ................................................................................... 2-1
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`2.1.2 Factors to Be Considered in All Public Health Assessments ......................... 2-2
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`2.1.3 How Does a Public Health Assessment Differ From a Risk Assessment? .... 2-3
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`2.2 When Is a Public Health Assessment Conducted?..................................................... 2-4
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`2.3 Who Conducts Public Health Assessments? .............................................................. 2-4
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`2.4 What Is the Role of the Site Community?.................................................................. 2-5
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`2.5 How Is a Public Health Assessment Conducted?....................................................... 2-7
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`2.5.1 Getting Started................................................................................................ 2-9
`2.5.2 Collecting Needed Information .................................................................... 2-10
`2.5.3 Exposure Evaluation: Evaluating Environmental Contamination Data ....... 2-10
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`2.5.4 Exposure Evaluation: Identifying Exposure Pathways ................................ 2-12
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`2.5.5 Health Effects Evaluation: Conducting Screening Analysis ........................ 2-13
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`2.5.6 Health Effects Evaluation: Conducting In-Depth Analyses ......................... 2-13
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`2.5.7 Formulating Conclusions and Recommendations and Developing a Public
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`Health Action Plan........................................................................................ 2-13
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`2.6 What Products and Actions Result From the Public Health Assessment Process? . 2-14
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`2.6.1
`Products ........................................................................................................ 2-14
`2.6.2 Public Health Actions................................................................................... 2-15
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`2.7 What Is the Format for Public Health Assessment Documents? ............................. 2-16
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`Chapter 3: Obtaining Site Information ............................................................................. 3-1
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`3.1 What Information Is Needed? .................................................................................... 3-1
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`3.1.1 Background Information................................................................................. 3-6
`3.1.1.1 Site Description ................................................................................. 3-6
`3.1.1.2 Site Operations and History .............................................................. 3-6
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`3.1.1.3 Regulatory History and Activities..................................................... 3-7
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`3.1.1.4 Land Use and Natural Resources Information .................................. 3-8
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`3.1.1.5 Demographic Information ................................................................. 3-9
`3.1.2 Community Health Concerns ....................................................................... 3-10
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`3.1.3
`Environmental Contamination Information.................................................. 3-11
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`3.1.4 Exposure Pathway Information .................................................................... 3-14
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`3.1.5 Health Outcome Data ................................................................................... 3-15
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`3.1.6
`Substance-Specific Information ................................................................... 3-17
`3.2 How Is Information Obtained?................................................................................. 3-17
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`3.2.1
` Government Agencies .................................................................................. 3-18
`3.2.2
`Internet Resources ........................................................................................ 3-21
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`Public Health Assessment Guidance Manual (Update)
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` 3.2.3 Community Members and Other Stakeholders ............................................ 3-21
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`3.2.4 Site Representatives...................................................................................... 3-22
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`3.2.5 Conducting the Site Visit.............................................................................. 3-22
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`3.2.5.1 Before the Site Visit ........................................................................ 3-23
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`3.2.5.2 During the Site Visit........................................................................ 3-23
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`3.2.5.3 After the Site Visit........................................................................... 3-24
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` 3.3
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` Identifying Information Gaps................................................................................... 3-25
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` 3.4 Documenting Relevant Information......................................................................... 3-25
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` 3.5 Confidentiality and Privacy Issues........................................................................... 3-27
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`Chapter 4: Involving and Communicating With the Community .................................. 4-1
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` 4.1 Definitions, Goals and Objectives, and Program Roles ............................................. 4-2
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` 4.1.1 Definitions ...................................................................................................... 4-2
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` 4.1.2 Goals and Objectives for Community Involvement ....................................... 4-4
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` 4.1.3 Program Areas Addressing Community Needs.............................................. 4-4
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` 4.2 Working and Communicating with Community Members........................................ 4-9
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`4.2.1 Earning Trust and Credibility......................................................................... 4-9
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`4.2.2 Confidentiality and Privacy............................................................................ 4-9
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` 4.2.3 Cultural Sensitivity....................................................................................... 4-10
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` 4.2.4 Environmental Justice................................................................................... 4-10
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` 4.2.5 Principles of Effective Communication ....................................................... 4-11
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`Planning Community Involvement Activities.......................................................... 4-12
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`4.3.1 Overview of Community Involvement in the Public Health Assessment .... 4-12
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`4.3.2 Developing Community Involvement Strategies ......................................... 4-13
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`4.3.3 Types of Community Involvement Activities .............................................. 4-15
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`Community Involvement Tools ............................................................................... 4-16
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`4.4.1 Tools for Initial Data Gathering ................................................................... 4-16
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`4.4.2 Community Meetings ................................................................................... 4-17
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`4.4.3 Community Groups and Committees ........................................................... 4-18
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`4.4.3.1 Community Groups Established by ATSDR .................................. 4-18
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`4.4.3.2 Community Assistance Panels (CAPs) ........................................... 4-19
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`4.4.3.3 Federal Advisory Committee Act (FACA) Committees................. 4-19
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` 4.4.4 Fact Sheets and Other Materials................................................................... 4-19
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`4.4.4.1 General Fact Sheets......................................................................... 4-19
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`4.4.4.2 Site-Specific Fact Sheets (Newsletters) .......................................... 4-21
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`4.4.4.3 Site-Specific Flyers (Meeting Announcements) ............................. 4-21
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`4.4.5 Media Support .............................................................................................. 4-21
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`4.4.6 Establishing Information Repositories ......................................................... 4-22
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`4.4.7 Access to Experts and Toll-Free Hotline...................................................... 4-22
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`Including Community Involvement Activities in the Public Health
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`4.5
`Assessment Process.................................................................................................. 4-22
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`4.6 Community Health Concerns in Public Health Assessment Documents ................. 4-22
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`4.6.1 How to Respond to Community Health Concerns ....................................... 4-23
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`4.6.2 How to Present Responses to Community Concerns in the PHA ................ 4-29
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`Public Comment Process and Release of Final Public Health
`Assessment Documents............................................................................................ 4-29
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` 4.3
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`4.4
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`4.7
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`Public Health Assessment Guidance Manual (Update)
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`4.7.1 Public Comment Process .............................................................................. 4-29
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`4.7.1.1 Releasing the Draft PHA................................................................. 4-30
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`4.7.1.2 Receipt of Public Comments........................................................... 4-31
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`4.7.1.3 Responding to Public Comments .................................................... 4-31
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`4.7.2 Release of Final PHA or PHC ...................................................................... 4-32
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`4.8 Disseminating Information to the Community......................................................... 4-32
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`4.8.1
` Developing Mailing Lists ............................................................................. 4-33
`4.8.2
` Clearance Procedures ................................................................................... 4-33
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`Chapter 5: Exposure Evaluation: Evaluating Environmental Contamination ............. 5-1
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`5.1
` Evaluating Environmental Sampling Data................................................................. 5-1
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`5.1.1 Background Information on Environmental Sampling .................................. 5-2
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`5.1.2 Validity of Environmental Sampling Data ..................................................... 5-5
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`5.1.3 Representativeness of Environmental Sampling Data.................................... 5-8
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`5.1.4 Conclusions About Data Usability ............................................................... 5-15
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`Evaluating Modeled Data......................................................................................... 5-17
`Considering Background Concentrations................................................................. 5-19
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`Identifying and Filling Critical Data Gaps ............................................................... 5-21
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`Summarizing and Presenting Environmental Data in the Public Health
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`Assessment Document ............................................................................................. 5-25
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`5.2
`5.3
`5.4
`5.5
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`6.2
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`Chapter 6: Exposure Evaluation: Evaluating Exposure Pathways ................................ 6-1
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`6.1
`Exposure Pathway Evaluation.................................................................................... 6-1
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`6.1.1 The Five Elements of an Exposure Pathway .................................................. 6-3
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`6.1.2 Developing a Site Conceptual Model............................................................. 6-4
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`Contamination Source(s) and Releases ...................................................................... 6-7
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`6.2.1
`Identifying Contamination Sources ................................................................ 6-7
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`6.2.2
`Identifying Affected Media ............................................................................ 6-8
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`6.2.3
`Identifying Physical/Safety Hazards .............................................................. 6-9
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`Evaluating Fate and Transport of Contaminants...................................................... 6-10
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`6.3.1 Fate and Transport Processes ....................................................................... 6-12
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`6.3.2 Physical and Chemical-Specific Factors That Influence Environmental
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`Fate and Transport........................................................................................ 6-13
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`6.3.3 Site-Specific Factors That Influence Environmental Fate and Transport .... 6-15
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`6.3.3.1 Climatic Factors .............................................................................. 6-15
`6.3.3.2 Geologic and Hydrogeologic Conditions........................................ 6-16
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`Identifying Point(s) of Exposure and Exposure Routes ........................................... 6-17
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`6.4.1 Possible Exposure Points by Environmental Medium ................................. 6-17
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`6.4.2 Exposure Routes ........................................................................................... 6-19
`6.4.3 Temporal and Spatial Considerations........................................................... 6-20
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`6.4.3.1 Temporal Considerations ................................................................ 6-20
`6.4.3.2 Spatial Considerations..................................................................... 6-20
`6.4.4 Conditions That Could Prevent Exposure .................................................... 6-21
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`Identifying Potentially Exposed Populations ........................................................... 6-21
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`6.5.1 Characterizing Potentially Exposed Populations.......................................... 6-22
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`6.5.1.1 Identifying Populations ................................................................... 6-22
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`6.3
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`6.4
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`6.5
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`Public Health Assessment Guidance Manual (Update)
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`6.6
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`6.5.1.2 Identifying Use Patterns.................................................................. 6-24
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`6.5.1.3 Other Factors Potentially Influencing Exposure ............................. 6-24
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`6.5.2 Estimating Numbers of People in Potentially Exposed Populations............ 6-25
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`Categorizing Exposure Pathway Information .......................................................... 6-28
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`6.6.1 Completed Exposure Pathways .................................................................... 6-29
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`6.6.2 Potential Exposure Pathways........................................................................ 6-29
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`6.6.3 Eliminated Exposure Pathways .................................................................... 6-30
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`Identifying the Need for Gathering Additional Exposure Data ............................... 6-31
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`6.7.1 Definition of Exposure Investigations.......................................................... 6-31
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`6.7.2 When an Exposure Investigation Should Be Considered............................. 6-32
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`Presenting Exposure Pathway Information in the Public Health
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`Assessment Document ............................................................................................. 6-33
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`6.7
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`6.8
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`7.3
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`Chapter 7: Health Effects Evaluation: Screening Analysis ............................................. 7-1
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`7.1 What Are Comparison Values?.................................................................................. 7-3
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`7.2
` Conducting Environmental Guideline Comparisons.................................................. 7-4
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`7.2.1 Selecting Environmental Guidelines .............................................................. 7-5
`7.2.2 What If No Comparison Values Exist? .......................................................... 7-9
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`Conducting Health Guideline Comparisons............................................................... 7-9
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`7.3.1 Estimating Site-Specific Exposure Doses .................................................... 7-10
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`7.3.1.1 How Are Exposure Doses Estimated? ............................................ 7-10
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`7.3.1.2 How Are Input Parameters Selected?.............................................. 7-12
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`7.3.1.3 What Are Some Sources of Input Parameters? ............................... 7-12
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`7.3.1.4 What Factors Should Be Considered When Selecting
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`Input Parameters?............................................................................ 7-13
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`7.3.2 Selecting Health Guidelines ......................................................................... 7-17
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`7.4 Other Factors That Influence the Screening Analysis.............................................. 7-18
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`7.5
`Presenting Screening Analysis Findings in the Public Health
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`Assessment Document ............................................................................................. 7-20
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`8.4
`8.5
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`Chapter 8: Health Effects Evaluation: In-depth Analysis ............................................... 8-1
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`8.1 When to Conduct an In-depth Analysis ..................................................................... 8-3
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`8.2
`Tools and Resources Needed to Support an In-depth Analysis ................................. 8-4
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`8.3
`Evaluating Studies on Which Exceeded Health Guidelines are Based ...................... 8-6
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`8.3.1 Compare Site-Specific Doses to Observed Effect Levels .............................. 8-8
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`8.3.2 Assess the Relevance of the Critical Study .................................................. 8-13
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`Reviewing Other Dose-Response Data.................................................................... 8-17
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`Evaluating Other Substance-specific Factors that Can Increase or Decrease
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`the Potential for Harm .............................................................................................. 8-18
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` Biologic Uptake............................................................................................ 8-18
`8.5.1
`8.5.2
` Mechanistic Data .......................................................................................... 8-21
`8.5.3 Sensitive Populations and Life Stages.......................................................... 8-22
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`8.5.4 Multiple Chemical Exposures ...................................................................... 8-25
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` Evaluating Site-specific Health Effects Data ........................................................... 8-27
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`8.6.1 Health Outcome Data ................................................................................... 8-27
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`8.6.2
` Biologic Data................................................................................................ 8-32
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`8.6
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`8.6.3 Medical Data and Information...................................................................... 8-33
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`Presenting Findings in the Public Health Assessment Document............................ 8-34
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`8.7
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`Chapter 9: Determining Conclusions and Recommendations......................................... 9-1
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`9.1
` Determining Conclusions ........................................................................................... 9-1
`9.1.1 Selecting a Conclusion Category.................................................................... 9-3
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`9.1.1.1 What Factors Influence the Selection of a Category? ....................... 9-4
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`9.1.1.2 How Are Categories Assigned? ........................................................ 9-5
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`9.1.1.3 What If Insufficient Information Exists? .......................................... 9-6
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`9.1.1.4 Is a Conclusion Category Always Needed? ...................................... 9-7
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`9.1.2 Presenting Conclusions in the Public Health Assessment Document ............ 9-7
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` Determining Recommendations and Developing a Public Health Action
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`Plan (PHAP)
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`9.2.1 Actions To Cease or Reduce Exposures....................................................... 9-10
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`9.2.2 Actions for Site Characterization ................................................................. 9-11
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`9.2.3
` Health Activities ........................................................................................... 9-12
`9.2.4 Factors To Consider When Developing Recommendations and the PHAP. 9-16
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`9.2.5 Presenting Recommendations and Public Health Action Plan in the Public
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`Health Assessment Document ...................................................................... 9-18
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`9.2
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`Appendix A Tribal-Specific Resources and Considerations.............................................. A-1
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`Appendix B Glossary of Terms ..........................................................................................B-1
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`Appendix C Community Check List...................................................................................C-1
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`Appendix D Guidelines for Effective Communication...................................................... D-1
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`Appendix E Chemical- and Site-Specific Factors That May Affect Contaminant
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`Transport.........................................................................................................E-1
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`Appendix F Derivation of Comparison Values ..................................................................F-1
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`Appendix G Calculating Exposure Doses.......................................................................... G-1
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`Appendix H Public Health Conclusion Categories............................................................ H-1
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`LIST OF TABLES
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`Contamination Information Needed by Environmental Medium ................ 3-12
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`Site-Specific Information That May Be Needed To Evaluate Contaminant
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`Fate and Transport ....................................................................................... 3-16
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`Information Available Through Government Agencies .............................. 3-19
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`Table 3-1.
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`Table 3-2.
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`Table 3-3.
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`Table 3-4.
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`Table 3-5.
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`Table 4-1.
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`Useful Government Sources of Information................................................ 3-20
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`Sample Site Summary Table........................................................................ 3-26
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`ATSDR Program Areas with Responsibilities for Working
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`with Communities.......................................................................................... 4-5
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`Table 4-2.
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`Table 4-3.
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`Table 5-1.
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`Table 6-1.
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`Table 7-1.
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`Table 9-1.
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`Table 9-2.
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`Table 9-3.
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`Table 9-4.
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`Table 9-5.
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`Issues to be Considered When Developing Community Involvement
`Strategies...................................................................................................... 4-14
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`Activities That Might Be Conducted at Three Different Levels of
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`Community Involvement and Participation ................................................. 4-24
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`Example Use of a Table To Display Data: Surface Water Sampling
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`Data for Selected Metals Along the XXX River ......................................... 5-30
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`Documenting Exposure Pathways ............................................................... 6-35
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`Additional Sources of Environmental Guidelines ......................................... 7-8
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`Summary of Conclusion Categories .............................................................. 9-4
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`Summary of Conclusion Categories With Recommended
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`Public Health Actions .................................................................................. 9-10
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`Factors to Consider When Selecting Health Activities................................ 9-13
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`Example Worksheet for Developing Recommendations and PHAP
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`(Completed to Show a Biologic Monitoring Action) .................................. 9-17
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`Examples of Conclusions, Recommendations, and Public
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`Health Actions ............................................................................................. 9-19
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`LIST OF FIGURES
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`Figure 1-1. Basic Components of the Public Health Assessment Process ....................... 1-4
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`Figure 2-1.
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`Types of NCEH/ATSDR Staff and External Partners That May Be
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`Involved in Supporting a Public Health Assessment ..................................... 2-6
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`Figure 2-2. Overview of the Public Health Assessment Process...................................... 2-8
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`Figure 3-1.
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`Figure 4-1
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`Figure 5-1.
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`Information Needed To Evaluate Exposures and Health Effects ................ 2-11
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`The Basic Iterative Information-Gathering Process for a Public
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`Health Assessment ......................................................................................... 3-2
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`Figure 3-2. Basic Data Needs for Conducting a Public Health Assessment .................... 3-4
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`Components of Effective Community Involvement ...................................... 4-3
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`Examples of Maps Used to Display Environmental Data ........................... 5-28
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`Example Use of a Chart to Display Data: Number of Exceedances of
`EPA’s Health-based Ozone Standard at Site X since 1982 ......................... 5-29
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`Evaluating Exposure Pathways...................................................................... 6-2
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`Site Conceptual Model—Exposure Pathway Schematic ............................... 6-5
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`Site Conceptual Model—Exposure Pathway Evaluation .............................. 6-6
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`Screening Analysis Overview........................................................................ 7-2
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`Environmental Guideline Hierarchy .............................................................. 7-7
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`Figure 5-2
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`Figure 6-1.
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`Figure 6-2.
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`Figure 6-3.
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`Figure 7-1.
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`Figure 7-2.
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`Figure 8-2.
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`Figure 8-3.
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`Figure 8-1. Overview of In-depth Analysis...................................................................... 8-2
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`Schematic of Various Low-dose Extrapolation Methods .............................. 8-7
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`Factors Affecting Whether Environmental Contamination May
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`Result in Harmful Effects ............................................................................ 8-20
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`Figure 8-4. Health Outcome Data Evaluation Decision Tree (For Evaluating Site-
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`related Exposures)........................................................................................ 8-29
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`Figure 9-1. Overview of Conclusion and Recommendation Process ............................... 9-2
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`Public Health Assessment Guidance Manual (Update)
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`Chapter 1
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`Introduction
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`The Agency for Toxic Su