Unjted States •",:••:,: vMf^^^i^^^^^ffic^Qf-^llutioii}^^
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                                                     & Reso tl rc    (M
Printed on paper that contains at least-20 percent postcoijisurher fiber.
                                                                            US. ERA

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               U.S. EPA
         The Design for the
      Environment Program
The Design for the  Environment  (DfE)
Program  harnesses  EPA's  expertise  and
leadership to facilitate information exchange
and research on risk reduction and pollution
prevention efforts. DfE works with both large
and small businesses on a voluntary basis, and
its wide-ranging projects include:

•     Changing general business practices
       to incorporate environmental
       concerns.

•     Working with specific industries to
       evaluate the risks, performance and
       costs of alternative chemicals
       processes and technologies.

•     Helping individual businesses
       undertake environmental design
       efforts through the application of
       specific tools and methods.

DfE Partners include:

• Industry
• Professional Institutions
• Academia
• Environmental and Public Interest Groups
• Other Government Agencies
     The University of Tennessee
   Center for Clean Products
       & Clean Technologies

The Center for Clean Products and Clean
Technologies   performs  interdisciplinary
research to develop, evaluate and promote
cleaner products and cleaner technologies that
minimize  pollution  at  the  source and
contribute    to    long-term    sustainable
development.

The goals of the Center are to:

• develop tools and databases for
   evaluating life-cycle environmental
   impacts;
• assist producers and other stakeholders in
   cooperative efforts to design for the
   environment;
• assess and formulate policies to
   encourage the use of cleaner products and
   cleaner technologies; and
• contribute to the development and
   demonstration of cleaner products and
   cleaner technologies.

The Center has an interdisciplinary core staff
of experienced engineers, policy analysts and
environmental scientists who collaborate with
faculty and students throughout the university.
The Center often works in partnership with
government,  industry  and  public-interest
groups  to  develop solutions to  complex
environmental problems.

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    Cleaner Technologies
  Substitutes Assessment
A Methodology & Resource Guide
        Lori E. Kincaid, Principal Investigator
             University of Tennessee

           Jed D. Meline, Project Officer
        U.S. Environmental Protection Agency

           Gary A. Davis, Senior Advisor
             University of Tennessee
                U.S. EPA
  This document was produced under, E^A Grant Number X821-543
                  to the ; «
            The University of Tennessee
      Center for Clean Products and Clean Technologies

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            For sale by the U.S. Government Printing Office
Superintendent of Documents, Mail Stop: SSOP, Washington, DC 20402-9328
                   ISBN 0-16-048959-8

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                                       Notice

 This document has been reviewed by the U.S. Environmental Protection Agency (EPA) and
approved for publication. It is based on experiences gained from projects conducted by EPA's
 Design for the Environment staff in collaboration with partners from industry, public interest
groups, and research/educational institutions. Mention of trade names or commercial products
                 does not imply endorsement or recommendation for use.
                               For More Information

To learn more about EPA's Design for the Environment Program or to obtain this document or
             additional information on other related materials, please contact:

              EPA's Pollution Prevention Information Clearinghouse (PPIC)
                         U.S. Environmental Protection Agency
                               401M Street, SW (3404)
                               Washington, DC 20460
                               Phone: (202) 260-1023
                                 Fax:(202)260-0178
              Or visit the Design for the Environment Program Homepage at:
                                 http://es.inel.gov/dfe
       To learn more about the University of Tennessee Center for Clean Products and
                   Clean Technologies, visit the Center's Web Page at:
                              http://www.ra.utk.edu/eerc/
                                         in

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                               ACKNOWLEDGMENTS
This publication was prepared by The University of Tennessee Center for Clean Products and
Clean Technologies in partnership with the U.S. Environmental Protection Agency (EPA), the
University of Tennessee Energy Analysis Diagnostic Center, and Oak Ridge National
Laboratory.  A special thanks is extended to Jed Meline, EPA Design for the Environment
Program, for his active participation and useful advice.

We appreciate the efforts of all of the contributing authors, especially Jack Geibig and Mary
Swanson, who wrote or assisted with the bulk of the module descriptions hi Part II of this
publication.  We also appreciate the efforts of the EPA Advisory Committee for their helpful
comments and reviews of segments of this document.
Contributing
Authors
U.S. Environmental Protection Agency
Advisory Committee
Center for Clean Products
and Clean Technologies

Gary A. Davis
Jack Geibig
Lori E. Kincaid
Dean Menke
Diane Perhac
Mary Swanson

Energy Analysis Diagnostic Center

Jeff Givens
Rich Jendrucko, PhD
Todd Thomas

Oak Ridge National Laboratory

Mary Lou Horner
Dennis Opresko
Robert Boethling
Joseph Breen
Kathryn Caballero
Richard Clements
James Darr
Susan Dillman
Jill Gendelman
Sondra Hollister
Patrick Kennedy
Susan Krueger
Elizabeth Margosches
Fred Metz
Vince Nabholz
Jean E. (Libby) Parker
Scott Prothero
Paul Quillen
Lorraine Randecker
Mary Katherine Powers
Pauline Wagner
Sherry Wise
Special thanks to Margaret Goergen, Tina Cordy, Barbara Griffith, and Patrice Burley of the
University of Tennessee for their invaluable assistance in preparing this document.
                                          IV

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                                                           Contents
                                                                          Page

Executive Summary	xiii


PARTI:  PROCESS OVERVIEW

CHAPTER 1: INTRODUCTION 	;	1-1
      What is EPA's Design For the Environment Program?	1-2
      What is a Cleaner Technologies Substitutes Assessment?  	1-3
      Who Participates in a Cleaner Technologies Substitutes Assessment?	1-4
      Why Participate in a Cleaner Technologies Substitutes Assessment?	1-6
      What is in This Publication? 	1-8

CHAPTER2: PREPARING FOR A CTSA 	2-1
      Preparing the Scoping Documents	2-2
      Selecting the Project Focus 	2-4
      Identifying Substitutes Within the Use Cluster	'.	2-7
      Selecting a Subset of Substitutes for Evaluation	2-15
      Establishing the Project Baseline	2-19
      Setting the Boundaries of the Evaluation	2-20

CHAPTERS: DEVELOPING A CTSA	.3-1
      Overview of the Information Module Approach	 3-3
      Flow of Information in a CTSA	3-5
      Identifying Data Analysis Methods and Analyzing Data 	3-19
      Developing a CTSA Document	3-20

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PARTH: INFORMATION MODULES
CHAPTER 4: OVERVIEW OF THE MODULE DESCRIPTIONS	 4-1
      Format of the Module Descriptions	 4-1

CHAPTERS: CHEMICAL & PROCESS INFORMATION	5-1
      Chemical Properties	5-3
      Chemical Manufacturing Process & Product Formulation	5-13
      Environmental Fate Summary	..;.... 5-21
      Human Health Hazards Summary	5-33
      Environmental Hazards Summary	5-55
      Chemistry of Use & Process Description	 5-67
      Process Safety Assessment	 5-73
      Market Information	5-87
      International Information	 5-91

CHAPTER 6: RISK	6-1
      Workplace Practices & Source Release Assessment	6-3
      Exposure Assessment	;	6-15
      Risk Characterization	 6-39

CHAPTER 7: COMPETITIVENESS	 7-1
      Regulatory Status	7-3
      Performance Assessment	7-13
      Cost Analysis	7-25
                                                                     s,
CHAPTER 8: CONSERVATION	8-1
      Energy Impacts	 8-3
      Resource Conservation  	,	 8-9

CHAPTER 9: ADDITIONAL ENVIRONMENTAL IMPROVEMENT OPPORTUNITIES . 9-1
      Pollution Prevention Opportunities Assessment	 9-3
      Control Technologies Assessment	9-9

CHAPTER 10: CHOOSING AMONG ALTERNATIVES 	10-1
      Risk, Competitiveness & Conservation Data Summary 	10-3
      Social Benefits/Costs Assessment	10-11
      Decision Information Summary	10-27


REFERENCES  	R-l
                                      VI

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APPENDIX A
Examples of Workplace Practices Questionnaires	 A-l

APPENDIX B
Environmental Releases And Occupational Exposure Assessment:
Screen Printing CTSA	B-l

APPENDIX C
Population Exposure Assessment For Screen Reclamation Processes:
Screen Printing CTSA	C-l

APPENDIX D
Background on Risk Assessment For Screen Reclamation Processes:
Screen Printing CTSA	 D-l

APPENDIX E
Background And Methodology For Performance Demonstrations:
Lithography CTSA	E-l

APPENDIX F
Chemical Volume Estimates: Screen Printing CTSA	,	F-l

APPENDIX G
Cost Analysis Methodology: Lithographic Blanket Washes CTSA	  G-l

APPENDIX H
Environmental Fate Summary Initial Review Exposure Report	  H-l

APPENDDU
Risk, Competitiveness & Conservation Data Summary and Social Benefits/Costs
Assessment: Lithography CTSA	1-1

APPENDIX J
Cost of Illness Valuation Methods	J-l
                                        VII

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                                  LIST OF TABLES
                                                                                 Page
Table 2-1:     Uses of Information From an Industry and Use Cluster Profile 	2-3
Table 3-1:     Overview of CTSA Information Modules	3-8
Table 3-2:     Chemical and Process Information 	3-11
Table 3-3:     Risk	3-12
Table 3-4:     Competitiveness	3-15
Table 3-5:     Conservation  	3-17
Table 3-6:     Additional Improvement Opportunities	3-17
Table 3-7:     Choosing Among Alternatives	3-18
Table 5-1:     Data Transferred From the Chemical Properties Module  	5-6
Table 5-2:     Mathematical Models Used to Estimate Chemical Properties  	5-9
Table 5-3:     References for Chemical and Physical Properties	5-9
Table 5-4:     Sources of Chemical and Physical Properties Data	5-10
Table 5-5:     Sources of Chernical Manufacturing Process and Product Formulation
              Information 	5-19
Table 5-6:     References for Estimating Environmental Fate Parameters  	5-29
Table 5-7:     Sources of Environmental Fate Data	5-30
Table 5-8:     Summary Table for Toxicity of Chemicals and Potential Substitutes	5-46
Table 5-9:     Computer Programs Used in Human Health Hazards Assessment	.5-47
Table 5-10:    Published Guidance on Health Hazards Assessment	5-48
Table 5-11:    Sources of Human Health Hazards Data	5-50
Table 5-12:    Supplemental Sources of Human Health Hazards Data	5-52
Table 5-13:    Example Aquatic Toxicity Profiles (in mg/1)	5-59
Table 5-14:    Analytical Models Used in Aquatic Toxicity Assessment  	5-62
Table 5-15:    Published Guidance on Aquatic Toxicity Assessment 	5-63
Table 5-16:    Sources of Aquatic Toxicity Data	5-64
Table 5-17:    Published Guidance on Chemistry of Use & Process Description  	5-72
Table 5-18:    Data Transferred From the Process Safety Assessment Module	5-81
Table 5-19:    Published Guidance on Process  Safety 	5-82
Table 5-20:    Sources of Process Safety Data	5-84
Table 5-21:    Sources of Market Information  	5-89
Table 5-22:    Sources of International Information	5-94
Table 6-1:     Analytical Models Used to Perform a  Source Release Assessment 	6-14
Table 6-2:     Published Guidance on Source Release Assessments and the Use  of Mass
              Balances	6-14
Table 6-3:     Example - Estimated Releases to Water from Traditional Formulations
              from Screen Reclamation at a Single Facility	."	6-22
Table 6-4:     Example - Estimated Cumulative Releases for St. Louis County, Missouri,
              from 135 Screen Printing Facilities	6-23
Table 6-5:     Example - Air Releases and Concentrations from a Single Model
              Screen Printing Facility	6-23
                                         vm

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Table 6-6:    Example - Occupational Exposure Estimates for Screen Reclamation,
             Ink Remover System	6-26
Table 6-7:    Analytical Models Used in Exposure Assessment	6-30
Table 6-8:    Published Guidance on Exposure Assessment  	6-35
Table 6-9:    Sources of Data for Exposure Assessment  	6-36
Table 6-10:   Typical Format for Risk Characterization Results	6-49
Table 6-11:   Published Guidance on Risk Characterization	6-51
Table 7-1:    Published Guidance and Data Sources	7-11
Table 7-2:    Published Guidance on Performance Assessment	7-22
Table 7-3:    Published Guidance for Cost Analysis 	7-34
Table 7-4:    Published Guidance on Cost Analysis	7-34
Table 8-1:    Published Guidance on Energy Assessments  	8-8
Table 8-2:    Sources of Energy Consumption Data	8-8
Table 8-3:    Example of Categorizing Similar Resources	8-12
Table 8-4:    Example of Tabulated Resource Consumption Data for One Substitute	8-14
Table 8-5:    Published Guidance on Estimating Resource Conservation 	8-15
Table 8-6.    Sources of Data on Resource Consumption Rates	8-16
Table 9-1:    Published Guidance on Performing Pollution Prevention Opportunities
             Assessment	9-8
Table 9-2:    Waste Characteristics and Treatment Objectives	9-14
Table 9-3:    Published Guidance on Control Technologies Assessment	9-17
Table 10-1:   Example Matrix of Environmental Release and Risk-Related Data	10-6
Table 10-2:   Example Matrix of Conservation Information	10-6
Table 10-3:   Baseline and Alternative 1: Social Benefits and Costs  	10-23
Table 10-4:   Analytical Models  	10-24
Table 10-5:    Sources of Social Benefits/Costs Assessment Published Guidance  	10-25
                                           IX

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                                  LIST OF FIGURES
                                                                                 Page

 Figure 1-1:    The DfE Process Promotes Informed Business Decisions That integrate Risk,
              Performance, and Cost Concerns	1_4
 Figure 1-2:    Contributions of DfE Partners	 1-5
 Figure 2-1:    Steps in a CTSA Project	2-2
 Figure 2-2:    Basic Functional Steps in Printing Wiring Board Fabrication	2-5
 Figure 2-3:    Traditional Dry Cleaning Chemicals	2-8
 Figure 2-4:    Existing and Emerging Dry Cleaning Alternatives	 2-9
 Figure 2-5:    Garment Cleaning Alternatives	:... 2-10
 Figure 2-6:    Integration of Screen Reclamation Methods	2-12
 Figure 2-7:    Screen Printing Substitutes Tree of Demonstrated Technologies	2-14
 Figure 2-8:    Screen Printing Substitutes Tree of Undemonstrated Technologies	2-16
 Figure 2-9:    Making-Holes-Conductive Substitutes Tree	2-17
 Figure 3-1:    Steps to Produce a CTSA  	3_2
 Figure 3-2:    CTSA Information Flows  	.'!.'.' 3-6
 Figure 3-3:    Risk Characterization Module: Example Information Flows	3-13
 Figure 3-4:    Workplace Practices & Source Release Assessment Module:
              Example Information Flows  	3-14
 Figure 3-5:    Performance Assessment Module: Example Information Flows   	3-16
 Figure 5-1:    Chemical Properties Module: Example Information Flows	5-8
 Figure 5-2:    Process Flow Diagram for the Manufacture of Ethanol by Indirect
              Hydration	5_16
 Figure 5-3:    Chemical Manufacturing Process & Product Formulation Module:
              Example Information Flows 	5-18
 Figure 5-4:    Environmental Fate Summary Module: Example Information Flows	5-28
 Figure 5-5:    Human Health Hazards Summary Module: Example Information Flows ... 5-47
 Figure 5-6:    Environmental Hazards Summary Module:  Example Information Flows ... 5-62
 Figure 5-7:    Example Process Flow Diagram of a Pattern Etch Process for PWB
              Manufacturing	5_70
 Figure 5-8:    Chemistry of Use & Process Description Module:
              Example Information Flows 	5_71
 Figure 5-9:    Process Safety Assessment Module: Example Information Flows	5-81
 Figure 5-10:   Market Information Module: Example Information Flows  	5-89
 Figure 5-11:   International Information Module: Example Information Flows	5-93
 Figure 6-1:    Flow Diagram of Manufacturing Process Without a Chemical Reaction	6-10
 Figure 6-2:   Natural Gas Furnace Process Diagram  	6-11
 Figure 6-3:    Workplace Practices & Source Release Assessment Module:
             Example Information Flows 	6-13
Figure 6-4:   Exposure Assessment Module: Example Information Flows	6-29
Figure 6-5:   Risk Characterization Module: Example Information Flows	6-50
Figure 7-1:   Regulatory Status Module: Example Information Flows	7-10

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Figure 7-2:    Performance Assessment Module:  Example Information Flows	7-22
Figure 7-3:    Cost Analysis Module: Example Information Flows	7-33
Figure 8-1:    Energy Impacts Module:  Example Information Flows	8-7
Figure 8-2:    Resource Conservation Module: Example Information Flows	8-15
Figure 9-1:    Pollution Prevention Opportunities Assessment Module:
             Example Information Flows	9-7
Figure 9-2:    Potential Treatment Technologies by Type of Waste Stream	9-15
Figure 9-3:    Control Technologies Assessment Module:  Example Information Flows ... 9-16
Figure 10-1:   Risk, Competitiveness & Conservation Data Summary Module:
             Example Information Flows 	•	10-9
Figure 10-2:   Social Benefits/Costs Assessment Module:  Example Information Flows .. 10-23
Figure 10-3:   Decision Information Summary Module:  Example Information Flows	10-31
                                  LIST OF BOXES
Why Focus on Function	•	• • • • 2-11
RECAP: Key Terms and Concepts	3-1
                                          XI

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Xll

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This publication presents the  methods and
resources needed to  conduct a Cleaner
Technologies Substitutes Assessment (CTSA),
a methodology for evaluating the comparative
risk,  performance,   cost,   and   resource
conservation of  alternatives  to  chemicals
currently used by specific industry sectors. The
CTSA methodology was developed by the U.S.
Environmental  Protection  Agency  (EPA)
Design for the Environment (DfE) Program,
the University of Tennessee Center for Clean
Products and Clean Technologies, and other
partners in  voluntary, cooperative, industry-
specific pilot projects.
EXECUTIVE
   SUMMARY
Part I of this publication is an overview of the CTSA process,  including the preparatory steps
leading up to a CTSA, and the types of data collected and analyses performed in a CTSA.  Part II
describes the data sets and analyses in more detail.
 Businesses operating in the 1990s face a variety of competing demands — maintaining high
 quality at low cost, staying competitive in a global marketplace, and meeting consumer
 preferences and regulatory demands for reduced environmental impacts.  Designing for the
 environment is an effective strategy for organizing and managing these challenging demands.

 The EPA Office of Pollution Prevention and Toxics created the DfE program in 1991 to help
 businesses incorporate environmental considerations into the design and redesign of products,
 processes, and technical and management system. DfE projects include broad institutional
 efforts aimed at changing general business practices, as well as voluntary, cooperative projects
 with trade associations and businesses in specific industries.

 A typical industry project includes developing a CTSA and a communication and
 implementation strategy. The CTSA methodology has grown out of DfE industry projects, which
 are cooperative, joint efforts with trade associations, businesses, public-interest groups, and
 academiato assist businesses in specific industries to select more environmentally-sound
 products, processes and technologies. A CTSA document is  the repository for the technical
 information developed by a particular DfE project, including detailed environmental, economic,
 and performance information on traditional and alternative chemicals, manufacturing methods
 and technologies. A CTSA does not recommend alternatives or make value judgements
 concerning an alternative. Instead, the goal is to provide businesses with information to make
 environmentally informed choices and design for the environment.
                                           xin

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  STEPS IN A CLEANER TECHNOLOGIES SUBSTITUTES ASSESSMENT PROJECT

  Figure ES-1 illustrates the basic steps leading up to and following a CTSA. First, DfE project
  organizers recruit partners from various stakeholder communities to create a project team.  Past
  CTSA project teams have been convened by EPA together with trade associations, industry
  research organizations, or other concerned representatives of the business community seeking to
  reduce the environmental impacts of their products and manufacturing processes. A goal of this
  publication, however, is to provide businesses, public-interest groups, and other stakeholders the
  information they need to perform comparative evaluations with or without the direct participation
  of EPA.

                      FIGURE ES-1: STEPS IN A CTSA PROJECT
                                   Recruit Partners
                              Prepare Scoping Documents

                        Select a Focal Use Cluster for Evaluation
                      Identify Substitutes Within the Focal Use Cluster
                              ifeV"^4^^
                        Select Subset of Substitutes for Evaluation
                             Establish the Project Baseline

                          Set the Boundaries of the Evaluation
                             Develop Information Products
                                Disseminate Results
Once a project team is assembled, the team members develop an Industry and Use Cluster Profile
document and a Regulatory Profile document to help define the project focus.  An Industry and
Use Cluster Profile gives market data for the industry, describes technological trends, and
presents a summary of key industry processes, individual steps within processes, chemicals
typically used in each step, and a preliminary list of substitutes for each step. These sets of
substitutes make up the use dusters for the industry. A use cluster is a product- or process-
specific application in which a set of chemical products, technologies, or processes can substitute
                                         XIV

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for one another to perform a particular function. A Regulatory Profile identifies the principal
federal environmental regulations that may affect the industry under study and the factors that
determine which regulations apply to any particular operation. The project team typically selects
the use cluster with the greatest opportunities for environmental improvement for the detailed
analysis of a CTSA.

Identifying Substitutes

Additional substitutes are identified as a CTSA progresses and more information is gained about
the characteristics of the use cluster and of the industry. All stakeholder groups are potential
sources of information about additional substitutes. For example, manufacturers and suppliers of
chemical products and technologies play an important role in substitutes identification, since they
frequently have an up-to-date understanding of current industry trends, and emerging products or
technologies.  Also, the participation of suppliers in the CTSA process is essential to developing
information on chemical product formulations, which is used in the risk characterization

Trade associations frequently track new developments; universities and other research
organizations may be involved in applied or basic research on new alternatives. Public-interest
groups concerned about human health risk or other environmental impacts may have
independently searched for options to prevent pollution.  DfE project teams use all of these
resources to develop a substitutes tree. A substitutes tree is a graphical depiction of the
substitute or alternative chemical products, technologies, or processes that form the use cluster
and their relationship to each other within the functional category defined by the use cluster. In a
DfE project, the terms substitute and alternative are used  interchangeably to mean any traditional
 or novel chemical product, technology, or process that can be used to perform a particular
 function.

 Establishing the Baseline and Boundaries of the Evaluation

 Due to time and resource constraints, the project team may select a subset of substitutes for
 detailed evaluation in a CTSA.  Past CTSAs have evaluated a subset of currently available
 substitutes, including substitutes that have not yet been widely adopted by industry. The project
 baseline(s) are substitute(s) that are currently industry standard practice or familiar to most of the
 industry, which come from this subset. With a familiar baseline as the basis for comparison, the
 comparative data on risk, performance, cost, and conservation developed through the project will
 be understandable to the majority of industry.

 Once the subset of substitutes and baseline(s) are established, the boundaries of the evaluation
 are set by identifying the life cycle stages and types of environmental impacts (i.e., human health
 and environmental risk to workers, energy impacts, etc.)  of greatest concern. Past CTS As have
 focussed on the areas where the project partners can most influence change, in the use and
 disposal of chemicals at operating facilities.  The project team is then ready to perform the
 detailed data collection and analysis needed to develop a CTSA (see below).
                                             xv

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  Disseminating Results

  Following completion of a CTSA, DfE project partners develop a variety of outreach tools to
  communicate CTSA results. These may include fact sheets, bulletins, pollution prevention case
  studies, software, videos, and training materials. CTSA results are disseminated to businesses
  and other stakeholders to encourage businesses to consider and use cleaner products, processes,
  and technologies.


  DEVELOPING A CLEANER TECHNOLOGIES SUBSTITUTES ASSESSMENT

 A CTSA uses information modules to develop as complete and systematic a picture as possible
 of the comparative risk, competitiveness (i.e., performance, cost, etc.), and resource conservation
 of the substitutes in a use cluster. An information module is a standard analysis or set of data
 designed to build on or feed into other information modules to  form an overall assessment of the
 substitutes. A CTSA records and presents facts collected in the information modules, but does
 not make value judgements or advocate particular choices.

 Figure ES-2 describes the basic process for developing a CTSA. The technical work typically
 starts with the collection of basic chemical properties and process information, followed by the
 collection of risk, competitiveness, and conservation data. At the same time, the project team
 develops methodologies for data analysis to ensure that all necessary data are collected. The next
 step is to analyze the collected data to determine the relative human health and environmental
 risk, competitiveness, and resource conservation of alternatives. Past DfE projects have shown
 that the choice of an alternative  will frequently involve making trade-offs. For example, when
 compared to the baseline, an alternative may cost slightly more, but have substantially reduced
 risk. The trade-off issues are evaluated to determine the relative benefits and costs of an
 alternative from both an individual perspective and a societal perspective. All of this is
 performed through the completion of 22 information modules, shown as bullets in Figure ES-3.

 Table ES-1 presents an overview of each of the information modules listed in Figure ES-3.  Part
 II of this publication describes each of these modules hi more detail, including a summary of the
 step-by-step process for completing a module, and sources of data, analytical models, and
 previously published guidance helpful in completing a module.  Since the CTSA process is
 applicable to numerous industry sectors, the module descriptions were developed to provide
 basic ^information suitable for a wide audience with a broad range of information needs.  The
 descriptions should give a DfE project team a basic understanding of the analytical concepts and
 methodology for completing a module, but they do not give a complete accounting of all of the
 assumptions, analytical methods or steps required for some of the more complicated analyses,
 such as exposure assessment.

For the more complicated analyses, a DfE project team should refer to published guidance, with
references provided in the module descriptions.  In addition, many of the modules describe
analyses or data evaluations that cannot be performed without substantial expertise and
                                          xvi

-------
experience (e.g., the Human Health Hazards Summary, Environmental Hazards Summary,
Exposure Assessment, and Risk Characterization modules). For these and other analyses, users
of this publication who do not have the necessary expertise are urged to seek outside assistance.


                   FIGURE ES-2: STEPS TO DEVELOP A CTSA
                     Collect Chemical and Process Information
                                                Develop Methodologies for
                                                      Data Analyses
Obtain Risk, Performance,
     and Cost Data
                              Evaluate Trade-Off Issues
                              Social Benefits/
                               Costs Assessment
                               Decision Information
                                  Develop CTSA
                            • Prepare Draft
                            • Perform Peer-Review
                              Publish Document
                                       xvn

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FIGURE ES-3: CTSA INFORMATION FLOWS
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The Chemistry of Use & Process Description module identifies: (1) the chemical/physical properties which contribute to
the effectiveness of the chemicals hi the use cluster; and (2) the process in which the chemicals are used. A process flow
diagram is created that schematically describes the process operations, equipment, and material flows.

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XIX

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TABLE ES-1: OVERVIEW OF CTSA INFORMATION MODULES
















Overview



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Exposure assessment is the quantitative or qualitative evaluation of the contact an organism (human or environmental]
have with a chemical or physical agent, which describes the magnitude, frequency, duration, and route of contact.




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Pollution prevention is the process of reducing or preventing pollution at the source through changes in productio
operation, and raw materials use. This module provides methods for identifying pollution prevention opportunity
can provide additional benefits beyond the benefits realized if one of the alternatives evaluated in the CTSA is
implemented.


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Control technologies are methods which can be used to minimize the toxicity and volume of pollutants. This mo<
provides methods for identifying control technologies that may be suitable for on-site treatment and disposal of pi
process waste streams.


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The Risk, Competitiveness & Conservation Data Summary module organizes data from the risk, competitiveness,
conservation components of a CTSA together with data from the Process Safety Assessment, Market Information
International Information modules to: (1) identify the trade-off issues associated with any one substitute; and (2)
the trade-off issues across substitutes. Data summaries are transferred to the Social Benefits/Costs Assessment an
Decision Informatiqn Summary modules for further analysis.
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Social Benefits/Costs Assessment is the process of qualitatively and systematically evaluating the impacts made o
society by individual decisions. Social benefits/costs assessment includes the benefits and costs to the individual
alternative choices (referred to as private benefits and costs) and the benefits and costs to others who are affected
choices (referred to as external benefits and costs). Consideration of these effects in decision-making by industry
result in improvements for industry and society as a whole.
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BENEFITS OF A CLEANER TECHNOLOGIES SUBSTITUTES ASSESSMENT

DfE partnerships developed the CTSA methodology described in this publication to help
business decision-makers achieve the tangible benefits that result from using a cleaner product or
technology. CTSA results give businesses the information needed to improve their bottom line
by evaluating and documenting voluntary changes a business can make to prevent pollution and
reduce risk. -Pollution prevention often lowers cost by reducing the amount of materials used in
production processes, the amount of waste streams that must be treated and disposed, and by
improving worker health and safety. In addition, a CTSA provides the necessary information for
companies to make informed business decisions that may reduce their regulatory burden or
potential liability costs. Also, companies that make voluntary changes to prevent pollution or
reduce risk may enjoy increased acceptance and market share from environmentally conscious
consumers.

Businesses that participate in voluntary DfE initiatives demonstrate their commitment to
continuous environmental improvement.  Company employees involved in day-to-day operations
ensure the project team understands the process constraints that need to be considered in the
design of environmentally preferable options. Stakeholder communities outside the company
provide unique perspectives and ideas to  broaden the evaluation beyond standard industry
concerns.

CTSA results also promote environmental competitiveness. Many companies are discovering
that proactive environmental business policies are necessary to remain competitive in today's
global marketplace.  In addition to the benefits of an improved company image, businesses are
finding that they can no longer afford to waste energy or other precious resources or pollute the
environment.
                                         xxn

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                ACRONYMS
1,1,1-TCA
T
ABC
ACGIH
APDR
API
AQUIRE
AsF
ASTM
AT
AT123D

ATSDR
BACT
BAT
BCF
BCT
BNA
BOD
bp
BPT
BTU
BW
C
CAA
CASRN
CC
CCRIS®
CEB
CERCLA

CFC
CFC-113
CFR
CHEMID®
CH4
CO
COG
COD
C02
CPSA
CR
CTSA
1,1,1 -trichloroethane
Atmospheric residence time
Activity-based costing
American Conference of Governmental Industrial Hygienists, Inc.
Acute potential dose rate
American Petroleum Institute
Aquatic Information Retrieval Toxicity Data Base
Assessment factor
American Society for Testing and Materials
Averaging time
Analytical Transient One-, Two-, and Three-Dimensional Simulation
and Groundwater Transport Model
Agency for Toxic Substance and Disease Registry
Best available control technology
Best available control technology economically practical
Bioconcentration factor
Best conventional pollution control technology
Bureau of National Affairs
Biochemical oxygen demand
Boiling point
Best practicable control technology currently available
British thermal unit
Body weight
Carbon
Clean Air Act
Chemical Abstracts Service Registry Number
Concern concentration
Chemical Carcinogenesis Research Information System Online Data Base
Chemical Engineering Branch
Comprehensive Environmental Response, Compensation, and Liability
Act
Chlorofluorocarbon
Chlorofluorocarbon-113
Code of Federal Regulations
Chemical Identification online chemical dictionary
Methane
Carbon monoxide
Concentration of concern
Chemical oxygen demand
Carbon dioxide
Consumer Product Safety Act
Contact rate
Cleaner Technologies Substitute Assessment
                     xxm

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 CWA
 UTM-TOX
 DART®
 DfE
 DFE
 EC
 EC50
 ECOCC
 ED
 EETD
 EF
 EFDB
 ELR
 EMICBACK

 EPCRA
 EPI
 ER
 ETICBACK
 EXAMS
 FATE
 FC
 Fed Reg
 FFDCA
 FIFRA
 FMEA
 GAMS
 GATT
 GEMS/PCGEMS

 GENE-TOX
 H20
 Hc
 HC1
 H
 HAD
 HAPs
 HAZOP
 HCFC
 Hcl
 HEC
 HED
 HERD
 HFC
HHE
 Clean Water Act
 Unified Transport Model for Toxicants
 Developmental and Reproductive Toxicology Online Data Base
 Design for the Environment (term coined by industiy)
 Design for the Environment (term used by EPA OPPT)
 Effective concentrations
 Effects concentration
 Ecotoxicity concern concentration
 Exposure duration
 Economics, Exposure and Technology Division of EPA
 Exposure frequency
 Environmental Fate Data Base
 Environmental Law Reporter
 Environmental Mutagen Information Center Backfile Online
 Genotoxicity Data Base
 Emergency Planning and Community Right-To-Know Act
 Estimation Programs Interface Chemical Properties Model
 Environment Reporter
 Environmental Teratology Information Center Backfile Online Data Base
 Exposure Analysis Modeling System
 Environmental Fate Constants Information System Data Base
 Fluorocarbon
 Federal Register
 Federal Food, Drug, and Cosmetic Act
 Federal Insecticide, Fungicide, and Rodenticide Act
 Failure mode and effects analysis
 GEMS Atmospheric Modeling Subsystem
 General Agreement on Tariffs and Trade
 Graphical Exposure Modeling System/Personal Computer Graphical
 Exposure Modeling System - Chemical Fate and Hansport Models
 Genetic Toxicology Online Data Base
 Water
 Henry's Law Constant
 Hydrochloric acid
 Hydrogen
 Health Assessment Documents
 Hazardous air pollutants
 Hazard and operability study
 Hydrochlorofluorocarbon
Hydrochloric acid
Human equivalent concentration
Human equivalent dose
Health and Environmental Review Division of EPA
Hydrofluorocarbon
Health Hazard Evaluations
                                      xxiv

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HI
HMTA
hp
HSA
HSDB
HQ
IARC
IDLH
IMES
IRIS
IRR
ISCLT

ISCST
kg
Ka,pKa
Kd
K
kW
kWh
LAER
LADC
LADD
LC
LCA
LD
LEL
LOEC
LOAEL
mp
MACT
MATC
MCCEM
MCLs
MCLG
MF
MLD
MOE
MSDS
Hazard index
Hazardous Materials Transportation Act
Horsepower
Hazardous Substances Act
Hazardous Substance Data Bank Online Data Base
Hazard quotient
International Agency for Research on Cancer
Immediately dangerous to life or health
Integrated Model Evaluation System
Integrated Risk Information System Online Data Base
Internal rate of return
Industrial Source Complex Long-Term Atmospheric Fate and Transport
Model
Industrial Source Complex Short-Term Atmospheric Fate and Transport
Model
Direct aqueous photolysis rate constant
Kilograms
Hydroxyl radical rate constant
Ozone rate constant
lonization or acid dissociation constant
Soil or sediment sorption coefficient
Organic carbon partition coefficient
Organic matter sorption coefficient
Octanol/water partition coefficient
Kilowatt
Kilowatt hour
Lowest achievable emission rate
Lifetime average daily concentration
Lifetime average daily dose
Lethal concentration
Life cycle assessment
Lethal dose
Lower explosive limit
Lowest-observed effects concentration
Lowest-observed adverseTeffect level
Melting point
Maximum achievable control technology
Maximum allowable toxicant concentration
Multi-Chamber Concentration and Exposure Model
Maximum contaminant levels for drinking water
Maximum contaminant level goal for drinking water
Modifying factor
Million liters per day
Margin of exposure
Material Safety Data Sheet
                                        xxv

-------
MW
Na
NAAQS
NAFTA
NEC
NESHAP
NIOSH
NO2
NOAEL
NOEC
NOEL
NPDES
NPV
NTP
02
03
OPPT
OR
OSHA
P
PDM
PDR
PEL
PMR
PM-10
POTWs
PPE
ppm
PRZM
PTPLU
Pv
PV
PWB
QSARs
RACT
RCRA
REL
RfC
RfD
RQ
RTECS®
S
SAR
SARA
SCIES
Molecular weight
Sodium
National Ambient Air Quality Standard
North American Free Trade Agreement
No effect concentration
National Emissions Standards for Hazardous Air Pollutants
National Institute of Occupational Safety and Health
Nitrogen dioxide
No-observed adverse effect level
No-observed effects concentration
No-observed effects level
National Pollutant Discharge Elimination System
Net present value
National Toxicology Program
Oxygen
Ozone
Office of Pollution Prevention and Toxics
Odds ratio
Occupational Safety and Health Administration
Parachor
Probabilistic Dilution Model
Potential dose rate
Permissible exposure limit
Proportionate mortality ratio
Particulate matter
Publicly owned treatment works
Personal protective equipment
Parts per million
Pesticide Root Zone Model
Point Plume Groundwater Model
Vapor pressure
Present value
Printed wiring board
Quantitative structure-activity relationships
Reasonably achievable control technology
Resource Conservation and Recovery Act
Recommended exposure limit
Reference concentration
Reference dose
Reportable quantity
Registry of Toxic Effects of Chemical Substances Online Data Base
Water solubility
Structure-activity relationship
Superfund Amendments and Reauthorization Act
Screening Consumer Inhalation Exposure Software
                                        xxvi

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SESOIL
SIC
SIP
SMR
SO2
SPAI
SPTF
SRC
STEL
STP
SUS
SWIP
V,
TCA
TCLP
THRs
TLV
TLV-C
TLV-STEL
TOXNET
TSCA
TSDF
TWA
UEL
UF
U.L.
U.S.C.
U.S.C.A.
U.S.C.S.
UTM-TOX
UV
voc
Seasonal Soil Compartment Model
Standard industrial classification
State Implementation Plan
Standardized mortality ratio
Sulfur dioxide
Screen Printing Association International
Screen Printing Technical Foundation
Syracuse Research Corporation
Short-term exposure limit
Sewage Treatment Plant fugacity model
Saybolt Universal Seconds
Survey Waste Injection Program
Half-life
Total cost assessment
Toxicity characteristic leaching procedure
Toxic and Hazardous Reviews
Threshold limit value
Threshold limit value - ceiling
Threshold limit value - short-term exposure limit
The National Library of Medicine's Toxicology Data Network
Toxic Substances Control Act
Treatment, storage, and disposal facility
Time-weighted-average
Upper explosive limit
Uncertainty factor
Underwriters Laboratory
United States Code
United States Code Annotated
United States Code Service
Unified Transport Model for Toxicants
Ultraviolet
Volatile organic compound
                                        xxvn

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XXV111

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           PARTI
         CLEANER
    TECHNOLOGIES
      SUBSTITUTES
      ASSESSMENT
PROCESS OVERVIEW

-------

-------
                                                                      Chapter 1
                                                 INTRODUCTION
This publication presents  the methods and
resources'  needed  to conduct  a  Cleaner
Technologies Substitutes Assessment (CTSA),
a methodology for evaluating the comparative
risk,  performance,   cost,   and  resource
conservation of  alternatives to chemicals
currently used by specific industry sectors. The
CTSA methodology -was developed by the U.S.
Environmental   Protection  Agency   (EPA)
Design for the Environment (DfE) Program,
the University of Tennessee Center for Clean
Products and Clean Technologies, and other f^^^^^^a^^m^mt^m^^m^gi^^mm^^^^^^
partners in voluntary, cooperative,  industry-
specific pilot projects.

This publication is designed for trade associations, businesses, citizen groups, government agencies,
or other stakeholders interested in learning about, initiating, or participating in a CTSA.  The goal
is to provide the CTSA methodology to anyone who can benefit from the increased efficiency and
reduced environmental risk that results from using a cleaner product, process, or technology. It
presents sources  of data, analytical models, and previously published guidance that can be used in
a CTSA.  A  companion publication,  Design for the Environment: Building Partnerships for
Environmental Improvement (EPA, 1995a), describes other aspects of DfE industry projects,
including how DfE projects are organized and how DfE partnerships disseminate project results.
The 1990s have ushered in a revolutionary new approach to environmental protection: together
with traditional criteria like performance, quality and cost, business leaders are taking the
environment into account in the design and redesign of products and processes. This new focus
on the environment helps create cleaner products and technologies that minimize environmental
impacts throughout their life cycles1 while fulfilling their function effectively, efficiently, and
economically.  Businesses are finding that by designing products and processes with the
environment in mind, they can reduce the environmental impacts of the products and services our
society now enjoys, which improves profitability and the quality of life while strengthening the
economy.

An important change has also been taking place in our national strategy for protecting the
environment. Through an array of partnership programs, EPA is demonstrating that voluntary
goals  and commitments achieve real environmental results in a timely and cost-effective way. In
addition to traditional, regulatory approaches to environmental protection, EPA is building
cooperative partnerships with a variety of groups, including large  and small businesses, public-
       1 As referred to here, the life cycle of a product or process encompasses extraction and processing of raw
materials, manufacturing, transportation and distribution, use/re-use/maintenance, recycling, and final disposal.

                                          1-1

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PART I: OVERVIEW OF CTSA PROCESS
interest groups, state and local governments, universities, and trade associations.  Among others,
these collaborative partnerships include the DfE Program, the 33/50 Program, WasteWi$e, Green
Lights, Energy Star, the Common Sense Initiative, and Project XL.

The results of these efforts are impressive. Thousands of organizations are working
cooperatively with EPA to set and reach environmental goals such as conserving water and
energy, and reducing greenhouse gases, toxic emissions, solid waste, indoor air pollution, and
pesticide risk. Program partners are making pollution prevention a central consideration in doing
business and working cooperatively to provide all stakeholders with effective tools to address
environmental issues. And these partners are achieving measurable environmental results often
more quickly and with lower costs than would be the case with regulatory approaches. EPA
views these partnerships as key to the future success of environmental protection.
WHAT IS EPA'S DESIGN FOR THE ENVIRONMENT PROGRAM?

The DfE Program in EPA's Office of Pollution Prevention and Toxics was created in 1991 to
promote the incorporation of environmental considerations into the design and redesign of
products, processes, and technical and management systems.  By developing and providing
businesses with information on designing for the environment, the program aims to encourage
pollution prevention and efficient risk reduction in a wide variety of activities. Under the DfE
Program, EPA works through voluntary partnerships with industry, professional organizations,
state and local governments, other federal agencies, and the public, including environmental and
community groups.

The DfE Program aims to turn pollution prevention into both a corporate and environmental
asset, by helping businesses incorporate environmental considerations into the product or process
design and decision-making process. The program has three goals:

 •     Encourage voluntary reduction of the use of specific hazardous chemicals by businesses,
       governments, and other organizations through actual design or redesign of products,
       processes, and technical and management systems.

 •     Change the way businesses, governments, and other organizations view and manage for
       environmental protection by demonstrating the benefits of incorporating environmental
       considerations into the up-front design and redesign of products, processes, and technical
       and management systems.

 »     Develop effective voluntary partnerships with businesses, labor organizations,
       government agencies, and envrronmental/community groups to  implement DfE projects
       and other pollution prevention activities.
                                           1-2

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CHAPTER 1
                                                                         INTRODUCTION
DfE projects include three distinct project types:

«      Institutional projects are aimed at changing specific aspects of general business practices
       in order to remove barriers and provide positive incentives for businesses and other
       organizations to undertake environmental design and pollution prevention efforts. These
       include environmental accounting, curriculum development, green chemistry, and
       insurance projects.

•      Cooperative industry projects are joint efforts with trade associations, businesses, public-
       interest groups, and academia to assist businesses in specific industries to select more
       environmentally-sound products, processes and technologies, especially through
       provision of easily-accessible information on the comparative risks, performance, and
       costs of alternatives to currently used chemicals.

•      Cooperative government projects are joint efforts with government organizations to
       promote the use of environmentally-preferred products by organizations. The General
       Services Administration Products Project is one such project to help implement the
       President's Executive Order 12873: "Federal Acquisition, Recycling and Waste
       Prevention."

This publication describes methods for performing the technical work of DfE industry projects.
WHAT IS A CLEANER TECHNOLOGIES SUBSTITUTES ASSESSMENT?

The CTS A methodology is a means of systematically evaluating the comparative human health
and environmental risk, competitiveness (e.g., performance, cost, etc.) and resource conservation
of traditional and alternative chemicals' manufacturing methods and technologies.  A CTS A
document is the repository for the technical information developed by a DfE industry project,
including risk, performance, cost, and resource conservation data. Project partners in DfE pilot
projects with the printing, dry cleaning, and printed wiring board industries have focussed the
project's technical work and the CTSAs for these industry sectors by evaluating a particular
group of traditional and nontraditional (i.e., unusual, new, or novel) substitutes or alternatives
that can be used to perform a key function within a given industrial process. In DfE terminology,
such a project focus area is called a use cluster.  A use cluster is a product- or process-specific
application in which a set of chemical products, technologies, or processes can substitute for one
another to perform a particular function.

A CTS A does not recommend alternatives. Instead, the goal is to promote informed business
decisions that integrate risk, performance, and cost concerns by providing businesses with easily
accessible information (Figure 1-1).  The DfE project team uses data from the CTS A to develop
fact sheets and summary reports designed to reach individual users and suppliers who may not
have the resources to develop the information on their own.
                                            1-3

-------
PART I: OVERVIEW OF CTSA PROCESS
  FIGURE 1-1: THE D£E PROCESS PROMOTES INFORMED BUSINESS DECISIONS
        THAT INTEGRATE RISK, PERFORMANCE, AND COST CONCERNS
WHO PARTICIPATES IN A CLEANER TECHNOLOGIES SUBSTITUTES
ASSESSMENT?

The DfE process catalyzes voluntary environmental improvement through stakeholder
partnerships. The technical work of a DfE industry project typically involves participants from
various stakeholder communities, including industry (users and suppliers of chemical products,
equipment or technologies), government (federal, regional, state, local), public-interest groups
(environmental, environmental justice, labor, consumer, etc.), and research and education
organizations (non-profit research centers, universities, technical schools, etc.). Each of these
stakeholder communities brings unique and valuable resources and perspectives to the project
(Figure 1-2). By involving representatives from each of these stakeholder communities, a DfE
technical workgroup can accomplish the following:

•     Gain the necessary expertise to perform the technical work.

»     Ensure the quality, credibility, and utility of the projects  technical results.

•     Provide a solid foundation for long-term continuous improvement.

Stakeholder partnerships promote consensus options or solutions to address complex
environmental problems that are far more effective and productive than those obtained by any
group acting alone.
                                         1-4

-------
CHAPTER 1
INTRODUCTION







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-------
PART I: OVERVIEW OF CTSA PROCESS
Past CTSA project teams have been convened by EPA together with trade associations, industry
research organizations, or other concerned representatives of the business community seeking to
reduce the environmental impacts of their products and manufacturing processes. A goal of this
publication, however, is to provide businesses, public-interest groups, and other stakeholders the
information they need to perform comparative evaluations with or without the direct participation
ofEPA.
WHY PARTICIPATE IN A CLEANER TECHNOLOGIES SUBSTITUTES
ASSESSMENT?

In the U.S. the problems with chemical pollution became particularly notable at the end of World
War II when petroleum supplies were plentiful and the development of new products and
technologies flourished. By the 1960s it was apparent that unchecked industrial and municipal
discharges were seriously degrading the country's natural resources.  The U.S. Congress
responded to the increasing environmental degradation by passing the Clean Water Act hi 1970,
the same year EPA was formed.  Smog-filled cities prompted Congress to pass the Clean Air Act
the next year. These statutes led to other such statutes (Resource Conservation and Recovery Act
[RCRA], Toxic Substances Control Act [TSCA], etc.) and a regulatory system focussed on
single environmental medium (air, water, land), end-of-pipe, command-and-control
environmental protection.

An unforeseen consequence of command-and-control regulation is that pollutants are often
shuffled from one environmental medium to another, with little net environmental improvement.
In other cases, regulation has caused industry to substitute materials which in turn may become
subject to regulation.  While our current regulatory system has reduced risk and improved the
environment, it has in some cases been inefficient and unnecessarily costly in achieving
environmental goals.

As a result, despite billions of dollars spent on pollution control equipment, in 1992 U.S.
industries still released over three billion tons of toxic chemicals to the environment and spent
$30 billion on environmental compliance. These persistent problems and costs have led many in
industry to make voluntary changes to prevent pollution and to re-evaluate the processes and
materials they use and the products they manufacture. DfE partnerships developed the CTSA
methodology described in this publication to help business decision-makers achieve the tangible
benefits that result from using a cleaner product or technology:

"      CTSA results can improve businesses' bottom line: A CTSA provides a systematic
       methodology for evaluating voluntary changes to prevent pollution and reduce risk.
       Pollution prevention often lowers cost by reducing the amount of materials used in
       production processes, the amount of waste streams that must be treated and disposed, and
       by improving worker health and safety.  A CTSA provides the necessary information for
       companies to make informed business decisions that may reduce their regulatory burden
                                          1-6

-------
CHAPTER 1
INTRODUCTION
       or potential liability costs or avoid regulation altogether. Also, companies that make
       voluntary changes to prevent pollution or reduce risk may enjoy increased acceptance and
       market share from environmentally conscious consumers.

       CTSA projects promote effective, efficient change through constructive partner ships:
       Businesses that participate in voluntary DfE initiatives demonstrate their commitment to
       continuous environmental improvement.  The result is effective and efficient change
       founded in the requisite expertise to identify innovative solutions.  Company employees
       involved in day-to-day operations ensure the project team understands the process
       constraints that need to be considered in the design of environmentally preferable options.
       Stakeholder communities outside the company provide unique perspectives and ideas to
       broaden the evaluation beyond standard industry concerns.

       Environmental evaluation and setting priorities for change involve value judgements. No
       simple metric exists that encompasses the range of environmental issues or addresses the
       concerns of all stakeholders.  By bringing together stakeholders who represent different
       interest groups, a project team better ensures the credibility and acceptability of CTSA
       results.  Instead of being adversaries, DfE stakeholders work together to find common
       ground and achieve shared, mutually beneficial goals. This leverages the resources that
       enable DfE partners to accomplish far more together than would be possible working
       separately.

       CTSA results promote environmental competitiveness in a global marketplace:
       Companies and businesses throughout the world are not practicing proactive
       environmental improvement to remain competitive in today's global marketplace.  In
       addition to the benefits of an improved company image, businesses are finding that they
       can no longer afford to waste energy or other precious resources or pollute the
       environment.

       For example, the German government has undertaken an aggressive regulatory program
       to ensure that German industries remain competitive in today's marketplace. Klaus
       Topfer, Germany's Environment Minister, recently outlined some of the thinking that lies
       behind the German "take-back"  policies.2 Topfer suggests that the markets of the future
       will be for products that minimize energy use and waste production.  Germany is
       attempting to stimulate industry to develop the technology that will be needed for these
       future markets by sending economic signals to industry that cause industry to internalize
       environmental costs (Center for Clean Products, 1995).

       In short, government, industry, and public interest groups alike are recognizing that
       voluntary changes to reduce risks by preventing pollution are good for business and good
       for the environment.
       2 "Take-back" regulations would require the manufacturer of certain products to take their products back
 from the consumer at the end of their useful lives and recycle the materials, preferably into new products.

                                           1-7

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PART I: OVERVIEW OF CTSA PROCESS
WHAT IS IN THIS PUBLICATION?

This publication is organized into two parts. Part I contains three chapters that provide an
overview of the CTSA process. Following this introduction, Chapter 2 describes the preparatory
steps that a DfE project team should perform before embarking on a CTSA. Chapter 3 outlines
the types of data and analyses performed in a CTSA.

Part II of this publication describes in detail each of the data sets collected and the analyses
conducted in a CTSA, including the following:

"      Goals or uses of the data.

•      Basic steps to collect the data or complete an analysis.

•      Flow of information into and out of each analysis.

•      References for data sources, analytical models, and previously published guidance.

Chapter 4 describes in more detail the types of information contained in Part II.  Chapter 5
describes the data sets and analyses concerning basic chemical properties and the products or
process description.  Chapter 6 describes the risk-related analyses.  Chapter 7 presents evaluation
criteria traditionally related to competitiveness, such as performance and cost. Chapter 8
addresses conservation issues, including energy impacts, and resource conservation.  Chapter 9
discusses additional environmental improvement opportunities, including how to conduct a
pollution prevention opportunities and control technologies assessment.  Chapter 10 describes
how all of this information is brought together to evaluate the trade-off issues and provide
interpretive decision information summaries that enable businesses to choose among alternatives.
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Project partners in a CTSA perform a number
of preliminary steps prior to embarking on the
detailed analyses of a CTSA.   These include
recruiting   partners,   preparing   scoping
documents,  selecting  a   use  cluster  for
evaluation, and setting the boundaries of the
evaluation.  These preliminary steps not only
ensure the selection of a productive project
focus, they also help build relationships among
the potential  team members and  lay  the
foundation for the  culture of collaboration
essential to project success.
            Chapter 2
PREPARING
 FOR A CTSA
 This  chapter summarizes the basic  steps
 leading up to a CTSA and the scoping documents which help a DfE project team select a use cluster.
 It then gives a more detailed overview of each of the preparatory analytical steps. Design for the
 Environment: Building Partnerships for Environmental Improvement (EPA, 1995a) addresses each
 of these steps and describes in more detail how to involve multiple stakeholders in the DfE process
 and how to disseminate results.
 Figure 2-1 illustrates the basic steps leading up to and following a CTSA. First, DfE project
 organizers recruit partners from various stakeholder communities to create a project team. Team
 members then develop an Industry and Use Cluster Profile document and a Regulatory Profile
 document to help define the project focus. An Industry and Use Cluster Profile gives market
 data for the industry, describes technological trends, and presents a summary of key industry
 processes, individual steps within processes, chemicals typically used in each step, and a
 preliminary list of substitutes for ea.ch step. These sets of substitutes make up the use clusters for
 the industry. A Regulatory Profile identifies the principal federal environmental regulations that
 may affect the industry under study and the factors that determine which regulations apply to any
 particular operation. The project team typically selects the use cluster with the greatest
 opportunities for environmental improvement for the detailed analysis of a CTSA.

 Once the use cluster is selected, team members identify substitutes within the use cluster, select a
 subset of these substitutes for evaluation in a CTSA, and establish the project baseline. The
 project baseline is typically the industry standard practice, to which other substitutes can be
 effectively compared. The next step is to set the boundaries of the evaluation by identifying the
 life cycle stages and types of environmental impacts (e.g., human health and environmental risk
 to workers, energy impacts, etc.) of greatest concern.

 Each of these steps sets the stage for the detailed substitutes assessments that are performed in a
 CTSA. Following completion of a CTSA, DfE project partners develop a variety of outreach
 tools to communicate the results of the CTSA. These may include fact sheets, bulletins,
 pollution prevention case studies, software, videos,  and training materials. The final phase  of a
                                          2-1

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PART I: OVERVIEW OF CTSA PROCESS
                       FIGURE 2-1: STEPS IN A CTSA PROJECT
DfE project is to disseminate CTSA results to businesses and other stakeholders, who may not
have the resources to develop the information on their own.  By providing a clear picture of the
trade-offs among environmental, economic, and performance concerns, CTSA projects
encourage continuous environmental improvement.
PREPARING THE SCOPING DOCUMENTS

The first task for the DfE project team is to conduct research and analysis to identify use clusters
within an industry and the use clusters that would provide a productive project focus (EPA,
1995a). Two outcomes of these initial scoping exercises, the Industry and Use Cluster Profile
and the Regulatory Profile, provide the foundation for selecting a use cluster and beginning a
CTSA. Printing Industry and Use Cluster Profile (EPA, 1994a),1 Printed Wiring Board Industry
       1  The printing industry is frequently divided into industry sectors, depending on the type of printing
process utilized.  The five most common printing processes are lithography, letter press, flexography, gravure, and
screen printing. The Printing Industry and Use Cluster Profile describes each of these industry sectors.  EPA's DfE
Program has worked with the screen printing and lithography sectors, and is currently working with the flexography
sector.

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CHAPTER 2
                                                                 PREPARING FOR A CTSA
and Use Cluster Profile (EPA, 1995b), Federal Environmental Regulations Potentially Affecting
the Commercial Printing Industry (EPA, 1994b), and Federal Environmental Regulations
Affecting the Electronics Industry (EPA, 1995c) are examples of Use Cluster Profile and
Regulatory Profile documents prepared during DfE industry projects.

Industry and Use Cluster Profile

The Industry and Use Cluster Profile gives market data for the industry, describes technological
trends, and presents a summary of each of the use clusters within the industry.  This information
helps the project team to select a use cluster for evaluation in the CTSA. It also provides
information to other sections of the CTSA, such as the exposure assessment. Table 2-1  lists
some of the information typically included in an Industry and Use Cluster Profile and gives
examples of how this information may be used in a CTSA.
TABLE 2-1: USES OF IOTORMATION FROM AN INDUSTRY AND USE CLUSTER
PROFILE
Type of Information
Geographic distribution of industry by size
(number of employees, sales) and function.
Key industry processes, individual steps within
processes, and chemicals typically used in each
step.
The set of readily identifiable substitutes for each
step, which make up the use clusters .a
Technology trends.
Potential Uses in a CTSA
Determine the aggregate number of workers
exposed, information needed in the exposure
assessment.
Identify traditional chemicals and processes
within the focal use cluster; provide the
foundation for the source release assessment,
exposure scenarios, and exposure pathways.
Preliminary pool of substitutes for evaluation in
the CTSA.
Identify potential substitutes; help select subset of
substitutes for evaluation.
 additional substitutes are usually identified as the CTSA process continues.

 The first Industry and Use Cluster Profile document prepared by a DfE industry project, Printing
 Industry and Use Cluster Profile (EPA, 1994a), did not contain information on the substitutes in
 printing industry use clusters. However, as the process for conducting DfE industry projects has
 evolved, project partners have recognized the added benefit of profiling traditional as well as
 newer, or more novel alternatives. Thus, the Printed Wiring Board document includes limited
 information on substitutes. The same is true for Regulatory Profile documents, which now seek
 to include more information regarding substitutes that are readily identifiable in the early stages
 of a DfE industry project.
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 PART I: OVERVIEW OF CTSA PROCESS
 Regulatory Profile

 The Regulatory Profile identifies the principal federal environmental regulations that may affect
 the industry under study and the factors that determine which regulations apply to any particular
 operation.  Such factors might include the size of the operation; the location of a facility (i.e., in
 an ozone non-attainment area); the types of chemical products it uses; and the types, quantity,
 and toxicity of the emissions and waste streams it generates. For the purposes of a CTSA, the
 Regulatory Profile helps focus the selection of alternatives by:

 •      Providing project participants with consistent information on the regulatory requirements
        affecting an industry.

 •      Determining if implementing a substitute would reduce the overall regulatory burden of
        a facility.2

 *      Determining if implementing a substitute would shift the environmental impact across
        environmental media, such as from air to water, or from water to land.3
 •      Identifying impending chemical or technology bans, phase-outs or other regulatory
        actions that could affect the market availability and use of affected substitutes.

 The Regulatory Profile also serves as a data source for the regulatory status section of the CTSA
 which evaluates in more detail the regulatory status of each of the potential substitutes selected
 for quantitative assessment in a CTSA.
SELECTING THE PROJECT FOCUS

Each use cluster constitutes an area where the relative human health and environmental risk,
performance, cost, and resource conservation of alternatives can be compared. For example,
Figure 2-2 illustrates the basic functional steps in printed wiring board (PWB) fabrication.  Each
step can be performed using a discrete set of products, processes, or technologies that can
substitute for one another to perform the desired function. And each of these sets of substitutes
comprise a discrete use cluster.4
       2 To date, Regulatory Profile documents have not explicitly analyzed the regulatory effects of
implementing a substitute, but the regulatory status data can be used by DfE project partners to determine what the
effects might be.

         Since a principal objective of the overall DfE process is to identify and evaluate substitutes that have the
greatest potential for reducing overall environmental impacts, attention is focussed on finding alternatives that
prevent pollution instead of simply shifting pollutants from one environmental medium to another.

         Some of the steps in Figure 2-2 can be broken down further to more narrowly define the use clusters.

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CHAFFER 2
                                                                 PREPARING FOR A CTSA
          FIGURE 2-2: BASIC FUNCTIONAL STEPS IN PRINTING WIRING
                                BOARD FABRICATION
                       Inner Layer Manufacture


                        Press Multilayer Panels  |
                                                        Panel Plate
                             "4
                             Strip & Etch
                                   ,
                            Surfece Finish
                                                 v s' i  t.
 For practical reasons, DfE project partners usually select one use cluster as the focal point for the
 project's technical work.  The PWB Project partners selected the making-holes-conductive
 (MHC) use cluster, which is the process of depositing a conductive surface in the barrels of
 drilled though-holes prior to electroplating.  When the technical analysis of a use cluster is
 complete, the project team can decide whether to extend the project to investigate other use
 clusters.

 Factors to consider when selecting a use cluster for evaluation include the following:

 •      The degree of risk associated with current practice in the use cluster: Use clusters that
         involve greater exposure to highly toxic chemicals may pose greater human health and
         environmental risk and offer greater potential for improvement. EPA uses a relative risk
                                            2-5

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 PARTI; OVERVIEW OF CTSA PROCESS
        ranking methodology to screen the relative health and environmental effects of different
        use clusters.  The Use Clusters Scoring System ranks use clusters into broad concern
        categories (high, medium, or low) based on use volumes, total environmental releases of
        chemicals, health and environmental hazards, exposure potential and other factors (EPA
        1993a).

        The degree of interest that industry and other stakeholders have in the use duster: DfE
        project teams typically represent different stakeholder communities with differing values.
        Understanding the interests of each of the partners is important to building consensus.
        The level of interest in the use cluster of each of the partners will also be an important
        factor motivating their participation. For example, the cooperation of suppliers in
        providing information on or samples of their products has proven to be essential to the
        success of past projects.

        The availability of potentially cleaner substitutes: The purpose of a CTSA is to evaluate
        the trade-offs among substitutes of human health  and environmental risk, performance,
        cost, and other environmental effects. Viable substitutes within a use cluster that are in
        use or ready to be demonstrated are necessary for a CTSA to have the best potential for
        real environmental gains in the near-term.  Processes or technologies that perform a
        similar function in other industries may also be viable substitutes. The DfE project team
        may elect to include new technologies that are still in the research and development stage,
        even though tangible environmental improvements from the use of these technologies
        may be less immediate.5

        The degree to which a use cluster is tied to other process steps outside of the use cluster:
        In some cases, implementing a substitute product, process, or technology might require
        changes in process steps outside of the use cluster. If so, the project team may need to
        evaluate these other changes as well to ensure that selection of a substitute does not
        adversely affect performance or cost outside of the use cluster or shift the environmental
        impacts from one part of the process to another. Project teams need to consider the time
        and resources they have available for the evaluation as well as the potential improvement
        opportunities of these more complex use clusters.

        The status of other ongoing projects related to a use cluster: If other projects are already
        evaluating a use cluster the project team should determine if a CTSA will add valuable
        information to information already being developed.  In some cases, it may be possible to
        coordinate the work of a DfE project team with other efforts that are not considering the
        full range of issues evaluated in a CTSA.
         This is not to discourage the application of environmental principles in research and development
activities.  It is simply to note that it may take longer to realize the environmental benefits.  If today's trends
continue, technologies of the future will undoubtedly be designed to minimize environmental impacts, and this
methodology can be used to inform that design process.

                                           2-6

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CHAPTER 2	PREPARING FOR A CTSA

Design for the Environment: Building Partnerships for Environmental Improvement (EPA,
1995a) also discusses factors for selecting a focal use cluster and how to solicit input from
stakeholder sectors.
IDENTIFYING SUBSTITUTES WITHIN THE USE CLUSTER

The Use Cluster and Industry Profile, with its preliminary list of chemicals, processes and
technologies employed in each use cluster, provides the initial pool of substitutes for evaluation
in a CTSA. The identification of substitutes is not limited to this preliminary stage of a CTSA,
however. Additional substitutes are identified as a CTSA progresses and more information is
gained about the characteristics of the use cluster and of the industry.

The project team begins to identify additional substitutes after the focal use cluster is selected.
All stakeholder groups are potential sources of information about additional substitutes.
Manufacturers and suppliers of chemical products and technologies play an important role in
substitute identification, since they frequently have an up-to-date understanding of current
industry trends, and emerging products or technologies. Also, the participation of suppliers in
the CTSA process is essential to developing generic chemical product formulations which may
be used in the risk characterization if necessary to protect proprietary formulation information
(see page 2-18 for a discussion of generic chemical product formulations).

At the same time, trade associations may be tracking new developments; their laboratories and
research facilities may be currently developing alternatives.  Universities and other research
organizations also may be involved in applied or basic research on new alternatives. Public-
interest groups concerned about human health risk or other environmental impacts may have
independently searched for options to prevent pollution. International organizations may have
information on alternatives used abroad. DfE project teams use all of these resources to develop
a substitutes tree.

The Substitutes Tree

 A substitutes tree is a graphical depiction of the substitute or alternative chemical products,
technologies, or processes that form the use cluster and their relationship to each other within the
 functional category defined by the use cluster. In a DfE project, the terms "substitute" and
 "alternative" are used interchangeably to mean any traditional or novel chemical product,
  technology, or process that can be used to perform a particular function.6  The substitutes tree
 developed for the DfE Dry Cleaning Project is illustrative of the thought processes that are
 employed in identifying substitutes.
        6 In the context of a CTSA, the term "alternative" does not necessarily connotate a new or novel substitute.
 Instead it is used to denote the concept of having a choice, either between a traditional product, process, or
 technology, or a new or novel product, process, or technology. In this manner, the terms "alternative" and
 "substitute" are synonymous: either of them represents a choice that can be made between products, processes, or
 technologies that can be used to perform a particular function.
                                             2-7

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 PART I: OVERVIEW OF CTSA PROCESS
 The Dry Cleaning Project evolved from several years of work by EPA with the dry cleaning
 industry to examine ways to reduce exposure to perchloroethylene (PCE).  PCE, a suspected
 carcinogen, is the chemical solvent most frequently used to dry clean clothes (EPA, 1995a).7
 The dry cleaning process was originally developed to clean water-sensitive fabrics. If the
 function of dry cleaning is defined as solvent-based cleaning, a number of chemical substitutes
 can be readily identified that are currently used in dry cleaning facilities (Figure 2-3). When
 identifying alternatives in a use cluster, however, the project team must be careful to not define
 the function too narrowly or too broadly. The following discussion illustrates the limitations that
 would have been imposed on the dry cleaning project if the function had been defined as solvent-
 based cleaning.

             FIGURE 2-3:  TRADITIONAL DRY CLEANING CHEMICALS
         Dry
      Cleaning
    Substitutes
Petroleum
Solvents
                                                                      Stoddard
l40°F      I
  ...... ''  •> ;'''''
LowVOC
                     I  I •*. W^^J^«,/j.«l^.«.ii^'  '  '
                           a** '       ***"
                      '     /ChemicalsX
                           fphased-Outj
                           JI   .          }
                           l   by Clean  |
                               Air Act
Recall that a goal of a CTSA is to evaluate both traditional and novel chemicals, processes, or
technologies that can substitute for one another to perform a particular function. The substitutes
tree shown ha Figure 2-3 is too narrow hi its scope since it only illustrates traditional chemicals.
Figure 2-4 shows the substitutes tree expanded to include newly available professional dry
cleaning technologies, and dry cleaning chemicals  and technologies that are currently under
development.  This also proved to be too narrowly defined.

Each of these substitutes or alternatives are dry cleaning processes, which is how the use cluster
has been defined in Figure 2-4. In the Dry Cleaning Project, however, the project gained
momentum when an alternative process called multi-process wet cleaning came to the attention
of the project partners.  This process primarily uses controlled application of heat, steam, and
soap to clean garments, including garments made from water-sensitive fabrics.  If the function of
the use cluster is redefined as professional garment cleaning (excluding water-washable garments
that are usually home-laundered), which is the ultimate function that dry cleaners provide and the
service that consumers seek, a whole new array of potential alternatives can be identified.
       7 The dry cleaning process typically involves a solvent-wash step and a tumble drying step. The process is
similar to residential laundering processes — except that a chemical solvent is the primary cleaning agent instead of
water and detergent.
                                           2-8

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CHAFFER 2
                                             PREPARING FOR A CTSA
   FIGURE 2-4: EXISTING AND EMERGING DRY CLEANING ALTERNATIVES
                                                          ra
                               PCE
                              Petroleum
                              Solvents
                  fstoddard I

                        v.' •£ *

                  J140°F  f
                  1	. 	    . *• •
                              [CFC-113^
Petroleum Solvents
Safer Technologies
• Nitrogen Inje^ion
•Oxygen Vacuum
                                                       .
                                                    emicalr%
                                                 Fhased-Out|
                                                «   by Clean }

                                                         x
                                                      *.
                                                    ~»\
                                 HCFCs r
                  Under
               Developmen
                 , I HCFC-123  |
                 JHCFG-141bI"
               ?w | HCFC-225  |
                  i            iv
                   ~~"w""T'Jr'"T""*"?v"~ >/
   Petroleum Solvents
   New Solvents
   •Higher Flash Points
                                    HFCs & PCs
                                     Liquid CO
                               2-9

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PART I: OVERVIEW OF CTSA PROCESS
Figure 2-5 illustrates the final substitutes tree for professional garment cleaning that was
developed during the Dry Cleaning Project.

              FIGURE 2-5: GARMENT CLEANING ALTERNATIVES

•••--':'.
1 Existing [^
/ X
t'" 1 i ^ * ? x { '
i^§J ^Stoddard |
ill,, ,i, ^>~- i.
Pelioleurn^ • • ' Vinftr
Solvents -^ 1l10 F

*iCFC-113 ' Low VOCJ t (, f < I'-T
.J111IZZZ.1? -S**H. y — *"ix

Cleaninn Ih — Newly jPhased-Outf
wlocu IIIIU ft A*M«:I««L»I~* ! L. MI t
fi..h«Hf>A n Available v .... _ I by Clean j

\ X
Under L^
Petroleum Solvents \^r^«/
Safer Technologies "F--I— «•
• Nitrogen Injection
• Oxygen Vacuum
r^ 	 x.-, s HCFC-Tai'"1
HCFCs { 	 «-, 	 iHCFC-141b
JHCFC-225
"^ s '•• ,
Petroleum Solvents
New Solvents '
• Higher Flash Points > > ~*"
Development k ' • l - " l
\
HCFs&FCs
\ . ' '' f'
.
Liquid CO2
«»...' ,« ; ' ; . , o^ o' %


, _~»u,,a j~-

Wei X . , ,
Cleaning £• 	 New|y
Substitutes \ Available
	 	 X
I Under S
{Development \

, Professional Laundering


• Hand Washing •
'' ' --1'1 ™J- 	 ! -—- J " i >» ') ' „ j JK
s Multiprocess Wet Cleaning

Machine Wet Cleaning
i
Ultrasonics 3 .

Microwave Drying
1 . ... ,~^*^.-f-f ( -* } *
                                     2-10

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CHAPTER 2
PREPARING FOR A CTSA
  Why Focus on Function?

  The function of a product, process, or technology is the action for which it is especially
  fitted or used.  Function implies a definite end or purpose that is served or a particular
  kind of work that is performed. By focussing on function, the CTSA process highlights
  the end served rather than the means to the end.  This opens the evaluation to an array of
  functional alternatives that are often overlooked in traditional pollution prevention
  opportunities assessments. A focus on function also provides a unit of equivalency (for
  example,  the amount of a chemical substitute required to perform a function) necessary to
  compare the risk, performance, and cost of alternatives.  The complete list of products.,
  processes, or technologies that can be used to perform a function is a use cluster.
Identifying Substitute Chemicals

The Industry and Use Cluster Profile typically lists the categories of chemicals (e.g., adhesive,
cleaning solvent, surfactant, etc.) and the major chemicals in each use cluster. Early in the
CTSA, project team members begin collecting data on the chemical and physical properties of
these chemicals.  A process description of the use cluster is prepared to help define the chemical
properties of the chemical products which enable them to perform the desired function (e.g., the
chemical properties of an organic solvent make it suitable for dissolving oily residues on clothes)
and to identify any functional groups in the use cluster.  A functional group is:

•     A discrete, functional step of a multi-step process or system.

•     The chemical components that can substitute for one another to perform a particular
       function of a chemical mixture.

For example, in the garment  cleaning use cluster, the traditional dry cleaning process uses
solvents to remove oils, stains,  and odors. Although small amounts of water, detergent, and
other additives may be used, chemical products in the dry cleaning process essentially employ
one functional group: chemical cleaning  solvents.  On the other hand, the screen reclamation use
cluster evaluated in the DfE Screen Printing Project typically consists of several steps  to remove
excess ink from a screen, remove the stencil that was used to block the ink, and remove any
residual contaminants or haze to permit the screen to be reused.8  Together these steps define two
to three basic functions which must be performed to restore a used screen to a reusable condition:
        8 The screen printing process involves stretching a porous mesh material over a frame to form a screen.
 Part of the screen mesh is blocked by a stencil to define an image. A rubber-type blade is swept across the
 surface of the screen, pressing ink through the uncovered mesh to print the image defined by the stencil. The
 screen and its stencil can be used repeatedly to print the same image multiple times, after which the screen is
 reclaimed enabling a new stencil to be applied.
                                            2-11

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PART I: OVERVIEW OF CTSA PROCESS
removal of ink, removal of emulsion (stencil), and removal of haze.9 Two additional functions,
screen degreasing and ink degrading, may be performed depending on the screen reclamation
method used. Figure 2-6 is a graphical model of the integration of screen reclamation methods,
depicting these five functional groups.

       FIGURE 2-6: INTEGRATION OF SCREEN RECLAMATION METHODS
',

Ben 1
easer I*
f
nk |_
radant I"*

i ^
V"f
. ^' r~
.- , ^-
( 3 (,
i Emulsion
' Removal
                                                           '^' ''M*.   ' V«  ,  ' . 'V-AA
                                                                    *     *    V    * I
              Haze Removal/
               Water Wash

                                         i
                                     Zl
            _      . _  ,  ,    ,
            Screen is Reclaimed
                                                 - T    -M- ? ^6  e* W
      9 Haze removal is required depending upon the type of ink used, effectiveness of ink removal and/or
emulsion removal products, and the length of time that ink and stencil have been on the screen.
                                        2-12

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CHAPTER 2	PREPARING FOR A CTSA

All of the chemical properties and data regarding the chemical properties which enable the
chemicals to perform the desired function are analyzed together to identify alternative chemicals
that have similar properties or that perform similar functions in other industries. In the Screen
Reclamation CTSA, EPA looked at chemicals for which Pre-Manufacturing Notices (PMNs)
required under the Toxic Substances Control Act (TSCA) had been filed in order to identify new
or novel chemical substitutes. For potential substitutes that were identified, companies
submitting PMNs were contacted to obtain permission to include these new chemicals in the
assessment.

This valuable resource may not be available for CTSAs not carried out by EPA. EPA publishes
Chemical-in-Progress Bulletins in the Federal Register, however, which are public sources of
information that give generic chemical identities.10 Routine searches of engineering and
environmental literature, particularly for similar use clusters,  also can be helpful.

Identifying Substitute Processes

During the Screen Printing Project, the project partners identified four main methods that are
used to manually reclaim a screen.  Because the actual process of screen reclamation can be
performed using any of these methods, a variety of products used in each of these methods was
evaluated.  By comparing the chemicals used in the methods, as well as the methods themselves,
a large array of choices becomes available. Figure 2-7 is a substitutes tree for screen
reclamation, depicting the four main screen reclamation methods, the functional groups within
each method, plus the additional alternatives of disposing of the screen mesh rather than
reclaiming the screen, or using an automatic screen washer. A substitutes tree focussing on
processes or methods can stimulate thought into how process steps can be combined, rearranged,
or replaced to reduce risk and increase efficiency.

Method 2 in Figure 2-7 is the most  common process used for screen reclamation, but each of the
methods are currently used by the industry. An objective of the Screen Reclamation CTSA was
to evaluate these alternative methods to provide standardized data on how well they work, what
they cost, and their relative risk.  Screen printers and other businesses are reluctant to change
from a product or process that is time-tested to a new product or process unless there are
demonstrated benefits.  This illustrates the importance of including the range of traditional
methods in a CTSA, since current industry practices may differ substantially in their
environmental effects.

Identifying Substitute Technologies

Other industry sectors may also employ a number of different technologies to accomplish the
same function. In the case of screen reclamation, most screen printers use some type of chemical
cleaning procedure, but the project team wanted to stimulate  thought on entirely new processes
       10 Chemical-in-Progress Bulletins can also be found on the World Wide Web at the following URL:
 http://www.epa.gov/docs/chemLibCIP.

                                           2-13

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PART I: OVERVIEW OF CTSA PROCESS

                                                         >•
                                                       E o:
                                                       uj E

                                                                    * m m

                                                                     '  Jt   lo-"'  { fe
                                                           >< >	,-• ' <^,'  ,	,'';'  '' /•»
                                        2-14

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CHAPTER 2
PREPARING FOR A CTSA
or technologies that could perform the screen reclamation function. Thus, the project team
examined the functional requirements of the screen reclamation process and reviewed literature
sources for similar functional requirements in other industries. Figure 2-8 illustrates some of the
technologies identified, primarily paint stripping technologies. Currently, some of these
technologies are used in high-technology applications and may not be economically feasible for
the average screen printing establishment. Others may be both technically and economically
viable. For example, a preliminary performance demonstration of a pressurized sodium
bicarbonate (baking soda) spray system indicated the technology may be feasible with
appropriate equipment modifications.

As previously mentioned, the PWB Project is focussing on "making-holes-conductive," the
process of depositing a conductive surface in the barrels of drilled through-holes in preparation
for electroplating.  PWB manufacturers have traditionally used an electroless plating process to
make the drilled through-holes conductive, but new technologies that deposit carbon, graphite, or
palladium are also employed. To date, the project has identified eight basic processes that use
alternative technologies to perform the making-holes-conductive function (Figure 2-9).
Each of these processes for making-holes-conductive is either currently used by the industry or
being tested at PWB manufacturing plants.
SELECTING A SUBSET OF SUBSTITUTES FOR EVALUATION

Once several substitutes have been identified, the project team must decide which of these to
evaluate. Traditional substitutes, those currently in widespread use, are usually selected for
evaluation because they provide a baseline against which the risk, performance, and cost of all
substitutes can be compared. In addition, dissimilar chemical formulations or methods within the
range of traditional substitutes may pose vastly different risks. Nonetheless, if a substantial
number of traditional substitutes are currently in use, the project team may have to place practical
limits on the number evaluated.  This is especially true for substitute chemical products.

The project team should also consider one or more new alternatives, depending on the project
resources. Factors to consider when selecting new or novel alternatives include the following:

•     The ability of an alternative to meet regulatory requirements in the application under
       review.

•     The potential for reducing human health and environmental risk or net environmental
       impacts.

•     The cost required to evaluate the alternative relative to others.

•     The viability of the alternative in terms of its known relative cost or performance.
                                          2-15

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PART I: OVERVIEW OF CTSA PROCESS
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 CHAPTER 2
PREPARING FOR A CTSA

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                                      2-17

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PART I: OVERVIEW OF CTSA PROCESS
•     The degree to which the suppliers or developers of the alternative are willing to
       participate in the project.  Participation may include providing information or samples to
       the project.

•     The applicability of the alternative to the industry as a whole.

•     The degree to which the alternative is ready to enter the market (e.g., the research and
       development stage of the alternative).

•     Whether or not implementing an alternative would require changes in process steps
       outside of the use cluster that would also have to be evaluated in the CTSA.

Participation by the developer(s) or supplier(s) of an alternative can be crucial to the project's
success.  For example, developers or suppliers of chemical products will need to provide
information on their specific product formulations to conduct the risk characterization and
samples of their products and material safety data sheets (MSDSs) for the performance
assessments. Developers or suppliers of technologies will need to provide operating instructions
in order to train staff of demonstration facilities in the correct use of the technology.
Furthermore, if the technology has not been introduced to the market, the developer may need to
provide one or more complete sets of equipment for the performance assessment.

Generic Chemical Formulations

The chemical formulations of commercial products containing several distinct chemicals are
frequently considered proprietary. When undertaking a risk characterization or performance
evaluation of such chemical products, the confidential nature of these formulations can
complicate a CTSA analysis. Manufacturers of these products typically prefer not to reveal their
chemical formulations because a competitor can potentially use the disclosed formulation to sell
the product, often at a lower price, since the competitor did not invest the research and
development resources in originally formulating and testing the product. In the DfE Screen
Printing Project, suppliers of chemical products also did not want to list their brand name with
the actual formulation because they feared a loss of market share if the product did not perform
well in the performance demonstration or risk characterization. EPA was concerned about
appearing to endorse brand name products that fared well in the CTSA evaluation. Due to these
concerns, the project partners did not disclose the brand names or actual formulations of any
chemical products in the Screen Reclamation CTSA.

However, to make the CTSA usable and flexible, the project partners devised a standard format
for representing each chemical product with a generic product formulation.  Each product was
assigned a code name and each supplier was asked to give the confidential product formulation
to EPA.  While EPA used the confidential formulations to conduct a detailed risk
characterization of each chemical product that appeared in the CTSA, the published CTSA
represented a chemical product only by a code name and the generic formulation developed by
EPA and the individual supplier.  The generic formulations allow the users of the CTSA to
compare different product systems while protecting the proprietary nature of the product

                                          2-18

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 CHAPTER 2	PREPARING FOR A CTSA

 formulation.11  Without the generic product formulations, the suppliers in the DfE Screen
 Printing Project would not have participated in the submission of chemical products.  While the
 generic formulations are important in obtaining supplier participation, they also make the CTSA
 a useful tool for evaluating other brand name products that may contain similar chemical
 constituents as those already evaluated. Given the formulation of a chemical product from a
 detailed MSDS, the human health risk, performance, and cost information can be compared with
 a product already evaluated in the CTSA. However, as a MSDS only lists chemical constituents
 which are hazardous to human health, environmental risks may not be able to be determined
 from the information presented solely on the MSDS.

 A DfE team will usually ask  suppliers to help develop the generic representative formulations
 since the suppliers are most knowledgeable of product components. A generic formulation may
 list only the primary chemicals and indicate the percent concentration of each chemical in a
 range, rather than the specific amount.12 The team may agree to allow some proprietary
 chemicals to remain unidentified if they are present in small quantities (for example, less than
 one percent by weight) and not deemed hazardous in such a small quantity.  However, some
 information about the chemical, such as the identity of a structurally similar compound, is
 necessary to determine if small quantities of the proprietary chemical could pose a hazard
 concern. Some of the chemicals may remain identified only by a generic family name, for
 example, replacing tripropylene glycol ether with the term propylene glycol series ether,
 although the risk characterization of the chemical product is still conducted using the specific
 chemical.
ESTABLISHING THE PROJECT BASELINE

A CTSA is a comparative evaluation requiring a baseline to compare the risk, performance, cost,
and other environmental effects of alternatives (substitutes).  DfE project teams select one or
more alternatives that are currently in widespread use or familiar to most of the industry to serve
as an industry standard(s) or project baseline(s). With a familiar baseline as the basis for
comparison, the comparative data on risk, performance, cost, and conservation developed
through the project will be understandable to the majority of industry.  The number of
alternatives selected depends on a number of factors, including the following:
       11  Because the brand names of the chemical products in the Screen Reclamation CTSA were not
associated with their individual performance, cost, and risk data, it was difficult for a printer to locate the product
that they wished to purchase.  To alleviate this problem, the project partners published the name, address, and phone
number of all the participating suppliers in the CTSA; a printer would need to call a supplier, state the generic
formulation or code name from the CTSA, and ask the supplier if they sold the product.  While this system involves
some work by the printer, the project partners felt that it was the only way to meet the needs of all participants.

         If the percent volumes are reported as a range, the exposure assessment and risk characterization would
have to be calculated based on some representative number within that range, usually the midpoint.

                                           2-19

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PART I: OVERVIEW OF CTSA PROCESS
       Is there a clear, industry-wide baseline? For many industries, it may be difficult to
       establish a single product, process, or technology as the baseline. Returning to the
       example of the Screen Reclamation CTSA, a baseline was established for the four main
       methods used in Screen Reclamation.  A variety of products and technologies used in
       each of these methods was evaluated.

       is ike type of product, process, or technology used dependent on the size of a business?
       The baseline may differ for small and large businesses. For example, automated
       leehnologies mat are cost-effective for large companies may not be economically feasible
       for small businesses.  The decision to include different project baselines for both small
       and large industry sectors will depend in part on the resources available to the project
       team and the primary environmental issues the project team plans to address (see Setting
       the Boundaries of the Evaluation, below).

       Are different products, processes, or technologies required to meet end-user performance
       requirements? Performance requirements and the alternatives typically employed to meet
       them may vary depending on the end-use of the product or service an industry sector
       provides.  For example, the Screen Printing Project focussed only on printed plastic or
       vinyl substrates, as other substrates, such as textiles, required different types of inks,
       stencils, and reclamation chemicals to meet performance requirements. The DfE project
       team may need to establish a baseline for each set of performance criteria or narrow the
       focus of the project to one set of performance criteria.

       Is the industry standard static or constantly changing?  Industry standard practice can
       change rapidly, especially in industries that are continuously evolving to meet increasing
       technological or other demands.  If the industry standard changes rapidly, the project
       team needs to build flexibility into the project baseline to ensure that current and
       pertinent data are collected.

       Are suppliers of the project, process, or technology participating in the project and
       willing to provide data?  To provide an adequate basis for comparison, data on the
       baseline must be at least as complete as the data on the alternatives. Again, suppliers are
       a crucial link to obtaining adequate information.
 SETTING THE BOUNDARIES OF THE EVALUATION

 The goal of designing for the environment is to design products and processes that minimize
 environmental impacts throughout their life cycles. Due to the complexity of the product life
 cycle, however, businesses often focus then- environmental improvement efforts on the areas
 where the greatest environmental improvement opportunities lie and where they can most
 influence change. The CTSA methodology provides a flexible format that enables DfE teams to
 use this concept to set the boundaries of the evaluation before embarking on a CTSA. Setting the
 boundaries of the evaluation involves the following considerations:
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 CHAPTER 2	PREPARING FOR A CTSA

 •      What are the life cycle stages where the most significant environmental effects are
        believed to occur? Environmental effects occur in each stage of the life cycle of a
        product or process, from extraction and processing of raw materials through
        manufacturing, use, and disposal. For practical purposes, past DfE projects have
        focussed on the use and disposal stages of the life cycle, where the greatest environmental
        impacts were believed to occur and the most data were available.  Other project teams
        may choose to focus on other life cycle stages.

 •      What are the primary environmental issues associated -with the use cluster? The DfE
        partners in the dry cleaning and printing projects were most concerned about the chemical
        risk from using toxic chemicals in dry cleaning and printing establishments. Partners
        working on other industry sectors may identify other issues, such as energy or
        nonrenewable resource consumption, as the primary environmental issues associated with
        a use cluster.

 •      To what degree can project partners influence change? DfE projects are designed to
        promote continuous environmental improvement. Due to time and resource constraints,
        project partners typically elect to focus their efforts on the areas where they can most
        influence change. Again, in DfE projects this has been in the use and disposal of
        chemicals at operating facilities.  Other industry sectors may find that their proactive
        suppliers actively participate in the project by seeking ways to reduce the environmental
        impacts of the products and services they provide.

 Each of these considerations is related. For example, the product life cycle must be reviewed to
 identify the primary issues associated with a use cluster. Without participation by suppliers or
 representatives from up-stream processes, the project team may find their ability limited to gather
 data as well as influence change in the up-stream process. The life cycle concept and each of
 these considerations are discussed in more detail below.

 The Life Cycle Concept

 Businesses, whether manufacturers of consumer products, commercial products, or commercial
 service  industries, have traditionally defined the life cycle of the product, goods, or service they
 provide as beginning with product conception and moving through design, manufacturing, use,
 and disposal. Performance, quality, and cost requirements for the manufacturing, use, and
 disposal phases of the product life cycle are  established during product conception. The product
 designer is charged with ensuring that these  requirements are met.

 In the 1990s, the term "product life cycle" has taken on new meaning. Environmental decision-
makers  in all stakeholder sectors have recognized that, to ensure the overall environmental
improvement of a product or process, all stages of the life cycle where significant environmental
 impacts can occur should be considered.  This can include the extraction and processing of the
raw materials used to make the product, product manufacturing, transportation, use, recycling,
and disposal. The concept of designing products and processes for the environment combines
these two definitions of the product life cycle. The environmental effects of all significant stages

                                          2-21

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PART I: OVERVIEW OF CTSA PROCESS
of the product life cycle can be evaluated to incorporate environmental considerations into the
design and redesign of products and processes.

"Extended product responsibility" is an emerging principle of pollution prevention that advocates
this life cycle approach to identifying opportunities to prevent pollution and addresses the
question, "How much can project partners influence change?" Under this principle, there is
assumed responsibility for the environmental impacts of a product throughout the product's life
cycle, also called the "product chain," including up-stream impacts inherent in the selection of
materials for the product, impacts from the manufacturer's production process, and down-stream
impacts from the use and disposal of the product. Thus, a shared "chain of responsibility" is
borne by designers, manufacturers, distributors, users, and disposers of products. The greater the
ability of the actor (i.e., designer, manufacturer, etc.) to influence the life cycle impacts of the
product system, the greater the degree of responsibility for addressing those impacts should be.
Because effective measures to reduce the life cycle environmental impacts of a product system
usually involve changes in more  than one link in the product chain, extended product
responsibility creates a need and  an opportunity for partnerships throughout the product chain
(President's Council on Sustainable Development, 1996).

The CTSA process provides a framework for bringing together the actors throughout the product
chain to address life cycle environmental impacts. From their origins in chemical risk
management, CTS As conducted  under the DfE Program have, thus far, focussed on the life cycle
stage where:

*     The greatest chemical risk is believed to occur.

»     The overall environmental impacts can most be affected by choices made by
       manufacturers and users of chemical products.

In the printing, dry cleaning, and printed wiring board industries, this has been in the
manufacturing or commercial process itself and in the release or disposal of chemicals from
manufacturing or commercial facilities. As conceptualized, however, the CTSA process is
intended to use a more holistic life cycle approach, to include all stages of the product life cycle.
The methods outlined in this publication focus on the use and disposal of chemicals by a
particular industry, but they can  also be applied to other stages of the life cycle, such as the
manufacturing processes of industry suppliers.

Identifying Life Cycle Boundaries

To set the boundaries of the evaluation from a life cycle perspective, the project team might ask,
 "In which stage of the life cycle  are the greatest environmental impacts believed to occur?" In
 some cases, this will be apparent, in others, it will not. For example, when considering the life
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 CHAPTER 2	PREPARING FOR A CTSA

 cycle of the automobile, practitioners of life cycle assessment13 agree that significant
 environmental impacts occur during the use of the automobile, due to the substantial amount of
 energy consumed and the emissions of air pollutants.  In the case of pesticides, the
 manufacturing of chemical ingredients and use by consumers may be equally important, since
 pesticide products are intentionally released to the environment during use.

 On a practical note, the time and resources available to conduct a CTSA may determine the
 degree to which up-stream or down-stream processes can be included in the evaluation. Due to
 time and resource constraints and the lack of readily available data, the chemical manufacturing
 process and other up-stream processes were not quantitatively evaluated in past CTSAs.

 The following considerations may be helpful when identifying the life cycle stages on which to
 focus:

 •     Are the natural resources used in the use cluster in abundant supply? Resources that are
       being rapidly depleted are a serious concern. An industry dependent on scarce resources
       may wish to focus on the extraction and processing of raw materials to evaluate the
       environmental impacts, especially the social benefits and costs, of alternatives.

 •     Do the natural resources occur only in low concentrations in their natural state?  The
       extracting and processing of raw materials that occur naturally in low concentrations may
       be of great environmental impact. For example, some metals that are found only in low
       concentrations in their ores may require more mining and processing of raw materials,
       more water and chemical use for extracting the metals, generate more mill tailings, and
       consume excessive energy.

 •     Is use of the product likely to cause risk to consumers exposed to toxic chemicals? Some
       products may have the greatest environmental impact during use by consumers. For
       example, the risk to workers manufacturing solvent-based paints could be small
       compared to the risk to persons using the paints who do not use personal protective
       equipment.

 •     What are the environmental impacts of disposal of the product?  Some products are
       intentionally released to the environment by the consumer after use. For example, the
       aquatic toxicity of household cleaning products that are rinsed down the drain by the
       consumer could be of significant concern.
         Life cycle assessment (LCA) is another tool for evaluating the life cycle environmental impacts of a
product or process. EPA defines LCA as follows:  "A concept and methodology to evaluate the environmental
effects of a product or activity holisticaUy, by analyzing the whole life cycle for a particular product, process, or
activity. The life cycle assessment consists of three complementary components — inventory, impact, and
improvement — and an integration procedure known as scoping (EPA, 1993a)."    .
                                           2-23

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PART I: OVERVIEW OF CTSA PROCESS
By focussing on the life cycle of the product, processes, or technologies in the use cluster, the
project team will most likely identify many of the primary environmental issues associated with
the use cluster, but in a holistic fashion.

Identifying Primary Environmental Issues

By involving representatives from up and down the product chain as well as public-interest
groups, labor organizations, and other stakeholder communities, DfE partnerships provide an
excellent forum for identifying the primary environmental issues associated with a use cluster.
Diverse stakeholder groups bring different resources and unique perspectives to the table to
ensure that important environmental issues are not overlooked. Examples of the issues the
project team may elect to focus on include the following:

 •      Reducing risk to workers, surrounding populations (human and ecological), or consumers
        through use of substitutes, unproved workplace practices that prevent pollution, or even
        pollution control technologies.

 •      Reducing energy impacts or conserving natural resources.

 •      Reducing workplace safety hazards.

 The Dry Cleaning and Screen Printing Projects are good examples of the flexibility of the CTSA
 methodology in organizing information and in focussing on different types of environmental
 improvement opportunities. In the Dry Cleaning Project emphasis was placed on evaluating
 different types of pollution control methods as well as alternative cleaning technologies, whereas
 the screen printing project focussed on improving workplace practices and substituting chemical
 systems to reduce risk to workers.

 Regardless of whether the focus is on alternative systems, technologies, or pollution control
 methods, the goal is to reduce risk, resource consumption, process safety hazards and/or other
 environmental effects, and provide tangible environmental improvements.  The following are
 examples of questions a project team might ask to determine where the greatest improvement
 opportunities lie:

 •      Where is a typical business located? Facilities located in urban areas may have different
        impacts than those in rural areas. For example, dry cleaning facilities are typically
        located in or near residential  areas.  Therefore, the dry cleaning team elected to evaluate
        the risk to persons living near these shops.

  •     Are many facilities located in areas with local or regional regulatory requirements?
         Local or regional regulatory requirements may cause many businesses to seek alternative
         products or processes.  For example, businesses that emit volatile organic compounds in
         non-ozone attainment areas may seek substitute chemical products that do  not contribute
         to photochemical smog.
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 CHAPTER 2
                                                                 PREPARING FOR A CTSA
 While these types of questions may identify the primary environmental issues associated with a
 use cluster, they will not necessarily identify the most significant problems for individual
 businesses. For example, a business located in a rural area where photochemical smog is not an
 overriding issue may be more concerned about the water releases to their septic system. Again,
 the flexible format of a CTSA is the key to providing sufficient information to enable individuals
 to make the best choices for their given situation.

 Evaluating the Ability to Influence Change

 DfE projects are action-oriented, designed to produce real, tangible environmental
 improvements. With limited resources available to the project, the project team needs to assess
 its ability to influence actors along the product chain to improve the environmental attributes of a
 product or process.  In this regard, the project team may  consider the following:

 •     Which actors along the product chain are represented on the project team? A DfE team
       strives to involve as many actors along the product chain as possible. Once again,
       suppliers are crucial to the project's success, not only for providing information on their
       products, but also for committing to strive to improve the environmental attributes of
       their products. In another example, public-interest groups can be instrumental in
       providing information to consumers on the improvements that businesses make when
       they implement a substitute.

 •     What percentage of the overall market for the chemicals is used in the use cluster?  If the
       quantity of a chemical used by an industry is small relative to the overall market for the
       chemicals, the project participants may elect to not evaluate the environmental impacts
       and risks from the chemical manufacturing process.  Their choice of whether or not to use
       that chemical would have only a slight effect on the overall risks from the chemical
       manufacturing process. The market information compiled in the Industry and Use
       Cluster Profile can be helpful when evaluating market share.

 B     Is the CTSA project a priority of the project partners? It is important to assemble
       project partners committed to an open, consensus-based evaluation process, but they must
       also be committed to the project at hand.  If the selected use cluster is a low priority of the
       process partners, it may be difficult to accomplish the goals of a CTSA in a realistic time
       frame.

Each DfE project team will have a different set of questions or issues to address to set the
boundaries of their own CTSA.  While these questions and the questions in preceding sections
may help the team to focus their project, an important point is that an open, consensus-oriented,
cooperative evaluation process produces the best project  design.
                                          2-25

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PART I: OVERVIEW OF CTSA PROCESS
                                     2-26

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                                                                  Chapter 3
The aim of a CTSA is to develop as complete
and systematic  a picture  as possible of the
trade-offs among risk,  competitiveness (i.e.,
performance, cost,  etc.),  and conservation
associated with the substitutes in a use cluster.
To accomplish this, a CTSA employs a modular
approach to data  collection and analysis
utilizing    "information    modules."   An
information module  is a standard analysis or
set of data designed to  build on or feed into
other information modules to form an overall
assessment of the substitutes. A CTSA records
and presents facts collected in the information ^^^^^maumma^^^^mmmmaf^^^^m^^^^
modules,  but does not make value judgements
or advocate particular choices.

This chapter summarizes  the information module approach, describes the flow of information
between modules, and provides an overview of the information modules currently in the CTSA
methodology.
                                                    DEVELOPING
                                                                  A  CTSA
RECAP: Key Terms and Concepts

A Cleaner Technologies Substitutes Assessment (CTSA) is a repository for all of the
technical information developed by a DfB project,, including risk,, competitiveness (ie.f
performance, cost, regulatory status, market availability)., and conservation data.

'A use cluster is a product- or process-specific application in which a competing set of
chemical products, processes, or technologies can substitute for one another to perform a
particular function.

A functional group is: (1) a discrete, functional step of a multi-step process or system; or
(2) the chemical components that can substitute for one another to perform a particular
function of a chemical mixture,

A substitute or an alternative is any traditional or novel product, technology, or process that
performs a particular function*

A substitutes tree is a graphical depiction of; (1) the alternative chemical products,
technologies, or processes that make up the use cluster; and (2) their relationship to each
other within the functional category defined by the use cluster.

An information module is a standard analysis or set of data on the substitutes.  Information
modules are designed to build on or feed into one another to form an assessment of the
substitutes.
                                       3-1

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PART I: OVERVIEW OF CTSA PROCESS
Once a DfE project team determines the project focus, establishes the project baseline, and sets
the boundaries of the evaluation, they are ready to begin collecting data and identifying specific
methodologies for data analysis. Figure 3-1 is a simplified flow diagram of the process for
developing a CTSA.


                    FIGURE 3-1: STEPS TO PRODUCE A CTSA
                     Collect Chemical and Process Information

                                                                     ' t-t. / 1'-»
          Obtain Risk, Performance,
                and Cost Data
Develop Methodologies for
      Data Analyses
                                    Analyze Data

                              Evaluate Trade-Off Issues
                              Social Benefits/
                               Costs Assessment
                              Decision Information
                               Summary
                                  Develop CTSA
                              Prepare Draft
                              Perform Peer-Review
                              Publish Document
                                                                   x*
                                                                   '  <
                                                                            T i

                        if "<  * V
                                                                         H
                           ^ '( r%fif
                                       3-2

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CHAPTERS	.'  '	DEVELOPING A CTSA

A GTS A typically starts with the collection of basic chemical properties and process information,
followed by the collection of risk, competitiveness, arid conservation data. At the same time, the
project team develops methodologies for data analysis to ensure that all necessary data are
collected. The next step is to analyze the collected data to determine the relative human health
and environmental risk, competitiveness, and resource conservation of alternatives. Past DfE
projects have shown that the choice of an alternative will frequently involve making trade-offs.
For example, when compared to the baseline, an alternative may cost slightly more, but have
substantially reduced risk.

To evaluate the trade-off issues, project partners prepare data summaries related to risk (releases
of pollutants to the environment, potential exposure levels, risk of chemical exposure to human
health and the environment), competitiveness (performance, cost, market availability, regulatory
status), and conservation (energy impacts and effects of resource conservation). All of this
information is combined to evaluate the social benefits and costs of implementing an alternative.
Finally, the risk, competitiveness, and conservation data summaries are organized together with
the results of the social benefits/costs assessment in a decision information summary that records
and presents facts, but does not make value judgements or advocate particular choices.

Following the overview of the information module approach below, the flow of information in a
CTSA and the steps in Figure 3-1 are discussed in more detail.
OVERVIEW OF THE INFORMATION MODULE APPROACH

The information module approach of the CTSA methodology is modeled after the risk
management process that EPA conducts under the authority of the Toxic Substances Control Act
(TSCA), with some important distinctions. The following sections describe this risk
management process and its relationship to the CTSA process. The benefits of this modular
approach are also discussed.

The Risk Management Process

Under TSCA, EPA has regulatory authority to perform the following activities regarding existing
chemicals:  (1) gather toxicity, production, use,.disposal, and fate information; (2) assess human
and environmental exposure; (3) determine if a chemical poses unreasonable risks; and (4) take
appropriate actions to control these risks, based on a social benefits and costs analysis.1 TSCA is
the only U.S. statute under which multi-media risk assessments are performed as part of the
regulatory rulemaking process.  •

To identify potential risk early in the screening process, EPA uses a two-phase risk management
process. Phase 1  is a screening level risk assessment and fact-finding mechanism, intended to
       1 "Unreasonable risk" generally has been interpreted to mean greater overall benefits (reduced risk, etc.)
than costs incurred in mitigating the risks.

                                           3-3

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PARTI: OVERVIEW OF CTSAPROCESS
ensure that EPA only focusses on chemicals with the potential to present unreasonable risk to
human health and the environment.  If this initial investigation finds that unreasonable risk may
exist, chemicals are evaluated further in Phase 2.

Phase 2 is a more detailed and comprehensive risk assessment process that includes a thorough
evaluation of the hazards and exposures to specific chemicals, identification of strategies to
reduce or eliminate risk, and an evaluation of pollution prevention opportunities.  To the extent
possible, EPA bases the Phase 2 assessments on existing information, although new data may
have to be generated. Each member of an EPA assessment team is responsible for completing
one or more standardized analyses (information modules) on the chemicals, including Chemical
Properties, Market Information, Chemistry of Use & Process Description, Source Release
Assessment, Human Health and Environmental Hazards Summaries, Exposure Assessment, and
Risk Characterization modules. These information modules build on or feed into each other to
form an assessment of the chemical. EPA's standardized assessment process is designed to
promote efficiency and consistency  among results. RM2 Handbook: Preparing RM2
Assessments for Single Chemicals describes the EPA risk management process in more detail
(Carstens, 1996).

Relationship of CTSA Process to EPA's Risk Management Process

The CTSA process is modeled after EPA's risk management process, with these important
distinctions:

•     The CTSA process is designed to assist a voluntary decision-making process and, as
       such, is not as rigorous or detailed an evaluation as the regulatory rulemaking process.
       In order to respond to a project team's needs in a timely manner and reduce resource
       needs, the CTSA process is designed to collect only the information necessary to
       adequately assist an individual making a voluntary business decision. As such, the data
       collection and analysis performed in a CTSA are quite detailed, but it is not necessary or
       intended to be as rigorous as the regulatory rulemaking process. For example, past
       CTSAs have qualitatively evaluated the social benefits and costs of implementing an
       alternative, but have not monetized overall social benefits and costs, which may be
       required for regulatory rulemaking.

•     A CTSA adds additional information modules to collect data on issues related to
       competitiveness, conservation, and pollution prevention. A CTSA contains the risk-
       related information modules in Phase 2 of EPA's risk management process, plus
       additional modules to address competitiveness issues (e.g., performance, cost, etc.) and
       conservation issues (energy  impacts and resource conservation). A CTSA also compiles
       extensive information on pollution prevention opportunities,  including improved
       workplace practices that prevent pollution, that may be more comprehensive than those
       compiled in the risk management process.
                                          3-4

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CHAPTERS
DEVELOPING A CTSA
By building on EPA's risk management process, the CTSA process has a range of standardized
data collection and analytical methods already available that can be tailored to the needs of a
specific project.

Benefits of the Modular Approach

The primary benefits of the information module approach arise from its flexible format, allowing
DfE project teams to tailor a CTSA to fit their needs. Additional analyses or modules can be
added or deleted, depending on the specific concerns and priorities of project participants.
Information can be easily organized to meet the requirements of a specific project and of the
people who will use the assessment.

For example, a DfE project team that already has information on the performance and cost of
alternatives may focus on collecting risk information. The risk data can be compiled in a CTSA
along with the previously available data on performance and cost.  In another example, an
energy-intensive industry such as the aluminum industry may be most concerned with the energy
impacts of alternative processes. The project team in this example may elect to focus their
efforts on identifying alternatives to reduce energy consumption and place less emphasis on the
chemical risk component of a CTSA.
FLOW OF INFORMATION IN A CTSA

A CTSA can be viewed as a three-stage process involving data collection, data analysis, and an
evaluation of the trade-offs among risk, competitiveness, and conservation. Figure 3-2 illustrates
the basic flow of information in a CTSA. Each of the bullets in the figure represents one of the
information modules that may be included in a CTSA. The modules included in a specific CTSA
can vary, depending on the information needs of the project team.

Basic chemical and process information are collected in the first stage for use in the analyses
performed later in a CTSA. In the data analysis stage, the chemical and process-specific
information are combined with additional data and systematically analyzed in eight modules.
These modules are divided into three groups focussing on risk, competitiveness, and
conservation. In the third stage, the results of the analytical modules are brought together to
evaluate the trade-offs to an individual and to society among risk, competitiveness, and
conservation considerations.  Again, the goal of a CTSA is not to recommend specific
alternatives, but to present the trade-offs among risk, competitiveness, and conservation in a way
that allows decision-makers to select the alternative that best fits their own goals, values, and
requirements.  The choices of substitutes are made by individuals outside of the CTSA process.

Throughout the CTSA process, data are collected on additional environmental improvement
opportunities, particularly pollution prevention opportunities that could be implemented
regardless of which substitute is used.  The Control Technologies Assessment module may or
may not feed directly into the overall evaluation of alternatives, depending on whether or not the
alternatives are affected by existing regulations and the information needs of the project team.

                                           3-5

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PART I: OVERVIEW OF CTSA PROCESS
                FIGURE 3-2: CTSA INFORMATION FLOWS



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                                3-6

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CHAPTERS
DEVELOPING A CTSA
Although the CTSA process is depicted hi Figure 3-2 as a linear, step-wise process, Dffi project
teams frequently work on the data collection and data analysis components at the same time. For
example, a project team may begin by collecting preliminary data on the regulatory status of
substitutes from the Regulatory Profile document to ensure that chemicals being banned or
phased-out are eliminated from consideration early in the CTSA process. In addition, data
requirements and information needs frequently cycle between modules to ensure that the
appropriate data needs are identified and data requirements are met. If a performance
demonstration project is planned as part of the Performance Assessment module, it is an
excellent opportunity to collect data on cost, energy use, and resource consumption.  This means
that the appropriate data requirements should be identified first hi the Cost Analysis, Energy
Impacts, and Resource Conservation modules, respectively.

The interactive nature of the modular approach requires careful coordination between disciplines
to ensure consistency of goals and terminology so that the modules fit together in a final analysis.
For example, one must be careful from module to module that similar terminology and units are
employed. Something as simple as a chemical name must be verified with a Chemical Abstract
System Registry Number (CAS RN)2 since chemical synonyms can be confused or used
differently by different disciplines.

Table 3-1 gives an overview of each of the information modules currently in the CTSA process.
The following sections summarize the data collected or analytical results of each module and list
some of the uses of data. The module descriptions in Part II of this publication describe in detail
the data that are transferred to and from each module.

Chemical and Process Information

Table 3-2 lists the information modules that develop data on basic chemical properties and
process information, some of the primary outputs from these modules, and how the data are used
in a CTSA.  DfE technical workgroup members typically begin by collecting data on basic
chemical properties and developing a process description of the use cluster.  However, data
collection for these modules do not have to be complete before the project team begins  collecting
data needed for other modules in a CTSA.
       2 A CAS RN is a unique identification code assigned to a chemical.

                                           3-7

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PART I: OVERVIEW OF CTSA PROCESS



TABLE 3-1: OVERVIEW OF CTSA BSIFORMATION MODULES

















Overview


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The chemical and physical properties of a substance are characteristics which identify it from other substances. In tl
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CHAPTERS
                                                       DEVELOPING A CTSA





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methodologies for obtaining comparative performance data.


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calculates comparative costs between the baselme process and the substitutes. As a mmunum, the cost ana
identify the dh-ect costs of the baselme process and the substitutes. If time and resources permit, data are a.
indirect and future liability costs as well as any less-tangible benefits that occur through the implementatiol

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CHAPTERS
                                                         DEVELOPING A CTSA
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Identify potential chemical substitutes; provide chemical identity
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Identify potential substitutes; provide basis for Workplace
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Guide the selection and use of safer alternatives; trade-off issue
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 PARTI;  OVERVIEW OF CTSA PROCESS
 Data collected in many of the chemical and process information modules will be partially driven
 by the boundaries of the evaluation, as determined by the project team (see Chapter 2). For
 example, the data collected in the Market Information module typically includes chemical and
 equipment market trends and the amounts used by the industry under study.  However, an
 energy-intensive industry especially concerned about energy impacts may be more interested in
 energy sources (i.e., hydroelectric, coal, etc.) and trends in energy prices. In this example, the
 data needs for the Energy Impacts module might drive the scope and direction of the Market
 Information module.

 Risk
 Table 3-3 lists the risk-related information modules from Figure 3-2, some of the primary outputs
 from these modules, and some of the uses of the risk-related data.  These modules typically build
 upon data compiled in the chemical and process information modules.
                                        TABLE 3-3;
        Module
       Summary of Results
                                                                        Uses of Data
 Workplace Practices &
 Source Release
 Assessment
Survey of workplace practices;
profile of a model facility, including
worker activities potentially
resulting in chemical exposure, and
the nature and quantity of both on-
site and off-site chemical releases.
Provide environmental release data and
information worker activities to the Exposure
Assessment module; identify pollution
prevention or control technology
opportunities.
 Exposure Assessment
Occupational, consumer and
ambient exposures, including routes
of exposure, estimates of dose, and
ambient concentrations.
Guide the selection and use of alternatives
with reduced potential for chemical exposure;
identity sources of chemical exposure and
identity methods for reducing exposure; input
to the Risk Characterization module; potential
trade-off issue evaluated in the Social
Benefits/Costs Assessment and Decision
Information Summary modules.0
 Risk Characterization
Potential risk to human health from
ambient environment, consumer and
occupational exposures; potential
risks to aquatic organisms.
Guide the selection and use of alternatives
with reduced risk to human health and the
environment; identity sources that pose
greatest risk to human health and the
environment; guide in selecting ways to
manage risks; trade-off issue evaluated in the
Social Benefits/Costs Assessment and
Decision Information Summary modules.
a) Data for the chemical hazard component of risk (risk is the integration of hazard and exposure) are collected in the
Chemical & Process Information component of a CTSA.
b) The risk summary of the Risk, Competitiveness & Conservation Data Summary module presents process safety
concerns together with other risk-related data. However, process safety data are collected in the data collection stage of a
CTSA since some process safety data, such as data regarding chemical safety hazards, are needed in the data analysis
stage. Early collection of process safety data can also ensure that substitutes posing unacceptable safety hazards are not
carried through the entire CTSA evaluation process.
c) Exposure levels may be included in these modules if risk could not be characterized due to a lack of hazard data.
                                               3-12

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CHAPTERS
                                                                     DEVELOPING A CTSA
For example, Figure 3-3 shows the flow of information into and out of the Risk Characterization
module.  The Exposure Assessment module identifies potential routes of exposure, estimates
potential dose rates or levels of exposure, and estimates concentrations in the ambient
environment from use or disposal of the chemicals in the use cluster.  The Human Health
Hazards Summary and Environmental Hazards Summary3 modules provide information on the
doses or concentrations of chemicals at which adverse health or environmental effects may
occur. The exposure data and hazard data are then combined to characterize the potential risk of
chemical releases to human health and the environment.  Similar flow diagrams for each module
are in the module descriptions in Part II of this publication. The flow diagrams illustrate the
transfers of data between modules and list two or three examples of data elements that are
transferred.  Not all interconnections are shown in the flow diagrams; the focus is on linkages
directly related to a particular module.

                 FIGURE 3-3: RISK CHARACTERIZATION MODULE:
                          EXAMPLE INFORMATION FLOWS
      Human Health
         Hazards
        Summary
       Environmental
         Hazards
         Summary
                       Exposure scenarios
                       and pathways
                       Potential dose rates or
                       exposure levels
                      •Ambient concentrations
* Endpoints of concern
» Reference doiies
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                               Risk i
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                                              •CapcerifsH
                                              • Hazard quotient
                                              • Maniin of exposure
                                              * EcotogtMil risk indicator
      Risk,
Competitiveness &
Conservation Data
    Summary
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        3 Environmental hazard summaries prepared in CTSA pilot projects and the module description in this
 publication focus on aquatic toxicity. Other techniques and information could be used to assess other environmental
 hazards, such as avian toxicity.
                                            3-13

-------
 PARTI; OVERVIEW OF CTSAPROCESS
 In another example, data on how workers store, handle and use chemicals, the sources of
 chemical releases, and the nature and quantity of releases from a typical facility are generated
 in the Workplace Practices & Source Release Assessment module (Figure 3-4). Past CTSA
 projects have designed a Workplace Practices questionnaire to collect industry-wide data in order
 to develop a model of a typical facility. The Workplace Practices questionnaires developed for
 the Screen Printing Project and the PWB Project are presented in Appendix A.


    FIGURE 3-4: WORKPLACE PRACTICES & SOURCE RELEASE ASSESSMENT
                    MODULE: EXAMPLE INFORMATION FLOWS
      Chemistry of
     Use & Process
      Description
  Workplace
  Practices &
Source Release
  Assesment   i
    • Una operations
    • Process flow diagram
    <* Potential sources of release
                                              t Chemical names
       activttes  :
       stream quantities
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"Compoaifion of releases
                                             " Waste stream quantities
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                                             • Compoaitton of raleases
                                               Release sources
                                          -  "Composition of rafeases
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                                                  Properties
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                                               & Conservation
                                               Data Summary
The Chemistry of Use & Process Description module provides preliminary information on the
process to guide the design of the Workplace Practices questionnaire and inform the source
release assessment.  Operating practices and environmental release data from the Workplace
Practices & Source Release Assessment module are used in a variety of modules, but are
particularly important to developing exposure scenarios and estimating exposure.  These data are
also used to identify pollution prevention opportunities or sources that can be controlled to
mitigate chemical releases. By studying workplace practices in the screen reclamation process,
the DfE team identified several simple workplace practices that screen printers can use to reduce
chemical usage, exposure and risk, such as keeping solvent containers closed when not in use or
draining excess solvent from cleaning rags into closed containers.
                                          3-14

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CHAPTERS
                                                                       DEVELOPING A CTSA
Competitiveness

Table 3-4 lists the competitiveness modules from Figure 3-2, some of the primary data or results
obtained from these modules, and some of the uses of these data.  These modules are designed to
develop industry-wide data on some of the issues traditionally important to industry when
choosing among alternatives, such as performance and cost. The  information is developed using
a consistent basis, such as cost per unit of production, to facilitate comparison of the alternatives.
                              TABIrl3-4: COMPETITIVENESS*
       Module
    Summary of Results
                                                                  Uses of Data
 Regulatory Status
Regulatory status of alternative
chemicals, processes, and
technologies.
Guide the selection and use of alternatives
with reduced regulatory costs; help select
subset of alternatives for evaluation; trade-
off issue evaluated in the Social
Benefits/Costs Assessment and Decision
Information Summary modules.
  Performance
  Assessment
Effectiveness of alternatives in
achieving the desired function;
energy and natural resources
consumption data; cost data.
Guide the selection and use of more
effective, efficient alternatives; provide data
to the Energy Impacts, Resource
Conservation and Cost Analysis modules;
trade-off issue evaluated in the Social
Benefits/Costs Assessment and Decision
Information Summary modules.
  Cost Analysis
Capital, operating, and
maintenance costs of
alternatives; indirect costs;
may include other costs, such
as liability costs, or less
tangible benefits or costs (e.g.,
benefit of improved sales due
to proactive corporate
environmental policies).
Guide the selection and use of more cost-
effective alternatives; trade-off issue
evaluated in the Social Benefits/Costs
Assessment and Decision Information
Summary modules.
 a)  The competitiveness summary of the Risk, Competitiveness & Conservation Data Summary module presents
 market information and international information concerning the availability of substitutes together with other
 competitiveness-related data. However, these data are compiled in the data collection stage of a CTSA since some
 information, such as chemical use volumes, may be needed to help set the boundaries of the evaluation and for data
 analysis (e.g., in the exposure assessment).

 The Performance Assessment module is an example of an interactive module that is designed to
 fulfill data needs of other modules as well as evaluate the comparative performance of the
 substitutes. The goal of the Performance Assessment module is to collect standardized data on
 objective evaluation criteria as well as subjective issues such as operator impressions of an
 alternative. The Performance Assessment module typically involves a performance
 demonstration of alternatives in a laboratory or manufacturing setting in the presence of an
                                              3-15

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PART I: OVERVIEW OF CTSA PROCESS
unbiased observer; but may only involve an assessment of existing performance information.
Because a performance demonstration is conducted under controlled or standardized conditions,
it also provides an excellent opportunity for collecting data for other modules, such as the Energy
Impacts, Resource Conservation, and Cost Analysis modules.

Figure 3-5 illustrates the flow of information into and out of the Performance Assessment
module. If a performance demonstration project is planned, data needs for the Cost Analysis,
Energy Impacts and Resource Conservation modules are identified in these modules and
included in a performance demonstration project workplan.  The performance demonstration
team is then responsible for collecting the data and communicating data back to the appropriate
module. A performance demonstration project can also be used to collect exposure data on new
alternatives not in use by the industry.

              FIGURE 3-5: PERFORMANCE ASSESSMENT MODULE:
                        EXAMPLE INFORMATION FLOWS

Chemistry of Use 1
& Process 1 	 3^
Description 1
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» Process flow diagram


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                                        3-16

-------
CHAPTERS
                                                                    DEVELOPING A CTSA
Conservation

Table 3-5 lists the information modules related to conservation issues. The primary data or
results of these modules and some of the uses of these data are also identified. The results of
these modules can be used by themselves to guide the selection and use of alternatives that
conserve energy and other resources. In a CTSA, the results of these modules are usually
combined with other modules to identify the trade-offs among alternatives.
                              TABLE 3-5; CONSERVATION
       Module
    Summary of Results
             Uses of Data
 Energy Impacts
Sources and rates of energy
consumption of alternatives.
Guide the selection and use of less energy-
intensive alternatives; provide energy
consumption rates to the Cost Analysis
module; trade-off issue evaluated in the
Social Benefits/Costs Assessment and
Decision Information Summary modules.
 Resource
 Conservation
Types of resources consumed;
sources and rates of resource
consumption of alternatives.
Guide the selection and use of less
resource-intensive alternatives; provide
resource consumption rates to the cost
analysis module; trade-off issue evaluated
in the Social Benefits/Costs Assessment and
Decision Information Summary modules.
 Additional Environmental Improvement Opportunities

 Table 3-6 lists the Pollution Prevention Opportunities Assessment and Control Technologies
 Assessment modules, the primary results of these modules, and some of the uses of these data.
 These modules can be stand-alone modules or build on other sections of a CTSA.  For example,
 in past DfE industry projects, the Pollution Prevention Opportunities Assessment module has
 focussed primarily on pollution prevention opportunities above and beyond the implementation
 of a substitute, such as unproved workplace practices.  The Control Technologies Assessment
 module can be used to identify control technologies required for regulated alternatives or to
 identify potentially feasible treatment technologies.
TABLE 3-6: ADDITIONAL ENVIRONMENTAL IMPROVEMENT OPPORTUNITIES
Module
Pollution Prevention
Opportunities
Assessment
Control
Technologies
Assessment
Summary of Results
Methods to prevent pollution
through improved workplace
practices or equipment
modifications.
Methods to reduce chemical
releases, and thus, exposure
and risk through control
technologies.
Uses of Data
Raise employee awareness of the benefits
of pollution prevention; implement
pollution prevention activities or complete
program to reduce risk and costs.
Identify applicable control technologies;
provide control technology requirements to
the cost analysis.
                                            3-17

-------
PART I:  OVERVIEW OF CTSA PROCESS
Choosing Among Alternatives

Table 3-7 lists the final information modules of a CTSA where data from the other modules are
brought together to form an assessment of the baseline and alternatives.  The Risk,
Competitiveness & Conservation Data Summary module prepares data summaries of data
collected hi both the data collection and data analysis stages of a CTSA. These data summaries
are provided to the Social Benefits/Costs Assessment module for an evaluation of the net
benefits or costs to society of implementing a substitute as compared to the baseline. The results
of the Social Benefits/Costs Assessment are presented together with the risk, competitiveness
and conservation data summaries hi the Decision Information Summary module. In addition to
presenting  information collected throughout a CTSA, the Decision Information Summary
module discusses the uncertainty hi the information and recognizes that there are additional
factors beyond mose assessed hi a CTSA which individual businesses may consider when
choosing among alternatives. None of these modules recommend alternatives, since the final
selection of an alternative will depend on the situation and values of those making the selection.
                    TABLE 3-7t CHOOSING AMONG ALTERNATIVES
       Module
    Summary of Results
             Uses of Data
 Risk,
 Competitiveness &
 Conservation Data
 Summary
Risk, competitiveness, and
conservation data summaries,
including uncertainties in the
data, and data interpretation, as
appropriate (e.g., assignment
of high, medium, or low
concern levels to human health
and environmental risk data).
Input to the Social Benefits/Costs
Assessment and Decision Information
Summary modules.
 Social Benefits/Costs
 Assessment
Qualitative assessment of
benefits or costs of substitutes
in terms of effects on health,
recreation, productivity, and
other social welfare issues;
identifies who will benefit and
who will bear the costs.
Guide the selection and use of alternatives
that provide societal benefits and have
reduced social costs; trade-off issue
evaluated in the Decision information
Summary module.
 Decision Information
 Summary
Identifies trade-off issues
associated with any one
substitute; compares the trade-
off issues across substitutes;
does not recommend
substitutes.
Lay out information to allow individual
businesses to make the best choice for their
particular situation, while considering
social benefits and costs of individual
choices.
Data are organized hi the trade-off evaluation modules to accomplish the following:

•      Identify the trade-off issues associated with any one substitute (e.g., reduced worker
       exposure but increased operating costs; reduced risk but increased energy consumption
       and reliance on scarce natural resources).
                                           3-18

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CHAPTERS
DEVELOPING A CTSA
•      Compare the trade-off issues across substitutes.

The goal is to present the data in a manner that allows individual businesses to make the best
choices for their particular situation, while considering the social benefits and costs of their
decision. For example, the alternative preferred by different shops within an industry sector may
vary depending on the performance required for customer satisfaction, the required turn-around
time, or water and energy costs.  A business located in an urban area might be more concerned
about volatile organic compounds (VOCs) that contribute to photochemical smog than aqueous
waste streams released to the local publicly-owned treatment works, particularly when the
business  considers the impacts to society of the cumulative effect of many businesses emitting
VOCs.

If an alternative is clearly superior in all respects, except it does not meet one of several
performance requirements, it may be time to reevaluate the performance requirements. For
example, unbleached paper made from 100 percent recycled fiber may not meet the traditional
brightness performance criteria of virgin paper, but many consumers concerned about the
environmental effects of the chlorine bleaching process are willing to accept less brightness  for
less pollution. This illustrates how performance needs can vary from business to business,
sometimes allowing for more or fewer choices among the alternatives identified. In another
example, an industry may find that a new substitute with reduced risk performs within acceptable
limits, but does not perform as well as the current industry standard. If performance was the only
criteria, clearly the industry standard would prevail.  Factoring the reduced risk into the
evaluation, however, makes the new substitute preferable as long as performance requirements
are met.
 IDENTIFYING DATA ANALYSIS METHODS AND ANALYZING DATA

 The DfE project team will need to identify the specific methods they will use to analyze the
 project data and evaluate the risk, performance, cost, and other environmental impacts associated
 with each alternative. The module descriptions in Part II of this publication give guidelines for
 data analysis and provide references for analytical models.  The Screen Printing: Screen
 Reclamation CTSA (EPA, 1994c) and the Lithographic Blanket Wash CTSA (EPA, 1996a)
 provide examples of the methods used for those projects. The following appendices are
 reproduced from either the Screen Printing Screen Reclamation or Lithographic Blanket Wash
 CTSAs:

 •     Appendix B, Environmental Releases and Occupational Exposure Assessment.

 •     Appendix C, Population Exposure Assessment for Screen Reclamation Processes.

 •     Appendix D, Background on Risk Assessment for Screen Reclamation Processes.

 •     Appendix E, Background and Methodology for Performance Demonstration.
                                          3-19

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PART I: OVERVIEW OF CTSA PROCESS
 •     Appendix F, Chemical Volume Estimates.

 •     Appendix G, Cost Analysis Methodology.

 •     Appendix H, Environmental Fate Summary Initial Review Exposure Report.

 •     Appendix I, Risk, Competitiveness & Conservation Data Summary and Social
       Benefits/Costs Assessment.

 •     Appendix J, Cost of Illness Valuation Methods.


 DEVELOPING A CTSA DOCUMENT

 A CTSA document is the repository of all of the technical information collected in a DfE
 industry project. As a minimum, it should include the following:

 "     A profile of the use cluster describing the overall product or process in which the use
       cluster occurs;  market information; the traditional products, processes, and technologies
       in the use cluster; and potential substitutes, including those evaluated in the CTSA, those
       not evaluated, and the reasons for excluding substitutes from evaluation.

 *     Information on chemicals in the use cluster, including the basic chemical properties data,
       market data, hazards summary data, and regulatory status.

 •     Summaries of the methodologies used to evaluate each of the trade-off issues (e.g., risk,
       performance, cost, social benefits and costs, energy impacts, resource conservation,
       process safety,  international implications, and regulatory status).

 "     Results of the evaluations, rncluding a summary of the trade-off issues.

 •     Descriptions of other environmental improvement opportunities identified during the
       course of the CTSA.

The project team circulates a draft CTSA for review and comment among the project partners
and other interested parties.  The team responds to comments and publishes a final document for
dissemination to anyone interested in a compilation of all the project's technical work. Usually
the project team will develop summary reports to disseminate to a wider, less technical,
audience.

Design for the Environment: Building Partnerships for Environmental Improvement (EPA,
 1995a) describes how to develop summary reports to communicate the results of a DfE industry
project.
                                         3-20

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              PART II
            CLEANER
       TECHNOLOGIES
         SUBSTITUTES
         ASSESSMENT
INFORMATION MODULES

-------

-------
The CTSA process is applicable to any industry
sector that can benefit from the reduced risk
and increased efficiency that results from using
a cleaner product, process, or technology.
Information  needs and understanding  of
environmental issues differ from business to
business  and from   industry  to  industry,
however. For example, the issues and methods
of assessing risk and exposure for computer
•workstations would differ substantially from
those of the dry cleaning industry. Industries
dominated by a few large companies, such as
the aerospace industry, will have different data
requirements than an industry with thousands
of member companies, such as the printing
industry.
                  Chapter 4
 OVERVIEW OF
   THE  MODULE
DESCRIPTIONS
For these reasons, the module descriptions in this publication are developed to:

•     Provide basic information suitable for a wide audience with a broad range of information
      needs.

•     Give a DfE project team a basic understanding of the analytical concepts and
      methodology for completing a module.

•     Provide references for sources of more detailed information.

The module descriptions were not formulated to give a complete accounting of all of the
assumptions, analytical methods, or steps required for some of the more complicated analyses,
such as exposure assessment. For these analyses, the reader is referred to published guidance,
with references provided in the module descriptions. In addition, many of the modules describe
analyses or data evaluations that cannot be performed without substantial expertise and
experience (e.g., the Human Health Hazards Summary, Environmental Hazards Summary,
Exposure Assessment, and Risk Characterization modules). For these and other analyses, users
of this publication who do not have the necessary expertise are urged to seek assistance in
completing the module.
FORMAT OF THE MODULE DESCRIPTIONS

Each of the module descriptions is organized according to a standard format that emphasizes the
basic concepts behind each module. The descriptions do not necessarily provide a detailed
accounting of all of the steps for completing the module. If, however, the basic methodology is
                                        4-1

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PART I: OVERVIEW OF CTSA PROCESS
the same regardless of the industry (e.g., data sources and methods for collecting or estimating
chemical properties data), the module gives a brief, step-by-step methodology.

The following describes the sections that are presented in each module:

•      The Overview section provides a brief overview of the types of data collected or analysis
       performed hi each module.

•      The Goals section contains a list of the module's goals.  This may include a description of
       how this module fits into the DfE process, whether information from this module is
       necessary input for any other module(s), and types of information a DfE project team
       would gain by completing this module.

•      The People Skills section includes a description of the skills, knowledge, or expertise
       required to complete the module. It should be noted that different types of knowledge are
       required to complete different modules. For example, the Human Health Hazards
       Summary requires expertise in toxicology and epidemiology, while the  Chemical
       Properties module requires a basic understanding of chemistry.

•      The Definition of Terms section lists definitions of some of the technical terms used in
       the module, and is intended to familiarize the reader with the terms and data points
       described in the Approach/Methodology section. In some cases, other relevant terms are
       included although they are not used in the module per se.  Many of the definitions include
       typical units of measure;  equivalent English units follow metric units where appropriate.

•      The Approach/Methodology section provides a brief summary of the basic module steps,
       including any data transfers to or from other modules.  Some modules consist almost
       entirely of a data collection effort (e.g., the Chemical Properties module) while in others,
       data collection is the first step of a more complex analysis (e.g., the Exposure Assessment
       module).

•      The Methodology Details section provides details and/or examples of the more complex
       steps in the Approach/Methodology section. In some of the modules this includes
       examples of a table or other format used to present module results.

•      The Flow of Information section contains examples of the information transfers into and
       out of the module (e.g., the Market Information module receives information from the
       Chemical Properties module and transfers information to the Cost Analysis module). It
       also illustrates these inputs and outputs between modules in a flow diagram, and lists two
       or three examples of data elements that are transferred.

•      The Analytical Models section provides a table of references for analytical models or
       software that can be used to complete this module, and the type of analysis performed by
       the model. For this and the next two sections, references are listed in shortened format
                                          4-2

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CHAPTER 4
OVERVIEW OF THE MODULE DESCRIPTIONS
       (author, date, title), with complete references given in the reference list following Chapter
       10.

•      The Published Guidance section provides a table of published guidance on methods for
       conducting this type of assessment, guidelines for interpreting results, and guidance on
       using standard default assumptions. This includes document references in shortened
       format and descriptions of the type of information provided.

•      The Data Sources section provides a table of data sources and the types of data to be
       found in the source. This includes on-line data bases, standard desk references, and other
       sources of published data.

The modules are described in Chapters 5 through 10, and are grouped together in the chapters
according to the basic kind of information collected or analyses performed.  Chapter 5 describes
the modules concerning basic chemical and process information.  Chapter 6 presents  the risk-
related modules. Chapter 7 presents modules traditionally related to competitiveness, including
performance, cost and regulatory status.  The modules in Chapter 8 address  conservation issues,
including energy impacts and resource conservation.  Chapter 9 discusses additional
improvement opportunities that may be realized through a pollution prevention or control
technology assessment. Chapter 10 describes how all of this information is brought together to
evaluate the trade-off issues from a societal or individual business perspective.
                                          4-3

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PARTI: OVERVIEW OF CTSA PROCESS
                                   4-4

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                                                            Chapter 5
                                              CHEMICAL &
                                                       PROCESS
                                           INFORMATION
This chapter presents module descriptions for the chemical and process information component
of a CTSA which consists of nine data gathering modules:

"     Chemical Properties.

"     Chemical Manufacturing Process & Product Formulation.

•     Environmental Fate Summary.

•     Human Health Hazards Summary.

•     Environmental Hazards Summary.

•     Chemistry of Use & Process Description.

•     Process Safety Assessment.

•     Market Information.

•     International Information.

The Chemical Properties, Environmental Fate Summary, Human Health Hazards Summary, and
Environmental Hazards Summary modules collect data on the properties of the chemicals in the
use cluster. The Chemical Manufacturing Process & Product Formulation, Chemistry of Use &
Process Description, Process Safety Assessment, Market Information, and International
Information modules collect data relating to the chemicals themselves, and/or the substitute
products, processes, or technologies in which they are used.  The information compiled in each
of these modules is used later in the data analysis components of a CTSA.
                                     5-1

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PART H: CTSA INFORMATION MODULES
For example, the Chemical Properties module provides chemical identity information to almost
every module in the CTSA. Among other things, this minimizes the potential for confusion
caused by chemical synonyms and ensures that DfE team members from different disciplines
have a common point of reference on chemical names.  The Hazards Summary modules combine
with data from the Exposure Assessment module to characterize human health and ecological
(aquatic) risks. The Chemistry of Use & Process Description module clearly defines the
processes in the use cluster so that DfE team members working on different process-related
modules have a common understanding of the processes.

Only the Process Safety Assessment, Market Information,  and International Information
modules of this component provide information directly to the final trade-off evaluations of a
CTSA.  The Process Safely Assessment module provides data on potential chemical hazards
(e.g;, fire, explosion, etc.) and precautions for safe use of equipment or chemicals to the Risk,
Competitiveness & Conservation Data Summary module for evaluation hi the Social
Benefits/Costs Assessment and Decision Information Summary modules. The Market
Information and International Information modules provide data on domestic and foreign
supply and demand and relevant trade issues.
                                          5-2

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                              CHEMICAL PROPERTIES
OVERVIEW: Chemical properties, physical properties, and the chemical structure of a
substance are characteristics which identify it from other substances. In this module, the physical
and chemical characteristics of the chemicals in the use cluster are detailed.
GOALS:

•     Identify the physical and chemical characteristics along with the chemical structures of
       the chemicals in the use cluster.

•     Determine a discrete appropriate name and Chemical Abstracts Service Registry Number
       (CAS RN), defined below for each chemical to be used throughout the assessment.

•     Facilitate the identification of potential chemical substitutes with similar properties to the
       chemicals in the use cluster.

•     Provide chemical names and/or properties to the following modules: Chemical
       Manufacturing Process & Product Formulation, Environmental Fate Summary, Human
       Health Hazards Summary, Environmental Hazards Summary, Chemistry of Use &
       Process Description, Process Safety Assessment, Market Information, Workplace
       Practices & Source Release Assessment, Exposure Assessment, Regulatory Status,
       Performance Assessment, and Control Technologies Assessment.
PEOPLE SKILLS: The following lists the types of skills or knowledge that are needed to
complete this module.

•      Knowledge of the basic concepts of chemistry, particularly physical and chemical
       properties.

Within a business or DFE project team, the people who might supply these skills include a
chemist, chemical engineer, or an environmental scientist.
DEFINITION OF TERMS:

Boiling Point (bp): The temperature at which a liquid under standard atmospheric pressure (or
other specified pressure) changes from the liquid to the gaseous state. It is an indication of the
volatility of a substance. The distillation range in a separation process, the temperature at which
the more volatile liquid of a mixture forms a vapor, is used for mixtures hi the absence of a bp.
Typical units are °C or °F.
                                          5-3

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PART H: CTSA INFORMATION MODULES
Chemical Abstracts Service Registry Number (CAS RN):  A unique identification code, up to ten
digits long, assigned to each chemical registered by the Chemical Abstract Service. The CAS
RN is useful when searching for information on a chemical with more than one name.  Over six
million chemicals have been assigned CAS RNs.

Chemical Structure: A description of how atoms in a chemical are connected and arranged,
including types of bonds between atoms.

Corrosivitv: As defined by EPA (40 CFR 261.22), a solid waste exhibits the characteristic of
corrosivity if: (1) it is aqueous and has a pH less than or equal to 2 or greater than or equal to
12.5, as determined by a pH meter using an EPA test method (Method 9049 in EPA Publication
SW-846); (2) it is a liquid and corrodes steel at a rate greater than 6.35 mm (0.250") per year
when tested at 55  °C as determined by the test method specified in the National Association of
Corrosion Engineers Standard TM-01-69 as standardized in EPA Publication SW-846. As
defined by OSHA (29 CFR 1910.1200), a chemical is corrosive if it causes visible destruction of,
or irreversible alternation hi living tissue by chemical action at the site of contact.

Density: The mass of a liquid, solid, or gas per unit volume of that substance, i.e., the mass in
grams contained hi 1 cubic centimeter (1 ml) of a substance at 20 °C and 1 atmosphere pressure.
Typical units are g/ml or lbs/in3.

Explosive: As defined by  OSHA (29 CFR 1910.1200), a chemical that causes a sudden, almost
instantaneous release of pressure, gas, and heat when subjected to sudden shock, pressure, or
high temperature.

Flammable: As defined by OSHA (29 CFR 1910.1200), a chemical that falls into one of the
folio whig categories:
•     Flammable aerosol: An aerosol that,  when tested by the method described in 16 CFR
        1500.45, yields a flame projection exceeding 18 inches at full valve opening, or a
       flashback (a flame extending back to the valve) at any degree of valve opening.
»     Flammable gas:
       - A gas that, at ambient temperature and pressure, forms a flammable mixture with air
        at a concentration of 13 percent by volume or less; or
        - A gas that, at ambient temperature and pressure, forms a range of flammable
       mixtures with ah- wider than 12 percent by volume, regardless of the lower limit.
 •      Flammable liquid: Any liquid having a flashpoint below 100 °F (37.8 °C), except any
        mixture having components with flashpoints of 100 °F (37.8 °C) or higher, the total of
        which make up 99 percent or more of the total volume of the mixture.
 •      Flammable solid: A solid, other than a blasting agent or explosive as defined in 29 CFR
        1910.109(a), that is liable to cause fire through friction, absorption of moisture,
        spontaneous chemical change, or retained heat from manufacturing or processing, or
        which can be ignited readily and when ignited burns so vigorously and persistently as to
        create a serious hazard. A chemical shall be considered to be a flammable solid if,
        when tested by the method described in 16 CFR 1500.44, it ignites and burns with a self-
        sustained flame at a rate greater than one-tenth of an inch per second along its major axis.

                                           5-4

-------
 CHAFFERS
                                                                 CHEMICAL PROPERTIES
 Flash Point:  As defined by OSHA (29 CFR 1910.1200), the minimum temperature at which a
 liquid gives off a vapor in sufficient concentration to ignite when tested as follows:
 •     Tagliabue Closed Tester: (see American National Standard Method of Test for Flash
       Point by Tag Closed Tester, Zl 1.24-1979 [ASTM D 56-79]) for liquids with a viscosity
       of less than 45 Saybolt Universal Seconds (SUS) at 100 °F (37.8 °C), that do not contain
       suspended solids and do not have a tendency to form a surface film under test.
 •     Penskv-Martens Closed Tester: (see American National Standard Method of Test for
       Flash Point by Pensky-Martens Closed Tester, Zl 1.7-1979 [ASTM D 93-79]) for liquids
       with a viscosity equal to or greater than 45 SUS at 100 °F (37.8 °C), or that contain
       suspended solids, or that have a tendency to form a surface film under test.
 •     Setaflash Closed Tester: (see American National Standard Method of Test for Flash Point
       by Setaflash Closed Tester [ASTM D 3278-78].)  Typical units are °C or °F.

 Melting Point (mp):  The temperature at which a substance changes from the solid to the liquid
 state. It indicates the temperature at which solid substances liquefy. Typical units are °C or °F.

 Molecular Weight TMW^: A summation of the individual atomic weights based on the numbers
 and kinds of atoms present in a molecule of a chemical substance. For polymers, this may
 include molecular weight distributions or average number MW (MWJ, ranges, and averages.
 Typical units are g/mole,  daltons, or Ibs/mole.

 Physical State:  Describes a chemical substance as a gas, liquid, or solid under ambient or other
 given conditions.

 Reactivity: As defined by EPA (40 CFR 261.23), a solid waste is considered reactive if it
 exhibits any of the following properties: (1) is normally unstable and readily undergoes violent
 change without detonating; (2) reacts violently or forms potentially explosive mixtures with
 water; (3) when mixed with water, generates toxic gases, vapors, or fumes in a quantity that can
 present a danger to human health or the environment; (4) is a cyanide or sulfide bearing waste
 which, when exposed to a pH between 2 and 12.5, can generate toxic gases, vapors, or fumes in a
 quantity that can present a danger to human health in the environment; (5) is capable of
 detonation or explosive reaction if subjected to a strong initiating source or if heated under
 confinement; (6) is readily capable of detonation or explosive decomposition or reaction at
 standard temperature and pressure; or (7) is a forbidden Class A or Class B explosive as defined
 by the Department of Transportation (49 CFR 173). As defined by OSHA (29 CFR 1910.1200),
 water-reactive means a chemical will react with water to release a gas that is either flammable or
presents a health hazard.

Vapor Pressure (Pv): The pressure exerted by a chemical in the vapor phase in equilibrium with
its solid or liquid form. It provides an indication of the relative tendency of a substance to
volatilize from the pure state. Typical units are mm Hg, torr, or in. Hg.

Water Solubility (S): The maximum amount of a chemical that can be dissolved in a given
amount of pure water at standard conditions of temperature and pressure. Typical units are
mg/L, g/L, or Ibs/gal.

                                          5-5

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PART II: CTSA INFORMATION MODULES
APPROACH/METHODOLOGY: The following presents a summary of the approach or
methodology for obtaining chemical properties data. Methodology details for Step 6 are
presented in the next section of this module.

Step 1:       Prepare a list of chemical names from the substitutes tree, the Industry and Use
             Cluster Profile, and other pertinent documents as chemicals are identified (e.g., by
             the Performance Assessment or Workplace Practices & Source Release
             Assessment modules).

             Obtain the CAS RN and the chemical structure for each chemical on the list and
             identify synonyms. This will expedite the search for data on chemical properties.
             (Refer to Tables 5-2, 5-3, and 5-4.)

             Determine the appropriate name to be used to identify the chemical from the
             synonyms.

             Collect measured and/or estimated data for all of the terms listed in the Definition
             of Terms, when applicable.  Many sources of data can be searched by CAS RN.
             Data are generally available from suppliers of the chemicals.  (See material safety
             data sheets [MSDSs], described in the Process Safety Assessment module.)

 Step 5:      Use standard or accepted mathematical models or computer programs to estimate
             the data. (See Table 5-2: Mathematical Models Used to Estimate  Chemical
             Properties.)

 Step 6:      Provide pertinent chemical properties to the appropriate modules (see
              Methodology Details below).
Step 2:



Step 3:


Step 4:
 METHODOLOGY DETAILS: This section presents the methodology details for completing
 Step 6 in the above section.

 Details: Step 6, Providing Pertinent Chemical Properties to the Appropriate Modules

 Table 5-1 lists examples of data that the Chemical Properties module transfers to other modules
 in a CTSA.
TABLE 5-1: DAT A TRANSFERRED FROM THE CHEMICAL .PROPERTIES MODULE
Module
Chemical Manufacturing Process & Product
Formulation
Human Health Hazards Summary
Data Transferred
CAS RN, synonyms, mp, bp
CAS RN, synonyms, chemical structure
                                           5-6

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CHAPTERS
CHEMICAL PROPERTIES
TABLE S-lf BAT A TRANSFERRED FROM THE CHEMICAL PROPERTIES MODULE
Module
Environmental Hazards Summary
Environmental Fate Summary
Market Information
Chemistry of Use & Process Description
Process Safety Assessment
Workplace Practices & Source Release
Assessment
Regulatory Status
Exposure Assessment
Performance Assessment
Control Technologies Assessment
Data Transferred
CAS RN, synonyms, chemical structure, S.
CAS RN, synonyms, chemical structure, Pv, S,
mp, bp, physical state, MW
CAS RN, synonyms
CAS RN, synonyms, chemical structure
CAS RN, synonyms, corrosivity, reactivity,
explosiviry, flammability, flashpoint
CAS RN, synonyms
CAS RN, synonyms, reactivity, flammability,
flashpoint, corrosivity
CAS RN, synonyms, chemical structure, Pv, S,
physical state
CAS RN, synonyms, Pv, bp, flashpoint
CAS RN, synonyms, physical state, reactivity, S,
flammability, flash point, mp, bp, density
FLOW OF INFORMATION: The Chemical Properties module is the basic starting point for
many of the other modules in the CTSA. The Chemical Properties module receives chemical
names from the substitutes tree and other sources and transfers data to the Chemical
Manufacturing Process & Product Formulation, Human Health Hazards Summary,
Environmental Hazards Summary, Environmental Fate Summary, Market Information,
Chemistry of Use & Process Description, Process Safety Assessment, Workplace Practices &
Source Release Assessment, Regulatory Status, Exposure Assessment, Performance Assessment,
and Control Technologies Assessment modules. Example information flows are shown in Figure
5-1.
                                        5-7

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PART H: CTSA INFORMATION MODULES
             FIGURE 5-1: CHEMICAL PROPERTIES MODULE:
                   EXAMPLE INFORMATION FLOWS




1


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                                5-8

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CHAPTERS
CHEMICAL PROPERTIES
ANALYTICAL MODELS: Table 5-2 presents references for analytical models that can be
used to estimate chemical properties.
TABLE 5-2: MATHEMATICAL MODELS USED TO ESTIMATE CHEMICAL
: PROPERTIES
Reference
Hunter, R.S. and F.D. Culver. 1992.
MicroQSAR Version 2.0: A Structure-Activity
Based Chemical Modeling and Information
System.
Syracuse Research Corporation. Continually
Updated. Estimation Programs Interface
(EPI°).
Syracuse Research Corporation. Updated
Periodically. MPBVP0.
Type of Model
Personal computer-based system of models. Uses ,
quantitative structure-activity relationships to
estimate chemical properties and aquatic toxicity
values.
A shell program used to access a series of models
used to estimate S, mp, bp, Pv, and environmental
fate properties.
This program estimates the mp, bp, and Pv of
organic compounds.
Note: References are listed in shortened format, with complete references given in the reference list following
Chapter 10.
PUBLISHED GUIDANCE:  Table 5-3 presents a reference for published guidance on chemical
and physical properties and the use of estimation models for these properties.
TABLE 5-3: REFERENCES FOR CHEMICAL AND PHYSICAL PROPERTIES
Reference
Lyman, W.J., et. al. 1990. Handbook of
Chemical Property Estimation Methods.
Type of Guidance
Methods for estimating density, Pv, S, and other
chemical properties relevant to the Chemical
Properties module.
Note: References are listed in shortened format, with complete references given in the reference list following
Chapter 10.
                                            5-9

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PART H: CTSA INFORMATION MODULES
DATA SOURCES: Table 5-4 lists sources of chemical and physical property data.
TABLE 5-4: SOURCES OF CHEMICAL AND PHYSICAL PROPERTIES DATA
Reference
Aldrich Chemical Company, Inc. 1990. Catalog
Handbook of Fine Chemicals.
Beilstein. Beilstein on-line data base. Updated
Periodically.
Buckingham,!. 1982. Dictionary of Organic
Compounds,
Chemical Abstracts Systems. 1994.
Farm Chemicals Handbook '87. 1987.
Handbook of Chemistry and Physics (CRC).
1992-1993.
Hawley, Gessner G., et. al., Ed. 1981.
Condensed Chemical Dictionary.
HSDB®. Hazardous Substances Data Bank
(HSDB). Updated Periodically.
Merck Index. 1989.
Perry's Chemical Engineering Handbook. 1 984.
Type of Data
Commercial catalog containing over 27,000
organic and inorganic chemicals (mostly for
research and development). Entries list the
chemical name, CAS RN, structure, MW, and
possibly the mp or bp, density, refractive index, a
Beilstein reference, and other data (e.g.,
"hygroscopic, irritant, or moisture sensitive").
Data base containing data on known organic
compounds. Its unique feature is its ability to
define reactants in products. It is an extensive
collection of physical properties and chemical
reactions.
Five volume set (plus supplements) with
molecular formula and name index. Lists, with
references, synthesis, spectra, physical properties,
and derivatives for a large number of organic
compounds.
Data base containing CAS RNs and chemical and
physical properties.
A commercial "magazine" of registered
agricultural herbicides, fungicides, and
pesticides. Contains measured values of Pv, S,
and many others. Usually listed by the
agricultural trade name.
Handbook containing CAS RNs and chemical
and physical properties.
A compendium of technical data and descriptive
information covering many thousands of
chemicals, including their industrial uses. Also
includes trademark names.
On-line data base containing CAS RNs,
synonyms, and chemical and physical properties.
Handbook containing chemical and.physical
properties and CAS RNs.
Handbook containing chemical and physical data.
                                     5-10

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CHAPTERS
                    CHEMICAL PROPERTIES
        TABLE 5-4: SOURCES OF CHEMICAL ANB PHYSICAL PROPERTIES DATA
                  Reference
                Type of Data
 RTECS®. Registry of Toxic Effects of Chemical
 Substances.  1995.
An on-line data base that contains chemical
identity information such as chemical name, CAS
RN, synonyms, molecular formula, MW, and
others. Also included are toxicity and
mutagenicity information.
 Sax, N. Irving and Richard J. Lewis, Sr. 1987.
 Hazardous Chemicals Desk Reference.
Handbook containing CAS RNs and chemical
and physical properties as well as synonyms,
hazard ratings, and current standards for exposure
limits.
 Syracuse Research Corporation (SRC). 1994.
 Environmental Fate Data Bases (EFDB®).
Data base containing CAS RNs and chemical and
physical property information.
 Syracuse Research Corporation (SRC). Updated
 Periodically. Water Solubility Data Base.
A compilation of measured S data, as well as data
on other physical property values for over 4,000
(and growing) chemicals stored on a searchable
computer data base (ChemBase v. 1.4). It
currently contains referenced data from the
Arizona data base, the Syracuse data base, the
Merck Index, on-line Beilstein, other pertinent
literature, and journal articles.
 U.S. Department of Health and Human Services.
 1985. CHEMLINE: Chemical Dictionary Online.
An on-line interactive chemical dictionary file
containing one million chemical substance
records. The data elements consist of CAS RNs,.
molecular formula, synonyms, ring information
(part of the structure of some chemicals), and a
locator to other on-line data bases that would
contain further information on that compound.
 U.S. Environmental Protection Agencj'.  1995d.
 Integrated Risk Information System (IRIS®).
An on-line data base that contains information
and data on numerous chemical substances.
Information includes substance identification
(name and CAS RN) and physical properties such
as color/form, odor, bp, mp, MW, density, vapor
density, Pv, solubilities, flash point, and others.
 Verschueren, K.  1983. Handbook of
 Environmental Data on Organic Chemicals.
An extensive text compiling information on
organic chemicals. The data given include
formula, physical appearance, MW, mp, bp, Pv,
and solubility.
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PART II: CTSA INFORMATION MODULES
TABLE 5-4! SOURCES OF CHEMICAL AND PHYSICAL PROPERTIES DATA
Reference
Worthing, Charles R. and S. Barrie Walker.
1987. Pesticide Manual.
Type of Data
An index of agricultural pesticides which
contains chemical names and physical properties,
such as mp or bp, Pv, S, and other useful
measured values.
Note: References are listed in shortened format, with complete references given in the reference list following
Chapter 10.
                                               5-12

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     CHEMICAL MANUFACTURING PROCESS & PRODUCT FORMULATION
OVERVIEW: Chemical manufacturing is the process through which a chemical is synthesized
from raw materials or other chemical, feedstocks. Product formulation is the process by which
chemical products, composed of one or more ingredients, are prepared according to the product
formula.  This module: (1) describes the process for manufacturing the chemicals in the use
cluster; and (2) describes the chemical product formulation process, if applicable. In both cases,
the descriptions focus on the industrial or laboratory means of synthesis, the necessary starting
materials and feedstocks, by-products and co-products, isolated or non-isolated intermediates,
and relevant reaction conditions (e.g., temperature, pressure, catalyst, solvents, and other
chemicals).
GOALS:
       Describe the processes for manufacturing chemicals in the use cluster.

       Describe the process for formulating chemical products used in the use cluster, if
       applicable.

       Compile chemical manufacturing and product formulation data to be used by subsequent
       modules if the impacts of these up-stream processes are being evaluated in a CTSA.
PEOPLE SKILLS:  The following lists the types of skills or knowledge that are needed to
complete this module.

•     Knowledge of chemical feedstocks, synthetic chemical reaction catalysts, and reaction
       conditions.

•     Understanding of chemical manufacturing processes, including both batch and continuous
       processes, as well as chemical equilibria, kinetics, and heat and mass transfer.

Within a business or DfE project team, the people who might supply these skills include a
chemist and a chemical or process engineer. Vendors of the chemicals or chemical formulations
may also be a good resource.
DEFINITION OF TERMS:

Catalyst: A substance that accelerates a chemical reaction but which itself is not consumed in the
reaction.

Chemical By-product: An unintended chemical compound that is formed by a chemical reaction.
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EARTH: CTSA INFORMATION MODULES
 Chemical Intermediate: A chemical substance that is formed during the reaction and then
 undergoes further reaction to produce a product.

 Chemical Product: In a CTSA, refers to products in the use cluster composed of one or more
 chemicals for which product formulation data must be obtained.

 Chemical Reaction: The process that converts a substance into a different substance.

 Feedstock: A raw material, pure chemical, or chemical compound that is used to synthesize a
 chemical.

 Unit Operation: A process step that achieves a desired function.
APPROACH/METHODOLOGY:  The following presents a summary of the approach or
methodology for describing the chemical manufacturing processes and product formulation
methods of chemicals or chemical products. Methodology details for Steps 3, 4, and 9 follow
this section.

Chemical Manufacturing

Step 1:        Obtain chemical information, including CAS RNs, synonyms, melting points, and
              boiling points from the Chemical Properties module.

Step 2:        Determine the primary industrial mode of synthesis for each chemical in the use
              cluster (refer to data sources in Table 5-5).

Step 3:        Develop a chemical manufacturing process flow diagram for the primary mode of
              synthesis.  The diagram should identify the major unit operations and equipment,
              as well as all input and output streams (see Methodology Details for an example
              chemical manufacturing process description).

Step 4:        Identify any chemical intermediates, catalysts, feedstocks, and chemical products
              or by-products involved in the synthesis that have the potential for release.

Product Formulation

Step 5:        Obtain chemical product formulation data for any chemical products being
              evaluated in the CTSA from the Performance Assessment module. When
              proprietary chemical products are being used, only generic formulations may be
              available.

Step 6:        Determine the primary industrial method of formulation for each chemical
              product being evaluated. Mixing operations, with or without the addition of heat
              or pressure, are typical manufacturing processes for product formulations.

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CHAPTERS	CHEMICAL MANUFACTURING PROCESS & PRODUCT FORMULATION

Step 7:        Develop a process flow diagram for the primary industrial method of formulation.
              The diagram should include the unit operations, material flows, and equipment
              used in the formulation process. If a chemical reaction occurs in the formulation
              process, determine if any special reaction conditions are required (e.g., the
              presence of heat, cooling, a catalyst, etc.). If a product is formulated by mixing
              only (e.g., does not involve chemical reactions), determine if any special
              conditions (e.g., heat, pressure, etc.) are required to get ingredients into solution.
              This information can be used to evaluate the energy impacts of the alternatives.

Step 8:        Identify any chemical intermediates, catalysts, feedstocks, and chemical products
              or by-products involved in the product formulation process that have the potential
              for release.

Transferring Information

Step 9:        Provide the following information to the modules listed below:
              •      Energy usage resulting from the chemical manufacturing and product
                     formulation processes (e.g., heat, pressure, etc.) to the Energy Impacts
                     module.
              •      Material streams usage resulting from the chemical manufacturing or
                     product formulation processes (e.g., chemical feedstocks, catalysts, etc.) to
                     the Resource Conservation module.
 METHODOLOGY DETAILS:  This section presents the methodology details for completing
 Step 3, 4, and 9 from the Chemical Manufacturing section above.

 Details: Steps 3 and 4, Example Description of Chemical Manufacturing Process

 The following description of the synthetic preparation of ethanol by indirect hydration is an
 example of the chemical manufacturing process description developed in Steps 3 and 4.  The
 process information was gathered from the data sources listed in the Table 5-5.

 Indirect Hydration of Ethanol

 The preparation of ethanol from ethylene using sulfuric acid is a three step hydration process as
 discussed below.  A flow diagram for this process is shown in Figure 5-2.
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PARTH: CTSA INFORMATION MODULES
                                  5-16

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CHAPTERS
            CHEMICAL MANUFACTURING PROCESS & PRODUCT FORMULATION
Step 1:
 Formation of monoethyl sulfate and diethyl sulfate by the absorption of ethylene
 in concentrated sulfuric acid.
                         CH2 = CH2 + H2SO4  ->
                     (Ethylene)    (Sulfuric Acid)

                       2CH2=CH2 + H2SO4  -+
                         (Ethylene)  (Sulfuric Acid)
                                     CH3CH2OSO3H
                                      (Monoethyl Sulfate)

                                      (CH3CH2O)2SO2
                                       (Diethyl Sulfate)
Step 2:
  Formation of ethanol by hydrolysis of ethyl sulfates.
                     CH3CH2OSO3H
                    (Monoethyl Sulfate)

                   (CH3CH2O)2SO2 4
                    (Diethyl Sulfate)
                         h H2O
                         (Water)

                         2H2O
                          (Water)
(CH3CH2O)2SO2
 (Diethyl Sulfate)
                              CH3CH2OH
                                (Ethanol)
 CH3CH2OH + H2SO4
  (Ethanol)   (Sulfuric Acid)

 2 CH3CH2OH + H2SO4
   (Ethanol)  (Sulfuric Acid)

CH3CH2OSO3H + (CH3CH2)2O
 (Monoethyl Sulfate)  (Diethyl Ether)
Step 3:
  Reconcentration of the dilute sulfuric acid.
The primary input streams for this process are the hydrocarbon feedstock containing 35-95
percent ethylene, methane, and ethane; 96-98 percent sulfuric acid, and water.

The adsorption is carried out in a column reactor at 80 °C and 1.3-1.5 MPa of pressure where the
ethylene feedstock is adsorbed in an exothermic reaction with the sulfuric acid. The column is
cooled to reduce the reaction temperature and to limit corrosion problems. The hydrolysis of the
ethyl sulfates in the second step of the process is done using just enough water to produce a 50-
60 percent sulfuric acid solution. The resulting mixture is separated by a stripping column to
yield sulfuric acid and a gaseous mixture of alcohol, ether, and water. The gaseous mixture is
mixed with water and then distilled until pure. Finally, the sulfuric acid is then reconcentrated
using a reboiler and a two stage vacuum evaporation system until the concentration is above 90
percent.

The primary output streams and by-products  of this reaction are the following:
 •      Ethanol (product).
 •      Dilute 50-60 percent sulfuric acid.
 •      Scrubber waste containing the unreacted methane and ethane as well as any other gases
        present.
 •      Diethyl ether (by-product).

 The intermediate compounds of monoethyl sulfate and diethyl sulfate are also present, although
 they are not waste streams, because they are consumed by the process.
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 PARTH: CTSA INFORMATION MODULES
 Details: Step 9, Transferring Information

 Past CTSAs have not quantitatively evaluated the chemical manufacturing and product
 formulation processes. Instead, attention has focussed on the relative effects of up-stream
 processes on energy and other resources consumption. If the effects of up-stream processes on
 human health and environmental risks are being quantified in a CTSA, the identities of chemical
 intermediates, catalysts, feedstocks, and chemical products or by-products are transferred to the
 Chemical Properties module and other modules that ultimately feed into the risk characterization.
 Process flow diagrams are transferred to the Workplace Practices & Source Release Assessment
 module.
FLOW OF INFORMATION: In a CTSA, this module receives information from the Chemical
Properties module and transfers information, if desired, to the Energy Impacts and Resource
Conservation modules. Example information flows are shown in Figure 5-3. This module could
also transfer information to other modules if these processes are being fully and quantitatively
evaluated. For example, chemical intermediates released during chemical manufacturing process
could be evaluated in the hazards summary modules.

        FIGURE 5-3: CHEMICAL MANUFACTURING PROCESS & PRODUCT
           FORMULATION MODULE: EXAMPLE INFORMATION FLOWS
                              Chemical
                            Manufacturing
                              Process &
                         Product Formulation
         i CAS RN and synonyms
Operating conditions
                                                                         Energy
                                                                         Impacts
                                                         of material
                                                     streams
                                                    i Operating conditions
                   Resource
                  Conservation

                                                                                  .
ANALYTICAL MODELS: None cited.
PUBLISHED GUIDANCE:  None cited.
                                        5-18

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CHAPTERS
CHEMICAL MANUFACTURING PROCESS & PRODUCT FORMULATION
DATA SOURCES: Table 5-5 lists data sources for both chemical manufacturing processes and
product formulation methods.
TABLE 5-5; SOUHCES OF CHEMICAL MANUFACTURING PROCESS
AND PRODUCT FORMULATION INFORMATION
Reference
HSDB®. Hazardous Substance Data Bank
(HSDB). Updated Periodically.
Kirk-Othmer Encyclopedia of Chemical
Technology. Updated Periodically.
Ullmann, Fritz. 1985. Ullmann's Encyclopedia
of Industrial Chemistry.
Type of Data
Contains brief summaries of chemical
manufacturing processes.
Comprehensive source of chemical synthesis
processes.
Comprehensive source of chemical synthesis
processes.
Note: References are listed in shortened format, with complete references given in the reference list following
Chapter 10.
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PARTH: CTSA INFORMATION MODULES
                                  5-20

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                       ENVIRONMENTAL FATE SUMMARY
OVERVIEW: The environmental fate of chemicals describes the processes by which chemicals
move and are transformed in the environment. Environmental fate processes that should be
addressed include: persistence in air, water, and soil; reactivity and degradation; migration in
groundwater; removal from effluents by standard waste water treatment methods; and
bioaccumulation in aquatic or terrestrial organisms.

Note:  There is no single accepted methodology for evaluating the environmental behavior of
       chemicals; this is particularly true in the selection of mathematical models to predict
       environmental fate parameters.  Thus it is important to document the approach and
       specific procedures used in the module. The approach presented below is one suggested
       by the types of information included in recent EPA Risk Management Reports.
GOALS:

•     Retrieve data or estimate key environmental fate parameters for each chemical in the use
       cluster.

•     Prepare environmental fate and treatability summaries for each chemical.

•     Provide data to the Human Health Hazards Summary, Environmental Hazards Summary,
       Exposure Assessment, and Control Technologies Assessment modules.


PEOPLE SKILLS: The following lists the types of skills or knowledge needed to complete this
module.

 •     Knowledge of the physical, chemical, and biological reactions of chemicals in the
       environment.

 •     Knowledge of standard waste water treatment systems and unit processes.

 •     Experience with the use of mathematical models for predicting the fate and
       transformation of chemicals hi the environment.

 Note:  The analysis described in this module should only be undertaken by someone familiar
        with environmental fate calculations. Furthermore, peer-review of the completed
        environmental fate summary is recommended.


 DEFINITION OF TERMS: Several terms from the Chemical Properties module are also used
 in the Environmental Fate Summary module and are defined here as well.
                                          5-21

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 PART II: CTSA INFORMATION MODULE
 Chemical Properties

 Vapor Pressure (Pv): The pressure exerted by a chemical in the vapor phase in equilibrium with
 its solid or liquid form. It provides an indication of the relative tendency of a substance to
 volatilize from the pure state. Typical units are mm Hg, torr, or in. Hg.

 Water Solubility (S): The maximum amount of a chemical that can be dissolved in a given
 amount of pure water at standard conditions of temperature and pressure. Typical units are
 mg/L, g/L, or Ibs/gal.

 Environmental Fate

 Atmospheric Residence Time M: The ratio of the total mass of a chemical in an atmospheric
 compartment to either the total emission rate or the total removal rate, under steady-state
 conditions. Units are typically in hours or days.

 Biochemical Oxygen Demand rBOD): The amount of oxygen consumed by microorganisms,
 over a specified time period, to metabolize a substance. Under certain environmental conditions,
 a high BOD may result in a reduction in oxygen levels in receiving waters to below critical levels
 for sustaining aquatic life.

 Bioconcentration Factor (BCF): The equilibrium ratio of the concentration of a chemical in an
 exposed organism to the concentration of the chemical in the surrounding water.

 Biodegradation: The transformation of chemical compounds by living organisms.  Not confined
 to microorganisms (e.g., bacteria, fungi) but chiefly a microbial process in nature; typically
 expressed in terms of a rate constant and/or half-life.

 Chemical Oxygen Demand fCOD): The amount of oxygen consumed in the oxidation of a
 chemical substrate by a strong chemical oxidant (such as dichromate).

 HilfJifeJivJ:  The time required to reduce the concentration of a chemical to 50 percent of its
 initial concentration. Units are typically in hours or days.

 Henry's Law Constant (Hc): The air/water partition coefficient, describing the relative
 concentrations of a chemical in air (the vapor phase) and the chemical dissolved in water, in a
 closed system at equilibrium. Hc can be measured directly or estimated as the ratio of Pv to S,
 and gives an indication of a chemical's tendency to volatilize from water to air or dissolve into
water from air.  H,. is typically expressed in units of atm-m3/mole or in dimensionless terms.

Hydrolysis:  A chemical transformation process in which a chemical reacts with water.  In the
process, a new carbon-oxygen bond is formed with oxygen derived from the water molecule, and
a bond is cleaved within the chemical between carbon and some functional group.
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CHAPTERS
ENVIRONMENTAL FATE SUMMARY
Hydroxyl Radical Rate Constant (KQH.): The rate constant (in cm3/mol/sec) for the reaction of
photochemically produced hydroxyl radicals with organic compounds in the atmosphere.
lonization or Acid Dissociation Constant (K^. pK^): An equilibrium ratio of the dissociation
products and the parent compound in. aqueous solutions. The degree of dissociation can alter the
solubility and adsorption characteristics of the compound. The pKa is the negative log of Ka.

Mobility:  The tendency for a chemical to move in the environment (i.e., through soil with the
percolation of water) .

Octanol- Water Partition Coefficient (KCT,):  The equilibrium ratio of a chemical's  concentration in
the octanol phase to its concentration in the aqueous phase of a two-phase octanol/water system,
typically expressed in log units (log Kow).  Kow provides an indication of a chemical's S, fat
solubility (lipophilicity), its tendency to bioconcentrate in aquatic organisms, and to sorb to soil
or sediment.

Organic Carbon Partition Coefficient (Koc): The proportion of a chemical sorbed to the solid
phase, at equilibrium in a two-phase, water/soil or water/sediment system expressed on an
organic carbon basis.  Chemicals with higher K00 values are more strongly sorbed and, therefore,
tend to be less mobile in the environment.

Oxidation: In general, a reaction in which electrons are transferred from a chemical to an
oxidizing agent, or where a chemical gains oxygen from an oxidizing agent. (Also see Redox
and Reduction.)

Percent Removal: The amount of the chemical that can be removed from sewage by standard
waste water treatment processes, expressed in terms of the percent of the initial amount removed
from the influent (liquid) waste stream.  The chief processes that may contribute to removal from
a liquid waste stream are degradation (biotic or abiotic), sorption, and volatization (also known
as air stripping).

Persistence: The ability of a chemical substance to remain in a particular environment in an
unchanged form.

Photolysis: The transformation of a chemical by light energy.

Plant Uptake:  The uptake of a chemical into plants is expressed in terms of a bioconcentration
factor for vegetation (Bv), which is the ratio of the concentration in the plant tissue to the
concentration in soil.

Redox:  Reduction-oxidation reactions.  Oxidation and reduction occur simultaneously; in
general, the oxidizing agent gains electrons in the process (and is reduced) while  the reducing
agent donates electrons (and is oxidized).
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PARTH: CTSA INFORMATION MODULE
Reduction: In general, a reaction in which electrons are transferred to a chemical from a
reducing agent, or where oxygen is removed from a chemical. (Also see Oxidation and Redox.)

Soil or Sediment Sorption Coefficient (Kd): The equilibrium ratio between a chemical sorbed to
the solid phase and in solution in a two-phase, soil/water or sediment/water system.

Smog-Forming Potential: The chemical reaction of hydrocarbons to produce atmospheric
photochemical oxidants such as ozone and other by-products contributing to the formation of
smog.

Transport:  The movement of a chemical through the environment, within a single phase or from
one phase to another.

Treatability: The amenability of a chemical substance or waste stream to removal during waste
water treatment, without adversely affecting the normal operation of the treatment plant.

Ultraviolet (UV):  That part of me electromagnetic spectrum at a frequency higher than visible
light (corresponding to wavelengths of 3000-4000 A).

Volatilization: The transport process by which a chemical substance enters the atmosphere by
evaporation from soil or water.
ADDITIONAL TERMS: The following additional terms are not used in this module
discussion per se, but are likely to be found in the literature pertaining to chemical fate
parameters.

Acclimation: The process in which continuous exposure of a microbial population to a chemical
results hi a more rapid transformation (biodegradation) of the chemical than initially observed.

Activated Sludge: The flocculated mixture of microorganisms and inert organic and inorganic
material normally produced by aeration of sewage. Constitutes the biological treatment process
most frequently employed for purification of domestic sewage.

BOD/COD Ratio: The ratio of the BOD to the COD for a chemical mixture.

Direct Aqueous Photolysis Rate Constant (kj):  The rate  constant (in day'1 or year1) for the direct
photolytic transformation of an organic compound in water.

Ozone Rate Constantrkoj): The rate constant (cm3/mol/sec) for the reaction of ozone with an
organic compound.

Ehotooxidation: A process in which solar radiation generates an oxidizing agent, such as the
hydroxyl radical, which reacts with (and transforms) a chemical.
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CHAPTERS
ENVIRONMENTAL FATE SUMMARY
Wet Deposition:  The process by which a chemical that is dissolved in water in the atmosphere
reaches land or a water body via precipitation (synonym: atmospheric washout).
APPROACH/METHODOLOGY: The following outlines the technical approach or
methodology for preparing an environmental fate summary. Further methodology details for
Steps 3 and 4 follow this section.

Step 1:       Obtain CAS RNs and synonyms, information on chemical structure, and physical
             and chemical properties, of the chemicals in the use cluster from the Chemical
             Properties module.

Step 2:       Obtain measured or estimated environmental fate and treatability data for each
             chemical from primary and secondary sources (see Table 5-7: Sources of
             Environmental Fate Data).

Step 3:       If environmental fate and treatability data are not available, estimate parameters
             using regression equations and mathematical models (see Details: Step 3, below).

Step 4:       Prepare environmental fate and treatability summaries for each chemical,
             focussing on water, air, soil and waste water treatment environments as
             appropriate. Fate summaries should focus on the fate processes that are most
             important for that particular chemical. (See Details: Step 4, below.)

Step 5:       Provide environmental fate summaries and environmental fate parameter values,
             and identify any products of chemical degradation (if applicable) to the Human
             Health Hazards Summary, Environmental Hazards Summary, and Exposure
             Assessment modules; and provide treatability parameters (e.g., percent removal),
             environmental fate, and treatability summaries to the Control Technologies
             Assessment module.
METHODOLOGY DETAILS: This section presents methodology details for completing
Steps 3 and 4, and examples of environmental fate and treatability summaries.  If necessary,
additional information on these and other steps can be found in the previously published
guidance.

Details:  Step 3, Estimating Environmental Fate Parameters

Numerous mathematical models, such as regression equations, have been developed for
estimating environmental parameters for chemicals.  Only a few examples will be presented here;
many others exist, and the ones most appropriate for a given chemical will depend on the
circumstances. Published guidance should be consulted for selecting specific methods and
equations.
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PART II: CTSA INFORMATION MODULE
The KB,, of a chemical can be estimated from Kow, from S or from BCF, for example:

       log K^ = 0.544 log K^H- 1.377

       log !£„. = -0.55 logS + 3. 64

       log K™ = 0.681  log BCF + 1.963

The T for a chemical can be estimated from the rate at which the chemical reacts with hydroxyl
radicals, for example:

       TOH.= 1/{KOH[OH-]}

where:
           is in liters/mole/sec and [OH-] is in units of moles/liter

The bioconcentration of a chemical in aquatic species can be estimated from the chemical's
octanol-water partition coefficient (K^), for example:

       log BCF = 0.76 log Kow - 0.23

Details:  Step 4, Preparing Environmental Fate and Treatability Summaries

Examples of environmental fate and treatability summaries (from the Screen Printing CTSA) for
acetone and dichloromethane are shown below:

Environmental Fate Summary for Acetone

If released on soil, acetone will volatilize into the air or leach into the ground where it will
probably biodegrade. Photolysis will be important on terrestrial surfaces and in surface waters
exposed to sunlight. If released to water, acetone may also be lost due to volatilization
(estimated t^ is 20 hours from a model river)  and biodegradation.  Bioconcentration in aquatic
organisms and adsorption to sediment should not be important transport processes in water. In
the atmosphere, acetone will be lost by photolysis and reaction with photochemically produced
hydroxyl radicals. Half-life estimates from these combined processes average 22 days and are
shorter in summer and longer in winter. In air, acetone may also be washed out by rain.  A rapid
and a moderate biodegradation rate for acetone used in the Sewage Treatment Plant (STP)
fugacity model results in 97 and 84 percent predicted total removal from waste water treatment
plants, respectively.

Environmental Fate Summary for Dichloromethane

If released to  soil, dichloromethane is expected to display high mobility. It may rapidly
volatilize from both moist and dry soil to the  atmosphere. Aerobic biodegradation may be
important for dichloromethane in acclimated  soils. If released to water, volatization to the

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CHAPTERS
ENVIRONMENTAL FATE SUMMARY
atmosphere is expected to be a rapid process.  Neither bioconcentration in fish and aquatic
organisms, nor adsorption to sediment and suspended organic matter are expected to be
significant. Dichloromethane has been found to slowly biodegrade under aerobic conditions.  It
is also expected to slowly biodegrade under anaerobic conditions in sediment and groundwater.
If released to the atmosphere, dichloromethane is expected to persist for long periods of time.
The estimated t,/2 for the gas-phase reaction of dichloromethane with hydroxyl radicals is
approximately 88 days. Direct photolytic degradation is not expected to occur.
Dichloromethane may undergo atmospheric removal by wet deposition processes, although any
removed by this process is expected to rapidly re-volatilize to the atmosphere. Using a slow
biodegradation rate for dichloromethane in the STP fugacity model, 64 percent total removal can
be predicted from waste water treatment plants.

Also, Appendix H presents an example of an Initial Review Exposure Report for
dichloromethane. This form shows the environmental fate data that are typically reported along
with some additional chemical property and toxicity information.

Relevant Environmental Fate Properties by Environmental Medium

For each type of environment, the types of fate and property data that are likely to be most
relevant are listed below.

For water, the following are likely to be the most important properties  and processes which
should be  considered in developing an environmental fate summary:
•      S.                                             •                   •    -  ''.
•      Volatilization (Hc, t,/2).
•      Adsorption to sediments and suspended particulate matter (K00, Kd).
•      Photolysis (t/2).
•      Hydrolysis (rate constant and t./2).
•      BCF.
•      Biodegradation.

For soil, the following are likely to be the most important properties and processes which should
be considered in developing an environmental fate summary:
•  -    S.
•      Volatilization (Hc).
•      Adsorption to organic matter (Koc and Kd).
•      Adsorption to inorganic matter.
•      Potential for groundwater contamination.
•      Potential for uptake by plants.
•      Biodegradation.
•      Hydrolysis.
•      Photolysis on soil surfaces.

For air, the following are likely to be the most important properties and processes which should
be considered in developing an environmental fate summary:

                                          5-27

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PART II: CTSA INFORMATION MODULE
Volatility (Pv,
T.
Photolysis (t^.
Reactivity with hydroxyl radicals, ozone
UV absorption.
Smog-formhig potential.
Ozone depleting potential.
Wet deposition.
                                              ), and other oxidants.
For treatability, the following are likely to be the most important properties and processes which
should be considered in developing an environmental fate summary:
•      Biodegradability.
•      Sorption potential (K00).
•      Volatilization (Hc).
•      Hydrolysis.
FLOW OF INFORMATION: In a CTSA, the Environmental Fate Summary module receives
information from the Chemical Properties module and transfers information to the Human Health
Hazards Summary, Environmental Hazards Summary, Exposure Assessment, and Control
Technologies Assessment modules. Example information flows are shown in Figure 5-4.

           FIGURE 5-4: ENVIRONMENTAL FATE SUMMARY MODULE:
                         EXAMPLE INFORMATION FLOWS
                                             S !   * « , S f   M -  '
                                              . I  ;..!».   i- "V. »
                                              ,r,  v^1^.
                                             ->,"_ ^  ^.1
       Chemical
      Properties
                         Environmental
                             Fate1
                           Summary
                  » CAS RN and synonyms
                  » Chemical structum
                  • Other chemical properties
                                                    • Environmental Itfte
                                                    * Hydrolyste products
                                                                       Human Health
                                                                         Hazards
                                                                        Summary
Environmontsi
paramafer value*
Hydroiyaisprodiiots
Environmental
  Hazards
  Summary
                          ' ^ ° Vga^t^w^ovaf"  * ^ "'5 *'u  ',
                                        « Environmental fates and
                                       u trtatability summaries
                                                                          Control
                                                                        Technologies
                                                                        Assessment
                                         5-28

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CHAPTER 5
ENVIRONMENTAL FATE SUMMARY
ANALYTICAL MODELS:  Environmental fate and transport modeling is performed as part of
the Exposure Assessment module. Models for estimating environmental fate parameters are
included in Table 5-6, below.
PUBLISHED GUIDANCE: EPA has not published comprehensive guidance on the
development of environmental fate summaries. Individual program offices may utilize different
approaches. Table 5-6 lists references hi which methods for estimating chemical properties and
environmental fate parameters are discussed.
• TABLE 5-65 REFERENCES FOR ESTIMATING ENVIROKMEHTAL FATE PARAMETERS :
Reference
BioByte, Inc.
CLOGP for Windows, Version 1.0. 1996.
MACLOGP (for Macintosh computers),
Version 2.0. 1996.
CLOGP VAX/VMS, Version 2. 10. 1996.
Boethling, R.S. 1993. "Structure Activity
Relationships for Evaluation of Biodegradability
in the EPA's Office of Pollution Prevention and
Toxics."
Briggs, G.C. 1981. "Theoretical and
Experimental Relationships between Soil
Adsorption, Octanol- Water Partition Coefficients,
Water Solubilities, Bioconcentration Factors, and
the Parachor."
Hamrick, K.J., et. al. 1992. "Computerized
Extrapolation of Hydrolysis Rate Data."
Hassett, J.J. 1981. "Correlation of Compound
Properties with Sorption Characteristics of
Nonpolar Compounds by Soils and Sediments:
Concepts and Limitations."
Kollig,H.P. 1993. Environmental Fate
Constants for Organic Chemicals under
Consideration for EPA's Hazardous Waste
Identification Projects.
Type of Guidance
Mathematical models used to estimate Kow.
Three versions currently available (as of June,
1996).
Describes the development, validation, and
application of SARs in EPA OPPT.
BCFs are estimated for neutral compounds from
KOW
Provides estimates of hydrolysis rate constants at
specific temperatures.
Sorption constants for nonpolar organic
compounds are correlated with S, KOW, or with
organic carbon content of soil or sediment.
Literature-derived data as well as model
computations are used to estimate hydrolysis,
adsorption, and oxidation-reduction parameters.
                                       5-29

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PARTH: CTSA INFORMATION MODULE

TABLE 5-6: REFERENCES FOR ESTIMATING ENVIRONMENTAL FATE PARAMETERS
Reference
Lyman, W.J., et. al. 1990. Handbook of
Chemical Property Estimation Methods.
Mackay, D., et. al. 1992. Illustrated Handbook
of Physical-Chemical Properties and
Environmental Fate for Organic Chemicals.
Meylan, W., et. al. 1992. "Molecular-
Topology/Fragment Contribution Method for
Predicting Soil Sorption Coefficients."
Syracuse Research Corporation (SRC).
Continually Updated. Estimation Programs
Interface (EPI°).
Type of Guidance
Describes methods for estimating residence time,
Kow, KO,,, BCF, acid dissociation constants,
hydrolysis, aqueous photolysis, biodegradation,
and volatilization rates, and other chemical
properties.
Provides physical-chemical data and fugacity
calculations for organic compounds.
Program for estimating Koc based on molecular
connectivity indices and structure-based
correction factors.
Series of models to estimate log Kow,
volatilization t,/2for water, soil-sediment sorption
coefficient, Hc, biodegradation, atmospheric
oxidation rates, rate of hydrolysis, rate of
removal in waste water treatment plants, and
other chemical properties.
Note: References are listed in shortened format, with complete references given in the reference list following
Chapter 10.
DATA SOURCES: Table 5-7 lists major sources of environmental fate data.
TABLE 5-7: SOURCES OF ENVIRONMENT AL FATE 3>ATA
Reference
Bedar, R.G. 1977. Biodegradability of Organic
Compounds.
Callahan, M.A., et. al. 1979. Water-related
Environmental Fate of 129 Priority Pollutants.
Darnall, K.R. 1986. "Reactivity Scale for
Atmospheric Hydrocarbons Based on Reaction
with Hydroxyl Radicals."
Farley, F. 1977. Photochemical Reactivity
Classification of Hydrocarbons and Other
Organic Compounds.
Hansch, C. and A. Leo. 1987. The Log P Data
Base.
Type of Data
Biodegradability values for various organic
compounds.
Information on environmental fate of priority
pollutants hi aqueous systems.
A classification of atmospheric chemical
reactivity and potential for smog formation based
on hydroxyl radical rate constants.
Classification for photochemical reactivity of
organic compounds.
List of Kow values.
                                            5-30

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CHAPTER 5
                                             ENVIRONMENTAL FATE SUMMARY
TABLE 5-7: SOURCES OF ENVIRONMENTAL FATE BATA
Reference
Helfgott, T.B., et al. 1977. An Index of
Refractory Organics.
Hendry D.G. and R.A. Kenley. 1979.
Atmospheric Reaction Products of Organic
Compounds.
Howard, P.H., et. al. 1991. Handbook of
Environmental Degradation Rates.
HSDB®. Hazardous Substances Data Bank
(HSDB). Updated Periodically.
Kollig, H.P. 1993. Environmental Fate
Constants for Organic Chemicals Under
Consideration for EPA's Hazardous Waste
Identification Projects.
Lyman, W.J., et. al. 1974. Survey Study to Select
a Limited Number of Hazardous Materials to
Define Amelioration Requirements.
Mabey, W. and T. Mill. 1978. "Critical Review
of Hydrolysis of Organic Compounds in Water
Under Environmental Conditions."
Mackay, D., et. al. 1992. Illustrated Handbook
of Physical-Chemical Properties and
Environmental Fate for Organic Chemicals.
Fitter, P. 1976. "Determination of Biological
Degradability of Organic Substances."
Reinbold, K.A., et. al. 1979. Adsorption of
Energy-Related Organic Pollutants: A Literature
Review.
State of California Air Resources Board. 1986.
Adoption of a System for the Classification of
Organic Compounds According to Photochemical
Reactivity.
Syracuse Research Corporation (SRC). 1994.
Environmental Fate Data Bases (EFDB©).
Type of Data
Biodegradability values for various organic
compounds.
Rate constants (KoH) for the reaction of organic
compounds with hydroxyl radical.
Provides environmental degradation t,/2 data for
chemicals in soil, air, surface water and
groundwater, and aerobic and anaerobic aqueous
biodegradation.
On-line data base including measured and
estimated chemical property and environmental
fate parameters.
Literature-derived data as well as model
computations to estimate hydrolysis, adsorption,
and oxidation-reduction parameters.
List of BOD5/COD ratios for various organic
compounds.
Data on hydrolysis rate constants of organic
compounds.
Provides physical-chemical data and fugacity
calculations for organic compounds.
List of removal efficiencies and average rate of
biodegradation for various organic compounds.
Adsorption data extracted from the literature.
Relative atmospheric reactivity scale.
Comprehensive on-line and personal computer-
based data base containing quantitative data on
environmental fate parameters.
                                  5-31

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PART H: CTSA INFORMATION MODULE
TABLE 5-7: SOURCES OF E3Nn^ON3^NTA^FATEiyATA
Reference
Trapp, S. 1993. "Modelling the Uptake of
Organic Compounds into Plants."
U.S. Environmental Protection Agency. 1974.
Proceedings of the Solvent Reactivity
Conference.
U.S. Environmental Protection Agency. 1991 a.
The Environmental Fate Constants Information
System Database (FATE).
U.S. Environmental Protection Agency. 1994d.
Treatability Database. Version 5.0.
Verschueren, K. 1983. Handbook of
Environmental Data on Organic Chemicals.
Type of Data
Describes estimating plant-soil BCFs using a
fugacity model based on the ratio of KOW:KOC, the
lipid fraction of plants, the organic carbon and
water content of the soil, and transfer and
metabolism kinetics.
Classification of chemical reactivity for
compounds associated with mobile source
emissions.
Provides data on Hc, Kow, Koc, Kd, koH, pKa, and
oxidation-reduction reactions of organic
compounds.
Personal computer-based collection of data
including Hc, Kow, treatability of organic
compounds, and other chemical properties.
Information derived from primary literature on
environmental parameters, including treatability.
 Chapter 10.
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                       HUMAN HEALTH HAZARDS SUMMARY
 OVERVIEW: Human health hazards assessment is the process of identifying the potential
 effects that a chemical may have on humans who are exposed to it, and of determining the levels
 at which these effects may occur. Exposure to a chemical may occur by inhalation, oral, or
 dermal routes through the production, use, or disposal of the chemical or products containing the
 chemical.
GOALS:

•     Compile existing information on potential health effects resulting from exposure to a
       chemical.

•     Guide the selection and use of chemicals that pose less risk to humans.

•     Assess the potential toxicity of chemicals in a use cluster to humans from available
       human data, supplementing with animal data when adequate human data are not
       available.

•     Identify the target organ(s) of toxicity by examining the potential effects resulting from
       acute (short-term) and chronic (long-term) exposure to the chemical by routes pertinent to
       human exposure.

•     Determine if there are levels of concern for the chemical (e.g., the no-observed adverse
       effect level [NOAEL] and the lowest-observed adverse effect level [LOAEL]), as well as
       references doses (RfD), carcinogen slope factors (q^), and cancer weight-of-evidence
       classifications.

•     Provide the above listed information, including the levels of concern, to the Risk
       Characterization module.
PEOPLE SKILLS:  The following lists the types of skills or knowledge that are needed to
complete this module.

•      Expertise in evaluating the adverse effects of chemicals on humans, animals, and other
       biological systems. This requires an understanding of clinical toxicology; procedures and
       results of standard toxicological test methods; pharmacokinetics, a discipline that
       includes chemical absorption, distribution, metabolism, and excretion; species differences
       among experimental animals; the cellular, biochemical, and molecular mechanisms of
       action of the chemicals; and relationships between chemical structure arid toxicity.

•      Expertise in analyzing data on adverse effects in human populations (in this case, from
       exposure to chemicals) and extracting information to identify possible causes. This
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PARTH: CTSA INFORMATION MODULES
       discipline requires knowledge of standard protocols for epidemiological studies;
       demographics; risk factors (e.g., smoking, alcohol consumption, race, sex, obesity, etc.);
       formal logic; and statistics.

•      Expertise in the collection, organization, and interpretation of numerical data; especially
       the analysis of population characteristics by inference from sampling.  This requires
       knowledge of population parameter estimation (involves a quantitative measure of some
       property of a sample), hypothesis testing (involves determining if differences in sample
       statistics [e.g., means] are of sufficient magnitude to distinguish differences between
       population parameters), and modeling.

Note:  The analysis presented in this module should not be undertaken -without the assistance of
       someone -with expertise in human health hazards assessment. Furthermore, peer-review
       of the completed hazard summary is recommended.


DEFINITION OF TERMS: Sources for the following definitions include Alderson,
UNDATED ("Epidemiological Method"); Amdur, et. al, 1991  (Casarett and Doull's
Toxicology); ATSDR, UNDATED (lexicological Profile Glossary); EPA, 1986a ("Guidelines
for Estimating Exposures"); EPA, 1986b (EPA Toxicology Handbook); EPA, 1988a ("Part II.
Proposed Guidelines for Assessing Female Reproductive Risk"); EPA, 1988b ("Part III.
Proposed Guidelines for Assessing Male Reproductive Risk");  EPA, 1991b ("Guidelines for
Developmental Toxicity Risk Assessment"); EPA, 1 994e (HEAST); EPA, 1 995d (IRIS®
glossary); Hodgson, et. al., 1988 (Dictionary of Toxicology); Huntsberger and Leaverton, 1970
(Statistical Inference in Biomedical Sciences); Lilienfeld and Lilienfeld, 1988 (Foundations of
Epidemiology); Norell, 1992 (A Short Course in Epidemiology); and Dorland, 1994 (Borland's
Illustrated Medical Dictionary).
 Acute Toxicitv: Immediate toxicity. Its former use was associated with toxic effects that were
 severe (e.g., mortality) in contrast to the term "subacute toxicity" that was associated with toxic
 effects that were less severe. The term "acute toxicity" is often confused with that of acute
 exposure.

 Association: In a formal, scientific context, a statistical relationship between a disease or adverse
 effect and biological or social characteristics.

 Carcinogenicitv: The ability of an agent to induce a cancer response.

 Chronic Toxicitv: Delayed toxicity. However, the term "chronic toxicity" also refers to effects
 that persist over a long period of time whether or not they occur immediately or are delayed. The
 term "chronic toxicity" is often confused with mat of chronic exposure.

 Confounder rConfounding Variable. Factor): A factor that is covariant with the studied exposure
 in the study base and masks the ability to distinguish the risk of developing the studied disease
 occasioned by any association between exposure and disease.

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 CHAPTERS
                                                     HUMAN HEALTH HAZARDS SUMMARY
 Developmental Toxicity:  Adverse effects produced prior to conception, during pregnancy, and
 during childhood. Exposure to agents affecting development can result in any one or more of the
 following manifestations of developmental toxicity: death, structural abnormality, growth
 alteration, and/or functional deficit. These manifestations encompass a wide array of adverse
 developmental end points, such as spontaneous abortion, stillbirths, malformations, early
 postnatal mortality, reduced birth weight, mental retardation, sensory loss and other adverse
 functional or physical changes that are manifested postnatally.

 Dose-Response: The relationship between the amount of an agent (either administered,
 absorbed, or believed to be effective) and changes in certain aspects of the biological system
 (usually adverse effects), apparently in response to that agent.

 Exposure Level: In general, a measure of the magnitude of exposure, or the amount of an agent
 available at the exchange boundaries (i.e., lungs, gastrointestinal tract, or skin), during some
 specified time. In the Exposure Assessment and Risk Characterization modules, "exposure
 level" is used specifically as a measure of exposure expressed as a concentration rather than as a
 potential dose rate.                                                      ,           ;     ;,

 Extrapolation:  An estimation of a numerical value of an empirical (measured) function at a point
 outside the range of data which were used to calibrate the function. For example, the quantitative
 risk estimates for carcinogens (according to EPA guidelines at the time of this writing) are
 generally low-dose extrapolations based on observations made at higher doses. Another example
 is extrapolation of health effects from occupational to general exposure levels.             .

 Human Equivalent Concentration (HEC):  The human exposure concentration of an agent that is
 believed to induce the same magnitude of toxic effect as that which a known animal or       .
 occupational exposure concentration has induced.  For HEC, the exposure concentration has been
 adjusted for dosimetric differences between experimental animal species and humans.  If
 occupational human exposures are used for extrapolation, the human equivalent concentration
 represents the equivalent human exposure concentration adjusted to a continuous basis.

 International Agency for Research on Cancer CIARO Classification:  A method for evaluating
 the strength of evidence supporting a potential human carcinogenicity judgment based on human
 data, animal data, and other supporting data. A summary of the IARC carcinogenicity
 classification system includes:
 •     Group 1: Carcinogenic to humans.
 •     Group 2A: Probably carcinogenic to humans.
 •     Group 2B: Possibly carcinogenic to humans.
 •     Group 3: Not classifiable as to human carcinogenicity.                         .
 •     Group 4: Probably not carcinogenic to humans.

Irritation: An inflammatory response, usually of skin, eye, or respiratory tract, induced by direct
action of an agent.
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EARTH: CTSA INFORMATION MODULES
T.r..0 (T.ftthal Concentration): The concentration of a chemical in air that causes death in 50
percent of the test organisms at the end of the specified exposure period. LC50 values typically
represent acute exposure periods, usually 48 or 96 hours. Typical units are mg/m3 or ppm.

T.D;o rLethal Dose): The dose of a chemical taken by mouth, absorbed by the skin, or injected
that is estimated to cause death in 50 percent of the test animals.

lowest-Observed Adverse Pffert Level fLOAEO: The lowest dose level in a toxicity test at
which there are statistically or biologically significant increases in frequency or severity of
adverse effects hi the exposed population over its appropriate control group.

Modifying Factor (MF>: An uncertainty factor that is greater than zero and less than or equal to
 10; the magnitude of the MF depends upon the professional assessment of scientific uncertainties
 of the study and data base not explicitly treated with the standard uncertainty factors (e.g., the
 completeness of the overall data base and the number of species tested); the default MF is 1.

 Mutaeen:  An agent that produces a permanent genetic change in a cell (other than changes that
 occur during normal genetic recombination).

 Neurotoxicitv: Any toxic effect on any aspect of the central or peripheral nervous system.  Such
 changes can be expressed as functional changes (such as behavioral or neurological
 abnormalities) or as neurochemical, biochemical, physiological or morphological perturbations.

 Nn-Observed Adverse Effect Level (NOAEU: The highest dose level in a toxicity test at which
 there are no statistically or biologically significant increases in the frequency or severity of
 adverse effects in the exposed population over its appropriate control; some effects may be
 produced at this level, but they are not considered adverse, nor precursors to adverse effects.

 Odds Ratio COR):  A technique for estimating the relative risk  (see below) from case-control
 (retrospective) studies. This refers to the odds, among diseased individuals, of being exposed as
 compared to non-diseased individuals.

 Pharmacokinetics: The dynamic behavior of chemicals within biological systems.
 Pharmacokinetic processes include uptake, distribution, metabolism, and excretion of chemicals.

 Proportionate M™ta1ii^ Ratio (PMIO: The number of deaths from a specific cause and  in a
 specific period of time per 100 deaths hi the same tune period.

 a,!: See Slope Factor.

 Reference Concentration OlfO: An estimate (with uncertainty spanning perhaps an order of
  magnitude) of the daily inhalation exposure to the human population (including sensitive
  subgroups) that is likely to be without an appreciable risk of deleterious noncancer effects during
  a lifetime. RfCs are generally reported as a concentration hi air (mg/m3).
                                            5-36

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 CHAPTERS
                                                     HUMAN HEALTH HAZARDS SUMMARY
 Reference Dose (RfD): An estimate (with uncertainty spanning perhaps an order of magnitude)
 of the daily oral exposure to the human population (including sensitive subgroups) that is likely
 to be without an appreciable risk of deleterious noncancer effects during a lifetime. RfDs are
 reported as mg/kg-day.

 Reportable Quantity (RQ):  The quantity of a hazardous substance that is considered reportable
 under the Comprehensive Environmental Response, Compensation, and Liability Act
 (CERCLA).  Reportable quantities are: (1) one pound; or (2) for selected substances, an amount
 established by regulation either under CERCLA or under Section 311 of the Clean Water Act.
 Quantities are measured over a 24-hour period.

 Reproductive Toxicity: The occurrence of effects on the male or female reproductive system that
 may result from exposure to environmental agents. The manifestations of such toxicity may
 include alteration in sexual behavior, fertility, pregnancy outcomes, or modifications in other
 functions that are dependent on the integrity of the reproductive system.

 Risk:  In general, risk pertains to the probability and severity of adverse effects (e.g., injury,
 disease, or death) under specific circumstances. In the context of a CTSA, risk is an'expression
 of the likelihood of adverse health or environmental effects from a specific level of exposure;
 only cancer risk is estimated as a probability.

 Risk Assessment:  The determination of the kind and degree of hazard posed by an agent, the
 extent to which a particular group of people has been or may be exposed to the agent, and the
 present or potential health risk that exists due to the agent.

 Risk Characterization: The integration of hazard and exposure information to  quantitatively or
 qualitatively assess risk.  Risk characterization  typically includes a description of the
 assumptions, scientific judgments, and uncertainties that are part of this process.

 Slope Factor (q^:  A measure of an individual's excess risk or increased likelihood of
 developing cancer if exposed to a chemical.  It is determined from the upperbound of the  slope of
 the dose-response curve in the low-dose region of the curve. More specifically, qi* is an
 approximation of the upper bound of the slope when using the linearized multistage procedure at
 low doses. The units of the slope factor are usually expressed as l/(mg/kg-day) or (mg/kg-day)'1.

 Standardized Mortality Ratio fSMRV The ratio of observed events to events expected if the age-
 and sex-specific mortality rates of a standard population (usually the general population) are
 applied to the population under study.

 Structure Activity Relationship fSARV The relationship of the molecular structure and/or
functional groups of a chemical with specific effects.  SARs evaluate the molecular structure of a
chemical and make qualitative or quantitative correlations of particular molecular structures
and/or functional groups with specific effects.
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Subchronic Exposure: Multiple or continuous exposures occurring usually over 3 months.  This
applies to animal, not human, exposure.

Subchronic Toxicitv: Effects from subchronic exposure. This also applies to animal, not human
exposure.

Uncertainty Factor CUF\.  One of several, generally 10-fold factors, used in operationally
deriving the RfD or RfC from experimental data. UFs are intended to account for: (1) the
variation in sensitivity among the members of the human population; (2) the uncertainty in
extrapolating animal data to the case of humans; (3) the uncertainty in extrapolating from data
obtained in a study that is of less-than-lifetime exposure; and (4) the uncertainty in using LQAEL
data rather than NOAEL data.

Unit Risk:  The upper-bound excess lifetime cancer risk estimated to result from continuous
exposure to an agent at a concentration of 1 \ig/L in water or 1 u.g/m3 in air (with units of risk per
u.g/m3 air or risk per |ig/L water).

Upper Bound: An estimate of the plausible upper limit to the true value of the quantity. This is
usually not a statistical confidence limit unless identified as such explicitly, together with a
confidence level.

Weight-of-Evidence Classification CEPAV.  In assessing the carcinogenic potential of a chemical,
EPA classifies the chemical into one of the following groups, according to the weight-of-
evidence from epidemiologic and animal studies:
 •      Group A: Human Carcinogen (sufficient evidence of carcinogenicity in humans).
 •      Group B: Probable Human Carcinogen (B1 - limited evidence of carcinogenicity in
        humans; B2 - sufficient evidence of carcinogenicity in animals with inadequate or lack of
        evidence in humans).
 •      Group C: Possible Human Carcinogen (limited evidence of carcinogenicity in animals
        and inadequate or lack  of human data).
 •      Group D: Not Classifiable as to Human Carcinogenicity (inadequate or no evidence).
 •      Group E: Evidence of Noncarcinogenicity for Humans (no evidence of carcinogenicity  hi
        adequate studies).

 (The "Proposed Guidelines for Carcinogen Risk Assessment" [EPA, 1996b] propose use of
 weight-of-evidence descriptors, such as "Likely" or "Known," "Cannot be determined," and "Not
 likely," in combination with a hazard narrative, to characterize a chemical's human carcinogenic
 potential - rather than the classification system described above.)


 ADDITIONAL TERMS: The following additional terms are not used in this module
 discussion per se, but are likely to be found in the literature pertaining to human health hazard
 and toxicity studies.
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CHAPTERS
HUMAN HEALTH HAZARDS SUMMARY
Acute Exposure: Exposure occurring over a short period of time.  (The specific time period
varies depending on the test method and test organism or the receptor of interest.)

Case-Control Study:  An epidemiological study in which comparisons are made between a group
of persons who have a disease (cases) and a group who do not (controls) regarding possible
exposures prior to study.

Case Report: An anecdotal description of the occurrence of a disease or adverse effect in an
individual or group of individuals.

Case Study: A detailed analysis of an individual or group.

Chronic Exposure: Continuous or intermittent exposure occurring over an extended period of
time, or a significant fraction of the animal's or the individual's lifetime.

Cohort Study: Epidemiological study comparing the morbidity and/or mortality of a group or
groups of people (called exposed) who have had a common insult (e.g., exposure to a chemical
suspected of causing disease) with a group believed to be unexposed or with the general
population.

Correlation: The degree to which two or more phenomena occur together or vary in similar
directions.

Cross-Sectional Study: An epidemiological study in which comparisons are made between a
group of persons who are found to have an exposure and a group who does not (unexposed).  The
characteristics under comparison are present in both exposed and unexposed groups at the time
of the study and exposure status is often determined after individuals are selected for study. Also
called a "prevalence" study.

EPA Health Advisory: An estimate of acceptable drinking water levels for a chemical, based on
health effects information.  A health advisory is not a legally enforceable federal standard, but
serves as technical guidance to assist federal, state, and local officials.

Human Equivalent Concentration (HEC):  See definition for Human Equivalent Dose.

Human Equivalent Dose (HEP): The human dose of an agent that is believed to induce the same
magnitude of toxic effect as that which  a known animal or occupational dose has induced. For
HEC, the dose has been adjusted for dosimetric differences between experimental animal species
and humans.  If occupational human exposures are used for extrapolation, the HED represents
the equivalent human exposure concentration adjusted to a continuous basis.

Irreversible Effect: Effect characterized by the inability of the body to partially or fully repair
injury caused by a toxic agent.
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PARTH: CTSA INFORMATION MODULES
Latency Period:  The time between the initial induction of a health effect and the manifestation
(or detection) of the health effect; crudely estimated as the time (or some fraction of the time)
from first exposure to detection of the effect.

Potentiation: The ability of one chemical to increase the effect of another.

Prevalence Study:  An epidemiological study that examines the relationship between exposure
and diseases as they exist at a given period in time.  (See also Cross-Sectional Study.)

Prospective Study: A study using a population sample based on exposure status, where exposure
may be related to the development of the disease under investigation. The individuals are then
followed for several years to see which ones develop and/or die from the disease. Also described
by the terms "cohort," "incidence," and "longitudinal." When based on exposure status
determined from some time in the past, this may be called "historical prospective."

Relative Risk: The likelihood that an exposed individual will have a disease expressed as a
multiple of the likelihood among unexposed (with disease incidence expressed as incidence rate
or cumulative incidence).

Retrospective Study:  Epidemiological study in which comparisons are made between a group of
persons who have a disease (cases) and a group who do not (controls). An attempt is made to
determine whether the characteristics (e.g., exposure to a chemical) were present in the past.
Also described as "case control," or "case history" studies.

Reversible Effect:  An effect that is not permanent, particularly an adverse effect that diminishes
when exposure to a toxic chemical ceases.

Spurious Association: A statistical association that represents a statistical artifact or bias.  It may
arise from biased methods of selecting cases and controls, recording observations or by obtaining
information by interview, and cannot be identified with certainty.

Statistical Tests of Significance: Methods for determining on a probabilistic basis if differences
hi groups under treatment (or observation) could have resulted by chance, or if they represent
"rare" events.  Also called "statistical tests of hypotheses." The question of random occurrence
may be put in the form of a hypothesis to  be tested, called the "null hypothesis."

Subacute Exposure:  A term, no longer commonly used, that denotes exposures that are longer
than acute and shorter than subchronic.

Subacute Toxicity:  Effects from subacute exposure.

Subclinical Toxicity: An observable effect which may or may not have any clinical significance
(i.e., not biologically significant). With humans it may also mean that the individual's illness is
undetected.
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HUMAN HEALTH HAZARDS SUMMARY
Toxicity Assessment:  Characterization of the toxicological properties and effects of a chemical,
including all aspects of its absorption, metabolism, excretion and mechanism of action, with
special emphasis on the identification of a dose-response relationship.

Transient Effect: An effect that disappears over time (irrespective of whether or not exposure
continues).
APPROACH/METHODOLOGY: The following presents a summary of the technical
approach or methodology for preparing a summary human health hazards profile for a CTSA.
Further details for Steps 4 through 8 are presented in the next section of this module.

Step 1:        Obtain the CAS RN, synonyms, and information on the chemical structure from
              the Chemical Properties module.

Step 2:        Review the Environmental Fate Summary module to determine if the chemical
              persists long enough in any environmental medium to be a potential health hazard
              and if any chemical degradation products need to be considered.

Step 3:        Review  preliminary exposure pathways from the Exposure  Assessment module,
              if available. The main routes to consider are oral, inhalation, and dermal.

Step 4:        Obtain peer-reviewed literature, beginning with secondary sources (e.g., EPA's
              Integrated Risk Information System [IRIS], EPA review documents, Agency for
              Toxic Substance and Disease Registry [ATSDR] Profiles, and the Hazardous
              Substances Data Bank [HSDB]). Resort to primary sources (e.g., journal articles)
              only when secondary sources are lacking or when more recent information is
              available in the primary literature that adds new information to the data base for
              that chemical.

              This should include a review of the pharmacokinetics of the chemical and an
              evaluation of the following toxicological endpoints for both humans and animals:
                    Acute toxicity.
                    Irritation/sensitization.
                    Neurotoxicity.
                    Subchronic/chronic toxicity (includes systems such as renal, hepatic,
                    hematopoietic, etc.).
                    Developmental/reproductive toxicity.
                    Genotoxicity.
                    Carcinogenicity.

Step 5:        Review the acquired literature and critically evaluate the quality of studies (e.g.,
              use of controls, appropriate numbers of animals, selection of appropriate human
              study groups, statistical analysis of the data).
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Step 6:        Construct a health hazards profile for each chemical using the most recent data
              available. Measured data should take precedence over modeled data. Toxicity
              summaries should include NOAELs, LOAELs, and RfDs or RfCs for chemicals
              not causing cancer; and q,*, unit risk values, and weight-of-evidence
              classifications for carcinogens.  Secondary sources that may contain these types of
              data are listed in Table 5-11: Sources of Human Health Hazard Data.

              Note: Data requirements for toxicity summaries may change as EPA guidance is
              updated,  e.g., changes in the proposed carcinogen risk assessment guidelines
              (EPA, 1996b).

              Present the data clearly and accurately, using consistent units so that comparisons
              may be easily made. Use the original dose units as well as converted units where
              possible. Note any assumptions made in dose conversions. Explicitly identify
              any data that are not peer-reviewed.

Step 7:        If some chemicals do not have the values listed in Step 6 and if the necessary data
              are available, RfDs, carcinogenicity slope factors, and unit risk values or other
              measures may be calculated. See Details: Step 7 (below), and Table 5-10:
              Published Guidance on Health Hazards Assessment.

Step 8:        In a tabular format, list the toxicity values and classifications that are described in
              Step 6 (see Details: Step 8, below) and provide to the Risk Characterization
              module.
METHODOLOGY DETAILS:  This section presents methodology details for completing
Steps 4 through 8. If necessary, additional information on these and other steps can be found in
the previously published guidance (see Table 5-10: Published Guidance on Health Hazards
Assessment).

Details: Step 4, Obtaining Literature Information

In vitro studies are useful for mutagenicity assays and for determining structure-activity
relationships and mechanisms of toxicity. Note that because of the importance of the various
manifestations of neurotoxicity, EPA places these effects in a separate section, rather than under
acute or chronic/subchronic toxicity, which could also be appropriate.

Toxicity values that are important for risk characterization include, but are not limited to, the
following:
 •      LD50 values for mammalian species.
 •      Concentrations of the chemical that cause irritation to the eyes, nose, or respiratory
        passages.
 •      Concentrations or doses that result in acute neurotoxicity; NOAEL and/or LOAEL for
        subchronic/chronic neurotoxicity.

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HUMAN HEALTH HAZARDS SUMMARY
•      NOAEL and/or LOAEL for subchronic/chronic non-carcinogenic systemic effects.  If an
       RfD is available, inclusion of the experimental details of the key study used to derive that
       value is required.
•      NOAEL or LOAEL for developmental/reproductive toxicity. Note that RfDs may be
       based on developmental or reproductive effects.
•      Epidemiological or animal bioassay data for carcinogenicity. This would include qj* and
       unit risk values, if available. The EPA, National Toxicology Program, and IARC classify
       chemicals as to their carcinogenicity. These classifications should be included when
       available.  (Note that epidemiological data may be available for other adverse effects such
       as developmental or reproductive effects.)
•      Regulatory standards and guidelines (e.g., RfDs and RfCs; Occupational Safety and
       Health Administration [OSHA], American Conference of Governmental Industrial
       Hygienists, Inc. [ACGIH], and National Institute for Occupational Safety and Health
       [NIOSH] exposure limits; drinking water standards; and drinking water health
       advisories).

Details:  Step 5, Evaluating Data Quality

Statistics are used to evaluate the magnitude of response in a study and to determine if an effect
is the result of exposure to a chemical. If statistics have not been performed on a particular
study, and if there are data for more than one dose, one possible protocol would be to first test for
a trend. If there is no trend, then determine if any dose group shows an increase or decrease
relative to controls.  If data are quantal proportions, some form of categorical analysis is
appropriate.

Commonly used statistical tests include analysis of variance and Bartlett's tests for homogeneity
(for endpoints such as organ and body weights, hematology, and biochemistry); Dunnett's
multiple comparison tables (for significance of differences); and life table test, incidental tumor  .
test, Fisher's exact test, and Cochran-Armitage trend test (for analysis of tumor incidence data).
Statistical methods are described in references listed in Table 5-10.  A statistician and a health
hazard assessment expert should be consulted for information regarding when and how these
tests are used and whether they are appropriate for the data in hand. It is generally not necessary
to perform statistics on data from HSDB, NIOSH, ATSDR, IRIS or other references listed under
Sources of Human Health Hazards Data in Table 5-11.

Details:  Step 6, Constructing the Health Hazards Profile

The level of detail presented in the health hazards profile may vary. For example, key studies
(such as those used in the derivation of toxicity values such as chronic RfDs, RQs, or
carcinogenicity slope factors) require more detailed reporting than supporting studies. A
detailed, but concise, description would include experimental details and incidence data for
effects, relating exposure and effect.  Supporting studies may be described with fewer details
and, where appropriate, as ranges of values. Adequate citations should be provided for both key
and supporting studies. When epidemiological data are available, epidemiological summaries
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PARTH: CTSA INFORMATION MODULES
should include population observed, comparison population, SMRs, PMRs, or ORs and
confounding factors.

The health hazards profile for discrete organic chemicals can be constructed using concentrations
or doses derived from experimental studies or can be estimated from structure activity
relationships (SARs; see next paragraph). The toxicity of inorganic chemicals typically cannot
be accurately estimated using SARs.  The hazard profile for inorganic chemicals should therefore
be constructed using effective concentrations based on measured toxicity test data.  If no data are
available, actual data from the nearest structural analog can be used.  Chemical mixtures such as
petroleum products (i.e., mineral spirits or solvent naphtha) may be evaluated from information
on the mixture, information from a "sufficiently similar" mixture, or information on the
individual components of the mixture. Constructing a Health Hazard Profile for chemical
mixtures is a complex process and the EPA "Guidelines for the Health Risk Assessment of
Chemical Mixtures" should be consulted (see published guidance listed in Table 5-10).

When measured data are not  available, evaluate data from studies on structurally-related
compounds. The use, application, development, and validation of SARs have been discussed in
a number of publications (see Federal Register citations in Table 5-10).  The use and
interpretation of SARs require expertise and caution.  Computer models that calculate toxicity
values based on SARs are available (see Table 5-9: Computer Programs Used in Human Health
Hazards Assessment). Briefly, the EPA approach to SARs involves the evaluation and
interpretation of available and pertinent data on the chemical under study or its potential
metabolites; evaluation of test data on analogous substances and potential metabolites; and the
use of mathematical expressions for biological activity or quantitative structure activity
relationships (QSARs).

Details:  Step 7, Deriving Health Hazard Values

Reference Dose/Reference Concentration fRfD/RfC)

RfDs and RfCs are derived following a thorough examination of the toxicologic and
epidemiologic literature for the subject chemical and selection of the studies that are judged to be
appropriate for risk assessment.  The LOAEL or NOAEL (chronic, subchronic, developmental,
or reproductive toxicity) is divided by uncertainty factors and a modifying factor to derive the
RED. If a study has more than one NOAEL, the highest is selected. If there is no NOAEL the
RfD may be derived from a LOAEL by applying an uncertainty factor of up to 10.  The lowest of
the LOAELs for systemic, developmental, or reproductive toxicity is chosen.

The RfD is calculated as follows:

       RfD  =  NOAEL fmg/kg-day)
                     UFs x MF
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CHAPTERS
HUMAN HEALTH HAZARDS SUMMARY
where:
       NOAEL      = No-observed adverse effect level
       UFs          '= Uncertainty factors
       MF          = Modifying factor (see Definition of Terms)

Ufs account for the following:
•      The variation in sensitivity among the members of the human population (a factor of 10).
•      The extrapolation of animal data to humans (a factor of 1 0).
•      Extrapolation from less than lifetime exposure (a factor of 10).
•      The use of LOAEL, rather than NOAEL, data (a factor of 1 0).
•      Extrapolation from experimental data that do not fully consider all possible adverse
       effects (a factor of from 1 to 10).

The methodology for the inhalation RfC includes dosimetric adjustments to account for the
species-specific relationships of exposure concentrations to deposited/delivered doses. This
requires knowledge of the anatomy and physiology of the lungs and airways to accurately
estimate the amount of the inhaled chemical that would reach the tissue where the effects occur.
The RfC is calculated similarly to RfD, as follows:
       RfC = NOAEL
                   UFs x MF
where:
       NOAEL [HEC] = the NOAEL or equivalent effect level dosimetrically adjusted to a
                     human equivalent concentration (HEC)

Slope Factor

The slope factor is a measure of the incremental risk or increased likelihood of an individual
developing cancer if exposed to a unit dose of the chemical for a lifetime.  The risk is expressed
as a probability (i.e., one chance in ten or one chance in one million), and the unit dose is
normally expressed as 1 mg of the chemical per unit body weight (kg) per day:

       Slope Factor = Risk per unit dose, or Risk per mg/kg-day

When based on animal data, the slope factor is derived by extrapolating from the incidences of
tumors occurring in animals receiving high doses of the chemical to low exposure levels
expected for human contact in the environment. The EPA uses qj* for its risk assessments (see
definition of slope factor).  The qj* for a chemical, in units of (mg/kg-day)"1, is based on the
linearized multistage procedure for carcinogenesis and can be calculated by computer program
(e.g., GLOBAL).

Slope factor or q^ values are used in the Risk Characterization module to estimate cancer risk
(in the range where it is expected to be linearly related to exposure).  It should be noted that the
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PARTH: CTSA INFORMATION MODULES
proposed carcinogen risk assessment guidelines (EPA, 1996b), if adopted, may require
modifications to this approach.

Unit Risk

The slope factor, or q^, can also be used to determine the incremental cancer risk that would
occur if the chemical was present in an environmental medium such as drinking water at a unit
concentration (i.e., 1 (j.g of chemical per liter of drinking water).  The calculation for drinking
water usually assumes the person weighs 70 kg and drinks 2 liters of water per day:
                                                            1-3
       Drinking Water Unit Risk = qt* x 1/70 kg x 2 L/day x 10

Air unit risk (risk per ug/m3) is derived from the linearized multistage procedure and calculated
using the GLOBAL program.

Details:  Step 8, Tabulating Toxicity Values

Table 5-8 is an example format for tabulating toxicity values.
TABLE 5-8: SUMMARY TABLE FOR TOXICITY OF CHEMICALS
AND POTENTIAL SUBSTITUTES
Chemical
LDjo/LCjo
Irritation (yes or no)
1. eye
2. skin
3. respiratory
Sensitization (yes or no)
Neurotoxicity (yes or no)
Developmental Toxicity (yes or no)
NOAEL/LOAEL* (target organ or effect)
RfD/RfC
EPA WOE"
Oral Slope Factor (mg/kg-day)'1
Unit Risk
1. air (risk per ug/m3)
2. water (risk per ug/L)
Exposure Limits
1. ACGffl
2. OSHA
3. NIOSH
#1

1.
2.
3.







1.
2.
1.
2.
3.
#2

1.
2.
3.







1.
2.
1.
2.
3.
#3

1.
2.
3.







1.
2.
1.
2.
3.
#4

1.
2.
3.







1.
2.
1.
2.
3.
#5

1.
2.
3.







1.
2.
1.
2.
3.
#6

1.
2.
3.







1.
2.
1.
2.
3.
#7

1.
2.
3.







1.
2.
1.
2.
3.
#8

1.
2.
3.







1.
2.
1.
2.
3.
#9

1.
2.
3.







1.
2.
1.
2.
3.
#10

1.
.2.
3.







1.
2.
1.
2.
3.
a) If more than one NOAEL select the highest; if no NOAEL, but more than one LOAEL, select the lowest.
Include NOAEL/LOAELs for neurotoxicity and developmental toxicity, if available.
b) WOE = weight-of-evidence classification for carcinogenicity.
                                           5-46

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CHAPTERS
  HUMAN HEALTH HAZARDS SUMMARY
FLOW OF INFORMATION: This module receives information from the Chemical
Properties, Environmental Fate Summary, and Exposure Assessment modules, and transfers
information to the Risk Characterization module.  Example information flows are shown in
Figure 5-5.  This module can also be used alone to guide the selection and use of chemicals that
are less toxic to humans.
         FIGURE 5-5: HUMAN HEALTH HAZARDS SUMMARY MODULE:
                        EXAMPLE INFORMATION FLOWS
    Summary  I • Hydrotysis
                                   Exposure
                                                           ^—»
 and pathways
                                    • Preliminary  *E8fanate»of<|ose
                                     ,expfc««a
                                     pathways
                                                concentrations
                                 Human Health
                                    Hazards
                                   Summary
                                 Environmental
                                    Hazards
                                   Summary
• EndpoWstrf
 con<»m
                                              ,» Unit risk
                                                                               5 -, '•
                                                                      T * J /
                          Risk
                      Characterization

ANALYTICAL MODELS: Table 5-9 presents references of computer programs that can be
used when estimating toxicity reference values.
TABLE 5-9: COMPUTER PROGRAMS USED IN HUMAN HEALTH
"HAZARDS ASSESSMENT
Reference
GLOBAL92
ICF Kaiser International, Inc.
Type of Model
A program which uses quantal cancer dose-
response animal bioassay data to predict the
probability of a specific health effect by fitting a
specific form of mathematical model to the data
provided.
                                        5-47

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PARTH:  CTSA INFORMATION MODULES
TABLE 5-9: COMPUTER PROGRAMS USED IN BtJMAN HEALTH
HAZARDS ASSESSMENT < „ ' **>&#,
	 - ' 'v ,»(,»•««, ,* ^v •• " , i vrTfWSBBfi*
Reference
QSAR: A Structure- Activity Based Chemical
Modeling and Information System. 1986.
RISKS 1
Contact Daniel Krewski
Health and Welfare Canada
TOXRISK
Crump, K., et. al. 1995.
Type of Model
Modified structure-activity correlations are used
to estimate chemical properties, behavior, and
toxicity. Developed by U.S. EPA,
Environmental Research Laboratory, Duluth,
MN, Montana State University Center for Data
Systems and Analysis, and Pomona College
Medicinal Chemistry Project.
For low-dose extrapolation of quantal response
toxicity data.
Software package for performing standard types
of health risk assessments. Provides some
quantal and time-to-tumor models.
Note: References are listed in shortened format, with complete references given in the reference list following
Chapter 10.
PUBLISHED GUIDANCE: Table 5-10 presents references for published guidance on health
hazard assessment.
TABLE 5-10: PUBLISHED GUIDANCE 
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CHAPTERS
                                        HUMAN HEALTH HAZARDS SUMMARY
TABLE 5-10: PUBLISHED GUIDANCE ON HEALTH HAZARDS ASSESSMENT
Reference
Gad, S;D. and C.S. Weil, Eds. 1986. Statistics
and Experimental Design for Toxicologists.
Gart, J.J., et. al. 1986. Statistical Methods in
Cancer Research. Vol. Ill: The Analysis of Long-
term Animal Experiments.
O'Bryan, T.R. and R.H. Ross. 1988. "Chemical
Scoring System for Hazard and Exposure
Identification."
Snedecor, G.W. and W.G. Cochran. 1980.
Statistical Methods.
U.S. Environmental Protection Agency. 1984a.
Methodology and Guidelines for Ranking
Chemicals Based on Chronic Toxicity Data.
U.S. Environmental Protection Agency. 1985.
Toxic Substances Control Act Test Guidelines:
Final Rules.
U.S. Environmental Protection Agency. 1986c.
"Guidelines for Carcinogen Risk Assessment."
U.S. Environmental Protection Agency. 1986d.
"Guidelines for Mutagenicity Risk Assessment."
U.S. Environmental Protection Agency. 1986e.
"Guidelines for the Health Risk Assessment of
Chemical Mixtures."
U.S. Environmental Protection Agency. 1988a.
"Part II. Proposed Guidelines for Assessing
Female Reproductive Risk and Request for
Comments."
U.S. Environmental Protection Agency. 1988b.
"Part III. Proposed Guidelines for Assessing
Male Reproductive Risk and Request for
Comments."
Type of Guidance
Methods for statistical analysis.
Methods for the statistical analysis of chronic
animal studies.
Ranking system for 1 1 parameters, including
acute and chronic toxicity.
General statistical methods.
Describes derivation of reportable quantity (RQ);
incorporates a 10-point severity ranking system
for the chronic toxicity of chemicals that can be
used in risk characterization.
Describes guidelines for performing tests of
chemical fate and environmental and health
effects.
Describes procedure for the performance of risk
assessment on potential chemical carcinogens.
(Soon to be revised.)
Describes procedure for the performance of risk
assessment on potential chemical mutagens.
Describes procedure for the performance of risk
assessment on mixtures of chemicals.
Proposed guidelines for the evaluation of
potential toxicity of environmental agents to the
human female reproductive system. Provides
discussion of female reproductive organs and
their functions, endpoints of toxicity in animal
assays, human studies, and risk assessment.
Proposed guidelines for the evaluation of
potential toxicity of environmental agents to the
human male reproductive system. Provides
discussion of male reproductive organs and their
functions, endpoints of toxicity in animal assays,
human studies, and risk assessment.
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 PART H: CTSA INFORMATION MODULES
        TABLE 5-10t PUBLISHED GUIDANCE ON HEALTH HAZARDS ASSESSMENT
                   Reference
              Type of Guidance
  U.S. Environmental Protection Agency.  1989a.
  Risk Assessment Guidance for Superfund.
  Volume I. Human Health Evaluation Manual
  (Part A).
Guidance for developing human health risk
assessments at Superfund sites.
 U.S. Environmental Protection Agency.  1991b.
 "Guidelines for Developmental Toxicity Risk
 Assessment."
Discusses basics of developmental toxicity and
EPA's risk assessment process for developmental
toxins.
 U.S. Environmental Protection Agency. 1991c.
 General Quantitative Risk Assessment Guidelines
 for Noncancer Health Effects.
Discusses various aspects of risk assessment
(hazard identification, dose-response assessment,
risk characterization). A draft document to be
used as guidance; not necessarily Agency policy
at present.
 U.S. Environmental Protection Agency. 1992a.
 "Guidelines for Exposure Assessment."
Provides a general approach and framework for
carrying out human or nonhuman exposure
assessments for specified pollutants. To be used
for risk assessment in conjunction with
toxicity/effects assessment.
 U.S. Environmental Protection Agency. 1993b.
 "Draft Report: Principles of Neurotoxicity Risk
 Assessment."
Discusses basics of neurotoxicity and EPA's risk
assessment process for neurotoxins. A draft
document to be used as guidance; not necessarily
Agency policy at present.
 U.S. Environmental Protection Agency. 1994f.
 Methods for Derivation of Inhalation Reference
 Concentrations and Application of Inhalation
 Dosimetry.
Describes procedure for the derivation of an
inhalation reference dose.
Note: References are listed in shortened format, with complete references given in the reference list following
Chapter 10.
DATA SOURCES: Table 5-11 lists sources of health hazard data that should be readily
available to most hazard assessors.
TABLE 5-11 : SOURCES OF HUMAN HEALTH HAZARDS DATA
i *Si
Reference
Clayton, G.D. and F.E. Clayton. 1994. Patty's
Industrial Hygiene and Toxicology.
Documentation of the Threshold Limit Values and
Biological Exposure Indices. UNDATED.
Type of Data
Toxicology and properties of selected industrial
chemicals and classes of chemicals.
Review of toxicity arid rationale for selection of
ACGIH exposure levels.
                                            5-50

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CHAPTERS
HUMAN HEALTH HAZARDS SUMMARY

TABLE 5-11: SOURCES OF HUMAN HEALTH HAZARDS DATA
Reference
HSDB®. Hazardous Substances Data Bank
(HSDB). Updated Periodically.
International Agency for Research on Cancer
(IARC). 1979. IARC Monographs on the
Evaluation of Carcinogenic Risk of Chemicals to
Man.
International Agency for Research on Cancer
(IARC). 1987. IARC Monographs on the
Evaluation of Carcinogenic Risk of Chemicals to
Man. Overall Evaluations ofCarcinogenicity.
International Programme on Chemical Safety
(IPCS). UNDATED. Environmental Health
Criteria Documents.
National Institute for Occupational Safety and
Health (NIOSH). UNDATEDa. Health Effects
Documents.
National Institute for Occupational Safety and
Health (NIOSH). 1992. NIOSH
Recommendations for Occupational Safety and
Health. Compendium of Policy Documents and
Statements.
National Toxicology Program (NTP).
UNDATED. NTP Toxicology and
Carcinogenesis Studies.
U.S. Air Force. 1989. The Installation
Restoration Toxicology Guide, Vols. 1-5.
U.S. Department of Health and Human Services.
UNDATEDa. Toxicological Profiles.
U.S. Department of Labor, Occupational Safety
and Health Administration. 1989a.
"Table Z-2. Limits for Air Contaminants."
Type of Data
An on-line data base that contains information on
a chemical's properties, human and
environmental toxicity, environmental fate,
regulations, and treatments.
Reviews the carcinogenicity of chemicals.
Provides IARC classification.
Summary of IARC Monographs, Volumes 1 to
42. Contains rationale for IARC weight-of-
evidence classifications.
A series of chemical profiles that include
information on exposure and toxicity.
Literature review of occupational exposure data,
health effects data, and animal studies. Rationale
for the derivation of NIOSH exposure levels.
NIOSH occupational exposure limits.
Reports results of NTP bioassays for
carcinogenicity and chronic toxicity. Provides
NTP classification.
Toxicological profiles of hazardous chemicals
found at U.S. Air Force sites. In addition to
health effects, these documents review
properties, regulations, and exposure.
Toxicological profiles of hazardous chemicals
most often found at facilities on CERCLA's
National Priority List. In addition to health
effects and risk levels, these documents review
properties, regulations, and exposure.
OSHA occupational exposure limits.
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* Hun BIIWS., tmi |],l'l> ii T1"1" ' "fSB^ :
TABLE 5-llt SOURCES OF HUMAN HEALTH HAZARDS DATA
Reference
U.S. Environmental Protection Agency.
UNDATEDa. Drinking Water Regulations and
Health Advisories.
U.S. Environmental Protection Agency.
UNDATEDb. Health Assessment Documents
(HAD).
U.S. Environmental Protection Agency.
UNDATEDc. Integrated Risk Information
System (IRIS*).
U.S. Environmental Protection Agency. 1991d.
Table 302.4. List of Hazardous Substances and
Reportable Quantities.
Type of Data
Maximum Contaminant Levels for drinking
water (MCLs), Maximum Contaminant Level
Goal (MCLGs), drinking water health advisories,
and ambient water quality criteria for the
protection of human health. MCLs are
promulgated pursuant to the Safe Drinking Water
Act. MCLG is a non-enforceable concentration
of a drinking water contaminant that is protective
of adverse human health effects and allows an
adequate margin of safety.
Reviews of health effects of specific chemicals.
Agency position on selected substances,
including reviews of selected studies used in the
derivation of RfD, RfC, qj*, and unit risk values.
When appropriate data are available, provides
EPA classification of carcinogenicity.
RQ values for selected hazardous chemicals.
Note: References are listed in shortened format, with complete references given in the reference list following
Chapter 10.

The following data bases (Table 5-12) are useful in the absence of other data, but information
given should be checked against primary sources for accuracy.  The TOXLINE and TOXLIT
sources provide abstracts that sometimes contain useful data; most of these data bases are good
sources of references to primary literature, such as journal articles.
TABLE 5-12: SUPPLEMENTAL SOURCES OF HUMAN HEALTH HAZARDS DATA
1 . . j i* <. i &ws &
Reference
CANCERLIT®. 1995.
CCRIS®. Chemical Carcinogenesis Research
Information System. 1995.
Types of Data
Bibliographic on-line data base containing
information on various aspects of cancer.
Factual data bank sponsored by National Cancer
Institute. Contains evaluated data and
information, derived from both short- and long-
term bioassays on 1,200 chemicals.
                                          5-52

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CHAPTERS
HUMAN HEALTH HAZARDS SUMMARY
TABLE 5-I2J SUPPLEMENTAL SOURCES OF HUMAN HEALTH HAZARDS DATA
Reference
CHEMID®. Chemical Identification System.
1995.
CHEMLINE®. Chemical Dictionary Online.
1995.
DART®. Developmental and Reproductive
Toxicology. 1995.
EMICBACK®. Environmental Mutagen
Information Center Backfile. 1995.
ETICBACK®. Environmental Teratology
Information Center Backfile. 1995.
GENE-TOX®. Genetic Toxicology. 1995.
MEDLINE®. MEDLARS Online. 1995.
RTECS®. Registry of Toxic Effects of Chemical
Substances. 1995.
TOXLINE®. 1995
TOXLIT®. 1995.
U.S. Environmental Protection Agency.
UNDATEDd. Health Effects Assessment
Summary Tables.
Types of Data
A chemical dictionary file for over 184,000
compounds of regulatory and biomedical interest.
Includes CAS RNs, molecular formulae, generic
and trivial names, MeSH headings, and file
locators for other files on the ELHILL® and
TOXNET® systems. Also provides names and
other data used to describe chemicals on over 20
key federal and state regulatory lists.
On-line data base that contains 1,142,000 records.
Includes chemical names, synonyms, CAS RNs,
molecular formulas, National Library of
Medicine file locators and, where appropriate,
ring structure information.
Bibliographic data base covering teratology and
developmental toxicology literature published
since 1989.
Contains references to chemical, biological, and
physical agents that have been tested for
geriotoxic activity.
Contains references on agents that may cause
birth defects.
An on-line data bank created by the EPA as a
multi-phase effort to review and evaluate the
existing literature and assay systems available in
the field of genetic toxicology.
Bibliographic data base covering medicine,
nursing, dentistry, veterinary medicine, and the
preclinical sciences. Good source of
epidemiological information.
On-line data base that briefly summarizes the
toxicity of a given chemical (not peer-reviewed).
Bibliographic toxicity data base. Abstracts are
available.
Bibliographic data base. Toxicity files from
Chemical Abstracts. Abstracts are available,
RfD, RfC, unit risk, and q,* values for selected
chemicals.
Note: References are listed in shortened format, with complete references given in the reference list following
Chapter 10.
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                     ENVIRONMENTAL HAZARDS SUMMARY
OVERVIEW:  Environmental hazards assessment is the process of identifying the adverse
effects that a chemical may have on organisms in the environment.  Currently, the CTSA process
for environmental hazards assessment focusses on aquatic toxicity.  Other environmental hazards
could include mammalian toxicity, avian toxicity, and habitat alteration or destruction (e.g.,
altering the temperature of a stream by discharging cooling water).

This module collects data on measured or predicted toxicity of chemicals to aquatic organisms to
characterize the potential aquatic toxicity hazard of chemical discharges to receiving waters.
Toxic chemical discharges can also affect the quality of water that may be a source of drinking
water and can be a detriment to the human food chain.  Aquatic toxicity data are combined with
estimated water concentrations from the Exposure Assessment module to assess the risk of
chemical exposure to aquatic organisms in the Risk Characterization module.
GOALS:
       Assess the toxicity of chemicals to the aquatic environment.

       Guide the selection and use of chemicals that are less toxic to aquatic organisms.

       Determine the aquatic toxicity concern concentration (CC) of chemicals.

       Provide the CCs to the Risk Characterization module.
PEOPLE SKILLS: The following lists the types of skills or knowledge that are needed to
complete this module.

•     Expertise in aquatic toxicology, including knowledge of standard aquatic toxicity test
       methods, relative sensitivity of aquatic species to chemical contamination, mechanisms of
       toxic action, and relationships of the molecular structure of chemicals to toxic action.

•     Knowledge of molecular structure and fate of chemicals in the aquatic environment.

Within a business or a DfE project team, the people who might supply these skills include an
aquatic toxicologist, an environmental scientist, a chemist, and/or an environmental engineer.
DfE project teams that do not have people with the necessary expertise to complete this module
should seek outside assistance.

Note: The analysis presented in this module should only be undertaken by someone with
       expertise in environmental hazards (toxicity) assessment. Furthermore, peer-review of
       the completed environmental hazards summary is recommended.
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 DEFINITION OF TERMS:

 Analog: A chemical compound structurally similar to another but differing often by a single
 element of the same valence and group of the periodic table as the element it replaces.

 Aquatic Toxicity Concern Concentration (CC): The concentration of a chemical in the aquatic
 environment below which no significant risk to aquatic organisms is expected.

 Aquatic Toxicity Profile: A compilation of the effective concentrations (EC), either measured or
 predicted, for a range of species.

 Assessment Factor (AsF): Adjustment value used in the calculation of a CC that incorporates the
 uncertainly associated with: (1) toxicity data (e.g., laboratory test versus field test; measured
 versus estimated data); (2) acute exposures versus chronic exposures; and (3) species sensitivity.

 Chronic Value: (See No Effect Concentration.)

 Daphnid:  Water flea; an aquatic invertebrate (Daphnia spp.) frequently used as the test organism
 in aquatic toxicity testing.

 Effects Concentration (EC50)):  The concentration of a chemical in water that causes 50 percent of
 the test organisms to show an adverse sublethal effect (such as growth inhibition) at the end of
 the specified exposure period.  Typical units are mg/L.

 Hydrolysis: A chemical transformation process in which a chemical reacts with water. In the
 process, a new carbon-oxygen bond is formed with oxygen derived from the water molecule, and
 a bond is cleaved within the chemical between carbon and some functional group.

 Lethal Concentration (LC;o)): The concentration of a chemical in water (or air) that causes death
 or complete immobilization in 50 percent of the test organisms at the end of the specified
 exposure period. LC50 values typically represent acute exposure periods, usually 48 or 96 hours
 but up to 14 days for fish.  Typical units are mg/L (mg/m3 or ppm for air).

 Lowest-Observed Effect Concentration (LOEC):  The lowest concentration at which there are
 statistically significant increases in adverse effects in the exposed population over its appropriate
 control group.

 Maximum Allowable Toxicant Concentration (MATC):  The range of measured values in the
 range from the no-observed effect concentration (NOEC) to the LOEC.

 Measured Concentrations: Chemical concentrations measured in the aqueous test solution at
 specified intervals and at the end of an aquatic toxicity test period. EPA aquatic toxicity test
methods in the Code of Federal Regulations require test results to be reported based on mean
measured concentrations. Many tests results are based on nominal concentrations, however, to
avoid the cost of chemical laboratory analysis.

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No-Effect Concentration (NEC): The concentration of a chemical that results in no significant
effects on the test organisms following a prescribed (usually chronic) exposure period. NEC is
the geometric mean of the NOEC and. the LOEC and is used to represent the threshold
concentration. This value may alternatively be called the geometric mean of the maximum
allowable toxicant concentration (GMATC), or the Chronic Value. Typical units are mg/L.

No-Observed Effect Concentration (NOEC):  A concentration at which there are no statistically
significant increases in adverse effects in the exposed population over its appropriate control
group.

Nominal Concentrations: Chemical concentrations added to the aqueous test solution at the
beginning of an aquatic toxicity test. Nominal concentrations can be higher than the actual
concentration causing a toxic effect, particularly if the chemical is volatile or was added to the
test solution at a concentration greater than its water solubility limit.

Qctanol/Water Partition Coefficient QELJI:  The equilibrium ratio of a chemical's concentration in
the octanol phase to its concentration in the aqueous phase of a two-phase octanol/water system,
typically expressed in log units (log K,,w).  Kow provides an indication of a chemical's water
solubility, fat solubility (lipophilicity), its tendency to bioconcentrate in aquatic organisms, and
to sorb to soil or sediment.  It is often used in toxicity structure-activity relationships.

Structure-Activity Relationship (SAIL): The relationship of the molecular structure and/or
functional groups of a chemical with specific effects.  SARs evaluate the molecular structure of a
chemical and make qualitative or quantitative correlations of particular molecular structures
and/or functional groups with specific effects.

Threshold Concentration: The concentration at which effects begin. (See No Effect
Concentration.)
 APPROACH/METHODOLOGY:  The following presents a summary of the technical
 approach or methodology for conducting an environmental hazards assessment focussing on
 aquatic toxicity.  Methodology details for Steps 3,4, 5, and 6 follow this section.

 Step 1:       Obtain the CAS RN and synonyms, chemical structure, and pertinent chemical
              properties information for each chemical from the Chemical Properties module.

 Step 2:       Obtain environmental fate parameter values and reactivity data from the
              Environmental Fate Summary module.  (For example, a chemical's Kow is required
              to predict effect concentrations.) If a chemical is highly water-reactive (for
              example, hydrolysis half-life less than one hour) consider collecting toxicity data
              for the hydrolysis product(s).

 Step 3:       Construct an aquatic toxicity profile for each chemical. The most frequently used
              toxicity profile for aquatic organisms consists of the following:

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              •      Fish acute toxicity value (usually a fish 96-hour LC50 value).
              "      Aquatic invertebrate acute toxicity value (usually a daphnid 48-hour LC50
                     value).
              «      Green algal toxicity value (usually an algal 96-hour EC50 value).
              •      Fish chronic value (usually a fish 28-day early life stage NEC).
              •      Aquatic invertebrate chronic toxicity value (usually a daphnid 21-day
                     NEC).
              •      Algal chronic toxicity value (usually an algal 96-hour NEC value for
                     biomass).

Step 4:        Use data quality checks to evaluate the validity of the data obtained in Step 3.
              Data that appear invalid (e.g., based on nominal concentrations instead of
              measured concentrations; inconsistent with the physical/chemical properties of the
              chemical, etc.) should be replaced with data of better quality or predicted data.

Step 5:        Calculate the CC for each chemical in water.  Concentrations in water below the
              CC are assumed to present low (acceptable) risk to aquatic species.

Step 6:        Rank chemicals for aquatic toxicity according to the lowest of their acute or
              chronic values. This ranking can be based on scoring the chemicals as High,
              Moderate, or Low concern for aquatic toxicity.

Step 7:        Provide the CCs to the Risk Characterization module.
METHODOLOGY DETAILS:  This section presents methodology details for completing
Steps 3,4, 5, and 6. If necessary, additional information on this and other steps can be found in
previously published guidance (Table 5-15: Published Guidance on Aquatic Toxicity
Assessment).

Details:  Step 3, Constructing the Aquatic Toxicity Profile

The aquatic toxicity profile may consist of only valid measured data, only predicted values, or a
combination of both. Depending on the availability of valid measured data or SARs to estimate
data, the toxicity profile may contain a minimum of one acute or chronic value to the full
compliment of three acute values and three chronic values. Examples from the Screen
Reclamation CTSA (EPA, 1994c) are shown in Table 5-13.
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                                     ENVIRONMENTAL HAZARDS SUMMARY
TABLE 5-13: EXAMPLE AQUATIC TOXICITY PROFILES (in mg/L)
Chemical
Acetone
Sodium
hypochlorite
Solvent naphtha
light aliphatic
C5 - C10
Fish
Acute
>1000
<1.7
0.64
Daphnid
Acute
>1000
<2.0
0.86
Algal
Acute
>1000
<2.0
0.23
Fish
Chronic
490
<0.17
0.05
Daphnid
Chronic
100
<0.2
0.05
Algal
Chronic
76
<0.2
0.11
cca
7.6
<0.02
0.005
Chronic Ecob
Hazard Rank
Low
Moderate
High
a) CC is derived by dividing the lowest chronic value (in mg/L) by 10.
b) See Details: Step 6 for guidelines on ranking chemicals for aquatic toxicity.

Chemical Mixtures:  Chemical mixtures, such as petroleum products (e.g., mineral spirits or
solvent naphtha), do not lend themselves to the standard assessment process using SARs. The
chemical constituents and the percentage of each in a mixture can vary. The toxicity of mixtures
can be determined by estimating the toxicity of each individual constituent and then evaluating
the potential toxicity of the product through a weighted average.  If the concentration of each
constituent in the mixture is not known, one approach is to assume that each component is
present in an equal percentage in the product and the geometric mean of the range of like toxicity
values provides the best estimate of the toxicity. The geometric mean of n positive numbers is
(a x b x c...)1/n.  If the concentration of the constituents is known, then the sum of the weight
fractions of each constituent multiplied by its toxicity provides an estimate of the toxicity of the
product.

Discrete (Single) Organic Chemicals:  The toxicity profile for single organic chemicals can be
constructed using effective concentrations based on toxicity test data (measured) or estimated
toxicity values based on SARs.

Inorganic Chemicals: The toxicity of inorganic chemicals typically cannot be as accurately
estimated using SARs as for organic chemicals. The toxicity profile for inorganic chemicals
should therefore be constructed using  effective concentrations based on measured toxicity test
data if possible.  If no data are available, actual data from the nearest analog can be used.

To construct the toxicity profile:

       (1)
       (2)
Collect valid measured data from peer-reviewed on-line data bases such as
Hazardous Substance Data Bank (HSDB) or from peer-reviewed open literature
sources.

When valid measured data are not available, use SAR estimates if available for
the chemical class. The use, application, development, and validation of SARs
have been presented in a number of publications (see section on previously
published guidance). Computer models that calculate toxicity values based on
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PARTII: CTSA INFORMATION MODULES
              SARs are also available (see section on analytical models). The following data
              hierarchy is preferred for SAR estimates (from lowest to highest):
              a)      Valid measured data from the nearest analog.
              b)      Predicted value based on valid measured data from two analogs that
                     bracket the chemical of concern.
              c)      Predicted value based on regression equation developed from valid
                     measured data for a similar class of compounds.

Details:  Step 4, Evaluating Data Quality

The following are examples of data quality checks. An exhaustive data quality evaluation
requires expert judgment and experience.

       (1)     Determine if the effective concentrations are based on mean measured
              concentrations or nominal concentrations.  Data based on mean measured
              concentrations are preferred, especially for volatile compounds.

       (2)     Determine if a chemical's physical/chemical properties are consistent with one
              another and with the chemical's effective concentrations.  For example, a chemical
              with a low Kow value would be expected to have a high water solubility limit. A
              chemical's LC50 value should be less than or equal to its water solubility limit
              unless it is a self-dispersing compound such as a surfactant. Measured
              concentrations that significantly exceed the water solubility limit of a compound
              suggest that the test laboratory may have artificially enhanced the water solubility
              to a level that cannot be realized hi the environment.

       (3)     Compare the test methods against the chemical's physical/chemical properties.
              For example, highly water reactive chemicals (as measured by the hydrolysis half-
              life) should be tested in a flow-through system instead of a static system where
              pure stock material is added directly to the system. With the static system the test
              organism may only be exposed to the hydrolysis products.

Details:  Step 5, Calculating the CCs

The CC for each chemical in water is calculated using the general equation:

       CC = acute or chronic toxicity value •*- AsF

AsFs are dependent on the amount and type of toxicity data contained in a toxicity profile and
reflect the amount of uncertainty about the potential effects associated with a toxicity value. In
general, the more complete the hazard profile and the greater the quality of the toxicity data, the
smaller the factor used.

One of the following specific  equations is used, depending on the availability of data:
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ENVIRONMENTAL HAZARDS SUMMARY
       a)     If the toxicity profile only contains one or two acute toxicity values (no chronic
             values):

             CC = lowest acute value + 1000

       b)     If the toxicity profile contains three acute values (no chronic values):

             CC = lowest acute value + 100

       c)     If the toxicity profile contains one chronic value:

             CC = chronic value +10, if the value is for the most sensitive species.

             Otherwise:

             CC = acute value for the most sensitive species +100

       d)     If the toxicity profile contains three chronic values:

             CC = lowest chronic value +10

       e)     If the toxicity profile contains a measured chronic value from a field study:

             CC = measured chronic value +1

Examples from the Screen Reclamation CTSA (EPA, 1994c) are shown in Table 5-13.

Details: Step 6, Ranking Chemicals for Aquatic Toxicity

Chemicals can be ranked for aquatic toxicity according to the following criteria:

       a)     For chronic values:

             <; 0.1 mg/L	High
             > 0.1 to <; 10 mg/L	Moderate
             > 10 mg/L	Low

       b)     For acute values:

             :£ 1 mg/L	High
             > 1 to ^ 100 mg/L	Moderate
             > 100 mg/L	Low
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Chronic toxicity ranking takes precedent over the acute ranking. This relative ranking of toxicity
can be used to guide the selection and use of chemicals that are less hazardous to aquatic
organisms. Examples from the Screen Reclamation CTSA (EPA, 1994c) are shown in Table 5-13.
FLOW OF INFORMATION:  This module can be used alone as a final data point to guide the
selection and use of chemicals that are less toxic to aquatic organisms. In a CTSA, this module
receives data from the Environmental Fate Summary and Chemical Properties modules and
transfers data to the Risk Characterization module. Example information flows are shown in
Figure 5-6.
         FIGURE 5-6: ENVIRONMENTAL HAZARDS SUMMARY MODULE:
                         EXAMPLE INFORMATION FLOWS
   Environmental
       Fata
                                                                              f i> Vi
     Summary  I • Ermronmantal fate
                 parameter values
                 i Hydrolysis products
     Chemical   •  .	     ^
     Properties  |«CASRN and synonyms
                 i Chemical structure
                 t Other chemical
                  properties
 Assessment   m Bg»sun> ssonariw „
                and pathways
              1» EstimatBoof do«jor
               exposure tevete
              • Ambient
               concentrations
Environmental
   Hazards
  Summary
                                                     • Ecotoxicityoarjcem
                                                      concentrationB
 Human Health
   Hazards
  Summary
                                                                             Risk
                                                                         Characterization
                                                                            ,1v  ,  ",>,*
                                                                             i i    f,« i V » '/1
ANALYTICAL MODELS: Table 5-14 presents references for SAR models that can be used to
predict aquatic toxicity values.  Since different SAR models may provide different or conflicting
results, one model should be used consistently throughout a particular CTSA project.
    TABLE 5-14: ANALYTICAL MODELS USED IN AQUATIC TOXICITY ASSESSMENT
                  Reference
                     Type of Model
 Clements, R.G. and J.V. Nabholz.  1994.
 ECOSAR: A Computer Program for Estimating
 the Ecotoxicity of Industrial Chemicals Based on
 Structure-Activity Relationships; User's Guide.
      PC format analytical model developed within the
      constraints of the regulatory program office of
      Office of Pollution Prevention and Toxics
      (OPPT). Uses SARs to predict acute and chronic
      ecotoxicity concentrations for daphnid, fish and
      algae. EPA uses this system exclusively for
      evaluating new and existing chemicals.
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CHAPTERS
                                                 ENVIRONMENTAL HAZARDS SUMMARY
TABLE 5-14: ANALYTICAL MODELS mm IN AQUATIC TOXICITY ASSESSMENT
Reference
Hunter, R.S. and F.D. Culver. 1992. MicroQSAR
Version 2.0: A Structure-Activity Based Chemical
Modeling and Information System.
QSAR: A Structure- Activity Based Chemical
Modeling and Information System. 1986.
Type of Model
Personal computer-based system of models.
quantitative SARs to estimate chemical
properties and aquatic toxicity values.
Uses
Available on-line and in PC format. Uses
quantitative SARs to estimate chemical
properties, environmental fate parameters,
aquatic LC50 in 7 common test organisms, and
NEC in fathead minnow.
Note: References are listed in shortened format, with complete references given in the reference list following
Chapter 10.
PUBLISHED GUIDANCE: Table 5-15 presents references for published guidance on
environmental toxicity assessment and the use of SARs.
TABLE 5-15; PUBLISHED GUIDANCE ON AQUATIC TOXICITY ASSESSMENT
Reference
Clements, R.G., Ed. 1988. Estimating Toxicity
of Industrial Chemicals to Aquatic Organisms
Using Structure Activity Relationships.
Clements, R.G., et. al. 1993a. "The Use and
Application of QSARs in the Office of Toxic
Substances for Ecological Hazard Assessment of
New Chemicals."
Clements, R.G., et. al. 1993b. "The Use of
Quantitative Structure- Activity Relationships
(QSARs) as Screening Tools in Environmental
Assessment."
Clements, R.G., Ed. 1994. Estimating Toxicity
of Industrial Chemicals to Aquatic Organisms
Using Structure-Activity Relationships.
Lipnick, R.L. 1993. "Baseline Toxicity QSAR
Models: A Means to Assess Mechanism of
Toxicity for Aquatic Organisms and Mammals."
Nabholz, J.V. 1991. "Environmental Hazard and
Risk Assessment Under the United States Toxic
Substances Control Act."
Type of Guidance
Describes the use of SARs by EPA OPPT.
Describes the use and application of QSARs for
the hazard assessment of new chemicals.
Describes the development, validation, and
application of SARs in EPA OPPT.
Describes the use of SARs by EPA OPPT.
Describes the development, validation, and
application of SARs in EPA OPPT.
Detailed discussion of a comprehensive toxicity
profile and risk assessment for existing
chemicals.
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TABLE 5-15: PUBLISHED GUIDANCE ON AQUATIC TOXICITY ASSESSMENT
Reference
Nabholz, J.V., et. al. 1993a. "Environmental
Risk Assessment of New Chemicals Under the
Toxic Substances Control Act (TSCA) Section
Five."
Nabholz, J.V., et. al. 1993b. "Validation of
Structure-Activity Relationships Used by the U.S.
EPA's Office of Pollution Prevention and Toxics
for the Environmental Hazard Assessment of
Industrial Chemicals."
U.S. Environmental Protection Agency. 1984b.
Estimating Concern Levels for Concentrations of
Chemical Substances in the Environment.
Zeeman, M.G. and James Gilford. 1993.
"Ecological Hazard Evaluation and Risk
Assessment Under EPA's Toxic Substances
Control Act (TSCA): An Introduction."
Zeeman, M.G., et. al. 1993. "The Development
of SAR/QSAR for Use Under EPA's Toxic
Substances Control Act (TSCA): An
Introduction."
Zeeman, M.G. 1995a. "EPA's Framework for
Ecological Effects Assessment."
Zeeman. M.G. 1995b. "Ecotoxicity Testing and
Estimation Methods Developed Under Section 5
of the Toxic Substances Control Act (TSCA)."
Type of Guidance
Describes the toxicity profile outlined in Step 3.
Describes the development, validation, and
application of SARs in EPA OPPT.
Describes the use of AsFs to determine the CC
for a chemical.
Provides an overview of the process used in the
environmental toxicity assessment of chemicals.
Describes the development, validation, and
application of SARs in EPA OPPT.
Provides an overview of the process used in the
environmental toxicity assessment of chemicals.
Describes the development, validation, and
application of SARs in EPA OPPT.
Note: References are listed in shortened format, with complete references given in the reference list following
Chapter 10.
 DATA SOURCES: Table 5-16 lists sources of aquatic toxicity data.
TABLE 5-16; SOURCES OF AQUATIC JOXICITY DATA ^ ^^
Reference
Aquatic Information Retrieval (AQUIRE) Data
Base. UNDATED.
Type of Data
Comprehensive data base of measured aquatic
toxicity values derived from open literature.
Some data not peer-reviewed. Data should be
confirmed with original literature citation.
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 CHAPTERS
                                                      ENVIRONMENTAL HAZARDS SUMMARY
TABLE 5-16: SOURCES OF AQUATIC TOXICITYBATA
Reference
Brooke, L.T., et. al., Ed. 1984 - 1990. Acute
Toxicities of Organic Chemicals to Fathead
Minnows (Pimephalespromelas).
Call, D J. and D.L. Geiger, Eds. 1992. Sub-
chronic Toxicities of Industrial and Agricultural
Chemicals to Fathead Minnows (Pimephales
promelas).
HSDB®. Hazardous Substances Data Bank
(HSDB). Updated Periodically.
U.S. Atomic Energy Commission. 1973.
Toxicity of Power Plant Chemicals to Aquatic
Life.
U.S. Environmental Protection Agency.
UNDATEDe. Ambient Water Quality Criteria
Documents.
Type of Data
Comprehensive source of measured fish toxicity
values for a single species (fathead minnows),
including fish LC50 data.
Source of measured fish toxicity values for a
single species (fathead minnows), including fish
EC50 data.
Measured aquatic toxicity values derived from
open literature. Peer-reviewed.
Aquatic toxicity values for inorganic chemicals.
Aquatic toxicity values for chemicals for which
ambient water quality criteria have been
developed. Useful for organic and inorganic
compounds.
Note: References are listed in shortened format, with complete references given in the reference list following
Chapter 10.
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Material Stream:  A flow of material (e.g., water, chemicals, product outputs, air emissions, etc.)
either into or out of a step in the process.

Unit Operation: A process step that achieves a desired function.
APPROACH/ METHODOLOGY: The following presents a summary of the approach or
methodology for evaluating the chemistry of use and preparing a process description. If there are
substantially different methods of performing the use cluster function within an industry, it may
be necessary to define the chemistry of use and prepare a process description for each of the
methods typically employed. Further methodology details for Step 4 follow this section.

Step 1:        Obtain chemical data including CAS KNs, molecular structure, and
               chemical/physical properties from the Chemical Properties module.

Step 2:        Identify the properties that contribute to the effectiveness of the use cluster
               chemicals or technologies in performing the desired function.  The properties may
               be chemical properties (e.g., a solvent with the ability to dissolve many different
               types of resins may be required in a paint stripping product), physical properties
               (e.g., a printing ink may have to be white, thus requiring the ink to contain a white
               pigment, such as titanium dioxide), or mechanical properties (e.g., a material
               substrate may need to meet specific mechanical qualifications for yield strength or
               fracture toughness). These properties are important criteria when selecting
               alternatives for a particular use cluster and identifying performance characteristics
               for the Performance Assessment.

 Step 3:        Examine the industry- or product-specific application of the use cluster chemicals
               to identify the following:
               •      Unit Operations, or process steps, required to perform the desired function
                      (e.g., cleaning, degreasing, plating, product assembly, drilling, painting,
                      drying, etc.). Identify any chemical, physical, or mechanical agents used
                      in conjunction with the use cluster chemicals (e.g., dilution with water,
                      heat, pressure, mechanical agitation, etc.).
               •      Equipment used in the process steps  (e.g., production machinery, reactors,
                      heaters, waste stream control technologies, etc.).
               •     Material streams that flow into, out of, or between steps in the process
                      (e.g.,  raw material inputs, product outputs, rinse water streams, solid waste
                      disposal, air emissions, waste water discharges, etc.).
               •     The manner in which raw materials, chemicals, or products are stored and
                      handled (e.g., chemical feedstock handling, methods of storage, etc.).
               •     Any other data that might be necessary to prepare a process description or
                      process flow diagram.

  Step 4:    Construct a process flow diagram using the information collected in Step 3.  An
            example flow diagram is shown in the Methodology Details section.

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                                                      J
 CHAPTERS
                                             CHEMISTRY OF USE & PROCESS DESCRIPTION
 Step 5:     Review the information obtained from Steps 1 through 4 with the objective of
            identifying alternative chemicals, processes, and/or technologies (i.e., substitutes)
            that could be used to accomplish the same function.  One approach to identifying
            substitutes is to consult with other industries that have similar functional
            requirements at some stage in the manufacturing or commercial service process.
            Another approach is to consult with vendors of chemicals or equipment who may be
            able to suggest process improvements that reduce environmental releases  Also,
            consult technical assistance organizations that have a broad overview of chemical
            uses and substitutes in many different industries.

 Step 6:     Transfer a description of the  unit operations and the process flow diagram to the
            following modules:
            •    Workplace Practices & Source Release Assessment.
            •    Process Safety Assessment.
            •    Exposure Assessment.
            •    Regulatory Status.
            •    Pollution Prevention Opportunities Assessment.
            •    Control Technologies Assessment.
            •    Performance Assessment.

 Step 7:     Provide data on material streams (e.g., water, raw materials, chemicals, etc.) to the
            Resource Conservation module, and a list of equipment used in the process to the
            Energy Impacts module.
METHODOLOGY DETAILS: This section presents the methodology details for completing
Step 4.

Details:  Step 4, Process Flow Diagram Example

Figure 5-7 is an example of a process flow diagram for the pattern etching use cluster of the
printed wiring board manufacturing process.

The pattern etching use cluster begins with the chemical etching of the unetched circuit panels
and ends with the final drying of the etched panel. The use cluster shown here has the functional
subgroups of chemical etching (Subgroup 1) and tin resist stripping (Subgroup 2). Subgroup 1
includes the actual etching step as well as a rinsing step to remove the excess etchant from the
panels. Subgroup 2 includes the actual tin-resist stripping process step and a rinsing and drying
step performed before the etched circuits can pass to the next step in the printed wiring board
manufacturing process.
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PARTH: CTSAINFORMAHON MODULES


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CHAPTERS
                CHEMISTRY OF USE & PROCESS DESCRIPTION
FLOW OF INFORMATION:  In a CTSA, this module receives information from the Chemical
Properties module and transfers information to the Workplace Practices & Source Release
Assessment, Exposure Assessment, Process Safety Assessment, Performance Assessment,
Regulatory Status, Energy Impacts, Resource Conservation, Pollution Prevention Opportunities
Assessment, and Control Technologies Assessment modules.' Example information flows are
shown in Figure 5-8.
     FIGURE 5-8: CHEMISTRY OF USE & PROCESS DESCRIPTION MODULE:
                        EXAMPLE INFORMATION FLOWS
                                               • Unit operations
                                               *PnKa:s8fkiw diagrams
                      ,**»
                                 •x  '-. -*r   .  -^ I
      »s
 Chemistry of
Use & Process
 Description  i
                                             \Atorkplace
                                            Practices &
                                           Source Release!
                                            Assessment
                                                Unit operations
                                                                         Exposure
                                                                        Assessment
                                               • Unit operations
                                               « Prooass flow clia^ams
                                              Process
                                               Safety
                                             Assessment
                                               • Unit operations
                                               • Chemical naquiremente for
                                                 substitute
                                               «r
                                                                       Performance
                                                                       Assessment
                                               • Process descriptions
                                                    s       S-
                                                                        Regulatory
                                                                          Status

                                               * Process equipment
                                                                          Energy
                                                                          Impacts

                                               • Types of matertalsin»ams
                                                                         Resource
                                                                       Conservation
                                                        1
                                                        •
                                                • Process flow diagrams
                                                    •       h
                                               Pollution
                                              Prevention
                                             Opportunities
                                             Assessment
|
I;
•
f
                                               9 Prccess flow diagrams
                                                                          Control
                                                                        Technologies
                                                                        Assessment
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ANALYTICAL MODELS: None cited.
PUBLISHED GUIDANCE: Although no publications were identified that provide guidance
for this module, chemical engineering textbooks explain the basic concepts of process flow
diagrams and provide numerous examples. Table 5-17 lists a few examples of chemical
engineering textbooks.
TABLE 5-17: PUBLISHED GUIDANCE ON CHEMISTRY OF USE & PROCESS
DESCRIPTION
Reference
Himmelblau, David M. 1990. Basic Principles
and Calculations in Chemical Engineering.
Luyben, William and L. Wenzel. 1988.
Chemical Process Analysis: Mass and Energy
Balances.
Type of Guidance
Examples of process flow diagrams.
Examples of process flow diagrams.
Note: References are listed in shortened format, with complete references given in the reference list following
Chapter 10.
DATA SOURCES:  None cited.
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                          PROCESS SAFETY ASSESSMENT
OVERVIEW:  The Process Safety Assessment module screens potential chemical substitutes to
determine if they could potentially pose a safety hazard in the workplace. Process operating
characteristics and workplace practices are combined with physical hazard data, precautions for
safe handling and use, and other data to determine if implementing a chemical substitute might
pose a safety hazard. Safe operating procedures for alternative technologies (equipment) are also
considered.
GOALS:
       Obtain information on chemical hazards (reactivity, corrosivity, etc.), proper handling
       and storage precautions, and proper use guidelines for each chemical formulation or
       technology being evaluated.

       Compare physical hazard data to process operating conditions and workplace practices to
       determine if any of the chemical substitutes might pose a safety hazard in the workplace.

       Determine what special actions, if any, need to be taken when using substitute chemicals,
       formulations, or processes.

       Guide the selection and use of chemicals or processes that are less hazardous in the
       workplace.
PEOPLE SKILLS:  The following lists the types of skills or knowledge that are needed to
complete this module.

•     Knowledge of chemicals used, and/or produced by the process as well as knowledge and
       understanding of the technologies and equipment used for the process.

•     Knowledge of the workplace practices and operating procedures for the given process.

•     Knowledge of process safety .analysis, Occupational Safety and Health Administration
       (OSHA) regulations, and guidelines pertaining to hazardous chemicals and industrial
       safety.

Within a business or a DFE project team, the people who might supply these skills include a
process engineer, safety engineer, safety specialist, or an industrial hygienist.
DEFINITION OF TERMS: The Process Safety Assessment module focuses on physical
hazards such as flammability and explosivity rather than health hazards from toxic chemical
exposure. Health hazards are characterized in other parts of the CTSA. The definitions of
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OSHA established limits for worker exposure to toxic chemicals (e.g., Permissible Exposure
Limit and Threshold Limit Value) are listed in this module, however, to assist the individual in
interpreting material safety data sheet data.

Combustible Liquid: As defined by OSHA (29 CFR 1910.1200), any liquid having a flash point
at or above 140 °F (37.6 °C), but below 200 °F (93.3 °C), except any mixture having components
with flashpoints of 200 °F (93.3 °C), or higher, the total volume of which makes up 99 percent or
more of the total volume of the mixture.

Compressed Gas:  As defined by OSHA (29 CFR 1910.1200):
"      A gas or mixture of gases having, in a container, an absolute pressure exceeding 40 psi at
       70°F(21.1°C).
•      A gas or mixture of gases having, in a container, an absolute pressure exceeding 104 psi
       at 130 °F (54.4 °C) regardless of the pressure at 70 °F (21.1 °C).
•      A liquid having a vapor pressure exceeding 40 psi at 100 °F (37.8 °C) as determined by
       ASTMD-323-72.

Corrosive:  As defined by OSHA (29 CFR 1910.1200), a chemical that causes visible destruction
of, or irreversible alterations hi, living tissue by chemical action at the site of contact. For
example, a chemical is considered to be corrosive if, when tested on the intact skin of albino
rabbits by the method described by the U.S. Department of Transportation in Appendix A to 49
CFR 173, it destroys or changes irreversibly the structure of the tissue at the site of contact
following an exposure period of four hours. According to the OSHA definition, this term shall
not refer to action on inanimate surfaces.

Explosive:  As defined by OSHA (29 CFR 1910.1200), a chemical that causes a sudden, almost
instantaneous release of pressure, gas, and heat when subjected to sudden shock, pressure,  or
high temperature.

Flammable: As defined by OSHA (29 CFR 1910.1200), a chemical that falls into one of the
following categories:
•      Flammable aerosol: An aerosol that, when tested by the method described in  16 CFR
       1500.45, yields a flame projection exceeding 18 inches at full valve opening, or a
       flashback (a flame extending back to the valve) at any degree of valve opening.
•      Flammable gas:
       - A gas that, at ambient temperature and pressure, forms a flammable mixture with air at
       a concentration of 13 percent by volume or less; or
       - A gas that, at ambient temperature and pressure, forms a range of flammable mixtures
       with air wider than 12 percent by volume, regardless of the lower limit.
•      Flammable liquid: Any liquid having  a flashpoint below 100 °F  (37.8 °C), except any
       mixture having components with flashpoints of 100 °F (37.8 °C) or higher, the total of
       which make up 99 percent or more of the total volume of the mixture.
•      Flammable solid: A solid, other than a blasting agent or explosive as defined in 29  CFR
       1910.109(a), that is liable to cause fire through friction,  absorption of moisture,
       spontaneous  chemical change, or retained heat from manufacturing or processing, or

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       which can be ignited readily and when ignited burns so vigorously and persistently as to
       create a serious hazard.  A chemical shall be considered to be a flammable solid if, when
       tested by the method described in 16 CFR 1500.44, it ignites and burns with a self-
       sustained flame at a rate greater than one-tenth of an inch per second along its major axis.

Flash Point: As defined by OSHA (29 CFR 1910.1200), the minimum temperature at which a
liquid gives off a vapor in sufficient concentration to ignite when tested as follows:
•      Tagliabue Closed Tester: (see American National Standard Method of Test for Flash
       Point by Tag Closed Tester, Zl 1.24-1979 [ASTM D 56-79]) for liquids with a viscosity
       of less than 45 Saybolt Universal Seconds (SUS) at 100 °F (37.8 °C), that do not contain
       suspended solids and do not have a tendency to form a surface film under test.
•      Pensky-Martens Closed Tester:  (see American National Standard Method of Test for
       Flash Point by Pensky-Martens  Closed Tester, Zl 1.7-1979 [ASTM D 93-79]) for liquids
       with a viscosity equal to or greater than 45 SUS at  100 °F (37.8 °C), or that contain
       suspended solids, or that have a tendency to form a surface film under test.
•      Setaflash Closed Tester: (see American National Standard Method of Test for Flash Point
       by Setaflash Closed Tester [ASTM D 3278-78].) Typical units are °C or °F.

Hazard: A condition or changing set of circumstances that presents a potential for injury, illness,
or property damage.  The potential or inherent characteristics  of an  activity, condition, or
circumstance which can produce adverse or harmful consequences. Hazards can be categorized
into four groups: biological, chemical, mechanical, and physical.

Hazardous Chemical: As defined by OSHA (29 CFR 1910.1200), any chemical which is a
physical hazard or a health hazard.

Hazardous Substance: Any substance which has the potential of causing injury by reason of its
being explosive, flammable, toxic, corrosive, oxidizing, irritating, or otherwise harmful to
personnel.

Immediately Dangerous to Life or Health (IDLH): The maximum inhalation level from which a
worker could escape  without any escape-impairing symptoms or any irreversible health effects.

Industrial Hygiene: The science and art devoted to the recognition, evaluation, and control  of
those environmental  factors or stresses arising hi or from work situations which may cause
sickness, impaired health and well-being, or significant discomfort and inefficiency among
workers or among the citizens of a community.

Irritant: As defined by OSHA (29 CFR 1910.1200), a chemical which is not corrosive but which
causes a reversible, inflammatory effect on living tissue by chemical action at the site of contact.
A chemical is a skin  irritant if, when tested on the intact skin  of albino rabbits by the methods of
16 CFR 1500.41 for  four hours exposure or by other appropriate techniques, it results in an
empirical score of five or more. A chemical is an eye irritant if so determined under the
procedure listed in 16 CFR 1500.42 or other appropriate techniques.
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Lower Explosive Limit (LEL): The minimum concentration of combustible gas or vapor in air
below which propagation of flame does not occur on contact with a source of ignition. The
lower limit of flammability of a gas or vapor at ordinary ambient temperatures expressed in
percent of the gas or vapor in air by volume.

Material Safety Data Sheet (TvfSDS^: As defined by OSHA (29 CFR 1910.1200), written or
printed material concerning a hazardous material which contains the following:
•     The identity of the hazardous material (except as provided for materials that are trade
       secrets).
•     The physical and chemical characteristics of the hazardous chemical (such as vapor
       pressure, flash point).
•     The physical hazards of the hazardous chemical, including the potential for fire,
       explosion, and reactivity.
*     The health hazards of the hazardous chemical, including signs and symptoms of
       exposure, and any medical conditions which are generally recognized as being aggravated
       by exposure to the chemical.
•     The primary route(s) of entry.
•     The OSHA PEL, ACGIH Threshold Limit Value, and any other exposure limit used or
       recommended by the chemical manufacturer, importer, or employer preparing the MSDS,
       where available.
•     Whether the hazardous chemical is listed in the National Toxicology Program (NTP)
       Annual Report on Carcinogens (latest edition) or has been identified as a potential
       carcinogen in the International Agency for Research on Cancer (IARC) Monographs
       (latest editions) or by OSHA.
•     Any generally applicable precautions for safe handling and use which are known to the
       chemical manufacturer, importer, or employer preparing the MSDS, including
       appropriate hygienic practices, protective measures during repair and maintenance of
       contaminated equipment, and procedures for clean-up of spills and leaks.
»     Any generally applicable control measures which are known to the chemical
       manufacturer, importer or employer preparing the MSDS, such as appropriate
       engineering controls, work practices, or personal protective equipment.
•     Emergency and first aid procedures.
»     The date of preparation of the MSDS or the last change to it.
"     The name, address, and telephone number of the chemical manufacturer, importer,
       employer or other responsible party preparing or distributing the MSDS, who can provide
       additional information on the hazardous chemical and appropriate emergency procedures,
       if necessary.
Mixture: As defined by OSHA (29 CFR 1910.1200), any combination of two or more chemicals
if the combination is not, in whole or in part, the result of a chemical reaction.

Occupational Safety and Health Act: Federal statute that governs workplace safety and the
exposure of workers to chemicals in the workplace.
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Occupational Safety and Health Administration (OSHA):  A federal agency under the United
States Department of Labor which develops and administers industrial safety and health
standards.

Organic Peroxide: As defined by OSHA (29 CFR 1910.1200), an organic compound that
contains the bivalent -O-O-structure and which may be considered to be a structural derivative of
hydrogen peroxide where one or both of the hydrogen atoms has been replaced by an organic
radical.

Qxidizer: As defined by OSHA (29 CFR 1910.1200), a chemical other than a blasting agent or
explosive as defined in 1910.109(a), that initiates or promotes combustion in other materials,
thereby causing fire either of itself or through the release of oxygen or other gases.

Permissible Exposure Limit (TEL):  An enforceable standard promulgated by OSHA. The TEL
for a substance is the 8-hour TWA or ceiling concentration above which workers may not be
exposed. Although-personal protective equipment may not be required for exposures below the
TEL, its use may be advisable where there is a potential for overexposure. In many cases, TELs
are derived from TLVs published in 1968.

Personal Protective Equipment (TTE): Any material or device worn to protect a worker from
exposure to or contact with any harmful substance or force.

Physical Hazard: As defined by OSHA (29 CFR 1910.1200), a chemical for which there is
scientifically valid evidence that it is a combustible liquid, a compressed gas, explosive,
flammable, an organic peroxide, an oxidizer, pyrophoric, unstable (reactive) or water-reactive.

Pvrophoric: As defined by OSHA (29CFR 1910.1200), a  chemical that will ignite spontaneously
in air at a temperature of 130 °F (54.4 °C) or below.

Reactive: Readily, susceptible to chemical change and the possible release of energy; unstable.
For example, as defined by OSHA (29 CFR 1910.1200), water-reactive means a chemical will
react with water to release a gas that is either flammable or presents a health hazard.

Recommended Exposure Limit (REL):  The workplace exposure concentration recommended by
the National Institute for Occupational Safety and Health (NIOSH) for promulgation by OSHA
as a PEL, but not enforceable as is the OSHA PEL. Typical units are parts per million (ppm).

Sensitizer:  As defined by OSHA (29 CFR 1910.1200), a chemical that causes a substantial
proportion of exposed people or animals to develop an allergic reaction in normal tissue after
repeated exposure to the chemical.

Threshold Limit Value (TLV): The airborne concentration of a substance representing a
condition under which it is believed that nearly all workers may be repeatedly exposed, day after
day, without adverse effect. Air at such a value may be breathed continually for 8 hours per day
and 40 hours per week without harm. Because of wide variation in individual susceptibility,

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exposure of an occasional individual at or even below the TLV may not prevent discomfort,
aggravation of a preexisting condition, or occupational illness. This is also referred to as the
threshold limit value - lime-weighted average (TLV-TWA). Typical units are ppm.

Threshold Limit Value - Ceiling (TLV-Q:  The concentration that should not be exceeded even
instantaneously. Typical units are ppm.

Threshold Limit Value - Short-Term Exposure Limit TTLV-STEL^: A 15-minute TWA exposure
that should not be exceeded at any time during the work day. Typical units are ppm.

Upper Explosive Limit (UEL):  The maximum proportion of vapor or gas in air above which
propagation of flame does not occur.  The upper limit of the flammable or explosive range.  See
also LEL.
APPROACH/METHODOLOGY: The following presents a summary of the approach or
methodology for assessing the process safety of chemical substitutes, processes, and/or
technologies. Methodology details for Steps 5, 6, 8, and 9 follow this section.

Step 1:        Obtain a MSDS for the chemical products in the use cluster, noting properties of
              the products, fire and explosion hazard data, reactivity data, precautions for safe
              handling and use, and control measures.  In DfE pilot projects, chemical suppliers
              have provided MSDSs for the chemical products evaluated in the Performance
              Assessment.  If an MSDS is not available, or a MSDS has not yet been generated
              for a new substitute chemical product, the information contained within an MSDS
              should be developed to adequately assess the potential safety hazards of a
              substitute.  (See the resources listed in the Published Guidance on Process Safety,
              Table 5-19, and Sources of Process Safety Data, Table 5-20.)

Step 2:        If a MSDS is not available for a substitute, obtain chemical identities, including
              CAS RNs and synonyms, and chemical properties for individual chemicals, such
              as reactivity and flashpoint, from the Chemical Properties module.

Step 3:        Obtain the process description and process flow diagram from the Chemistry of
              Use & Process Description module.

Step 4:        Obtain a description of worker activities and workplace practices from the
              Workplace Practices & Source Release Assessment module.

Step 5:        Compare MSDS data against the process description and workplace practices to
              determine if the substitute chemical might pose a safety hazard.
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Step 6:       Determine and list special precautions or actions that should be taken if a
             substitute is used that presents a safety hazard. This information could affect the
             feasibility or the cost of the process and therefore, whether or not to use that
             particular substitute.

Step 7:       If a substitute is considered a hazardous chemical, refer to OSHA 29 CFR ,
              1910.119 to determine the process safety management of that substitute. This
             would include using hazard evaluation techniques such as what-if scenarios,
             checklists, hazard and operability study (HAZOP), failure mode and effects
              analysis (FMEA),  and other analyses. Appendix A to  1910.119 also contains a
              list of highly hazardous chemicals, toxics, and reactives. (Also refer to Table 5-10
              for other sources of published guidance.)

Step 8:        Review OSHA regulations to determine and list safe operating procedures,
              including safe start-up and shut-down procedures, that apply to the baseline or to
              the substitutes.

Step 9:       Provide results of the Process Safety Assessment module to the Cost Analysis and
              the Risk, Competitiveness, & Conservation Data Summary modules.


METHODOLOGY DETAILS: This section presents the methodology details or examples for
 completing Steps 5, 6, 8, and 9 above.

 Details:  Step 5, Comparing MSDS Data with the Process Description and Workplace
 Practices

 The following are examples of chemical properties that may be incompatible with certain
 operating conditions:
 •     Flammable chemicals used in an area where welding occurs.
 •     Flammable chemicals used in a process that operates at elevated temperatures near the
        chemical flashpoint.
 •     Water-reactive chemicals used in an area where aqueous spray washing occurs.
 •     Water-reactive chemicals used in a humid environment where water condenses on chilled
        equipment.

 Details: Step 6, Determining or Listing Special Precautions or Actions to be Taken if
 Substitute is Used

 Examples of special precautions include the following storage conditions:
  •     Flammable liquids, which should be stored in flammable liquid storage cabinets or
        refrigerators.                                                           (
  •      Caustics, which should not be stored next to acids.
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 PARTII; CTSA INFORMATION MODULES
 »     Oxidizers, which should be stored separately from flammable and combustible materials
        as well as reducing agents (some oxidizers, such as perchloric acid, must be used only in
        a water wash-down fume hood made of stainless steel).
 »     Peroxide-forming compounds, which should be stored in airtight containers in a dark,
        cool, dry area.
 •     Compressed gases, which should be stored in a locked, upright position and contained
        within gas cylinders in a dry, cool location away from fumes, direct and indirect heat or
        flames.
 •     Chemicals that are highly flammable or corrosive (hazardous gases must be stored and
        used in fume hoods or ventilated cabinets and adequate PPE should be used).

 Other examples of special precautions to be taken if a substitute presents a safety hazard are the
 use of chemical protective clothing and respirators.  Specific examples warranting the use of
 chemical protective clothing include:
 •      Handling liquid chemicals during electronic  component manufacture.
 •      Maintenance and quality assurance activities for chemical production.
 •      Application of pesticides and other agricultural chemicals.
 •      Chemical waste handling and emergency chemical spill response.

 Specific examples warranting the use of respirators include:
        While engineering controls are being installed or tested.
        While engineering controls are being repaired or maintained; during fire fighting
        activities.
        During escape from suddenly occurring hazardous atmospheres.
        To eliminate hazardous conditions associated with emergencies.
        For operations where other controls are not feasible.
        For certain short-term operations where installing engineering controls would be
        economically impractical.

Details: Step 8, Reviewing OSHA Safe Operating Procedures

OSHA has established safe operating procedures that are either industry-specific or apply to the
operation of equipment in numerous industry sectors. An example of a widely applicable OSHA
standard is 29 CFR 1910.147, the OSHA standard entitled "The Control of Hazardous Energy
(Lockout/Tagout)." This standard covers the servicing and maintenance of machines and
equipment in which the unexpected energization or start-up of the machines or equipment, or
release of stored energy could cause injury to employees. For some types of equipment the
standard permits "tagout" or placement of a tagout device on an energy isolating device in
accordance with established procedure to warn that equipment may not be operated if the
employer can demonstrate that using the tagout will provide full employee protection.
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Details: Step 9, Providing Results of the Process Safety Assessment to the Cost Analysis
and the Risk, Competitiveness & Conservation Data Summary Modules


Table 5-18 indicates the type of information transferred from the Process Safety Assessment

module.
     TABLE S-18: DATA TRANSFEREES FROM THE PROCESS SAFETY ASSESSMENT
                                      MODULE
                  Module
                                                        Data Transferred
  Cost Analysis
                        Whether or not substitute requires special
                        equipment which must be purchased. (Examples
                        would include flammable liquid storage cabinets,
                        fume hoods, ventilated cabinets, and PPE.)
  Risk, Competitiveness & Conservation Data
  Summary
                        Corrosivity, explosivity, flammability
                        possibilities and whether or not substitute is a
                        hazardous chemical or substance, and a
                        comparison of all substitutes to assess differences
                        in physical or mechanical hazards.
 FLOW OF INFORMATION: In a CTSA, this module receives data from the Chemical
 Properties, Chemistry of Use & Process Description, and Workplace Practices & Source Release
 Assessment modules. The Process Safety Assessment module transfers data to the Cost Analysis
 and the Risk, Competitiveness & Conservation Data Summary modules.  Example information

 flows are shown in Figure 5-9.


              FIGURE 5-9: PROCESS SAFETY ASSESSMENT MODULE:
                         EXAMPLE INFORMATION FLOWS
      Chemical
      Pro"°ertieS    I. CAS RNs and synonyms
 Chemistry of
Use & Process
 Description    | * process desenptian
       Workplace
       Practices &
     Source Release
      Assessment
' * Workpkce fwa-ficea
• WorkoractivTtos
                                              Process
                                               Safety
                                            Assessment
                                                     Cost
                                                   Analysis
                                               indudingapecia!.
                                               chemical prodticte
                                                     Risk,
                                                Competitiveness &
                                                Conservation Data
                                                   Summary	
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ANALYTICAL MODELS:  None cited.
PUBLISHED GUIDANCE:  Table 5-19 presents references for published guidance on process
safety.
             TABLE 5-19t PUBLISHED GUIDANCE OK PROCESS SAFETY
                  Reference
                                                            Type of Guidance
 American Petroleum Institute. UNDATED.
 Management of Process Hazards.
 Describes recommended practices to prevent or
 minimize process hazards.
 Dow Chemical Company.  1987. Dow's Fire and
 Explosion Index Hazard Classification Guide.
 Helps the user quantity the expected damage of
 potential fire and explosion incidents; identifies
 equipment likely to contribute to the creation or
 escalation of an incident; and communicates fire
 and explosion risk potential to management.
 National Safety Council. UNDATEDa. Accident
 Prevention Manual for Industrial Operations.
 Three volumes containing accident prevention
 information concerning administration,
 engineering and technology, and environmental
 issues.
National Safety Council. UNDATEDb.
Fundamentals of Industrial Hygiene.
 Illustrated reference covers monitoring,
 evaluation, and control of workplace health
 hazards.  It deals with OSHA regulations,
 professional standards, exposures, and worker's
 right to know laws.
National Safety Council. 1983. Accident
Investigation... A New Approach.
Includes a seven-point program to cover
environmental issues. Defines the components of
a comprehensive program and of regulatory
compliance.
Stull, D.R., Ed.  UNDATED. Fundamentals of
Fire and Explosion.
Reviews the fundamentals of fire and explosion.
Topics include thermochemistry;
kinetochemistry; ignition (gases, liquids, and
solids); flames and dust explosions; thermal
explosions; gas phase detonations; condensed
phase detonations; evaluating reactivity hazard
potential; blast effects, fragments and craters; and
protection against explosions.
Texas Chemical Council. UNDATED.
Recommended Guidelines for Contractor Safety
and Health.
Includes a comprehensive model for a contractor
safety and health program in the chemical
industry.  Describes responsibilities, safety
requirements, safety and health training, safety
program, substance abuse, safety audit, and
accident reporting.
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TABLE 5-19: PUBLISHED GUIDANCE ON PROCESS SAFETY
Reference
U.S. Department of Labor, Occupational Safety
and Health Administration. UNDATEDa. The
Control of Hazardous Energy (Lockout/Tagout),
29 CFR 1910.147.
U.S. Department of Labor, Occupational Safety
and Health Administration. UNDATEDb.
Process Safety Management of Highly Hazardous
Chemicals, 29 CFR 1910.119.
U.S. Department of Labor, Occupational Safety
and Health Administration. UNDATEDc.
Regulations Relating to Labor, 29 CFR 1926.64,
Subpart D — Occupational Health and
Environmental Controls.
U.S. Department of Labor, Occupational Safety
and Health Administration. UNDATEDd.
Regulations Relating to Labor, 29 CFR 1910,
Subpart Z - Toxic and Hazardous Substances.
U.S. Department of Labor, Occupational Safety
and Health Administration. UNDATEDe.
Training Requirements in OSHA Standards and
Training Guidelines.
U.S. Department of Labor, Occupational Safety
and Health Administration. 1970. Occupational
Safety and Health Act of 1970, Public Law No.
91-596.
U.S. Department of Labor, Occupational Safety
and Health Administration. 1986. Safety &
Health Guide for the Chemical Industry.
U.S. Department of Labor, Occupational Safety
and Health Administration. 1989b. Chemical
Hazard Communication.
U.S. Department of Labor, Occupational Safety
and Health Administration. 1993. Process Safety
Management Guidelines for Compliance.
U.S. Department of Transportation. UNDATED.
Hazardous Materials Transportation
Regulations, 49 CFR 100 to 177.
Type of Guidance
Describes the OHSA regulations for the servicing
and maintenance of machines and equipment in
which the unexpected energization or start-up of
the machines or equipment, or release of stored
energy could cause injury to employees.
Describes the OSHA regulations for process
safety management of highly hazardous
chemicals.
Describes the OSHA regulations for preventing
or minimizing the consequences of catastrophic
releases of toxic, reactive, flammable, or
explosive chemicals.
Describes the OSHA regulations for hazard
communication.
Describes OSHA training guidelines and
requirements for general industry, maritime,
construction, agricultural, and federal employees.
Describes original OSHA statute.
Contains guidelines used by OSHA compliance
officers to evaluate employer safety programs,
particularly in the areas of disaster prevention
and emergency response.
Contains a summary of the OSHA Hazard
Communication Standard.
Describes a systematic approach to designing a
process safety management program.
Lists and describes hazardous materials as well
as requirements for shipping, labeling, and
transporting hazardous materials.
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TABLE 5-19; PUBLISHED GlfflQtANCE ON PROCESS .SAFETY ,
Reference
U.S . Department of Transportation. 1 994.
Emergency Response Guide.
Type of Guidance
Lists chemicals which are health hazards and the
emergency measures needed in the events of fire,
explosion, injury, spills, and accidental releases.
Note: References are listed in shortened format, with complete references given in the reference list following
Chapter 10.
DATA SOURCES: Table 5-20 lists sources of process safety data.
TABLlB5-20:SOTJltCESOFmOCESB$A|lBl['VJOATA "
Reference
Hazardous Chemicals Data Book. 1986.
Mercklndex. 1989.
National Fire Protection Association. 1995. Fire
Protection Guide on Hazardous Materials.
NIOSH/OSHA Pocket Guide to Chemical
Hazards. 1995.
Type of Data
Includes the following data on certain hazardous
chemicals: chemical description, fire and
explosion hazards, life hazards, personal
protection needed, fire fighting measures, usual
shipping containers, storage information, and
special remarks regarding electrical installations
and NFPA code numbers pertaining to the
specified chemical.
Handbook containing some caution and/or human
toxicity statements for some substances.
Includes complete text of four different fire
codes. Also includes chemical hazard data,
quantitative health hazard rating based on recent
research, and information needed on handling
and storage of hazardous chemicals.
Lists known hazardous chemicals along with
their health hazards, exposure limits, chemical
and physical properties, incompatibilities, and
suggested PPE, including recommended
respirators.
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CHAPTERS
                                                   PROCESS SAFETY ASSESSMENT
TABLE 5-20: SOURCES OF PROCESS SAFETY » ATA
Reference
Sax, N. Irving and Richard J. Lewis, Sr. 1989.
Dangerous Properties of Industrial Materials.
Threshold Limit Values for Chemical Substances
and Physical Agents in the Work Environment.
UNDATED.
Type of Data
A three-volume set containing hazard
information. Volume I contains essays on
selected topics relating to hazardous materials, a
CAS RN cross-index, a synonym cross-index,
and the list of CODEN bibliographic references
given in the data section. Volumes II and III list
and describe more than 20,000 materials in
alphabetical order by entry name. Descriptions
include physical and chemical properties, clinical
data on experimental animals and humans, a
material's hazard potential, IARC Cancer Review
and the U.S. National Toxicology Program
cancer testing program conclusions, OSHA
PELs, ACGIH TLVs, and NIOSH RELs, DOT
classifications, and Toxic and Hazardous
Reviews (THRs). Fire and explosion hazards are
briefly summarized.
Lists TLVs for many chemicals found in the
workplace.
 Chapter 10.
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PARTII;  CTSA INFORMATION MODULES
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                             MARKET INFORMATION
OVERVIEW: The market information module contains economic data used to evaluate the
importance of the target industry sector to the overall market for the alternatives under review,
and conversely, the economic importance of the alternatives to the industry sector. Market
information includes chemical/technology cost information, production and manufacturing
volumes, chemical/technological use breakdowns, and an analysis of market trends that could
affect future supply and demand.
GOALS:
       Evaluate the importance of the target industry sector to the overall market for the baseline
       and alternative chemicals and technologies.

       Compile price information for the baseline and alternatives to be used in the Cost
       Analysis module.

       Identify trends in the manufacturing and use of the baseline and alternatives that may
       influence future supply and demand.

       Compile information for the International Information module.
PEOPLE SKILLS:  The following lists the types of skills or knowledge needed to complete this
module.

 •     Knowledge of market information data sources and the capability to evaluate market
       trends.

 Within a business or a DfE project team, the people who might supply these skills include a
 purchasing agent or an economist. Vendors of the chemicals or technologies may also be a good
 resource.
 DEFINITION OF TERMS: Not applicable.


 APPROACH/METHODOLOGY: The following presents a summary of the technical
 approach or methodology for the Market Information module.

 Step 1:       Obtain chemical CAS RNs and synonyms from the Chemical Properties module.

 Step 2:       Using the most current data available, determine the total volumes of the
              chemicals and chemical products produced both in the U.S. and internationally,
                                          5-87

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PARTH: CTSA INFORMATION MODULES
              volumes imported and exported, volumes used by the target industry, and the
              names and locations of current producers (see Table 5-21: Sources of Market
              Information). Some of this information will have been collected in the Industry
              and Use Cluster Profile, but chemical use volumes may be unavailable or
              considered proprietary.

              When data are unavailable, a project team may estimate information so that the
              transfer of information to other modules will occur. Appendix F gives a detailed
              example of how chemical volumes were estimated in the screen reclamation use
              cluster.

Step 3:        For the baseline and/or alternative technologies and processes, identify the size of
              the market for the technology both in the U.S. and internationally, quantities
              exported and imported, quantities used by the target industry, and the names and
              locations of manufacturers within the U.S. and internationally.

Step 4:        Transfer information on chemicals or technologies primarily supplied by
              manufacturers outside of the U.S. to the International Information module.
              Information on international trade issues, as well as source, availability, and cost
              data for these alternatives are compiled in the International Information module.

Step 5:        Collect market price information for the baseline and alternative chemicals and
              technologies produced in the U.S. from the appropriate chemical or equipment
              vendors. Transfer market price information to the Cost Analysis module.

Step 6:        Evaluate the importance of the target industry to the overall market for the
              baseline and alternatives in the use cluster. If the  industry is a major market for
              an alternative (i.e., the amount of chemical produced fluctuates in response to the
              demand for the chemical in this industry; a technology was specifically developed
              and marketed for the target industry, etc.), consider evaluating the environmental
              impacts of upstream processes, such as the chemical manufacturing process, in the
              CTSA.

Step 7:        Identify factors that could potentially affect the future supply or demand of the
              baseline or substitutes produced in the U.S.  Possible factors include, but are not
              limited to:
              •     Proposed legislation on the manufacturing or use of a use cluster chemical,
                    such as bans or phase-outs (see the Regulatory Status module).
              •     Any recent or expected improvements in technologies that could affect the
                    future demand for a substitute in the target industry or in other industries.
              •     Resource or production limitations.

Step 8:        Transfer any information about expected changes  or shortfalls in the supply or
              demand for the baseline and  alternative chemicals and technologies to the Risk,
              Competitiveness & Conservation Data Summary module.

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CHAPTERS
                                            MARKET INFORMATION
FLOW OF INFORMATION: The Market Information module receives data from the
Chemical Properties and Regulatory Status modules and transfers information to the
International Information, Cost Analysis, and Risk, Competitiveness & Conservation Data
Summary modules.  Example information flows are shown in Figure 5-10.

                FIGURE 5-10: MARKET INFORMATION MODULE:
                        EXAMPLE INFORMATION FLOWS
•CAS RN and
 synonyms
                                  ;  Market
                                  information
                                                              and
                                                    countries of origin
                                                    of alternatives   <
                                                                     International
                                                                     Information
                                                                   ,-?  s   v •,
                                                                         ")
                                                                f     f  <  '
                                                   « Equipment prk»a
                                                   •Chemicat prices '
                                                        Cost
                                                      Analysis
          ,   - ,»      y-.
          s-    \   < *
                                                         short falls
                                                                        Risk,
                                                                   Competitiveness
                                                                    & Conservation
                                                                    Data Summary
ANALYTICAL MODELS: None cited.
PUBLISHED GUIDANCE:  None cited. EPA risk management documents (Preliminary Life-
Cycle Analysis and Pollution Prevention Assessment reports) provide examples of the types of
market information collected during the second phase of EPA risk management assessments.
 DATA SOURCES: Table 5-21 lists sources of market information.
TABLE 5-21; SOURCES OF MARKET INFORMATION
Reference
Chemical Business News Data Base. Updated
Periodically.
Chemical Economics Handbook. Updated
Periodically.
Type of Data
Data base containing chemical market trends.
Chemical volume and consumption data.
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PARTH:  CTSA INFORMATION MODULES
TABLE 5-21: SOURCES OF MARKET INFORMATION
Reference
Chemical Industry Notes Data Base. Updated
Periodically.
Chemical Marketing Reporter. Updated
Periodically.
Directory of Chemical Producers: United States
Producers. Updated Periodically.
Kirk-Othmer Encyclopedia of Chemical
Technology. Updated Periodically.
Mannsville Chemical Products Synopsis.
Updated Periodically.
Mines Data Base. Updated Periodically.
Type of Data
Data source for chemical industry production
trends.
and
Profiles of chemicals containing production data
and market trend information.
Chemical production information including
manufacturers and production data.
Chemical production information including
manufacturers and production data.
Chemical volume and consumption data.
Data source for raw mineral and metal
production.
Note:  References are listed in shortened format, with complete references given in the reference list following
Chapter 10.
                                             5-90

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                          INTERNATIONAL INFORMATION
OVERVIEW: The International Information module collects data pertaining to the use or
production of alternatives in other parts of the world, the impact of international trade on the
selection of alternatives, and the impacts of switching to an alternative on international trade.
Primarily, the international trade issues are driven by the source and availability of alternatives,
and possible indirect costs (e.g., taxes, tariffs, or prohibitions) imposed on alternatives.
GOALS:
       Identify alternatives in use or attempted in other countries and the reasons for using or not
       using the alternatives.

       Identify the alternative chemicals and technologies in use in the U.S. that are primarily
       supplied by international sources.

       Identify possible trade implications concerning use of alternatives.

       Understand how trade implications impact availability and the relative social
       benefits/costs of alternatives.
PEOPLE SKILLS: The following lists the types of skills or knowledge that are needed to
complete this module.

•     Ability to search data bases, government agencies, trade association literature,
       government documents, international organizations, and trade agreements to identify
       alternative chemicals and technologies used in other countries and to determine the
       source of the alternatives.

•     Knowledge of international trade regulations, agreements and treaties, and ability to
       determine the international trade implications of selections of particular alternatives.

Within a business or a DfE project team, the people who might supply these skills include a
purchasing agent,  an economist, or an attorney.
 DEFINITION OF TERMS:  Not applicable.
 APPROACH/METHODOLOGY: The following presents a summary of the approach for
 collecting international data and identifying international issues that could influence the selection
 of a substitute. Methodology details for Steps 1, 2, and 5 follow this section.
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PARTH: CTSA INFORMATION MODULES
Step 1:        Identify the countries of interest that contain a large target industry sector.
              Service-oriented businesses such as the dry cleaning industry will most likely be
              present hi almost all industrialized countries.  Other industries, such as the printed
              wiring board industry, may be concentrated hi certain regions of the world (i.e., in
              Asia, North America, etc.).

Step 2:        Identify the alternatives that are being used or have been tried in the countries
              identified in Step 1. If these alternatives differ from those of the U.S., identify the
              conditions driving the choice of alternatives, such as the presence or absence of
              regulations. This information may be useful for planning for the future and for
              spotting trends, including treatment by a national government of chemicals of
              concern. If new alternatives are identified in this step, the project team will need
              to decide whether they should be quantitatively evaluated in the CTSA.

Step 3:        Review the Market Information module to obtain data on the
              manufacturers/countries of origin of alternative chemicals, products, or
              technologies being evaluated in the CTSA.

Step 4:        Investigate potential international sources of alternatives with particular attention
              to the following:
              •      Production capacity, the capability of producers of meeting market
                     demand, and the stability  of pricing structures.
              •      The price of chemicals and/or technologies supplied by foreign sources.
              •      Potential problems arising from reliance on foreign suppliers, including
                     additional costs, such as taxes or tariffs, which may make imported
                     alternatives more expensive than domestic.

Step 5:        Investigate international trade regulations, agreements, and treaties for their
              impact on the chemicals or technologies. Examples of international trade
              agreements include the General Agreement on Tariffs and Trade (GATT) and the
              North American Free Trade Agreement (NAFTA).

Step 6:        Provide the price of chemicals and/or technologies primarily supplied by foreign
              sources to the Cost Analysis module. Market price information should reflect the
              suppliers price plus any additional costs, such as international taxes or tariffs or
              shipping costs.

Step 7:        Based on the information collected hi Steps 1 through 5, assess the relative social
              benefits and costs, including the potential indirect costs of selecting an alternative.
              Indirect costs of alternatives only supplied by international sources might include
              taxes, tariffs, or prohibitions in addition to foreign relations conflicts or loss of
              U.S. jobs. International bans or prohibitions on chemicals or technologies could
              affect a company's ability to market products made with that technology.
                                           5-92

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CHAPTERS
                                                       INTERNATIONAL INFORMATION
Step 8:
             Alternatives that have been discontinued in some countries may have less stable
             pricing structures.

             Provide information on source, availability, and possible indirect costs of the
             alternatives to the Risk, Competitiveness & Conservation Data Summary module.
METHODOLOGY DETAILS: This section presents methodology details for completing
Steps 1, 2, and 5.

Details: Steps 1,2, and 5, Identifying Countries of Interest, Alternatives in Use, and
International Trade Regulations, Treaties, or Agreements

Trade associations and chemical and equipment suppliers may be good resources for
international manufacturing or market share data.  Federal agencies and programs that may be
able to provide information include the U.S. Department of Commerce, the U.S. Agency for
International Development, the U.S. Trade and Development Program, and the U.S. Trade
Representative. International organizations include the Organization of Economic Co-operation
and Development, the United Nations Conference on Trade and Development, the United
Nations Development Program, the United Nations Environment Program, the World Trade
Organization, and the World Bank.
FLOW OF INFORMATION: The International Information module receives data from the
Market Information module and transfers data to the Cost Analysis and Risk, Competitiveness &
Conservation Data Summary modules. Example information flows are shown in Figure 5-11. If
new alternatives are identified, the project team must decide whether to include them in the
detailed analyses of the CTSA. If so, these alternatives must be returned to the beginning of the
CTSA process.

             FIGURE 5-11: INTERNATIONAL INFORMATION MODULE:
                         EXAMPLE INFORMATION FLOWS
              I f
      Market
    Information
                        International
                        Information
                                            « CkffitofciTemkaals and/or
                                              technologies from
                                                                       Cost Analysis

       Oi
        '
                                               saw international sources
                                               iterrraiional trade issues ;
                                            • Other indirect costs
                                                                   Risk, Competitiveness
                                                                    & Conservation Data
                                                                        Summary
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EARTH: CTSA INFORMATION MODULES
ANALYTICAL MODELS: None cited.
PUBLISHED GUIDANCE: None cited.
DATA SOURCES: Table 5-22 presents references for data bases, published literature, and
government contacts.
              TABLE 5-22: SOURCES OF 1ENTERNATIONAL INFORMATION
                  Reference
               Type of Data
 Brownson, Ann L., Ed. 1994. Federal Staff
 Directory/1.
Directory of federal programs, services and data
bases such as the U.S. Department of Commerce
Trade Data Services; U.S. Department of
Commerce International Data Base, Census
Information; and contacts within the U.S.
International Trade Commission. Federal trade
services and databases are useful for collecting
international information, and for identifying
addresses and telephone numbers of international
organizations.
 Russell, John J., Ed.  1994. National Trade and
 Professional Associations of the United States.
Directory of U.S. Trade Associations
representing various industry sectors, including
associations aimed at expanding international
trade. (For example, the U.S. - ASEAN Council
for Business and Technology strives to expand
trade between the U.S. and Southeast Asia.)
 U.S. Congress. 1992. Trade and Environment:
 Conflict and Opportunities.
Background paper describing the potential for
conflict between trade and the environment, as
reflected in disputes about the trade impacts of
environmental laws and about the environmental
impacts arising from efforts to liberalize trade
and investment.
Note: References are listed in shortened format, with complete references given in the reference list following
Chapter 10.
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                                                                   Chapter 6
                                                                       RISK
This chapter presents module descriptions for the risk-related component of a CTSA, including
the following analytical modules:

•      Workplace Practices & Source Release Assessment.

•      Exposure Assessment.

•      Risk Characterization.

Data from the Workplace Practices & Source Release Assessment module combine with data
from the Chemical Properties and Environmental Fate Summary modules to provide the
foundation for the Exposure Assessment module. Data from the Exposure Assessment module
then combine with data from the Human Health Hazards Summary and Environmental Hazards
Summary modules to characterize risks in the Risk Characterization module.

Data from all three of these modules flow into the final trade-off evaluations presented in
Chapter 10. For example, the source and quantities of environmental releases from the
Workplace Practices & Source Release Assessment module are qualitatively evaluated in the
Social Benefits/Costs Assessment module for the effects of pollution on health, recreation,
productivity, and other social welfare issues. The social benefits of reduced risk are considered
more quantitatively using data from the Risk Characterization module.

The Exposure Assessment module provides the amounts of environmental releases that were not
quantified in the Workplace Practices & Source Release Assessment module (e.g., solvent
emissions from open containers that were modeled during the Exposure Assessment) to the Risk,
Competitiveness & Conservation Data Summary module for evaluation with the other release
data. It also provides an evaluation of the potential for exposure (e.g., high, medium, or low) by
different pathways (e.g., ingestion, inhalation, dermal) to the Risk, Competitiveness &
Conservation Data Summary module. Past CTSAs have used exposure levels as an indicator of
the potential for risk when health and environmental hazard data are not available.

The Risk Characterization module provides human health and ecological risk data to the Risk,
Competitiveness & Conservation Data Summary module for evaluation in the Social
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PART H: CTSA INFORMATION MODULES
Benefits/Costs Assessment and Decision Information Summary modules.  The former module
considers the social benefits of reduced risk and folds these benefits into an overall evaluation of
the net benefits (or costs) to society of a substitute.  The Decision Information Summary module
presents the risk data directly in the final trade-off evaluations where individual decision-makers
consider all of the issues to choose the alternative that best fits their particular situation.
                                           6-2

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          WORKPLACE PRACTICES & SOURCE RELEASE ASSESSMENT
OVERVIEW:  The survey of workplace practices and source release assessment is the process
of: (1) identifying and collecting data on workplace activities that may contribute to worker
exposure; and (2) identifying the sources and amounts of environmental releases. The collected
data are analyzed to determine the sources, nature, and quantity of both on-site releases (e.g.,
chemicals released to the sewer, evaporative, or fugitive emissions from the process, etc.) and
off-site transfers (e.g., discharges to publicly owned treatment works).
GOALS:
       Collect workplace practices data through discussions with industry experts, review of
       existing information, the performance demonstration project, or the dissemination of a
       questionnaire to industry.

       Create a profile of a typical or model facility which can be used as the model for source
       release and exposure assessment calculations.

       Perform a source release assessment on the model facility to identify and characterize
       both on-site and off-site chemical releases and transfers.

       Provide data needed for the Exposure Assessment module which estimates possible
       exposure concentrations to human health and the environment.
PEOPLE SKILLS: The following lists the types of skills or knowledge that are needed to
complete this module.

•      In-depth knowledge of the process under review, including waste streams and their point
       sources.

•      Understanding of the concepts of material balances.

•      Knowledge of the workplace activities associated with the operation of the process.

•      Experience with exposure assessment guidance and methodology.

•      Understanding of chemical fate, transport modeling and exposure modeling.

•      Knowledge of chemistry or environmental science.

•      Knowledge of surveying techniques and methodologies if a survey is utilized.
                                          6-3

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PARTII: CTSA INFORMATION MODULES
              they should be included in the entire CTSA process (e.g., collect chemical
              properties, hazard data, etc.).

Step 9:        Create a profile of an average (model) facility from the tabulated data in Step 6.
              This is done by computing the average or other representative value of the
              appropriate survey data collected during the survey (i.e., number of workers
              employed, number of shifts operated, amount of chemical used, amount of
              chemical released to air, etc.). The profile will be used as the model facility for
              source release and exposure assessment calculations.

Source Release Assessment

Step 10:      Using the data from the model facility, the process flow diagram, and the results
              of the site visits, identify the sources of chemical releases to the environment.
              The sources of some of the releases will be clearly identified in the questionnaire
              while others, such as open containers of volatile chemicals that result in air
              emissions, will have to be modeled using other data, such as chemical properties
              data from the Chemical Properties module, together with the workplace practices
              data.  In a CTSA, the modeling of chemical releases or transfers that cannot be
              explicitly estimated from the survey data (i.e., volatization of volatile organic
              compounds [VOCs] from open containers, etc.) is usually done in the Exposure
              Assessment module.

Step 11:      Characterize each of the chemical releases identified in Step 10 by determining
              the following attributes:
              •     Location of the release; on-site (i.e., fugitive or evaporative process
                     releases to air, stack emissions, etc.) or off-site (i.e., air releases from
                     contaminated rags that have been sent to a cleaning service, etc.).
              •     Media to which the release takes place (i.e., air, water, or land).
              •     Quantity of the release. (In some cases, such as evaporative losses of
                     VOCs from open  containers, the quantity of release will need to be
                     estimated using mathematical models. See the Exposure Assessment
                     module for information on models used by EPA.)
               •     Composition of the release (e.g., weight or volume percent), if known or
                     reported.

Peer-Review and Data Transfer

 Step 12:      Verify the accuracy and consistency of the source release and exposure
              assessment profile created for the model facility by using any or all of the
               following methods:
               •     Perform a physical examination on one  or more facilities with similar
                     characteristics to  the model facility.
               •     Have knowledgeable industry representatives review the profiles.
                                            6-6

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 CHAPTER 6
WORKPLACE PRACTICES & SOURCE RELEASE ASSESSMENT
              •      Perform data quality checks such as checking that the reported value for
                     the amount of chemical disposed does not exceed the amount of chemical
                     purchased.
              •      Perform material balances on the model facility and check the model for
                     reasonableness.

 Step 13:      Submit the survey and source release results for peer-review by industry experts.
              Clearly state all assumptions used in calculating the releases, as well as any
              sources of uncertainty.

 Step 14:      Provide source release and workplace practices data collected by the questionnaire
              to the Exposure Assessment and Pollution Prevention Opportunities Assessment
              modules; source release data to the Control Technologies Assessment module;
              chemical handling data and process operating practices to the Process Safety
              AssessmenUnodule; and source release data to the Risk, Competitiveness &
              Conservation Data Summary module.
METHODOLOGY DETAILS:  This section presents the methodology details for completing
Steps 2, 3, 5, and 12. If necessary, additional information on conducting a source release
assessment can be found in the published guidance.                       :

Details:  Step 2, Identifying Data Requirements

An important step in the performance of both the source release and exposure assessments is the
identification of the data that must be collected.  Data types that are typically collected for use hi
this or other CTSA modules include, but are not limited to, the following:

Facility and Employee Information                                      '
       Total population of workers in the industry.
       Number of workers at the facility.
       Number of workers at the facility who are potentially exposed to the chemicals in the
       use cluster.
       Number of operating days per year.
       Number of shifts run per day.
       Number of hours per shift.
       Number of hours of worker exposure to use cluster chemicals per shift.
       Dimensions of the operating area in which chemical exposure may occur.
Worker Exposure Information

•      Name of chemical.
•      Concentration of chemical.
•      Operations/activities leading to potential chemical exposure.
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PARTH: CTSA INFORMATION MODULES
•      Duration of potential chemical exposure.
•      Frequency of potential chemical exposure.
•      Personal protective equipment used.

Source Release Information
       Amount of chemical purchased per year.
       Amount of chemical used per day.
       Total chemical releases by facility per year.
       Location of release (on-site or off-site).
       Media of chemical release.
       Amount of chemical releases per site per day.
       Frequency of chemical releases.
       Duration of chemical releases.
 Other Information

       Pretreatment standards and discharge permits.
       Types of in-process engineering controls used to reduce exposures.
       Types of end-of-pipe control technologies used to reduce releases and exposures.
       Types of pollution prevention practices used to reduce or prevent releases.
       Types of recycling used hi waste streams or elsewhere to mitigate releases.

 Details: Step 3, Creating a Workplace Practices Questionnaire

 The workplace practices questionnaire is the primary tool in the CTSA process for gathering data
 from industry. Because the information to be collected is often case-specific, the ideal
 questionnaire is tailored to the selected industry, and it results from the collaborative efforts of
 individuals possessing the people skills listed in this module.

 The required exposure and source release data may be obtained directly  from the questionnaire,
 or indirectly through calculations using the questionnaire results, together with other information.
 Data should be collected and presented on a per unit production basis, or some other basis that
 allows a comparative evaluation of the baseline and alternatives. The workplace practices
 questionnaire should not be unduly lengthy, as this will influence the quality and quantity of the
 responses that will be received.

 Details: Step 5, Disseminating the Workplace Practices Questionnaire to Industry

 Surveys should be disseminated to facilities of various sizes and production levels in a manner
 that will ensure the confidentiality of the facilities responding.  Trade associations can fulfill this
 role by providing a list of target facilities to participate in the survey, and by acting as an
 intermediate, assuring the confidentiality of those facilities that participate.  Trade associations
 have been responsible for disseminating the questionnaires for all of the previously performed
 CTSAs.
                                            6-8

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CHAPTER 6
                               WORKPLACE PRACTICES & SOURCE RELEASE ASSESSMENT
Details:  Step 12, Verifying Accuracy and Consistency: Material Balance Principles

A material balance is an accounting of the flows of a material into and out of a system.
Performing a material balance involves the following steps:

       (1)   Define a system boundary around which the material balance will be calculated.
             The boundary of the system for the material balance can be chosen as the entire
             process or any portion of the process where material streams enter or leave the
             system.  Typically, for this type of application, the entire process shown in the
             process flow diagram created in the Chemistry of Use & Process Description
             module is  selected.

       (2)    Develop a set of material balance equations that include terms for all of the
              streams entering or leaving the system boundary. A material balance can be
              performed using a:
              •      Material or substance (e.g., lubricating oil, plastic pellets, etc.).
              •      Chemical compound (e.g., water [H2O], hydrochloric acid [HC1], natural
                     gas [CH4], etc.).
              •      Individual chemical element (e.g., Hydrogen [H], Carbon [C], Sodium
                     [Na], etc.).

              The material balance equation states that the inputs of the material must equal the
              outputs of the material plus any accumulation. This condition holds true as long
              as there is not a chemical reaction taking place.

        (3)    Enter quantities for known input and output streams into the set of material
              balance equations. Stream data can come directly from questionnaire data that
              have been collected or from individual company records if the questionnaire data
              on a stream are inconclusive. Input stream data can be typically obtained
              from purchase or inventory information.  Output stream data can be obtained from
              reported waste stream information or calculated from chemical properties together
              with chemical use data.

        (4)    Mathematically solve the set of equations for any unknown or unqualified terms
              that remain.  Only one unknown term for each material balance equation can be
               quantified. Therefore, there must be at least as many different material balance
               equations as there are unknown streams in order to solve the equation set. If there
               are more unknown terms than equations, and the system boundary cannot be
               redrawn to correct the situation, then performing a material balance is not possible
               and the unknown release will have to be modeled. In cases where the equation
               cannot be made to balance because of inaccuracies in data, then the releases,
               again, will have to be modelled.

  For cases in which a chemical reaction occurs within the system, a material balance must
  consider the rate of consumption or production of the chemical constituents (see combustion

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 PARTII: CTSA INFORMATION MODULES
 example below). The balanced chemical equation is used to determine the limiting reactant of
 the chemical reaction. The limiting reactant is the reactant that is consumed entirely as the
 chemical reaction occurs.  Through the use of a properly balanced chemical equation and molar
 ratios, the unknown reactant and product streams can be quantified. For additional assistance
 with applications involving chemical reactions consult a chemical engineering text (see
 Published Guidance section).

 Shown below are two examples of material balance equations. The first is an example of a
 situation where a chemical reaction is not present in the process. Finally, a typical combustion
 problem is used as an example of a situation involving a chemical reaction within the system
 boundary.

 Example. Material Balance Without a Chemical Reaction Present

 Figure 6-1 is an example of a material storage and component manufacturing process. The
process is being run at steady-state so there is no accumulation of material within the system
boundary. No chemical reaction occurs in the process.

      Material Balance for Material 'A'
      Mass In = Mass Out - Mass Accumulation
      Mass In = Mass AInput[l]
      Mass Out = Mass Aevap [3]+ Mass Aair [4]+ Mass Aprod [5]+ Mass
      Mass A Accumulation = 0

      Material Balance for Material 'TV
      Mass In = Mass Out - Mass Accumulation
      MassIn = MassBInput[2]
      Mass Out = Mass B^ [5] + Mass  Bdisp [6] + Mass Bwater [7]
      Mass B Accumulation = 0
  FIGURE 6-1: FLOW DIAGRAM OF MANUFACTURING PROCESS WITHOUT A
                              CHEMICAL REACTION
r
A_... ni i
* "input I'J |w
|j»


L_


Release to air
(Evaporation)
Material 'A'
MM*.*.:.!
Material 	
Storage

	 * 	 , 	 _ _
System boundary

Release to air
Material 'A'
•-^~ — ff^-"-
v
— *?• Manufacturing

_^llll-p3C_
Water discharge
Material 'B'
Product outputs
"",1
ucJ. product
•i 	 *J ^^. A O
Solid waste outputs


                                       6-10

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CHAPTER 6
                         WORKPLACE PRACTICES & SOURCE RELEASE ASSESSMENT
Example. Chemical Reaction Present Within the System Boundary

In a material balance in which a chemical reaction is involved, the moles of a species (chemical
compound) and the total moles of the reaction are not conserved. The mass balance must be
made around the total mass and the mass or moles of each atomic species.  In the example below,
a total mass balance, and a carbon, hydrogen, and oxygen balance  can be written. Figure 6-2 is
an example of a furnace where the  combustion of natural gas represents the reaction. The
combustion of natural gas (CH4) takes place in the presence of excess oxygen (O2) which is
typically supplied by air. Therefore, natural gas represents the limiting reactant and will be the
basis for all calculations.

          FIGURE 6-2:  NATURAL GAS FURNACE PROCESS DIAGRAM
Natural gas—.
                                        FURNACE
                                  (with combustion reaction)
                                           T
 The combustion process is described by the following balanced chemical reaction:

              Balanced Chemical Reaction: CH4 + 2 O2 -> CO2 + 2 H2O

 This equation shows that for every one mole of CH4 that reacts with two moles of O2, one mole
 of carbon dioxide (CO2) and two moles of water (H2O) are produced. From this information, and
 using the basis of 100 kilograms (kg) per hour of CH4, the following data can be calculated:

       (1)    Calculate the moles of natural gas (CH4) consumed using the molecular weight for
              CH4. The molecular weight can be found by consulting a periodic table and
              totaling the individual atomic weights of one carbon atom (C = 12) and four
              hydrogen atoms (H = 1).

              Molecular weight of CH. :   12+ 4(1) =16

              Moles of CH.:             100 kg + 16 kg/mol = 6.25 moles of CH4

        (2)    Calculate the moles of reactant consumed and reaction products produced by
              using the molar ratios defined by the chemical equation. In this case, the equation
              shows that for every one mole of CH4 consumed, two moles of O2 are consumed,
              one mole of CO2 is produced, and two moles of H2O are produced.
                                          6-11

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PARTII:  CTSA INFORMATION MODULES
      (3)
      (4)
      (5)
             Moles of CCs produced:
             Moles of HoO produced:
             Moles of O2 reacted:
                           moles of CH4 = moles of CO2
                           6.25 moles CH4 = 6.25 moles CO2
                           6.25 moles CO2 produced

                           2 x moles of CH4 = moles of H2O produced
                           2 x 6.25 moles CH4 = 12.5 moles H2O produced
                           12.5 moles H2O produced

                           2 x moles of CH4 = moles of O2 reacted
                           2 x 6.25 moles CH4 = 12.5 moles O2 reacted
                           12.5 moles O2 reacted
 Calculate the flow rates of unknown input and output streams using the molecular
 weights for each of remaining streams. The molecular weights for CO2, H2O, and
 O2 were calculated using method of step 1 above. The input flow rate of oxygen
 is supplied by:
            Molecular weights:



            kg of CO2 produced:

            kg of H2O produced:

            kg of Oo reacted:
                          C02   = 12+ 2 (16) = 44 kg/mol
                          H2O   = 2(1)+16= 18kg/mol
                          O2     = 2(16) = 32kg/mol

                          6.25 moles CO2 x 44 kg/mol = 275 kg CO2

                          12.5 moles H2O x 18 kg/mol = 225 kg H2O produced

                          12.5 moles O2 x 32 kg/mol = 400 kg O2 reacted
Calculate the input flow rate of air required to supply the needed oxygen. This
quantity differs from the amount of O2 reacted because air contains only 21
percent oxygen.
            Composition of air:
            kg of air required:
                          21 percent Oxygen (O2)
                          79 percent Nitrogen (N2)

                          400 kg O2 •*• 0.21 kg O2/kg air = 1904.7 kg air
Verify that the mass balance calculation was performed correctly by checking
that the total mass of the input streams is equivalent to the total mass of the
output streams (i.e., total mass is conserved).

Total kg of input streams:    100 kg CH4 + 400 kg O2 = 500 kg input material

Total kg of output streams:   275 kg CO2 + 225 kg H2O = 500 kg output material

             500 kg Input material = 500 kg Output material

                           6-12

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CHAPTER 6
                               WORKPLACE PRACTICES & SOURCE RELEASE ASSESSMENT
FLOW OF INFORMATION: In a CTSA, this module receives information from the
Chemistry of Use & Process Description module and transfers information to the Chemical
Properties, Exposure Assessment, Pollution Prevention Opportunities Assessment, Control
Technologies Assessment, Process Safety Assessment, and Risk, Competitiveness &
Conservation Data Summary modules. Example information flows are shown in Figure 6-3.


    FIGURE 6-3- WORKPLACE PRACTICES & SOURCE RELEASE ASSESSMENT
                   MODULE: EXAMPLE INFORMATION FLOWS
                                                                        Chemical
                                                                        Properties
                                                                         Exposure
                                                                       Assessment
                                                                         Pollution
                                                                        Prevention
                                                                       Opportunities
                                                                        Assessment
                                                                          Control
                                                                       Technologies
                                                                       Assessment
                                                                          process
                                                                           Safely
                                                                        Assessment
                                                                            Risk,
                                                                       Competitiveness
                                                                       & Conservation
                                                                       Data Summary


,.  I  ^'  ^
       1    T-
;  ^ v  ;   * "-
       x>."  s\ ^
                                ^ (
                                »i i
                                £,
                               5- /^
 Chemistry of
Use & Process
  Description
                        Workplace
                        Practices &
                      Source Release
                        Assesm0nt
       Unit operations
              flow diagram
                                             « Chemical names
                                          Chemical handting „
                                          activities      •
                                        * Operating practices
                                        • Waste stream quantities '
                                          OimpoEitkan of releases   '
                                         * Worker aclivrtes
                                              « Release sources
                                              * Composition of raieases
                                          Release sources
                                         • Composition of releases
                                         «\Mwkeracf\aBe8L   -
                                         » Waste atraam quantities
                                         • Release sources
                                         • Composftton of raieases
                          '_ -C
                                         • Waste stream quantities
                                         • Release sources
                                         m Composrtion of releases
                                           6-13

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  PARTH; CTSA INFORMATION MODULES
  ANALYTICAL MODELS: Table 6-1 presents references for analytical models that can be
  used to perform a source release assessment.
            TABLE 6-lj ANALYTICAL MQBELS USEB TQ PERFORM A SOURCE
                                RELEASE. ASSESSMENT^
                  Reference
                                                          Type of Model
  U.S. Environmental Protection Agency. 1992b.
  Strategic Waste Minimization Initiative (SWAM)
  Version 2.0.
Software tool for personal computers to aid in
preparing a source release assessment.
 Note: References are listed in shortened format, with complete references given in the reference list following
 Chapter 10.                                                                      6
 PUBLISHED GUIDANCE:  Table 6-2 presents references for published guidance on source
 release assessments and the use of mass balances.
TABLE 6-2: PUBLISHED GUIDANCE ON SOURCE RELEASE ASSESSMENTS A1SB THE
USEOFMASSBAJpA^M.r;, VM1It , ]
Reference
Lorton, G.A., et. al. 1988. Waste Minimization
Opportunity Assessment Manual.
Luyben, William and L. Wenzel. 1988.
Chemical Process Analysis: Mass and Energy
Balances.
U.S. Environmental Protection Agency. 1987a.
Estimating Releases and Waste Treatment
Efficiencies for the Toxic Chemical Release
Inventory Form.
U.S . Environmental Protection Agency. 1 99 1 e.
Chemical Engineering Branch Manual for the
Preparation of Engineering Estimates.
U.S. Environmental Protection Agency. 1992c.
User's Guide: Strategic Waste Minimization
Initiative (SWAMI) Version 2.0.
Type of Guidance
Describes the EPA method for performing a
source release assessment.
Describes the use of mass balances.
Describes methods to determine waste streams by
measurement, mass balance, or estimation.
Describes various approaches and data sources
for release estimation.
User's Manual for the SWAMI software package.
Note. References are listed in shortened format, with complete references given in the reference list followins
Chapter 10. . ,
DATA SOURCES: None cited.
                                        6-14

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                             EXPOSURE ASSESSMENT
OVERVIEW: An exposure assessment is the quantitative or qualitative evaluation of the
contact an organism (human or environmental) may have with a chemical or physical agent,
which describes the magnitude, frequency, duration, and route of contact.
GOALS:

•     Estimate occupational exposure to workers.

•     Estimate consumer exposure from product use (if applicable).

•     Estimate exposure to humans and aquatic organisms from releases to the ambient
       environment.
 PEOPLE SKILLS: The following lists the types of skills or knowledge that are needed to
 complete this module.

 •     Knowledge of exposure assessment guidance and methodology, including in the context
       of an occupational setting.

 •     Understanding of chemical fate, transport modeling and exposure modeling.

 •     Background in chemistry and environmental science.

 •     Background in occupational health or industrial hygiene.

 Within a business or a DfE project team, the people who might supply these skills include a
 chemist, environmental scientist, industrial hygienist, and/or chemical engineer.

 Note:  The analysis presented in this module should only be undertaken by someone with
        expertise in exposure assessment.  Because  of the complexity and multidisciplinary
        nature of exposure assessments, it may be necessary even for the experienced exposure
        assessor to  seek assistance from others with expertise in certain areas of the assessment.
        Furthermore, peer-review of the completed exposure assessment is recommended.
  DEFINITION OF TERMS:

  Acute Exposure:  Exposure occurring over a short period of time (e.g., 14 days or less for fish).
  The specific time period varies depending on the test method and test organism or the receptor of
  interest.
                                           6-15

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  PARTII;  CTSA INFORMATION MODULES
  Agute Potential Dose Rate (APDR): The dose, usually expressed on a per day basis, averaged
  over a period of time corresponding to an acute exposure period.

  Averaging Time (AT): The time period, usually expressed in units of days, over which exposure
  is averaged when calculating an average dose rate.

  Pioconcentration Factor (BCF): The equilibrium ratio of the concentration of a chemical in an
  exposed organism to the concentration of the chemical in the surrounding water.

  Chronic Exposure: Continuous or intermittent exposure occurring over an extended period of
  time, or a significant fraction of the animal's or the individual's lifetime (e.g., > 20 days for
  daphnids).

  Contact Rate (CR): The amount of contaminated medium contacted per unit time or event (e.g.,
 m3 per day  of air inhaled, liters per day of water ingested).

 Dose:  See Potential Dose Rate.

 Exposure: The contact of an organism (human or environmental) with a chemical or physical
 agent, expressed in terms of concentration and time.

 Exposure Concentration, Exposure Point Concentration: The chemical concentration, in its
 transport or carrier medium, at the location of contact with an organism. Also defined, typically
 for exological risk, as the Expected Environmental Concentration (EEC) or Predicted
 Environmental Concentration (PEC).

 Exposure Descriptor:  A term used to characterize the position an exposure estimate has in the
 distribution of possible exposures (e.g., high-end, central tendency) for the population of interest.

 Exposure Duration (ED): The duration of exposure, typically expressed in terms of days or
 years.

 Exposure Frequency (EF): The frequency of exposure, expressed in units of days per year,
 events per year, events per lifetime, etc.

 Exposure Level: In general, a measure of the magnitude of exposure, or the amount of an agent
 available at the exchange boundaries (i.e., lungs, gastrointestinal tract, or skin), during some
 specified time.  In the Exposure Assessment and Risk Characterization modules, "exposure
 level" is used specifically as a measure of exposure expressed as a concentration rather than as a
potential dose rate.

Exposure Pathway: The physical course a chemical takes from the source to the organism
exposed. An example of an exposure pathway might be inhalation by a worker of volatile
organic compounds (VOCs) that have evaporated from a solvent to the air.
                                         6-16

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CHAPTER 6
                                                                EXPOSURE ASSESSMENT
Exposure Point: The location of potential contact between an organism and a chemical or
physical agent.

Exposure Route: The route by which a chemical (or physical agent) comes in contact with the
body of a receptor (e.g., by inhalation, ingestion, or dermal contact).

Exposure Scenario:  A description of the specific circumstances under which exposure might
occur, consisting of facts, assumptions, and inferences about how exposure takes place.  An
exposure scenario may comprise one or more exposure pathways.

Exposure Setting: The time frame and location, including a facility and its surrounding
environment, where exposure might occur.

T.ifetime Averap* nai1Y r.onr.entration (LAPP:  The estimated daily concentration (usually in
air) during the exposure duration, averaged over a lifetime.

T.ifetime Average Hailv Dose (LAPDV. The estimated potential daily dose rate received during
  .                                 .
 the exposure duration, averaged over a lifetime. LAPP is typically expressed in units of mg/kg-
 day.

 Peak Exposure- T.evel or Pose: The maximum exposure level or maximum potential dose rate.

 Potential Pose Rate (PDIO; The amount of a chemical ingested, inhaled, or applied to the skin
 per unit time (e.g., in units of mg/day).  PDR may also be expressed per unit body weight per
 unit time (e.g., in mg/kg-day). PPR is the amount of a chemical that is available at the body s
 exchange boundaries and potentially could be  absorbed into the body. (Related terms used
 elsewhere include "intake" or simply "dose," although the term dose implies that absorption is
 taken into account while PPR does not. The concepts of intake, dose and potential dose are
 described in detail in "Guidelines for Exposure Assessment" [EPA, 1992a].)

 Receptor: The organism of interest (human or non-human) involved in a particular exposure
 pathway.
  APPROACH/METHODOLOGY: The following presents a summary of the approach or
  methodology for conducting an exposure assessment. Further details on Steps 2, 3, 5, 6, 7, 8,
  and 9 are presented in the next section of this module.  It should be noted that this is intended as
  a simplified overview of the exposure assessment process, which will vary on a case-by-case
  basis The reader is referred to guidance documents (see Table 6-8) for further information. The
  guidance documents alone, however, do not substitute for experience; professional judgement
  plays an important role in the exposure assessment process, as stated in "Guidelines for Exposure
  Assessment" (EPA, 1992a):

         "Exposure assessments are done for a variety of purposes and for that reason, cannot
         easily be regimented into a set format or protocol."... "Professional judgement comes

                                            6-17

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  PARTII; CTSA INFORMATION MODULES
         into play in virtually every aspect of the exposure assessment process, from defining the
         appropriate exposures scenarios, to selecting the proper environmental fate models, to
         determining representative environmental conditions, etc."

  With these caveats, the steps involved in exposure assessment are summarized below.

  Step 1:       Identity the potentially exposed population^), including any sensitive or highly
               exposed subpopulation(s).  For example, populations may include workers in a
               facility and residents living near a facility; special subpopulations may include
               children, the elderly, or residents living especially close to a facility.
               Occupational and population exposures are evaluated separately.

  Step 2:        Characterize the exposure setting. This includes characterizing the physical
               environment, all waste streams, and defining the exposure scenarios to be
               evaluated for the identified population(s). Collect information on the exposure
               setting from the Chemistry of Use & Process Description and the Workplace
               Practices & Source Release Assessment modules, and the Industry and Use
               Cluster Profile (see Chapter 2).

 Step 3:        Based on the characterization from Step 2, evaluate any possible exposure
               pathways and select complete exposure pathways to evaluate.  Collect information
               pertaining to exposure pathways from the Workplace Practices & Source Release
               Assessment and Environmental  Fate Summary modules. The potential for
               population exposures should be  evaluated for releases to water, releases to air, and
               releases to land.

               Perform a literature search for available chemical concentration data, such as
               chemical concentrations in indoor air.

              Estimate concentrations in all media where exposure could occur. (For the
              aquatic exposure assessment, estimate concentrations in water where exposure to
              aquatic organisms could occur.)  Concentrations can be from measured data
              and/or estimated using chemical fate and transport models. Use information from
              the previous steps, the Industry and Use Cluster Profile, and the following
              modules to estimate concentrations: Chemical Properties, Environmental Fate
              Summary, Workplace Practices & Source Release Assessment, Performance
              Assessment, and Control Technologies Assessment.

Step 6:        Select values for exposure parameters used to estimate PDR for the population(s)
              of interest, clearly documenting the data sources and any assumptions made.
              Collect information pertaining to occupational exposure parameters from the
              Workplace Practices & Source Release Assessment module.

Step 7:        Quantify exposure either in terms of PDR or exposure level.
Step 4:


Step 5:
                                          6-18

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CHAPTER 6
                                                                EXPOSURE ASSESSMENT
Step 8:

Step 9:
Evaluate uncertainties.

Provide exposure information to the Human Health Hazards Summary, Risk
Characterization, and Risk, Competitiveness & Conservation Data Summary
modules.
METHODOLOGY DETAILS: This section presents methodology details for completing
Steps 2 3 5  6 7 8 and 9.  Additional information on these and other steps can be found in the
previously published guidance (see Table 6-8: Published Guidance on Exposure Assessment). In
addition detailed examples of occupational exposure assessment and population exposure
assessment are presented in Appendix B and C, respectively, from the Screen Reclamation
CTSA (EPA, 1994c).

Details: Step 2, Characterizing the Exposure Setting

 This involves characterizing the physical setting with regard to actual or potential exposure for
 the populations) of interest (e.g., workers, consumers, persons exposed through releases to the
 ambient environment, and aquatic organisms). In a CTSA, some of this characterization is
 performed in other modules.  An evaluation of the process flow or the unit operations involved in
 the use cluster is performed in the Chemistry of Use & Process Description module.  The
 Workplace Practices & Source Release Assessment module provides information on the
 occupational setting and worker activities required to characterize worker population exposure
 (e g number of workers, job descriptions), the chemical release/emission points, and the
 quantity of chemical released for a "model" or "sample" facility, as well as the media to which
 the chemical is released.

 Information on product use by consumers, and land use and demographic data for areas
 surrounding the facilities and other release points could be used to assess potential exposures to
 other human populations.  Additional information on the location of aquatic environments might
 be used to assess exposure to aquatic organisms, and to humans through the food chain.

  Characterizing the exposure setting leads to defining exposure scenarios to be evaluated.  Some
  example scenarios include:                                               .
  •      Nearby residents using groundwater in their homes that has been contaminated by
         releases from a landfill.
  •      Consumers bringing dry-cleaned clothes into their homes, potentially exposing
         themselves to perchloroethylene.
  •      Workers in a facility using a specific piece of equipment or performing a specific process.

  Many other exposure scenarios are possible, and are very case-specific. The definition of
  exposure scenarios leads to selection of the exposure pathways to be evaluated.  An exposure
  scenario may comprise one or several pathways.
                                            6-19

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   PARTH; CTSA INFORMATION MODULES

   Example data elements that may be used to characterize the exposure setting and define the
   exposure scenarios are listed below, along with sources of those data.

   •     Sizes for small and medium facilities: from the Workplace Practices & Source Release
         Assessment module.
   •     Average number of workers at a facility: from the Workplace Practices & Source Release
         Assessment module.
   »     Total population of workers in the industry: from the Workplace Practices & Source
         Release Assessment module, the Industry and Use Cluster Profile, and other sources (e g
         ISESTC6S' C6nSUS data' Nati°nal Institute for 0ccUPational Safety and Health
         [NIOSH], Health Hazard Evaluations [HHE]).
  •      Operations/activities in handling the chemicals: from the Workplace Practices &  Source
         Release Assessment module, professional judgement, and other sources (e g  NIOSH
         HHE, industry sources).                                               '
  »      Chemical fate in the environment: from the Environmental Fate Summary module.

  Details: Step 3, Selecting Exposure Pathways

  Selection of exposure pathways involves professional judgement and is based on the
  t^St^T^l^^ 'f ^ P°tentially exP°sedP°P^tions, and exposure scenarios
  from Steps 1 and 2.  All of the pathways considered should be documented,  with reasons for
  selection or exclusion of each pathway. A complete exposure pathway consists of:
  •     A source of chemical and mechanism for release.
  •     An exposure point.
  •     A transport medium (if the exposure point differs from the source).
  •     An exposure route.

 For example, an occupational exposure pathway in a printing shop could consist of volitization
 of lacquer thinner from an open container as the source and mechanism of release- a worker's
 breathing zone  as the exposure point; air as the transport medium (transport from the container to
 the worker's breathing zone); and inhalation as the exposure route.

 Typical exposure pathways evaluated for occupational exposure are inhalation of airborne
 chemicals and dermal contact. Typical exposure pathways evaluated for human exposures in the
 ambient environment are:
 •     Inhalation of chemicals in air.
 •     Ingestion of chemicals in drinking water, from either groundwater or surface water
 »     Ingestion offish that have been exposed to bioaccumulative chemicals. EPA's Exposure
       Assessment Branch generally assumes that chemicals with a BCF of > 100 will
       bioaccumulate. (BCF values come from the Environmental Fate Summary module.)

Other pathways are possible, and will vary on a case-by-case basis. Other possible pathways
might include:                                                            ^      J
•     Ingestion of mother's milk by an infant, where the mother has been exposed to the
       chemical(s) of interest.
                                         6-20

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     •	         	
      Incidental ingestion of soil by nearby residents where the soil has been contaminated by
      releases from a nearby facility.
      Inhalation of VOCs from household water use.

Additional data elements that may be used to select occupational exposure pathways, and sources

                        equipment used: from the Workplace Practices & Source Release
                        :, using professional judgement, and checked against other sources of

 .     Types of engineering controls used to reduce exposures (e.g., ventilation)-from the
       Workplace Practices and Source Release Assessment module profejssional judgement,
       and other sources of information (e.g, NIOSH HHE, Material Safety Data Sheets
       [MSDSs]).

 Details: Step 5, Estimating Concentrations

 Exposure concentrations can be determined by measurements or by fate and transport models
 Se Table 6 T Analytical Models Used in Exposure Assessment).  Selection of fate and
 transport models depends in part on the available data and on the data ^ ^^°™
 assessment  Typical data sources for exposure assessment, listed in order ot preference, inciuuc.
 .Hal monitoring data for the compound of interest at the location where exposure could
        occur.
  •     Monitoring data for a similar process.
  •     Models to estimate worker exposures and environmental releases.
  I     Administrative controls and permit requirements to roughly estimate exposure and/or
        releases.

  Additional data elements that may be used to estimate exposure concentrations, and sources of
  those data, are listed below.
  .      Chemical formulations: from the Performance Assessment module
  "      Amount Jf chemical used per day: from the Workplace Practices &  Source Release
         Assessment module and professional judgement.
  .      Media™?elease: from the Workplace Practices & Source Release Assessment module
         and types of control technologies used to reduce releases/exposures.
  .      Amount of releases per site-day: data for waste streams that can be  quantified are
         obLed from the Workplace Practices & Source Release Assessment module; otiier
         releTe rates^re modeled in the exposure assessment using information on conditions for
         potential releases from the Workplace Practices & Source Release Assessment module.
   .     Dumber of shifts run per day and number of operating days: from the Workplace
         Practices & Source Release Assessment module.
   .     Number of facilities in the industry: from the Workplace Practices & Source Release
         Assessment module, the Industry and Use Cluster Profile, and other sources (e.g,
         industry sources, census data, NIOSH HHE).
                                            6-21

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   PARTH; CTSA INFORMATION MODULES
                      of releases per site-day
                                         *
                                       : determined fr°™
          oatindys                    *****
   •      Pretreatment standards and discharge permits: from the Workplace Practices & Source
          Release Assessment module or other sources                     ^actices & bource

   "                         n°l°    ^ t0        rdeaS6S and ^sequent exposures: from
         Frequency and duration of releases: determined from number of shifts run per day
         number of operating days, and duration of potential exposures            P    Y'
                   '            '^ ^(specifically, chemical/physical parameter values used
                                                      ^ ^ ™ Arties and
                                                              concentrations used in the
      Population^) of
     Interest/Pathways
   Workers, inhalation of
   VOCs in air.
                          chemical z
      Exposure
    Concentration
        -
cone, a (mg/m3)
                                         cone, z (mg/m3)
        Comments
 (e.g., Details, Assumptions)

Concentrations estimated
using a volatilization model
and average measured
concentrations in solution x.
                        Facility (g/day)
                                        Treatment
                                         Removal
 Naptha, light aliphatic
 Isobutyl isobutyrate
           Water Treatment
     1,000 MLD Receiving
a) Example taken from Screen Reclamation CTSA (EPA 1994C) "             —	—
b) ug/1 is micrograms per liter, which is parts per billion for a substance in water. MLD is minion liters per day.
                                          6-22

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CHAPTER 6
                                                              EXPOSURE ASSESSMENT
  some areas there may be several facilities connected to the same waste water treatment plant.
   an example, the combined effects of multiple screen printing facilities in St. Louis County,
     ouriTee demonstrated in the Screen Reclamation CTSA. Dun and Bradstreet data showed
    screen printing facilities in St. Louis County.  It was assumed that the waste water from all
     TSities goes to the St. Louis County Sewer Company, which releases into the Meramec
       Table 6-4 presents the surface water concentrations for the combined facilities' releases.
      TABLE 6-4'
      T
        Substance
  - ESTIMATED CUMULATIVE RELEASES FOR ST. LOUIS
     RI, FROM 135 SCREEN PRINTING FACILITIES*
  Total Amount
Released to Water
    From All
Facilities (kg/day)
       49
       26~
Waste Water
 Treatment
  Removal
 Efficiency
  Naptha, light aliphatic
  Isobutyl isobutyrate
Amount to Water
  After Waste
Water Treatment
     (g/day)
                                                  Average
                                               Concentration
                                                in Meramec
                                               River, (ug/l)b
  7,895 MLD (million liters per day).

  Table 6-5 is an example of calculating and presenting air concentrations from releases to air.
     TABLE 6-5= EXAMPLE - AIR BHJJOB
JCj "" .Ti-UlV JWJlilJLAMK*^*-'-"-'**' *J«J- i—'	
'MODEL SCREEN PRATING FACILITY
                                                        Highest Average Concentration at
   Amount of Releases per Day
                                                              100 Metersb (ug/m3)
    Methyl ethyl ketone
    Naptha, light aliphatic
    Isobutyl isobutyrate      ,	.	




   Appendix C.

                                            6-23

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   PARTH;  CTSA INFORMATION MODULES _

   Details: Step 6, Selecting Values for Exposure Parameters for the Population^) of Interest

   Typical required parameters include:
         Contact rate (CR) (e.g., water ingestion, inhalation, or dermal contact rates)
         Exposure frequency (EF).
         Exposure duration (ED).
         Body weight (BW).
         Averaging time (AT).

  Additional data elements that may be used to determine parameter values for quantifying worker
  exposure are listed below, along with the appropriate sources.
  »      Duration of potential exposures: from the Workplace Practices & Source Release
         Assessment module.
  •      Frequency of exposures: from the Workplace Practices & Source Release Assessment
               at     Pr°feSS1°nal Jud§ement recluired to interpret the applicability of survey
  •     Number of shifts run per day and number of operating days: from the Workplace
        Practices & Source Release Assessment module.

  If data are not available, professional judgement may be used to select default parameter values.
  See Table 6-9: Sources of Data for Exposure Assessment, for documents containing measured or
  default values for exposure parameters.                                            ^mcuur

                      **** ** d°CUmentmg the
                                                            and assumptions used in the
   Population/ Pathways       Parameter
Workers in Ocupational Setting

Inhalation of VOCs
                         inhalation rate
                         exposure frequency
                         exposure duration
                         body weight
                         averaging time
  Adults in a Residential Setting
 Inhalation of VOCs
 Released from Site
                       inhalation rate
                       exposure frequency
                       exposure duration
                       body weight
                       averaging time
                                           Value, Units
                                          _ mVday
                                          _ days/year
                                             years
                                          _kg
                                             days
_ mVday
_ days/year
   years
_kg
   days
                                                                Reference, Rationale
               Information from the Workplace
               Practices & Source Release
               Assessment module or default
               values from EPA guidance (e.g.,
               EPA, 1990a; EPA, 1991f).
Information from the Workplace
Practices & Source Release
Assessment module or default
values from EPA guidance (e.g.,
EPA, 1990a;EPA, 1991f).
 	-•     	|	—  •"    	| — ~"J"	   *-"• -rr., i77va, Jc.jr/1, iyyli).

dSSLSSy VT^T u0f Prenented- EXP°SUre freq" ncy ^ exP°sur^ duration for Corkers are typically
determined from the Workplace Practices & Source Release Assessment module.               Wicany
                                          6-24

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CHAPTER 6
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Details:  Step 7, Quantifying Exposure

The concentration and other parameter values selected in Steps 5 and 6 are used to quantify
exposure in pathway-specific exposure equations. Equations for several pathways can be found
in "Guidelines for Exposure Assessment" (EPA, 1992a), Risk Assessment Guidance for
Superfund (EPA, 1989a), and in Dermal Exposure Assessment: Principles and Applications
(EPA, 1992d). A generic equation for quantifying exposure is:
       PDR = (C)(CR)(EF)(ED)/[(BW)(AT)]
where:
       BW
       AT

For example:
PDR   = potential dose rate (mg/kg-day) (LADD, APDR or other dose rate)
C      = chemical concentration in exposure medium (average or peak concentration
         contacted during the exposure period)
CR    = contact rate; the amount of contaminated medium contacted per unit time or
         exposure event (i.e., nrVday of air inhaled, L/day of water ingested, etc.)
EF    = exposure frequency (days/year)
ED    = exposure duration (years); exposure frequency and duration may also be
         combined into one term, also called exposure frequency but expressed in units
         of days
       = body weight; the average body weight over the exposure period (kg)
       = averaging time; the time period, in days, over which exposure is averaged
       For a chemical concentration of 5 mg/L in water, 2 liters of water ingested per day, an
       exposure frequency of 365 days per year, an exposure duration of 9 years, a body weight
       for an adult of 70 kg, and an averaging time of 25,550 days (for a 70-year lifetime), the
       LADD for ingestion of drinking water is typically calculated as follows:

       LADD = (5 mg/L)(2 L/day)(365 days/year)(9 years)/[(70 kg)(25,550 days)]
             = 0.018 mg/kg-day

An acute PDR can also be calculated using an exposure frequency and duration, and an
averaging time of one day:

       APDR = (5 mg/L)(2 L/day)(l day)/[(70 kg)(l day)]
             = 0.14 mg/kg-day

An example of occupational exposure results is shown in Table 6-6.
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TABLE 6-6: EXAMPLE - OCCUPATIONAL EXPOSURE ESTIMATES tfOR SCREEN
RECLAMATION, INK REMOVER SYSTEM" I
7 ., rt ., „ ~ i ! j ! K i -H -^ .-K^ ^
Substance
Methyl ethyl ketone
n-Butyl acetate
Methanol
Naptha, light aliphatic
Toluene
Isobutyl isobutyrate
Inhalation (mg/day)b
I
165
44
21
98
110
1
II
5.3
1.3
4.7
1.6
2.3
0.4
m
3
1
2
1
1
0
IV
20
5.3
15
6.2
9.2
1.7
Dermal (mg/day)
Routine
468
234
78
312
312
156
Immersion
2,180
1,090
364
1,460
1,460
728
                                                                ; Scenario II = pouring 1 ounce
                                                                i a 5 gallon pail; Scenario IV =
Details: Step 8, Evaluating Uncertainties

A discussion of uncertainties in the overall risk assessment process is presented in the Risk
Characterization module.  Sources of uncertainty in the exposure assessment could include:
•     Description of exposure setting - how well the typical facility used in the assessment
       represents the facilities included in the CTSA; the likelihood of the exposure pathways
       actually occurring.
•     Possible effect of any chemicals that may not have been evaluated, including minor
       ingredients in a formulation.
»     Chemical fate and transport model applicability and assumptions - how well the models
       and assumptions that are required for fate and transport modeling represent the situation
       being assessed and the extent to which the models have been verified or validated.
•     Parameter value uncertainty, including measurement error, sampling error, parameter
       variability, and professional judgement.
•     Uncertainty in combining pathways for an individual.

In a CTSA, uncertainty is typically addressed qualitatively.  Because of the uncertainty inherent
in the parameters and assumptions used in estimating exposure, and the variability that is
possible within a population, there is no one number that can be used to describe exposure.
Using exposure (or risk) descriptors is a method typically used to provide information about the
position an exposure estimate has in the distribution of possible outcomes for a particular
population.  "Guidelines for Exposure Assessment" (EPA, 1992a), Habicht (1992), and others
provide guidance on the use of risk descriptors, which include the following:
 •      Central tendency: represents either an average estimate (based on average values for the
        exposure parameters) or ^median estimate (based on 50thpercentile or geometric mean
        values) of the actual distribution.
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                                                                 EXPOSURE ASSESSMENT
 •     High-end: represents approximately the upper 10th percentile of the actual (measured or
       estimated) distribution. The high-end descriptor is a plausible estimate of individual risk
       for those persons at the upper end of the exposure distribution (i.e., a person exposed to
       an amount higher than 90 percent of the people who are exposed to the substance).  It is
       also no higher than the individual in the population who has the highest exposure.
 •     Bounding estimate: an intentional overestimate of exposure used for screening purposes.
       Bounding estimates are useful in developing statements that exposures, dose's, or risks are
       "not greater than" the estimated value.
 •     Worst case: a combination of events and conditions such that, taken together, produces
       the highest conceivable risk.
 "     What-if: represents, an exposure estimate based on postulated questions (e.g., what if the
       worker is exposed to  the concentration predicted by a particular air dispersion model).
       The estimates based on these what-if scenarios do not give any indication as to the
       likelihood of the exposure actually occurring, but may be useful for decision-making or to
       add perspective to the risk assessment.

Two types of quantitative uncertainty analysis (discussed in EPA, 1990a and EPA, 1992a) are
sensitivity analysis and probability analysis.  Sensitivity analysis requires data on the range of
exposure parameter values, and gives information on how the results are impacted by variation
within the different parameters. Sensitivity analysis can be used to determine  the percent
contribution to the overall uncertainty and/or variability from specific exposure parameters.
Probability analysis (e.g., Monte Carlo simulation) requires data on the range  and probability
function, or distribution, of the exposure parameters and yields a probability function that
describes the  range of possible results.  (Although not generally recommended for a CTSA, the
increasing use of Monte Carlo simulation and availability of software for performing this type of
analysis warrants mention of the technique.)

Details: Step 9, Transferring Information

Data elements that are transferred from the Exposure Assessment module are listed below:
•     Preliminary exposure pathways: to the Human Health Hazards Summary module.
•     Exposure scenarios and pathways, ambient aquatic exposure concentrations, PDR,
       human exposure levels,  and uncertainty information: to the Risk Characterization
       module.
•     Modeled release information (i. e,, releases not quantified in the Workplace Practices &
       Source Release Assessment module but modeled in the Exposure Assessment module
       instead, such as releases ofVOCsfrom containers of solvent left open  during operating
       hours) and potential for exposure (e.g., high, medium, low) via a particular pathway
       (e.g., inhalation, ingestion, dermal): to the Risk, Competitiveness & Conservation Data
       Summary module.

To the extent possible, include "unit of production" information with the exposure assessment
results. For example, report the square feet of printed wiring board produced during the time
period corresponding to the PDR.  This can be determined by multiplying ED  (in years) by the
production rate (in fWyear).  This may  not be possible in all cases, depending  on the available

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data. This information is used in the Risk Characterization module to express risk on a "per unit
of production" basis.


FLOW OF INFORMATION: The Exposure Assessment module receives information from
the Chemical Properties, Environmental Fate Summary, Chemistry of Use & Process
Description, Workplace Practices & Source Release Assessment, Performance Assessment,
and Control Technologies Assessment modules. It transfers information to the Human Health
Hazards Summary, Risk Characterization, and Risk, Competitiveness & Conservation Data
Summary modules.  Examples of information flows are shown in Figure 6-4.
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                                                  EXPOSURE ASSESSMENT
Ii
H O
cc
CO
CO
co
O
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ANALYTICAL MODELS:  Table 6-7 presents references for analytical models that can be
used to estimate exposure concentrations.  This list contains the major models used by the U.S.
EPA Office of Pollution Prevention and Toxics, in the Exposure Assessment Branch, for their
work, and is not all-inclusive.

Note:  Chemical fate and transport modeling is a highly technical undertaking, and should be
      performed only by someone with the appropriate technical background and experience
       with the particular models to be used. Additional sources of information on models
       includes the Integrated Model Evaluation System (IMES), developed by the Office of
       Research and Development -within the U.S. EPA. IMES is currently undergoing review
       by EPA and is available to assist in the selection of appropriate fate models.
TABLE 6-7: ANALYTICAL MODELS USED IN EXPOSURE ASSESSMENT "
Reference
AMEM (A.D. Little Migration Estimation
Model):
A.D. Little, Inc. Lastest version, 1993.
AT123D"-b (Analytical Transient One-,
Two-, and Three-Dimensional Simulation
model):
Yeh, G.T. 1981. AT123D: Analytical Transient
One-, T\vo-, and Three-Dimensional Simulation
of Waste Transport in an AQUIFER System.
BOXMOD":
General Sciences Corporation. 199 la. GEMS
User's Guide.
DERMAL:
Versar, Inc. 1995a. DERMAL User's Manual
ENPART»-b:
General Sciences Corporation. 1985a. A User's
Guide to Environmental Partitioning Model.
Type of Model
Multimedia environmental fate; models migration
of additives, monomers, and oligomers from
polymeric material.
Groundwater model; estimates spread of
contaminant plume through saturated zone,
considers adsorption and degradation.
Air model; estimates exposure in urban areas
with diffuse emissions. BOXMOD is
implemented in the Graphical Exposure
Modeling System (GEMS).
Estimates consumer dermal exposure for a
variety of product categories.
Multimedia environmental fate model to screen
for chemical partitioning in the environment.
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 CHAPTER 6
                                                                    EXPOSURE ASSESSMENT
TABLE 6-7: ANALYTICAL MODELS USED W EXPOSURE ASSESSMENT
Reference
EXAMS-IIa'b (Exposure Analysis Modeling
System):
Burns, L.A., et al. 1982. Exposure Analysis
Modeling System (EXAMS) User Manual and
System Documentation.
Burns, L.A., et. al. 1985. Exposure Analysis
Modeling System: User's Guide for EXAMS II.
FLUSH:
Versar, Inc. 1995b. FLUSH User's Manual.
Fugacity models:
Type of Model
Surface water model; simulates fate, transport,
and persistence of organic chemicals in surface
water.
Surface water model; estimates surface water
concentrations from disposal of household
products.
Multimedia fate and transport models.
 For example: Mackay, D. 1993. Multimedia
 Environmental Models, The Fugacity Approach.
 GAMS3 (GEMS Atmospheric Modeling
 Subsystem):

 General Sciences Corporation. 1990a. Draft
 GAMS Version 3.0 User's Guide.
Air exposure model; estimates average annual
concentrations, LADD and risks; incorporates
ISCLT and TOXBOX as the air fate and transport
models.
 GEMS/PCGEMS (Graphical Exposure Modeling
 System):

 General Sciences Corporation. 1988a. PCGEMS
 User's Guide Release 1.0.

 General Sciences Corporation. 1991b. Graphical
 Exposure Modeling System, GEMS User's Guide.

 Harrigan, P. and A. Battin.  1989.  Training
 Materials for GEMS and PCGEMS: Estimating
 Chemical Concentrations in Surface Waters.

 Harrigan, P. and A. Nold. 1989. Training
 Materials for GEMS and PCGEMS: Estimating
 Chemical Concentrations in Unsaturated Soil and
 Groundwater.

 Harrigan, P. and S. Rheingrover. 1989. Training
Materials for GEMS and PCGEMS: Estimating
 Chemical Concentrations in the Atmosphere.
Modeling system for general population exposure
assessment. Includes fate and transport models
along with some relevant data needed to run those
models, and where possible applies results to
assess the population exposed. Includes many of
the models listed below, as well as population
data.
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         TABLE 6-7: ANALYTICAL MODELS USED IN EXPOStJRE ASSESSMENT
                  Reference
              Type of Model
 INPUFF':

 General Sciences Corporation. 1986. INPUFF
 User's Guide.
Air model; estimates air exposure from short term
releases or continuous plume.
 ISCLT"ib (Industrial Source Complex Long-
 Term), and ISCST (Industrial Source Complex
 Short-Term):

 U.S. Environmental Protection Agency. 1992e.
 Industrial Source Complex (ISC2) Dispersion
 Models User's Guide.
Air model; ISCLT calculates average annual air
concentrations and exposures.

Air model; ISCST calculates short term air
concentrations and exposures.
  MCCEM (Multi-Chamber Concentration and
  Exposure Model):

  Geomet Technologies, Inc.  199la. MCCEM
  User's Manual, Version 2.3.

  Geomet Technologies, Inc.  1991b. MCCEM
  Documentation Model, Version 2.3.
 Air model; estimates consumer inhalation
 exposure.
  PDM 3.1 (Probabilistic Dilution Model):

  Versarjnc. UNDATED.  User's Guide to PDM
  3.1.
 Surface water model; estimates frequency that
 concentration of concern is exceeded.
  PRZM*-0 (Pesticide Root Zone Model):
 Soil model; simulates vertical transport in the
Carsel, R.F., et. al. 1984. Users Manual for the
Pesticide Root Zone Model (PRZM) Release 1.
PTPLU*-b (Point Plume):
General Sciences Corporation. 1988b. User's
Guide for PTPLU in GEMS.
Pierce, T.E. and D.B. Turner. 1982. PTPLU -A
Single Source Gaussian Dispersion Algorithm
User's Guide.
ReachScan:
Versar Inc 1992a. ReachScan User's Manual.
vadose zone, plant uptake, runoir, etc.
Air model; calculates maximum short term air
concentrations.
Surface water model; estimates downriver
concentrations and exposures.
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CHAPTER 6
                                                                   EXPOSURE ASSESSMENT
          TABLE 6-7: ANALYTICAL MODELS USED IN EXPOSURE ASSESSMENT
                  Reference
                                                             Type of Model
 ReachScan/PDM:

 Versar, Inc. 1992b. ReachScan/PDM User's
 Manual.
 Surface water model; combines downriver
 concentration estimates from REACHSCAN with
 the concentration of concern (COC) exceedance
 information from PDM.
 SCIES (Screening Consumer Inhalation Exposure
 Software):

 Versar, Inc. 1994. SCIES User's Manual,
 Version 3.0,
 Air model; estimates consumer inhalation
 exposure for a variety of product categories.
 SEAS (Screening Exposure Assessment
 Software):

 U.S. Environmental Protection Agency.  1995e.
 Surface water concentration estimation; simple
 dilution calculations from flow data. Calculates
 by single facility or by groupings of Standard
 Industrial Classifications (SICs). SIC-based
 stream information used to calculated mean and
 low flows for the industry.
 SESOIL3-15 (Seasonal Soil Compartment Model):

 Bonazountas, M. and J. Wagner.  1981. SESOIL,
 a Seasonal Soil Compartment Model.
 Soil/vadose zone model; long-term fate
 simulations for organic and inorganic chemicals.
 STP (Sewage Treatment Plant fugacity model):

 Clark, B., et al.  1995. "Fugacity Analysis and
 Model of Organic Chemical Fate in a Sewage
 Treatment Plant."
Estimates chemical fate in sewage treatment
plants.
SWIPa (Survey Waste Injection Program):

General Sciences Corporation.  1985b.  User's
Guide to SWIP Model Execution Using Data
Management Supporting System.

J.S. Geological Survey. UNDATEDa. "Detailed
Model Description and Capabilities."

U.S. Geological Survey. UNDATEDb. "Revised
Documentation for the Enhanced Model."
Groundwater model; estimates chemical or
thermal pollutant transport and transformation in
groundwater systems.
TOXBOX3:

General Sciences Corporation. 1990a. Draft
 rAMS Version 3.0 User's Guide.
Air model; estimates air exposure levels over
arge areas from diffuse sources.  Available only
ivithin the GEMS Atmospheric Modeling
 ubsection.
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         TABLE 6-7: ANALYTICAL MODELS USED IN EXPOSURE ASSESSMENT
                  Reference
               Type of Model
 TOXSCREEN°'b:

 Hetrick, D.M. and L.M. McDowell-Boyer.  1983.
 User's Manual for TOX-SCREEN: A MultiMedia
 Screening-Level Program for Assessing the
 Potential of Chemicals Released to the
 Environment.
Multimedia environmental fate; models fate of
chemicals released to air, water, soil, or a
combination.
 TRIAIR*:

 General Sciences Corporation.  1990b. Draft
 TRIAIR User's Guide.
Air model; models dose and air concentrations
using TRI data and ISCLT model. Must be run by
OPPT personnel.
  TRIWATER:

  General Sciences Corporation. 1990c.
  Implementation of the T.R.I. Regional Surface
  Water Modeling System in GEMS.

  General Sciences Corporation. 1993. Final
  Report, GEMS and RGDS Linkage III, EPA
  Contract 68-dO-0080, Work Assignment No. 3-4.
 Surface water model; estimates surface water
 concentrations and risks from point source
 releases.  Must be run by OPPT personnel.
  UTM-TOX" (Unified Transport Model for
  Toxicants):

  Browman, M.G., et. al. 1982.  Formulations of
  the Physicochemical Processes in the ORNL
  Unified Transport Model for Toxicants (UTM-
  TOX), Interim Report.

  General Sciences Corporation. 1985c.
  Characterization of Data Base Requirements for
  Implementation of UTM-TOXUnder GEMS:
  Parameter Sensitivity Study.

  Patterson, M.R., et. al. 1984.  A  User's Manual
  for UTM-TOX, the Unified Transport Model
 Multimedia environmental fate; simulates
 dispersion of chemicals in soil, air, and water.
   Valley11:

   Burt,E.  1977. VALLEY Model User's Guide.

   General Sciences Corporation. 1989.  User's
   Guide for Valley in GEMS.
 Air model; estimates 24-hour average air
 concentrations in complex terrain.
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 CHAPTER 6
                                                                EXPOSURE ASSESSMENT
         TABLE 6-7; ANALYTICAL MODELS USED M EXPOSURE ASSESSMENT
                  Reference
                                                          Type of Model
 Other models as required; from various sources,
 for example:

 U.S. Environmental Protection Agency.  1988c.
 Superfund Exposure Assessment Manual.
a) Model is implemented in GEMS.
b) Model is implemented in PCGEMS.
c) Model is available from other sources in a more recent version than the version implemented in GEMS
Note: References are listed in shortened format, with complete references given in the reference list following
Chapter 10.
PUBLISHED GUIDANCE: Table 6-8 presents references for published guidance on exposure
assessment. Some of these documents may not have been published outside of EPA.
TABLE &•$: PUBLISHED GUIDANCE ON EXPOSURE ASSESSMENT
Reference
Gilbert, R.O. 1987. Statistical Methods for
Environmental Pollution Monitoring.
Habicht, F.H. II. 1992. Guidance on Risk
Characterization for Risk Managers and Risk
Assessors.
Harrigan, P. 1994. Guidelines for Completing
the Initial Review Exposure Report.
U.S. Environmental Protection Agency. 1989a.
Risk Assessment Guidance for Superfund, Volume
I: Human Health Evaluation Manual (Part A).
U.S. Environmental Protection Agency. 1989b.
Toxic Chemical Release Inventory Risk Screening
Guide.
U. S . Environmental Protection Agency. 1 99 1 e.
Chemical Engineering Branch Manual for the
Preparation of Engineering Assessments.
Type of Guidance
Guidance on statistical methods for summarizing
and using environmental monitoring data.
Guidance for risk assessors on describing risk
assessment results in EPA reports, presentations
and decision packages; includes guidance on use
of exposure descriptors.
Information on models, assessing releases to
various media, and environmental fate default
values as well as guidance on assessing exposure
to consumers from use of various products.
Detailed guidance for developing health risk
information at Superfund sites; may also be
applicable to other assessments of hazardous
wastes and hazardous materials.
Guidance for risk screening for ranking and
further evaluation.
Describes various approaches and data sources
for occupational exposure estimation.
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TABLE 6-8: PUBLISHED GUIDANCE ON EXPOSURE ASSESSMENT
Reference
U.S. Environmental Protection Agency. 199 If.
Human Health Evaluation Manual, Supplemental
Guidance: "Standard Default Exposure Factors."
U.S. Environmental Protection Agency. 1992a.
"Guidelines for Exposure Assessment."
U.S. Environmental Protection Agency. 1992d.
Dermal Exposure Assessment: Principles and
Applications. Interim Report.
U.S. Environmental Protection Agency. 1992f.
EPA Supplemental Guidance to RAGS:
Calculating the Concentration Term.
U.S. Environmental Protection Agency. 1992g.
RM1/RM2 Process Manual, Version 1.0.
U.S. Environmental Protection Agency. 1994g.
Guidelines for Completing the Initial Review
Exposure Report - Final Draft.
U.S. Environmental Protection Agency. 1994h.
Guidelines for Statistical Analysis of
Occupational Exposure Data.
Versar, Inc. 1988. The Nonexposure Aspects of
Risk Assessment, An Introduction for the
Exposure Assessor, Final Draft.
Wood, P. 1991. Existing Chemical
Assignment/RMl Exposure Report.
Type of Guidance
Standard default values for exposure parameter to
be used in the Superfund remedial
investigation/feasibility study process; may also
apply to exposure assessments in general.
EPA guidance on exposure assessment.
Guidance on procedures for assessment of dermal
exposure pathways.
Calculating exposure point concentrations from
environmental sample data.
Guidance for exposure assessors on performing
RM1 and RM2 exposure assessments.
Guidance for preparation of initial exposure
assessments for substances submitted under the
Pre-manufacture Notification Program.
Guidance on using occupational exposure data.
Guidance on interpreting results.
Information on chemical properties, production
and use information, and consumer uses (if
applicable).
Note: References are listed in shortened format, with complete references given in the reterence list loiiowmg
Chapter 10.
 DATA SOURCES: Table 6-9 lists sources of data for exposure assessment.
TABLE 6-9: SOURCES OF DATA FOREXPOSURE ASSESSMENT
Reference
American Industrial Health Council. 1994.
Exposure Factors Sourcebook.
Type of Data
Summary and evaluation of current scientific
documentation and statistical data for various
exposure factors used in risk assessments.
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CHAPTER 6
                                                     EXPOSURE ASSESSMENT
TABLE 6-9: SOURCES OF DATA FOR EXPOSURE ASSESSMENT
Reference
Chambers of Commerce.
Dun and Bradstreet, various sources.
Eastern Research Group, Inc. 1992. Inventory of
Exposure-Related Data Systems Sponsored by
Federal Agencies.
Environmental monitoring data from various
sources.
GEMS/PCGEMS models.
Industry, trade associations.
National Institute for Occupational Safety and
Health (NIOSH). UNDATEDb. Health Hazard
Evaluations.
Open literature.
U.S. Census Bureau.
U.S. Environmental Protection Agency. 1989a.
Risk Assessment Guidance for Superfund, Volume
I: Human Health Evaluation Manual (Part A).
U.S. Environmental Protection Agency. 1990a.
Exposure Factors Handbook.
U.S . Environmental Protection Agency. 1 99 1 f.
Human Health Evaluation Manual, Supplemental
Guidance: "Standard Default Exposure Factors."
U.S. Environmental Protection Agency. 1992d.
Dermal Exposure Assessment: Principles and
Applications. Interim Report.
Type of Data
Number of businesses of interest within a
specified area.
Business census information.
Description of and contacts for other sources of
exposure data.
Air, water, other environmental concentrations.
Contains census data, chemical properties for
SARA Title III chemicals, and default model ,
parameters (chemical, environmental, population,
and site property data).
Chemical release information, controls used
Occupational exposure data.
Other exposure parameter data, other fate and
transport models, etc.
Population, demographic data, some information
on activity patterns (e.g., average time in a
residence, average tenure for different
occupations, etc.).
Detailed guidance for developing health risk
information at Superfund sites, including values
for exposure parameters; may also be applicable
:o other assessments of hazardous wastes and
lazardous materials.
Data on human physiological and behavioral ,
jarameters.
Standard default values for exposure parameter to
)e used in the Superfund remedial
nvestigation/feasibility study process; may also
apply to exposure assessments in general.
Guidance on assessment of dermal exposure.
Note. References are listed in shortened format, with complete references given in the reference list following
Chapter 10.
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                                    6-38

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                               RISK CHARACTERIZATION
  OVERVIEW: Risk characterization (also referred to in the CTSA process as risk integration) is
  the integration of hazard and exposure information to quantitatively or qualitatively assess risk
  Risk characterization typically includes a description of the assumptions, scientific judgments
  and uncertainties that are part of this process.                                            '

  The level of risk characterization necessary in a CTSA varies depending on the differences
  between the substitutes being assessed in the use cluster. The risk characterization identifies in a
  manner that facilitates decision-making, the areas of concern as they differ among the substitutes
  Risks may vary m terms of magnitude, type, or domain of application.  If the differences in risk
  among the substitutes are great, then a detailed, quantitative characterization of risk may not be
  necessary. If the differences in risk associated with the substitutes are more subtle then a
  quantitative  analysis may be necessary.  The methods outlined here describe a more detailed
  quantitative  risk characterization.                                                     '
 GOALS:

 •      Integrate chemical hazard and exposure information to assess and compare risks from
        ambient environment, consumer, and occupational exposures.

 •      Provide risk estimates to the Risk, Competitiveness & Conservation Data Summary
        module.

 •      Present risk information and discuss uncertainty in a manner that assists in decision-
        making.
PEOPLE SKILLS: The following lists the types of skills or knowledge that are needed to
complete this module.

•     Knowledge of risk assessment guidance and methodology.

•     Understanding of chemical exposures.

•     Understanding of human, other mammalian, and aquatic toxicology.

•     Ability to present and interpret the results of risk characterization for decision-making.

Within a business or a DfE project team, the people who might supply these skills include a risk
assessment specialist.
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Note:  The analysis presented in this module should not be undertaken without the assistance of
       someone with expertise in human health and environmental risk assessment.
       Furthermore, peer-review of the completed risk characterization is recommended.
DEFINITION OF TERMS: Several terms from the Human Health Hazards Summary,
Environmental Hazards Summary, and Exposure Assessment modules are used in the Risk
Characterization module and are defined here as well.

Human Health Hazards Summary

n^opmental Toxicitv: Adverse effects produced prior to conception, during pregnancy, or
during childhood. Exposure to agents affecting development can result in any one or more of the
following manifestations of developmental toxicity: death, structural abnormality, growth
alteration and/or functional deficit. These manifestations encompass a wide array of adverse
developmental end points, such as spontaneous abortion, stillbirths, malformations, early
postnatal mortality, reduced birth weight, mental retardation, sensory loss and other adverse
functional or physical changes that are manifested postnatally.

International Apmcv for Research nn Cancer fTAR(T> Classification: A method for evaluating
the strength of evidence supporting a potential human carcinogenicity judgment based on human
data, animal data, and other supporting data.  A summary of the IARC carcinogenicity
classification system includes:
 •      Group 1 :  Carcinogenic to humans.
 •      Group 2A: Probably carcinogenic to humans.
 •      Group 2B: Possibly carcinogenic to humans.
 •      GroupS: Not classifiable as to human carcinogenicity.
 •      Group 4: Probably not carcinogenic to humans.

 T.oWest-ObservH A riverse Effect T.eve1  (LOAEU;  The lowest dose level in a toxicity test at
 which there are statistically or biologically significant increases in frequency or severity of
 adverse effects in the exposed population over its appropriate control group.

              Adv--» ***** T ™* fNTOAEU: The highest dose level in a toxicity test at which
  Mn-rerve    v--»    *
  there are no statistically or biologically significant increases in the frequency or severity of
  adverse effects in the exposed population over its appropriate control; some effects may be
  produced at this level, but they are not considered adverse, nor precursors to adverse effects.

  Pharmacokinetics:  The dynamic behavior of chemicals within biological systems.
  Phannacokinetic processes include uptake, distribution, metabolism, and excretion of chemicals.

  inference Concentration OlfO: An estimate (with uncertainty spanning perhaps an order of
  magnitude) of the daily inhalation exposure to the human population (including sensitive
  subgroups) that is likely to be without an appreciable risk of deleterious noncancer effects during
  a lifetime.  RfCs are generally reported as a concentration in air (mg/m ).

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CHAPTER 6
                                                              RISK CHARACTERIZATION
Reference Dose TRfD): An estimate (with uncertainty spanning perhaps an order of magnitude)
of the daily oral exposure to the human population (including sensitive subgroups) that is likely
to be without an appreciable risk of deleterious noncancer effects during a lifetime. RfDs are
reported as mg/kg-day.

Risk: In general, risk pertains to the probability and severity of adverse effects (e.g., injury,
disease, or death) under specific circumstances. In the context of a CTSA, risk is an expression
of the likelihood of adverse health or environmental effects from a specific level of exposure;
only cancer risk is estimated as a probability.  (Also see Cancer Risk, Individual Risk and
Population Risk.)

Slope Factor (g^: A measure of an individual's excess risk or increased likelihood of
developing cancer if exposed to a chemical. It is determined from the upperbound of the slope of
the dose-response curve in the low-dose region of the curve.  More specifically, q,* is an
approximation of the upper bound of the slope when using the linearized multistage procedure at
low doses. The units of the slope factor are usually "expressed as  1/(mg/kg-day) or (mg/kg-day)'1.

Unit Risk: The upper-bound excess lifetime cancer risk estimated to result from continuous
exposure to an agent at a concentration of 1 (o.g/L in water or 1 (J,g/m3 in air (with units of risk per
|4,g/m3 air or risk per ug/L water).

Weight-of-Evidence Classification (EPA): In assessing the carcinogenic potential of a chemical,
EPA classifies the chemical into one of the folio whig  groups, according to the weight-of-
evidence from epidemiologic and animal studies:
•      Group A: Human Carcinogen (sufficient evidence of carcinogenicity in humans).
•      Group B: Probable Human Carcinogen (B1 - limited evidence of carcinogenicity in
       humans; B2 - sufficient evidence of carcinogenicity in animals with inadequate or lack of
       evidence in humans).
•      Group C: Possible Human Carcinogen (limited evidence of carcinogenicity in animals
       and inadequate or lack of human data).
•      Group D: Not Classifiable as to Human Carcinogenicity (inadequate or no  evidence).
•      Group E: Evidence of Noncarcinogenicity for Humans (no evidence of carcinogenicity in
       adequate studies).

(The "Proposed Guidelines for Carcinogen Risk Assessment" [EPA, 1996b] propose use of
weight-of-evidence descriptors, such as "Likely" or "Known," "Cannot be determined," and "Not
likely," in combination with a hazard narrative, to characterize a chemical's human carcinogenic
potential - rather than the classification system described above.)

Environmental Hazards Summary

Aquatic Toxicity Concern Concentration (CC): The concentration of a chemical in the aquatic
environment below which no significant risk to aquatic organisms is expected.
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Exposure Assessment

Acute Potential Dose Rate (APDR): The dose, usually expressed on a per day basis, averaged
over a period of time corresponding to an acute exposure period.

Exposure Concentration. Exposure Point Concentration: The chemical concentration, in its
transport or carrier medium, at the location of contact with an organism.  Also defined, typically
for ecological risk, as the Expected Environmental Concentration (EEC), or Predicted
Environmental Concentration (PEC).

Exposure Level:  In general, a measure of the magnitude of exposure, or the amount of an agent
available at the exchange boundaries (i.e., lungs, gastrointestinal tract, or skin), during some
specified time. In the Exposure Assessment and Risk Characterization modules, "exposure
level" is used specifically as a measure of exposure expressed as a concentration rather than as a
potential dose rate.

Exposure Pathway:  The physical course a chemical takes from the source to the organism
exposed. An example of an exposure pathway might be inhalation by a worker of volatile
organic compounds (VOCs) that have evaporated from a solvent to the air.

Exposure Scenario:  A description of the specific circumstances under which exposure might
occur, consisting of facts, assumptions, and inferences about how exposure takes place. An
exposure scenario may comprise one or more exposure pathways.

Lifetime Average Daily Concentration (LAPP: The estimated daily concentration (usually in
air) during the exposure duration, averaged over a lifetime.

Lifetime Average Dailv Dose (TADD^): The estimated potential daily dose rate received during
the exposure duration, averaged over a lifetime.  LADD is typically expressed in units of mg/kg-
day.

Peak Exposure Level or Dose: The maximum exposure level or maximum potential dose rate.
Potential Dose Rate
                          The amount of a chemical ingested, inhaled, or applied to the skin
 per unit time (e.g., in units of mg/day). PDR may also be expressed per unit body weight per
 unit time (e.g., hi mg/kg-day). PDR is the amount of a chemical that is available at the body's
 exchange boundaries and potentially could be absorbed into the body. (Related terms used
 elsewhere include "intake" or simply "dose," although the term dose implies that absorption is
 taken into account while PDR does not.  The concepts of intake, dose, and potential dose are
 described in detail in "Guidelines for Exposure Assessment" [EPA, 1992a].)

 Receptor: The organism of interest (human or non-human) involved in a particular exposure
 pathway.
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CHAPTER 6
RISK CHARACTERIZATION
Risk Characterization

Cancer Risk:  The probability of developing cancer over a lifetime as a result of exposure to a
potential carcinogen.  Cancer risk could be estimated for an individual or a population (see
Individual Risk and Population Risk).  The cancer risk estimated in a CTSA is the upper bound
excess lifetime cancer risk.

Ecological Risk Indicator: The ratio of the exposure concentration (EEC or PEC) to the CC. In
ecological risk characterization this approach is typically referred to as the ecological quotient
method.

Hazard Index (HI): The sum of more than one hazard quotient for multiple chemicals and/or
multiple exposure pathways. Calculation of HI assumes additivity of the chemical effects. This
is valid only where the chemicals elicit the same effect by the same exposure route and
mechanism of action.

Hazard Quotient (HO):  The ratio of potential rate (PDR) or exposure level for a single chemical
over a specified time period to the RfD or RfC for that chemical derived from a similar exposure
period.

Individual Risk: An estimate of the probability of an exposed individual experiencing an adverse
effect, such as "1 in 1,000" (or 10"3) risk of cancer.

Margin of Exposure (MOE):  The ratio of the NOAEL or LOAEL to a PDR or exposure level.

Population Risk: An aggregate measure of the projected frequency of effects among all exposed
people, such as "four cancer cases per year."
APPROACH/METHODOLOGY:  The following presents a summary of the approach or
methodology for conducting a risk characterization. Further details for Steps 1 through 9 are
presented in the next section of this module. This summary is intended as an overview of the
process, and may vary on a case-by-case basis.  The reader is referred to guidance documents
(see Table 6-11 for further information).

Step 1:        Collect and organize information from the Exposure Assessment, Human Health
              Hazards Summary, and Environmental Hazards Summary modules.

Human Health Risk (occupational, consumer, etc.)

Step 2:        For each chemical in a pathway, calculate the indicator of cancer risk and/or
              noncancer risk.
              •      For each chemical that is classified in the hazard summary as a
                     carcinogen, estimate cancer risk.
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PARTH: CTSA INFORMATION MODULE
              •     For each chemical that exhibits noncancer health effects and for which an
                    RfD or RfC is available (note: this may include chemicals that are also
                    classified as carcinogens), calculate the indicator of noncancer risk,
                    expressed as an HQ.
              •     For chemicals without a RfD or RfC, calculate the indicator of noncancer
                    risk, expressed as a MOE.

Step 3:        For multiple chemicals (e.g., exposure to a formulation made up of a mixture of
              chemicals), calculate total cancer risk and the noncancer HI for each pathway,
              using the information from Step 2.

Step 4:        If applicable, and exposure is possible via more than one pathway, combine risks
              across pathways that affect the same individual(s) over the same time periods by
              summing cancer risks and summing HQs or His.

Step 5:        If applicable, calculate population cancer risk.

Step 6:        Discuss and assess sources of uncertainty and variability of risk characterization
              results.

Step 7:        Summarize and present the risk characterization results.  The chemical- and
              pathway-specific results from Step 2 as well as totals from Steps 3 and 4 (if
              applicable) and population cancer risk from Step 5  (if applicable) should all be
              presented.  (Large tables  of data may be more appropriately included as an
              appendix to the Risk Characterization module.)

Environmental (aquatic) Receptors

Step 8:        Compare CC for each chemical to the exposure concentration (EEC or PEC).
              Typically, this is done for the aquatic environment. A numerical indicator of
              ecological risk may also be calculated as the ratio of the exposure concentration to
              the CC.  This  approach is typically referred to as the ecological quotient method.

Transfer Information

Step 9:        Provide human health and environmental risk information to the Risk,
              Competitiveness & Conservation Data Summary module. Express risk
              characterization information on a "per unit of production" basis, if applicable.
METHODOLOGY DETAILS: This section presents methodology details for completing
Steps 1 through 9. Additional information on these and other steps can be found hi the published
guidance (see Table 6-11: Published Guidance on Risk Characterization). In addition, an
example of background information on risk assessment is presented in Appendix D, from the
Screen Reclamation CTSA (EPA, 1994c).

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CHAPTER 6
RISK CHARACTERIZATION
Details:  Step 1, Collecting and Organizing Data

Data to be provided by the Human Health Hazards Summary module include:
•      Characterization of chemicals by hazard type: carcinogenicity, acute or chronic toxicity,
       developmental toxicity, etc.
•      qj* or unit risk, and weight-of-evidence for chemicals classified as carcinogens.
•      RfD and/or RfC for chemicals that exhibit noncancer toxicity.
•      LOAEL or NOAEL for chemicals where an RfD or RfC is not available.
•      Pharmacokinetic data (e.g., chemical absorption factors).

Data to be provided by the Environmental Hazards Summary module include the CC.

Data to be provided by the Exposure Assessment module include:
•      Outline of exposure scenarios, populations) of interest, and pathways to be evaluated
       (these are described in the Exposure Assessment module).
»      Potential dose rates (e.g., the PDR, LADD, and APDR).
•      Exposure levels (e.g., the lifetime average exposure level, and the peak exposure level
       [expressed as concentrations]).
•      Modeled or measured ambient environmental (water) concentrations.

Details:  Step 2, Calculating Chemical Risk

Cancer Risk

For chemicals classified as carcinogens, upper bound excess lifetime cancer risk, expressed as a
unitless probability, is typically estimated by the linear low-dose cancer risk equation, where:

       cancer risk = LADD x qj*

For example:
       for an LADD of 0.3 mg/kg-day and a qt* of 0.02 (mg/kg-day)'1:
       cancer risk = (0.3) x (0.02)
                  = 0.006

This cancer risk (on an individual basis) would mean a 6 in  1,000 risk of developing cancer from
exposure to this particular chemical, in addition to baseline cancer risk.

Alternatively, cancer risk can be calculated by the lifetime average exposure level (in air or
water) x unit risk factor (this is a variant of the linear low-dose equation).

For example:
       for a lifetime average exposure level of 0.4 |^g/m3 and a unit risk of 0.0002
       cancer risk = (0.4) x (0.0002)
                  = 0.00008 (or 8 x lO'5)
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PARTH: CTSA INFORMATION MODULE
For higher doses (cancer risks above approximately 0.01), this linear equation is not considered
valid. In this case the results should state "risks are above 0.01 but cannot be estimated more
exactly." Cancer risk numbers are typically presented to one significant figure.

Noncancer Risk

For chemicals that exhibit noncancer toxicity, an HQ is calculated by:

       HQ = PDR/RfD

For example:
       for a PDR of 0.4 mg/kg-day and an RfD of 0.05 mg/kg-day:
       HQ = (0.4) / (0.05)
          = 8

Chemicals that exhibit developmental toxicity are evaluated separately, using an RfD for
developmental effects (RfDDT). Short-term exposure can be of concern for developmental effects
(because of the window of fetal vulnerability) so a peak exposure is used rather than a PDR for
the entire duration of exposure:

       HQDT = peak exposure / RfDDT

Alternatively, if an RfC (typically for air) or RfC for developmental effects (RfCDT) and
corresponding exposure level is available, the HQ can be calculated by:
       HQ = lifetime average exposure level / RfC
or:
       HQDT = peak exposure level / RfC
                                     •DT
HQs (non-developmental) are typically calculated for long-term (chronic) exposure periods.
They can also be calculated for subchronic or acute (shorter-term) exposure periods if subchronic
or acute RfD (or RfC) and dose rates (or exposure levels) are determined in the Human Health
Hazards Summary and Exposure Assessment modules. It is important to keep the exposure
durations consistent; for example, subchronic RiDs combined with subchronic dose rates.

The HQ is based on the assumption that there is a level of exposure (i.e., the RfD) below which it
is unlikely, even for sensitive subgroups, to experience adverse health effects. Unlike cancer
risk, the HQ does not express probability (only the ratio of the estimated dose to the RfD or RfC)
and it is not linear; i.e., an HQ of 10 does not mean that adverse health effects are 10 times more
likely to occur than for an HQ of 1.

For chemicals where an RfD or RfC is not available, MOE is calculated by:

       MOE = NOAEL / PDR or LOAEL / PDR
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CHAPTER 6
RISK CHARACTERIZATION
Alternatively, MOE can be calculated with an exposure level rather than a dose rate:

       MOE = NOAEL or LOAEL / lifetime average exposure level

As with the HQ, the MOE is not a probabilistic statement of risk. Very high MOE values, such
as values greater than 100 for a NOAEL-based MOE or 1,000 for a LOAEL-based MOE, imply a
very low level of concern. As the MOE decreases, the level of concern increases.

Details:  Step 3, Calculating Pathway Risk for Multiple Chemicals

For pathways where exposure to more than one chemical is being assessed, the cancer risk results
for each chemical are typically summed for each pathway:

       cancer riskTOT = £ cancer risk for each chemical

It should be noted that summing cancer risks assumes additivity of the chemical effects.  Risks
from exposures to more than one carcinogen are typically assumed to be additive, unless
available information suggests otherwise.

The HQs can also be summed to calculate an HI:

       HI = E HQ for each chemical

Alternatively, HI can be calculated by:

       HI = PD^/RfD, + PDR2/RfD2 + ... + PDR/RfDj

Calculation of an HI also assumes additivity of the chemical effects. This is valid only where the
chemicals elicit the same effect by the same  mechanism of action. Typically, if an HI exceeds
unity, the chemicals are segregated by effect and mechanism and segregated His  recalculated.
This segregation by mechanism of action and type of effect is not a simple exercise and should
only be performed by an experienced lexicologist.

Details:  Step 4, Summing Pathway Risks, if Applicable

In some situations, a receptor may be exposed to a chemical, or a mixture of chemicals, through
more than one pathway (for example, a worker may be inhaling volatile chemicals from a
solution and at the same time be exposed through the skin).  In this case the total risk is equal to
the risks from all relevant pathways. Cancer risks can be summed across pathways, where:

       total exposure cancer risk = cancer risk (pathway t) + cancer risk (pathway2) + ...
                           cancer risk (pathway J
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PARTH: CTSA INFORMATION MODULE
HI should be summed separately for different exposure durations (e.g., chronic, subchronic,
shorter term durations); an HI for multiple pathways and similar exposure durations can be
calculated by:

       total exposure HI = HI (pathway!) + HI (pathway2) + ... HI (pathway^

Results are typically presented for each pathway separately (Step 3) as well as combined across
pathways.

Details:  Step 5, Calculating Population Cancer Risk, if Applicable

Cancer risks may be characterized in terms of individual or population risk.  Risk to a population
is typically calculated by:

       cancer risk = individual cancer risk x number in exposed population

Population risks may also be calculated separately for areas with different levels of exposure.
Population data sources may include the number in the exposed population from the Exposure
Assessment module, census data, or other demographic data or work place surveys.

Details:  Step 6, Assessing Uncertainty and Variability

Because information for risk characterization  comes from the Environmental Hazards Summary,
Human Health Hazards Summary, and Exposure Assessment modules, an assessment of
uncertainty should include those uncertainties in the hazard and exposure data. There is also the
issue of compounded uncertainty; as uncertain data are combined in the assessment, uncertainties
may be magnified in the process. EPA guidance (e.g., Risk Assessment Guidance for Superfund
[EPA, 1989a]; "Guidelines for Exposure Assessment" [EPA, 1992a]) contains detailed
descriptions of uncertainty assessment, and the reader is referred to these for further information.

Uncertainties in the hazard data could include:
•     Uncertainties from use of quantitative structure-activity relationships (QSARs) for
       aquatic toxicity.
•     Using dose-response data from high dose studies to predict effects that may occur at low
       levels.
•     Using data from short-term studies to predict the effects of long-term exposures.
•     Using dose-response data from laboratory animals to predict effects in humans.
•     Using data from homogeneous populations of laboratory animals or healthy human
       populations to predict the effects on the general human population, with a wide range of
       sensitivities.
•     Assuming 100 percent absorption of a dose when the actual absorption rate may be
       significantly lower.
«     Using toxicological potency factors from studies with a different route of exposure than
       the one under evaluation.
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CHAPTER 6
                                                               RISK CHARACTERIZATION
•      Effects of chemical mixtures (effects may be independent, additive, synergistic or
       antagonistic).
•      Possible effects of substances not included because of a lack of toxicity data.
•      Carcinogen weight-of-evidence classifications; for any chemicals assessed as carcinogens
       (described in the Human Health Hazards Summary module), the weight-of-evidence
       classification should be presented with any cancer risk results.

Uncertainties in the exposure data could include:
•      Description of exposure setting - how well the typical facility used in the exposure
       assessment represents the facilities included in the CTSA; the likelihood of the exposure
       pathways actually occurring.
•      Possible effect of any chemicals that may not have been included because they are minor
       or proprietary ingredients in a formulation.
•      Chemical fate and transport model applicability and assumptions - how well the models
       and assumptions that are required for fate and transport modeling represent the situation
       being assessed and the extent to which the models have been verified or validated.
•      Parameter value uncertainty, including measurement error, sampling error, parameter
       variability, and professional judgment.
•      Uncertainty in combining pathways for an individual.

In the CTSA, uncertainty is typically addressed qualitatively. Variability in the exposure
assessment is typically addressed through the use of "exposure descriptors," which are discussed
in the Exposure Assessment module.

Details:  Step 7, Summarizing and Presenting Results

The risk characterization results are typically presented hi tables, with the cancer risk, HQ and/or
HI, and MOE calculated for each chemical. The results are also explained and summarized in
the text along with the tables.  The actual format of the tables can vary greatly, depending on the
 complexity of the analysis (the number of chemicals, scenarios, and pathways being assessed).
 A typical format is shown in Table 6-10.
TABLE 6-10: TYPICAL FORMAT FOR RISK CHARACTERIZATION RESULTS
(e.g., Dermal Contact with Solution X in Occupational Setting Performing Task Y)
Chemical
chemical a
chemical z
sum of cancer risk,
or HI, for pathway:
Cancer Risk
[weight-of-evidence classification]
result for a [B2]
result for z[El]
sum of cancer risks
HQ
result for a
result for z
sum of HQs
(when appropriate)
MOE
result for a
result for z
(not summed)
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 PARTH: CTSA INFORMATION MODULE
 Details: Step 8, Comparing CC to Aquatic Concentrations


 Exposure concentrations below the CC are assumed to present low risk to aquatic species.
 Exposures that exceed the Cc indicate a potential for adverse impact on aquatic species.  The
 level of concern increases as the ratio of exposure concentration to CC increases.


 An ecological risk indicator may be calculated as a unitless ratio, for example:


       With a daily stream concentration of 2 mg/1 and a CC of 1 mg/1, the ecological risk
       indicator = (2)/(I) = 2


 An ecological risk indicator greater than 1 indicates that the estimated or measured chemical
 concentration exceeds the concentration of concern for the aquatic environment based on
 chemical toxicity to aquatic  organisms. The greater the number of days the CC is exceeded, the
 greater the potential risk.


 Details: Step 9, Expressing Risk on a "Per Unit of Production" Basis


 Where possible, also express risk characterization results on a "per unit of production" basis
 using an amount that is produced during the corresponding exposure period. For example,
 cancer risk can be expressed as risk/amount produced.  This information will facilitate evaluating
 tradeoffs among alternatives in the Social Benefits/Costs Assessment and Risk, Competitiveness
 & Conservation Data Summary modules.
FLOW OF INFORMATION: The Risk Characterization module receives information from
the Exposure Assessment, Human Health Hazards Summary, and Environmental Hazards
Summary modules and transfers information to the Risk, Competitiveness & Conservation Data
Summary module. Examples of information flows are shown in Figure 6-5.


                FIGURE 6-5: RISK CHARACTERIZATION MODULE:
                         EXAMPLE INFORMATION FLOWS
     Exposure
    Assessment
   Human Health
     Hazards
                  * Exposure scenarios
                   and pathways
                  * Potential doea rates or
                   exposure tevefa
                  • Ambient concentrations
     Summary   |»Bri*»W»flf««««it
            y   »«Refo»netdose«
                 « Slope fadore
                   Unit risk
Environmental
  Hazards
  Summary   |« Ecotoxidty concern
                concentrations
                                              Risk
                                        Characterization
                                            • Cancer risk > '
                                            "Hazard quotient
                                            • Margin of exposure  "
                                            Mfioological nak indicator
                                             J
      Risk,
 Competitiveness &
 Conservation Datii
	Summary
                                         6-50

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CHAPTER 6
                                                       RISK CHARACTERIZATION
ANALYTICAL MODELS: None cited.
PUBLISHED GUIDANCE: Table 6-11 presents references for published guidance on risk
characterization.
TABLE 6-11: PUBLISHED GUIDANCE ON RISK CHARACTERIZATION
Reference
Barnes, D.G. and M. Dourson. 1988.
"Reference Dose (RfD): Description and Uses in
Health Risk Assessments."
Habicht, F.H. II. 1992. Guidance on Risk
Characterization for Risk Managers and Risk
Assessors.
Nabholz, J.V. 1991. "Environmental Hazard and
Risk Assessment Under the United States Toxic
Substances Control Act."
Nabholz, J.V., et. al. 1993a. "Environmental
Risk Assessment of New Chemicals Under the
Toxic Substances Control Act (TSCA) Section
Five."
U.S. Environmental Protection Agency. 1987b.
The Risk Assessment Guidelines of 1986.
U.S. Environmental Protection Agency. 1989a.
Risk Assessment Guidance for Superjund, Volume
I: Human Health Evaluation Manual (Part A).
U.S. Environmental Protection Agency. 1990a.
Exposure Factors Handbook.
U.S. Environmental Protection Agency. 1991b.
"Guidelines for Developmental Toxicity Risk
Assessment."
Type of Guidance
EPA's principal approach to assessing risk for
health effects, other than cancer and gene
mutations, from chronic chemical exposure.
Guidance for managers and assessors on
describing risk assessment results in EPA reports,
presentations, and decision packages with respect
to reliability and uncertainty of the results of risk
characterization.
Discussion of environmental risk assessment
procedures (as practiced under TSCA).
Discussion of environmental risk assessment
procedures (as practiced under TSCA).
Guidance on risk assessment methods; includes
Guidelines for Mutagenicity Risk Assessment,
Guidelines for Carcinogen Risk Assessment, and
Guidelines for the Health Risk Assessment of
Chemical Mixtures, originally published in the
September 24, 1986 Federal Register, FR
51(185).
Detailed guidance for developing health risk
information at Superfund sites; may also be
applicable to other assessments of hazardous
wastes and hazardous materials.
Data related to exposure frequency and duration,
and other human physiological and activity
parameters.
Guidance on assessing developmental toxicity
risks; a revision of the Guidelines for the Health
Risk Assessment of Suspect Developmental
Toxicants, FR 51(185), September 24, 1986.
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 PARTH:  CTSA INFORMATION MODULE
TABLE 6-11: PUBLISHED GUIDANCE ON RISK CBEARACTERIZATION "
Reference
U.S. Environmental Protection Agency. 199 If.
Human Health Evaluation Manual, Supplemental
Guidance: "Standard Default Exposure Factors."
U.S. Environmental Protection Agency. 1992a.
"Guidelines for Exposure Assessment."
U.S. Environmental Protection Agency. 1994i.
Guidelines for Reproductive Toxicity Assessment.
U.S. Environmental Protection Agency. 1994J.
Pesticide Occupational and Residential Cancer
Risk Policy Statement.
U.S. Environmental Protection Agency. 1994k.
"Final Report: Principles of Neurotoxicity Risk
Assessment."
U.S. Environmental Protection Agency. 19941.
OPPT Risk Assessment SOPs.
U.S. Environmental Protection Agency. 1996b.
"Proposed Guidelines for Carcinogen Risk
Assessment."
Zeeman, M.G. 1995a. "EPA's Framework for
Ecological Effects Assessment."
Zeeman, M.G. 1995b. "Ecotoxicity Testing and
Estimation Methods Developed under Section 5
of the Toxic Substances Control Act (TSCA)."
Type of Guidance
Exposure factors guidance to be used in the
Superfund remedial investigation/feasibility
study process.
EPA guidance on exposure assessment; assessing
uncertainly and variability in exposure data.
Guidance on assessing reproductive toxicity
risks.
EPA's risk management policy with regard to
occupational and residential (not dietary) cancer
risks resulting from the use of pesticides.
(Reflects Assistant Administrator's policy
direction on risk which may be applicable to
OPPT programs.)
Guidance on assessing neurotoxic risks.
A collection of guidance documents on various
EPA exposure and risk characterization
procedures.
Guidance on assessing carcinogenic risks; a
revision of the Guidelines for Carcinogen Risk
Assessment, FR 5 1(1 85), September 24, 1986.
Provides an overview of the process used in the
environmental toxicity assessment of chemicals
Describes the developoment, validation, and
application of SARs in the EPA OPPT.
Note: References are listed in shortened format, with complete references given in the reference list following
Chapter 10.
DATA SOURCES: Hazard and exposure data are provided by the Human Health Hazards
Summary, Environmental Hazards Summary, and Exposure Assessment modules.
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                                                                  Chapter 7
                                    COMPETITIVENESS
This chapter presents module descriptions for the competitiveness component of a CTS A,
including the following modules:

•      Regulatory Status.

•      Performance Assessment.

•      Cost Analysis.

Each of these modules provides information on basic issues traditionally important to the
competitiveness of a business: its need or ability to comply with environmental regulations; the
performance characteristics of its products relative to industry standards; and the direct and
indirect costs of manufacturing its products.  A CTSA weighs these traditional competitiveness
issues against a new generation of competitiveness issues: the health and environmental
impacts of alternative products, processes, and technologies.

 Data from all three of these modules are considered in the Social Benefits/Costs Assessment
 and Decision Information Summary modules along with risk data, conservation issues, and
 other information.  In addition, the Regulatory Status and Performance Assessment modules
 transfer data to other modules of a CTSA.  For example, the Regulatory Status module
 determines if control technologies are required for a particular alternative and transfers that
 information to the Control Technologies Assessment module.

 The Performance Assessment module is one of the most important data gathering modules of a
 CTSA  A DfE project team typically conducts a performance demonstration project during
 this module where performance data are collected together with data on capital, operating, and
 maintenance costs; energy and other resource consumption rates; waste generation rates; and
 worker exposure (particularly for new or novel alternatives not evaluated in the Workplace
 Practices & Source Release Assessment module). These data are then transferred to the
 appropriate modules.  For example, cost data from the Performance Assessment module can
 be used to perform a comparative cost analysis of alternatives in the Cost Analysis module.
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                               REGULATORY STATUS
OVERVIEW:  The Regulatory Status module determines the statutes and regulations that
govern the chemicals and industrial processes in the use cluster.  Although federal environmental
regulations are typically assessed in a CTSA, this module also provides guidance in conducting
searches of other Federal regulations and state and local regulations that may be pertinent to the
use cluster being assessed or the group performing the evaluation.
GOALS:
       Determine the pertinent laws and regulations, including those governing use and release
       to the workplace or environment, affecting the chemicals, processes, and technologies in
       the use cluster or the use cluster industry.

       Assist in the evaluation of economic and social costs and benefits of the use of a
       particular chemical, process, or technology by determining the regulatory requirements
       that lead to costs of compliance (such as treatment costs, permit costs, and reporting
       costs) and public disclosure of environmental information, possibly affecting public
       relations.
 PEOPLE SKILLS:  The following lists the types of skills or knowledge that are needed to
 complete this module.

 •      Ability to identify laws and regulations affecting the chemicals and technologies in the
            cluster or the target industry, including environmental, consumer product safety, and
use
        occupational safety and health laws and regulations.

 •     Ability to do legal research and search legal data bases.

 •     Legal expertise required to interpret laws and regulations and their application in a
        particular jurisdiction or particular situation.

 Within a business or DFE project team the people who might supply these skills include
 environmental compliance managers and corporate attorneys, particularly those specializing in
 environmental compliance.  Environmental consultants and law firms can also provide the skills
 and knowledge necessary.
  DEFINITION OF TERMS:

  CnJ* nf Federal K^latinns fCFR): The official codification of federal regulations that were
  originally published in the daily Federal Register. Citation note: In a citation to the CFR (e.g.,
                                             7-3

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  40 CFR 129), the first number is the number of the title on a particular topic (Title 40 covers
  "Protection of Environment"), and the second number indicates the "part" or the section number
  (part 129 regulates "Toxic Pollutant Effluent Standards").  Updating: If the CFR part or section
  has been repealed or amended, the List of CFR Sections Affected (LSA) will provide a citation
  for the current material in the Federal Register.

  Federal Register (Fed. Reg,): A daily publication of proposed and final federal regulations
  Citation note: In a citation to the Fed. Reg., the first number indicates the volume and the second
  number indicates the page.  A complete citation also includes the date of publication For
  example, 60 Fed. Reg. 5320 (Jan. 27, 1995) is Volume 60, page 5320, published on January 27,
  JL yy+jf

 Regulation: A rule or order having the force of law issued by the executive branch of
 government (e.g., by a federal administrative agency) to implement a statute.
        : A law enacted by the legislative department of government, whether federal state  city
 or county.                                                                        '   •"

 United States Code (U.S.C.): The official text of federal statutes.  Citation note • In a citation to
 the Code (e.g., 49 U.S.C. 1261), the first number is the number of the title for a particular topic
 (Title 49 covers "Transportation"), and the second number is the section number of the statute
 The United States Code Annotated (U.S.C.A.) and the United States Code Service (U.S.C.S.)
 follow the same numbering system and include annotations to federal regulations implementing
 the particular Code section.  Updating: All of these texts are updated regularly by pocket parts at
 the end of each volume and/or supplementary volumes.
 APPROACH/METHODOLOGY: The following presents a summary of the approach or
 methodology for identifying regulations affecting substitute chemicals, processes, or
 technologies.  Further methodology details for Steps 2, 3, and 4 follow this Section.

 Step 1 :        Obtain chemical identities including CAS RNs and synonyms from the Chemical
              Properties module. Identify the industry sector and specific process type (e.g.,
              printing - lithographic) from the Chemistry of Use & Process Description module.

 Step 2:        Search secondary materials to preliminarily determine the statutes and regulations
              that apply to a particular chemical, process, or technology.

Step 3 :        Review federal statutes by reviewing  codifications (e.g., United States Code) or
              looseleaf services (e.g., Environment Reporter).

Step 4:        Review the federal regulations by original publication, codification, looseleaf
              service, or computer data base.
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Step 5:        Search case law for court interpretations of federal statues and regulations. In
              order to perform a thorough and comprehensive regulatory analysis, if time and
              resources permit, an environmental attorney, qualified law student, or paralegal
              should conduct an up-to-date search of case law from the federal courts to
              determine if there have been any court interpretations of statutes and regulations
              applicable to the chemical, process, or technology, and to determine the status of
              challenged regulations. Official case reporters can be used, such as U.S. Reports,
              or unofficial reporters, such as United States Law Week, Supreme Court Reports,
              Federal Reporter, and Federal Supplements.  Other sources include Environment
              Reporter Cases and WESTLAW® or LEXIS® computer data bases.

Step 6:        Review state statutes, regulations, and case law.  Most states are administering
              federal environmental and occupational health and safety regulatory programs
              with federal approval and may have stricter and/or different requirements than
              federal statutes and regulations. Therefore, for a specific facility location it may
              be desirable to research state law  as part of the regulatory analysis.  In addition to
              official codifications of the state statues and regulations that may be available in a
              major law library, the Environment Reporter is a valuable resource for locating
              state environmental statutes and regulations.  For completeness, state court
              decisions should also be reviewed for interpretations of state statutes and
              regulations. State statutes and case law can also be searched using WESTLAW®
              or LEXIS® computer data bases.

Step 7:        Review local statutes and regulations. In some states, local governments also
              administer environmental statutes and regulations and may have different and
              stricter requirements than federal and state statutes and regulations. For a specific
              location, it may be desirable to review these local requirements, which can be
              obtained by consulting the local government, by visiting a local law library, or by
              consulting a local industrial development office which may have special packets
              concerning local regulations. For completeness, state court decisions should be
              reviewed for interpretation of local statutes and regulations.

Step 8:       Provide the results of the search to the Risk, Competitiveness & Conservation
              Data Summary module. If a control technology would be  required for one of the
              substitute chemicals in the application being evaluated, provide these
              requirements to the Control Technologies Assessment module. Additional
              regulatory information, such as specific disposal requirements, should be provided
              to the Regulatory Status module. If a chemical is planned for a ban or phase-out,
              provide this information to the Market Information module.
 METHODOLOGY DETAILS: This section presents methodology details for completing
 Steps 2, 3, and 4.  If necessary, additional information on these and other steps can be found in
 the published guidance.
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 Details: Step 2, Searching Secondary Sources

 There are several commercial sources that can be used to preliminarily determine the statutes and
 regulations that apply to a particular chemical.  These sources -will provide only a brief summary
 of the major regulations governing a chemical, however. They are not official sources and are
 not updated as often as the federal regulations. Even sources that are updated frequently (e.g.,
 by supplements or a looseleaf service) cannot be relied upon as authoritative law.

 Examples of secondary sources include:
 •     EPA Registry of Lists: A data base of federal regulations applicable to specific chemicals
       that can be searched by chemical.  It is maintained and updated by EPA for its own use
       and is not generally available to the public.
 •     The Suspect Chemicals Sourcebook: This reference shows what regulations apply to any
       given chemical. It directs the researcher to a Source List (e.g., Clean Water Act Section
       311) which provides  capsule descriptions of each chemical and complete chemical
       listings for each regulation. In many cases, the original regulation is reprinted (e.g., from
       the Code of Federal Regulations or the Federal Register).
 •     Law of Chemical Regulation and Hazardous Waste: This source is a legal treatise with an
       update service that keeps it fairly current.  It analyzes not only environmental laws, but
       also occupational safety and health regulations, food additive regulations, and consumer
       product regulations with footnotes to key statutory and regulatory texts.  Since it is not
       organized by chemical name, there is no simple way to find all the regulations governing
       a particular chemical. The treatise is organized by broader topic, such as "Regulation of
       the Generation, Transportation, Storage, and Disposal of Hazardous Waste."
 •     Regulatory Profiles:  Profiles developed by EPA listing pertinent environmental
       regulations affecting specific industries. See the  section on data sources for examples of
       EPA regulatory profiles that are currently available.
 •     Topical Material: Treatises and looseleaf services exist for specific federal statutes.  See
       the section on data sources for some examples of guides to the Emergency Planning and
       Community Right-to-Know Act (EPCRA) and the Toxic Substances Control Act
       (TSCA). These can be searched for applicability to the chemicals of interest.

Details:  Steps 3  and 4, Searching Federal Statutes and Regulations

Identifying Applicable Statutes and Regulations

Federal statutes that may apply include laws governing releases of pollutants to air, land, or
water, as well as laws governing the shipment of hazardous materials, the safety of consumer
products containing hazardous chemical ingredients, and the exposure of workers to chemicals in
the workplace.  The discussion that follows identifies some of the key provisions of several
federal statutes. It does not attempt an in-depth analysis nor does it list all the provisions that
may apply.
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The Clean Air Act (CAA) (42 U.S.C. 7401-7671q): Governs emissions of air pollutants to the
environment. In addition to the Code of Federal Regulations, federal air regulations can be
located easily in the Environment Reporter (ER) Federal Regulations Binders. Examples of key
provisions include:
•     National Ambient Air Quality Standards (NAAQS): EPA has established NAAQS for six
      criteria pollutants:
      (1) Sulfur dioxide (SO2).
      (2) Nitrogen dioxide (NO2).
      (3) Carbon monoxide (CO).
      (4) Ozone.
      (5) Lead.
      (6) Particulate matter (PM-10).
•     Hazardous Air Pollutants (HAPs): The National Emissions Standards for Hazardous Air
      Pollutants (NESHAPs) control 189 pollutants listed at 42 U.S.C. 7412. The regulatory
      standards for these substances are spelled out at 40 CFR 61.  Sources must also prepare
      and implement risk management plans with the Chemical Safety and Hazard
      Investigation Board.
•      State Implementation Plans (SIPs): The states are authorized to establish programs for
      implementing the CAA. Regulations for each SIP can be found at 40 CFR 52. These can
      also be found in the ER Federal Regulations Binder at Tab 125.
•      Chlorofluorocarbons (CFCs) or halons will be phased-out under Title VI of the CAA
      Amendments, at 42 U.S.C. 7671.

The Comprehensive Environmental Response, Compensation, and Liability Act
(CERCLA) (42 U.S.C. 9601-9675): Governs the cleanup of sites where hazardous substances
have been released or disposed. Examples of key provisions include:
•      A list of "hazardous substances" (see 42 U.S.C. 9601 for definition; see 40 CFR 302.4 for
       list of chemicals).
•      Reportable Quantity (RQ) for releases of chemicals (see 40 CFR 302.4).  If there is a
       release of the substance greater than the RQ, any person in charge of the facility must
       notify the National Response Center.

The Clean Water Act (CWA) (33 U.S.C. 1251-1387): Governs the discharge of pollutants to
United States waters, but does not cover ground water. Federal water pollution regulations can
be found in the ER Federal Regulations Binder and the Code of Federal Regulations. Examples
of key provisions include:
•     The National Pollutant Discharge Elimination System (NPDES). NPDES permits are
       needed for point source discharges into  surface waters (see 33 U.S.C. 1342 & 40 CFR
       122.2). Permits include limits on discharge of specific chemicals as required by
       regulations for specific industry categories.
•     "Priority pollutants" are listed at 40 CFR 122, Appendix D.
•     National effluent standards source categories.  The CWA has a system of minimum
       national effluent standards for several industry categories (see 33 U.S.C. 1316 for the
       categories and 40 CFR 400-460 for effluent guidelines and standards; toxic pollutants
       regulated under these standards are found at 40 CFR 401.15).

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 The Emergency Planning and Community Right-To-Know Act (EPCRA) (42 U.S.C. 11001-
 11050; also known as Superfund Amendments and Reauthorization Act [SARA] Title III):
 Requires reporting to EPA for toxic chemical releases to the environment and off-site transfer of
 chemicals. Reports are publicly available. Facilities must file an annual Toxic Release
 Inventory for each chemical listed at 40 CFR 372.65 if the facility has more than 10 employees
 and manufactures, processes, or otherwise uses amounts of chemicals in excess of the threshold
 reporting amount (see 40 CFR 372.25).

 The Federal Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C. 301-395): Governs
 chemicals used as food additives or in cosmetics.

 The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
 (7 U.S.C.  136-136y): Governs chemicals used as active ingredients in pesticides.

 The Hazardous Materials Transportation Act (HMTA) (49 U.S.C. 1801-1812): Governs
 shipments of hazardous materials in commerce by road, air, rail, and water. Examples of key
 provisions include:
 •      The listing of materials that are hazardous to transport in the Hazardous Materials Table
       (49 CFR 172.101), which also contains regulations for packaging, labeling, and
       transportation.

 The Consumer Product Safety Act (CPSA) (15 U.S.C. 2051-2084) and The Hazardous
 Substances Act (HSA) (15 U.S.C. 1261-1277): Governs the safety of consumer products,
 including hazardous chemical ingredients.  "Hazardous substances" defined by 15 U.S.C.
 1261(f)(l)(A) or by any regulation issued by the Consumer Product Safety Commission are
 subject to labeling requirements, and the Commission may ban a product through regulation.

 The Occupational Safety & Health Act (OSHA) (29 U.S.C. 651-678): Governs the exposure
 of workers to chemicals in the workplace. Examples of key provisions include:
 "      The Hazard Communication Standard, explained in 29 CFR 1910.1200, mandates notice
       requirements, labeling requirements, and the availability of Material Safety Data Sheets
       (MSDSs).  Requires employers to inform and train employees about hazardous
       chemicals.
 "      Hazardous air contaminants in the workplace are controlled by Permissible Exposure
       Limits (PELs).  These are found in 29 CFR 1910.1000 Table Z-l-A.

The Resource Conservation and Recovery Act (RCRA) (42 U.S.C. 6901- 6991): Governs the
generation, transport, treatment, storage and disposal of hazardous chemical waste.  In addition
to the Code of Federal Regulations, the ER Federal Regulations Binder is a good resource to
locate regulations on hazardous waste.  Key provisions include:
 •      Definition of hazardous waste:
       Solid waste as defined by RCRA that fits any category below is hazardous waste subject
       to RCRA regulation:
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       -  Listed wastes- (see 40 CFR 261 - four lists).
       -  Characteristic wastes (e.g., ignitable, corrosive, reactive, or toxic wastes.  See 40
         CFR 261.2).
       -  Substances derived from listed wastes.
       -  Substances mixed with either listed or characteristic wastes.
•      Treatment, Storage, and Disposal Facility (TSDF) regulations: Permitting requirements
       are found at 40 CFR 264-265, 270).

The Toxic Substances Control Act (TSCA) (15 U.S.C. 2601-2692): Governs manufacturing,
use, and disposal of toxic chemicals; requires premanufacturing notices for new chemicals, and
comprehensive reporting for certain existing chemicals. In addition to the Code of Federal
Regulations, the ER Federal Regulations Binder is a good resource to locate TSCA regulations.
TSCA regulates "chemical substances and mixtures" as defined in the act and regulations (40
CFR 710).  Substances regulated under FIFRA and FFDCA are exempt.

Codifications of Federal Statutes

Codifications of federal statutes include:
•      United States Code (U.S.C.').
m      United States Code Annotated. (U.S.C.A.).
•      United States Code Service (U.S.C.S.).

Other publications which are useful tools for locating the text of environmental statutes include:
•      Environmental Law Reporter Statutes Binder.
•      ER Federal Laws Binder (published by the Bureau of National Affairs [BNA]).

These publications do not contain other federal laws, such as the Occupational Safety and Health
Act (OSHA), which may apply to the chemical being researched.  Other looseleaf services
specialize in a particular area,  such as:
•      Chemical Regulations  Reporter (published by BNA).
•      Occupational Safety and Health Reporter (published by BNA).
•      Food and Drug Law Reporter  (several publishers).

Locating Federal Regulations

Sources that can be used to access the regulations in text form include:
•      Annotations to the U.S.C.A. or U.S.C.S., which cite regulations that implement particular
       statutory provisions.
•      Index to the Code of Federal Regulations.
•      ER Federal Regulations Binder.
•      Federal Register where the regulation was originally published (also contains explanatory
       materials not codified in the CFR).
•      Computer data bases.
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Searching Computer Data Bases

The WESTLAW® network has data bases for both the Code of Federal Regulations (FENV--
GFR) and the Federal Register (FENV-FR).  Within these data bases, it is possible to search by
chemical name (e.g.,"benzene"). However, the search may produce hundreds of citations
because the computer will pull up any document within the data base where the term appears.
Thus, it will be necessary to review the text of the retrieved documents to determine whether
each regulation specifically regulates the substance in question or merely mentions it in passing.

The LEXIS® network can also search for federal regulations. LEXIS® is organized by libraries
and files. For a general search, enter the CODES library and then choose either the CFR file for
citations to the Code of Federal Regulations or the FEDREG file for citations to the Federal
Register. Again, relevant citations may also appear. Both of these on-line data bases charge for
the use of their service, including on-line time changes and charges for documents downloaded.
FLOW OF INFORMATION: The Regulatory Status module receives information from the
Chemical Properties and Chemistry of Use & Process Description modules and transfers
information to the Market Information, Control Technologies Assessment, Cost Analysis, and
Risk, Competitiveness & Conservation Data Summary modules. Example information flows are
shown in Figure 7-1.

                  FIGURE 7-1: REGULATORY STATUS MODULE:
                        EXAMPLE INFORMATION FLOWS
    Chemical
    Properties
  » CAS RN and
    synonyms
   Chemistry of
  Use & Process
    Description
                            Regulatory
                              Status
  • Industry category
  • Process type
                                               i Bans and phaae-«Ljts
                                                Required control*
                                              * Emission limits
• Regulated substitutes
• Required disposal
 mettwds
                                                                       Market
                                                                     Information
                         Control
                      Technologies
                      Assessment
                                                                            ,	A	A/TA!,
                          Cost
                        Analysis
                                                                        Risk,
                                                                   Competitiveness
                                                                    & Conservation
                                                                    Data Summary
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ANALYTICAL MODELS: None cited.
PUBLISHED GUIDANCE: Table 7-1 lists published guidance and sources of regulatory data.
TABLE 7-1: PCBLISHEB GUIDANCE AM> DATA SOURCES
Reference
Chemical Regulations Reporter. Updated
Periodically.
Code of Federal Regulations Index. Updated
Periodically.
Environment Reporter. Updated Periodically.
Environmental Law Reporter. Updated
Periodically.
Food and Drug Law Reporter. Updated
Periodically.
Index to the Code of Federal Regulations.
Updated Periodically.
LEXIS® Network.
Occupational Safety & Health Reporter.
Updated Periodically.
Orloff, Neil, et. al. Updated Periodically.
Community Right-To-Know Handbook.
Stever, Donald W. Updated Periodically. Law of
Chemical Regulation & Hazardous Waste.
Suspect Chemicals Sourcebook. Updated
Periodically.
United States Code. Updated Periodically.
United States Code Annotated. Updated
Periodically.
United States Code Service. Updated
Periodically.
U.S. Environmental Protection Agency. 1994b.
Federal Environmental Regulations Potentially
Affecting the Commercial Printing Industry.
Type of Guidance
Looseleaf service for regulations regarding toxic
chemicals.
Index to CFR providing guide to updates in
Federal Register.
Looseleaf service: text of federal and state laws
and regulations.
Looseleaf service: news, statute texts.
Looseleaf service.
Index to CFR.
On-line data base of federal and state regulations
and court opinions.
Looseleaf service.
Compliance guide to EPCRA.
Comprehensive legal treatise.
Regulatory analysis by chemical.
Official text of federal statutes.
Text of federal statutes with annotations.
Text of federal statutes with annotations.
Regulatory profile of the commercial printing
industry.
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TABLE 7-1: PUBLISHED GOTBANCE AMD DATA SOURCES
Reference
WESTLAW* Network.
Type of Guidance
On-line data base of federal and state regulations
and court opinions.
Note: References are listed in shortened format, with complete references given in the reference list following
Chapter 10.
DATA SOURCES: None cited.
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                           PERFORMANCE ASSESSMENT
OVERVIEW:  The Performance Assessment module measures how well a product or process
performs to meet the functional requirements of the use cluster.  Performance data are collected
for both the baseline and the substitute processes and used as a basis for a comparative
evaluation. The amount of effort required to perform a useful performance assessment may vary
depending on the thoroughness of the study and the specific nature of the process under
consideration. The performance assessment can involve an actual operating trial of the baseline
and substitutes during a performance demonstration project or, if both the baseline and
substitutes are well known and documented, the compiling of performance information from
literature sources. This module provides assistance in developing  methodologies for collecting
comparative performance data and conducting a performance assessment. The focus of this
module is on the design of an actual operating trial rather than compiling performance
information from literature sources.
GOALS:
       Design accurate and reliable performance measures.

       Select and use protocols for measuring performance to achieve reproducible testing
       results, and to remove bias from the interpretation of results.

       Develop a supplier data sheet to facilitate collection of required data from vendors and
       suppliers.

       Develop an observer data sheet to ensure that consistent and complete data are collected
       during performance testing.

       Evaluate relative performance of substitutes.
PEOPLE SKILLS:  The following lists the types of skills or knowledge that are needed to
complete this module.

•      Familiarity with the required characteristics of the baseline and substitutes and the factors
       affecting performance.

•      Knowledge of measuring techniques and quality control testing procedures.

•      Familiarity with the details of the operation of the baseline and substitutes under review.

•      Ability to analyze variability of results using qualitative or statistical techniques.
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Within a business or DfE project team, the people who might supply these skills include a
process engineer, process operator, industrial engineer, or statistician.  Vendors of equipment or
chemicals used in the process may also be a good resource.
DEFINITION OF TERMS:

American Society for Testing and Materials TASTM): An independent group that sets standard
testing procedures for a variety of materials (e.g., environmental effects on galvanized metal
surfaces, light bulb life testing).

Bias: Testing error caused by systematically favoring some outcomes over others.

Blind Testing: An experimental method in which the material or process under study is not
known to an operator to avoid influence on performance/results testing.

Generic Formulation: A generic classification into which a group of similar chemicals or
chemical formulations can be grouped, in order to be evaluated, protecting the proprietary nature
of a formulation.

Objective Characteristics: Characteristics which when measured are independent of the
measurer's influence  (e.g., weight, size).

Reproducibility: The ability of a test to give consistent results.

Subjective Characteristics:  Characteristics  which when measured and assigned a value are
influenced by the perceptions of the measurer (e.g., color, sound, taste).

Test Vehicle:  A standardized unit that can be used as a basis for testing different processes (e.g.,
a standard circuit board design that can be used to test the ability of several different processes to
plate a conductive material into the holes on the board).

Underwriters Laboratory (U.L.):  An independent group that tests and certifies the safety of
electrical appliances (e.g., toasters, electric  hand drills, lamps).

Variability:  The measured difference in certain characteristics of similar items (e.g., paint
thickness, color consistency, part cleanliness).
APPROACH/METHODOLOGY: The following presents a summary of the technical
approach or methodology for designing and conducting a performance demonstration. Further
methodological details for Steps 4, 5, 6, 9,12, and 13 are included in the Methodology Details
section. In the procedure described below, the example of the use of a liquid cleaning agent
applied to the surface of an ink-coated printing screen is used. Examples of an observer data
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sheet, and the testing methodology protocol for the screen printing industry are included hi
Appendix E.

Performance Protocol

Step 1:        Obtain chemical properties data relevant to performance from the Chemical
              Properties module. Relevant properties for the example of a liquid cleaning agent
              to remove ink from a printing screen include vapor pressure (reflects tendency for
              evaporation), boiling point (indicates usable temperature range), and flashpoint
              (indicates fire ignition temperature level).

Step 2:        Review the functional requirements of the use cluster listed in the Chemistry of
              Use & Process Description module.  For the cited example, a minimal amount of
              residual ink on the screen after cleaning may be a specified requirement. A
              performance criteria may be that the screen must be cleaned until no visible ink
              residue remains on the screen surface.

Step 3:        Identify relevant performance characteristics that could be qualitatively or
              quantitatively evaluated during the performance demonstration.  These might
              include the ease of use (e.g., the physical effort required to clean the screens), the
              time required to accomplish the desired function (e.g., cleaning), the effectiveness
              of the substitute in achieving the function, or the effect of the substitute on the
              quality of the finished product (e.g., will use of the cleaner reduce the life of the
              screen).

Step 4:        Identify variables which could significantly influence the results of the
              performance demonstration if not properly controlled. These might include
              process variables outside of the use cluster such as upstream process chemistry
              that must be adjusted to be compatible with the substitutes.

Step 5:        Define methods of measuring each of the performance characteristics identified in
              Step 3. These methods, which may include laboratory testing as well as on-site
              analysis during the demonstration, should minimize the effect on results of the
              variables identified in Step 4. If applicable, the design and use of a test vehicle
              can help accomplish the above objectives.

Step 6:        Define the parameters or conditions under which the demonstration of the
              baseline and substitutes will be performed. These parameters include when and
              where the demonstration will take place, along with who will observe the
              demonstration. Performance demonstration conditions should simulate real
              operating conditions as much as possible.

Step 7:        Establish a procedure to quantitatively or qualitatively analyze each of the
              performance measures identified in Step 5. Analysis may be required on-site
              during the performance demonstration (e.g., how many cycles a screen will

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              process before failure, testing to what extent a part is dried, etc.) or after the
              demonstration at a special test facility (e.g., the amount of light transmitted
              through a cleaned screen).  Suppliers of chemicals and equipment should be
              consulted to ensure that the analysis methods are unbiased and do not favor a
              particular product or technology.

Step 8:        Establish a performance scale for each of the performance measures to facilitate a
              comparative evaluation of the substitutes.  The scale should consider both
              subjective and objective characteristics. (For example, visual inspection could be
              used to assign a high, medium or low level of cleanliness. A quantitative test,
              such as light transmission through cleaned screens, could be used to quantitatively
              measure the amount of residual ink left on a screen after cleaning.) Some
              objective characteristics can be evaluated using standard product specifications,
              such as military specifications.

Step 9:        Develop a performance demonstration protocol based on the information
              developed in Steps 3 through 8.

Step 10:       Review the Energy Impacts, Resource Conservation, and Cost Analysis modules
              to determine what data are required from the performance demonstration to
              complete those modules. Include in the protocol methods for collecting energy
              use, resources consumption and cost data, if required.  The following data are
              typically gathered by the performance assessment:
              •      Energy Impact data: Collect data on energy consumed by motors, pumps,
                     air fans, and other energy consuming process equipment. Data may
                     include power rating, average duty, and average load.
              »      Resource Conservation data: Collect data on quantities of resources used
                     in the process.  Use direct measurement or examine historical records to
                     determine rates of resources consumption (e.g., the amount of spent
                     cleaner generated in the cleaning of screens).
              •      Cost Analysis data: Collect information on costs, such as operating and
                     maintenance costs, process equipment costs, raw materials, utilities, as
                     well as applicable indirect costs (e.g., waste management expenditures).

Step 11:       If time and resources allow, perform test runs to evaluate the performance
              demonstration protocol for factors such as reproducibility. Performing trial runs
              will ensure that all important variables have  been identified and controlled, and
              will highlight significant errors or impracticalities in the protocol.

Supplier and Observer Data Sheets

Step 12:       Develop a supplier data sheet to collect consistent data from suppliers and vendors
              of the use cluster chemicals or technologies.  One important purpose of
              the supplier data sheet is to collect information regarding the proprietary
              formulations of chemical products, which is necessary for the risk characterization

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              component of a CIS A. The same data sheet should be disseminated to each of
              the vendors or suppliers of the chemicals or technologies being employed in the
              demonstration.

 Step 13:      Develop an observer data sheet to facilitate the collection and recording of
              consistent data at the time of the performance demonstrations. Because similar
              types of data must be collected, it may be helpful to use the questionnaire
              developed in the Workplace Practices & Source Release Assessment module as a
              basis for developing the observer data sheet. The data sheet should be completed
              by the observer for each test run at each performance demonstration site. In order
              to ensure an efficient on-site performance demonstration, it may be useful to
              distribute portions of the observer data sheet to participating test facilities prior to
              the demonstration.  To minimize the variation in data recording, it is preferable to
              have the same observer complete the on-site portion of each data sheet.

Performance Results

Step 14:       Conduct performance demonstrations for each of the alternatives using the
              performance protocol developed in Step 9. The demonstrations should be carried
              out in the presence  of a neutral observer who can record the process conditions
              and complete  the observer data sheet.

Step 15:       If the test vehicle is to be shipped to an off-site laboratory for analysis, the
              observer should record the identification code of the test vehicle, package it
              according to a standard protocol and ship it to this laboratory. Only reporting the
              identification  code to the off-site laboratory, and not the type of substitute
              demonstrated  on the test vehicle, ensures  blind testing by the off-site laboratory.

Step 16:       Compare the performance results with the previously-defined performance
              characteristics to evaluate the comparative efficacy of the substitutes (e.g.,
              substitute 1 failed to clean the screen effectively and was time-consuming, but
              substitute 2 cleaned the surface effectively and quickly). It is important to note
              that results from the performance demonstration may not be easily comparable,
              particularly if all key variables are not identified or able to be controlled.

Step 17:       Transfer energy use, resource consumption and cost data to the appropriate
              modules. Transfer chemical formulation data to the Exposure Assessment
              module. Transfer performance assessment results from Step 14 to the Risk,
              Competitiveness & Conservation Data Summary module.
METHODOLOGY DETAILS: This section presents methodology details for completing
Steps 4, 5, 6, 9, 12, and 13.  If necessary, additional information on these and other steps can be
found in the published guidance.
                                          7-17

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PARTH: CTSA INFORMATION MODULES
Details:  Step 4, Identifying Variables

Given the screen cleaning example, the types of variables that could significantly influence the
results of the performance demonstration, if not properly controlled, include the following:
»      Environmental:
       - Ambient light levels needed for operator to judge screen cleanliness after cleaning
         operations.
       - Ambient air temperature can affect cleaning agent efficiency.
"      Human Operator:
       - Different operators may handle and clean screens with different speeds and
         thoroughness.
 •     Process System:
       - Ink type and viscosity may affect cleaner action.
       - Design of screens may affect ease of cleaning along edges and in corners.

Details: Step 5,  Measurement Methods and Test Vehicle Design

To reduce the potential for variation in the test results and thus improve the reproducibility of the
test protocol, the performance demonstration should be designed to:
•      Minimize the influence of secondary parameters (e.g., room temperature variation) to
       isolate the effect of the chemical/process on the performance results.
•      Consider the different application methods or operational characteristics that may be
       required with one or more of the substitutes (e.g., spray application in lieu of hand wipe-
       on of screen cleaning agent).
•      Use blind testing to minimize operator influence on the test outcome (e.g., different
       screen cleaning agents being evaluated could be provided to a worker in containers
       labeled with a number of different codes, several of which could be for the same cleaning
       agent).
•      Minimize the potential for compounded effects caused by lack of control over several
       process variables. In this regard, it is important to identify all key variables so that all but
       a single performance measure can be controlled to the extent possible or practical.

A test vehicle can be developed and used to standardize the conditions and minimize the
variables that can occur when testing several different processes.  The use of a test vehicle is not
always possible and should only be used when it is applicable and makes sense (e.g., a test
vehicle may not be needed to test the efficacy of different chemical agents removing ink from a
silkscreen). A test vehicle  should not be used unless it can be designed to test all of the
alternatives being considered.  The design of the test vehicle should be  done using input from
manufacturers, DfE project team members, and suppliers of chemicals or technologies to ensure
that the test vehicle performs its function without favoring a particular process being tested. The
test vehicle should be designed to:
 •     Facilitate the testing of the performance characteristics listed in Step 3 for all of the
       alternatives being evaluated.
 •     Minimize the effect on results of the variables identified in Step 4 (e.g., use a screen with
        a consistent amount of stencil coverage and intricacy).

                                           7-18

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 CHAPTER?
                                                             PERFORMANCE ASSESSMENT
 •     Be broadly applicable to the range of products being evaluated (e.g., the variation of hole
       sizes on a circuit board test vehicle should be representative of the range of hole sizes
       used for a circuit board).

 In addition, to minimize variation, test vehicles used at different demonstration sites should be
 manufactured under identical conditions at a single facility prior to shipment to the
 demonstration sites. This will minimize the variation in the test vehicles themselves.

 Test vehicles that will be shipped to an off-site laboratory following processing at the
 demonstration site should be labeled with an identification code. The laboratory should use the
 same test methods to analyze all of the test vehicles, regardless of whether the test methods are
 qualitative or quantitative.

 Standard ASTM or U.L. methods and military or other product specifications are  available for
 some manufacturing processes and products and may be useful in designing the performance
 demonstration. Trade associations may have developed standard testing procedures for other
 processes or products. However, unique tests may need to be developed for many processes or
 products.

 Details:  Step 6, Selecting the Demonstration Sites

 The performance demonstration may be carried out at any of the following facility types:
 •      Current operating facility.
 •      Operating facility that acts as a supplier test site.
 •      Supplier or trade association test site or demonstration facility.

Details:  Step 9, Developing the Performance Demonstration Protocol

The performance demonstration protocol may include:
 •      A description of the test vehicle, if applicable, including specifications for manufacturing
       the test vehicle.
 •      The performance characteristics to be reported from the performance demonstrations.
 •      The processing or testing methodology (a step-by-step description of how the on-site
       performance demonstrations will be conducted, including any processing or testing
       requirements).
 •      The processing or testing parameters (the conditions under which the demonstration
       should be performed).
•      The analysis procedures that will measure the performance characteristics.
•   >;   The performance scale that will be used to compare the results of the performance
  ';   assessment.
•      The number of times each test or analysis should be run.
                                          7-19

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PARTH: CTSA INFORMATION MODULES
Details:  Step 12, Preparing a Supplier Data Sheet

The supplier data sheet can be used to collect the following types of data:
•      Process operating parameters (e.g., compatibility with other process steps, product life,
       limitations, etc.).
•      Material safety data sheets.
•      Product formulation data.
•      Equipment operating and maintenance procedures.
•      Waste disposal requirements.
•      Energy, cost, or resource data listed in Step 10 that are best supplied by vendors or
       suppliers (e.g., equipment power rating, equipment costs, maintenance costs, etc.).
•      Any other data that are best supplied by the vendors or suppliers.

When proprietary chemical products are being used, the use of generic formulations may be
necessary to obtain proprietary chemical formulation data from the supplier. A generic
formulation allows the chemical formulation data to be evaluated in the process while protecting
the proprietary nature of the chemical product.  The generic formula is typically developed
through the combined efforts of the suppliers and vendors of the chemical products along with
members of the DfE project team, especially persons involved in the Exposure Assessment and
Risk Characterization components of a CTSA (see Chapter 2: Preparing for a CTSA). An
example method for preparing a generic formula is shown below.

(1)    Group similar chemicals into categories. The categories can either be by chemical name
       or by similar chemical compound (e.g., alcohols).

(2)    Provide a range of concentrations for the actual quantity of a chemical within the product
        formulation (e.g., 50-60 percent toluene).

(3)     Exclude quantities of specific chemicals that are under a concentration agreed upon by
        the project team (e.g., one percent), such as surfactants or salts. Do not exclude
        potentially hazardous materials or chemicals that are regulated.

This method can be used to  group formulations with specific chemicals in a range of
 concentrations (e.g., Product A: 20-40 percent methyl ethyl ketone, 15-25 percent butyl acetate,
 10-20 percent methanol, 20-40 percent toluene), or to specify the actual concentrations of a
 chemical group (e.g., 40 percent propylene glycol series ethers, which can represent a number of
 different, but structurally  similar, chemicals).

 Details:  Step 13, Developing an Observer Data Sheet

 The observer data sheet should collect the following types of data:
 •     Personnel (e.g., facility contact, individuals performing demonstration, etc.).
 »     Demonstration conditions (e.g., ambient air temperature, air ventilation rate, humidity,
        etc.).
                                           7-20

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CHAPTER?
PERFORMANCE ASSESSMENT
•      Process description (e.g., equipment used, process steps, chemical product compositions,
       etc.).
•      Type and identification code of test vehicle, if applicable.
•      Observed operating procedures (e.g., time a panel is immersed in a chemical bath, process
       cycle time, amount of chemical used to clean a screen, etc.).
•      Exposure data (e.g., chemical handling procedures, worker activities, personal protective
       equipment worn by workers, etc.).
•      Process variables (e.g., temperature of chemical baths, worker operation inconsistencies).
•      Energy, cost, and raw materials data listed in Step 10 (e.g., average energy load and duty,
       utility costs, water consumption rates, etc.).
•      Any other data that are best collected by a neutral observer at the time of the performance
       demonstration.

In order to ensure an efficient on-site performance demonstration, it may be useful to distribute
portions of the observer data sheet to participating demonstration sites prior to the demonstration.
The partial observer data sheet should include:
•      A description of the process as it is performed at the specific test facility.
•      Data that are difficult or time consuming to obtain (e.g., annual sludge volumes, data
       from company purchase records, equipment reliability data).
•      Process history data (e.g., recent changes in equipment or operating practices that could
       effect the validity of data collected).
•      Employee data (e.g., number of employees per shift, hours per shift).
•      Any other data that can be collected by the facility that will help prepare observers for the
       demonstration or that are not readily available on-site.

By collecting and reviewing  the facility completed portion of the observer data sheet prior to the
facility test, the performance demonstration will be facilitated by allowing:
•      Observers to become familiar with important process information prior to the
       performance demonstration.
•      Data to be collected that are difficult or time consuming to obtain during a short on-site
       visit (e.g., annual chemical consumption, utility costs).
•      The demonstration site to obtain the particular chemical products or technologies that are
       to  be tested.
FLOW OF INFORMATION: The Performance Assessment module receives data
requirements from the Energy Impacts, Resource Conservation, and Cost Analysis modules.  It
receives chemical and process information from the Chemistry of Use & Process Description and
Chemical Properties modules.  Performance data are transferred to the Exposure Assessment,
Risk, Competitiveness & Conservation Data Summary, Cost Analysis, Energy Impacts, and
Resource Conservation modules. Example information flows are shown in Figure 7-2.
                                           7-21

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PARTH:  CTSA INFORMATION MODULES
              FIGURE 7-2: PERFORMANCE ASSESSMENT MODULE:
                        EXAMPLE INFORMATION FLOWS
    Chemistry of Use
       & Process
       Description
   * Un& operations
   • Required! chemical properties
   • Process flow diagram
       Chemical
       Properties
                              Performance
                              Assessment
    CASRN
    Chemical properties affecting performance
 fanwufatfops  , ,   *P
            ^ L ^- ^"
                                                         V", » «• *
» EffectSveness of
     Risk,
Competitiveness &
Conservation Data B
   Summary
                                                 ^HBsmweji        i ^^^^^^_^_
                                                *Opferatin^riialrjteharice} 	vr ,7-'^!-,,?"^
                                                 nT/.i.^rnanto/  ^    r  -  »V J f >'! ^ >l U^
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                       Impacts
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                                                        '    , ' >1M\^...^^.^...^.b.it.^t
          >} .; u^i

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                       Resource
                     Conservation
ANALYTICAL MODELS: None cited.
PUBLISHED GUIDANCE: Table 7-2 presents references for published guidance relevant to
the design of a performance demonstration project.
TABLE 7-2: PUBLISHED GUIDANCE ONPEI^OItMANCE ASSESSMENT
Reference
Kume, Hitoshi. 1987. Statistical Methods for
Quality Improvement.
Montgomery, Douglas C. 1991. Design and
Analysis of Experiments.
Type of Guidance
Methods for using statistics to measure
performance, specifically quality, for the baseline
and alternative chemicals or processes.
Information on designing non-biased experiments
and statistical analysis of the results.
                                       7-22

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CHAPTER?
PERFORMANCE ASSESSMENT
TABLE 7-1: PUBLISHED GCflDANCE ON PERFORMANCE ASSESSMENT .
Reference
Ray, Martyn S. 1988. Engineering
Experimentation: Ideas, Techniques, and
Presentation.
Type of Guidance
In-depth coverage of experimental techniques and
equipment for measuring performance.
Note: References are listed in shortened format, with complete references given in the reference list following
Chapter 10.
DATA SOURCES: None cited.
                                          7-23

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PARTH: CTSA INFORMATION MODULES
                                   7-24

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                                   COST ANALYSIS
OVERVIEW:  The Cost Analysis module identifies the costs associated with the baseline and
alternatives, and calculates comparative costs between them.  As a minimum, the cost analysis
should identify and compare the direct and indirect costs of the baseline and the substitutes.  If
tune and resources permit, data are also collected on future liability costs and less-tangible
benefits that occur through the implementation of a substitute.
GOALS:

•      Categorize and determine the costs that are incurred by the baseline and the substitutes.

•      Identify less-tangible benefits that can result from the implementation of a substitute.

•      Perform a comparative cost analysis of the baseline versus the substitutes.


PEOPLE SKILLS: The following lists the types of skills or knowledge that are needed to
complete this module.

•      Knowledge of current bookkeeping and accounting practices.

•      Knowledge of, and ability to perform, cost analysis practices and procedures.

•      Knowledge of product and customer buying base to identify less-tangible benefits.

•      Knowledge of costs incurred by the baseline and substitutes and other aspects of direct
       cost allocation.

Within a business or a DfE project team, the people who might supply these skills include a
purchasing agent, marketing specialist, floor manager, an accountant, or an economist. Vendors
of process equipment or chemicals may also be a good resource.


DEFINITION OF TERMS:

Cost Allocation:  The method of assigning costs  that have been incurred to the products and
processes that generated the costs.

Direct Costs:  Costs that are readily assignable to a specific process or product.  These costs
include capital expenditures, and operating and maintenance costs (e.g., labor, materials, utilities,
etc.).
                                           7-25

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 PART II: CTSA INFORMATION MODULES
 Discounting: Economic analysis procedure by which monetary valuations of benefits and/or
 costs occurring at different times are converted into present values which can be directly
 compared to one another.

 Expanded Time Horizon:  The concept of evaluating an economic analysis over an extended
 period of time (e.g., 10-20 years) as opposed to the traditional 3-5 year period. This concept is
 important to identifying the pollution prevention benefits of a substitute, because many of the
 liability costs and less-tangible benefits occur over a longer period of time.

 Indirect Costs:  Costs that are incurred by the operation of a business but not typically allocated
 to a specific process or product. Administrative costs, regulatory compliance costs, and
 workman's compensation costs are all examples of indirect costs.

 Internal Rate of Return (IRR): The discount rate at which the net savings or net present value  of
 an investment are equal to zero. An investment is economically justifiable when the IRR equals
 or exceeds a company's desired rate of return.

 Less-Tangible Benefits: Benefits that may occur but cannot be readily quantified (e.g., reduced
 health maintenance costs due to a safer work environment, or increased product sales due to
 better product performance, etc.).

 Liability Costs:  Difficult to quantify costs incurred as a consequence of uncertain future liability
 for clean-up of hazardous substance releases or for liabilities from personal injury claims
 stemming from environmental releases or product use.

 Net Present Value fNPV): The present value of future cash  flows of an investment less the
 current cost of the investment.

 Present Value (PV): A concept which specifically recognizes the time value of money, i.e., the
 fact that $1 received today is not the same as $1 received in  ten years.  Even if there is no
 inflation, $1 received today can be invested at a positive interest rate (say 5 percent), and can
 yield $1.63 in ten years. Present value refers to the value in today's terms of a sum of money
 received in the future. In the example above, the PV of $1.63 received  in ten years is $1, i.e., $1
 received today is the same as $1.63 ten years in the future. Alternately, the PV of $1 received in
ten years is $0.61.  The rate at which future receipts are converted into PV terms is called the
 discount rate (analogous to the interest rate given above). The formulation for calculating PV is
 given in the Methodology Details section.
APPROACH/METHODOLOGY: The following presents a summary of the approach or
methodology for performing a cost analysis. Further methodology details for Steps 1,2,4, 5, 6,
7, and 8 follow this section.
                                          7-26

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CHAPTER?
                                                                          COST ANALYSIS
Step 1:        Determine data requirements for the cost analysis and provide them to the
              Performance Assessment module so that cost data can be collected during the
              performance demonstration project. Data should be collected on a per unit
              production basis, or some other basis that allows a comparative evaluation of the
              trade-off issues (e.g., energy impacts, resource conservation, risk, etc.).

Step 2:        Obtain the data identified in Step 1 from the Performance Assessment module.
              Obtain additional cost-related data from the Energy Impacts, Resource
              Conservation, Control Technologies Assessment, Regulatory Status, Process
              Safety, Market Information and International Information modules. Energy,
              chemical, and resource consumption data are usually collected in the Performance
              Assessment module and compiled in the Energy Impacts arid Resource
              Conservation modules, respectively.

Step 3:        Review the Workplace Practices & Source Release Assessment module to
              determine if resource consumption rates, waste generation rates, and worker
              activities reported for the baseline and alternatives are consistent with the data
    :         obtained in Step 2.  If the data are not consistent, it may be necessary to have
              knowledgeable industry personnel review and resolve any inconsistencies.

              Note:  To ensure that the cost analyses for alternatives are comparable, data
  ,                   from the Workplace Practices & Source Release Assessment module
                     should be used in actual cost calculations only if the data are available for
                     all of the alternatives being evaluated.  The Workplace Practices &
                     Source Release Assessment module may not contain information on new
                     or novel alternatives that are not widely used.

 Step 4:       Calculate the direct costs associated with the operation of the baseline and the
              alternatives using the data gathered in Step 2 and cheeked in Step 3. Direct costs
              include capital expenditures, operating costs, and maintenance costs.. Waste
              management costs are also examples of direct costs, but many businesses allocate
              these costs to overhead.              .                  ,

 Step 5:       Calculate indirect costs for the baseline and alternatives. The data gathered in
              Step 2 will determine many indirect costs, while other indirect costs can be
  ,;           estimated from other sources.  Indirect costs are considered hidden costs because
              they are often allocated to overhead rather than their source, or are omitted
              altogether from a cost analysis.

 Step 6:       If time and resources permit, identify future liability costs associated with the
              operation of the baseline and alternatives.  In most instances, the estimation of
              future liability cost is subject to a high degree of uncertainty. Therefore, the need
              to quantify the future liability may be less important than recognizing that the
              future liability exists.
                                           7-27

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PART II: CTSA INFORMATION MODULES
Step 7:        If time and resources permit, identify any less-tangible benefits that could result
              from the implementation of a substitute. The benefits of a cleaner product,
              process, or technology can be substantial and should not be overlooked when
              performing a cost analysis.

Step 8:        Perform cost analyses of the baseline and alternatives using the cost data collected
              in Steps 3 through 6. The cost analyses should be performed using a traditional
              cost accounting method or an alternative cost method. An example of a cost
              analysis can be found in Appendix G.

Step 9:        Provide the results of the cost analysis to the Risk, Competitiveness &
              Conservation Data Summary module.
METHODOLOGY DETAILS:  This section presents the methodology details for completing
Steps 1,2,4, 5, 6, 7, and 8. If necessary, additional information on conducting a cost analysis
can be found in the published guidance. Appendix G contains the cost analysis from the
Lithography CTSA.

Details: Step 1, Collecting Cost Data

The following information may be needed for the cost analysis:
•     Labor requirements (e.g., cycle time to produce a product unit, ease of use, number of
      employees to operate process, maintenance labor costs).
•     Waste generation rates (e.g., waste water discharges, solid wastes generated).

Equipment and/or chemical costs may also be collected from suppliers during the performance
demonstration if this information was not compiled in the Market Information (cost of U.S.
supplied equipment and /or chemicals) and International Information modules (cost of foreign
supplied equipment and/or chemicals).

If an actual performance demonstration is not planned during the CTSA (e.g., if performance
data are behig collected from existing sources instead of tests performed as part of the CTSA),
cost estimates can be obtained using standard cost estimating techniques and/or cost estimation
software combined with data from equipment vendors or other sources.

Details: Step 2, Obtaining Cost-Related Data From Other Modules

Cost-related data are obtained from the following modules:
•     Chemical and other resource consumption rates (e.g., water, raw stock, etc.) should be
      obtained from the Resource Conservation module.
»     Energy consumption rates should be obtained from the Energy Impacts module.
"     Control technology equipment requirements should be obtained from the Control
      Technologies Assessment module. Costs of controls can be estimated using information
      contained in regulatory background documents or obtained from vendors and suppliers.

                                         7-28

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CHAPTER?
                                                                         COST ANALYSIS
•      Regulations requiring specific disposal methods for process wastes (e.g., processes that
       generate listed hazardous wastes) should be obtained from the Regulatory Status module.
       Costs of these disposal methods can be estimated using information contained in
       regulatory background documents or obtained from suppliers or disposal companies.
•      OSHA requirements for special conditions or equipment needed to ensure process safety
       should be obtained from the Process Safety module. Costs of these requirements can be
       estimated using information contained in regulatory background documents or obtained
       from vendors and suppliers.
•      Chemical and process equipment costs should be obtained from the Market Information
       module (U.S. supplied), International Information module (foreign supplied), and/or from
       supplier information provided to the performance demonstration, as noted in Step 1.

Details: Step 4, Calculating Direct Costs

Direct costs include the following:
 •     Capital expenditures (e.g., process equipment, control technologies, installation, project
       engineering, etc.).
 •     Operating costs (e.g., direct labor, raw materials, utilities, quality assurance testing, etc.).
 •     Maintenance costs (e.g., equipment cleaning and repair).

 The details for Step 8, below, discuss how to calculate present value for costs that are incurred
 over time.

 Details:  Step 5, Calculating Indirect Costs

 Indirect costs are hidden costs obscured in a cost category of overhead, or omitted completely.
 They include:
 •      Supervision and administrative costs.
 •      Regulatory compliance costs (e.g., permitting, monitoring, manifesting, employee
        training, etc.).
 •      Waste management expenditures (e.g., on-site pollution control costs, waste disposal
        charges, etc.).
 •      Insurance, rent, taxes, etc.

 Not all indirect costs will be relevant to the cost analysis. For example, costs that are constant
 for both the baseline and the alternative may be excluded from the analysis.

 The details for Step 8, below, discuss how to calculate  present value for costs that are incurred
 over tune. The following is a discussion of two methods for determining  indirect costs.

 Traditional Estimation Method:  This method determines and allocates  indirect costs to a process
  or product based on some measurable parameter (e.g.,  labor hours, capital investment). For
  example, maintenance costs for a piece of equipment can be estimated based on the capital cost
  of that equipment, where maintenance costs equal some function of capital cost.  This method is
  the most common accounting  method used throughout industry.

                                            7-29

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 PART II: CTSA INFORMATION MODULES
 Activity-Based Costing (ABO Method: This method of accounting allocates indirect costs to
 products or processes, based on how the products or processes actually incur these costs. This
 allocation is done using a series of cost drivers that are keyed to the activities required to produce
 the products.  For example, the operating costs of an ion exchange bed used to treat liquid waste
 streams from various sources would be divided and attributed directly to each individual source  "
 in proportion to the percentage of its overall use.

 Traditional Estimation Method vs. ABC Method: Traditional estimation methods are less
 complicated and time consuming than ABC methods.  Little or no change to the current financial
 accounting methods are typically required. In contrast, ABC provides for a more accurate
 picture of costs by evaluating the actual activities of each process. ABC allows managers to cite
 specific problem areas in a process that would otherwise go undetected.  As a result, the direct
 benefits of a substitute that addresses these problems are more easily identified. ABC, however,
 is time consuming because of the considerable effort needed to track each activity in the process.
 Therefore, additional administrative costs may be incurred to set up an ABC system, but the
 opportunities for cost savings identified by the ABC method probably would more than offset
 this cost.

 In many cases it may be difficult to determine all indirect costs for substitutes that are not in
 widespread use. In these cases, ABC methods can be supplemented with the traditional
 estimation methods for the unavailable data. For example, determining if a waste stream is
 hazardous as defined by RCRA may not be possible until an alternative is fully implemented and
 the nature of the waste realized. Assumptions that are made about the applicability of
 environmental regulations and the associated costs should be explicitly stated. The Regulatory
 Status module helps to identify potential compliance issues.

 Details: Step 6, Identifying Liability Costs

 Liability costs include the following:
 "     Penalties and fines (e.g., penalties stemming from non-compliance with current or future
       environmental regulations).
 •     Personal injury (e.g.,  liability claims stemming from environmental releases of chemicals
       or consumer use of a product).
 »     Property damage (e.g., liability claims stemming from environmental releases from
       disposal sites).
 •     Clean-up costs (e.g., Superfund mandated corrective  action).
 •     Natural resource damages (e.g., Superfund mandated damages).

Details: Step 7, Identifying Less-Tangible Benefits

Less-tangible benefits include:
 •     Increased sales due to improved product quality, enhanced public image, consumer trust
       in green products, or other effects.
"     Reduced health maintenance costs due to a safer work environment.
                                          7-30

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CHAPTER?
                                                                        COST ANALYSIS
•      Improved worker productivity due to cleaner working conditions (e.g., fewer volatile
       solvents in cleaning area, less dizziness).
•      Increased worker productivity due to improved employee relations.

Details:  Step 8, Conducting a Cost Analysis

When conducting the cost analysis, the project team should select long-term financial indicators
that account for the time value of money and all cash flows from implementing the baseline or a
substitute.  Two commonly used financial indicators include NPV and IRR. Formulas for
calculating PV and NPV are discussed below. Discussions on IRR and other financial indicators
may be found in economic analysis textbooks.

Calculating Present Value and Net Present Value

For a one-time cost or benefit, PV is given by the formula:
                               = _CFt_
                                (1+r)'
 where:
       CFt represents the value of a one-time cash flow, CF, received in year t, and r represents
       the discount rate

 For a series of benefits to be received over several years, present value is given by the formula:
                                 T

                                 1=1  (1+r)'
 where:
        £ represents the summation of benefits in the time period which ranges from year 1 to
        yearT
 NPV is given by the formula:
                            NPV = PV -1
 where:
        I is the initial outlay or investment cost
                                           7-31

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 PART H: CTSA INFORMATION MODULES
 Costing Methods

 Traditional costing methods or Total Cost Assessment (TCA) can be used to perform the cost
 analysis.  Both methods allow for the calculation of a net cash flow, IRR, or NPV.  The methods
 differ in which costs are calculated and how costs are allocated. The following is a discussion of
 the advantages and disadvantages of different costing methods.

 Traditional Costing Method: This method of cost analysis typically ignores future liability costs
 and considers all indirect costs as overhead or omits them altogether.  These overhead costs, if
 considered, are randomly allocated to a process or product based on some measurable, yet
 arbitrary parameter (e.g., labor hours, capital equipment costs). This method is the most
 common accounting method used throughout industry.

 Total Cost Assessment (TCA): This accounting method attempts to analyze all of the costs and
 liabilities, along with the potential benefits, over an expanded time horizon to gain a more
 comprehensive profile and comparison of alternatives.

 Traditional Costing Methods vs. TCA:  Traditional cost accounting is the easiest and least
 complicated of the cost analysis methods. The need to quantify or estimate difficult-to-determine
 indirect costs and future liabilities is minimized or eliminated. The potential impacts the
 substitutes have on indirect costs are considered qualitatively. In contrast,  TCA is an important
 improvement over traditional costing methods. By using an expanded time horizon, including
 indirect costs, and quantifying less-tangible costs, TCA is a more representative cost accounting
 method. One limitation of the TCA method is that there are no commonly accepted methods of
 quantifying some future liability costs, and little or no agreement on how less-tangible benefits
 should be valued. Both methods require little or no  changes to the current financial/managerial
 accounting methods typically used in industry.
FLOW OF INFORMATION: This module provides data needs to the Performance
Assessment module, receives information from the Regulatory Status, Process Safety
Assessment, Market Information, Workplace Practices & Source Release Assessment,
Performance Assessment, Control Technologies Assessment, Energy Impacts, Resource
Conservation, and International Information modules, and transfers information to the Risk,
Competitiveness & Conservation Data Summary module. Example information flows are shown
hi Figure 7-3.
                                         7-32

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CHAPTER 7
                                                                          COST ANALYSIS
                       FIGURE 7-3: COST ANALYSIS MODULE:
                          EXAMPLE INFORMATION FLOWS
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            Information   | • Chemical prices/
                           volumes   "
                          *'
            Workplace
            Practices &
          Source Release 1* Waatostream
           Assessment  I quantities
           Performance
                          » Effectiveness of
                                -Totaicoat
                                 of baseline  .
                                 and substitutes
                        o » Operating coufa
              Control
           Technologies
              Energy
              Impacts
Enargvf&jnswnptio
                                             7-33

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 EARTH; CTSA INFORMATION MODULES
 ANALYTICAL MODELS: Table 7-3 lists references for computer models to assist with a cost
 analysis. Tellus Institute, with funding from the EPA DfE Program and the National Institute for
 Standards and Technology, is developing environmental cost accounting and capital budgeting
 software designed to help small and medium-sized businesses cost pollution prevention projects.
 Currently, software is available for screen printers; software packages for lithographers,
 flexographers, the metal fabrication and finishing industries, and printed wiring board
 manufacturers are under development.
TABLE 7-3: ANALYTICAL MODELS FOR COST ANALYSIS " i " "
Reference
Tellus Institute. 1993. P2/Finance: Version 2.0.
Tellus Institute. 1995. P2/Finance for Screen
Printers: Version 1.0.
Type of Model
Financial analysis and cost evaluation software
for the personal computer.
Financial analysis and cost evaluation software
for the personal computer.
Chapter 10.
PUBLISHED GUIDANCE: Table 7-4 presents references for published guidance on cost
analysis.
TABLE 7~4t PUBLISHED GUIDANCE ON CoiFANALYSIS
"' f ~,™ ' ' , if ' jo , yv
Reference
Brimson, James A. 1991. Activity Accounting -
An Activity-Based Costing Approach.
Brown, Lisa, Ed. 1992. Facility Pollution
Prevention Guide.
Collins, Frank, Ed. 1991. Implementing Activity
Based Costing.
Northeast Waste Management Officials
Association. UNDATED. Costing and Financial
Analysis of Pollution Prevention Investments.
Tellus Institute. 1991a. Alternative Approaches
to the Financial Evaluation of Pollution
Prevention Investments.
Tellus Institute. 1991b. Total Cost Assessment:
Accelerating Industrial Pollution Prevention
Through Innovative Project Financial Analysis,
with Applications to the Pulp and Paper Industry.
Type of Guidance
Describes activity based costing method.
Provides overview of total cost assessment issues
and method.
Describes activity based costing method.
Provides methods of financial analysis.
Describes and compares various costing methods.
Describes total cost assessment methods.
                                        7-34

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CHAPTER 7
                                                                COST ANALYSIS
TABLE 7-4: PUBLISHED GUIDANCE 'ON COST ANALYSIS
Reference
U.S. Environmental Protection Agency. 1989c.
Pollution Prevention Benefits Manual: Phase II.
Type of Guidance
Formulas for incorporating future liabilities into a
cost analysis.
Chapter 10.
DATA SOURCES: None cited.
                                       7-35

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PART II; CTSA INFORMATION MODULES
                                  7-36

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                                                                 Chapter 8
                                           CONSERVATION
This chapter presents module descriptions for the conservation component of a CTS A, including
the following modules:

•     Energy Impacts.

•     Resource Conservation.

Businesses are finding that by conserving energy and resources they can cut costs, improve the
environment, and improve their competitiveness. Energy use and resource consumption may be
significant factors in evaluating alternatives. Data from both of these modules are considered in
the Social Benefits/Costs Assessment and Decision Information Summary modules along with
risk data, traditional competitiveness information (e.g., regulatory status, performance, and cost),
and other information.

The Energy Impacts module may involve assessing energy consumption both during chemical
manufacturing and during process operation. This is used to compare energy uses of the baseline
and substitutes. The Resource Conservation module includes evaluating the amount of materials
currently used in the process (renewable and nonrenewable resources) and the effects substitutes
would have on resource use. Both of these modules use the Performance Assessment module as
a key data source.
                                         8-1

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PARTH: CTSA INFORMATION MODULES
                                  8-2

-------
                                 ENERGY IMPACTS
OVERVIEW: Energy consumption, either during the manufacture of a chemical or the use of a
product, process, or technology can vary with a selected chemical or process change. The
Energy Impacts module describes methods for evaluating the energy impacts of the baseline and
substitutes within a use cluster. In a CTSA, data on the energy impacts of the baseline and
substitutes are usually collected in the Performance Assessment module.
GOALS:

•      Determine the energy requirements of the baseline and of the substitutes.

•      Evaluate the relative energy impacts of the baseline as compared to the substitutes.

•      Provide data on energy requirements and relative energy impacts to the Cost Analysis and
       Risk, Competitiveness & Conservation Data Summary modules.
PEOPLE SKILLS: The following lists the types of skills or knowledge that are needed to
complete this module.

•     Familiarity with sources and rates of energy consumption (e.g., equipment) in the use
       cluster.

•     Ability to perform simple energy calculations involving power ratings (kW or BTU/hr),
       duty (hr/day), and equipment load (percent of rated power used during equipment
       operation).

Within a business or DfE project team, the people who might supply these skills include a plant
engineer, environmental engineer, line supervisor, line operator, or equipment vendors.
DEFINITION OF TERMS:

British Thermal Unit (BTU): The quantity of heat required to raise the temperature of one pound
of water from 60 to 61 °F at a constant pressure of one atmosphere.

Duty: Period of time equipment is operated under powered conditions (e.g., lights may be
utilized for 16 hrs/day).

Horsepower (hp):  The predominant English unit of power used to describe motor ratings in the
U.S. In the metric system the usual measure of power is Joules/hr. One hp = 42.43 BTU/min =
2.7 x 106 Joules/hr = 0.7457 kilowatts (kW).
                                          8-3

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PART O: CTSA INFORMATION MODULES
Kilowatt Hour (kWh): One kWh is the quantity of energy converted or consumed in 1 hour at
the constant power rate of 1 kW. One kWh is equivalent to 3413 BTU.

Load: A factor reflecting the actual power used by a piece of equipment relative to the design
power rating. For example, an electric motor may be oversized and draw only 80 percent of its
nominal power rating when operating a specific piece of equipment.

Nominal Power Rating: The nominal energy use rate of energy consuming equipment operating
under design conditions (e.g., an electric motor may have a power rating of 1 hp).
APPROACH/METHODOLOGY:  The following presents a summary of the technical
approach or methodology for evaluating the energy impacts of substitutes. Methodology details
for Steps 3,4, and 6 follow this section.

Step 1:       Review the Chemistry of Use & Process Description module to identify pieces of
             equipment that consume energy in the baseline or the substitutes. Note equipment
             that would be added or deleted, depending on the substitute.  Examples of
             specific pieces of equipment which consume energy include drive motors, air
             fans, direct resistance heating elements, refrigeration system compressors, and
             natural gas-fired ovens.

Step 2:       Review the Control Technologies Assessment module to identify the control
             technologies that are recommended or required for the baseline or the substitutes.
             This can include air pollution control technologies, chemical destruction
             technologies (e.g., incineration, etc.) as well as in-plant waste water treatment
             technologies. The energy consumption of control technologies should also be
             evaluated, particularly if a control technology is required to meet environmental
             regulations.

Step 3:       Based on the equipment identified hi Steps 1 and 2, determine the data required to
             evaluate the rates of energy consumption of the baseline and of the substitutes.
             Provide data requirements to the Performance Assessment module so that energy
             consumption data can be collected during the performance demonstration project.
             For each piece of energy using equipment, typical data requirements include:
             •     The nominal power rating.
             »     The average duty.
             •     The average load.
             "     Production capacity/through-put (e.g., parts/hr, ft2 processed/day).

             Data should be collected on a per unit production basis, or some other basis that
             allows a comparative evaluation of the energy trade-off issues.

Step 4:       Obtain data from the Performance Assessment module and calculate the energy
             requirements of the baseline and of the substitutes. Again, energy requirements

                                          8-4

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CHAPTER 8
ENERGY IMPACTS
             should be calculated on a common basis to allow for a comparative evaluation of
             the substitutes.

Step 5:       Provide the energy requirements for the baseline and the substitutes to the Cost
             Analysis module. The cost of energy usages can be obtained from supplier (e.g.,
             electric utility, natural gas utility) rate schedules.

Step 6:       If up-stream energy Impacts are being evaluated in the CTSA, review the
             Chemical Manufacturing & Product Formulation module to evaluate energy
             requirements during the manufacturing of chemical ingredients or the formulation
             of chemical products. CTSA pilot projects have qualitatively evaluated up-stream
             energy impacts.

Step 7:       Tabulate energy requirements calculated in Step 4 together with data on up-stream
             energy impacts from Step 6 to evaluate the relative energy impacts of the baseline
             as compared to the substitutes.

Step 8:       Report the relative energy impacts of the substitutes to the Cost Analysis and
             Risk, Competitiveness & Conservation Data Summary modules.
METHODOLOGY DETAILS: This section presents methodology details for completing
Steps 3,4, and 6.  If necessary, additional information on this and other steps can be found in
previously published guidance.

Details:  Step 3, Collecting Data on Energy Consumption

Data for each substitute should be collected for a consistent unit process, such as the time to
complete the function defined by the use cluster one time. This facilitates a comparative
evaluation of the substitutes. The following summarizes sources of nominal power rating, duty,
and load data:
•     The nominal power rating is tisually displayed on an identification plate on the equipment
       (e.g., a pump motor nameplate may read 1.0 hp). In some cases where nameplate data
       are unavailable, power ratings may be obtained from the manufacturer's literature or from
       equipment vendors.
•     Duty can be measured using a simple timer or estimated by the equipment operator.
       Again, duty should be measured for a consistent process (e.g., the time a pump is required
       to dispense a solvent when cleaning ten 3,200 in2 printing screens).
•     Electric load can be calculated from the average current amperage and the supply voltage
       (e.g., average current amperage multiplied by supply voltage yields average electric
       power in kW). The average current amperage can be measured with an electric current
       (amp) meter. Gas use can be  measured with gas metering equipment or it can be
       estimated by knowledgeable plant personnel.
                                           8-5

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PART II: CTSA INFORMATION MODULES
If performance data are being collected from existing sources instead of tests performed as part
of the CTSA, estimates of energy usage data can be obtained from equipment vendors or other
sources.

Details:  Step 4, Calculating Energy Requirements

Depending upon the particular circumstances, the method for calculating energy use will vary.
For example, if each piece of energy consuming equipment in a process is unique and the
required data can be readily collected (for example, with a dedicated power meter), the electrical
energy consumption rate can be estimated using the following formula:

       Net Energy Consumption (energy use/time)
             = (No. pieces of equipment) x (power rating/unit) x (average duty) x (load)

Example: A coolant system for a machining operation requires 2 pumps to supply the operation
with coolant liquid. The characteristics and operating parameters of each pump are as follows:
       pump power rating
       average duty
       estimated operating load
= 10hp
= 8 hours/day
= 80 percent
Thus, the estimated net energy consumption for the coolant pumping operation is calculated as:

       Net Energy Consumption (kWh/day)
             = (2 pumps) x (10 hp/pump) x (1 kW/0.746 hp) x (8 hours/day) x (0.80)
             = 172kWh/day

For equipment using natural gas, the net energy consumption may be given by:

       Net Energy Consumption (BTU/day)
             = (rating hi BTU/hr) x (hours/day duty) x (load)

Details: Step 6, Evaluating Up-stream Energy Impacts

The following are examples of the types of questions a DfE project team might consider when
qualitatively evaluating up-stream energy impacts:
•      Are chemical ingredients made from raw materials that have an energy equivalence (e.g.,
       petroleum-based chemicals versus vegetable-based)?
•      Under what types of reactor conditions are chemical ingredients manufactured (e.g., what
       is the reactor temperature, pressure, and retention time)?
•      Is the chemical formulation a simple mixing process? Does it involve chemical reactions
       between the formulation ingredients?  Are heat or pressure required to get chemical
       ingredients into solution?
                                         8-6

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CHAPTER 8
                                                             ENERGY IMPACTS
FLOW OF INFORMATION:  Data requirements for the Energy Impacts module are identified
based on information from the Chemistry of Use & Process Description, Control Technologies
Assessment, and Chemical Manufacturing Process & Product Formulation modules and collected
in the Performance Assessment module. (The energy impacts of up-stream processes, such as
chemical manufacturing or product formulation, could be collected from suppliers during a
performance demonstration project. Up-stream energy impacts have not been quantitatively
evaluated in DfE pilot projects, however.) The Energy Impacts module transfers data to the Cost
Analysis and Risk, Competitiveness & Conservation Data Summary modules. Example
information flows are shown in Figure 8-1.

                    FIGURE 8-1: ENERGY IMPACTS MODULE:
                        EXAMPLE INFORMATION FLOWS
         Chemistry of Use &
        Process Description

        Control Technologies
           Assessment
      ,T
Chemical Manufacturing
  Process & Product
     Formulation
   **"
    Performance
    Assessment
                  data

                                                        impacts
                                                       •*-*•
                                                                     Cost Analysis
                                                                  X    - -?"
                                                                f \
                                                                         Risk,
                                                                    Competitiveness &
                                                                    Conservation Data
                                                                       Summary
                                                                         », p ,, V>
ANALYTICAL MODELS:  None cited.
                                         8-7

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EARTH: CTSA INFORMATION MODULES
PUBLISHED GUIDANCE: Table 8-1 presents references for published guidance on
estimating energy consumption for process equipment and performing energy audits.
•& wav** 1. \f t* "• > -i i
TABLE 8-lr PUBLISHED GUIDANCE ON ENERGY ASSESSMENTS
ft -Mpfta P tvv^
Reference
Smith, Craig B. 1 98 1 . Energy Management
Principles, Applications, Benefits, and Savings,
Thumann, Albert. 1979. Handbook of Energy
Audits.
Type of Guidance
Methods for performing energy audits and
calculating energy consumption for process
equipment.
Methods for performing energy audits and
calculating energy consumption for process
equipment.
Note: References are listed in shortened format, with complete references given in the reference list following
Chapter 10.
DATA SOURCES: Table 8-2 lists sources of energy consuming equipment data.
TABLE 8-2: SOURCES OF ENERGY CONSUMPTION DATA
Reference
American
Economy.
Systems.
Council for an Energy-Efficient
1991. Energy-Efficient Motor
Garay, PaulN. 1989. Pump Application Desk
Book.
Type of Data
Methods for determining energy consumption
and efficiency for various types of electric
motors.
Methods for determining energy consumption
and efficiency for various liquid pumping
systems.
Note: References are listed in shortened format, with complete references given in the reference list following
Chapter 10.
                                            8-8

-------
                            RESOURCE CONSERVATION
OVERVIEW:  Resource conservation is the process of selecting and using products, processes,
or technologies that minimize the overall use or consumption of resources while effectively
achieving a desired function. The Resource Conservation module describes methods for
identifying the relative amounts of resources or materials used or consumed by a business as a
consequence of changing from a chemical, process, or technology to a substitute. In a CTSA,
resource consumption data are usually collected in the Performance Assessment module.

The methods described here focus on direct resource use rates (e.g., the amount of materials
consumed to manufacture a product), not indirect resource use rates (e.g., the amount of land that
is consumed by landfilling waste). Indirect resource consumption is qualitatively evaluated in
the Social Benefits/Costs Assessment module.
GOALS:
       Determine the relative amounts of resources consumed by the baseline and the
       substitutes.

       Evaluate the relative effects on resource conservation of the baseline as compared to the
       substitutes.

       Provide data on resource consumption rates and relative impacts to the Cost Analysis and
       Risk, Competitiveness & Conservation Data Summary modules.
PEOPLE SKILLS:  The following lists the types of skills or knowledge that are needed to
complete this module.

•      Familiarity with the types, sources, and supply of resources consumed by the baseline and
       substitutes.

•      Familiarity with the common operating practices employed by the industry that might
       affect the rate of resources consumption.

Within a business or a DfE project team, the people who might supply these skills include a plant
engineer, material scientist, environmental engineer, line operator, or suppliers of the substitutes.
DEFINITION OF TERMS:

Natural Resources: Material or substance which in its basic form is found in nature. For
example, water, petroleum, and wood are natural resources in the sense that they do not have to
be made hi an industrial process.
                                          8-9

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PART II: CTSA INFORMATION MODULES
Renewable Resource:  As defined in Society of Environmental Toxicology and Chemistry
publications, a renewable resource is one that is being replenished at a rate greater than or equal
to its rate of depletion.  For example, wood used to make paper can be replaced with wood
supplied by the growth of new trees as long as the rate of paper production combined with the
rate of wood consumption does not exceed the rate of replenishment.

Resource: Material or substance used as a process raw material or required for process operation
(e.g., oil for machine lubrication or a chemical feedstock for a chemical reactor).
APPROACH/METHODOLOGY: The following presents a summary of the technical
approach or methodology for evaluating the potential impacts of substitutes on resource
conservation. Further methodology details for Steps 1,3,6, and 7 follow this section.

Step 1:        Review the Chemistry of Use & Process Description module to identify the types
              of resources consumed and the specific process steps where resources are
              consumed by the baseline and by the substitutes. It may be useful to categorize
              resources (e.g., chemical products, water, renewable vs. nonrenewable, etc.) to
              facilitate the evaluation of the relative impacts of alternatives in Step 7.
              (Although energy may be derived from renewable and nonrenewable resources,
              this module does not focus on energy consumption, which is addressed in the
              Energy Impacts module.)

Step 2:        Review the Control Technologies Assessment module to identify the control  .
              technologies that are recommended or required for the baseline or the substitutes.
              This can include air pollution control technologies, chemical destruction
              technologies, and in-plant waste water treatment technologies. Evaluate the
              control technologies to identify the types of resources they consume (e.g.,
              chemical flocculants used in waste water treatment).

Step 3:        Determine the data required to evaluate the rates of consumption of the resources
              identified in Steps 1  and 2. Provide the data requirements to the Performance
              Assessment module so that resource consumption data can be collected during the
              performance demonstration project.  Data should be collected on a per unit
              production basis, or some other basis that allows a comparative evaluation of the
              resource impacts.  If performance data are being collected from existing sources
              instead of tests performed as part of the CTSA, estimates of resource consumption
              can be obtained from equipment vendors, industry representatives, or other
              sources.

Step 4:        Obtain data from the Performance Assessment module and calculate the resource
              requirements of the baseline and of the substitutes. Resource requirements should
              be calculated using a common basis, such as a per unit production basis or the
              amount of solvent required to perform a cleaning function one time. This
              facilitates a comparative evaluation  of the substitutes.

                                          8-10

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CHAPTER 8
                                                              RESOURCE CONSERVATION
Step 5:       Provide the resource requirements calculated in Step 4 to the Cost Analysis
              module, where consumption rates will be converted into monetary values.

Step 6:       If up-stream resource conservation impacts are being evaluated in the CTSA,
              review the Chemical Manufacturing Process & Product Formulation module to
              evaluate resource requirements during the manufacturing of chemical ingredients
              or the formulation of chemical products. CTSA pilot projects have qualitatively
              evaluated up-stream resource conservation impacts.

Step 7:       Tabulate resource requirements in Step 4 together with data on up-stream resource
              consumption from Step 6. Evaluate the relative impacts on resource conservation
              of the baseline as compared to the substitutes.

Step 8:       Report the results of the evaluation to the Cost Analysis and Risk,
              Competitiveness & Conservation Data Summary modules.
METHODOLOGY DETAILS: This section presents methodology details for completing
Steps 1, 3, 6, and 7. If necessary, additional information on this and other steps can be found in
the published guidance.

Details:  Step 1, Categorizing Resources

To simplify the process for evaluating the relative impact of substitutes on resource conservation,
it is useful to develop a means of categorizing similar resources.  For example, different chemical
products used in one or more process steps could be categorized together, as could water
resources, or process materials such as lubricating oils. Table 8-3 gives an example of
categorizing the resources consumed during a three-step process to clean manufacturing
equipment.

In this example, the equipment is cleaned with a chemical cleaning product; the resources
consumed are water, chemicals, and the machine oil necessary to lubricate the cleaning
equipment. After cleaning, the cleaned equipment is rinsed with water; process materials are
also consumed hi this step as the manufacturing equipment degrades incrementally with each
cleaning, until it must be replaced. In the final step, some amount of trial processing is required
after the cleaning, which results hi finished products that do not meet specifications and must be
discarded. The two resources consumed in this step are the waste product from the run and the
machine oil that is used to lubricate the equipment.
                                          8-11

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PARTH:  CTSA INFORMATION MODULES
TABLE 8-3: EXAMPLE OF CATEGORIZING SIMILAR JRESOURCES
•> •> jjtf& .......
Process
Step
Step 1 -
Cleaning
Step 2 -
Rinsing
Step 3 -
Waste Run
Resources
Water
Dilute chemical
product with
water
Water rinse
None
Chemical
Products
Chemical
cleaning product
None
None
Final Product
Materials
None
None
Trial processing
after cleaning to
achieve acceptable
quality
Process Materials
Machine oil to lubricate
cleaning equipment
Manufacturing
equipment depleted
after x cleanings
Machine oil to lubricate
manufacturing
equipment
Details:  Step 3, Collecting Data on Resource Consumption Rates

Data on resource consumption rates can be estimated based on purchase (inventory) records,
process operator judgement, vendor data, or measured directly.  Whichever technique is used,
resource consumption data should be collected or converted into consistent units for the baseline
and the substitutes, usually in unit mass (pounds or kilograms) per unit time or unit production.
The following are examples of different types of data that can be used to estimate resource
consumption rates.

Example. Using Existing Records

For the example of using purchase records to estimate the amount of plastic used in a plastic
extrusion operation:
•     Records show that 2,500 Ibs of plastic pellets are purchased each year.
•     It is estimated by the process specialist that 40 percent of this amount is used in the
       specific process under review.
•     (0.40) (2,500 lbs/year) = 1,000 Ibs used per year in process.

For the example of using purchasing records to estimate the amount of paint used in a parts
painting operation:
•     A potential substitute is a technology change where an improved paint spray system with
       a higher application efficiency will be utilized.
•     It is estimated from case study data that a 35 percent reduction in paint use will be
       achieved since overspray losses will be substantially reduced with the use of the new
       system.
•     From purchasing records it is calculated that 20,000 Ibs of paint are currently purchased
       annually.
                                           8-12

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 CHAPTER 8
                                                              RESOURCE CONSERVATION
 •     The reduction in raw material (resource) use is estimated as:
       (20,000 Ibs per year) - ([1-0.35] x [20,000 Ibs per year]) - 7,000 Ibs per year.

 Example. Using Direct Measurement

 For the example of using direct measurement to determine the amount of water utilized per year
 in a continuous flow rinse tank operation:
 •     Divert water flow from tank inlet into a container of known volume.
 •     Collect liquid until 1.5 gallon container is full (determine time interval using a
       stopwatch).
 •     Determine amount of time rinse tank is utilized per year.
 •     If it takes 5 minutes to collect 1.5 gallons, and the tank is used 8 hours/day, 5 days/week,
       52 weeks/year:

       Water Consumption Rate = (1.5 gal/5 min) (60 min/hr) (8 hr/day) (5 day/wk)
                                  (52 wks/yr) = 37,440 gallons/yr

       Converting to Ibs/yr:

       Water Consumption Rate = (37,440 gal/yr) x (8.34 Ibs/gal) = 312,249 Ibs/yr

Details:  Step 6, Evaluating Up-stream Resource Conservation Impacts

The following are examples of the types of questions a DfE project team might consider when
qualitatively evaluating up-stream resource conservation impacts:
 •     Are chemical products made from renewable or nonrenewable resources?
 •     Are scarce resources consumed to manufacture the chemicals or technologies in the use
       cluster?
 •     Are the raw materials used to manufacture the substitutes only found in low
       concentrations in their natural state (e.g., metals only in low concentrations in their ores)?

Details:  Step 7, Evaluating the Impacts on Resource Conservation

Tabulate the types and quantities of resources consumed by each substitute and baseline
technology. Use the tabulation to determine if use of a substitute would result in a relative
increase or decrease in overall resource consumption for similar categories of resources.  The
table may also be used to determine if renewable resources are being substituted for
nonrenewable ones or if scarce resources are being substituted for resources in abundant supply.
For the example above (see Table 8-3), Table 8-4 gives an example format for tabulating
consumption rates.
                                          8-13

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PARTH:  CTSA INFORMATION MODULES
TABLE 8-4: EXAMPLE OF TABULATED RESOURCE CONSUMPTION DATA FOR OP*
^SUBSTITUTE t ~,7-
Process
Step
Step 1 -
Cleaning
Step 2 -
Rinsing
Step 3 -
Waste Run
TOTAL
Resource
Water
Rate
(gallons/hr)
1
100
0
101
Chemical Product
Rate
(Ib/hr)
10
0
0
10
Renewable
yesa
N/A
N/A
—
Waste Product
Rate
(Ib/hr)
N/A
N/A
5
5
Renewable
N/A
N/A
no
—
Process Materials
Rate
(ami/time)
1 Ib/shift
2 sets/yr
1 Ib/shift
Renewable
no
no
no
2 Ib/shift of oil
2 sets equipment/yr
N/A: Not applicable.
a) A citrus oil-based cleaner might be an example of a cleaner made from renewable ingredients. (However,
petrochemicals are frequently used in the manufacture of chemicals made from vegetable products.)
FLOW OF INFORMATION: Data requirements for the Resource Conservation module are
identified based on inforaiation from the Chemistry of Use & Process Description, Control
Technologies Assessment, and Chemical Manufacturing Process & Product Formulation
modules and collected in the Performance Assessment module. (The resource impacts of up-
stream processes, such as chemical manufacturing and product formulation, could be collected
from suppliers during a performance demonstration project.  Up-stream resource conservation
impacts have not been quantitatively evaluated in DfE pilot projects, however.) The Resource
Conservation module transfers data to the Risk, Competitiveness &  Conservation Data Summary
and Cost Analysis modules.  Example information flows are shown  in Figure 8-2.
                                           8-14

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 CHAPTERS
                                                        RESOURCE CONSERVATION
              FIGURE 8-2: RESOURCE CONSERVATION MODULE:
                       EXAMPLE INFORMATION FLOWS
       Chemistry of Use &
       Process Description
       Control Technologies
          Assessment
      Chemical Manufacturing!
        Process & Product
          Formulation
          Performance
          Assessment
f 1

f
                                         s
                                 i  Resource
                                 Conservation
                                                   m
             Risk,
        Competitiveness &
        Conservation Data
           Summary
                                                                    Cost
                                                                   Analysis
ANALYTICAL MODELS:  None cited.
PUBLISHED GUIDANCE: Table 8-5 presents published guidance on estimating the rates of
resource consumption.                                                 ,
TABLE 8-5s PUBLISHED GD1BANC1 ON ESTIMATING RESOURCE CONSUMPTION
Reference
Brown, Lisa, Ed. 1992. Facility Pollution
Prevention Guide.
Dally, James W., et. al. 1984. Instrumentation
for Engineering Measurements.
Theodore, Louis and Young C. McGuinn. 1992.
Pollution Prevention.
Type of Guidance
General methods for identifying and quantifying
process materials consumption.
Methods for analyzing waste stream and raw
material input quantities are discussed in cases
where physical measurements are required.
General description of process analysis.
Note: References are listed in shortened format, with complete references given in the reference list following
Chapter 10.
                                     8-15

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PART H: CTSA INFORMATION MODULES
DATA SOURCES:  Table 8-6 lists sources of data which may be useful in calculating resource
consumption rates.
TABLE8-6: SOURCES OF DATA ONRESOtmO) CONSUMPTON^TJES _ ^ "'
Reference
Bolz, Ray E. and G.L. Tuve. 1970. Handbook of
Tables for Applied Engineering Science.
Type of Data
Contains data which may be useful hi analysis,
such as material densities.
Chapter 10.
                                         8-16

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                                                              Chapter 9
                                                ADDITIONAL
                                     ENVIRONMENTAL
                                          IMPROVEMENT
                                        OPPORTUNITIES
This chapter presents module descriptions for identifying additional environmental improvement
opportunities, including the following modules:

•     Pollution Prevention Opportunities Assessment.

•     Control Technologies Assessment.

Pollution prevention involves changes in production, operating processes, or raw materials used
to prevent or reduce pollution at the source. Although the entire CTSA process can be thought of
as a means of evaluating pollution prevention opportunities, the Pollution Prevention
Opportunities Assessment module involves assessing workplace practices and process conditions
for pollution prevention opportunities above and beyond the use of a substitute.  This assessment
results in a specific list of suggested actions that could be taken to reduce or eliminate pollution
for each of the alternatives.

The Control Technologies Assessment module involves an assessment of end-of-the-pipe
treatment and disposal technologies for pollution generated for the alternatives.  Control
technologies are used to reduce the tojdcity and/or volume of pollutants released. The
information from this module can be used to identify available options that may be used for the
evaluated process and substitutes.

Data from the Pollution Prevention Opportunities Assessment  module do not necessarily flow
into other modules in a CTSA. This module is intended to give individual businesses ideas for
preventing pollution, regardless of which alternative they use.  Recommended control
technologies from the Control Technologies Assessment module may flow into the Cost
Analysis module for costing, particularly if the controls are required by environmental
regulation.
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                                   9-2

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            POLLUTION PREVENTION OPPORTUNITIES ASSESSMENT
OVERVIEW:  Pollution prevention is the process of reducing or preventing pollution at the
source through changes in production, operation, and materials use. Pollution prevention can
result in reduced materials usage, pollution control, and liability costs. It can also help protect
the environment and may reduce risks to worker health and safety.

The improved Pollution Prevention Opportunities Assessment module focusses on workplace
practices and equipment (other than the substitutes being evaluated in a CTS A) that can be used
to reduce pollution at the source.  It also describes methods individual businesses can use to
identify pollution prevention opportunities, which often apply to many or all of the substitutes
being evaluated.
GOALS:
       Perform a pollution prevention opportunities assessment for the specific process under
       consideration.

       Arrive at a specific list of actions which can be implemented to prevent pollution.
PEOPLE SKILLS:  The following lists the types of skills or knowledge that are needed to
complete this module.

•      Knowledge of the process under review, including the types and amounts of chemicals
       used in the process; the sources, nature and quantity of waste streams; and process
       optimization techniques.

•      Knowledge of waste tracking for the process under review, including access to records of
       rates of materials purchases and associated costs.

•      Knowledge of federal, state, and local waste stream release reporting and historical waste
       disposal practices.

Within a business or DfE project team, the people who might supply these skills include a plant
engineer, environmental engineer, line supervisor, line operator, or suppliers of chemicals or
equipment.
DEFINITION OF TERMS:

Pollution Prevention: As defined in the Pollution Prevention Act of 1990, pollution prevention is
the reduction in the amount or hazards of pollution at the source (see Source Reduction).
                                          9-3

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Recycling: In-process recovery of process material effluent, either on-site or off-site, which
would otherwise become a solid waste, air emission, or a waste water stream.

Reuse: On-site recovery and subsequent introduction of a waste stream back into the process.

Source Reduction: As defined in the Pollution Prevention Act of 1990, any practice which: (1)
reduces the amount of any hazardous substance, pollutant, or contaminant entering any waste
stream or otherwise released into the environment (including fugitive emissions) prior to
recycling, treatment, or disposal; and (2) reduces the hazards to public health and the
environment associated with the release of such substances, pollutants, or contaminants.  Source
reduction includes equipment or technology modifications, process or procedure modifications,
reformulation or redesign of products, substitution of raw materials, and improvements in
housekeeping, maintenance, training, or inventory control.

Waste Management Hierarchy: National policy declared in the Pollution Prevention Act of 1990
which gives the following hierarchy to waste management, ordered from highest to lowest level
of desirability:
»      Pollution prevention at the source.
"      Recycling in an environmentally safe manner.
•      Treatment in an environmentally safe manner.
»      Disposal or other release into the environment only as a last resort and in an
       environmentally safe manner.
APPROACH/METHODOLOGY: The following presents a summary of the technical
approach or methodology for conducting a pollution prevention opportunities assessment.  Steps
6 and 7 of the methodology concern implementing pollution prevention opportunities which
would normally be done by individual businesses outside of the CTSA process. These steps are
presented here to emphasize the importance of following through on a pollution prevention
program.

Since the overall CTSA mainly focuses on pollution prevention through process modifications,
reformulation or redesign of products, and chemical substitution, the methodology presented here
focuses on identifying equipment modifications and improved workplace practices to prevent
pollution. Further methodology details for Steps 3 and 4 follow this section.
Step 1:
Obtain the process flow diagram from the Chemistry of Use & Process
Description Module.  The process flow diagram from this module provides the
framework to identify process input and output streams, including waste point
              sources.
Step 2:
Review the Workplace Practices & Source Release Assessment module to identify
the types and quantities of hazardous and non-hazardous releases to air, land, or
water, and the workplace practices associated with these releases.
                                           9-4

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CHAPTER 9
POLLUTION PREVENTION OPPORTUNITIES ASSESSMENT
Step 3:        Evaluate each of the sources of releases and the associated workplace practices
              identified in Step 2 for pollution prevention opportunities. The best results occur
              when all plant personnel are involved in discussions to identify pollution
              prevention opportunities.  In addition, EPA and many state agencies have
              prepared industry-specific guides to pollution prevention.  Many states also
              provide pollution prevention technical assistance to small- and medium-sized
              businesses.

Step 4:        Evaluate each of the pollution prevention opportunities identified in Step 3 to set
              priorities for implementing a pollution prevention activity.  Factors that could be
              considered include:
              •      Company priorities (e.g., for the elimination of a "problem" chemical
                     such as an EPA-regulated solvent).
              •      Relative amounts of waste streams.
              •      Relative toxicity of waste streams.
              •      Percentage of an existing waste stream that would be prevented.
              •      Regulatory status of waste streams, both before and after a pollution
                     prevention opportunity is implemented.
              •      Employee health (e.g., cancer risk) and safety (e.g., fire risk).
              •      Cost of waste steam management (e.g., treatment and disposal costs).
  '            •      Ease of implementation.
              •      Cost of implementation and payback period.
              •      Potential for waste stream recyclability or reuse.
              •      Potential for regulations that may phase out certain chemicals or
                     processes.

Step 5:        Prior to implementing pollution prevention opportunities, review federal, state,
              and local regulations relating to the waste stream(s) under consideration.  The
              Regulatory Status module should have relevant information pertaining to existing
              wastes streams, but may not cover new waste streams or changes in waste stream
              characteristics that would result from implementing a pollution prevention
              measure. This step is needed to assure that pollution prevention measures do not
              result in a violation of existing regulations. For example, if a pollution prevention
              measure would result in a waste water discharge of a regulated substance beyond
              acceptable limits, the measure would have to be eliminated from further
              consideration. Measures  that shift pollution from one media to another or create
              new waste streams are not typically considered to be pollution prevention,
              however.

 Step 6:       Develop a schedule for implementing technically and economically feasible
              pollution prevention opportunities. (Pollution prevention projects are usually
              more cost-effective than indicated by traditional costing methods that lump
              environmental compliance costs into an overhead cost factor and do not consider
              potential liability costs and less tangible benefits. See the Cost Analysis module
              for more details.)

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PARTH: CTSA INFORMATION MODULES
Step 7:        Conduct periodic, in-house audits to assess the effectiveness of the pollution
              prevention program and to identify new pollution prevention opportunities on a
              regular basis.
METHODOLOGY DETAILS: This section presents the methodology details for completing
Steps 3 and 4. If necessary, additional information on conducting a pollution prevention
opportunities assessment can be found in the published guidance.

Details:  Step 3, Identifying Pollution Prevention Opportunities

Pollution Prevention through Improved Workplace Practices

Improved workplace practices that prevent pollution are often inexpensive and easy to
implement, while offering almost immediate reduction of waste. The basic framework for
pollution prevention through improved workplace practices involves:
•      Raising employee awareness of pollution prevention benefits.
"      Materials management and inventory control.
•      Process improvement.
•      Periodic in-house audits.

Raising employee awareness is the best way to get employees to actively participate in a
pollution prevention program. Materials management and inventory control includes
understanding how chemicals and materials flow through a facility to identify the best
opportunities for pollution prevention. Process improvement through improved workplace
practices includes reevaluating the day-to-day operations in a facility to identify good operator
practices that prevent pollution.  Finally, in-house audits are used to collect real-time data on the
effectiveness of a pollution prevention program. This step gives both operators and managers the
incentive to strive for continuous improvement.

Examples of process improvements through improved workplace practices include:
"      Training operators in techniques to optimize the process (e.g., manual adjustment of pH
       levels to extend the life of a plating bath).
"      Training of employees to not "overuse" materials (e.g., only using the amount needed to
       perform a particular task).
»      Covering containers to reduce  evaporative losses (e.g., covering solvent containers while
       not  in use).
•      Covering containers of chemicals between process steps to minimize contamination.
•      Improved inventory control (e.g., using chemicals before the listed expiration date).
«      Improved handling of materials (e.g., training of personnel to reduce spills and wastage of
       liquids and solids).
•      Segregation of raw materials and waste streams.
                                          9-6

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CHAPTER 9
        POLLUTION PREVENTION OPPORTUNITIES ASSESSMENT
Pollution Prevention through Equipment Modifications

Modifying equipment to prevent pollution is usually more complicated and costly than changes
in workplace practices. However, substantial improvements in process operation can be
achieved through equipment modifications that are not equipment, process or technology
substitutions.  For example, pollution prevention through equipment modification for a chemical
reactor/chemical delivery system could include:
•      Increasing reactor volume and monitoring residence time to obtain an increased product
       yield.
•      Installing sample loops on product sampling purge line to return unused sample to the
       process.
•      Using an adjustable applicator system to control the quantity and direction of a chemical
       product (e.g., cleaning agent, paint or coating, etc.) applied to a substrate.
•      Installing a recirculation system to recirculate chemicals that are being discarded before
       they are completely spent.

Details: Step 4, Setting Priorities

The percentage of a waste stream that would be prevented by a pollution prevention activity can
be estimated based on:
•      Knowledge of chemical reactions and mass and energy balance calculations.
•      Professional judgement and process experience of the process specialist, waste manager,
       process operator and others familiar with the process.
•      Data provided by vendors (e.g., chemical vendors).
•      Data from published case studies of similar waste streams or facilities (see reference
       section).
FLOW OF INFORMATION: This module can be used alone to help identify pollution
prevention opportunities in a commercial business or manufacturing facility.  In a CTSA, this
module receives data from the Chemistry of Use & Process Description and Workplace Practices
& Source Release Assessment modules. Example information flows are shown in Figure 9-1.

     FIGURE 9-1: POLLUTION PREVENTION OPPORTUNITIES ASSESSMENT
                   MODULE: EXAMPLE INFORMATION FLOWS
     Workplace Practices
      & Source Release
         Assessment
                                                              Pollution Prevention
                                                               : /Opportunities
                                                                 Assessment
• ReteaM* sources
• Workplace pracfijies
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PARTH: CTSA INFORMATION MODULES
ANALYTICAL MODELS: None cited.
PUBLISHED GUIDANCE: Table 9-1 presents examples of published guidance on performing
a pollution prevention opportunities assessment. Additional guidance can be obtained by
contacting the U.S. Environmental Protection Agency's Pollution Prevention Information
Clearinghouse at (202) 260-1023.
TABLE 9-1: PUBLISHED GUIDANCE ON PERFORMING POLLUTION PREVENTION
OPPORTUNITIES ASSESSMENT
•- iXK J f •" *i*,i'! "i i 11 «ii -Mift& } ; j ; } ;
Reference
Brown, Lisa, Ed. 1992. Facility Pollution
Prevention Guide.
Freeman, Harry M. 1994. Industrial Pollution
Prevention Handbook
Higgins, Thomas E. 1989. Hazardous Waste
Minimization Handbook
Metcalf, Cam, Ed. 1991. Waste Reduction
Assessment and Technology Transfer Training
Manual.
Theodore, Lewis and Young C. McGuinn. 1992.
Pollution Prevention.
U.S. Environmental Protection Agency. 1992h.
Pollution Prevention Information Exchange
System: User Guide Version 2.1
U.S. Environmental Protection Agency. 1992L
Pollution Prevention Case Studies Compendium.
U.S. Environmental Protection Agency. 1992J.
Guide to Pollution Prevention: The Metal
Finishing Industry.
U.S. Environmental Protection Agency. 1992k.
PIES. Pollution Prevention Information
Exchange System.
U.S. Environmental Protection Agency. 1994m.
Pollution Prevention Directory.
Type of Guidance
Methods for performing assessments, ranking of
pollution prevention options, and assessment of
waste reduction benefits.
Technical reference on pollution prevention
strategies and technologies.
Outlines specific approaches to industrial
pollution prevention.
Example of pollution prevention assistance
provided by many states. Check with local state
agencies for a state specific guide.
Outlines assessment procedures.
Users guide on accessing online database and
performing information searches.
Case studies of pollution prevention assessments.
Provides pollution prevention guidelines for
specific industries. Call EPA at (513) 569-7562
to obtain guides for other industries or processes.
On-line data base containing a compilation of
different types of pollution prevention data.
Directory of U.S. pollution prevention sources.
Note: References are listed in shortened format, with complete references given in the reference list following
Chapter 10.
DATA SOURCES: None cited.
                                         9-8

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                     CONTROL TECHNOLOGIES ASSESSMENT
OVERVIEW:  Control technologies can be used to minimixe the toxicity and volume of
released pollutants.  Most control technologies involve altering either the physical or chemical
characteristics of a waste stream to isolate, alter the concentration of, or destroy target chemicals.
This module describes methods for identifying control technologies that may be suitable for on-
site treatment and disposal of product or process waste streams.
GOALS:

•     Identify treatment and disposal options for residual waste(s) remaining after the
       implementation of pollution prevention or waste minimization (including recycling)
       opportunities.


PEOPLE SKILLS: The following lists the types of skills or knowledge that are needed to
complete this module.

•     Knowledge of materials, chemical properties, and available processes to ameliorate
       hazardous properties, including ability to guide the selection of control technologies
       based on specific waste stream chemical characteristics.

 •     Familiarity with the details of how chemicals are used in the process under consideration,
       including an understanding of the nature and amounts of waste streams requiring control
       technology application.

 •     Knowledge of environmental statutes, and regulatory requirements pertaining to
       environmental releases (e.g., water and air emissions), waste disposal requirements (e.g.,
       landfilling), and the applicable control technologies.

 Within a business or DfE project team, the people who might supply these skills include a plant
 engineer, environmental engineer, line supervisor, regulatory specialist, or suppliers of control
 technology equipment.
 DEFINITION OF TERMS: The following definitions are compiled from EPA regulatory
 documents and the references listed in Table 9-3.

 Absorption: A unit operation involving the removal of a substance from a gas by contacting the
 substance with a liquid into which the desired component dissolves.  The rate of transfer of the
 desired material from the gas to the liquid is dependent on its concentration in the gas and the
 liquid, the mass transfer coefficients in each phase, the solubility of the material in the liquid, and
 the amount of gas-liquid interfacial area available. Typical examples of importance in pollution
 abatement are the removal of sulfur dioxide from stack gases by absorption with alkaline
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 PARTH; CTSA BMFORMAHON MODULES
 solutions and the absorption of carbon dioxide from combustion products into aqueous amine
 solutions.                                    .

 Best Available Control Technology (BACTV A term applied to control technologies required
 under the Clean Air Act and its amendments for certain air releases from major new sources
 depending upon the class of attainment area.  EPA determines BACT requirements by: (1)
 identifying all control technologies; (2) eliminating technically infeasible options; (3) ranking
 remaining control options by effectiveness; (4) evaluating the most effective controls and
 documenting results;  and (5) selecting BACT.

 Best Available Control Technology Economically Practical rRATV A term applied to
 technology-based effluent limitations required under the Clean Water Act for certain water
 releases from existing sources. More recently-issued permits are likely to require compliance
 with BAT standards, which are usually more, stringent than BPT standards.

 Best Conventional Pollution Control Technology mCTV A term applied to technology-based
 effluent limitations required under the Clean Water Act for water releases of conventional
 pollutants (e.g., oil and grease, fecal coliform, biochemical oxygen demand, total suspended
 solids, pH) from certain existing sources.

 Best Practicable Control Technology Currently Available (EPTt: A term applied to technology-
 based effluent limitations required under the Clean Water Act for certain water releases from
 existing sources.
        Adsorption:  Adsorption is the accumulation of a substance at the interface between two
phases. In carbon adsorption, gases, liquids or solutes sorb onto the surface of activated carbon.
Carbon adsoiption is most frequently used for VOC abatement.

Chemical Oxidation/Reduction Reactions: Those reactions in which electrons are transferred
from one chemical species to another, resulting in the oxidation state of one reactant being
raised, while the oxidation state of the other reactant is lowered.  When electrons are removed
from an ion, atom, or molecule, the substance is oxidized; when electrons are added to a
substance, it is reduced.

Chemical Precipitation: A process by which a soluble substance is converted to an insoluble
form either by a chemical reaction or by changes in the composition of the solvent to diminish
the solubility of the substance hi it. The precipitated solids can then be removed by settling
and/or filtration.

Pigposaj: Defined by the Resource Conservation and Recovery Act (RCRA) as the discharge,
deposit, injection, dumping, spilling, leaking, or placing of any solid waste or hazardous waste
into or on any land or water so that any constituent thereof may enter the environment or be
emitted into the air or discharged into any waters, including groundwater.
                                          9-10

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CHAPTER 9
                                                  CONTROL TECHNOLOGIES ASSESSMENT
Electrodialvsis: Process to remove ions from water by forcing their migration through a
membrane with an electric field.

Electrolytic Recovery:  The use of ion-selective membranes and an electric field to separate
anions and cations in solution, used primarily for the recovery of metals from process streams or
waste waters.

Evaporation: The conversion of a liquid into vapor. In waste treatment, evaporation involves the
vaporization of a liquid from a solution or a slurry. Evaporation is commonly used for the
removal of water from  sludges.

Filtration:  A method for separating solid particles from a fluid of liquid or gas, through the use
of a porous medium, that retains the particles as a separate phase or cake and allows  the filtrate to
pass through.  The driving force in filtration is a pressure gradient, caused by gravity, centrifugal
force, vacuum, or higher than atmospheric pressure.

Fluidized Bed Incineration: Process using a single refractory-lined  combustion vessel and high-
velocity air to either fluidize the bed (bubbling bed) or entrain the bed (circulation bed);
primarily used for processing sludges or shredded solid materials.

Hazardous Air Pollutants fMAPS'): A statutory list of designated chemicals deemed hazardous as
defined by the Clean Air Act and its amendments.

Hyperfiltration: A method to separate ionic or organic components from water by limiting the
size of membrane pores through which a contaminant can pass.

Incineration:  The destruction of wastes by high temperature oxidation (e.g., burning). Liquid
injection incineration is used for gases, liquids, and slurries, while rotary kilns are used for all
types of wastes including solids.

Ion Exchange: A process where undesirable ions are removed from an aqueous waste stream via
exchange with counterions associated with an interactive polymer resin matrix, well-suited to the
detoxification of large flows of waste water containing relatively low levels of heavy-metal
contaminants, such as  those emanating from electroplating facilities.

 Liquid Injection  Incineration:  A process where a pumpable liquid waste is burned directly in a
 burner (combustor) or injected into the flame zone or combustion zone of the incinerator
 chamber (furnace)  via nozzles.

 Lowest Achievable Emission Rate (LAER^ Technology: A term applied to control  technologies
 required under the Clean Air Act and its amendments for air releases from certain new sources in
 nonattainment areas. LAER is the most stringent emission limitation derived from either of the
 following: (1) the most stringent emission limitation contained in the implementation plan of any
 state for such class or  category of source; or (2) the most stringent emission limitation achieved
 in practice by such class or category of source.

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 PARTH: CTSA INFORMATION MODULES
 Maximum Achievable Control Technology (MACT): A term applied to control technologies
 required under the Clean Air Act and its amendments to achieve acceptable emission limits for
 HAPs (see above listing).

 Membrane Separation: A process which separates a contaminant (solute) from a liquid phase
 (solvent, typically water) by the application of a semi-permeable membrane and includes reverse
 osmosis, ultrafiltration, hyperfiltration, and electrodialysis.

 Molten Glass:  A process which destroys and/or immobilizes hazardous wastes into a stable glass
 form. The final product is reduced in volume and mass by driving moisture from the waste
 permanently, destroying portions of the waste thermally, and consolidating the residuals into a
 dense glass and crystalline product.

 Ozonation:  The treatment of industrial waste or waste water using ozone (O3) as an oxidizing
 agent.

 Pyrolysis:  The chemical decomposition or change brought about by heating in the absence of
 oxygen.

 Reasonably Available Control Technology (RACT):  The lowest emission limitation that a
 particular source is capable of meeting by the application of control technology that is reasonably
 available considering technological and economic feasibility. Applied to control technologies
 required under the Clean Air Act and its amendments for certain air releases from major existing
 sources in ozone non-attainment areas

 Reverse Osmosis: A membrane-separation technique in which a semipermeable membrane
 allows water permeation while acting as a selective barrier to the passage of dissolved, colloidal,
 and particulate matter used to separate water from a feed stream containing inorganic ions.

 Rotary Kiln:  Equipment which provides a number of functions necessary for incineration. A
 rotary kiln provides for the conveyance and mixing of solids, provides a mechanism for heat
 exchange, serves as host vessel for chemical reactions, and provides a means of ducting the gases
 for further processing.

 Sedimentation: The process by which particles are separated from a fluid of liquid or gas by
 gravitational forces acting on the particles.  Sedimentation is often used in removal of solids
 from liquid sewage wastes.

 Solidification: A treatment process in which materials are added to the waste to produce a solid.
It may or may not involve a chemical bonding between the toxic contaminant and the additive.

Stabilization: A process (such as solidification or a chemical reaction to transform the toxic
component to a new,  nontoxic compound or substance) by which a waste is converted to a more
chemically stable form.
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CHAPTER 9
                                                  CONTROL TECHNOLOGIES ASSESSMENT
Stripping: A physical unit operation in which dissolved molecules are transferred from a liquid
into a flowing gas or vapor stream.  The driving force for mass transfer is provided by the
concentration gradient between the liquid and gas phases, with solute molecules moving from the
liquid to the gas until equilibrium is reached.  In air stripping processes, the moving gas is air,
usually at ambient temperature and pressure, and the governing equilibrium relationship is
Henry's Law Constant. In steam stripping processes, the moving gas is live steam, and the
vapor-liquid equilibrium between water and the organic compound(s) is the key equilibrium
relationship. Steam stripping is more widely applicable than air stripping because it can
effectively remove less volatile or more soluble compounds.

Treatment:  Defined by RCRA as any method, technique or process, including neutralization,
designed to change the physical, chemical, or biological character or composition of any
hazardous waste so as to neutralize it, or render it nonhazardous or less hazardous or to recover
it, make it safer to transport, store, or dispose of, or amenable for recovery, storage, or volume
reduction.

TJItrafiltration: The application of membranes to separate moderately high molecular weight
 solutes from aqueous solutions, primarily used to separate organic components from water
 according to the size (molecular weight) of the organic molecules.


 APPROACH/METHODOLOGY: The following presents a summary of the technical
 approach or methodology for identifying potentially applicable control technologies for treating
      atrolling a waste stream. Methodology details for Steps 7 and 8 follow this section.

               Obtain a description of the unit operations and the process flow diagram for the
               baseline and substitutes from the Chemistry of Use & Process Description
               module.
or cont

Stepl:



Step 2:


StepS:
  Step 4:
Review the Workplace Practices & Source Release Assessment module to identify
the sources, nature and quantity of releases from the baseline and alternatives.

Review the Regulatory Status module to identify any control technology
requirements for the baseline and the substitutes. For example, air releases may
be subject to the required use of MACT or BACT.  Water releases may be subject
to BAT or BPT control technology requirements.

Use the results of Steps 1 through 3 to identify the waste streams, if any, that will
be the subject of the control technologies assessment.  If a regulatory requirement
exists for certain waste streams generated by the baseline or the alternatives, it
must be included as part of the process in the CTSA, with some exceptions.  For
example, if the CTSA is focussing on small businesses that are exempt from
regulatory requirements due to the quantity of wastes or emissions they generate,
it may not be necessary to include control technologies required for major
                sources.
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 PARTH; CTSA INFORMATION MODULES
 Step 5:        Obtain physical/chemical properties of the chemicals of concern in the waste
               streams identified in Step 4 from the Chemical Properties module.

 Step 6:        Obtain chemical fate properties (e.g., biodegradation data, biochemical oxygen
               demand, chemical oxygen demand, etc.) and treatability summaries for the
               chemicals of concern from the Environmental Fate Summary module.

 Step 7:        Characterize the waste streams identified in Step 4 to determine the
               concentrations of hazardous constituents and properties needing modification
               (e.g., acid neutralization) for treatment/disposal.

 Step 8:        Prepare a list of potential treatment processes or control technologies that provide
               the desired function (e.g., acid neutralization, removal of cyanides, etc.) while
               meeting regulatory requirements.

 Step 9:        Provide a list of candidate control technologies to the Cost Analysis module so
              that the cost of the controls can be estimated.  It may also be necessary to provide
              this information to the Energy Impacts and Resource Conservation modules,
              particularly if the potential control technologies are energy-intensive or require
              treatment chemicals and/or water. Also provide the type of control and its
              removal efficiency (e.g., the amount of pollutants that it typically removes from a
              similar waste stream) to the Exposure Assessment module.
METHODOLOGY DETAILS: This section provides methodology details for completing
Steps 7 and 8. If necessary, additional details on this and other steps can be found in the
published guidance.

Details:  Step 7, Characterizing Waste Streams

Table 9-2 gives examples of waste characteristics and the objectives of treating the waste.
TABLE 9-2: WASTE CHARACTERISTICS ANB TREATMENT OBJECTIVES
Waste Characteristic
Corrosive
Flammable
Reactive
Toxic
Bio-hazardous
Treatment Objective
pH neutralization.
Destroy active component.
Consume active component in a controlled
reaction.
Destroy toxic constituents.
Destroy biological hazard.
                                          9-14

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CHAPTER 9
                                                CONTROL TECHNOLOGIES ASSESSMENT
Details: Step 8, Identifying Potential Treatment Technologies


Figure 9-2 illustrates the applicability of broad classes of treatment technologies to certain types

of waste streams.


      FIGURE 9-2: POTENTIAL TREATMENT TECHNOLOGIES BY TYPE OF

                                  WASTE STREAM
            Separation/filtration
            Carbon adsorption
            Air and stream stripping
            Electrolytic recovery
            Ion exchange
            Membranes
            Chemical precipitation
            Chemical oxidation/reduction
            Ozonation
             Evaporation
             Solidification
             Liquid injection incineration
             Rotary rains
             Fluidized bed incineration
             Pyrolysis
             Molten glass
                                           Type of Waste Streams
                               "orm of
                               Waste
X
X
                                         X
   X
   X
                                            (0
     X
     X
     X
     X
X
X
        X
                                                 o
   X
X
                                                 X
  X
     X
X
      X
X
                                                              CO
             X
          X
                       X
                       X
                       X
                          X
                X
                   X
                             X
                                                                        CO
                                                                        D
                                                                        o>
                                                                        a
                               X
                               X
                        X
                        X
                                    X
     Source: Freeman (1989).
                                           9-15

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 PARTH; CTSA INFORMATION MODULES
 FLOW OF INFORMATION:  This module can be used alone to guide the selection of control
 technologies for treating or controlling waste streams in a facility. In a CTSA, this module
 receives data from the Chemistry of Use & Process Description, Workplace Practices & Source
 Release Assessment, Regulatory Status, Chemical Properties, and Environmental Fate Summary
 modules and transfers data to the Cost Analysis, Exposure Assessment, Energy Impacts, and
 Resource Conservation modules. Example information flows are shown in Figure 9-3.


         FIGURE 9-3: CONTROL TECHNOLOGIES ASSESSMENT MODULE:
                          EXAMPLE INFORMATION FLOWS
     Chemistry of Use
       & Process
       Description
   • Un4 operations
   • Current controls
   »Proce« flow diagram
   Workplace Practices
    & Source Release
      Assessment
   • RoloMO sources
   » Waste atrwun quantities
   * Regutetary requirements
       Chemical
       Properties
   • CAS RN and synonyms
   • CbemteaJpropcrtiea
     Environmental
     Fate Summary
H
   • Environmental fata and
    treotablity summaries
                                   Control
                                Technologies
                                 Assessment
                                                !-  II.VB i-f V l  M
                                    Reconunended/requfred
                                    control technotogies
  Cost
Analysis
                                                     * Recommencled/reiquinBd
                                                       cortroltecfinciloaiea
                                                        Exposure
                                                       Assessment
                                                     * RecommemtedAiuquired
                                                       control tecftndofiiies
                                                         Energy
                                                         Impacts
                                                      conlroltBchnologios
                                                        Resource
                                                       Conservation
ANALYTICAL MODULES:  Various computer programs are available for either monitoring,
controlling, or managing air emissions, water discharges, and hazardous wastes.  Check with
EPA Headquarters (Washington, D.C., 202-382-2080) or consult trade magazines for
information on the software packages currently available.
                                         9-16

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CHAPTER 9
CONTROL TECHNOLOGIES ASSESSMENT
PUBLISHED GUIDANCE: Table 9-3 presents references for published guidance on the
selection of control technologies to mitigate waste releases.
TABLE 9-S; PUBLISHED GUIDANCE ON CONTROL TECHNOLOGIES ASSESSMENT
Reference
Freeman, Harry M. 1989; Standard Handbook of
Hazardous Waste Treatment and Disposal.
Masters, Gilbert M. 1991. Introduction to
Environmental Engineering and Science.
Reynolds, Tom D. 1996. Unit Operations and
Processes in Environmental Engineering.
U.S. Environmental Protection Agency. 1987c.
A Compendium of Technologies Used in the
Treatment of Hazardous Wastes.
U.S. Environmental Protection Agency. 1990b.
Treatment Technologies.
Walk, Kenneth and Cecil F. Warner. 1981. Air
Pollution, Its Origin and Control.
Type of Guidance
Information on various treatment technologies for
hazardous waste.
Provides overview of treatment technologies for
hazardous waste.
Information on the design of processes to treat
industrial waste.
Describes the various treatment technologies
available for air, water, and land releases.
General information on treatment technologies
for waste streams.
Information on the regulatory aspects of air
pollution and treatment methods to mitigate its
impact.
Note: References are listed in shortened format, with complete references given in the reference list following
Chapter 10.
 DATA SOURCES: None cited.
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                                  9-18

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                                                              Chapter  10
                                                      CHOOSING
                                                             AMONG
                                           ALTERNATIVES
This chapter presents the module descriptions for the final trade-off evaluations of a CTSA,
including the following modules:

•     Risk, Competitiveness & Conservation Data Summary.

•     Social Benefits/Costs Assessment.

•     Decision Information Summary.

First, data summaries are prepared in the Risk, Competitiveness & Conservation Data Summary
module, including a discussion of the uncertainties in the data and, in some cases, the
significance of results (e.g., whether the risk characterization indicates a "clear," "possible," or
"negligible" level of concern for a substitute). These data summaries provide the basic
information needed for an individual decision-maker to consider the private (internal) benefits
and costs of implementing a substitute.

Next, the data summaries are transferred to the Social Benefits/Costs Assessment module to
evaluate the net benefits or costs to society of implementing a substitute as compared to the
baseline. This involves a qualitative assessment of health, recreation, productivity, and other
social welfare issues including benefits or costs that cannot be quantified in monetary terms.
Thus, the Social Benefits/Costs Assessment module provides information needed to assess the
external benefits and costs of implementing a substitute.

The results of the Risk, Competitiveness & Conservation Data Summary and the Social
Benefits/Costs Assessment modules are combined in the Decision Information Summary module
to identify the overall advantages an disadvantages of the baseline and the substitutes from both
an individual business perspective and a societal perspective. The Decision Information
Summary mmodule does not make value judgements or recommendations. The actual decision
of whether or not to implement a substitute is made outside of the CTSA process.
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                                  10-2

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         RISK, COMPETITIVENESS & CONSERVATION DATA SUMMARY
OVERVIEW: The Risk, Competitiveness & Conservation Data Summary module organizes
data from the risk, competitiveness, and conservation components of a CTSA together with data
from the Process Safety Assessment, Market Information, and International Information
modules. Data organized in this module are transferred to the Social Benefits/Costs Assessment
module for analysis of: (1) the benefits and costs to the individual of alternative choices (referred
to as private benefits and costs); and (2) the benefits and costs to others who are affected by the
choices (referred to as external benefits and costs).  Data are also transferred to the Decision
Information Summary module where they are combined with the results of the Social
Benefits/Costs Assessment to identify the overall advantages and disadvantages of the baseline
and the substitutes.
GOALS:
       Compile data on the baseline to serve as a basis of comparison when evaluating the trade-
       offs among risk, competitiveness, and conservation.

       Compile data on each of the substitutes to identify the trade-offs among risk,
       competitiveness, and conservation issues associated with a substitute.

       Compile information on the uncertainties in the data that should be considered in the
       decision-making process.

       Develop simplified, interpretive summaries of the data that note clear distinctions in
       trade-off issues of the substitutes as compared to the baseline.

       Transfer data to the Social Benefits/Costs Assessment and Decision Information
       Summary modules.
PEOPLE SKILLS:  The Risk, Competitiveness & Conservation Data Summary module
requires the people skills outlined in the previous module descriptions for the analytical
components of a CTSA, as well as the people skills required for the Social Benefits/Costs
Assessment module.  Completing this module should be a joint effort by all members of a DfE
project team. Knowledgeable personnel and technical experts who completed the analytical
modules are needed to evaluate results and identify uncertainties in the information.
DEFINITION OF TERMS:  None cited.
 APPROACH/METHODOLOGY:  The following presents a summary of a general approach
 for organizing the data compiled in a CTSA. Methodology details for Steps 10 and 12 follow
 this section.

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PART II: CTSA INFORMATION MODULES
Risk
Step 1:
Step 2:
Step 3:
Step 4:
Obtain data on environmental releases and transfers of pollutants from the Survey
of Workplace Practices & Source Release Assessment module. Note any
assumptions, scientific judgements, and uncertainties in the data.  The Exposure
Assessment module analyzes modeled or measured environmental concentrations
of pollutants to determine exposure levels, but other effects of emissions (e.g., a
smokestack that deposits soot on someone's laundry) may be considered in the
Social Benefits/Costs Assessment.

Review the Exposure Assessment module to determine the potential for chemical
exposure via the evaluated pathways (e.g., dermal, inhalation, ingestion).  In past
CTSAs, exposure potential has been used as an indicator of risk potential when
toxicity data were not available. Note any assumptions, scientific judgements,
and uncertainties included hi the assessment.

Obtain data on the human health and environmental risks of alternatives from the
Risk Characterization module.  Note any  assumptions, scientific judgements, and
uncertainties included in the assessment.

Review the Process Safety Assessment module to determine if the baseline or
alternatives pose particular process safety hazards.  List special precautions or
actions that may be required to mitigate safety hazards.
Competitiveness

Step 5:        Review the Regulatory Status module to determine which alternatives are
              regulated by environmental statutes, including any bans or restrictions that may
              affect availability. Alternatives being banned or phased-out should have been
              eliminated from consideration when the Regulatory Status module was
              completed.  However, other alternatives may be under consideration for a ban or
              phase-out.

Step 6:        Obtain data on the relative performance of the substitutes as compared to existing
              performance standards or as compared to the baseline from the Performance
              Assessment module. Note any assumptions, judgements, or uncertainties that
              should be reported with the performance data.

Step?:        Obtain the costs of alternatives from the Cost Analysis module. Note the  .
              assumptions and types of costs (e.g., operating, capital, indirect, etc.) that are
              included in the cost figures.

Step 8:        Review the Market Information and International Information modules to identify
              any current or anticipated problems with the supply of or demand for the
                                          10-4

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CHAPTER 10
RISK, COMPETITIVENESS & CONSERVATION DATA SUMMARY
              substitutes. This can include supply shortfalls or international trade issues (e.g.,
              taxes, tariffs, or prohibitions) that might limit the availability of a substitute.

Conservation

Step 9:        Review the Energy Impacts and Resource Conservation modules for conservation
              data. Note alternatives that consume scarce resources or that are derived from
              nonrenewable resources.

Data Summaries and Data Transfer

Step 10:       Construct data summary tables of the data obtained hi Steps 1 through 9.

Step 11:       Review the data for each alternative to determine the trade-off issues associated
              with any one substitute. Note changes in trends from the baseline to the
              substitutes (e.g., the baseline performs well, is cost-effective, but consumes large
              amounts of water and has a high potential for worker exposure; an alternative
              performs well, is expected to be cost-effective if supply/demand relationships
              stabilize; has reduced water consumption and potential for exposure as compared
              to the baseline).

Step 12:       Using data from the baseline, trends among trade-offs identified hi Step 11, and
              existing published guidance or data from modules describing the levels of concern
              for different parameters (e.g., risk assessment guidance on concerns for risk),
              develop simplified, interpretive summaries of the data that note clear distinctions
              in trade-off issues of a substitute as compared to the baseline.

Step 13:       Transfer the risk, competitiveness, and conservation data summary information
              and any assumptions, judgements, or uncertainties that should be reported with
              the data to the Social Benefits/Costs Assessment and Decision Information
              Summary modules.
METHODOLOGY DETAILS: This section provides methodology details for completing
Steps 10 and 12. In some cases, information on interpreting the significance of results can be
found in the published guidance listed previously in other module descriptions.

Details: Steps 10 and 12, Constructing Data Summary Tables and Interpretive Summaries

In Step 10, relevant information from the CTSA can be structured hi table, or matrix, format for
ease of understanding. Data summaries that compare the substitutes to the baseline should be
presented using some consistent unit of measure for each category.  Table 10-1 is an example of
a matrix that can be used to compare the impacts of alternatives on health and the environment.
Data for the baseline and the alternatives should be included in the matrix. A DfE project team
may show quantitative data in the matrices, or use symbols (e.g.,"+" or  "-") or text to illustrate

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PARTH:  CTSA INFORMATION MODULES
the impacts of the alternatives as compared to the baseline. Note that impacts which are stronger
than others can also be recognized (e.g., high, medium, or low positives or negatives).
TABLE 10-1: EXAMPLE MATRIX OF ENVmOlSrMENTAL RELEASE AND
RISK~RELATEJ> DATA
Alternative
Baseline
Alternative
1
On-site Releases*
Air


Water


Land


Off-site Transfers"
POTWC


Hazardous
Waste
Disposal


Recycling


RiskM
Worker
Exposed
Population


Risk
Characterization


General
Exposed
Population


Risk
Characterizati


a) Data on environmental releases and transfers are obtained from the Survey of Workplace Practices & Source
Release Assessment and the Exposure Assessment modules (environmental releases and transfers that must be
modeled).
b) Risk data are obtained from the Risk Characterization module. Quantitative data included here could include
individual or population cancer and non-cancer risk to workers and other exposed human populations, and risk to
aquatic organisms.  Qualitative data might include an assessment of the potential for exposure to the health and
environmental hazards identified in the Human Health Hazards and Environmental Hazards Summary modules.
c) Publicly Owned Treatment Works.
d) Data on population sizes are obtained or can be developed from the Survey of Workplace Practices & Source
Release Assessment and Exposure Assessment modules.

Table 10-2 is an example matrix for compiling conservation information. The cost of energy and
other resources should have already been incorporated in the Cost Analysis module.  However, it
is important to note the rate of resource consumption, or choices that consume scarce resources
or that are derived from nonrenewable resources.
TABLE 10-2: EXAMPLE MATRIX OF CONSERVATION INFORMATION3
Alternative
Baseline
Alternative 1
Alternative 2
Energy Consumption11
Natural gas
(BTU/hr)



Electricity
(kWh/day)



Other Resources Consumption0
Water
(gallons/day)



Chemical
Product
(gallons/yr)



Machine Oil
(gallons/mo)



a) Resource data are usually collected in units of mass or volume per unit time (m/t or L3/t). To convert to mass or
volume per unit production, multiply by the reciprocal of the production rate (e.g., 10 Btu/hr x 1 hr/50 widgets = 0.2
Btu/widget).
b) Energy data are obtained from the Energy Impacts module.
c) Other resource data are obtained from the Resource Conservation module.
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 CHAPTER 10	RISK, COMPETnTVENESS & CONSERVATION DATA SUMMARY

 To the extent possible, data should be normalized to some consistent basis, preferably per unit
 production ($/widget, Btu/widget, No. of product rejects/widgets produced, etc.).  Normalization
 allows the baseline and substitutes to be compared directly. The following discusses the data
 summaries in more detail.

 Exposure Potential and Health or Ecological Risk. The exposure potential and risk associated
 with using the baseline or a substitute can be presented together, particularly since risk is a
 function of exposure potential.  For each system, qualitative descriptors could be used to list the
 potential for dermal (skin), inhalation, and ingestion exposure as high (+++), moderate (++), or
 low (+). Below each exposure scenario would be listed the corresponding risk level. Concerns
 for risk could be categorized as "clear," "possible," negligible," or "not quantified."

 "Clear" concern indicates an inadequate margin-of-safety according to generally accepted risk
 assessment standards for exposure to the chemicals in question (see the list of published guidance
 in the Risk Characterization module). "Possible" concerns indicate that the margin-of-safety is
 slightly less than desirable and may not afford adequate protection in some circumstances.
 "Negligible" concerns indicate that an adequate margin-of-safety exists for exposure to the
 chemicals in question under the expected conditions of use.

 For some chemicals evaluated in a CTSA, there may be insufficient data to quantify the risk, and
 although the exposure potential may be well-characterized, the precise risk cannot be quantified;
 these risks should be listed as "not quantified." Categorizing of risk into concern levels should
 only be undertaken by someone with expertise in accepted risk assessment standards.

 Regulatory Status. Highlight alternatives that have a clearly different regulatory  status as
 compared to the baseline or other alternatives. These might include alternatives being banned or
 phased-out, alternatives with no VOC content, or alternatives that do not use or contain regulated
 toxic chemicals.

 Process Safety. Briefly summarize the safety hazards associated with the baseline in general.
 Use qualitative descriptors to indicate if an alternative improves working conditions by reducing
 safety hazards or may negatively influence working conditions by introducing a new safety
hazard (e.g.,"+" for improved safety;"-" for reduced safety).  Special precautions  or actions
required to mitigate additional safety hazards of alternatives should be listed.

Performance.  If performance data were collected on more than one measure of performance,
the data can be combined into one overall assessment of the relative performance of a substitute
or listed separately. If a substitute performs well, but fails to meet some traditional performance
measure (e.g., the brightness requirement of virgin paper), it may be necessary to assess the
performance measure to determine if industry standards are changing in response to
environmental or other concerns.

Cost. Cost data should be provided in terms of dollars per unit production or some other
consistent unit. The categories of costs (e.g., capital, operating, maintenance, indirect, etc.) and
any assumptions that are included in the cost data should be clearly documented.

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PARTH:  CTSA INFORMATION MODULES
Energy and Resource Consumption. The types of energy or other resources evaluated and any
assumptions should be clearly documented. If the project team focusses on a particular category
of resources (e.g., water usage), information should be provided on the reasons for concern about
the resource (e.g., continuing usage of large amounts of water could limit the industry's potential
for growth; reliance on a scarce resource creates societal burdens and limits growth potential;
mandated restrictions on use are anticipated, etc.).

Market and International Information. Businesses need to be aware of any expected supply
shortfalls or international conditions that could limit the availability of a substitute. This
information should also be briefly summarized.
FLOW OF INFORMATION:  This module summarizes the data on risk, competitiveness, and
conservation compiled throughout a CTSA. The data summaries should report the technical data
compiled in a CTSA in an understandable manner that will assist individual decision-makers in
the decision-making process. The Risk, Competitiveness & Conservation Data Summary
module receives data from the Workplace Practices & Source Release Assessment, Exposure
Assessment, Risk Characterization,  Process Safety Assessment, Regulatory Status, Performance
Assessment, Cost Analysis, Market Information, International Information, Energy Impacts, and
Resource Conservation modules. It transfers data to the Social Benefits/Costs Assessment and
Decision Information Summary modules. Example information flows are shown in Figure 10-1.
ANALYTICAL MODELS: None cited.
PUBLISHED GUIDANCE: None cited.
DATA SOURCES: None cited.
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CHAPTER 10
RISK, COMPETITIVENESS & CONSERVATION DATA SUMMARY
  FIGURE 10-1: RISK, COMPETITIVENESS & CONSERVATION DATA SUMMARY
                  MODULE: EXAMPLE INFORMATION FLOWS
 Risk
          Workplace Practices & Source
             Release Assessme
       "' *Wastestneam quantities
 Source 1  \..
 2.J-*
            Exposure Assessment
      J—
        * Modelled release mfonnafam
             Risk Characterization
     >'
         • Cancer risk
           Process Safety Assessment
      h»
  v ,(  !  * Process safety hazards
 Competitiveness

        m
            Performance Assessment
           EfJectivenessofsubsStiites
                Cost Analysis
      V*
        '' * Comparative cost results
  T  «?   r
              Market Information
      ]—
          Suofrfy shortfalls
             International information
       V-
  ,     -   "international sources
 Conseryatiorv
                Energy Impacts
      V-
             Resource Conservation

                                                                      ^ *-
   Social
Benefits/Costs
 Assessment

                                                                      Decision
                                                                     Information
                                                                      Summary
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                                   10-10

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                       SOCIAL BENEFITS/COSTS ASSESSMENT
OVERVIEW: Policy makers decide on policies for society in part by utilizing social
benefits/costs assessment to evaluate the impact of those decisions on others. Social
benefits/costs assessment is the process of systematically evaluating the impacts made on all of
society by individual decisions. It includes the benefits and costs to the individual of alternative
choices (referred to as private benefits and costs) and the benefits and- costs to others who are
affected by the choices (referred to as external benefits and costs).  Public decision-makers utilize
social benefits/costs assessment to choose the best alternative among several options. Benefits
are determined by the differences in risks between the baseline system or product and the
alternative; costs are determined by the differences in the costs of using the alternative system
versus the baseline. The criterion is to choose the alternative with the largest net benefits, i.e.,
the alternative with the largest positive difference between benefits and costs. Social
benefits/costs assessment is important because it provides a complete view of the effects of
alternative choices regarding pollution, allowing the policy maker to make choices based upon
both private and external benefits and costs.

In a free market economy, firms typically make decisions based upon the knowledge at hand in
order to maximize profits.  However, this is often without full  knowledge of the effects of those
decisions on others. Private effects could include changes in worker productivity, worker
compensation claims, liability claims, hazardous waste disposal costs, costs of meeting
regulatory requirements, and sales due to negative or positive publicity. External effects include
the effects of pollution on health, recreation, and productivity, which ultimately can impact
publicity (related to sales and good will) and liability. By considering these effects, social
benefits/costs assessment can be used by industry to improve the outcome of decision-making for
a business and for society as a whole. Further information on the relevance of social
benefits/costs assessment can be found in the Methodology Details section of this module.
GOALS:
       Describe expected private and external benefits of the alternatives relative to the baseline,
       including any beneficial effects that cannot be quantified in monetary terms and the
       identify of those likely to receive the benefit.

       Describe expected private and external costs of the alternatives relative to the baseline,
       including any adverse effects that cannot be quantified in monetary terms and the identify
       of those likely to bear the costs.

       Determine the potential net benefits (benefits minus costs) of the alternatives as compared
       to the baseline, including an evaluation of effects that cannot be quantified in monetary
       terms.
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PEOPLE SKILLS:  The following lists the types of skills or knowledge that are needed to
complete this module.

•      Knowledge of social benefits/costs assessment of human health and environmental risk
       management options.

Within a business or DfE project team, the people who might supply these skills include an
economist or a policy analyst.
DEFINITION OF TERMS:

Benefit:  A benefit is the value to society of a good or service. From a firm's perspective, the
benefit of a good or service can be measured by the revenue the firm receives from its sales as
compared to the costs incurred when producing its products.  From the consumer's perspective,
the benefit can be measured by what the consumer would be willing to pay for the good or
service.  Some goods and services, such as environmental amenities and health risk reductions,
are not generally for sale in a market economy. However, these goods and services do provide
benefits to society which should be recognized. Economists attempt to estimate the value of
these goods and services through various nonmarket valuation methods, which are briefly
described in the Methodology Details section below.

Direct Medical Costs: Costs associated specifically with the identification and treatment of a
disease or illness (e.g., costs of visits to the doctor, hospital costs, costs of drugs).

Discounting: Economic analysis procedure by which monetary valuations of benefits and/or
costs occurring at different tunes are converted into present values which can be directly
compared to one another.

Exposed Population: The estimated number of people from the general public or a specific
population group who are exposed to a chemical, process, and/or technology. The general public
could be exposed to a chemical through wide dispersion of a chemical in the environment (e.g.,
DDT). A specific population group could be exposed to a chemical due to its physical proximity
to a manufacturing facility (e.g., residents who live near a facility using a chemical), through the
use of the chemical or a product containing a chemical, or through other means.

Exposed Worker Population:  The estimated number of employees in an industry exposed to the
chemical, process, and/or technology under consideration. This number may be based on market
share data as well as estimations of the number of facilities and the number of employees in each
facility associated with the chemical, process, and/or technology under consideration.

Externality: A cost or benefit that involves a third party who is not a part of a market
transaction; "a direct effect on another's profit  or welfare arising as an incidental by-product of
some other person's or firm's legitimate activity" (Mishan, 1976).  The term "externality" is a
general term which can refer to either external benefits or external costs.

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 CHAPTER 10
                                                     SOCIAL BENEFITS/COSTS ASSESSMENT
 External Benefits:  A positive effect on a third party who is not part of a market transaction. For
 example, if an educational program (i.e., a smoking-cessation class) results in behavioral changes
 which reduce the exposure of a population group to a disease (i.e., lung cancer), then an external
 benefit is experienced by those members of the group who did not participate in the educational
 program (i.e., those inhaling second-hand smoke).  External benefits also occur when
 environmental improvements enhance enjoyment of recreational activities (e.g., swimming,
 hiking, etc.).

 External Costs: A negative effect on a third party who is not part of a market transaction. For
 example, if a steel mill emits waste into a river which poisons the fish in a nearby fishery, the
 fishery experiences an external cost to restock as a consequence of the steel production. Other
 examples of external costs are the effects of second-hand smoke on nonsmokers, increasing the
 incidence of respiratory distress, and a smokestack which deposits soot on someone's laundry,
 thereby incurring costs of relaundering.

 Human Health Benefits: Reduced health risks to workers in an industry or business as well as to
 the general public as a result of switching to less toxic or less hazardous chemicals, processes,
 and/or technologies. An example would be switching to a less volatile chemical or a new
 method of storing or using a volatile, hazardous chemical, to reduce the amount of volatilization,
 thereby lessening worker inhalation exposures as well as decreasing the formation of
 photochemical smog in the ambient air.

 Human Health Costs: The cost of adverse human health effects associated with production,
 consumption and disposal of a firm's product. An example is the cost to individuals and society
 of the respiratory effects caused by stack emissions, which can be quantified by analyzing the
 resulting costs of health care and the reduction in life expectancy,  as well as the lost wages as a
 result of being unable to work.

 Illness Costs:  A financial term referring to the liability and health care insurance costs a
 company must pay to protect itself against injury or disability to its workers or other affected
 individuals. These costs are known as illness benefits to the affected individual. Appendix J
 summarizes several cost of illness valuation methods.

 Indirect Medical Costs:  Indirect medical costs associated with a disease or medical condition
 resulting from exposure to a chemical, product or technology. Examples would be the costs of
 decreased productivity of patients suffering a disability or death and the value of pain and
 suffering borne by the afflicted individual and/or family and friends.

 Individual Risk: An estimate of the probability of an exposed individual experiencing an adverse
 effect, such as " 1 in 1,000" (or ID'3) risk of cancer.                                        .

Net Benefit: The difference between the benefits and the costs.  For a company this could be
 interpreted as revenue - costs, assuming that the revenue and the costs are fully determined.
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Opportunity Cost:  A hidden or implied cost incurred due to the use of limited resources such
that they are not available for an alternative use.  For example, the use of specific laborers hi the
production of one product precludes their use in the production of another product. The
opportunity cost to the firm of producing the first product is the lost profit from not producing
the second. Another example would be a case where in hiring legal representation to respond to
a lawsuit, and due to limited financial resources, a firm must cancel a planned expansion. The
opportunity cost of responding to the lawsuit is the lost gain from not expanding.

Population Risk: An aggregate measure of the projected frequency of effects among all exposed
people, such as "four cancer cases per year."

Present Value:  The value in today's terms of a sum of money received in the future.  Present
Value is a concept which specifically recognizes the time value of money, i.e., the fact that $ 1
received today is not the same as $1 received in ten years time. Even if there is no inflation, $1
received today can be invested at a positive interest rate  (say 5 percent), and can yield $1.63  in
ten years; $1 received today is the same as $1.63 received ten years in the future. Alternately, the
present value of $1 received in ten years is $0.61. The rate at which future receipts are converted
into present value terms is called the discount rate (analogous to the interest rate given above).
The formula for calculating present value is given in the Cost Analysis module.

Private (Internalized^ Benefits: The direct gain received by industry or consumers from their
actions in the marketplace. One example includes the revenue a firm obtains in the sale of a
good or service. Another example is the satisfaction a consumer receives from consuming a
good or service.

Private (Internalized^) Costs: The direct negative effects incurred by industry or consumers from
their actions in the marketplace.  Examples include a firm's cost of raw materials and labor, a
firm's costs of complying with environmental regulations, or the cost to a consumer of
purchasing a product.

 Social Benefit: The total benefit of an activity that society receives, i.e., the sum of the private
benefits and the external benefits.  For example, if a new product prevents pollution (e.g.,
 reduced waste in production or consumption of the product), then the total benefit to society of
 the new product is the sum of the private benefit (value of the product that is reflected in the
 marketplace) and the external benefit (benefit society receives from reduced waste).

 Social  Cost: The total cost of an activity that is imposed on society. Social costs are the sum of
 the private costs and the external costs. Therefore, in the example of the steel mill, social costs
 of steel production are the sum of all private costs (e.g., raw material and labor costs) and the
 sum of all external costs (e.g., the costs associated with replacing the poisoned fish).

 Willingness-to-Pav: Estimates used in benefits valuation intended to encompass the full value of
 avoiding a health or environmental effect, which are often not observable in the marketplace.
 For human health effects, the components of willingness-to-pay include the value of avoided
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CHAPTER 10
                                      SOCIAL BENEFITS/COSTS ASSESSMENT
pain and suffering, impacts on the quality of life, costs of medical treatment, loss of income, and,
in the case of mortality, the value of a statistical life.
APPROACH/METHODOLOGY: The following presents a summary of the approach or
methodology for conducting a social benefits/costs assessment. This should be used as a general
guideline. After completing this procedure, it will be possible to compare the baseline with the
alternatives for both private and external benefits and costs. It should be recognized that not all
benefits may be quantifiable, but they should still be considered in a qualitative manner. Further
information on the relevance of and framework for quantitative social benefits/costs analysis and
methodology details for Steps 7 through 11 follow this section. Appendix I presents the social
benefits/costs assessment from the Lithography CTSA.
Step 1:
Step 2:
Step 3:
Step 4:
Obtain risk, competitiveness, and conservation data summary information,
including interpretive data summaries, from the Risk, Competitiveness &
Conservation Data Summary module. The risk summary information may include
data on environmental releases and transfers of pollutants, chemical exposure
levels, health and environmental risks from toxic chemical exposure, and process
safety information. The competitiveness summary information may include
information on the regulatory status of chemicals, performance data, cost data, as
well as market information and international information related to the availability
of a substitute. The conservation data summary typically describes energy
impacts and effects on resource conservation.

From the competitiveness summary, eliminate any alternatives that exhibited
clearly unacceptable performance or that are banned or being phased-out. Keep in
mind  that there may be a variety of reasons that an alternative did not work (e.g.,
standards that are more stringent than necessary, worker apprehension, or misuse
of the alternative due to lack of familiarity), and that some of these conditions
may change over time.  For instance, recycled paper has become acceptable in
many circumstances even though it doesn't have the brightness attainable with
virgin feedstock.

Review data in the risk summary on the relative risk of alternatives, as compared
to the baseline. This provides information necessary to determine both private
and external effects. For instance, improving  a worker's health may lead to fewer
sick days and possibly a more productive employee and therefore provides private
benefits. External benefits include the reduction in health care cost, which may
lead to lower overall premiums.  It may be necessary to review exposed
population and release and transfer information included in the risk summary,
particularly if chemical toxicity data were not available.

Review data on the process safety hazards posed by the baseline and alternatives.
This provides information about the relative safety of the various alternatives.
Replacing a carcinogen with a fire hazard may or may not be appropriate.

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PARTH: CTSA INFORMATION MODULES
Step 5:        Review the rates of energy and natural resource consumption of the baseline and
              alternatives from the conservation summary. Differences in operating costs,
              which should incorporate the cost of energy and other resources, should have
              already been incorporated in the Cost Analysis module.  However, it is important
              to note choices that consume scarce resources or that are derived from
              nonrenewable resources, as conservation of those resources could play an
              important role. In addition, as scare resources are used, there is a potential for
              them to become more costly.

Step 6:        Using quantitative risk characterization data from the risk summary, if available,
              quantify changes in individual or population risks as a result of implementing an
              alternative as compared to the baseline. Options that reduce risk provide the
              social benefit of reduced mortality and morbidity.

Step 7:        For all of the data hi the risk, competitiveness and conservation data summaries,
              identify other potential external effects (in addition to quantitative individual or
              population risk) of implementing an alternative as compared to the baseline. For
              examples of potential effects see the Methodology Details section, below.

Step 8:        For each effect identified in Steps 3 through 7, identify which relate to private or
              external effects and the affected populations (e.g., workers at a facility, consumers
              using the finished product, persons fishing in the stream that receives pollutants,
              etc.). Some of this information will be summarized in the risk summary from the
              Risk, Competitiveness & Conservation Data Summary module.

Step 9:        Evaluate the effects of each alternative compared to the baseline to determine if
              the effects are beneficial to  society or create additional societal burdens.  These
              effects would not necessarily be considered by firms in typical business planning.
              However, consideration of the effects of each alternative could eventually affect a
              firm's profitability in the long run by increasing employee productivity, lowering
              the potential for lawsuits, reducing the likelihood of regulation, or through other
              means. Keep in mind that the larger the societal effect, the greater the potential
              for future regulation.

Step 10:      Compare the results of Step 9 to the results of the'cost analysis, performance
              assessment, and other competitiveness data (regulatory status, market availability
              of a substitute, etc.) found in the competitiveness summary.  For example, does
              the alternative increase or decrease private costs (e.g., capital costs, operating and
              maintenance costs)? Does the alternative perform as well as or better than the
              baseline, resulting hi a product with increased societal value? Keep in mind that
              performance may be acceptable even if different from the baseline. (Recall the
              example about the acceptability of recycled paper given in Step 2.) Are there
              environmental regulations affecting the alternative?  Is the supply of a substitute
              stable?
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CHAPTER 10
SOCIAL BENEFITS/COSTS ASSESSMENT
Step 11:       Use the results of Steps 9 and 10 to qualitatively evaluate the net benefits or costs
              of the alternatives. For example, the value of reduced human health risks would
              most likely greatly exceed the value of slightly higher operating costs. To
              develop a quantitative estimate of net benefits or costs economists monetize
              benefits using the concepts of willingness-to-pay and discounting. There are
              many texts which describe various monetization techniques (see sections on
              analytical models and published guidance for references on quantitative social
              benefits/costs analysis). The Cost Analysis module gives the formula for
              calculating present value.

Step 12:       Transfer the results of the Social Benefits/Costs Assessment to the Decision
              Information Summary module.
METHODOLOGY DETAILS: This section presents further information on the relevance of
and framework for social benefits/costs analysis and provides methodology details for
completing Steps 7 through 11.  If necessary, additional information on this and other steps can
be found in previously published guidance (see section on published guidance).

Relevance of Social Benefits/Costs Analysis

Imagine a pasture which is open for common use by cattle producers in a community. Every
cow that grazes on the pasture represents additional revenue a producer can receive, with no
additional cost to the producer for grazing. Therefore, with other costs held constant, each
producer has an incentive to graze as many cows as possible on the pasture.  Since every
producer has the same incentive, the pasture can easily become overgrazed, resulting  in the
eventual destruction of the pasture and the elimination of the food supply for the cattle. There
was no incentive for a single producer to constrain use of the common resource in order to
preserve it, thereby resulting in the ruin of free pasturage for all.

A similar problem occurs with pollution.  Each generator of waste may find it cheaper to emit
wastes into the environment than to treat the wastes, or to use an alternative process which does
not cause the wastes.  However, with many generators of wastes, the ability of the environment
to assimilate wastes becomes overwhelmed, and pollution results.  Increases in pollution lead
directly to reductions in the quality of life in the affected area.

The fundamental similarity in each case is that a resource is being used, but no recognition of the
costs of its use is being acknowledged. If the resource were privately held, the owner would
have the right to demand payment for the use of the resource and has an incentive to prevent use
of the resource to the point of destruction. However, in many instances, private ownership is not
feasible - for example, ownership rights of the air for assimilating emissions have not generally
been established in market economies. Therefore, failure to recognize the costs of utilizing a
resource will eventually lead to  its overuse, and in some cases, its destruction.
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 PARTH: CTSA INFORMATION MODULES
 The approach to solving this problem that has generally been used in the U.S. is for the
 government to assume responsibility for commonly held resources such as the air, and to impose
 limits on their use through the implementation of standards, technology requirements, and other
 policies. Social benefits/costs analysis is the means by which the services of these resource are
 valued in developing these policies.  Social benefits/costs analysis also provides information to
 decision-makers about what levels of standards and what types of technology requirements
 would allow the most efficient use of commonly held resources.  Companies can be proactive in
 their use of common resources and employ social benefits/costs analysis in making decisions
, about technology choices.

 Framework for Social Benefits/Costs Analysis

 Social benefits/costs analysis is widely used hi government. Its function is to help decision-
 makers choose the policy option which is best from society's perspective among a choice of
 several alternative options. The criterion used is to choose the option which yields the greatest
 net benefit, i.e., the option for which the difference between social benefits and costs is the
 largest. Since benefits and costs are measured from a societal perspective, all the  private and
 external effects are considered. Oftentimes it is  easier to estimate the costs of policy  alternatives
 than the benefits of those alternatives; information on such factors as the costs to business  of new
 technology, the costs to consumers of higher prices, etc., is more readily available than
 information on the value of reduced health risks  or the value of an endangered species.

 Economists attempt to place a monetary value on benefits such as reduced health risks and
 environmental improvements for policy decision-making because monetizing benefits makes
 them easier to compare to costs, and therefore makes them less likely to be ignored.  While
 monetization of benefits may likely be difficult for a DfE or other CTSA development team
 given resource limitations, a very brief overview of benefits estimation is given here to help
 convey the concept of social benefits/costs analysis. It is also given to assist those firms or
 industry groups that do have the resources to do  quantitative social benefits/costs analysis, rather
 than the qualitative assessment that is the focus of this module.

 The main methods economists use in valuing social benefits include  travel cost techniques,
 hedonic pricing, and contingent valuation. These willingness-to-pay estimates are then used to
 estimate a total benefit to society of the potential improvement.  Travel cost methods  use an
 estimate of how much people actually spend on trips to environmental sites as the basis for
 calculating the value of benefits at those sites. Hedonic pricing methods use wage or price
 differentials to estimate market valuations of health risks on the job or environmental problems
 such as air pollution. Contingent valuation is a survey method in which individuals are asked
 what they would be willing to pay for health or environmental benefits, such as reduced health
 risk, improved air or water quality, or preservation of an endangered species.

 The benefits estimation techniques described here are highly resource-intensive, and are not
 generally conducted in the EPA Office of Pollution Prevention and Toxics. Instead, economic
 literature reviews can provide information on existing studies, from which social benefits
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CHAPTER 10
SOCIAL BENEFITS/COSTS ASSESSMENT
estimates can be drawn. However, if resources and information are too limited to conduct a
quantitative analysis, then a qualitative analysis will provide useful information.

Cost analysis is conducted by identifying all the relevant inputs (e.g., labor, equipment, energy)
to a production process, and placing a monetary value on the use of these inputs for a given
production level or time period.  The monetary value of the inputs is their price times the amount
used in the process. In this way, performance is incorporated into the analysis. Price and use
information can be obtained from supplier, industry associations, etc. The cost analysis is
repeated for each alternative under consideration.  All direct and indirect costs, including less
tangible costs such as liability costs, should be included in the analysis.

Again, the importance of the social benefit/cost analysis is not to develop a precise numerical
estimate of social benefits and costs, but to use a systematic form of analysis in order to identify
the best alternative among a choice of several possible options. The quantitative following
approach discussed in this module can be used when a project team has limited resources and/or
limited information.

Details:  Steps 7 through 11, Identifying and Evaluating Social Benefits and Costs

External Effects of Pollution

Recall that externalities are effects on third parties who are not part of a market transaction.
Market economies do not implicitly have mechanisms which consider these effects.  Failure to
recognize external costs means that costs are being imposed on someone else.  Legislative,
administrative, or judicial remedies can often be imposed on perpetrators, therefore recognition
of the external effects on others can be a proactive business decision.  Freeman (1982) lists the
folio whig external effects of pollution:

       Effects on Living Systems (Involving Biological Mechanisms)
       1. Human health
              a. mortality
              b. morbidity
       2. Economic productivity of ecological systems
              a. agriculture
              b. commercial fisheries
              c. forestry
       3. Other ecological system effects impinging directly on human activities
              a. sports fishing
              b. hunting
              c. wildlife observation
              d. water-based recreation
              e. home gardening and landscaping
              f. commercial, institutional, public landscaping
       4. Ecological system effects not directly impinging on humans
              a. species diversity
              b. ecosystem stability
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PARTH: CTSA INFORMATION MODULES
       Effects on Nonliving Systems
       1. Producers
             a. damages to materials, for example, corrosion
             b. soiling
             c. reduction in product quality
       2. Households
             a. damages to materials
             b. soiling
       3. Changes in weather and climate
       4. Other
             a. visibility
             b. tranquility

In addition to the external effects of pollution from operating plants, externalities also occur from
consumption of energy or nonrenewable resources. For example, economists say that energy is
not priced optimally because the price does not reflect the value of the externalities that occur
from energy production and use.  A decrease in energy consumption will reduce these
externalities, resulting in social benefits.

Evaluating the Effects of Alternatives on Society

Examples of the types of questions that could be asked in evaluating these effects are: Would the
alternative avoid or mitigate illness or disease when compared to the baseline?  Would the
alternative reduce employee absence or turnover through the provision of a better workplace?
Would the alternative improve air quality by decreasing the cumulative air emissions from the
industry as a whole? Would the recreational value of streams and rivers be improved due to
decreases in the environmental loading of pollutants from all businesses in the industry?  Would
the alternative decrease the  cumulative hazardous waste from the industry, thus requiring less
land for hazardous waste disposal? Note that some effects may have substantially stronger
positives and negatives than others. This should be taken into consideration.

Developing Social Benefits and Costs Information

For the baseline and each alternative, the social (private and external) benefit and cost
information should now be  developed. This type of information can be identified from data
reviewed in Steps 3 through 6 (obtained from the Risk, Competitiveness & Conservation Data
Summary module), and from additional information obtained in Steps 7 through 10.

For an example of how to develop this information, suppose we are currently using a chemical in
a production process (the baseline) which has the following concerns:

       (1)    It can cause both acute (for nausea) and chronic (for lung disease) worker health
             risks.
       (2)    It has a noxious odor both in the plant and in the surrounding area.
                                          10-20

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CHAPTER 10
SOCIAL BENEFITS/COSTS ASSESSMENT
       (3)     It is a hazardous substance, and must be disposed of in a hazardous waste facility.
              This poses a threat of groundwater contamination by the landfill, and subsequent
              liability problems.
       (4)     Some of the chemical is released into waste water, and could be contributing to
              the reduced stock of gamefish in a nearby reservoir.

Alternative 1 is being considered which would avoid use of this chemical entirely, but it has the
following problems:

       (1)     It would require investment in new equipment.
       (2)     It would utilize more energy, resulting in higher energy costs and an increase in
              emissions from energy production or consumption to the air.
       (3)     It is more labor intensive, leading to higher labor costs.
       (4)     It results  in a slightly inferior final product.

From information contained in the risk, competitiveness and conservation data summaries, it is
possible to say something, even if qualitative, about the impact on social benefits and costs from
changing from the Baseline to Alternative 1.  For example, the risk characterization summary
should show that there are health concerns for acute and chronic conditions associated with the
Baseline that do not exist with Alternative 1. The risk summary will also show that releases to
waste water and transfers to landfills decline to zero with Alternative 1, but that releases to the
air will increase.  On and off-site odor information will also be contained in this table.  From the
conservation summary, data will show that Alternative 1 will utilize more energy than the
Baseline.  The Cost Analysis  reviewed in Step  10 will show that Alternative 1 has higher
equipment, labor, and energy costs, but lower hazardous waste costs than the Baseline. The
Performance Assessment results reviewed in Step 2 will indicate that Alterative 1 yields a
slightly inferior final product.

However, assessment of the social benefits and costs will demonstrate that this is just part of the
story.  Reductions in health risks in moving from the Baseline to Alternative 1 may reduce
employee absence from illness, and therefore contribute to increased productivity, a private
benefit to the firm.  Another private benefit is the ability of the firm to market to environmentally
concerned consumers. These consumers might try to avoid products made with the Baseline, or
might be willing to pay a premium for products they consider to be "green."  External benefits
include reduced odor in the nearby vicinity of the plant, improved water quality in the reservoir,
and reduced health risks to workers.  Private costs associated with Alternative 1 are those costs
which were identified in the Cost Analysis module, while external costs are associated with
increased air emissions.

A table which illustrates the range of social benefits and costs can be constructed. Table 10-3 is
a depiction of such a table. This table shows the social benefits and costs of Alternative 1
relative to the Baseline. Note that it may not be possible to identify either quantity or unit values
for all of the items listed under type. As stated above, a review of economic literature might
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PARTH: CTSA INFORMATION MODULES
provide information, but generally resources may be too limited to provide monetary valuation of
external benefits. A qualitative description should be included in that case. A problem with
qualitative descriptions is the difficulty in weighing the benefits and costs - there is a tendency to
ignore those benefits which are not quantified. It may be possible to get an idea of the magnitude
of the qualitative description through the use of quantified aspects such as affected population
size. For instance, it appears that the choice is clear in looking at benefits of $1,000 versus $50
per individual; however, if in the first case 5 individuals are affected and in the second 100
individuals are affected, the choices appear equal.

After compiling social benefits and costs information, the DfE team calculates the net benefits
for each alternative. The net benefit is simply the difference between social benefits and costs.
This information is then transferred to the Decision Information Summary module.
                                          10-22

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CHAFFER 10
                                            SOCIAL BENEFITS/COSTS ASSESSMENT
TABLE 10-3: BASELINE ANB ALTERNATIVE Is SOCIAL BENEFITS AND COSTS
Type
enefits
Private
imployee
productivity
Product quality
Odor within plant
Revenue from
"green" consumers
External
lealth risk to
workers
Odor outside
plant
Ambient water
quality
'otential for
contamination in
landfill
Total Benefits
Costs
Private
Mew equipment
costs
Hazardous waste
disposal costs
Labor costs
Energy costs
Potential for
liability claims
External
Air emissions
Total Costs
Net Benefits
Unit




,evel
(H, M, L)


Worker lives
aved
Level
H, M, L)
jpm of
chemical
^evel
(H, M, L)



$
$
$
$
Expected
value
of damages

Amount of
particulate


Quantity




Obtain from Performance
Assessment)
Obtain from Risk
Characterization)
Obtain from Market
nformation)

Obtain from Risk
Characterization)
Obtain from Risk
Characterization)
Obtain from Risk
Characterization)
(Obtain from Risk
Characterization)



^Obtain from Cost
Analysis)
(Obtain from Cost
Analysis)
(Obtain from Cost
Analysis)
(Obtain from Cost
Analysis)
(Obtain from Cost
Analysis)

(Obtain from Risk
Characterization)


Total Value (+,-,$)
Baseline


Negative - Employees may be
Dsentor ill on job
ositive - Results in superior
uality product
Negative - May cause
bsences, high turnover, poor
morale
•lone

Negative - Potential for
mployees to acquire lung
lisease
Negative - Complaints from
community
Negative - Potential source of
reduced fish stocks
Negative - Leaks could
contaminate groundwater



None
Positive - Must pay to dispose
of chemical
Positive
Positive
Positive - High legal fees and
damages if contamination
event occurs

None


Alternative 1


ositive - Fewer absences and
more productive on job
Negative - Inferior quality
ould lead to reduced sales
ositive - Reduced potential
'or sick days or employee
turnover
Positive - May be able to sell
:o new consumers, or charge a
ligher price

Positive - Workers less likely
o suffer from lung disease
Positive - "goodwill" of
community
Positive - Possible increase in
fish populations and more
ishing
None



Positive - Must purchase new
machinery
None
Positive - Higher than for
Alpha
Positive - Higher than for
Alpha
None

Positive - New technology
causes air emissions


                                      10-23

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  PARTII;  CTSA INFORMATION MODULES
  FLOW OF INFORMATION:  This module can be used to guide the selection and use of
  alternatives that produce societal benefits while optimizing performance and cost requirements- In a
  CTSA this module receives data from the Risk, Competitiveness & Conservation Data Summary
  module and transfers data to the Decision Information Summary module. Example information
  flows are shown in Figure 10-2.

            FIGURE 10-2: SOCIAL BENEFITS/COSTS ASSESSMENT MODULE:
                            EXAMPLE INFORMATION FLOWS
          Risk,
    Competitiveness &
    Conservation Data
        Summary
*Rj»k summary
« CompBtitivenasft summary
* Conservation summary
             Ckxnpefibvenea* summary
    Social
Benefits/Costs
 Assessment
                         • N^Bodaltwnefitaifcw
                             r"  i-MOjfc.^*,,,,
                               7    " «-,t   •»
                            ' -,   /,   *./S
 Decision
Information
 Summary
 ANALYTICAL MODELS: Table 10-4 lists references for applications of social benefits/costs
 assessment and Regulatory Impact Analyses prepared by EPA that can be used as analytical
 frameworks for performing social benefits/costs assessments of voluntary pollution prevention
 opportunities.
                           TABLE 10-4J ANALYTICAL MODELS
                  Reference
                                                            Type of Model
  Arnold, Frank S. 1995. Economic Analysis of
  Environmental Policy and Regulation.
                      Presents a wide variety of practical applications
                      of economics to environmental policies.
  Augusfyniak, Christine.  1989. Regulatory
  Impact Analysis of Controls on Asbestos and
  Asbestos Products.
                      Example of an application of benefit/cost analysis
                      for regulatory decision-making.
  Clark, L.H. 1987. EPA's Use of Benefit-Cost
 Analysis 1981 -1986.
                      Discusses the contributions that benefit/cost
                      analysis has made to EPA's regulatory process
                      and examines the limitations of benefit/cost
                      analysis.
 U.S. Environmental Protection Agency.  1993c.
 Review and Update of Burden and Cost Estimates
 for EPA's Toxic Release Inventory Program.
                      Analysis to review and update estimates of the
                      incremental burden and costs to industry and
                      EPA developed for the 1990 Section 313
                      Information Collection Request established under
                      the Emergency Planning and Community Right-
                      to-know Act.
Note: References are listed in shortened format, with complete references given in the reference list following
Chapter 10.
                                           10-24

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CHAPTER 10
                                                   SOCIAL BENEFITS/COSTS ASSESSMENT
PUBLISHED GUIDANCE: Table 10-5 lists sources of published guidance on social benefits/costs
assessment.
TABLE 10-5: SOURCES OF SOCIAL BENEFITS/COSTS ASSESSMENT PUBLISHED
GUIDANCE
Reference
Estes, Ralph W. 1976. Corporate Social
Accounting.
Freeman, A. Myrick, III. 1979. The Benefits of
Environmental Improvement: Theory and
Practice.
Freeman, A. Myrick, III. 1982. Air and Water
Pollution Control: A Benefit-Cost Assessment.
Kneese, Allen V. 1984. Measuring the Benefits
of Clean Air and Water.
Mishan, E.J. 1976. Cost-Benefit Analysis.
Seneca, Joseph and M.K. Taussig. 1984.
Environmental Economics.
Tietenberg, Tom. 1994. Environmental
Economics and Policy.
U.S. Environmental Protection Agency. 1983.
Guidelines for Performing Regulatory Impact
Analysis.
U.S. Environmental Protection Agency. 1993d.
Guidance on the Preparation of Economic
Analyses and Regulatory Impact Analysis in
OPPT.
Type of Guidance
Case study textbook. Provides an overview of
social accounting as it has been and may be
applied in corporations, government institutions,
and non-corporate organizations.
Basic textbook. Technical review of application
of economic tools and theory to social
benefits/costs analysis.
Case study textbook. Describes in layman's
terms the term benefits and economist's methods
for measuring benefits. Discusses tools available
for social benefits/costs analysis and how they are
being applied in practice.
Case study textbook of social benefits/costs
analyses as applied to urban air pollution and
rural and regional air and water pollution.
Basic textbook. Theoretical discussion of
environmental economics and the theory of social
benefits/costs analysis.
Basic textbook. Introduction to environmental
economics and the theory of social benefits/costs
analysis.
Introduction to environmental economics and the
theory of social benefits/costs analysis.
EPA guidelines for assessing benefits, analyzing
costs, and evaluating benefits and costs.
EPA guidance for preparing economic analyses
and Regulatory Impact Analyses in support of
rulemakings under the Toxic Substances Control
Act, the Emergency Planning and Community
Right-to-Know Act, the Asbestos Hazard
Emergency Response Act, and the Residential
Lead-Based Paint Hazard Reduction Act.
 Note: References are listed in shortened format, with complete references given in the reference list following
 Chapter 10.
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PARTH: CTSA INFORMATION MODULES
DATA SOURCES: None cited.
                                  10-26

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                      DECISION INFORMATION SUMMARY
OVERVIEW: The Decision Information Summary is the final module of a CTSA.  It combines
the results of the Risk, Competitiveness & Conservation Data Summary module with the Social
Benefits/Costs Assessment module to identify the advantages and disadvantages of the baseline
and the substitutes from both an individual business and a societal perspective. The Decision
Information Summary module does not include value judgements or recommendations. Instead,
the trade-off issues and uncertainty in the data are summarized to enable decision-makers to
make decisions that incorporate their own circumstances, while considering the results of a
CTSA. A key point is that decisions about whether or not to use an alternative are made outside
of the CTSA process.
GOALS:
       Compile the results of the Risk, Competitiveness & Conservation Data Summary and the
       Social Benefits/Costs Assessment modules for the baseline and the substitutes.

       Compile information on the uncertainties in the data that should be considered in the
       decision-making process.

       Identify the trade-offs among risk, competitiveness, conservation, and social
       benefits/costs associated with the baseline and substitutes.
 PEOPLE SKILLS: The Decision Information Summary module requires the skills outlined in
 the previous module descriptions for the analytical components of a CTSA. Knowledgeable
 personnel and technical experts who completed the analytical modules are needed to evaluate
 results and identify uncertainties in the information. Completing this module should be a joint
 effort by all members of a DfE project team.


 DEFINITION OF TERMS: Several terms from the Exposure Assessment and Risk
 Characterization modules are used in the Decision Information Summary module.  Refer to these
 modules for definitions.


 APPROACH/METHODOLOGY: The following presents a summary of the approach or
 methodology for preparing a decision information summary. Methodology details for Steps 1, 2,
 and 3 follow this section.

 Step 1:       Obtain data summaries from the Risk, Competitiveness & Conservation Data
              Summary module.  The data summaries should describe any assumptions,
              scientific judgements,  and uncertainties in the data.
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 PART H: CTSA INFORMATION MODULES
 Step 2:        Obtain information regarding the net social benefits/costs of the baseline and
               alternatives from the Social Benefits/Costs Assessment module. Note any
               assumptions, scientific judgements, and uncertainties included in the assessment.

 Step 3:        Identify other factors that an individual business might consider when choosing
               among alternatives. Consider these additional factors when listing uncertainties in
               the data that should be considered in the individual decision-making process. For
               example, workplace practices data from large facilities  may not be representative
               of the types of workplace practices at smaller facilities.

 Step 4:        Review the data and uncertainties for each alternative to determine the trade-off
               issues associated with any one substitute from both an individual business and a
               societal perspective. Note changes in trends from the baseline to the substitutes
               (e.g., the baseline performs well, is cost-effective, but consumes large amounts of
              water and has a high potential for worker exposure; an alternative performs well,
               is expected to be cost-effective if supply/demand relationships stabilize; and has
              greater net social benefits due to reduced water consumption and potential for
              exposure as compared to the baseline).

 Step 5:       In addition to publishing the Decision Information Summary in a CTSA, provide
              results to the communications and implementation work groups of a DfE project
              team. These workgroups typically prepare CTSA summary brochures that present
              the CTSA results hi a user-friendly format. (For more information on the roles of
              these work groups, see the companion publication, Design for the Environment:
              Building Partnerships for Environmental Improvement  [EPA, 1995a].)


 METHODOLOGY DETAILS:  This section provides methodology details for completing
 Steps 1,2, and 3. In some cases, information on interpreting the significance of results  can be
 found in the published guidance listed previously in other module descriptions.

 Details:  Steps 1,2, and 3, Identifying Uncertainties and Other Factors Important to
 Decision-Making

 Identifying Uncertainties in the Risk Characterization

 Because information for risk characterization comes from the Environmental Hazards Summary,
 Human Health Hazards Summary, and Exposure Assessment modules, an assessment of
 uncertainty should include the uncertainties in the hazard and exposure data. There is also the
 issue of compounded uncertainty; as uncertain data  are combined in the assessment, uncertainties
may be magnified in the process. EPA guidance documents (e.g., Risk Assessment Guidance for
Superfund\EPA., 1989a]; "Guidelines for Exposure Assessment" [EPA, 1992a]) contain detailed
descriptions of uncertainty assessment, and  the reader is referred to these for further information.
                                         10-28

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CHAPTER 10
                                                      DECISION INFORMATION SUMMARY
Uncertainties in the hazard data could include:
•      Uncertainties from use of quantitative structure-activity relationships (QS ARs) for
       aquatic toxicity.
•      Using dose-response data from high dose studies to predict effects that may occur at low
       levels.
•      Using data from short-term studies to predict the effects of long-term exposures.
•      Using dose-response data from laboratory animals to predict effects in humans.
•      Using data from homogeneous populations of laboratory animals or healthy human
       populations to predict the effects on the general human population, with a wide range of
       sensitivities.
•      Assuming 100 percent absorption of a dose when the actual absorption rate may be
       significantly lower.
•      Using toxicological potency factors from studies with a different route of exposure than
       the one under evaluation.
•      Effects  of chemical  mixtures (effects may be independent, additive, synergistic or
       antagonistic).
•      Possible effects of substances not included because of a lack of toxicity data.
•      Carcinogen weight-of-evidence classifications; for any chemicals assessed as carcinogens
       (described in the Human Health Hazards Summary module), the weight-of-evidence
       classification should be presented with any cancer risk results.

Uncertainties in the exposure data could include:
 •     Description of exposure setting - how well the typical facility used in the exposure
       assessment represents the facilities included in the CTSA; the likelihood of the exposure
       pathways actually occurring.
 •     Possible effect of any chemicals that may not have been included because they are minor
       or proprietary ingredients in a formulation.
 •     Chemical fate and transport model applicability and assumptions - how well the models
       and assumptions that are reqtiired for fate and transport modeling represent the situation
       being assessed and the extent to which the models have been verified or validated.
 •     Parameter value uncertainty, including measurement error, sampling error, parameter
       variability, and professional judgment.
 •     Uncertainty in combining pathways for an individual.

 In the CTSA, uncertainty is typically addressed qualitatively.  Variability in the exposure
 assessment is typically addressed through the use of exposure descriptors, which are discussed in
 the Exposure Assessment module.

 Identifying Uncertainties in Performance and Cost Data

 The Performance Assessment module is typically designed to evaluate characteristics of a
 technology's performance, not to define parameters of performance or to substitute for thorough
 on-site testing. Thus, performance demonstration projects conducted during CTSA pilot projects
 are intended to be a "snapshot" of a substitutes performance at actual operating facilities.
                                           10-29

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 PART II: CTSA INFORMATION MODULES
 Similarly, the Cost Analysis module evaluates the average cost of a substitute at a "typical" or
 "model" facility using data collected from performance demonstration sites, the Workplace
 Practices & Source Release Assessment module, and other sources. Neither the Cost Analysis
 nor the Performance Demonstration are intended to yield absolute cost or performance
 information, but they do result in comparative information on the relative cost or performance of
 the baseline and substitutes.

 Uncertainties in the Social Benefits/Costs Assessment

 Due to tune and resource constraints, the CTSA process utilizes a qualitative assessment of
 social benefits and costs that does not provide monetary valuation of external benefits. A
 problem with qualitative descriptions is the difficulty in weighing the benefits and costs - there is
 a tendency to ignore those benefits or costs that are not monetized.  The project team members
 who perform the social benefits/costs assessment may illustrate the  magnitude of a qualitative
 description through the use of quantified aspects such as affected population size.  The Decision
 Information Summary module should contain both the qualitative and quantitative results of the
 Social Benefits/Costs Assessment. The importance of social benefits/costs assessment is not to
 develop a precise numerical estimate of social benefits and costs, but to recognize that these
 benefits and costs exist and use a systematic form of analysis to identify the best alternative(s)
 among a choice of several possible options.

 Other Factors Important to Decision-Making

 A CTSA provides comparative information on the relative risk, performance, costs and resource
 conservation of alternatives to individual decision-makers, but actual decisions about whether or
 not to implement an alternative are made outside of the CTSA process. Individual decision-
 makers typically consider a number of other factors before deciding upon an alternative. A few
 examples of these other factors include the following:
 •     The individual business circumstances, including cultural and political circumstances.
 •     The position of the business within the overall market it serves (e.g., steady, growing,
       shrinking).
 "     The status of the overall market for the product being delivered, including the outlook for
       long-term growth.
 •     The availability of funds for capital investments, if required.


FLOW OF INFORMATION: The Decision Information Summary is the final module of a
CTSA. It combines the results of the Risk, Competitiveness & Conservation Data Summary
with the Social Benefits/Costs Assessment modules to identify the overall advantages and
disadvantages  of the baseline and the substitutes from both an individual decision-maker's
perspective and a societal perspective. The actual decision of whether or not to implement an
alternative is made by individual decision-makers outside of the CTSA process, who typically
consider a number of other factors, such as their individual business  circumstances, together with
the information presented hi a CTSA.  The relationship of the CTSA process to the actual
                                         10-30

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CHAPTER 10
                                              DECISION INFORMATION SUMMARY
decision-making process and example information flows among the final modules of a CTSA are
shown in Figure 10-3.
         FIGURE 10-3: DECISION INFORMATION SUMMARY MODULE:
                       EXAMPLE INFORMATION FLOWS
     Risk,
Competitiveness &
Conservation Data
   Summary
• Rieic summary
» CompelitfvBnes
» Conservation summary
  I)
     Social Benefits/
    Costs Assessment
                                r_
                                   Decision
                                  Information
                                   Summary
  \ r
  K.  •*  \   -, yt  f  ^ ^    ^   -v(; ,-r
    n'
^  x " 1
  '  --'I
 -•?1
                                                                    Individual
                                                                    business
                                                                    circumstances
                                                                 Individual
                                                                 Decisions
                                             bTSA boundary
ANALYTICAL MODELS: None cited.
PUBLISHED GUIDANCE: None cited.
DATA SOURCES: None cited.
                                      10-31

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PART II: CTSA INFORMATION MODULES
                                   10-32

-------
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Christopher  G. Ingersoll and Thomas W. La Point, Eds. American Society for Testing and
Materials. Philadelphia, PA. ASTM STP 1216.

Zeeman, M.G.  1995a. "EPA's Framework for Ecological Effects Assessment" Screening and
 Testing Chemicals  in Commerce. U.S. Congress, Office of Technology Assessment.
 Washington, D.C.  OTA-BP-ENV-166.

 Zeeman, M.G.  1995b. "Ecotoxicity Testing and Estimation Methods Developed Under Section
 5 of the Toxic Substances Control Act (TSCA).  Fundamentals of Aquatic Toxicology: Effects,
 Environmental Fate, and Risk Assessment. 2nd Edition.  G. Rand, Ed. Taylor & Francis.
 Washington, D.C.
                                         R-23

-------

-------
           APPENDIX A
EXAMPLES OF WORKPLACE PRACTICES
         QUESTIONNAIRES

-------

-------
               WORKPLACE PRACTICES QUESTIONNAIRE
                                       FOR
                              SCREEN PRINTERS

                                    Prepared by
                        Screen Printing Association International
                                 in cooperation with
                               University of Tennessee
                   Center for Clean Products and Clean Technologies,
                       and EPA Design for the Environment Staff

This questionnaire is designed to characterize typical screen printing facilities and workplace
practices associated with the screen printing/reclamation process.  The results of the
questionnaire will be used to estimate exposure and characterize risk from this process and to
help identify pollution prevention opportunities.  Pollution Prevention is the use of materials,
processes, practices or products that  avoid, reduce or eliminate wastes or toxic releases,
through activities such as material substitution, source reduction and closed loop recycling.
This information is being developed for industry use to help printers make informed choices
about the environmental attributes of alternative cleaning and reclamation products and
technologies.
Please mail completed questionnaires to:
                                      Marcia Y. Kinter
                                      Director of Government Affairs
                                      Screen Printing Association International
                                      10015 Main Street
                                      Fairfax, VA  22031-3489

If you have questions about the questionnaire or would like a copy of the summary of results,
please contact Lori Kincaid from the Center for Clean Products and Clean Technologies,
University of Tennessee at 615/974-4251 (fax 615/974r1838).

Respondents to this questionnaire are guaranteed anonymity.  Responses will not be attributed
to any individual or company in reports or other written documentation of the results of this
research.  Company name and other information requested below are optional.
 Company Name
 Address

 Questionnaire Completed by
 Title
 Telephone Number
                                       A-l

-------
     APPENDIX A
 1)
         The purpose of this questionnaire is to characterize typical screen printing facilities and workplace practices associated
         with the screen printing/reclamation process.  The business profile and general facility information requested below
         allows us to understand your workplace practices within the context of your overall printing business.
Business Profile
         Approximately what percentage of your
         products are printed on the following
         substrates? (Please check the boxes that
         annl\

Plastics (rigid/flexible)
Paper (coated or uncoated)
Metal
Ceramic
Glass
Other (specify below)
<50%
D
D
n
a
a
a
50-95%
a
o
a
o
n
a
95-100%
n
a
a
a
a
a

2)      Please list the major products produced at your facility.
3)      General Facility Information

        How many staff do you employ? How many hours per day does your staff spend removing ink and cleaning/reclaiming
        screens? Ink removal is the removal of the bulk of the ink from the screens prior to further cleaning/reclamation.
        Screen cleaning/reclamation activities include residual ink removal, emulsion removal, and haze removal.  Questions
        about ink removal do not pertain to press-side operations, unless this is the only site used for ink removal.  Please
        assume a 5-day work week with one 8-hour shift each day. (Please check the boxes that applv.1
Number of Employees
at this Location
0-5 o
6-10 a
11-15 n
16-30 o
31-50 a
>50 n
Number of Employees
Involved in Ink
Removal
1-3 D
4-6 n
7-10 n
>11 o
specify

Number of Employees
Involved in Screen
Cleaning/Reclamation -
1^3 0
• 4-6 n
7-10 n
>n n
specify

Average time
(hr/day) a single
individual is involved
w/ ink removal
<1 D
1-2 D
2-4 D
4-6 0
6-8 n
other O
Average time (hr/day) a
single individual is involved
w/ cleaning/reclaiming
screens
<1 D
1-2 O
2-4 o
4-6 n
6-8 n
other D
                                                       A-2

-------
                                                      OF WORKPLACE PRACTICES QUESTIONNAIRES
4)      Equipment and Materials Use       .
A)      \yhatiypesofandhowmuchinkdoyouuseinyourprintingptocesses? What do you use as a reducer/retarder? What
      "is the primary substrate you use with each ink type?  (Please check or list all that apply)
Type of Ink
Traditional solvent-based
UV Curable
Water-based
Other (specify)*
Volume of Ink Used/Year*1
(gallons)




Type of
Reducer/Retarder


Water D
Solvent D
Water/Solvent D
Mixture
(specify trade
name)

Primary
Substrate
Plastic D
Paper C3
Metal D
Glass D
Ceramic D
Other (specify) D
Plastic D
Paper D
Metal D
Glass D
Ceramic D
Other (specify) D
Plastic D
Paper D
Metal D
Glass D
Ceramic D
Other (specify) D
Plastic D
Paper O
Metal D
Glass D
Ceramic ' D
Other (specify) D
            11 Other types of ink include metallic inks, etc.
            b If you do not use a type of ink, enter "0"
                                                    A-3

-------
  APPENDIX A
 The remaining questions are only in reference to solvent- or UV-based inks printed on plastic/vinyl substrates.  If your facilit
 does not primarily use these types of substrates or inks, please do not complete the rest of the questionnaire.

 B)   - What is the average number of screens cleaned/reclaimed each day for future use?
        (Please check the appropriate box)
 C)     Please specify the average size of frame used at your facility?	
        (Please specify units; e.g. ft x ft or in x in, ect.)

 D)     Do you have separate areas for ink removal and screen reclamation activities?
        If yes, please check all that apply in the following table.
Dyes
D no
Separate areas for ink removal and screen cleaning/reclamation activities*
Size of Ink
Removal Area
(ft2)
<2o n
20-50 D
50-100 D
100-200 D
>20o n
Specify size 	
Type of
Ventilation
local (mechanical) O
plant (facilily-wide) D
natural O
other (specify below) D
Size of Screen
Reclamation Area (ft2)
<20 O
20-50 D
50-100 n
100-200 D
>200 O
Specify size
Type of
Ventilation
local (mechanical) D
plant (facility-wide) D
natural D
other (specify) D
                * Screen cleaning/reclamation activities include residual ink removal, emulsion removal, and haze removal.
B)      Do you have a combined area for ink removal and screen reclamation?     D yes
        If yes, please check all that apply in the following table.
    D no
Combined area for ink removal and screen reclamation activities
Size of Combined Area (ft2)
<20
20-50
50-100
100-200
>200
Specify Size
D
n
a
D
n

Type of Ventilation
local (mechanical)
plant (facility-wide)
natural
other (specify)

n
D
n
n

                                                      A-4

-------
EXAMPLES OF WORKPLACE PRACTICES QUESTIONNAIRES












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-------
APPENDIX A

















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-------
                    EXAMPLES OF WORKPLACE PRACTICES QUESTIONNAIRES
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^^

-------
     APPENDIX A
8)

A)
Screen Cleaning/Reclamation Alternatives
9)

A)
B)
Do you use a screen degreaser?
Trade Name of Product
D yes   D no
Do you use a separate ink degradant before applying emulsion remover? (Answer yes only if the ink degradant is
different than the primary ink removal product)?    D yes  D no
Trade Name of Product	

 Materials Storage

 Where do you store ink removal and screen reclamation products and in what quantity? (Please check all that apply.)
                       Ink Removal and Screen Cleaning
                                      •Area(s)
                      30- or 55-gallon drum with bung
                      hole kept open                  D

                      30- or 55-gallon drum with bung
                      hole kept closed                 D

                      30- or 55-gallon drum with top
                      removed                        D

                      Open pail                      D

                      Closed pail                     D

                      Quart or smaller squirt bottle     D

                      Safety can                '      D

                      Safety cabinet                   D

                      Not kept in the press room        d

                      Other (specify below)            D
                                                              Ink/Chemical Storage Room
                                                  30- or 55-gallon drum with bung hole kept open    D

                                                  30- or 55-gallon drum with bung hole kept closed   D
                                                  30- or 55-gallon drum with top removed

                                                  Open pail

                                                  Closed pail

                                                  Quart or smaller squirt bottle

                                                  Safety can

                                                  Safety cabinet

                                                  No separate storage area

                                                  Other (specify below)


                                                  Size of storage room
                                                          D

                                                          D

                                                          D

                                                          D

                                                          D

                                                          D

                                                          D

                                                          D
                                                    ftx
 How do you retrieve ink removal and screen reclamation products from ink/chemical storage?  If you keep both large and small]
 containers in the ink removal and screen cleaning/reclamation areas, how do you transfer the products from large containe  to
 small containers for use?
                           Retrieval from Storage Room
                     Entire container moved to press room D
                     Pumped into smaller container        D
                     Poured into smaller container         D
                     Ladled into smaller container         D
                     Other (specify below)                D
                                                        Transfer from Large to Small Container for Use
                                                     Pumped into small container used at work station   D
                                                     Poured into smaller container                     D
                                                     Ladled into smaller container                     D
                                                     Other (specify below)                            D
                                                            A-8

-------
                                        EXAMPLES OF WORKPLACE PRACTICES QUESTIONNAIRES
10)    Waste Disposal

A)     Please indicate the quantity of waste you dispose of annually as hazardous waste for:

       spent solvent waste  	 (Number of 55 gal. drums)  OR 	  (gal. in bulk)

       ink waste          	 (Number of 55 gal. drums)  OR 	  (gal. in bulk)

       used shop rag waste 	  (Number of 55 gal. drums)  OR  	 (gal. in bulk)

B)     What quantity of wastes from ink removal and screen cleaning/reclamation operations do you generate annually? How
       are these waste materials treated or disposed of? (Please check all that apply.)
Ink Removal Wastes
Quantity
Generated
Annually
(gallons)








Method of Storage Prior
to Treatment and/or
Disposal
In closed containers D
In open containers O

No specified n
container
Other (specify) D



Method of Treatment or
Disposal
Filter or treat n
prior to disposal or
recycle
Send to recycler n

Recycle on site D
Discharge to sewer O
Dispose as
hazardous waste Q
Dispose as non-
hazardous waste
n
Other (specify)
D
Screen Cleaning/Reclamation Wastes
Quantity
Generated
Annually








Method of Storage
Prior to Treatment or
Disposal
In open containers D
In closed O
containers
No specified D
containers
Other (specify) D



Method of Treatmen
and/or Disposal
Filter or treat D
prior to disposal
or recycle
Discharge to D
sewer
Discharge to n
septic tank
Hazardous O
Waste
Non-Hazardous D
waste


                                                  A-9

-------
 APPENDIX A
C)      How are waste rags contaminated with ink removal and screen cleaning/reclamation products stored, treated or dispose
        of?  (Please check all that applv.>

Method of Storage Prior to
Pretreatment or Disposal
la open containers D
In closed containers d
No specified containers D





Method of Pretreatment
Centrifuge D
Allow liquid to drain out D
Other (specify) D
None O




Method of Recycle or Disposal
On-site water laundry O
On-site dry cleaner D
Off-site water laundry O
Off-site dry cleaner D
Hazardous waste O
Non-hazardous waste O
Do not use rags O
Other (specify) D
                                                  A-10

-------
                           EXAMPLES OF WORKPLACE PRACTICES QUESTIONNAIRES
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-------
APPENDIX A
 WORKPLACE PRACTICES QUESTIONNAIRE
                    FORTHE
  MAKING HOLES CONDUCTIVE PROCESS

     DESIGN FOR THE ENVIRONMENT (DfE)
       PRINTED WIRING BOARD PROJECT
   This document is prepared by the University of
   Tennessee Center For Clean Products and Clean
     Technologies in Partnership with U.S. EPA
   Design for the Environment (DfE) Program, IPC,
     PWB manufacturers, and other Df E Partners

                   March 1995
       *Note: This survey is not as long as it looks
        since you will only complete a part of it.
       This survey has 7 sections; however, we ask
        you to complete only sections 1,2,3 and
        the section that pertains to your making
            holes conductive (MHC) process.
                       A-12

-------
                             EXAMPLES OF WORKPLACE PRACTICES QUESTIONNAIRES
                WORKPLACE PRACTICES QUESTIONNAIRE
           FOR THE MAKING HOLES CONDUCTIVE PROCESS

                     Design for the Environment Project
      POEASERETO]RNBY"FRIpAY? MARCH 31/1995 TO:  'IPC—ATEN: STAR
                  , <7380j*/tiNCOLN"AVENUE, LINCOLNWOOD, IL ^0646-1705
DO NOT COMPLETE ALL SECTIONS OF THE QUESTIONNAIRE. The following
explains which sections you should complete based on the type of making holes
conductive (MHC)  process used at your facility, provides background information on the
questionnaire, and describes how the data will be handled to ensure confidentiality.

•1.    This questionnaire was prepared by the University of Tennessee Center for Clean
      Products and Clean Products in partnership with the EPA DfE Program, IPC, PWB
      manufacturers, and other members of the DfE PWB Industry Project.

2.    For the purposes of this survey and the DfE Project, the "Making Holes Conductive
      (MHC)" process is defined as beginning after the desmear and etchback steps and
      ending prior to the dry film resist outer layer step (if required)  and copper
      electroplating step.

3.    Shaded sections of the questionnaire denote areas where responses to questions
      should be entered. Unshaded sections are instructions or keys required to answer
      the question.

4.    Throughout the questionnaire, many questions request specific data, such as
      chemical volumes, the amount of water consumed by the MHC line or the
      characteristics of wastewater from the MHC line. If specific data are not readily
      available, estimates based  on your knowledge of the process and the facility, are
      adequate.  In cases where  no data are available and there is no basis for an
      accurate estimate, mark your response as "ND."

5.    Please complete sections 1 through 3 of the questionnaire, regardless of which
      process is used at your facility to make drilled through-holes conductive prior to
      electroplating.

6.    After completing Sections  1 through 3,  please complete only the section(s) of the
      survey that corresponds to  the MHC process(es) currently being operated at your
      facility, as listed below.

      Electroless Copper	 Section 4
      Graphite-based  	Section 5
      Carbon-based   	Section 6
      Palladium-based	Section 7
                                    A-13

-------
APPENDIX A
         If the MHC process used at your facility is not listed, you have completed the
         questionnaire.

   7.     If your responses do not fit in the spaces provided, please photocopy the section to
         provide more space or  use ordinary paper and mark the response with the section
         number to which it applies.

   8.     Appendix A contains the definitions of certain terms and acronyms used in the
         survey form.

   9.     Confidentiality
         All information and data entered into this survey form are confidential.  The
         sources of responses will not be known by IPC, University of Tennessee, EPA, or
         other project participants. Any use or publication of the data will not identity the
         names or locations of the respondent companies or the individuals completing the
         forms.

         Please use the following procedures to ensure confidentiality:

         (1)    Complete the survey form.  Make a copy of the completed form and retain
                it for your records.
         (2)    Separate the facility and contact information page of the survey form from
                the remainder of the form.  Place the facility and contact information into
                Envelope #1 and seal the envelope.
         (3)    Place the remainder  of the survey form plus any additional sheets or
                exposure monitoring data into Envelope #2 and seal it.
         (4)    Place sealed Envelopes #1 and #2 into the  larger return envelope and mail
                it to IPC.
         (5)    When the package is received by IPC, only Envelope #1 will be opened.
                IPC will place a code number on the outside of Envelope #2 and forward it
                to the Center for Clean Products and Clean Technologies at the University
                of Tennessee. Envelope #1 will  not be sent to the University of Tennessee.
         (6)    Questions, clarifications, or requests for further information from the
                University of Tennessee will be relayed by code number to IPC, who will be
                able to contact the respondent  When it is determined that no further
                communications with respondents are necessary, the matrix of code numbers
                and respondents will be destroyed by IPC.

   10.    If you have any questions regarding the survey form, please contact Jack Geibig of
         the University of Tennessee Center for Clean Products and Clean Technologies at
         615-974-6513 (e-mail: JGEIBIG@UTKVX.UTK.EDU).
                            Y"M^                         IPC— ATTN:,STAR ' ;,;'
                           '                                            tf0''''
                                                                       ''
                                          A-14

-------
                              EXAMPLES OF WORKPLACE PRACTICES QUESTIONNAIRES
                    Section 1. Facility Characterization


Estimate manufacturing data for the previous 12 month period or other convenient time period of 12
consecutive months (e.g., FY94).  Only consider the portion of the facility dedicated to PWB
manufacturing when entering employee and facility size data.
1.1 General Information
Size of portion of facility used
for manufacturing PWB's :
Number of full-time equivalent
employees (FTE's):
Number of employee work days
per year:
sq.ft.

days/yr
Number of days MHC line is in
operation:
Total PWB panel sq. footage
processed by the MHC process:

days/yr
sq.ft./yr

1.2  Facility Type
Type of PWB manufacturing facility (check one) Independent

OEM

1.3  Process Type
Estimate the percentage of PWBs manufactured at your facility using the following methods for
making holes conductive (MHC). Specify "other" entry.
Standard electroless copper
Palladium-based system
Carbon-based system
Graphite-based system
Electroless nickel
Other:
TOTAL
%
%
%
%
%
%
100 %
                                      A-15

-------
APPENDIX A
Process Data
Number of hours per shift:
Number of hours the MHC line is in operation per shift:
Average square feet of PWB panel processed
by the MHC line per shift:
Shift
1



2



3



4



          1.5  Process Area Employees
          Complete the following table by indicating the number of employees of each type that perform work duties
          in the same process room as the MHC line for each shift and for what length of time. Report the number
          of hours per employee by either the month or the shift, whichever is appropriate for the worker category.
          Consider only workers who have regularly scheduled responsibilities physically within the process room.
          Specify "other" entry.
Type of Process
Area Worker
Line Operators
Lab Technicians
Maintenance Workers
Wastewater Treatment Operators
Supervisory Personnel
Contract Workers
Other:
Other:
Number of
Employees per Shift
1



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per Employee
in Process Area
(first shift)
Hrs
Hrs
Hrs
Hrs
•• • ;• - Hrs
Hrs
„•",•.-•- . Hrs
Hrs
Hours per Month
per Employee
in Process Area
(first shift)
Hrs
Hrs
Hrs
Hrs
Hrs
Hrs
Hrs
Hrs
                                                    A-16

-------
                                     EXAMPUES OF WORKPLACE PRACTICES QUESTIONNAIRES
                           Section 2.  General Process Data

The information in this section will be used to identify the physical parameters of the process equipment as well
as any operating conditions common to the entire process line.

     2.1  Process Parameters
MHC process line dimensions Length:
Width:
Average time for panel to complete process:
Size of the room containing the process:
Temperature of the process room:
Is the process area ventilated (circle one)?
Air flow Rate:
Type of ventilation? (check one) general
ft.
ft.
min.
sq.ft.
«F
Yes .-No
cu.fL/min.
local
    2.2  General Water Usage
Amount of water used by the MHC process line
when operating:
gal./day
    2.3   Wastewater Characterization
           Estimate the average and maximum values for the wastewater from the making holes conductive line.

Flow
TDS
pH
Cu
AVERAGE
gpm
mg/I

mg/I
MAXIMUM
gpm
mg/1

mg/I

Pd
Sn
TSS
TTO
AVERAGE
mg/1
mg/1
mg/1
• mg/1
MAXIMUM
mg/1
mg/1
mg/1
mg/1
    2.4  Wastewater Discharge and Sludge Data
Wastewater discharge type (check one) Direct
Annual quantity of sludge generated:


Indirect

Percent solids of sludge
Percentage of total quantity generated fay the MHC process:
Method of sludge recycle/disposal (see key at right):
Zero




                                                                                     Methods of Sludfg
                                                                                     Recycle/Disposal
                                                                                     (RJ— Metals Reclaimed
                                                                                     [D]—Stabilized and
                                                                                         Landfilled
                                                                                     (O]—Other
   2.5 Panel Rack Specifications- (non-conveyorized MHC process only)
Average number of panels per rack:
Average space between panels in rack:
Average size of panel in rack: Length
in.
- ...
'in.
Width in.
                                            A-17

-------
APPENDIX A
                                                                    S.:i'?£|^*-:
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                                        A-18

-------
                                         EXAMPLES OF WORKPLACE PRACTICES QUESTIONNAIRES
           3.2  Rinse Bath Water Usage
           Consult the process schematic in section 3.1 to obtain the process step numbers associated with each of the
           water rinse baths present. Enter, in the table bciow, the process step number along with the flow control and
           flow rate data requested for each water rinse bath. If the water rinse bath is part of a cascade, you need only
           report the daily water flow rate of one bath in the cascade.
Process Step
Number '








Flow
Control "








Daily Water
Flow Rate c
gaL/day
gaL/day
gaUday
gal./day
gal ./day
galVday
gaL/day
gal./day
Cascade Water
Process Steps d








     •Process step number- Consult the process schematic in question 4.1 and enter the
                      process step number of the specific water rinse lank.
     t>Flow control- Consult key at right and enter the letter for the flow control method used
                      for that specific rinse bath.
     «DaiIy water flow rate- Enter the average daily flow rate for the specific water rinse tank.
     ••Cascade Water Process Steps- Enter the process step number for each water rinse tank in
                      cascade with the present tank.
Flow Control Methods Key
[CJ— Conductivity Meter
[PJ—PH Meter
(VJ—Operator control valve
[R]— Flow Restricter
[N]— None (continuous flow)
[O]—Other (explain)
33 Rack Cleaning- (non-conveyorized MHC process only)
Complete the following section by using the keys to the right of the table to identify the rack
cleaning process used.
Frequency of cleaning:
Number of personnel involved:
Personal protective equipment (see key at right):
Rack cleaning method used (see key at right):
* If the above answer is [C], also enter the process step
number from the process schematic (section 3.1)
and do not complete section 3.4 below.
Average time required to chemically clean rack
(if applicable) :
Cleaning schedule (see key at right):
Is rack cleaning attended (circle one):




min.

Yes No
                                                                         Personal Protective Equipment Key
                                                                         [E]— Eye protection           [G]— Gloves
                                                                         (L]—Labcoat/sleeved garment   [A]—Apron
                                                                         [R]—Respiratory protection    [B]—Boots
                                                                         [Z]— All except Respiratory     [N]— None
                                                                              Protection

                                                                         Rack Cleaning Methods Key
                                                                         (C]—Chemical bath on making holes conductive line
                                                                         [D]— Chemical bath on another line
                                                                         [T]— Temporary chemical bath
                                                                         [S]— Manual scrubbing with chemical
                                                                         [M]—Non-chemical cleaning
                                                                         (NJ—None

                                                                         Rack Cleaning Schedule
                                                                         [A]— After Hours
                                                                         [L]— During operating hours- in MHC process room
                                                                         {M]— During operating hours-outside MHC process
                                                                              room
          3.4 Rack Cleaning Chemical Composition (non-conveyorized MHC process only)
Chemical Name Cone. Volume






gal.
gal.
gal.
                                                  A-19

-------
APPENDIX A
       3.5   Conveyor Equipment Cleaning
       Complete the following table on conveyorized equipment cleaning in the MHC process line by providing
       the information requested for each cleaning operation performed. If more space is needed or more than
       two cleaning operations occur, report them on a separate sheet of paper.
_ Equipment Cleaning
Data
Description of cleaning
operation:
(briefly describe equip, cleaned)
Process steps affected *
Frequency of cleaning:
Duration of cleaning:
Number of personnel involved:
Personal protective equipment
(sec key at right):
Cleaning method used
(see key at right):
Cleaning chemical used b
Cleaning Operation
no.l



min.




Cleaning Operation
no.2



mm.




                                                                                                    Personal Protective
                                                                                                     Equipment Key
                                                                                                    f£]— Eye protection
                                                                                                    [G]—Gloves
                                                                                                    PL]— Labcoat/sleeved
                                                                                                         garment
                                                                                                    [A]—Apron
                                                                                                    [R]— Respiratory protection
                                                                                                    [B]—Boots
                                                                                                    [Z]— All except Respiratory
                                                                                                         Protection
                                                                                                    [N]—None

                                                                                                    Conveyor Cleaning
                                                                                                    Methods Key
                                                                                                    [C]—Chemical rinsing or
                                                                                                         soaking
                                                                                                    (Sj— Manual scrubbing with
                                                                                                         chemical
                                                                                                    [M]—Non-chemical cleaning
                                                                                                    [N]—None
  « Process Steps Affected-Consult the process schematic from section 4.1 and enter the process step numbers of the specific
                            steps affected by the cleaning operation.
  *> Cleaning Chemical Used- Enterthe name of the chemical or chemical product (or bath type, if applicable) used in the
                            specific cleaning operation.
          3.6   Filter Replacement
          Complete the following table on filter replacement in the MHC process line by providing the information
          requested for each set of filters replaced.
Replacement Information
Bath filtered (enter process step from 3.1) :
frequency of replacement:
Duration of replacement:
Number of personnel involved:
Personal protective equipment
(see key below):
Type of filter
(see key below):
Number of filters changed in assembly:
Area of Filter:
Filter Assembly
no.l


mm.




sq. in.
Filter Assembly
no.2


mm.




sq. in.
Filter Assembly
no.3


mm.




sq. in.
                Personal Protective Equipment Key
                [E]— Eye Protection           [G]— Gloves
                [L]— Labcoat/Sleeved garment  [A]— Apron
                [R]_ Respiratory Protection     [BJ— Boots
                (Z)— All except Respiratory     (NJ—None
                     Protection
Filter Type Key
[B]— Bag Filter
[C]— Cartridge Filter
[O]— Other (specify)
                                                            A-20

-------
                              EXAMPLES OF WORKPLACE PRACTICES QUESTIONNAIRES
3.7  Process History
Complete the table below by indicating what making holes conductive processes) your facility has employed in
the past. Briefly explain the reasons for the process change and summarize how the change has had an affect
upon production.                                                              '
FORMER MAKING
" HOLES CONDUCTIVE
PROCESS
ELECTROLESS COPPER
PALLADIUM-BASED
GRAPHITE-BASED
CARBON-BASED
COPPER SEED
ELECTROLESS NICKEL
OTHER (specify)
DATE OF
CHANGE TO
CURRENT
PROCESS







REASONS FOR CHANGE AND RESULTS
Reason Result
(see key) {see key)











Water Consumption
Process Cycle- time
Cost
Worker Exposure
Performance
Customer Acceptance
Product Quality
Process Maintenance
Other:
Other:
Other:











                                        Reasons
                                        fX]— Mark all of the selections
                                             that apply
Results of change
[B]— Better
[W]—Worse
[N]— No Change
     The remainder of the survey is dedicated to questions that are strictly
      specific to the type of making holes conductive process operated at
        your facility. You should complete only the section(s) of the
     survey that corresponds to the MHC process(es) that is currently
                              being operated.

       Select the making holes conductive process(es) that your facility
      currently operates and complete only the section(s) listed.  If your
       process is not listed, then you have completed the questionairre.

              Electroless Copper	* Section 4 (pgs. 9-17)
             Graphite-Based	— Section 5 (pgs. 19-26)
              Carbon-Based.	 Section 6 (pgs. 27-34)
              Palladium-Based	Section 7 (pgs 35-43)
                                     A-21

-------
APPENDIX A
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-------
EXAMPLES OF WORKPLACE PRACTICES QUESTIONNAIRES
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      A-23

-------
APPENDIX A
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                                    A-24

-------
                              EXAMPLES OF WORKPLACE PRACTICES QUESTIONNAmES
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-------
APPENDIX A
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                             A-26

-------
                                              EXAMPLES OF WORKPLACE PRACTICES QUESTIONNAIRES
 4.5 Chemical Bath Sampling
 Provide information on Ihe chemical bath sampling procedures used in your facility. Duration of sampling and personnel involved
 should include only the portion of the testing procedure involving the manual sampling of the chemical baths, not automated sampling
 or the testing that may occur in another part of the facility, such as the lab.
BATH TYPE
CLEANER/
CONDITIONER
MICRO ETCH
PRE-DIP
ACTIVATOR/
CATALYST
ACCELERATOR
ELECTROLESS
COPPER
REDUCER/
NEUTRALIZER
ANTI-TARNISH/
ANTI-OXIDANT
OTHER (specify)
TYPE OF
SAMPLING «









FREQUENCY1"









DURATION OF
SAMPLING c
mm.
mm.
min.
min.
min.
min.
min.
min.
min.
NUMBER OF
PEOPLE*1









PROTECTIVE
EQUIPMENT4









» Type of Sampling- Consult the key at right and enter the letter for the type of sampling
         performed on the specific chemical bath.
b Frequency- Enter the average amount of time elapsed or number of panel sq. ft.
         processed between samples. Clearly specify units (e.g., hours, square feet, etc.)
c Duration of Sampling- Enter the average time for manually taking a sample from tile-
         specific chemical tank. Consider only time spent at the chemical bath.
A Number of People- Enter the number of people actually involved in manually taking the
         chemical samples. Exclude people doing the testing but not the sampling.
1 Personal Protect. Equip.- Consult key at right and enter the letters for all protective
         equipment worn by the people performing the chemical sampling.
TypejpfSartijIinsLKcv
[A]—Automated Sampling   [B]—Both
(M]— Manual Sampling     [N]— None

Personal Protective Equipment Key
[E]— Eye Protection           [G]— Gloves
[L]— Labcoat/Sleeved garment  [A]— Apron
{RJ—Respiratory Protection    [BJ— Boots
fZ]— All except Respiratory    [N]— None
     Protection
           4.6  Chemical Handling ActivitiesrChemical Sampling
           Complete the table below by indicating what method your facility uses to manually collect bath
           samples and the type of container used.
Method of Obtaining
Samples
Chemical Sample
Container
Drain/Spigot:
Pipette:
Ladle:
Other (Specify):
Open-top container:
Closed-top container:






                                                        A-27

-------
APPENDIX A




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                                    A-28

-------
                          EXAMPLES OF WORKPLACE PRACTICES QUESTIONNAIRES
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                                A-29

-------
APPENDIX A
            4.8  Chemical Handling Activities: Chemical Additions
            Complete the following table by indicating the methods your facility uses while performing
            chemical additions.
ACTIVITY
Chemical Retrieval
from Stock into
Container
Container
Method of Chemical
Addition
OPTIONS
Pump:
Pour:
Scoop (solid):
Other (specify):
Open-top container:
Closed-top container:
Safety container:
Other (specify):
Pour directly into tank:
Stir into tank:
Pour into automated chemical
addition system:
Other (specify):












     4.9 Other Bath Related Activities
     Complete the following table for any other bath related activities that your facility engages in.
BATH TYPE
CLEANER/
CONDITIONER
MICRO ETCH
PRE-DIP
ACTIVATOR/
CATALYST
ACCELERATOR
ELECTROLESS
COPPER
REDUCER/
NEUTRALIZER
ANTI-TARNISH/
ANTI-OXIDAKT
OTHER (specify)
TYPE OF ACTIVITY
(describe)









FREQUENCY'









DURATION
OF
ACTIVITY1"









NUMBER
OF PEOPLE









PROTECTIVE
EQUIPMENT1









      * Frequency- Enter the average amount of time elapsed or number of panel sq. ft. processed since (lie last time
                       the activity was performed. Clearly specify units (e.g., hours, square feet, etc.)
      t> Duration ofActivity- Enter the average time for performing the specified activity. Clearly specify units.
      « Personal Protect. Equip.- Consult key on the previous page and enter the letters for alLprotcctivc
                       equipment worn by the people performing the activity.
                                                          A-30

-------
APPENDIX A
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-------
APPENDIX A
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a

-------
                                           EXAMPLES OF WORKPLACE PRACTICES QUESTIONNAIRES
5.5  Chemical Bath Sampling                                                                         .
Provide information on the chemical bath sampling procedures used in your facility. Duration of sampling and personnel
should include only the portion of the testing procedure involving the manual sampling of the chermcal baths, not automated samphng
or the testing that may occur in another part of the facility, such as the lab.
BATH TYPE
CLEANER/
CONDITIONER
GRAPHITE
FIXER
POST-CLEAN
ETCH
ANTI-TARNISH/
ANTI-OXIDANT
OTHER (specify)
TYPE OF
SAMPLING '






FREQUENCY11






DURATION OF
SAMPLING c
min.
min.
min.
min.
min.
min.
NUMBER OF
PEOPLE d






PROTECTIVE
EQUIPMENT'






» Type of Sampling- Consult the key at right and enter the letter for the type of sampling
         performed on the specific chemical bath.
b Frequency- Enter the average amount of time elapsed or number of panel sq. ft.
         processed between samples. Clearly specify units (e.g., hours, square feet, etc.)
« Duration of Sampling- Enter the average time for manually taking a sample from the
         specific chemical tank. Consider only time spent at the chemical balh.
A Number of People- Enter the number of people actually involved in manually taking (he
         chemical samples. Exclude people doing the testing but not the sampling.  -
< Personal Protect Equip.- Consult key at right and enter the letters for all protective
         equipment worn by the people performing flic chemical sampling.
Type of Sampling Key
[A]— Automated Sampling  [B]— Both
[M]— Manual Sampling    [N]— None

Personal Protective F.quipmcnt Key
[E]— Eye Protection           [GJ— Gloves
ILJ— Labcoat/Slecved garment  [A]— Apron
[R]— Respiratory Protection    03]— Boots
[Z]_ All except Respiratory    [NJ— None
     Protection
           5.6  Chemical Handling Activities:Chemical Sampling
           Complete the table below by indicating what method your facility uses to manually collect bath
           samples and the type of container used.
Method of Obtaining
Samples
Chemical Sample
Container
Drain/Spigot:
Pipette:
Ladle:
Other (Specify):
Open-top container:
Closed-top container:






                                                        A-35

-------
APPENDIX A
                                  A-36

-------
                             EXAMPLES OF WORKPLACE PRACTICES QUESTIONNAIRES
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                                      A-37

-------
APPENDIX A
              5.8   Chemical Handling Activities: Chemical Additions
              Complete the following table by indicating the methods your facility uses while performing
              chemical additions.
ACTIVITY
Chemical Retrieval
from Stock into
Container
Container
Method of Chemical
Addition
OPTIONS
Pump:
Pour:
Scoop (solid):
Other (specify):
Open-top container:
Closed-top container:
Safety container:
Other (specify):
Pour directly into tank:
Stir into tank:
Pour into automated chemical
addition system:
Other (specify):












       5.9 Other Bath Related Activities
       Complete the following table for any other bath related activities that your facility engages in.
BATH TYPE
CLEANER/
CONDITIONER
GRAPHITE
FIXER
POST-CLEAN
ETCH
ANTI-TARNISH/
ANTI-OXIDANT
OTHER (specify)
TYPE OF ACTIVITY
(describe)






FREQUENCY"






DURATION
OF
ACTIVITY6






NUMBER
OF PEOPLE






PROTECTIVE
EQUIPMENT0






        » Frequency- Enter the average amount of time elapsed or number of panel sq. ft. processed since the last time
                         tlie activity was performed. Clearly specify units (e.g., hours, square feel, etc.)
        * Duration of Activity- Enter the average time for performing the specified activity. Clearly specify units.
        c Personal Protect. Equip.- Consult key on the previous page and enter the letters for all protective
                         equipment worn by the people performing the activity.
                                                           A-38

-------
                        EXAMPLES OF WORKPLACE PRACTICES QUESTIONNAIRES
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-------
APPENDIX A
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EXAMPLES OF WORKPLACE PRACTICES QUESTIONNAIRES
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                                A-42

-------
                                             EXAMPLES OF WORKPLACE PRACTICES QUESTIONNAIRES
  6.5  Chemical Bath Sampling
  Provide information on the chemical bath sampling procedures used in your facility. Duration of sampling and personnel involved
  should include only the portion of the testing procedure involving the manual sampling of the chemical baths, not automated sampling
   Frequency- Enter the average amount of time elapsed or number of panel sq. ft.
         processed between samples. Clearly specify units (e.g., hours, square feet, etc.)
c Duration of Sampling- Enter the average time for manually taking a sample from the
         specific chemical tank. Consider only time spent at the chemical bath.
* Number of People- Enter the number of people actually involved in manually taking the
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« Personal Protect Equip.- Consult key at right and enter the letters for all protective
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Type of Sampling Key
[A]—Automated Sampling  [B]—Both
[M]— Manual Sampling    [N]— None

Personal Protective Equipment Key
[E]—Eye Protection           [GJ—Gloves
[L]—Labcoat/Sleeved garment  [A]—Apron
[R]— Respiratory Protection    (B]— Boots
|Z]— All except Respiratory    [N]— None
     Protection
           6.6  Chemical Handling Activities:ChemicaI Sampling
           Complete the table below by indicating what method your facility uses to manually collect bath
           samples and the type of container used.
Method of Obtaining
Samples
Chemical Sample
Container
Drain/Spigot:
Pipette:
Ladle:
Other (Specify):
Open-top container:
Closed-top container:






                                                       A-43

-------
APPENDIX A



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                                    A-44

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                  EXAMPLES OF WORKPLACE PRACTICES QUESTIONNAIRES
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                        A-45

-------
APPENDIX A
               6.8  Chemical Handling Activities: Chemical Additions
               Complete the following table by indicating the methods your facility uses while performing
               chemical additions.
ACTIVITY
Chemical Retrieval
from Stock into
Container
Container
Method of Chemical
Addition
OPTIONS
Pump:
Pour:
Scoop (solid):
Other (specify):
Open-top container:
Closed-top container:
Safety container:
Other (specify):
Pour directly into tank:
Stir into tank:
Pour into automated chemical
addition system:
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         6.9  Other Bath Related Activities
         Complete the following table for any other bath related activities that your facility engages in.
BATH TYPE
CLEANER
CONDtnONER
CARBON
POST-CLEAN
ETCH
ANTI-TARNISH/
ANTl-OXIDANT
OTHER (specify)
TYPE OF ACTIVITY
(describe)






FREQUENCY*






DURATION
OF
ACTIVITY11






NUMBER
OF PEOPLE






PROTECTIVE
EQUIPMENT*






          • Frequency- Enter the average amount of time elapsed or number of panel sq. ft. processed since the last time
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          •> Duration of Activity- Enter the average time for performing the specified activity. Clearly specify unils.
          « Personal Protect. Equip.- Consult key on the previous page and enter the letters foralLprotective
                           equipment worn by the people performing the activity.
                                                            A-46

-------
                                   EXAMPLES OF WORKPLACE PRACTICES QUESTIONNAIRES
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                                      A-48

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                     EXAMPLES OF WORKPLACE PRACTICES QUESTIONNAIRES
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                           A-49

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                         EXAMPLES OF WORKPLACE PRACTICES QUESTIONNAIRES
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                              A-51

-------
APPENDIX A
      7.5 Chemical Bath Sampling                                                                          , •    ,   ,
      Provide information on the chemical bath sampling procedures used in your facility. Duration of sampling and personnel involved
      should include only the portion of the testing procedure involving the manual sampling of the chemical baths, not automated sampling
      or the testing that may occur in another part of the facility, such as the lab.
BATH TYPE
CLEANER/
CONDITIONER
PRE-D1P
PALLADIUM
CATALYST
ACCELERATOR
ENHANCER
POST-CLEAN
ETCH
ANTI-TARNISH/
ANTI-OXIDANT
OTHER (specify)
TYPE OF
SAMPLING •








FREQUENCY11








DURATION OF
SAMPLING c
mm.
mm.
mm.
min.
mm.
mm.
mm.
mm.
NUMBER OF
PEOPLE d








PROTECTIVE
EQUIPMENT'








      «Typ« ofSampling- Consult the key at right and enter the letter for the type of sampling
               performed on the specific chemical bath.
      h Frequency- Enter the average amount of time elapsed or number of panel sq. ft.
               processed between samples.  Clearly specify units (e.g., hours, square feet, etc.)
      « Duration ofSampling- Enter the average time for manually taking a sample from the
               specific chemical tank. Consider only time spent at the chemical balh.
      «l Number of People- Enter the number of people actually involved in manually taking the
               chemical samples. Exclude people doing the testing but not the sampling.  ..
      « Personal Protect. Equip.- Consult key at right and enter the letters for all protective
               equipment worn by the people performing the chemical sampling.
Type of Sampling Key
[A]— Automated Sampling  |B]— Both
[M]—Manual Sampling     [N]— None

Personal Protective Equipment Ktv
[E]— Eye Protection           [G]— Gloves
[L]— Labcoat/Sleevcd garment   [A]— Apron
[RJ—Respiratory Protection     [B]— Boots
[Z]— AH except Respirators'     [N j— None
     Protection
                  7.6  Chemical Handling Activities:ChemicaI Sampling
                  Complete the table below by indicating what method your facility uses to manually collect bath
                  samples and the type of container used.
Method of Obtaining
Samples
Chemical Sample
Container
Drain/Spigot:
Pipette:
Ladle:
Other (Specify):
Open-top container:
Closed-top container:






                                                              A-52

-------
EXAMPLES OF WORKPLACE PRACTICES QUESTIONNAIRES






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APPENDIX A






















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                                    A-54

-------
                                       EXAMPLES OF WORKPLACE PRACTICES QUESTIONNAIRES
      7.8  Chemical Handling Activities: Chemical Additions
      Complete the following table by indicating the methods your facility uses while performing
      chemical additions.
ACTIVITY
Chemical Retrieval
from Stock into
Container
Container
Method of Chemical
Addition
OPTIONS
Pump:
Pour:
Scoop (solid):
Other (specify):
Open-top container:
Closed-top container:
Safety container:
Other (specify):
Pour directly into tank:
Stir into tank:
Pour into automated chemical
addition system:
Other (specify):












7.9  Other Bath Related Activities
Complete the following table for any other bath related activities that your facility engages in.
BATH TYPE
CLEANER/
CONDITIONER
PRE-DIP
PALLADIUM
CATALYST
ACCELERATOR
ENHANCER
POST-CLEAN
ETCH
ANTI-TARNISH/
ANTI-OXIDAjNT
OTHER (specify)
TYPE OF ACTIVITY
(describe)








FREQUENCY1








DURATION
OF
ACTIVITY11








NUMBER
OF PEOPLE








PROTECTIVE
EQUIPMENT1








 * Frequency- Enter the average amount of time elapsed or number of panel sq. ft- processed since the last time
                 the activity was performed. Clearly specify units (e.g., hours, square feet, etc.)
 •> Duration of Activity- Enter the average time for performing the specified activity. Clearly specify units.
 « Personal Protect. Equip.- Consult key on the previous page and enter the letters for alLprolective
                 equipment worn by the people performing the activity.
                                                   A-55

-------
APPENDIX A
                              Definitions and Abbreviations
  Direct discharge    Wastewater discharge directly to a stream or river
  Indirect discharge  Wastewater discharge to a publicly owned treatment works (POTW)
  Zero discharge     No industrial wastewater discharge
  Cu
  cu.ft.
  DfB
  EPA
  F
  ft.
  gal.
  gal./day
  gpm
  hrs.
  Ibs.
  MHC
  •min.
  mg/1
  OEM
  Pd
  PWB
  sec.
  sq.ft.
  sq. in.
  Sn
  TDS
  TSS
  TTO
copper
cubic feet
Design for the Environment
U.S. Environmental Protection Agency
Fahrenheit
feet
gallons
gallons per day
gallons per minute
hours
pounds
making holes conductive
minutes
milligrams per liter
Original equipment manufacturer
palladium
printed wiring board
seconds
      square feet
square inch
tin
Total dissolved solids
Total suspended solids
Total toxic organics
year
                                      A-56

-------
                APPENDIX B
ENVIRONMENTAL RELEASES AND OCCUPATIONAL
EXPOSURE ASSESSMENT: SCREEN PRINTING CTSA

-------

-------
       Specific quantities for environmental releases and occupational exposure to chemicals
can be determined for a particular system used in screen reclamation. This summary provides an
overview of the releases and exposure and methodology used in determining the releases and
exposure for the traditional ink remover, emulsion remover, and haze remover products.

       While the greatest environmental releases and occupational exposure occur during the
actual process of screen reclamation, releases and exposure also occur from volatilization from
open containers, transfer operations, sampling operations, and waste rags. Air releases and the
inhalation exposures occur as a result of volatilization during these operations.  Releases to air
occur by volatilization of chemicals from open containers, from the surface of the screen as it is
being cleaned, and from rags used in the cleaning process. Estimation of releases to land and
water is based on a mass balance relationship. Dermal exposures can also be estimated based on
operations, formulation concentrations, and established dermal exposure models.1

       It is assumed that workers perform the following activities during each step of the screen
reclamation process. Some of these steps are not necessary or are altered for certain methods
assessed here. (See  Figure 2-7 in Chapter 2 for an outline of the steps involved in each method.)

Step 1. Ink removal
•      Open 55-gallon drum of ink remover;
•      Pour ink remover into 5-gallon pail;
•      Dip rag or brush into pail;
•      Remove ink  from screen;
•      Toss rag into laundry pile; and
•      Drum waste  ink for disposal.

Step 2. Emulsion removal
•      Open container of emulsion remover;
•      Dip brush into container;
•      Remove emulsion from screen; and
•      Rinse screen.

Step 3. Haze removal
•      Open container of haze remover;
•      Dip brush into container;
•      Remove haze from screen; and
•      Rinse screen.

       To support the assessments, numerous sources of information were used in gathering
data.  Preliminary information was collected from the 11-page Screen Printing Workplace
Practices Questionnaire. Meetings with printers to discuss the basic data assumptions used in
the assessment were held at Screen Print '93 hi New Orleans in October 1993 and at the SPAI
       1  U.S. EPA. Dermal Exposure Assessment: Principles and Applications. Office of Health and
Environmental Assessment, Jan. 1992, Document no. EPA/600/8-9/01 IF.

                                           B-l

-------
 APPENDIX B
Environmental Committee Meeting in January 1994. Information was also verified though
facilities participating in the Screen Printing Performance Demonstration from February to May
1994.  These operation assumptions and data are presented in Table B-l.
f f *• w^n j j 4j;k w t ,-+ •*& Viv^r#*'ivs£
TABLE B-l: ASSUMPTION AND DATA FROM INDUSTRY AND TRADE GROUPS
Type of Data
Number of employees involved in ink removal
Hours per employee per day in ink removal
Number of employees in screen reclamation
Hours per employee per day in screen reclamation
Average number of screens cleaned per day
Average screen size
Size of combined screen reclamation/ink removal area
Amount of ink remover per screen
Amount of haze remover per screen
Amount of haze remover per screen
Average value
Number
3
1
2
1.5
6
2,127
80
8 (traditional)
4 (alternative)
3.5
3
Units
employees
hours
employees
hours
screens
in2
ft2
oz
oz
oz
a) Normalized from Workplace Practices Questionnaire to remove printing establishments larger than 20
employees.
ESTIMATION METHODOLOGY

       In general, in evaluating traditional and alternative screen reclamation systems, it is
assumed that all releases to air, land, or water occur via the four scenarios described below.
Using this assumption cleaning fluid usage has been partitioned to air, land, and water with
concentrations of mass. Volatilization is estimated using a number of established models as
documented below. Water and land releases are estimated to be all cleaning fluids not
volatilized. The exposure/release scenarios are defined as follows:

•      Scenario I.  Actual screen cleaning operations.  Air releases are due to volatilization of
       chemicals from the screen surface. Unvolatilized material is assumed to be disposed to
       land or water. Ink, emulsion, and haze removal for  6 screens a day; each screen is
       approximately 2100m2.

•      Scenario II. Releases to the atmosphere from pouring of 1 oz of material for sampling.
       This is assumed to take place over  15 minutes each  day.
                                          B-2

-------
	ENVIRONMENTAL RELEASES AND OCCUPATIONAL EXPOSURE ASSESSMENT

•      Scenario III. Releases to the atmosphere from pouring of cleaning mixtures from a 55-
       gallon drum into a 5-gallon pail.

•      Scenario IV. Releases from rags stored in a two-thirds empty drum. The water releases
       in this case occur in a commercial laundry. The drum is opened to add more rags once
       per day and to transfer the rags from the storage drum to a laundry. Rags are used only
       for the ink removal step.

       Releases shown in the above scenarios will occur during the use of Reclamation Methods
1, 2, and 4 of Exhibit 1-2. In addition to these releases, in Method 3 (SPAI Workshop Process),
an ink degradant is applied after the ink remover, followed by a water rinse; a screen degreaser is
then applied prior to use of the emulsion remover. For the purposes of this assessment, Method
3 is evaluated only in conjunction with system Omicron.

Assumptions for Environmental Releases

       The environmental releases model prepared for this report assumes that releases to air
equal the total airborne concentration of chemicals from:
•      Volatilization of solvents  from screens;
•      Emissions from transfer operations;
•      Emissions from sampling operations; and
•      Volatilization from waste dirty rags.

       The following assumptions and sources of information were used in the model:
 •      Typical airborne concentrations;
 •      Typical ventilation rates;
 •     Emission factors from EPA (AP-42) (an EPA compendium of emission factors from the
       Office of Air);
 •     Formulation data and physical properties; and
 •     Average amounts of ink, haze, and emulsion remover used per site-day of 36 ounces, 21
       ounces, and 18 ounces.

       The model addresses releases to three media: air, water, and land. Releases to air result
 from volatilization from the screens during cleaning and fluid sampling and transfers. Releases
 for all systems studied were associated with ink removal, emulsion removal, and haze removal.

        Water releases result primarily from the emulsion removal phase which is typically a
 rinse  step using a water and sodium hypochlorite or sodium periodate solution for the traditional
 systems, and a water and sodium periodate solution for the alternative systems. The emulsion
 removal phase may also generate a contaminated rinsewater. In either phase, waste water results
 from screen rinsing and the spray or rag application of haze and emulsion removers.

        Off-site releases to land result from the cleaning of non-disposable rags and the
 landfiUing of disposable rags. It is assumed that rags are used only to remove the ink.  The
 model assumes that non-disposable rags sent to a laundry contain 0.75 grams of ink remover per

                                           B-3

-------
 APPENDIX B
 18 rags. This assumption is based on:
 •      Limited data on how much material stays on a damp shop rag with mineral spirits;
 «      The average number of rags used to remove ink per screen (3 per screen); and
 •      The average number of screens cleaned per day (6 screens).

 The model assumes weekly laundering of non-disposable shop rags and 250 days of use per year.
 Similarly, rags sent to a landfill are assumed to contain 0.75 grams of ink remover per 18 rags.

        For systems Omicron and Beta, which have ink remover products that are water-
 miscible, it was assumed that nonlaunderable rags were used and the discharge to water occurred
 at the screen printing facility.  This assumption was made given that a water rinse is used with
 these products in removing ink.

        For aqueous solutions, the density of all components is assumed equal to 1 g/cm3. For
 nonaqueous solutions, ideal solution behavior is assumed and the density of each component is
 used to find the amount of the component in 4 ounces of ink remover.

 Assumptions for Occupational Exposure

       In order to estimate occupational exposure to chemicals during the screen cleaning
 process, an inhalation model and a dermal exposure model  was developed.  The assumptions
 underlying each model are described below.

       Inhalation Model
       The inhalation model used in the  CTSA is a mass balance model. It assumes that the
 amount of a chemical in a room equals the amount leaving the room minus any generated in the
 room.  The model is valid for estimating  the displacement of vapors from containers, and the
 volatilization of liquids from open surfaces. Assumptions include:
 •      Incoming room air is contaminant-free;
 "      Generation and ventilation rates are constant over time;
 *      Room air and ventilation air mix ideally;
 •      Raoult's law is valid (i.e., the volatilization and interaction of vapors);
 •      Ideal gas law applies (i.e., the interaction of vapors);
 •      Inhaled doses of each chemical were based on "typical case" ventilation parameters, since
       these seem to give the best fit to the highest observed values (see below). Actual
       ventilation conditions are unknown; and
 •      Median values were used for the composition; worst case evaluation for air releases
       would include the most volatile compound at its maximum concentration.

We used the following assumptions for the frequency and duration of inhalation exposure for
ink, emulsion, and haze removal:
"      6 screens cleaned per day;
•      1 to 3 workers per site;
»      3 hours per day exposure total; and
•      250 days per year.

                                         B-4

-------
          	ENVIRONMENTAL RELEASES AND OCCUPATIONAL EXPOSURE ASSESSMENT

The four scenarios described on pages, B-3,4 were modelled for assessing inhalation exposure.
Inhalation exposures occur as a result of volatilization during these scenarios.  The model
assumes that shop workers do not wear respirators in any of the four scenarios.

       Dermal Model
       Dermal exposure is caused by contact with the material. Contact with the material
includes touching damp rags, dipping hand(s) into a pail of ink remover, and manually applying
the brush or rag to the screen to loosen the ink.  Two scenarios, routine contact with two hands
and routine immersion with two hands, were modelled for assessing dermal exposure. Routine
contact occurs from touching rags and manually applying the brush or rag to the screen. Routine
immersion occurs from dipping hand(s) into a pail or ink, haze, or emulsion remover.

       Dermal contact models from the CEB handbook (CEB, 1991) were used by adjusting the
concentration of the chemical in the mixture. Dermal exposure assumes no gloves or barrier
creams will be used.  Although exposure was estimated for the emulsion removers or haze
removers containing sodium hypochlorite or sodium hydroxide, it is usually expected that use of
these chemicals would result in negligible exposure given that use of these solutions without
gloves causes irritation and corrosivity effects.
 OVERVIEW OF METHODOLOGY

       CEB (Chemical Engineering Branch) models the evaporation of chemicals from open
 surfaces, such as the surface of a screen, using the following model:
                               G =
0.02MP
  RT   \
                                                                                    (1)
 where:
        G     =      Volatilization rate, g.m^.s'1
        M    =      Molecular weight, g.mol'1
        P     =      Vapor pressure, mm Hg
        R     =      Gas constant, 0.0624 mmHg.m3.mol'1.K'1
        T     =      Temperature, K
        D"ab   =      Diffusivity, ernes'1
        v,     =      Air velocity, m.8"1
        z     =      Distance along pool surface, m

 The air velocity is assumed to be vz = 100 ft-min'1. Since Dab is not available for many of the
 chemicals of interest to CEB, the following estimation equation is used:
                                           B-5

-------
 APPENDIX B
                        ab
     _4.09xlQ-sTl-\l/29+l/Af)0-sM
                                                      "0-33
                                                                                     (2)
 where:
       T
       M
       P,
Diffusion coefficient in air, cm2.sec"1
Temperature, K
Molecular weight, g.mol"1
Total pressure, atm
This equation is based on kinetic theory and generally gives values of £>ab that agree closely with
experimental data. The value of G computed from eqs (1) and (2) above is used in the following
mass balance expression to compute the airborne concentration in the breathing zone:
                           C =
           l.7xW5TGA
              MQk
(3)
where:
       Cv
       r
       G
       M
       A
       Q
       k
Airborne concentration, ppm
Ambient temperature, K
Vapor generation rate, g.m
Molecular weight, g. mol"1
Area of surface, m2
Ventilation rate, ft^min"'
Mixing factor, dimensionless
The mixing factor accounts for slow and incomplete mixing of ventilation air with room air.
CEB sets this factor to 0.5 for the typical case and 0.1 for the worst case. CEB commonly uses
values of the ventilation rate Q from 500 fV.min-1 to 3,500 fV.mur1. An effective ventilation rate
of 250 ftVmin was used, which was equal to the mixing factor of 0.5 multiplied by the lowest
ventilation rate (500 ftVmin). The value of Cv from equation (3) is converted to mass/volume
units as follows:
                  M
                  V
                                                                                     (4)
                                          B-6

-------
                 ENVIRONMENTAL RELEASES AND OCCUPATIONAL EXPOSURE ASSESSMENT
where:
       Cm    =     Airborne concentration., mg.m"3
       Cv    =     Airborne concentration, ppm
       M    =     Molecular weight, g.mol'1
       Vm    =     Molar volume of an ideal gas, l.mol'1

At 25 °C, Vm has the value 24.45 Lmol'1. Since a worker can be assumed to breathe about 1.25
m3 of air perhour, it is a straightforward matter to compute inhalation exposure once Cm has been
determined. Equations (3) and (4) can be combined to yield the following, given the "typical
case" choice of ventilation parameters:
                                                                                    (5)
where:
       G
       A
       t
Total amount inhaled, mg.day1
Vapor generation rate, g. m^.s"1
Area of surface, m2
Duration of exposure, s
 The advantage of equation (5) is that the quantity GAt is often known beforehand, since it is
 equal to the total amount of the chemical released to the atmosphere. It is also useful when
 computing the total dose due to a sudden release of material, such as occurs when a container is
 opened. In this case, it is difficult to ascertain the duration of exposure, but it is a simple matter
 to estimate the amount of vapor in the container's headspace/

 Example 1. Estimate the vapor generation rate and worker exposure during removal of ink
 from a printing screen using 100 percent toluene. The worker cleans screens for I hour each day
 in a room with a ventilation rate of 3, 000ft3. min'1. The screen area is 2,217 in2. Assume a
 mixing factor of k = 0.5.

 Toluene has the following physical properties:
 Molecular weight:
 Vapor pressure:
 Diffusion coefficient:
       92. 14 g. mol'1
       28 mrnHg at 25
       0.076 cmlsec"1
 Using these values in equation (1) gives:
 Generation rate G:
 Airborne concentration:

 Exposure over 1 hour:
        0.28 g.s-'.m-2
        141 ppm (Cv)
        534mg.m-3(Cra)
        667 mg
                                           B-7

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 APPENDIX B
 If the CEB worst-case parameters are used in equation (2), i.e., a mixing factor of k = 0.1 and a
 ventilation rate of 500 tfjnin'1, then the estimated airborne concentration is Cv = 4,216 ppm.
 Exposures and volatilization rates are calculated by multiplying the pure-component values from
 Exhibit 4 by the mole fraction of that component in the liquid phase. A typical screen has an
 area of 2127 in2 = 1.37 m2. Each worker cleans screens for 1 hour per day.  Amounts released
 should be checked against amount used to ensure mass balance.

 Example 2. If a -worker cleans 6 screens using 8 oz/screen of mineral spirits, the amount of
 spirits used will be:

               6 x 8 x 29.57 fluid oz/cc x 0.78 g/cc = 1107 g

 The amount volatilized will be:

               0.01087 g.m-2.s-' x 3600 s x 1.37 m2 = 53 g

 Thus, the amount volatilized is not limited by the amount used. For the case of the traditional
 haze remover, however, volatilization is limited by the amount used. If 3 oz of haze remover
 containing 30 wt percent (32 volume percent or 21  mole percent) acetone is used per screen, the
 total amount available is:

              6 x 3 x 0.32 x 29.57 fluid oz/cc x O.79 = 133g

 The amount that would volatilize over 1 hour is:

              1.49 x 1.37 x 3600s = 7,350g


 UNCERTAINTIES

 Occupational Exposure: Uncertainties

       Determining occupational exposure levels associated with screen cleaning requires
 making assumptions about the cleaning process, the workplace environment, health and safety
 practices, and waste management practices. This section describes the uncertainties involved in
 assessing occupational exposure for screen cleaning. It also explains the assumptions underlying
 the exposure assessment model developed for the CTSA.

       EPA has published Guidelines for Exposure Assessment in the Federal Register. These
 are guidelines for the basic terminology and principles by which the Agency is to conduct
 exposure assessments. There are several important issues relevant to this assessment.  If the
 methodology is one which allows the assessor to in  some way quantify the spectrum of exposure,
 then the assessor should assess typical exposures, as well as high end exposures or bounding
 exposures. Typical exposures refer to exactly that, how much the typical person is exposed to
the particular substance in question. High end refers to a person exposed to amounts higher than

                                          B-8

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         	ENVIRONMENTAI. RELEASES AND OCCUPATIONAL EXPOSURE ASSESSMENT

90 percent of the people (or ecological species of interest) exposed to the substance.  Bounding
estimates are judgements assuming that no one will be exposed to amounts higher than that
calculated amount. However, in many cases, all we can do is give a picture of what the exposure
would be under a given set of circumstances, without characterizing the probability of these
circumstances actually occurring.  These are called "What if scenarios.  They do not try to judge
where on the exposure scale the estimate actually falls. All of the exposure assessments fall into
the "What if category for this assessment.

       Although the screen cleaning process is relatively straightforward, occupational exposure
levels will differ in actual shop environments because  of many variables such as variations in:
•      Toxicity of the chemicals used;
•      Amount of chemicals applied;
•      How the chemicals are applied;
»      Compliance with health and safety and waste management procedures;
•      Equipment operating time;
•      Ventilation conditions and shop lay-out; and
•      Temperature conditions (ambient and solvent).

       All of these variables will  influence the impacts of chemicals used in the screen cleaning
process on shop workers. Based on studies of screen printing operations conducted by the
National Institute for Occupational Safety and Health  (NIOSH), it appears that many of the small
to medium sized operations do not follow health and safety precautions.2 Specifically, workers
were observed performing screen  reclamation without protective gloves or proper breathing
apparatus. Nor did shop workers  wear protective aprons to reduce dermal exposure.  According
to one study, some workers used solvent to wash their arms and hands after completing the
screen cleaning process. In another study, rags and paper towels contaminated with solvent were
placed in an open trash can. Both of these practices will also increase exposure levels
 significantly.

        There are also differences  in how screen printers wash the screens; this affects
 occupational exposure. Some shops use automated screen washers which blast the screens with
 solvent or hot water in an enclosed system.  Others use a hose in a sink to flush the screens by
 hand or the cleaner is spread  on the screen by hand, and the worker uses a rag or paper towel to
 wipe down the screen. Exposure  levels will differ if individual  workers use more (or less)
 cleaner than specified, and if they allow it to remain on the screen longer than specified.

        During research to support Ms assessment a NIOSH Health Hazard Evaluation (HHE)
 document on screen washing was located and used to validate exposure estimates. CEB initially
 estimated occupational exposures by applying the relatively conservative models that are
 normally used for review of new  chemicals. The resulting exposure estimates were high in
 comparison to actual monitoring  data.  These data indicated that, after necessary corrections were
        2 Sources: Health Hazard Evaluation Report No. HETA 84-299-1543, (Chicago, IL: Impressions
 Handprinters). Health Hazard Evaluation Report No. HETA 81-3 83-1151, (Chicago, IL: Main Post Office).
                                            B-9

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  APPENDIX B
 made, the exposures predicted by the CEB model were within the range of the NIOSH
 observations, as long as the "typical case" ventilation parameters were chosen. Use of the "worst
 case" ventilation parameters in the CEB model leads to results that exceed the range of the
 experimental data by about an order of magnitude.  The theoretical basis of the CEB model was
 investigated and a standard engineering formula for mass transfer in laminar boundary layers was
 found to provide a closer approximation to the upper end of NIOSH data when used with the
 same "worst case" ventilation parameters.

        Both the CEB model (when used with the "typical case" ventilation parameters) and the
 boundary-layer approach can provide estimates of inhalation exposures which agree with the
 experimental data within one order of magnitude or better.  It is difficult to obtain better
 agreement than this without knowing a great deal more about each exposure scenario, such as the
 details of the screen cleaning process at each site, the solvent temperature, the air temperature,
 and the ventilation pattern in the screen cleaning area.  These items are not routinely recorded'by
 NIOSH investigative teams.

       Dermal Exposure Mode]
       The dermal exposure model  is based on the concentration of material contacting the skin
 and the surface area contacted. Dermal exposure levels will differ in actual shop environments
 because of many variables such as variations in:
 «     Type of worker activity;
 «     Likelihood or type of contact (i.e., routine or immersion);
 •     Frequency of contact (i.e., routine or incidental);
       Potential surface area contacted;
       Likelihood and effectiveness of protective equipment being used;
       Amount of chemical remaining on the skin; and
       Evaporation rate of the chemical.
       In estimating dermal exposure, it was assumed that gloves were not worn.  However,
assuming that gloves are worn, dermal exposure is assumed to be negligible to none depending
on the chemical in question. In situations where the chemical is corrosive (e.g., sodium
hypochlorite), dermal exposure to shop workers using gloves is zero. The model assumes that
one hand (surface area 650 cm2) is routinely exposed during the screen cleaning process (1 to 3
mg/cm2 typically remaining on the skin).3

Environmental Releases: Uncertainties

       Determining environmental releases associated with screen cleaning requires making
assumptions about the cleaning process, the workplace environment, and waste management
practices. This section describes the uncertainties involved in assessing environmental releases
associated with screen cleaning. It also explains the assumptions underlying the environmental
       5 Source: U.S. Environmental Protection Agency, Chemical Engineering Branch Manual for the
Preparation of Engineering Assessments, (February 28,1991), p. 4-36.
                                          B-10

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	ENVIRONMENTAL RELEASES AND OCCUPATIONAL EXPOSURE ASSESSMENT

release assessment model developed for the CTSA.

Uncertainties
       Uncertainties related to environmental releases overlap with the uncertainties associated
with occupational exposure. They include variations in:
•      Toxicity of the chemicals used;
•      Amount of chemicals applied;
•      How the chemicals are applied;
•      Compliance with waste management procedures;
•      Equipment operating time;
•      Ventilation conditions and shop lay-out; and
•      Temperature conditions (ambient and solvent).


RELEASE AMOUNTS VS. OCCUPATIONAL EXPOSURES

       Air releases were computed in two different ways, depending on the particular scenario
under consideration.  For Scenario I (evaporation from a screen) and Scenario II (evaporation
during sampling), the equations used for computing the total mass of material volatilized can be
condensed into the following expression:
                  GAt = -
   8.24xl(T8M0-835P(—+—)
                    29  M
                                                                                    (6)
                                          .0.5
 where:
       GAt
       M
       P
       vz
       A
       t
       T
       z
       Pt
Mass released (= flux x area x time)
Molecular weight (g.mol"1)
Vapor pressure (mmHg)
Air velocity (ft-min"1)
Area of surface (cm2)
Duration of release (s)
Air temperature (K)
Length of surface (cm)
Total pressure (atm)
 For all cases of interest here, the temperature T, total pressure Pt, and air velocity vz are assigned
 fixed values. These are 298 K, 1 atmosphere, and 100 ft-mur1, respectively. In addition, the
 surface is taken to be square, so that z = A05. Thus, the mass of material released has the
 following dependencies:
                                          B-ll

-------
 APPENDIX B
                                      29  M
                                                                (7)
                                   QAt^A
                                         0.75
                                                                (8)


                                                                (9)
 For Scenario III (releases from pouring) and Scenario IV (releases from drum of rags), the vapor
 space of the container was assumed to be saturated. The model used can be represented
                             QAt=
                                      MPV
                                   (24.45)(760)
                                                               (10)
where:
       M
       P
       V
Molecular weight (g.mo"1)
Vapor pressure (mmHg)
Volume of container (1)
For each scenario, the container volume is fixed, so that:
                                                                                   (11)
                                                                                   (12)
Releases to water and/or land disposal are computed by a mass balance approach; any chemical
not volatilized is assumed to be disposed to one of these two media.

       The amount of each chemical inhaled by workers is given by the following expression:
                                    719
                                    —
                                    Qk
                                                               (13)
where:
       Q
       k
Inhaled dose (mg.day1)
Ventilation rate (ft3.min"1)
Mixing factor (dimensionless)

                     B-12

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                 ENVIRONMENTAL RELEASES AND OCCUPATIONAL EXPOSURE ASSESSMENT
In this report, Q is fixed at 3,000 f^.mirjfr and k = 0.5. Thus,


                                7-0.48 GAt
                                                  (14)
Thus, the inhaled dose has the same dependencies as the amount released, no additional variables
being introduced.

Based on the above expressions, the amount released to the atmosphere in Scenarios I and II is
approximately proportional to M°-&35P. For Scenario III and IV, the dependence is approximately
MP. The vapor pressure is generally lower for compounds with higher molecular weights. An
idea of the sensitivity of vapor pressure to molecular weight can be obtained from a molecular
model of the liquid state.  According to Fowler and Guggenheim (Statistical Thermodynamics,
Cambridge,  1956), for a liquid whose intermolecular potential energy can be represented by the
Lennard-Jones function:
                                                                                   (15)
the vapor pressure can be estimated to be:
                                                                                   (16)
As noted in the development of an expression for Dab, the diffusivity, in Appendix K of the CEB
Manual, the quantities e and o can be roughly correlated with molecular weight.  When these
parameters are regressed against experimental data for Q-Cg and substituted into the expression
for vapor pressure, a relationship of the following form is observed:
r0.23g -M°'S1
                                                                                    (17)
 Somewhat different dependencies will be found with different sets of experimental data, but all
 of the resulting expressions will show that vapor pressure falls off rapidly with molecular weight
 within a homologous series of compounds. Thus, the amount of chemical volatilized and the
 resulting inhaled dose will be approximately proportional to:
                                                                                    (18)
                                          B-13

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APPENDIX B
                                   B-14

-------
                APPENDIX C
POPULATION EXPOSURE ASSESSMENT FOR SCREEN
  RECLAMATION PROCESSES: SCREEN PRINTING
                   CTSA

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-------
       The purpose of a general population exposure assessment is to account for amounts of
chemicals with which people who are not directly involved in the screen printing process may be
in contact. There are several ways that the general population may be exposed to substances
used in the screen reclamation process. People may breathe the air containing vapors which have
been carried away by air currents from a screen printing facility. The vapors would be
environmental releases stemming from evaporation of products at the screen printing facility.
People may drink water which contains residues from the reclamation products, which can
originate with the facility discharging the products down the drain. People may also drink well
water that contains contaminants which have migrated from a landfill where wastes are disposed.
The amount which a person may come in contact with varies  with how far away they are located
from the facility, how many of the different routes of contact  they actually have (such as
drinking, breathing, touching), how long the chemical has been in the environment, and how the
chemical moves through the environment. The amounts also depend on such environmental
conditions as the weather or the amount of water that is flowing in the receiving stream or river
where the facility's discharges go.

       EPA has published Guidelines for Exposure Assessment in the Federal Register.  These
are guidelines for the basic terminology and principles by which the Agency is to conduct
exposure assessments. There are several important issues relevant to this assessment. If the
methodology is one which allows the assessor to hi some way quantify the spectrum of exposure,
then the assessor should assess typical exposures, as well as high end exposures or bounding
exposures. Typical exposures refer to exactly mat, how much the typical person is exposed to
the particular substance in question. High end refers to a person exposed to amounts higher than
90 percent of the people (or ecological species of interest) exposed to the substance. Bounding
estimates are judgments assuming that no one will be exposed to amounts higher than that
calculated amount.  However, in many cases, all we can do is give a picture of what the exposure
would be under a given set of circumstances,  without characterizing the probability of these
circumstances actually occurring. These are called "What if scenarios.  They do not try to judge
where on the exposure scale the estimate actually falls.  All of the exposure assessmenst fall into
the "What if category for this assessment.

        The fate of the chemical in the environment is how we refer to the breakdown
(transformation) and mobility of the chemical through air, water, and land.  There is a different
chemical fate for release through a waste water treatment facility as opposed to an air release or a
landfill release. There are also different processes by which degradation may occur. For
example, in air, a chemical may be broken down by sunlight  (by either direct photolysis or
photooxidation) or by reaction with water in the atmosphere (hydrolysis). In water and soil, an
important degradation process is biodegradation, where the substance may be decomposed by
bacteria and other biota in the environment.1  Each of these processes will have its own rate
(speed) at which it occurs, and this may vary with the concentration of the chemical in the
system. Often the way we present the fate for a chemical is by giving a half-life value.  This
term simply means the amount of time it takes for one-half of the substance initially present to be
        1 Note: Hydrolysis and photolysis may also be important depending on the chemical and the
 environmental compartment.

                                           C-l

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APPENDIX C
lost by degradation. There are other ways to present fate. If we are interested in how much of a
chemical is removed from water during its trip through a waste water treatment facility (such as a
POTW - Publicly Owned Treatment Work), we will give a removal amount, usually in percent.
The Screen Printing CTSA has summaries of the chemical fate of all of the chemicals identified
as being used in screen reclamation products.

       There are two perspectives to address when handling exposure concerns for any
commercial process. The first is best described as a local point of view, i.e., a single facility in
normal operation will have certain releases which affect a specific area and specific local
population. Since we do not have information for each screen printing facility, we use a "model
facility" approach to calculate typical releases and environmental concentrations.  This will not
allow us to specify the number of people around the facility, because the population varies
considerably  depending on the location of the screen printing facility. The other perspective is to
view the overall impact, i.e., what is the impact of all of the printing facilities for the general
population. While one facility may not be releasing very much of any given chemical, the
cumulative effect of all of the printers in an area could be serious.

       For this assessment, we have tried to present a view of the local concerns by presenting
exposures for a standard set of conditions, by which we are trying to simulate a single facility for
all of the methods and systems. The overall perspective is presented only for the traditional
systems, which are the systems which are considered to already be in common use.  It was felt
that it would  be far too hypothetical to do an overall perspective for the alternative formulations
since we do not have a basis for predicting how many screen printers might use any given
formulation.

       The effects of a chemical may be a short-term (acute) effect, such as the effect a poison
would have on the body, or it could be long-term, such as a carcinogen. For long-term (chronic)
effects, it is most helpful to have average, or typical, exposures, since the effect will vary with
the cumulative exposure. For acute effects, a peak exposure estimate would be more helpful.
This can then be compared to levels at which the chemical is known to give immediate health
problems.  In general for this assessment, average concentrations are calculated.
OVERVIEW BY MEDIA

Air

       Releases to air are from evaporation of chemicals during the process.  This may be from
allowing screens to dry during reclamation, or from rags or open drums of chemicals located
around the facility. These vapors are then carried and mixed with outside air. The air
concentration will depend on weather conditions. Stagnant conditions will not move vapors
away quickly, so local concentrations will be higher than the concentrations of the chemical
farther from the plant. There is the potential that everyone outside the facility could be affected.
The chemical concentrations will decrease with distance, but the number of people may increase
with distance, depending on the location of the screen printing facility. Usually the exposure

                                           C-2

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	POPULATION EXPOSURE ASSESSMENT FOR SCREEN RECLAMATION PROCESSES

assessor will use a computer program to determine the number of people around a known facility
by using census data. Since the locations of all the screen printing facilities across the country
are not known to us, we use the model facility approach, and do not count population for the
model facility.

       For our model facility, we assume a building height of three meters, and a width often
meters.  This is a building approximately the size of a garage. We then pick sample weather
conditions, usually from San Bernardino, to determine what the air concentration of a chemical
will be at a set distance from the printing facility. We use San Bernardino because the weather
conditions there will give the highest average concentrations around the facility of any of the
approximately 500 weather stations hi the United States.  However, none of the average
concentrations across the country will be even ten times less than the average concentrations at
San Bernardino.  If the highest concentration were 10 ug/m3, then anywhere in the country the
concentration would be greater than 1 ug/m3. We would say that there is less than an order of
magnitude difference.

       Methodology References
             Air Modeling Parameters for ISCLT90
             MODEL - Industrial Source Complex. Long Term: U.S. EPA, Office of Air and
             Radiation, Office of Air Quality Planning and Standards, Research Triangle Park,
             NC 27711, Version 90, as implemented by the Office of Population Prevention
             and Toxics in the Graphical Exposure Modeling System, GEMS Atmospheric
             Modeling Subsection.

             The following default parameters were used:
             •     Regulatory default setting for ISCLT;
             •     Facility location at 34° latitude, 117° longitude;
             •     The Star Station (meteorological) data from the station closest to the point
                    of release, San Bernardino, CA:
             •     Urban Mode (U3);
             •     Standard Polar grid, with 3 calculations per segment;
             •     Single point of release at the facility location; and
             •     Release height of 3 meters for fugitive releases from an area source of 10
                    meters by 10 meters (100 m2).

Surface Water

       Releases to surface water are those releases discharged through a drain at a screen
printing facility that end up going to public sewers or POTW. This discharge is treated before
being released, and the effectiveness of the treatment determined, so that the amount actually
getting through to the receiving water body can be calculated. The receiving water will dilute the
discharge from the POTW, and a stream concentration can be calculated using stream flow
information.
                                          C-3

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APPENDIX C
       We use average stream concentrations to calculate average drinking water consumption.
We assume that people actually drink the two liters a day that is recommended for good health.
If the chemical is one that will accumulate in animals or plants, we calculate ingestion of the
chemical from eating fish.

       The other issue for surface water is the effect that a chemical may have on aquatic
organisms, from algae to fish. If the food chain is broken in a stream, the consequences are dire.
No algae, no fish. A healthy stream with numerous organisms will also have a better ability to
handle chemical releases than one whose quality is already compromised.  The organisms lower
on the food chain, such as algae, tend to have shorter lives, making shorter exposure time periods
more critical. Since concentrations will vary with the stream flow, there may be periods of lower
flow conditions where the same amount released as on a regular flow situation will cause
problems. We use historical stream data to try to predict how often this will happen.

       Cumulative releases to the same POTW may be estimated by counting the number of
screen printers in an area and distributing the releases across all the POTWs in the area. We have
to assume that the releases are for the same products, or very similar products. As for air, this
cumulative number is expected to be far more significant than the amount for any single screen
printer.

       Methodology Reference
              Single Site

              Concentration = Chemical Loading / Streamflow

              In general, the concentration will be in ug/L, and the chemical loading is in grams
              or kilograms. The streamflow used is the harmonic mean streamflow in Million
              Liters per Day (MLD) for drinking water concerns, if the location is known.
              Otherwise, the streamflow will be assumed to be 1000 MLD.

              US-Wide Water Releases

              The methodology used is outlined in its entirety in a report from VERSAR, Inc.
              For Task Ml, subtask 101, from Contract 68-D3-0013. Copies of this report are
              available from either VERSAR, Inc. or from Sondra Hollister at EPA.

Septic Systems

       There appears to be a significant minority of screen printers who do not release water to a
waste water treatment plant. These printers are assumed to release to septic systems. The
releases of this type are not modeled in this assessment. There are some general guidelines that
may be used to determine if there will be exposure to any of the screen reclamation chemicals
from septic system seepage. Each chemical will have an estimated potential migration to ground
water, which is usually used for landfill assessments. This can be directly applied to septic
systems, because the potential to migrate to ground water will be the same. Of course the

                                           C-4

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	POPULATION EXPOSURE ASSESSMENT FOR SCREEN RECLAMATION PROCESSES

individual characteristics of the system will determine the actual speed that each chemical travels
into the ground water. If the septic system is relatively leaky, and the ground water table is
relatively high, the time that a chemical takes to get into the ground water will be shorter than for
a septic system which is sealed well and where the ground water table is low.

Landfill

       Our usual techniques for estimating exposures from landfill releases are not applicable to
printing. For a typical situation, we would assume one facility sending waste to a landfill. For
the printing industry, the use of landfills cannot be so simplified. A lack of data limits the
determination of exposures. We do not know how many printers are sending a portion of their
wastes to a hazardous waste handler, and sending another portion to the county landfill, or how
many printers will be sending to any given landfill. For these reasons, even though the
exposures from landfill releases may be significant, we will not be able to calculate exposures
from landfill seepage and migration into ground water. However, we can give the expected fate
of the chemical in the landfill -- will the chemical migrate to ground water rapidly, moderately,
or negligibly.
                                          C-5

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APPENDIX C
                                    C-6

-------
             APPENDIX D
 BACKGROUND ON RISK ASSESSMENT FOR
SCREEN RECLAMATION PROCESSES: SCREEN
            PRINTING CTSA

-------

-------
HUMAN HEALTH RISK

Assessment of the human health risks presented by chemical substances includes the following
components of analysis:

•      Hazard Identification is the process of determining whether exposure to a chemical can
       cause an adverse health effect and whether the adverse health effect is likely to occur in
       humans.

•      Dose-response Assessment is the process of defining the relationship between the dose
       of a chemical received and the incidence of adverse health effects hi the exposed
       population. From the quantitative dose-response relationship, toxicity values are derived
       that are used in the risk characterization step to estimate the likelihood of adverse effects
       occurring in humans at different exposure levels.

•      Exposure Assessment identifies populations exposed to a chemical, describes their
       composition and size, and presents the types, magnitudes, frequencies, and durations of
       exposure to the chemical.

•      Risk Characterization integrates hazard and exposure information into quantitative and
       qualitative expressions of risk. A risk characterization includes a description of the
       assumptions, scientific judgments, and uncertainties embodied in the assessment.

Quantitative Expressions of Hazard and Risk

       The manner in which estimates of hazard and risk are expressed depends on the nature of
the hazard and the types of data upon which the assessment is based.  For example, cancer risks
are most often expressed as the probability of an individual developing cancer over a lifetime of
exposure to the chemical in question. Risk estimates for adverse effects other than cancer are
usually expressed as the ratio of a toxicologic potency value to an estimated dose or exposure
level. A key distinction between cancer and other toxicologic effects is that most carcinogens are
assumed to have no dose threshold; that is, no dose or exposure level can be presumed to be
without some risk. Other toxicologic effects are generally assumed to have a dose threshold; that
is, a dose or exposure level below which a significant adverse effect is not expected.

Cancer Hazard and Risk

       EPA employs a "weight-of-evidence" approach to determine the likelihood that a
chemical is a human carcinogen.1 Each chemical evaluated is placed into one of the five
weight-of-evidence categories listed below.
       1  The "Proposed Guidelines for Carcinogen Risk Assessment" (EPA, 1996b) propose use of
weight-of-evidence descriptors, such as "Likely" or "Known," "Cannot be determined," and "Not likely,"
in combination with a hazard narrative, to characterize a chemical's human carcinogenic potential - rather
than the classification system described above.

                                           D-l

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APPENDIX D
•      Group A - human carcinogen;
•      Group B - probable human carcinogen. B1 indicates limited human evidence; B2
       indicates sufficient evidence in animals and inadequate or no evidence in humans;
•      Group C - possible human carcinogen;
•      Group D - not classifiable as to human carcinogenicity; and
•      Group E - evidence of noncarcinogenicity for humans.

       When the available data are sufficient for quantitation, EPA develops an estimate of the
chemical's carcinogenic potency. EPA "slope factors" express carcinogenic potency in terms of
the estimated upper-bound incremental lifetime risk per mg/kg average daily dose. "Unit risk" L
a similar measure of potency for air or drinking water concentrations and is expressed as risk per
ug/m3 in air or as risk per fig/1 in water for continuous lifetime exposures.

       Cancer risk is calculated by multiplying the estimated dose or exposure level by the
appropriate measure of carcinogenic potency. For example an individual with a lifetime average
daily dose of 0.3 mg/kg of a carcinogen with a potency of 0.02/mg/kg/day would experience a
lifetime cancer risk of 0.006 from exposure to that chemical. In general, risks from exposures to
more than one carcinogen are assumed to be additive, unless other information points toward a
different interpretation.
is
       Chronic Health Risks

       Because adverse effects other than cancer and gene mutations are generally assumed to
have a dose or exposure threshold, a different approach is needed to evaluate toxicblogic potency
and risk for these "systemic effects." "Systemic toxicity" means an adverse effect on any organ
system following absorption and distribution of a toxicant to a site in the body distant from the
toxicant's entry point. EPA uses the "Reference Dose" approach to evaluate chronic (long-term)
exposures to systemic toxicants. The Reference Dose (RfD) is defined as "an estimate (with
uncertainty spanning perhaps an order of magnitude) of a daily exposure to the human population
(including sensitive subgroups) that is likely to be without appreciable risk of deleterious effects
during a lifetime" and is expressed as a mg/kg/day dose. The RfD is usually based on the most
sensitive known effect; that is, the effect that occurs at the lowest dose .  EPA calculates a
comparable measure of potency for continuous inhalation exposures called a Reference
Concentration or RfC, expressed as a mg/m3 air concentration. Although some RfDs and RfCs
are based on actual human data, they are most often calculated from results obtained in chronic
or subchronic animal studies. The basic approach for deriving an RfD or RfC involves
determining a "no-observed-adverse-effect level (NOAEL)" or "lowest-observed-adverse-effect
level (LOAEL)" from an appropriate toxicologic or epidemiologic study and then applying
various uncertainty factors and modifying factors to arrive at the RfD/RfC.

        RfDs and RfCs can be used to evaluate risks from chronic exposures to systemic
toxicants. EPA defines an expression of risk called a "Hazard Quotient" which is the ratio of the
estimated chronic dose/exposure level to the RfD/RfC. Hazard Quotient values below unity
imply that adverse effects are very unlikely to occur. The greater the Hazard Quotient exceeds
unity, the greater is the level of concern. However, it is important to remember that the Hazard

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	BACKGROUND ON RISK ASSESSMENT FOR SCREEN RECLAMATION PROCESS

Quotient is not a probabilistic statement of risk.  A quotient of 0.001 does not mean that there is a
one-in-a-thousand chance of the effect occurring. Furthermore, it is important to remember that
the level of concern does not necessarily increase linearly as the quotient approaches or exceeds
unity because the RfD/RfC does not provide any information about the shape of the
dose-response curve.

       An expression of risk that can be used when an RfD/RfC is not available is the
"Margin-of-Exposure (MOE)."  The MOE is the ratio of aNOAEL  or LOAEL (preferably from a
chronic study) to an estimated dose or exposure level. Very high MOE values such as values
greater than 100 for a NOAEL-based MOE or 1000 for a LOAEL-based MOE imply a very low
level of concern. As the MOE decreases, the level of concern increases. As with the Hazard
Quotient, it is important to remember that the MOE is not a probabilistic statement of risk.

       Developmental Toxicity Risks

       Because of the many unique elements associated with both the hazard and exposure
components of developmental toxicity risk assessment, these risks are treated separately from
other systemic toxicity risks.

       EPA defines developmental toxicity as adverse effects on the developing organism that
may result from exposure prior to conception, during prenatal  development, or postnatally to the
tune of sexual maturation. Adverse developmental effects may be detected at any point in the
life span of the organism.  The major manifestations of developmental toxicity include: (1) death
of the developing organism, (2) structural abnormality, (3) altered growth, and (4) functional
deficiency.

       There is a possibility that a single exposure may be sufficient to produce adverse
developmental effects.  Therefore, it is assumed that, in most cases, a single exposure at any of
several developmental stages may be sufficient to produce an adverse developmental effect. In
the case of intermittent exposures, examination of the peak exposure(s) as well as the average
exposure over the time period of exposure is important.

       EPA has derived Reference Doses and Reference Concentrations for developmental
toxicants in a similar manner to the RfDs and RfCs for other systemic toxicants. The RfDDT or
RfCDT is an estimate of a daily exposure to the human population that is assumed to be without
appreciable risk of deleterious developmental effects. The use of the subscript DT is intended to
distinguish these terms from the more common RfDs and RfCs that refer to chronic exposure
situations for other systemic effects.

       Developmental toxicity risk can be expressed as a Hazard Quotient (dose or exposure
level divided by the RfDDT or RfCDT) or Margin-of-Exposure (NOAEL or LOAEL divided by the
dose or exposure level), with careful attention paid to the exposure term, as described above.
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APPENDIX D
NOTE:       The closely related area of reproductive toxicity is also an important aspect of
              systemic toxicity. For purposes of this report, toxicity information on adult male
              and female reproductive systems -will be assessed as part of the chronic toxicity
              risk.

       Assumptions and Uncertainties

       Estimated doses assume 100 percent absorption. The actual absorption rate may be
significantly lower, especially for dermal exposures to relatively polar compounds. The
assessment used the most relevant toxicological potency factor available for the exposure under
consideration. In some cases the only potency factor available was derived from a study
employing a different route of exposure than the exposure being evaluated. For example, oral
RfD values were sometimes used to calculate Hazard Quotients for inhalation and dermal
exposures. For the occupational risk assessment, RfC values were converted to units of dose
assuming a breathing rate of 20 mVday and a body weight of 70 kg.  This conversion was done
because occupational inhalation exposures were calculated as a daily dose rather than as an
average daily concentration. The general population risk estimates compare RfC values directly
to average daily concentrations because continuous exposure is assumed for the general
population. Most of the Margin-of-Exposure calculations presented in the assessment are based
on toxicity data that have not been formally evaluated by the Agency. Simple esters of glycol
ethers were assumed to present the same hazards at approximately the same potencies as the
corresponding alcohol. The same potency data were used in risk estimates for each alcohol and
its corresponding ester unless specific data for each compound were available.

       All risk estimates are based on release and exposure values estimated from information
on product usage and work practices obtained from industry surveys. No actual measures of
chemical release or exposure levels were available.

       Certain formulation components are described in the CTS A by their category name, such
as propylene glycol series ethers.  However, all risk calculations in the CTS A are based on
chemical-specific hazard and exposure data. Thus, risk values may appear for some category
members but not others because of limitations in available data.
ECOLOGICAL RISK

       The basic elements of ecological risk assessment are similar to those employed in human
health risk assessment. This report will address only ecological risks to aquatic species.
Quantitative evaluation of aquatic risks involves deriving an "ecotoxicity concern concentration
(ECO CC)" for chronic exposures to aquatic species. The ECO CC may be based either on valid
toxicologic test data on the subject chemical or on quantitative structure-activity relation analysis
of test data on similar chemicals. The ECO CC is typically expressed as a mg/1 water
concentration. Concentrations below the ECO CC are assumed to present low risk to aquatic
species. A notation of "N.E.S." rather than a numeric estimate of the ECO CC indicates that no
adverse effects are expected in a saturated solution during the specified exposure period.

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            APPENDIX E
BACKGROUND AND METHODOLOGY FOR
  PERFORMANCE DEMONSTRATION:
        LITHOGRAPHY CTSA

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E-l    BACKGROUND AND OVERVIEW OF METHODOLOGY

       This section of the lithography CTSA summarizes performance information collected
during laboratory and production run performance demonstrations with substitute blanket washes
carried out between November 1994 and January 1995.  Performance data collected included
information such as quantity of wash used, time spent to wash the blanket, ink coverage, and the
effectiveness of the wash. Data from the performance demonstrations, in conjunction with risk,
cost and other information presented in other sections of the CTSA, provides a more complete
assessment of substitute blanket washes than has otherwise been available from one source.

       In a joint and collaborative effort, EPA worked with the Printing Industries of America
(PIA), the Graphic Arts Technical Foundation (GATF),  and other industry representatives to
organize and conduct the performance evaluations of 36 substitute blanket washes and the
baseline. The demonstration methodology was developed by consensus and was designed to
allow the evaluation of the maximum number of blanket washes given the resources available to
the project. Performance data were collected for each product in two distinct phases: (1) a
laboratory test of the chemical and physical properties and the efficacy of the substitute products,
and (2) evaluations conducted in a production setting at volunteer printing facilities.  The intent
of the laboratory evaluations was to independently measure some of the properties of the washes,
such as volatile organic compound (VOC) content, and to assure that the blanket washes sent to
volunteer printers would provide an acceptable level of performance. Facility  demonstrations
were undertaken at the request of printers participating in the Dffi project so that blanket washes
could be evaluated under the more variable conditions of production runs at printing facilities.  It
should be noted that the performance demonstrations are not rigorous scientific investigations.
Instead, much of this chapter documents the printers' experiences with and opinions of these
products as they were used in production at their facilities.

       Participation in the demonstration project was open to all blanket wash manufacturers.
Prior to the start of the demonstrations, the DfE project  staff contacted nearly 100 blanket wash
manufacturers to explain the project goals and request their submission of a product. All those
who responded and submitted blanket washes were included in the first phase  of the
demonstrations.

Methodology

       The performance evaluation methodology developed by the workgroup is described
below and covers both the laboratory testing protocol and the on-site demonstrations
methodology. In developing the methodology, the workgroup agreed that product names would
be masked.  Neither the volunteer printers nor the DfE observers knew the manufacturer of the
products being evaluated.  Trade names are not listed in this report, instead the blanket washes
are referenced by a numerical code and a genericized chemical formulation. This agreement to
mask product names was made for several reasons:

 •      The chemical formulations of commercial products containing distinct chemicals are
        frequently considered proprietary. Manufacturers of these products typically prefer not to
        reveal their chemical formulations because a competitor can potentially use the disclosed
                                           E-l

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APPENDIX E
       formulation to sell the product, often at a lower price, since the competitor did not have to
       invest in research and development.

•     The performance of products may vary depending on use and shop conditions, and
       suppliers were concerned about the characterization of the performance of their products.

"     The EPA was concerned about appearing to endorse brand name products that fared well
       in the CTS A evaluation.

       In the initial stages of the Lithography Project the Project partners chose VM&P Naphtha
as the baseline against which to compare the 36 substitute blanket washes. VM&P Naphtha,
composed of 100 percent solvent naphtha, light aliphatic and referred to as formulation 28 in
certain sections of the text, was chosen primarily because it is well known among lithographers
as an effective blanket wash. Many lithographers have used VM&P in their shops and know
how it works in their applications and what it costs. VM&P is known to be highly effective at
very low cost, however, because of its high VOC content (100 percent) printers are searching for
formulations to replace it.

       As the Performance Demonstration was being conducted, some suppliers who had
submitted blanket washes chose to withdraw.  Their reasons included not wishing to reveal to
EPA their complete formulations or concern over the potential results of the performance tests.
The formulations that were withdrawn after work had already begun were numbers 2,13, and 15.
For this reason, those numbers are missing from all the tables in the CTS A.

Laboratory Evaluations

       Laboratory testing was carried out by GATF in Pittsburgh, Pennsylvania. A total of 36
products were submitted plus the baseline. For each wash, the flash point, VOC content, and pH
were tested.  The vapor pressure of the product was not tested, but was submitted by the supplier.
Two additional tests, a blanket swell test and a wipability test, were conducted to determine the
efficacy of each wash prior to sending it out for field demonstrations.  Only products that passed
this functional demonstration stage were used  in the field demonstration portion of the project.
For both of these tests, GATF followed the manufacturer's instructions for diluting or mixing the
product.

       The blanket swelling potential of each  product was tested to determine the  effect of the
wash on the  blankets. The procedure used (detailed in Section E-3) involved measuring the
thickness of the blanket test square (2x2 inches), maintaining contact between the test square
and the wash for one hour, and taking another  thickness measurement to calculate the percent
swell. Another measurement is taken after 5 hours. Any wash where the blanket swell exceeded
3 percent after 5 hours indicated that the wash may dimensionally distort the blanket and was
eliminated from field demonstrations.

       Washability of each blanket wash was  evaluated using both a wet and  a dry ink film
(detailed in Section E-4).  To measure the washability, a standard volume of ink was evenly

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	BACKGROUND AND METHODOLOGY FOR PERFORMANCE DEMONSTRATION

applied to a section of a new, clean test blanket. A measured volume of the wash was applied to
a cleaning pad. The pad was attached to a mechanized scrubber and the number of strokes
required to remove the wet ink were recorded. The procedure was repeated for a dry ink film
where the ink was dried with a blow dryer for 20 minutes prior to the cleaning. The dry ink and
wet ink tests were repeated for each alternative blanket wash submitted. Any wash where more
than 100 strokes were required to clean the blanket (with cleanliness determined by using a
reflective densitometer) was eliminated from the field demonstrations.

       Based on the results of the blanket swell and the washability tests, 22 of the original 36
products submitted (plus the baseline) qualified for further evaluation through field
demonstrations. Prior to shipping substitute blanket washes to printers for these on-site
evaluations, each wash was repackaged into a generic container so that those printers
demonstrating the products did not know the manufacturer or product name. Masked Material
Safety Data Sheets (MSDSs) were also developed and shipped along with the substitute blanket
washes to be evaluated.

Printing Facility Demonstrations

       PIA affiliates recruited printers located in the Boston, Baltimore, and Washington, D.C.
areas, who volunteered their facilities and their time to conduct the field demonstrations of the
substitute products. A total of 17 facilities participated.  Each substitute product was
demonstrated at two facilities and each facility demonstrated a minimum of two and up to five
different blanket washes. The product brand name was replaced with a blanket wash number so
that the demonstration facilities did not know what product they were using. In addition, the
facility names have been replaced with a facility number. A list of participating facilities
appears at the front of this document.

       To start the on-site demonstration, an "observer" from the DfE project visited each of the
volunteer facilities. DfE observers were not EPA employees, but were drawn from staff of the
contractor, Abt Associates, Inc. The observers called each facility to review the details of their
operation, discuss the goals of the project, and to schedule a site visit.  The substitute products, a
baseline product, MSDSs, application instructions, and a measuring device were shipped to each
facility prior to the DfE observer's arrival.

       During each one-day site visit, the observer collected information on the background of
the facility, as well as data specific to blanket wash performance. Background data included
information on the size of the presses, the number of employees, and current blanket washing
practices.  After collecting the initial background data, the observers documented information on
three types of blanket washes: the blanket wash currently used at the facility, a baseline blanket
wash, and the substitute wash. All information was recorded on an Observer's Evaluation Sheet
(see Sections E-7 and E-8). Starting with their standard wash, the press operator cleaned the
blanket while the observer recorded the quantity of wash used, the time required to clean the
blanket, the length of the run, the type and color of the ink on the blanket, and the number of
wipes used. After restarting the press, the press operator was asked to comment on the
effectiveness of the blanket wash and to determine if there were any changes in subsequent print

                                           E-3

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 APPENDIX E
 quality that could be attributed to the blanket wash. This procedure was then repeated using
 Blanket Wash 28, VM&P Naphtha, the selected baseline.  Naphtha was used at all participating
 facilities. By comparing the differences in the performance of the baseline at the two different
 facilities, any significant effects of facility-specific operating conditions (e.g., the type of ink,
 size of blanket, and operator's effort) on the performance of the substitute wash were more
 apparent. After cleaning the blanket with the baseline wash, the press operator then used the
 substitute wash provided. The observer recorded the same type of information as was recorded
 for both the current wash and the baseline wash. The total number of washes required varied
 from one facility  to the next, since the observer was on-site for one day and recorded information
 on as many washes as were required during production that day.

       After the observer's visit, the facility continued to use the substitute wash for one week.
 During the week, the printer at each volunteer print shop was asked to record information on
 product performance. The data recorded were similar to that collected by the on-site observer.
 However, the Fruiter's Evaluation Sheets (Section E-9) were simplified in an effort to minimize
 volunteer printers' burden and production disruptions. Facility background information such as
 the press size and type of shop towel used were recorded by the observer only. At the end of the
 week, the observer interviewed the press operator to obtain an overall opinion of the product.
 The exit interview information was recorded on another standardized form (Section E-10).

 Data Collection, Summary, and Analysis

       The information summarized hi the following section comes from five sources.

 •     Laboratory results: the chemical characteristics and the results of the blanket swell and
       washability tests were reported for each wash.
 •     Facility background information: the observer collected information on operating
       conditions while on-site at each volunteer print shop.
 •     Observer's data: DfE observers recorded information on the performance of the facility's
       current blanket wash, a baseline wash, and the substitute blanket wash.
 »     Printer's data: press operators recorded performance data for each blanket wash
       completed during the week-long demonstration of the substitute blanket wash.
 "     Follow-up interviews: observers interviewed the press operators at the end of the week-
       long demonstration on their overall opinion of the substitute blanket wash.

       For each of the 22 substitute blanket washes in the field demonstrations, data from the
 sources mentioned above were analyzed and are summarized in this section. The experiences of
 the two facilities who demonstrated each product are presented individually. As part of the
 analysis, a number of correlations were attempted for each facility but the results were typically
 not statistically significant due to small sample size.  These analyses were run to determine if
 variations in the printer's opinion of the effectiveness of the blanket depended on any other
 variables such as ink coverage, effort and time spent on blanket washing, or run length. Where
 appropriate, these results were included within the text summaries of each substitute blanket
 wash. Additionally, some summary statistics, such as average amount of product used, were
presented in accompanying tables.

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                 BACKGROUND AND METHODOLOGY FOR PERFORMANCE DEMONSTRATION
Limitations
       The widely variable conditions between and within printing facilities, the limited number
of facilities, and the short duration of the performance demonstrations do not allow the results to
be interpreted as definitive performance testing of the blanket washes.  In addition, some
facilities did not provide the full complement of evaluation forms because they found the
performance of the substitute wash to be unacceptable and they discontinued use before the end
of the week.

       As mentioned previously, the performance demonstrations are not scientifically rigorous
but are subjective assessments which reflect the conditions and experience of two individual
print shops. There are a number of reasons why the results of performance demonstrations for
any given blanket wash may differ from one facility to another.  Among these  reasons are:

•     Variability in operating conditions. Because performance demonstrations were carried
       out during production runs, many factors which affect the performance of the blanket
       washes were not controlled during the evaluations including: ink type,  ink coverage,
       condition of the blanket, the  length of the run prior to blanket cleaning, and the ambient
       conditions such as temperature, humidity, and ventilation.
•     Variability of print jobs. Different types of jobs had different requirements for blanket
       cleanliness. Observers noticed that what one facility considers to be a  clean blanket
       another facility may find unacceptable.
•     Variability of staff involved in performance demonstrations. Press operators' attitudes
       towards alternative blanket washes differ from one operator to the next and can affect
       their perception of performance. As previously mentioned, some of the information
       recorded was subjective and varied depending on a variety of factors including the
       attitude, perception, and previous experiences of the operator. For example, many of the
       substitute products were low in VOC content and did not evaporate as  quickly as some of
       the more traditional blanket  washes.  Often, an extra step was needed to wipe the blanket
       with a dry rag to remove a residue left by some of the substitute washes. While extra
       cleaning steps can be time consuming and lead to increased production costs, even a
       minimal extra effort was regarded as an unacceptable burden by some  operators. Other
       operators understood that some changes in their procedures and even some extra effort
       may be needed in order to effectively clean the blanket with an alternative product.
 •      Variability in application method. Press operators' overall opinion of the blanket wash
       could have been affected by their current application method. For example, operators
       who are accustomed to using high solvent blanket washes where little  effort is required
       may differ in their opinion of "moderate effort" from operators who are currently using an
        alternative where some extra effort is already required.  All manufacturers were asked to
        supply application procedures for their product. When instructions were supplied, the
        observer reviewed the procedures with the press operators, verified the correct procedure
        was used when the observer was on-site, and asked in the  interview at the end of the week
        if the application procedures had been modified in any way. If any changes were made,
        the type of change and the reason for the change were described in the performance
        summary.

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 APPENDIX E
 •     Short term nature of the demonstrations. Printers used the substitute blanket washes in
        their facilities for one week. Any long term effects such as premature blanket wear or
        corrosion would not have been apparent.

 Blanket Wash Summaries

        A summary of the performance of each of the 22 substitute blanket washes is presented hi
 Chapter 4 of the lithography CIS A. Since the trade names of the substitute blanket washes are
 not given in the lithography CTSA, each blanket wash is identified by a numerical code and a
 generic chemical formulation. The specific types of chemicals that make up each of the generic
 formulations are explained in greater detail in Chapter 2 of that document. In addition, the
 facility names have been replaced with a facility number.

        Performance of each product is presented separately for the two facilities, and includes a
 description of the facility's current blanket wash, their past experience in testing alternative
 blanket washes, their overall opinion of the substitute wash performance, and, if applicable, a
 summary of the factors that may have influenced performance. A table is also included for each
 blanket wash which presents the results of the laboratory test of both the substitute blanket wash
 and the baseline wash. Averages of the volume of wash used, time required, and effort required,
 as recorded by the printers during field demonstrations are also included in each product
 performance table.
 E-2   METHODOLOGY DETAILS

       This section presents information on the methods that were used to gather the
 performance demonstration data at the print shops and in the laboratory, as presented in Chapters
 4 and 7 of the Lithography CTSA. Specifically, this section includes:

 •     Characteristics to be Reported Out of the Performance Demonstration.
 •     Demonstration Methodology.
 •     Blanket Swell Test (laboratory test).
 •     Washability/wipe Test (laboratory test).
CHARACTERISTICS TO BE REPORTED OUT OF THE PERFORMANCE
DEMONSTRATION

Cost of Each Product as Utilized

Product Cost

       Interested product suppliers should include the manufacturer's suggested retail price (to
the end user) of their products ($ per 5 gallon drum) upon submission of samples for
                                         E-6

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	BACKGROUND AND METHODOLOGY FOR PERFORMANCE DEMONSTRATION

demonstration so that the cost per volume used in a cleaning cycle can be determined and
reported.

Disposal/Spoilage Costs

       Suppliers should provide specific recommendations for the disposal or treatment of
wastes associated with using their products. Based upon these recommendations and the wastes
determined in the field tests, disposal or treatment costs will be estimated.

Labor/Down-time Costs

       This information will be based on the time required to wash a standard 19" x 26" blanket
(based on two measures: button-push to completion of wash excluding time for other activities,
such as refilling paper; and, after washing, zero the counter and count the number of sheets to get
back to salable printing), a standard press operator wage, and standard press time costs. The
costs of time and paper losses while returning to salable printing following the wash should be
included here as well as any costs that may be associated with changes in or destruction of the
blanket or other printing system components. The standard press operator wage information will
be obtained from the wage and hourly survey developed by the National Association of Printers
and Lithographers.

Storage Costs

        These costs will include any special storage required due to hazardous components
present in the blanket wash materials.

Product Constraints

        The blanket wash supplier should provide information about product compatibility with
 specific inks (e.g. petroleum or vegetable oil based, UV water based), if known. If the supplier
 does not provide information regarding product incompatibilities, it will be assumed that there
 are none.

 Special Safety Storage Requirements

        Suppliers should provide information about the flammability (as measured by flash point)
 of the product. This will be confirmed by the laboratory test in the pre-screening procedure.

 Ease of Use

        The physical effort required to effectively clean the blanket using the test product will be
 evaluated and reported. This is a subjective judgement based on the experience of the press
 operator.
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 APPENDIX E
 Duration of the Cleaning Cycle

        The measured time will be the entire cleaning cycle from press shut down to completion
 of the cleaning process (this excludes any activity unrelated to blanket cleaning).  This
 information when correlated with labor and press-time costs will attempt to measure the total
 costs associated with the use of the product.

 Effectiveness of the Blanket Wash Solution

        This will be the subjective judgement of the press operator. The basic criteria will be
 whether the blanket is sufficiently clean to resume printing based on the judgement of the
 operator. VM&P Naphtha will be used as the baseline blanket wash to measure a test solution's
 efficacy, and the operator should also compare against what is normally used on the press.

 Printing Equipment and Ink

        Information will include the manufacturer, type and age of the press, the blanket and the
 ink, and the length of press run prior to blanket wash. This is  basically descriptive information
 that may assist in discovering and reporting incompatibilities between the blanket washes and
 equipment or inks. Additionally, the type of printing job, type of fountain solution, paper size
 relative to press size, paper type, brief description of blanket condition (Note: the blanket used
 should be runable with no smashes or repairs) along with a general description (light, medium,
 and heavy) of ink coverage will also be reported.
DEMONSTRATION METHODOLOGY

Product Pre-Screening and Masking

       The project will demonstrate alternative blanket washes. Products, product information
and MSDSs will be submitted by suppliers in properly labeled generic commercial containers to
an independent laboratory (e.g., GATF or university).  The independent laboratory will test the
flash point and VOC content of the alternative blanket washes.  The vapor pressure of the
product will be submitted by the supplier (the supplier will note whether the vapor pressure is
based on a calculation or test data.) The pH of the product will be provided by the supplier and
will be verified by the laboratory.  Suppliers wishing to participate in the performance
demonstration will have to make direct arrangements with the independent laboratory.

       The laboratory will mask all products by removing the trade names and manufacturer
from the containers and assign each sample a random ID number. Suppliers will provide a
masked MSDS in addition to the standard MSDS sent for shipping. They will also give
directions for use of the product without any identifying names, labels or characteristics.

       The laboratory will perform a standard test for blanket swelling potential of each product.
They will also perform a washability/wipe test for cleaning effectiveness on all of the products

                                          E-8

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  	   BACKGROUND AND METHODOLOGY FOR PERFORMANCE DEMONSTRATION

submitted.  The blanket swell test and the washability/wipe test proposed methodologies are
described in Sections E-3 and E-4.  The directions for each specific product will be used as much
as possible, including the manufacturer's directions for dilution or mixing. Any deviation from
the manufacturers directions will be noted along with the reasons for the deviation. Only
products that pass this functional demonstration stage will be used in the field demonstration
portion of the project.

       Based on the results of the product pre-screening, products will be grouped into
categories based on their formulation and/or chemical parameters.  These categories should be
consistent with the categories used in the EPA risk assessment. One or more products
successfully completing the screening will be chosen to "represent" each of the categories; these
representatives (one or two per category) will be from the average of the class. The selection of
masked products will be sent to volunteer printers for field demonstration.  The selection of
printers will take into account the type of inks being used as well as the sizes and types of
blankets. The variety of inks and blankets used for the demonstration  will depend on the
number of demonstration sites.  Each printer will test a limited number of products. This number
will be determined when the number of volunteer printers is established.  Although contingent
upon the number of categories, the number of volunteer printers, and available resources, each
representative blanket wash will be field demonstrated by at least two.

Documentation of Existing Conditions at Volunteer Facility

       Once the products have been shipped to the volunteer printing facilities, an observer1 will
record the type, color, and manufacturer of the ink currently being used on the press.  The
 observer will also document the type, model, and condition of the press and blanket being used
 for the demonstration and the type of paper being run on the press. The observer will also briefly
 describe the experience of the press operators participating in the test and will document any past
 experiences that the printer has had with the demonstration of blanket washes; the observer will
 note any potential biases. The current waste and wipe disposal practices and costs will be
 documented by the observer. NOTE: Presence of observer should be cleared with insurance
 carrier if necessary, and the purpose of the observer should be carefully explained to the
 personnel in the pressroom.

        The observer will record the product name and cleaning procedure for the blanket wash
 currently used by the company. The observer will record the cost of the current blanket wash
 solution.  The observer will also record how the product is being stored (in bulk and at the press)
 and disposed of as waste.
         1 A contract is currently being prepared by EPA to staff this function. This observer will not
  provide technical assistance to the printers. The observer will serve to document the demonstration and
  record the operators observations. The observer will ensure the operator performs the demonstration
  according to the final approved methodology. The observer will additionally serve as the press operators
  conduit to the technical assistance personnel. This conduit is necessary so as to clearly document the
  direction given and the actions taken.
                                             E-9

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 APPENDIX E
        The observer will document the current practices by observing the clean up of a blanket,
 utilizing the company's current product. This will include any pre-application dilution of the
 product. The observer will measure the quantity used for the cleaning with the company's
 current blanket wash solution and record the time required for the cleanup. The pressman will
 use a clean rag to clean the blanket, and the observer will record the size and weight of the rags
 used for cleaning before and after the cleaning. This will provide an estimate of the retention
 factor of the product.

        The observer will describe the density of the image currently being printed and will
 record information on the relative frequency of blanket cleaning.  The observer will document
 the number of images required to obtain an acceptable print.

 Establishing Evaluation Baseline at Volunteer Facility

        The blanket will be cleaned by the press operator using the baseline solution (VM&P
 Naphtha). This initial cleaning will serve to familiarize the press operator with the baseline
 product performance.  The printer will compare the baseline solution with the blanket wash that
 is typically used.  It has been suggested that this initial cleaning should not be used for
 comparative purposes, but the information noted in each of the sections below should be noted
 for reference hi any case.

 Demonstration

       The press will then be restarted for printing and then stopped for cleaning according to
 the company's standard procedures. The observer will measure the time of cleaning from button
 push to completion of wash excluding time for other activities, such as refilling paper, and will
 ask the press operator to zero the counter in order to count the number of sheets to get back to
 salable printing. The observer will document the volume of baseline solution used and describe
 the procedure used to ensure the directions were adhered to by the operator. This procedure will
 be followed for three complete cleaning  cycles.

 Press Operator Evaluation

       At the completion of these cycles the press operator will subjectively evaluate the
 condition of the blanket, i.e., scaling, picking, etc.  Additionally, the operator will evaluate the
 ease of use and performance of the baseline solution. The observer will describe the density of
 the image currently being printed. The observer will document the number of images required to
 obtain an acceptable print image for each of the cleaning cycles.

 Resetting the Blanket

       The blanket will be cleaned by the press operator using the test blanket wash solution.
This initial cleaning will serve to familiarize the press operator with the product and to avoid
complications with the previously used solutions. The press operator should measure the volume
                                          E-10

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	BACKGROUND AND METHODOLOGY FOR PERFORMANCE DEMONSTRATION

after each cleaning (the volume used in the initial cleaning may not be used for comparative
purposes).

Demonstration

       The press will be restarted for normal operation and then be stopped for cleaning
according to the company's standard practice.  The observer will measure the time of cleaning
from button push to completion of wash excluding time for other activities, such as refilling
paper, and will ask the press operator to zero the counter in order to count the number of sheets
to get back to salable printing. The observer will document the volume of solution used and
describe the procedure used to ensure the directions were adhered to by the operator. This
procedure will be followed for five complete cleaning cycles.

Press Operator Evaluation

       At the completion of these cycles the press operator will subjectively evaluate the
condition of the blanket, i.e., scaling, picking etc.  Additionally, the press operator will document
the density of the last printed image. The press operator will document the number of images
required to obtain an acceptable print image for each of the cleaning cycles. The press operator
will compare the relative performance of the test solution as compared to the baseline solution.

Long Term Test

       After completion of the above demonstration, a longer term test will be performed by the
printer. This test will consist of continued use of the supplied product for a period of one week.
 The blanket will not be cleaned with any other solutions until the observer returns.  The press
 operator will record the total number of copies printed, the number and relative frequency of
 blanket washes performed, the volume of product  used for each blanket wash, the total amount of
 product used, and the number of images required to obtain an acceptable print quality for each
 cleaning cycle.

        At the completion of this phase, the observer will return to the shop and will record the
 press operator's data. The observer will then document the procedures used in a final cleaning of
 the blanket by the press operator. This will indicate whether there has been any deviation from
 the initial cleaning procedure by the press operator. If there has been a deviation the observer
 shall record the reasons for the deviation.

        The press operator will then evaluate the condition of the blanket and describe the density
 of the product currently being printed.

        If at any time during this phase of the demonstration there is problem with the solution or
 the press, the press operator or company point of contact will document the problem as
                                           E-ll

-------
 APPENDIX E
 specifically as possible and call the technical assistance provider2 for guidance. Any corrective
 action will be documented by both the technical assistance provider and the press operator. The
 observer will record the actions documented by the press operator.

 Trouble Shooting

        If problems arise during the field demonstration of the blanket solutions, the following
 procedures will be followed. If the observer is present, the problem will be documented and the
 observer will call the technical assistance provider for guidance. If the observer is not present the
 press operator will document the problem and contact the technical assistance provider.

        The technical assistance provider will first review the procedures used by the press
 operator to ensure they are in compliance with the instructions provided with the product.  If the
 procedures are correct then the technical assistance provider will contact one of the printers
 currently using a product hi that category for assistance. Names of these support printers will be
 provided by the suppliers of the products. The technical assistance provider will relay and filter
 the recommendation of the support printer to the press operator. The technical assistance
 provider will ensure the confidentiality of the products is maintained during this period.  The
 identity of the product in the field will remain masked, and the identity of the specific product
 being used by the support printer providing guidance will not be asked or provided by the printer.

       The observer and/or the technical assistance provider will document all actions
 recommended and taken.

       If the recommendations provided by the technical assistance provider are unsuccessful,
 the press operator will then attempt to solve the problem. The observer and/or the technical
 assistance provider will document the actions taken by the press operator and the success or
 failure of the actions.

       The above procedures will be repeated for each product tested at the printer test site.

 Results and Final Report

       Final results will be assembled from the test sites and provided to a contractor to develop
 into a final report. The report will be developed so that the blanket wash products submitted for
 testing are grouped according to their formulations/chemical parameters (e.g., VOC content,
 vapor pressure). The results from similar products in a grouping will be reported in ranges so
 that the scope of performance from each group can be reported in the information provided to
 printers. The parameters delineating the grouping will be clearly defined so that both printer and
 supplier can determine the grouping for any particular blanket wash of interest.  Special attention
       2 A contract will be prepared by EPA to staff this function. The technical assistance provider
(i.e., GATF, university, etc.) will be available to trouble-shoot during the field demonstration portion of
the project.
                                           E-12

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	BACKGROUND AND METHODOLOGY FOR PERFORMANCE DEMONSTRATION

will be paid to the report-out of information on water-miscible products so that printers realize
that the category characteristics are based on the use of proper amounts of water.  (Note: No
results will be provided for individual/named products, but blanket washes participating in the
study will be listed hi the report, along with their grouping.) Results from the field
demonstration will be evaluated and assembled so that for any particular group the "average"
experience with the products in the group is presented, along with the extreme reactions.

       The report will thus have two parts. One part that presents the independent laboratory's
screening and other information founded in essentially concrete or quantitative data and a second
part that gives experiential anecdotes derived from the subjective evaluations of the
demonstration site personnel. Both types of information can be used to develop a second type of
information product: case studies of individual demonstration locations that discuss specific
actions, changes in techniques, attitude adjustments or other factors that could be significant to a
printer that is contemplating product substitution. The products would continue to be masked in
the case study. It may be possible to combine several sites with similar experiences into a single
report focussing on a single group of products.
E-3   BLANKET SWELL TEST

       The purpose of this test is to determine the effect of blanket washes on lithographic
blankets by measuring any change in thickness by the use of a micrometer.

Equipment:

       Crystallization Dish
       Cady Gauge (gauge +/- 0.0005 inch)
       Swell Test Clamp
       2x2 inch squares compressible blankets
       VM&P Naphtha, Varnish Makers' and Painters' Naphtha; petroleum fractions meeting
       ASTM specifications. (Distillation range, at 760mm Hg 5 percent at 130 °C; greater than
       90 percent at 145 °C)
       Various Blanket Washes

 Experimental Procedure:

       This procedure involves measuring and adding 10 ml of the blanket wash to a
 crystallization dish using a graduated cylinder. An initial caliper measurement is taken of the 2 x
 2 inch blanket sample and then it is placed over the mouth of the dish. The dish and blanket are
 placed into the swell clamp where the blanket is tightened down onto the mouth of the dish until
 a leak proof seal is formed.  The various washes are kept in contact with the blanket for one hour.
 Caliper readings are taken and the percent swell is calculated. The blanket is re-tightened,
 exposed for an additional five hours, and the caliper is measured again. This same procedure
 will be repeated for each blanket wash. The VM&P Naphtha will be used as a control.
                                           E-13

-------
 APPENDIX E
       Percent Swell =    Final Caliper - Initial Caliper  x 100
                                Initial Caliper
       Sample

 1. Control
   (VM&P Naphtha)

 2.

 3.

 4.

 5.

 6.

 7.

 8.

 9.

 10.

 11.

 12.

 13.

 14.

 15.
% Caliper Change After 1 Hour     % Caliper Change After 6 Hours
Temperature
Relative Humidity

Blanket Type	
                                        E-14

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	BACKGROUND AND METHODOLOGY FOR PERFORMANCE DEMONSTRATION

E-4    WASHABILITY/WIPE TEST

Equipment:

       Ink - Sheetfed Process Black
       Blanket - Compressible Blanket Cut Into Squares
       Quickpeek Brayer Apparatus
       Gardner Scrubber Apparatus
       Graduated Cylinder
       Control Blanket Wash - VM&P Naphtha
       Playtex® Panty Shield
       Status T Reflective Densitometer
       Standard 1200-1500 Watt Blow Dryer
       Various Candidate Blanket Washes

Experimental Procedure:

       The procedure involves an initial evaluation by using both a dry and wet ink film drawn
down on separate pieces of blanket using a quickpeek brayer apparatus. The ink stripes will
measure 2 inches wide and 5 inches in length. The amount of ink applied will be determined by
using one small or large hole on the Quickpeek apparatus. The blanket will be new and cleaned
with the standard prior to applying the ink films.  One of the ink films will be dried with a
standard blow dryer.

       The piece of blanket will then be placed into the holder of the Gardener Scrubber
Apparatus. A measured volume of standard and candidate washes will be evaluated.  The
number of strokes necessary to clean the blanket with the standard will be determined. Once the
area has been cleaned with the standard, the densitometer will be used to evaluate the cleanliness
of the blanket. Each candidate wash will be placed onto a clean Playtex® Panty Shield and the
cleanliness of the blanket will be measured after the same number of strokes found necessary by
the standard. If the blanket is not clean, the number of strokes necessary to clean the blanket will
be noted. Any residue or other unusual conditions will be indicated.

       One of the wet ink films will be dried for 20 minutes with the blow dryer.  The same
volume of standard and blanket wash as used for the wet ink will be use. The above procedure
will be repeated.

       The following represents a more detailed review of the step-by step procedure for the
 Gardner Scrubber Apparatus:                                                       ,

        1.     A piece of blanket is cut to fit into the holder of the Gardener Scrubber apparatus
              and the section to be scrubbed is drawn on the blanket.  A measured quantity of
              ink is spread evenly onto the surface of the blanket, ensuring that the thickness of
              the ink is uniform in the area to be scrubbed  Inking should be done on a counter
              or other level surface - inking in the holder will result in an uneven surface.

                                          E-15

-------
APPENDIX E
       2.     The wooden block is used to hold the sample collector, in this case a Playtex®
              Panty Shield.  A new, dry shield should be weighed, without the coated paper that
              protects the adhesive. Solvent will be placed on the shield, not on the inked
              surface. The initial weight of the shield should be noted and the shield placed on
              the wooden block. Affix the shield on the side of the block not marked "top"
              block using the shield's adhesive, and place the block in its holder. Make sure the
              shield ends are inside the metal holder.  They can be forced in by hand or held
              with thumbtacks. Use the side screw to ensure the block is held securely.

       3.     Prepare a pipet with 0.4 mL of standard solvent.  Ensure that the Scrubber counter
              is reset and that the holder is in a position where it can be stopped after the test.
              The far right hand side of the tray is suggested.

       4.     Place the inked blanket into the tray. Hold the wooden block with the panty
              shield up and away from the inked  surface so that no ink gets on the panty shield.
              Pipet the wash onto the pad using a swirling motion to evenly distribute the
              solvent over the surface.

       5.     Turn the pad over and start the scrubber. It should be allowed to go back and
              forth 20 times. At the completion of the last cycle, lift the pad off the blanket
              surface.

       6.     Lift the tray and blanket out of the apparatus.

       7.     Remove the block holder and remove the panty shield.  Place in a 110  C forced
              draft oven for 2 hours to drive off the solvent. Weigh the dried panty shield and
              note the weight.

       8.     Clean the piece of blanket and re-ink to perform more tests.

       9.     Complete the tests for the blanket wash materials being tested with 2 replications
              each. Repeat the test using the standard solvent upon completion of the test
              series.

Note: A modified method may need to be developed for aqueous cleaners.
E-5    CATEGORIZATION FOR LITHOGRAPHIC BLANKET WASHES

       Table E-l presents the following categories and classification of formulations that were
developed by the DfE Lithography Project Core Group and reviewed by the blanket wash
suppliers. The categorization was developed to assist with the development of the Performance
Demonstrations.
                                          E-16

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                 BACKGROUND AND METHODOLOGY FOR PERFORMANCE DEMONSTRATION
TABLE E-l; CATEGORIES AND CLASSIFICATIONS OF FORMULATIONS
Category
1.
la.
2.
2a.
3.
4.
5.
6.
6a.
7.
8.
8a.
9.
Mix
Vegetable fatty ester
Vegetable fatty ester (+glycol)
Ester/Petroleum
Ester/Petroleum (+surfactant)
Ester/Water
Petroleum
Petroleum/Terpene
Petroleum/Water
Petroleum/Water (diluted for use)
Water/Petroleurn/Ester
Terpene
Terpene (+ additives)
Detergent
Washes
All
1
26
29
14
19
3
21
36
38
6
11
18
40
9
10
31
32
35
13
15
5
8
20
37
39
12
30
33
22
34
16
24
27
4
7
23
25
17
Pass" to Demo
1
26
29
14
19
21
36
38
6
11
40
9
10
31
32
13
20
37
39
30
12
22
34
24


a)  1 indicates formulations passed blanket swell test (^3.0%) and basic washability.
                                            E-17

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APPENDIX E
E-6   PERFORMANCE DEMONSTRATION FORMS

The following four forms (shown on the following pages) were used by the observers and
printers to record information for the performance demonstrations:

•     Observer's Evaluation Sheet
•     Observer's Performance Evaluation Sheet
•     Fruiter's Evaluation Sheet
"     End-of-Week Follow-up Questionnaire
                                       E-18

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	BACKGROUND ANB METHODOLOGY FOR PERFORMANCE DEMONSTRATION

E-7   OBSERVERS EVALUATION SHEET
FACILITY NAME:
DATE:
      Ask each participating printer in the substitute blanket wash performance demonstrations
to answer these questions when you call to schedule your visit to their facility. Once on-site,
verify the answers.

1.    Printing Process
      Approximately what percentage of your business (based on annual sales) is in the
      following segments? Please check all boxes that apply.

Lithography/Offset
Gravure
Flexography
Screen printing
Letterpress
Other (specify)
<50%
D
D
n
n
n
n
50 - 95%
n
n
n
n
n
n
95 - 100%
n
n
n
n
n
n
2.     Products
       What percentage of your lithography business (based on annual sales) is in the following
       products? Please check all boxes that apply.

Commercial Printing
Direct-mail Products
Business Forms
Publications (other than news)
Packaging
News
Other (specify)
<50%
n
n
n
n
n
n
n
50 - 95%
n
n
n
n
n
n
n
95 - 100%
n
n
n
n
n
n
n
3.     General Facility Information
       How many employees are at this location?
                                        E-19

-------
APPENDIX E
4.
5.
6.
       How many employees work in the press room?
       How many shifts does your facility run per day?
Press Type(s)
Describe the press(es) that will be used for the performance demonstrations. The
required press size is in the 19" x 26" class.
       1.  Press size:
       2.  Press size:
                     (in. x in.)
                     (in. x in.)
                           # of print units:      Print speed:
                                                          (# impressions/hour)
                           # of print units:     Print speed:
                                                          (# impressions/hour)
Blanket information
On the press(es) that will be used for the demonstration, what is the average number of
times a blanket is washed per shift?	

What type of blanket do you use on the press(es) that will be used for the demo:
       - Manufacturer:	

       - Type (e.g., 3-ply compressible, etc.)	
             - Number of impressions on this blanket prior to the demonstrations:
                1 week or less...D    1 week to 3 months...D    3 months or more...D

             - Do you have any automatic blanket washers in your facility?	
Blanket Washes
Press Used
in Demo.


Trade Name of Blanket
Wash/Manufacturer


Cost
($/gaIIon)


Dilution
Ratio
(wash: water)


Ink Type(s)
conventional D
vegetable oil-based D
uv n
waterless D
other D

conventional n
vegetable oil-based D
uv n
waterless D
other D
                                         E-20

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	BACKGROUND AND METHODOLOGY FOR PERFORMANCE DEMONSTRATION

7.     Experience with Substitute Blanket Washes
       a. Have you tried any substitute blanket washes for environmental or worker health and
       safety reasons?
       - Did the substitute wash work better, the same, or worse than your old wash? Why?
       b. Besides substitute washes, have you changed any equipment, procedures or work
       practices that reduced your use of blanket wash solution or reduced the time required to
       wash the blanket?  Yes	D  No	D  - If yes, please describe:
8a.    Cleaning Procedure - CURRENT PRODUCT
       Record blanket cleaning procedure using the chart below and the space at the bottom of
       the page for additional comments. In each column, check all that apply.
Method for Applying
Blanket Wash
Use squirt bottle D
to spray directly
on blanket
Use squirt bottle D
to spray on wipe
and apply wipe
to blanket
Dip wipe in D
blanket wash
and apply to
blanket
Use safety D
plunger can

None Used D
Other D
(specify)
Type of Wipe
Used to Clean
the Blanket
Disposable D
Size:
Wet D
Dry D
Reusable D
Size:
Wet D
Dry D

Other D
(specify)
Avg. No. of Wipes
Used/Cleaning
(cleaning+excess)
1-2 n
2-4 D
4-6 D
6-8 n

s-io n
Other D
(specify)
Method for
Removing Excess
Wash from
Blanket
Clean dry rag D
Clean wet rag D
Allow to D
evaporate
No excess D

Other D
(specify)
Wipes
Management
Send off-site D
for laundering
Launder on- D
site
Dispose of as
hazardous
waste
Dispose of as D
non-
hazardous
waste

Other D
(specify)
                                        E-21

-------
APPENDIX E
•      Was the rotation of the blanket during washing (circle one): manual or automatic?

•      Note any other steps taken hi washing the blanket:

•      For the current blanket wash product, ask the press operator if there are ever any
       variations hi the cleaning procedure, and if so, under what circumstances?

 8b.    Cleaning Procedure - BASELINE PRODUCT
       Clean the blanket using the baseline product, VM&P Naphtha, recording the required
       information on the observer's evaluation sheet for each cleaning.

•      Note the condition of the blanket before cleaning:

       Weigh the Naphtha container before use. Record weight:	__^—
       Pour Naphtha onto a clean, dry wipe.
       Weigh the Naphtha container again. Record weight:
       Record the difference in weight on the evaluation sheet.
       Clean the blanket.
       Was the rotation of the blanket during washing (circle one): manual or automatic?
       Note any other steps taken hi washing the blanket:

8c.    Cleaning Procedure - SUBSTITUTE PRODUCT #
       Clean the blanket using the substitute blanket wash. Follow the manufacturers
       instructions and record the required information on the observer's evaluation sheet for
       each cleaning.

       Note the condition of the blanket before cleaning:
       Describe the cleaning procedure:
       Was the rotation of the blanket during washing (circle one): manual or automatic?
                                         E-22

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              BACKGROUND AND METHODOLOGY FOR PERFORMANCE DEMONSTRATION
E-8   OBSERVER'S PERFORMANCE EVALUATION SHEET
Facility Name_
        Date
Demo Type: (Check one and enter -wash #)
      Current Wash	     Baseline Wash	

                             Wash#	(1-3)
Substitute Wash	
(enter code #	)
Wash#	(1-5)
Ink used before wash-up

Run length
Ink coverage (obtain a
sample sheet for each level of
coverage)
Substrate
Drying time
Dilution
Quantity of wash used
Cleaning time

Ease of cleaning



Excess wash


Wipes used
Specify ink color, type, and manufacturer:
conventional 	 D
vegetable oil-based. . . . D other (specify)
Record length of run (# impressions)
(check one):
Heavy Medium Light

Record substrate printed:
Time from end of press run to start of blanket wash: minutes
(enter wash:water ratio or "none" if used at fell strength)
ounces (pour wash on wipe; record volume of wash poured)
minutes (time for blanket cleaning only)
rotations (corresponding number of blanket rotations)
(check one for each question):
• Compared to your standard wash, was the effort needed:
Lower Same Higher
• Compared to the baseline wash, was the effort needed:
Lower Same Higher
• Did the wash cut the ink: Well Satisfactorily
Unsatisfactorily
Did you have to remove excess wash? (check one) Yes
No
If "Yes", how was it removed? (check all that apply):
Wet wipe Dry wipe Allow to evaporate
Enter the total number of fresh wipes used for blanket washing
(includes both wipes used for washing and for removing excess wash):
                                   E-23

-------
APPENDIX E
  Odor
(check one):
       Odor not noticed_
       odor
                                                             Odor detected
     Strong
  Printer's opinion of the
  wash performance?
The wash performance was (check one):
                     Good          Fair
Poor
  Examine the blanket
Evaluate the blanket appearance after the wash:
  Printing after the wash
Specify the ink color and type used after the wash:

How many impressions were run to get back to acceptable quality?
                               Does the printer think the wash caused problems with the print quality? Yes
                               or No  If yes, explain:
                                            E-24

-------
	BACKGROUND AND METHODOLOGY FOR PERFORMANCE DEMONSTRATION




E-9   PRINTER'S EVALUATION SHEE1




Facility name:	
Date:
Press Operator's Initials:
Answer these questions far the BLANKET WASH ONLY (do not include the ratter cleaning)
Ink used before
wash-up
Run length
Ink coverage
Quantity of
wash used for
this cleaning
Cleaning
rotations
Ease of
cleaning
Wipes used
What is your
opinion of this
blanket wash?
Examine the
blanket
condition after
the wash
Printing after
the wash
Specify ink color:
Specify ink type: conventional 	 D other
vegetable oil-based.. .D
Record length of run:
# impressions =
circle one:
Estimate the image coverage: Heavy Medium Light
# of ounces from Portion Aid dispenser provided

rotations (record the number of blanket rotations cnmplc.tp.il
during the blanket cleaning)
circle one:
The effort needed to clean the blanket was: Low Medium High
Number of fresh wipes used for blanket washing:
circle one:
The wash performance was: Good Fair Poor
Is there any residue, debris, etc. on the blanket? Yes 	 D No 	 D
If yes, please explain:
How many impressions were run to get back to acceptable print quality?
Did the blanket wash cause problems with the print quality? Yes...D No...D
If yes, please explain:
Comments or suggestions - Use the back of this sheet or the space below for any comments:
                                     E-25

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APPENDIX E
E-10   END-OF-WEEK FOLLOW-UP QUESTIONNAIRE
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-------
            APPENDIX F
CHEMICAL VOLUME ESTIMATES: SCREEN
          PRINTING CTSA

-------

-------
       Volumes for chemicals used within screen reclamation were estimated.  Volumes of the
chemicals produced within the nation, export volumes, and import volumes were estimated from
information obtained from the following sources: Chemical Economics Handbook1, US ITC2,
Manville3, US EPA reports4, Kirk-Othmer5, and industry sources. In some cases, volumes
reported represent broader categories than the individual chemical. Volumes for the portion of
the chemicals used within screen reclamation was not readily available.

       The Workplace Practices Questionnaire6, SPAI's 1990 Survey7, and expert opinion
estimates were used to develop an estimate of the chemical volumes.. The following
methodology summarizes the  assumptions and calculations used to estimate the annual national
totals of chemicals used in screen reclamation.

       The information needed to develop the estimates included the average screen size, the per
screen volume of each type of reclamation product, market shares, the number of screens cleaned
yearly, and the number of screen printing operations.  This information is summarized in Table
F-l.

       The screen size, in conjunction with the amount of product used or purchased and the
number of screens cleaned, was used to determine the per screen product usage. Typical
formulations were then used to determine the chemical breakdown of the reclamation products.
Combining this information resulted in estimates of the volumes of chemicals used for screen
reclamation.  Additional detail of the methodology is given below.
       1 SRI.  Selected reports from 1985 to 1993.  Chemical Economics Handbook. SRI International, Menlo
Park, CA.

       2 USITC. 1993 and 1994. Synthetic Organic Chemicals: United States Production and Sales. 1991. U.S.
International Trade Commission, Washington, DC.

       3 Manville.  Selected reports from 1990 -1993. Manville Chemical Products Corporation, Ashbury Park,
NJ.

       4 US EPA reports, including the Toxic Substances Control Act Chemical Substance Inventory (1985),
"Aqueous and Jerpene Cleaning" (1990), "Economic analysis of final Test Rules for DGBE and DGBA" (1987),
"Glycol Ethers: An Overview" (1985).

       5 Kirk-Othmer, 1981, "Oils, essential." Kirk-Othmer Encyclopedia of Chemical Technology. 3rd ed., vol
16. New York: Wiley.

       6 The Workplace Practices Questionnaire was developed by EPA, SPAI and the University of Tennessee
in 1993.  It contains information on 115 screen printing facilities' operating and work practices characteristics. See
Appendix B for a reproduction of the blank questionnaire and Appendix C for a summary of responses.

       7 Screen Printing Association International,  1990 Industry Profile Study. Fairfax, VA 1991.

                                            F-l

-------
APPENDIX F
AVERAGE SCREEN SIZE

       Estimated from the Workplace Practices survey, observations were weighted by the
number of screens cleaned per day. This is a normalization technique which incorporates the
frequency of screen cleaning as well as the size of the screens. The average screen size was
estimated to be 2,916 square inches. This  value differs from the average in the appendix due to
this normalization to incorporate incomplete responses.
PER SCREEN PRODUCT USAGE

       Usage levels for three types of reclamation products were calculated using information
collected through the Workplace Practices survey: ink remover, emulsion remover, and haze
remover. Information used included average screens printed per day, volumes of products
purchased each year, and the unit price of the products. Certain observations such as those from
facilities carrying out in-plant recycling, were excluded from the calculations as these would
distort the average volume used per screen of one-time ink removal operations. The average
volume used per screen was calculated by dividing the annual amount of product purchased by
the number of screens cleaned per year (assuming 252 working days and the midpoint of the
range of screens cleaned per day).
DERIVATION OF MARKET SHARE OF TRADITIONAL AND ALTERNATIVE
SCREEN RECLAMATION PRODUCTS

       Current use of screen reclamation products is divided between traditional products,
generally high VOC solvents, and alternative products, usually low or no VOC content products.
To calculate the market share represented by each type of product, data was collected from the
Work Practices Survey for Screen Printers (see Appendix A). In the calculation, market share is
not based on volume used but rather on total screen area cleaned since traditional and alternative
products may require very different quantities to clean the same screen area.

       The formula used to calculate market share is as follows:
              Market ShareAlt = AAlt/AAlt+Tra
Market ShareTra =Atra/A
                    •Alt + Tra
where:
AU   denotes Alternative Product
TY,   denotes Traditional Product     F
A = total screen area cleaned daily = £ [# of screens cleaned daily x area of screens]
                                  N
F = number of facilities cleaning screens
                                          F-2

-------
                                                           CHEMICAL VOLUME ESTIMATES
Ink Removers

       A simplistic decision rule, based on expert opinion, was used to classify ink removers as
alternative or traditional.  If the price of an ink remover in the Work Practices survey was below
$5.60/gallon then it was considered traditional. If the unit price was above $18.90/gallon then
the product was considered to be alternative. An additional seven ink removal products were
assigned as traditional or alternative based on having a brand name in common with a product
assigned using the price thresholds.8 As the Work Practices Survey collected brand names, we
did not know the composition of the product and had no other method to determine which
category the products fit into. Once facilities were identified as using either traditional or
alternative products, the screen area cleaned per day for each facility was estimated.9 The screen
area cleaned per day is then summed across facilities within product types. To estimate market
share, the screen area cleaned using each type of product was then divided by the total screen
area cleaned daily with both types of products.  The results indicate that the percentage of total
screen area cleaned using traditional products equals 65.6 percent and the percentage of total
screen area cleaned using alternative products equals 34.4 percent.

Emulsion Removers

       As there is little difference among emulsion removers used in the Work Practices survey,
no distinction was made between traditional and alternative emulsion removers.

Haze Removers

       The market share of haze removers used by printing operations that is considered to be
traditional and the market share that is considered to be alternative  is not known. Consequently,
in the cost analysis, it was assumed that all haze removers currently used are traditional products.
NUMBER OF SCREENS CLEANED

       The number of screens cleaned per year was taken from SPAI's 1990 survey, where
facilities reported which range they fit into.  In order to use this information for our calculations,
an average value was chosen to represent each range.  For the top range of 41 screens or more, 50
screens per day was used. The remaining figures are reported in Table F-l.
         A substantial portion (~ 70 percent) of screen area reported in the Work Practices survey could not be
assigned to traditional or alternative products and were, therefore, not included in the above calculation.

       9 Data reported in the Work Practices Survey was limited to the total volume of alternative and traditional
products purchased annually and the total number of screens cleaned per day at the facility. The number of screens
cleaned per day with each type of product was not indicated. As a result, the average price of the ink remover was
calculated and used to establish which type of product the facility was using.

                                            F-3

-------
APPENDIX F
       Using an SPAI estimate of 20,000 screen printing facilities (excluding textile printers),
the total number of screens cleaned per day can be estimated. For example, 57 percent of
facilities clean one to ten screens, or an average of 5.5 a day, resulting in 62,700 screens a day for
that particular range. Continuing the analysis results in an estimate of 272,710 screens cleaned
per day.
TABLE F-l: INFORMATION FOR SCREEN RECLAMATION CHEMICAL VOLUME
ESTIMATES "
:
Description
Average screen size"
Per screen product usage8




Ink remover market sharea-d
Screens cleaner per dayb





Number of Screen Printing Facilites"
Number of Screens Cleaned Per Day4
Data
2916 sq. in.
Product
Ink remover (traditional)
Ink remover (alternative)
Emulsion remover
Haze remover
Oz./Screen (Gal./Screen)
98 (0.7663)
22(0.1731)
8.8 (0.0685)
2 (0.0160)
Traditional - 65.6%
Alternative - 34.4%
Range of # of Screens
1 to 10
11 to 20
21 to 30
31 to 40
41 or more
Value Used
5.5
15.5
25.5
35.5
50
%of
Facilities
57.0
23.2
9.8
4.1
5.9
20,000
272,710
a) Based on raw data from WPQ for screen printing adjusted for incomplete responses.
b) SPAI's 1990 Industry Profile.
c) SPAI estimate.
d) Calculated value.
NATIONAL ESTIMATES OF SCREEN RECLAMATION PRODUCTS

       Multiplying product usage per screen by market share by the total number of screens
cleaned per year provides estimates of the amount of screen reclamation products used
nationally. All facilities are assumed to use ink remover, emulsion remover, and haze remover;
this may result in an overestimate of chemicals used as not all facilities use haze remover, at least
not on all screens. Market share estimates, developed by EPA in consultation with industry
experts, are provided in Table F-2.
                                           F-4

-------
                                                                   CHEMICAL VOLUME ESTIMATES
TABLE ¥-2: ESTIMATED MARKET SHARE FOR SCREEN RECLAMATION PRGBTFCTS
Chemical
Market Share (%)
Ink Remover, Traditional Formulations
Xylene
Mineral spirits
Acetone
Lacquer thinner"
20
20
&
20
40
Ink Remover, Alternative Formulations
Propylene glycol methyl ether
Methoxypropanol acetate
Dibasic estersb
Diethylene glycol
Propylene glycol methyl ether acetate
Perpineols/d-limonene (50/50)
Propylene glycol
Pripropylene glycol methyl ether
Diethylene glycol butyl ether
Cyclohexanone
10
10
30
3
5
7
5
15
10
5
Emulsion Remover
Bleach (sodium hypochlorite) (12% solution in water)
Sodium metaperiodate (4% solution in water)
Periodic acid (10% solution in water)
Sodium bisulfate (50% solution in water)
10
80
5
5
Haze Remover
Sodium hydroxide (20% solution in water)
Potassium hydroxide (20% solution in water)
Sodium hydochlorite (12% solution in water)
Mixture of 65% glycol ethers c and 35% N-methylpyrrolidone
Mixture of 10% d-limonene, 20% sodium hydroxide, and 70%
Mixture of 10% xylene, 30% acetone, 30% mineral spirits
25
25
10
10
10
20
a) The formulation for lacquer thinner is as follows:
        (1)     Methyl ethyl ketone
        (2)     N-butyl acetate
        (3)     Methanol
        (4)     Solvent naphtha, light aliphatic
        (5)     Toluene
        (6)     Isobutyl isobutyrate
b) This category includes dimethyl glutarate, dimethyl adipate, dimethyl succinate in a 2:1:1 ratio.
c) This category includes propylene glycol methy ether, methoxypropanol acetate, propylene glycol methyl ether
acetate, tripropylene glycol methyl ether, and diethylene glycol mono butyl ether in equal portions.
78933
123-86-4
67561
64742-89-8
108883
97858
30%
15%
5%
20%
20%
10%
                                                   F-5

-------
APPENDIX F
ESTIMATES OF CHEMICAL USAGE FOR SCREEN RECLAMATION

       To estimate the amount of individual chemicals used, the product volumes estimated
earlier were combined with the market share estimates to determine the amount of individual
chemicals used.  Chemicals that are solids at room temperature are reported in units of mass
(pounds) and those that are liquids are reported in units of volume (gallons). The estimated
amount of chemicals is reported in Table F-3.  Many of the chemicals do not have estimates; the
chemical's specific information provided for this analysis (reported in Table F-l) is an overview
and, therefore, did not cover all of the chemicals used in screen reclamation. We were unable to
collect volume information directly from reclamation product manufacturers.
TABLE F-3: ESTIMATED ANNUAL AMOUNT OF CHEMICALS CURRENTLY USED IN
SCREEN RECLAMATION
(Liquids are reported by volume, solids by weight)
Chemical
Acetone
Alcohols, C8 - CIO, ethoxylated
Alcohols, C12 - C14, ethoxylated
Benzyl alcohol
2-Butoxyethanol
n-Butyl acetate
Butyrolactone
Cyclohexanol
Cyclohexanone
Diacetone alcohol
Dichloromethane
Diethyl adipate
Diethyl glutarate
Diethylene glycol
Diethylene glycol monobutyl ether
Diethylene glycol butyl ether acetate
Diisopropyl adipate
Dimethyl adipate
Dimethyl glutarate
Dimethyl succinate
Dipropylene glycol methyl ether
Dipropylene glycol methyl ether acetate
Dodecyl benzene sulfonic acid, triethanol amine
salt
Ethoxylated castor oil
Volume
(gallons)
6,920,000
NAa
NA
NA
NA
1,920,000
NA
NA
270,000
NA
NA
NA
NA
122,000
420,000
NA
NA

609,000
304,000
NA
NA
NA
NA
Weight
(pounds)

NA
NA
NA
NA

NA
NA

NA
NA
NA
NA

NA
NA
NA
2,700,000
5,500,000

NA
NA
NA
NA •
                                        F-6

-------
            CHEMICAL VOLUME ESTIMATES
TABLE F-3: ESTIMATED ANNUAL AMOUNT OF CHEMICALS CURRENTLY USED IN
SCREEN RECLAMATIOH
(Liquids are reported by volume* solids by weight)
Ethoxylated nonylphenol
Ethyl acetate
Ethyl lactate
Ethyl oleate
Fumed silica
Furfuryl alcohol
Isobutyl isobutyrate
Isobutyl oleate
Isopropanol
d-Limonene
Methoxypropanol acetate
Methanol
Methyl ethyl ketone
Methyl Lactate
Mineral spirits
N-methyl pyrrolidone
2-octdecanamine, N, ndimethyl, noxide
Phosphoric acid, mixed ester w/isopropanol &
ethoxylated tridecanol
Potassium hydroxide
Propylene carbonate
Propylerie glycol
Propylene glycol ethyl ether
Propylene glycol methyl ether acetate
Silica
Silica, fumed (amorphous, crystalline-free)
Sodium bisulfate
Sodium hexametaphosphate
Sodium hydroxide
Sodium hypochlorite
Sodium lauryl sulfate
Sodium metasilicate
Sodium periodate
Sodium salt, dodecylbenzene sulfonic acid
Solvent naphtha, heavy aromatic
Solvent naphtha, light aliphatic
NA
NA
NA
NA
NA
NA
2,630,000
NA
NA

420,000
610,000
3,720,000
NA
6,920,000
38,000
NA
NA

NA
203,000
418,000
217,000
NA
NA

NA

68,000
NA
NA

NA
NA
2,160,000
NA
NA
NA
NA
NA
NA

NA
NA
1,100,000



NA


NA
NA
1,060,000
NA



NA
NA
2,350,000
NA
1,450,000

NA
NA
11,700,000
NA
NA

F-7

-------
APPENDIX F
TABLE F-3t ESTIMATED ANNUAL AMOUNT OF CHEMICALS "CURRENTLY USED IN
•: SCREEN RECLAMATION _ f *
(Liquids are reported by volume, solids by weight)
Solvent naphtha, light aromatic
Special tall oil
Terpineols
Tetrahydrofurfuryl alcohol
Toluene
1,1,1 -trichloroethane
1 ,2,4-trimethylbenzene
Triethanolamine salt, dodecyl benzene sulfonic acid
Tripropylene glycol methyl ether
Trisodium phosphate
Xylene
NA
NA

NA
2,670,000
NA
NA
NA
623,000
NA
6,800,000
NA
NA
1,100,000
NA

NA
NA
NA

NA

a) Not available. Some chemical amounts were not estimated; sufficient information on the use of those chemicals
in the screen printing industry was not available.
                                                F-8

-------
           APPENDIX G
   COST ANALYSIS METHODOLOGY:
LITHOGRAPHIC BLANKET WASHES CTSA

-------

-------
BLANKET WASH COST ANALYSIS METHODOLOGY

       The methodology described below was used to estimate the cost of using the baseline
blanket wash as well as the cost of using 22 substitute blanket washes. The primary source of
information for the cost estimates was the performance demonstration conducted during
production runs at 17 volunteer facilities in late 1994 and early 1995. This information was
supplemented by several other sources, including: (1) industry statistics collected by trade
groups; (2) lease prices for cloth printer's wipes from a large east coast industrial laundry; and (3)
EPA's risk assessment work.

       The performance demonstration collected data on the use of donated, substitute blanket
wash products and the baseline, VM&P Naptha.  Substitute products were screened for blanket
swell and washability; each was then sent to two printing facilities. Each facility also tested the
baseline product; results are presented comparing the substitute products to the baseline.
Although each facility was to use the substitute product for one week, performance problems  and
scheduling conflicts resulted in some products being used more than others.

       Certain assumptions were used in this analysis to smooth out the differences among the
various facilities participating in the performance demonstration in order to make the results
comparable and to remain consistent with assumptions used in other parts of this CTSA.  For
example, it was assumed that there are four blankets or "units" per press, each of which is
washed 10 times per shift. Additionally, it was assumed that work is performed for one 8-hour
shift per day, 5 days per week, 50 weeks per year.  Using these assumptions, the following costs
were estimated for individual facilities involved in the performance demonstrations for the
baseline blanket wash and each substitute blanket wash:

 •     Total cost/wash.
 •     Total cost/press.
 •     Total cost/press/shift/year.

       A general description of the cost estimation methodology and data sources used is below,
 followed by a more detailed description of the methodology.

 General Description of Costing Methodology

       In general, the cost estimate for each reclamation method combines product cost  and
 product performance data.  Variations in the sample sizes, the value for 'n', found in the labor rate
 (time), the number of wipes per cleaning, quantity of wash used and number of cleanings used to
 determine performance are due to differences in the way the data for each factor was collected.
 For example,  in the case of the time required to clean the blanket, only the data collected by the
 observer on the first day of the demonstration were used in the assessment. In determining the
 average quantity of blanket wash used, data collected during the entire week were utilized in the
 assessment resulting in a higher sample size. The final cost estimates are a combination of the
 three distinct  cost elements listed below:
                                           G-l

-------
 APPENDIX G
 Labor

        The time spent to clean the blanket was recorded in the performance demonstrations by
 the observer on the first day of the demonstration for each product, as it was not feasible for press
 operators to time themselves while cleaning. Therefore, estimates of time to clean the blanket
 recorded by observers were used to calculate the labor cost.1 The labor cost was calculated as the
 total time spent multiplied by (1) the average wage rate for lithography press operators of
 $15.52/hour; (2) an industry fringe rate (to account for holiday and vacation) of 1.07; and (3)  an
 industry multiplier of 1.99 to account for overhead costs. All of these cost elements were
 calculated from industry statistics reported in NAPL's 1993 Cost Study and are explained in more
 detail in the next section.

 Blanket wash products

        The quantity of blanket wash used per blanket was recorded during the observer's visit
 and by the press operator during the week of demonstrations.  Average usage per blanket was
 calculated at each facility for both the baseline product and the 22 substitute products.
 Multiplying usage per wash, accounting for dilution where necessary, by the unit cost of each
 product (provided by each participating manufacturer and summarized in Table G-l) yielded the
 blanket wash costs.

 Materials (i.e.. wipes)

        The  only materials consumed in manual blanket washing are the wipes used by the press
 operator to wash the blanket. All but one of the print shops participating in the performance
 demonstration used cloth wipes; the other used disposable wipes.  Materials costs were therefore
 calculated by multiplying the number of wipes used,  as recorded in the performance
 demonstrations, by the lease price of a cloth printer's wipe. (A representative of Standard
        1 An alternative method of determining the labor time was examined, apart from using the average time
estimates compiled by observers. Within each facility, observers and press operators collected data on the number
of blanket rotations per wash. Because only observers compiled time estimates, the rotations data included more
observations and was, therefore, considered as an alternative method for estimating labor time. However, this
approach was abandoned after further analysis found poor correlation between time and number of rotations.
Although occasionally high correlation was found to exist, the majority of facilities did not show a high degree of
correlation.  Eight facilities with the greatest number of observations were analyzed separately to determine if time
and number of rotations were correlated. Again, poor correlation was found. This is interpreted to mean that there
was not a preset cleaning speed for the rotation of the cylinders; we were not, therefore, able to use the number of
rotations multiplied by the average time per rotation recorded by the observer to determine the labor time involved
with cleaning the cylinders. In addition, the ink coverage changed from one cleaning to the next, adding a variation
which affected the cleaning time. However, poor correlation between time and number of rotations was also found
to exist for facilities that reported consistent ink coverage.
       The trend in the number of rotations necessary to clean a cylinder was also examined to determine if there.
was a learning curve involved with using the alternative cleaners.  While it is believed that there is a learning curve,
the demonstration timetable was too short for this observation, which was further complicated by variable ink
coverage.

                                              G-2

-------
	COST ANALYSIS METHODOLOGY: LITHOGRAPHIC BLANKET WASHES CTSA

Uniform Services, one of the largest industrial laundries in Massachusetts, provided an estimated
lease price of $0.11 per wipe.)
TABLE G-l: SUBSTITUTE BLANKET WASHES, MANUFACTURER PRICING
Blanket Wash Number and Type
Baseline - VM&P Naphtha
1 - Vegetable Fatty Ester
6 - Ester/Petroleum + Surfactant
9 - Ester/Water
10 - Ester/Water
11 - Ester/Petroleum + Surfactant
12 - Petroleum/Water Diluted for Use
14 - Vegetable Fatty Ester + Glycol
19 - Vegetable Fatty Ester + Glycol
20 - Petroleum/Water
21 - Ester/Petroleum
22 - Water/Petroleum/Ester
24 - Terpene
26 - Vegetable Fatty Ester
29 - Vegetable Fatty Ester
30 - Petroleum/ Water Diluted for Use
3 1 - Petroleum
32 - Petroleum
34 - Water/Petroleum/Ester
37 - Petroleum/Water
38 - Ester/Petroleum
39 - Petroleum/Water
40 - Ester/Petroleum + Surfactant
Product Cost per Gallon ($)**
(based on the 55 gallon drum price)($)
5.88
20.00
12.35
10.26
9.55
12.15
16.40
9.55
11.80
10.80
10.08
13.15
17.85
12.24
18.00
5.00
9.80
2.85
15.00
14.80
19.00
8.95
10.25
 ** Unit costs supplied by manufacturers participating in the performance

 Figure G-l shows a graphical display of the relative cost changes (substitute compared to
 baseline) at each facility followed by a summary of the cost comparisons in Table G-2.2 Figure
 G-l illustrates the range of percentage cost changes (compared to the baseline) measured at each
 facility. Two points are plotted for each of the substitute products because each was tested at two
        2 Products 9, 22, and 32 are not included within Figure G-l because VOC content for these products was
 not available.
                                             G-3

-------
 APPENDIX G
 facilities. Formulations are arranged by ascending VOC content.  Cost comparisons for each
 blanket wash against the baseline are provided at the end of this section; summary paragraphs are
 followed by tables providing specific results.  Absolute and relative cost variations are reported
 for each substitute. An increase in the time required to clean the blanket, quantity of wash
 solution used, number of wipes expended, and costs of labor and materials is preceded by a plus
 sign; conversely, decreases are denoted by a minus sign.
200X
150X
4-
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10 30 14 37 2t 24 12 19 29 1 20 34 21 & 39 40 11 3* 31
Formula If umber (sorted by VOC content)



\^-




    FIGURE G-l: BLANKET WASH COSTS CHANGES ARRANGED BY LOWEST
                 TO HIGHEST VOC CONTENT OF FORMULATIONS
Details Related to Data Sources and Methodological Approach

       As mentioned above, the blanket wash cost comparison considered three cost elements
when comparing the performance of baseline and substitute blanket cleaners: labor costs (time x
wage rate); blanket wash use (quantity x unit price), adjusting for dilution; and material and
equipment costs # wipes x cost per wipe). Each element is described in more detail below. Also,
Figure G-2 presents a graphical display of the relative contribution of labor, product use, and
material use to the overall cost differences (compared to the baseline) for each of the substitute
products. For example, performance results for product 1, tested at facility 6 indicate that overall
costs per wash were $0.41 greater for Blanket Wash 6 compared to the baseline. The 40.41
difference is divided up as follows: costs associated with labor were $0.19 higher than the
baseline, costs associated with product use (i.e., price x quantity) were $0.11 greater than the
baseline, and costs associated with material and equipment use were $0.11 greater than the
baseline.
                                          G-4

-------
COST ANALYSIS METHODOLOGY: LITHOGRAPHIC BLANKET WASHES CTSA


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APPENDIX G

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-------
COST ANALYSIS METHODOLOGY: LITHOGRAPHIC BLANKET WASHES CTSA





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-------
APPENDIX G
               1.5
               0.5
              -0.5
1-3   6-11  9-10
   1-6   6-15  9-15
•3   1-1
 10-4  11
                                            13-13  14-6  19-18  30-1
                                Labor
                                            &  13-13 U-16
                                       Formulation. - Facility
                            Product Use
                                        19-19  30-13
Materials
         •6  33-13
          21-17  33-13
             -0.2
                24-16  36-5   39-7
                   24-17 26-15  39-8
                                 30-18  31-7  33-1

                                                  34-1
                                   30-19 31-8  32-5  34-19
                                       Formulation - Facility
                                     37-3  38-2  39-5  40-1
                                        37-4  38-4  39-8  40-10
                                Labor
                           Product Use
Materials
         FIGURE G-2: COST DIFFERENCE BETWEEN SUBSTITUTE AND
                          BASELINE BLANKET WASHES
                                         G-8

-------
	COST ANALYSIS METHODOLOGY; LITHOGRAPHIC BLANKET WASHES CTSA

Labor Costs

The hourly wage and overhead rate for press operators was calculated from the NAPL1993 Cost
Study.  The NAPL study presents a number of facility-specific characteristics, including: annual
wages and overhead costs by press type and brand, number of shifts per day, length of work
week, and vacations and holidays allowed. Because of the many variables impacting hourly
wages and overhead rates, several assumptions were made to facilitate comparisons along the
various alternatives.

Assumptions

•      Based on a review of press sizes used in the performance demonstrations as well as
       discussions with performance demonstration observers, wage rates and overhead
       expenses for a 26-inch, 2-unit press were used in this analysis.

•      The NAPL 1993 Cost Study presents three possible employment scenarios (referred to as
       areas A, B, and C), each with differing wages and overhead costs. The "areas"  are
       defined as follows: (1) area A: 35 hours/week, 4 weeks paid vacation, and 11 paid
       holidays; (2) area B: 37.5 hours/week, 3 weeks paid vacation, and 10 paid holidays; and
       (3) area C: 40 hours/week, 2 weeks paid vacation, and 8 paid holidays. It was assumed
       that press operations at performance demonstrations shops operate under a 40 hour work
       week and are offered 2 weeks paid vacation and  8 paid holidays per year.

•      Annual wages and overhead rates vary according to the number of (eight hour) shifts the
       press facility operates per day. As the number of shifts increase, the wage rate for all
       shifts increases and the overhead rate decreases.  To estimate average wage and overhead
       rates for this analysis, hourly wage estimates and overhead rates were weighted according
       to the proportion of facilities participating in performance demonstrations operating one,
       two or three shifts per day.

•      The NAPL cost study provides overhead expenses for seven brands of presses within the
       26-inch, 2-unit press category. Overhead rates were calculated by averaging across the
       seven brands. Annual wages do not vary across the seven brands of presses.

Hourly -wage rate for a press operator

       As mentioned above, annual wage rates, presented in the NAPL cost study, do not vary
across press type; however, wages do vary according to the number of shifts operated per day.  In
this analysis, a weighted average of $15.52/hour was calculated given that nine of the facilities
that participated in the performance demonstration operate one  shift per day, four facilities
operate two shifts per day, and four facilities operate three shifts per day. Calculations of the
average hourly wage are presented in Table G-3 below.
                                           G-9

-------
 APPENDIX G
TABLE G-3; CALCULATION OF AVERAGE HOURLY RATE
v ^ ' y i- -4 s ^VbJSJte jj j jnfl J.J.JH j j,! fjjpjw j, j j i i i J : w ; ; n w ] fH T< -t-t-w ' t !ji
# Shifts (8 hrs.)
1
2
3
Annual Wage
$31,200
$64,740
$99,060
Hourly Wage
$15.00
$15.56
$15.88
Totals:
Weight (Facilities x shifts)
9
8
12
29
Wage x Weight
$135
$124
$191
$450

Total wage x weight:
Total/29:


$450.04
$15.52
Source: NAPL 1993 Cost Study.

Fringe rate

       To account for costs associated with fringe benefits such as holiday and vacation time, a
fringe rate was calculated. The NAPL Cost Study indicates that press operators working a 40
hour week receive eight paid holidays and two weeks vacation per year. To calculate the fringe
rate, non-productive hours were subtracted from total hours of operation per year (i.e., 2,080
hours minus 144 hours = 1936 hours). The ratio of total hours to productive hours is equal to the
fringe rate applied to each hour worked (2080/193 6 = 1.074).

Overhead rate

       Overhead rates for this analysis are calculated according to the following formula:3

depreciation + rent & heat + fire & sprinkler insurance + pension fund + welfare benefits + payroll taxes + workmen's comp. +
light & power + direct supplies + repairs to equipment + general factory + administrative & selling overhead	
                               direct labor + supervisory and misc. labor
       The NAPL cost study provides overhead expenses for seven brands of presses within the
26-inch, 2-unit press category. For the purposes of this analysis, overhead rates were averaged
across the seven brands. As with the hourly wage calculations, a weighted average was
calculated, accounting for the variability in the number of shifts a facility may operate per day.
The overhead rate was estimated to be 1.99.

Total Labor Cost

       The total labor cost associated with the use of an individual blanket wash was calculated
by multiplying the average cleaning time by the press operator's hourly wage, overhead rate, and
fringe rate. For example, the total labor cost for Blanket Wash 1, tested by facility 3, was
       3 Overhead cost elements were taken directly from the NAPL 1993 Cost Study.

                                            G-10

-------
	COST ANALYSIS METHODOLOGY: LITHOGRAPHIC BLANKET WASHES CTSA

calculated by multiplying the average time spent cleaning (37.5 seconds) by the wage per second
($15.52/60min/60sec4), overhead rate (1.99), and fringe rate (1.074) for a total cost of $0.35 per
wash.

Blanket Wash Use

       Costs attributable to blanket wash use were calculated by multiplying the average
quantity of blanket cleaner used per wash cycle by the price of the appropriate wash.  In cases   .
where participants diluted blanket wash with water, the unit price was multiplied by the ratio of
cleaner used and not the total quantity of the mixture. For example, if the dilution ratio was 1:1,
the unit price of the blanket wash was multiplied by 0.5 to account for dilution and then
multiplied by the volume used. As mentioned above, blanket wash prices were provided by
manufacturers participating hi the performance demonstrations. During the performance
demonstrations it was observed that most printing facilities purchased blanket cleaner in 55-
gallon quantities. This was assumed to be true of all printing facilities participating in the
performance demonstration.

Material arid Equipment Costs

       Because the performance demonstrations were limited to manual blanket washing, the
only materials or equipment affecting the cost of blanket washing were the wipes used by the
press operator to remove ink and paper products.  The cost of press wipes were calculated by
multiplying the average number of wipes used per wash by the lease price of a cloth printer's
wipe.  A representative of Standard Uniform Services, one of the largest industrial laundries in
Massachusetts, estimated  a lease price of $0.11 per wipe.

Waste Disposal

        Because blanket washing wastes may be classified as hazardous wastes by regulations
implementing RCRA and therefore require more careful and costly handling and disposal,
printers may reduce waste disposal costs if wastes associated with alternative blanket washes do
not contain any RCRA listed wastes, eliminating the need to be handled as hazardous waste.5
Disposal costs were not considered in this cost comparison, however, because all but one of the
printers participating in the performance demonstrations use cloth wipes that are leased from an
industrial laundry. Industrial laundries currently do not distinguish between hazardous and
nonhazardous blanket washes when  laundering wipes; it was therefore assumed that there would
be no savings hi waste handling or processing costs associated with switching to an alternative
blanket wash product. In addition, the impact of alternative cleaners on the costs of handling and
processing used wipes is unclear. For example, according to the Uniform and Textile Service
        4 The wage rate of $15.52 per hour translates to $0.0043 per second.

        5 Costs of managing hazardous wastes include placing the waste in a closed and properly labeled
 container, manifesting shipments and using special shipping arrangements, and shipping to a permitted hazardous
 waste treatment or disposal facility.

                                           G-ll

-------
APPENDIX G
Association, wipes impregnated with vegetable-oil based cleaners have a higher potential for
spontaneous combustion when piled together in a laundry bag. Vegetable-oil based cleaners
break down, creating exothermic heat and the potential for spontaneous combustion. In addition,
the vegetable oil-based cleaners may make wastewater treatment and permit compliance more
difficult for the industrial laundry (Dunlap, 1995).

       While there is a potential for reduction in waste treatment and disposal costs attributed to
the use of alternative blanket cleaners, the current state of federal regulations is in flux.  Also,
there are many different state and local regulations which might dictate different treatment for
hazardous blanket wash wastes. Specifically, future changes to RCRA and the Clean Water Act
(CWA) could potentially create a cost advantage for printers using alternative blanket cleaners.
Currently, under RCRA, the mixture rule classifies a non-hazardous waste as hazardous when
combined with a listed waste (F, P, K, and U listed wastes). The mixture rule was struck down
by a 1991 District of Columbia Circuit Court ruling, but was temporarily reenacted while EPA
conducts a review of the rule. EPA has not provided definitive guidance on the treatment of
solvent contaminated shop towels, leaving it to each state to provide guidance on the
identification and management of press wipes.6 Many states have responded by recognizing a
conditional exemption from the mixture rule for contaminated press wipes. EPA's Office of
Solid Waste is currently considering changes to the definition of hazardous and solid wastes that
could potentially exempt press wipes from hazardous waste classification. Also, EPA is
currently developing categorical standards for the industrial laundry industry that could
potentially impact the cost of treating press wipes.
       6  The EPA is planning to develop guidance to the States for the use, reuse, transportation, and disposal of
shop towels.

                                          G-12

-------
            APPENDIX H
ENVIRONMENTAL FATE SUMMARY INITIAL
      REVIEW EXPOSURE REPORT

-------

-------
flNITlAL REVIEW EXPOSURE REPORT I 000075-C
r
Assessor
SAT
Submitter
Seai
Health:
Eco:
Max.P\
(kgfyr)
19-2 Page 1 of:
ch()Y Focus Date:
Eocus Rep:
SAT Rep;
T Manuf.
Import
Use: PRINTING INKS CLUSTER
Consumer
Qno,
( )yes, see consumer exp. page
Analogs/Comments


CBI STAMP
Chemical Name:
DICHLOROMETHANE
Trade Name:
Structure:
1 EBR CRITERIA |
Surface dw ( )y ( )n
Ground dw ( )y ( )n
Ambient Air( )y ( )n
Total rei()y()n
Water rel()y ()n
Consumer ( )y ( )n
                                                H-l

-------


b&nTIAL REVIEW EXPOSURE REPORT | 000075-09-2
Page 2 of:
r""""" NE^-'" CLEAR, COLORLESS VOLATILE LIQUID MWCHK
5rATE MPT, 84.93
MOLWT 84.93
METHOD
PROPERTY Submitted
MP(Q -97.00 --97.00
BP (C) 40.00
@ P (ton)
VP (torr) 340.00
S-H2O (g/L) 17.00
S-Org(g/L)
LogKbw 1.25
pILpKa
Light Absorption (nm) A >290
%<500 FORM CH2C12
% < 1000 CAS.
ICB-CRSS Method/Ref

@ 760 torr

@20C



LogKoc
U'td^tL*^ LogB07 BCF
Solvent: ak-^/yHf^ ^ H(atmm3/mol)
HYDRO i(l/2) @pH 7, 25 C 1000.00 da AERUD

PCGems/EPI
-97.00
26.37 @ 760 torr

7.23E402
16309.850 mg/L
mg/L
1.25
1.38
0.72
3.01E-03

Volatilization (H20) t(l/2) River 1.12 hr Lake 3.73. da
AOPT(t/9)99
CATEGORY
RATING 1 2
Sorption 
Removal ^ unknown high.
BivJi^aJ.tlkw Destruction unknown complete
3 4
strong v.strong
low negligible
moderate ( j^^fiSg^ible"^
partial
Comments:
^_-— 	 -^
AEROBIC BIODEGRADATION ]
t(l/2)
Ultimate <= days <^1weeks
Primary <=days weeks.
months^ > months
months > mont&s
Comments: B (OC^TS— ^^
-------
ENVIRONMENTAL FATE SUMMARY INITIAL REVIEW EXPOSURE REPORT
INITIAL REVIEW EXPOSURE REPORT ij nnnn 7^ _ „mon^
> months
Comments: t/.A-<^tvL^s^^t bs^r^tziJy-Qur- J-^^-^s^L / yea£
=> years
Comments: h -^-dl-^ - ~7oO <^?n.-.^.

SORPTION TO SOIL & SEDIMENT

v.strong
strong
moderate
S^low )
Comments: "•*=r^— -
^^_^=============^_
MIGRATION TO GROUND WATER

negl
slow(^((
Comments: CJL^^^c. <^(A^ 4~*&&t^^X7,
I
VOLATILIZATION Rivers
(w/ sediment) Lakes


negl
negl
moderate
ragid))


slow
sloyt^^'

^- 	 .
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:==moderate^)
rapid^_^
MMMWrtB^^MM—
rapid
Comments:

PHOTOLYSIS A. Direct
B. Indirect
\
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slow
slow
Comments: ~£:(l[-^ "•? ( v*su~- /lL (&XL~~+r0^^,

J^^, JL.fr* ^*±*=&ss§^- lv-7',0"1^ -4^fci -7^-4^ cd~M
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rapid




	 : 	 	 	 7 . j

                  H-3

-------

-------
                APPENDIX I
RISK, COMPETITIVENESS & CONSERVATION DATA
    SUMMARY AND SOCIAL BENEFITS/COSTS
      ASSESSMENT: LITHOGRAPHY CTSA

-------

-------
       Earlier sections of the lithography CTSA evaluated the risk and performance of the
baseline blanket wash as well as the alternatives. These data provide the basis for comparing the
benefits and costs of using the alternative blanket washes instead of the baseline.  Relevant data
include: worker health risks, public health risks, flammability risks, ecological risks, energy and
natural resource use, volatile organic compound (VOC) content, and labor, materials, and
product costs. Each is discussed in turn below.

Worker Health Risks

       The majority of substitute formulations, as well as the baseline, present some concern for
dermal exposure, driven primarily by high exposure levels. The dermal exposure estimates
provide an upper-bound estimate which no worker is expected to exceed because the exposure
assessment assumes that no gloves or barrier creams are used by workers when cleaning a
blanket. Worker inhalation risks are very low for nearly all of the blanket wash products due to
low or negligible exposure levels. Only one of the substitute formulations (Blanket Wash 3)
triggered inhalation concerns. The components of all other substitute products present low or no
concern. The baseline presents low inhalation concern. Table 1-1 presents a summary of worker
risks beginning with the baseline product, VM&P Naphtha.  The risk assessment assumed that
components of concern present a greater risk than components of low to moderate concern, and
components of low to moderate present a greater risk than components of low concern, and so on
(no/low concern < low to moderate concern < concern).
TABLE 1-1: SUMMARY OF RISK CONCLUSIONS OF SUBSTITUTE AND BASELINE
.BLANKET WASH CLEANERS
Formula
Number
Baseline
(28)
1
3
4
5
6
Chemicals Identified as a Concern in the
Risk Assessment
Hydrocarbons, petroleum distillates
No individual chemicals of concern identified
Hydrocarbons, aromatic
Hydrocarbons, aromatic
Hydrocarbons, aromatic
Terpenes
Ethoxylated nonylphenols
Hydrocarbons, aromatic
Ethoxylated nonylphenol
Propylene glycol ethers
Hydrocarbons, petroleum distillates
Hydrocarbons, aromatic
Fatty acid derivatives
Alkyl benzene sulfonates
Worker Health Risk
Dermal
concern
no/low concern11
concern
concern
concern
concern
no/low concern
concern
no/low concern
concern
concern
moderate concern3
no/low concernb
no/low concernb
Inhalation
no/low concern
no/low concern"
no/low concern
concern
no/low concern
no/low concern
no/low concern'
no/low concern
no/low concernb
no/low concern
no/low concern
no/low concern*1
no/low concern15
no/low concern1"
                                          1-1

-------
APPENDIX I
TABLE 1-1: SUMMARY OFRISK CONCLUSIONS OF SUBSTITUTE AND BASELINE
BLANKET WASH CLEANERS
Formula
Number
7

8
9
10
11
12
14
16
17
18
19
20
21
Chemicals Identified as a Concern in the
Risk Assessment
Terpenes
Ethoxylated nonylphenol
Propylene glycol ethers
Ethoxylated nonylphenol
Hydrocarbons, aromatic
Ethoxylated nonylphenol
Fatty acid derivatives
Fatty acid derivatives
Hydrocarbons, petroleum distillates
Hydrocarbons, aromatic
Alkyl benzene sulfonates
Hydrocarbons, petroleum distillates
Hydrocarbons, petroleum distillates
Fatty acid derivatives
Propylene glycol ethers
Terpenes
Glycols
Ethoxylated nonylphenol
Alkali/salts
Fatty acid derivatives
Hydrocarbons, petroleum distillates
Dibasic esters
Alkyl benzene sulfonates
Esters/lactones
Propylene glycol ethers
Fatty acid derivatives
Hydrocarbons, petroleum distillates
Alkyl benzene sulfonates
Hydrocarbons, aromatic
Hydrocarbons, aromatic
Hydrocarbons, petroleum distillates
Fatty acid derivatives
Worker Health Risk
Dermal
concern
no/low concern
concern
no/low concern
moderate concern"
no/low concern
no/low concern"
no/low concern11
concern
moderate concern3
no/low concern"
concern
low to moderate concern"
no/low concern"
no/low concern"
concern
no/low concern
no/low concern
no/low concern
possible concern
concern
concern
no/low concern"
no/low concern"
no/low concern"
no/low concern"
concern
no/low concern"
moderate concern"
concern
concern
no/low concern"
Inhalation
no/low concern
no/low concern1"
no/low concern
no/low concernb
no/low concern13
no/low concern13
no/low concern1"
no/low concernb
no/low concern
no/low concern13
no/low concern11
no/low concern
no/low concern"
no/low concern13
no/low concernb
no/low concern
no/low concern
no/low concern13
no/low concern13
no/low concern1"
no/low concern
no/low concern
no/low concern"
no/low concern"
no/low concern"
no/low concern13
no/low concern
no/low concern"
no/low concern"
no/low concern
no/low concern
no/low concern"
                                      1-2

-------
DATA SUMMARY AND SOCIAL BENEFITS/COSTS ASSESSMENT
TABLE 1-1; SI3MMARY GFRISK CONCLUSIONS OF SUBSTITUTE ANI> BASELINE
BLANKET WASH CLEANERS
Formula
Number
22
23
24
25
26
27
29
30
31
32
33
34
35
Chemicals Identified as a Concern in the
Risk Assessment
Hydrocarbons, aromatic
Fatty acid derivatives
Terpenes
Nitrogen heterocyclics
Alkyl benzene sulfonates
Terpenes
Ethylene glycol ethers
Ethoxylated nonyiphenol
Terpenes
Esters/lactones
Esters/lactones
Esters/lactones
Fatty acid derivatives
Terpenes
Fatty acid derivatives
Hydrocarbons, aromatic
Propylene glycol ethers
Hydrocarbons, aromatic ,
Hydrocarbons, petroleum distillates/
Hydrocarbons, petroleum distillates
Hydrocarbons, aromatic
Hydrocarbons, petroleum distillates
Propylene glycol ethers
Terpenes
Alkoxylated alcohols
Fatty acid derivatives
Hydrocarbons, petroleum distillates
Hydrocarbons, aromatic
Hydrocarbons, petroleum distillates
Worker Health Risk
Dermal
moderate concern3
no/low concern"
possible concern
possible concern
concern
concern
possible concern
no/low concern
concern
possible concern
concern
no/low concern
no/low concern3
concern
no/low concern*
concern
no/low concern*
concern
low to moderate concern3
low to moderate concern3
concern
concern
no/low concern
concern
no/low concern
no/low concern3
low to moderate concern3
concern
low to moderate concern3
Inhalation
no/low concern3
no/low concern3
no/low concern
no/low concern
no/low concern1"
no/low concern
no/low concern
no/low concern1"
no/low concern
no/low concern
no/low concern1"
no/low concern1"
no/low concern1"
no/low concern
no/low concern1"
no/low concern
no/low concern3
no/low concern
no/low concern3
low to moderate
concern3
no/low concern
no/low concern
no/low concern
no/low concern
no/low concern
no/low concern1"
no/low concern3
no/low concern
no/low concern3
          1-3

-------
APPENDIX I
TABLE 1-1: SUMMARY OFRISK CONCLUSIONS OF SUSsfrTUTE AND BASELINE
BLANKET WASH CLEANERS
Formula
Number
36
37
38
39
40
Chemicals Identified as a Concern in the
Risk Assessment
Hydrocarbons, petroleum distillates
Hydrocarbons, aromatic
Propylene glycol ethers
Fatty acid derivatives
Hydrocarbons, aromatic
Hydrocarbons, petroleum distillates
Hydrocarbons, petroleum distillates
Fatty acid derivatives
Alkoxylated alcohols
Hydrocarbons, petroleum distillates
Hydrocarbons, petroleum distillates
Propylene glycol ethers
Alkanolamines
Ethylene glycol ethers
Hydrocarbons, petroleum distillates
Ethoxylated nonylphenol
Hydrocarbons, aromatic
Fatty acid derivatives
Worker Health Risk
Dermal
concern
moderate concern3
no/low concern
no/low concern"
possible concern
low to moderate concern"
low to moderate concern"
no/low concern"
no/low concern"
low to moderate concern
concern
concern
concern
possible concerns
concern
no/low concern
moderate concern"
no/low concern"
Inhalation
no/low concern
no/low concern1"
no/low concern
no/low concern1"
no/low concern
no/low concern"
no/low concern3
no/low concern1"
no/low concern
no/low concern3
no/low concern
no/low concern
no/low concern1"
no/low concern
no/low concern
no/low concern1"
no/low concern1"
no/low concern1"
                                                                      of concern for this chemical

                                                                      of concern for this chemical
a) Risks for these chemicals in this product could not be quantified; therefore, the level
is based upon a structure-activity analysis of potential hazard.
b) Risks for these chemicals in this product could not be quantified; therefore, the level
is based upon a low risk call based on estimates of no or extremely low exposure.

Public Health Risks
       In addition to worker exposure, members of the general public may be exposed to blanket
wash chemicals due to their close physical proximity to a printing facility or due to the wide
dispersion of chemicals. Individuals in the general public that are exposed to blanket wash
chemicals are potentially subject to health risks.  The EPA risk assessment identified no concerns
for the general public through ambient air, drinking water, or fish ingestion due to use of blanket
washes.  Using the model facility approach, the general population exposure assessment
predicted that exposure levels would be extremely low for all media examined.  Because of the
low exposure levels, no concerns were identified for the general public from the use of blanket
wash chemicals.
                                             1-4

-------
                               DATA SUMMARY AND SOCIAL BENEFITS/COSTS ASSESSMENT
Flammability Risk

       Some blanket wash chemicals in this assessment present risks of fire and explosion
because of their flammability and high volatility. In order to assess the relative fire hazard of the
substitute and baseline blanket washes, the flash points of each product is compared to OSHA
and EPA definitions of flammable liquids.1 Flammable liquids are defined by OSHA as having a
flash point less than 141 °F. Similarly, EPA defines RCRA ignitable wastes (40 CFR 261.21) as
having a flash point of 140°F or less. Table 1-2 presents the flash points of the baseline as well
as the alternative blanket washes. Flash points were developed as part of the performance
demonstration.
TABLE 1-2: RELATIVE FLAMMABILITY RISK OF SUBSTITUTE AND BASELINE
BLANKET WASHES
Blanket Wash
Baseline (28)
1
3
4
5
6
7
8
9
10
11
12
14
16
17
18
19
20
21
Flash Point (°F)
50
230+
114
114
139
152
165
115
230+
230+
150
125
230+
145
220+
150
230+
170
115
Blanket Wash
22
23
24
25
26
27
29
30
31
32
33
34
35
36
37
38
39
40

Flash Point (°F)
157+
140
100
220+
230+
145
230+
100+
105
220
105
138
105
175
82
230+
155
155

       1  Flash point is defined as the lowest temperature at which a liquid gives off vapor within a test
vessel in sufficient concentration to form an ignitable mixture with air near the surface of the liquid.
                                           1-5

-------
APPENDIX I
Ecological Risk

       The EPA risk assessment evaluated the ecological risks of the substitute products as well
as the baseline blanket wash; in the analysis for this CTSA, only the risks to aquatic species
were considered.  Evaluation of aquatic risks involved comparing a predicted ambient water
concentration to a "concern concentration" for chronic exposures to aquatic species using a
hypothetical receiving stream (a relatively small stream at low flow conditions). The concern
concentration is expressed in mg/L water. Exposure concentrations below the concern
concentration are assumed to present low risk to aquatic species.  Exposures that exceed the
concern concentration indicate a potential for adverse impact on aquatic species. The following
formulations were found to pose a risk to aquatic species: Blanket Washes 3, 5, 6, 8, 11, 18, and
20. All the chemicals of concern are amine salts of an alkybenzene sulfonate.  Switching to these
substitutes would likely increase aquatic risks rather than decrease them. The baseline product
was not identified as creating an aquatic species risk.

Energy and Natural Resource Use

       The life cycle of any product begins with the extraction of raw materials from the
environment, and continues through the manufacture, transportation, use, recycle, and disposal of
the product. Decisions at each stage of a product's life will impact its energy and natural
resource demand. A previous section of the CTSA presented a discussion describing the issues
to consider when cleaning the blanket and purchasing blanket washes but does not analyze the
individual energy and natural resource requirements of the substitute and baseline washes due to
various data limitations. The issues discussed include: (1) optimization of the washing technique
to reduce blanket wash use, press wipe use, and waste print runs; (2) derivation of blanket wash
products from non-renewable (petroleum and natural gas) and renewable (plant products)
chemical raw materials (it is not clear, however, which raw materials demand the least energy
and natural resources without a full life-cycle analysis); (3) lack of differentiation between
products in terms of energy consumption during the product formulation process because the
same basic processes are used to formulate all blanket wash products; and (4) reduction in
packaging requirements and transportation/distribution energy consumption due to the use of
concentrated formulations, assuming the products are diluted by the printer. A thorough
quantitative evaluation of each life-cycle stage was beyond the scope of the CTSA.

VOC Releases

       The VOC content of the alternative and the baseline blanket washes was independently
tested by the GATF laboratory in Pittsburgh, Pennsylvania. VOCs are currently regulated under
clean air legislation occupational exposure rules and toxics use and release reporting laws;
therefore, substitution of high VOC cleaners has the potential to reduce the regulatory burden for
printers. Table 1-3 presents a summary of the relative VOC content of the baseline and
alternative blanket washes.
                                           1-6

-------
                               DATA SUMMARY AND SOCIAL BENEFITS/COSTS ASSESSMENT
TABLE 1-3: VOC CONTENT OF THE SUBSTITUTE AMD BASELINE BLANKET WASHES
Blanket Wash
Baseline (28)
1
3
4
5
6
7
8
9
10
11
12
14
16
17
18
19
20
21
VOC Contemt
(lbs/gal;% by weight)
6.2; 100%
2.3; 30%
6.4; 91%
6.4; 89%
2.5; 30%
3. 5; 47%
3.0; 36%
3.3; 41%
0.11; 10%
0.16; 2%
4.3; 61%
1.3; 20%
0.97; 12%
7.2; 99%
0.051; 0.6%
4.4; 60%
1.8; 22%
2.7; 35%
3. 5; 47%
Blanket Wash
22
23
24
25
26
27
29
30
31
32
33
34
35
36
37
38
39
40

VOC Content
(% by weight)
Not measured; 2.17%
0.48; 6%
1.5; 19%
4.1; 55%
1.3; 18%
7.2; 93%
2.1; 30%
0.48; 7%
6.6; 99%
6.5; 99%
3 A; 46%
2.8; 39%
6.7; 99%
3.5; 48%
1.0; 14%
4.9; 65%
2.9; 37%
3.8; 52%

Performance

       The performance of each of the substitute blanket washes as well as the baseline was
demonstrated using both laboratory and production run tests. The laboratory tests determined the
flash point, VOC content, and pH and demonstrated the blanket swell and wipability of each
product.  The production run tests, conducted at two facilities for each of the substitute products
and at all facilities for the baseline, collected information such as quantity of wash used, time
spent to wash the blanket, ink coverage, and the effectiveness of the wash.  Summary results are
presented in Table 1-4. The widely variable conditions between and within printing facilities and
the short duration of the production runs used for the performance demonstrations does not allow
the results to be interpreted as definitive performance assessments of the blanket washes.
                                           1-7

-------
APPENDIX I






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-------
DATA SUMMARY AND SOCIAL BENEFITS/COSTS ASSESSMENT






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-------
APPENDIX I
       Prior to testing the blanket washes in a print shop, the 36 substitute blanket washes were
tested in the laboratory for blanket swell potential and wipability.  Of the 36 washes, 22 were
deemed to be satisfactory for demonstrations at volunteer printing shops (two shops
demonstrated each blanket wash). The results of the performance demonstrations were highly
variable between the two print shops using a particular blanket wash and among the many
blanket washes themselves.  Performance varied to a great extent based on the amount of ink
coverage. Excluding trials with heavy ink coverage, 11 washes gave good or fair performances
at both facilities, 7 washes gave good or fair performance at one facility but not the other, and the
remaining 4 washes performed poorly at both facilities.

Labor. Materials, and Product Costs

      The costs of using each of the substitute blanket washes as well as the baseline depends
on variations in labor costs, product use, and material and equipment use at each facility that
participated in the performance demonstrations.  Each substitute blanket wash product was tested
by two facilities. The baseline product was tested by all facilities. Costs for each product are
presented on a per wash basis, a per press basis, and a cost per press/shift/year basis. In
comparing the cost data for the substitute and the baseline products, the costs of using the
substitute blanket cleaners exceed the cost of using the baseline product in nearly all cases. In
some cases smaller quantities of wash or less cleaning time was required, resulting in a cost
savings when using the substitute instead of the baseline wash. (Blanket Washes 26, 32, 37, and
40 resulted in costs savings relative to the baseline product. Overall, however, the costs of using
the substitute blanket washes exceed the costs of using the baseline wash in the large majority of
cases. Costs associated with using the substitute blanket washes range from a low of $ 1.72 to a
high of $8.80 per press.2 Costs of using the baseline product range from $1.64 to $3.64 per press.
Where costs of the alternative blanket washes exceed the baseline, percentage cost increases
range from 1 percent to 179 percent.) Table 1-5 presents a summary of the cost comparisons.

      Disposal  costs were not considered in this cost comparison because all but one of the
printers participating in the performance demonstrations use cloth wipes that are leased from an
industrial laundry.  Many industrial laundries currently do not distinguish between hazardous and
nonhazardous blanket washes when laundering wipes; therefore, it was assumed that there would
be no savings in  waste handling or processing costs associated with switching to a substitute
blanket wash product.
cleaned.
         Presses are assumed to have four units; therefore, four blankets are washed each time a press is
                                          MO

-------
DATA SUMMARY AND SOCIAL BENEFITS/COSTS ASSESSMENT


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                                DATA SUMMARY AND SOCIAL BENEFITS/COSTS ASSESSMENT
Introduction to Social Benefit/Cost Assessment

       Social benefit/cost analysis is a tool used by policy makers to systematically evaluate the
impacts to all of society resulting from individual decisions.  The decision evaluated in this
analysis is the choice of a blanket wash product. Printers have certain criteria which they use to
evaluate the benefits and costs of alternative blanket cleaners such as price, drying time,
flexibility of use for rollers and blankets, propensity to cause blanket swell, etc. A printer might
ask what impact their choice of blanket washes will have on  operating costs, compliance costs,
liability costs, and insurance premiums.  This business planning process is unlike social
benefit/cost analysis, however, because it approaches the comparison from the standpoint of the
individual printing firm and not from the standpoint of society. A social benefit/cost analysis
seeks to compare the benefits and costs of a given action, considering both the private and
external costs and benefits.3 Therefore, the analysis will consider the impact of the alternative
blanket cleaners on operating costs, regulatory costs, and insurance premiums, but will also
consider the external costs and benefits of the alternative blanket cleaners such as reductions in
environmental damage and reductions in the risk of illness for the general public. External costs
are not borne by the printer, however; they are true costs to society.

       Benefits of the substitute blanket cleaners may include private benefits such as increased
profits resulting from improved worker productivity, a reduction in employee sickness, or
reduced property and health insurance costs and external benefits such as  a reduction in
pollutants emitted to the environment or reduced use of natural resources. Costs of the substitute
blanket cleaners may include private costs such as higher operating expenses resulting from a
higher priced blanket wash and external costs such as increase in human health risks and
ecological damage.  Several of the benefit categories considered in this analysis share elements
of both private and external costs and benefits.  For example, use of the substitute blanket washes
may result in energy and natural resource savings.  Such a benefit may result in private benefits
in the form of reduced product usage and waste print runs as well as external benefits in the form
of reduced consumption of non-renewable resources.

Benefit/Cost Methodology

       The methodology for conducting a social benefit/cost assessment can be broken down
into four general  steps: (1) obtain information on the relative performance, human and
environmental risk, process safety hazards, and energy and natural resource requirements of the
       3 Private costs include any direct costs incurred by the decision maker and are typically reflected
in the firm's balance sheet. In contrast, external costs are incurred by parties other than the primary
participants to the transaction.  Economists distinguish between private and external costs because each
will affect the decision maker differently. Although external costs are real costs to some members of
society, they are not incurred by the decision maker and firms do not normally take them into account
when making their decisions.  A common example of external costs is the electric utility whose
emissions are reducing crop yields for the farmer operating downwind. The external costs incurred by
the farmer in the form of reduced crop yields are not considered by the utility when deciding how much
electricity to produce. The farmer's losses do not appear on the utility's balance sheet.

                                            1-13

-------
APPENDIX I
baseline and the alternatives; (2) construct matrices of the data collected; (3) when possible,
monetize the values presented within the matrices; and (4) compare the data generated for the
alternative and the baseline in order to produce an estimate of net social benefits.  The Findings
section presents the results of the first task by summarizing the performance data, risk data, and
energy and natural resource information for the baseline and the alternative blanket washes.  In
Table 1-5 the data required to make a determination of the relative costs and benefits of switching
to an alternative blanket wash are organized according to formulation number, beginning with
the baseline. Ideally, the analysis would quantify the social benefits and costs of using the
substitute and baseline blanket wash products, allowing identification of the substitute product
whose use results in the largest net social benefits. However, because of data limitations and
production facility variations, the analysis presents instead a qualitative description of the risks
associated with each substitute product compared to the baseline. Benefits derived from a
reduction in risk are described and discussed, but not quantified; the information provided can be
very useful in the decision making process. A few examples are provided to quantitatively
illustrate some of the benefit considerations. Personnel in each individual facility will have to
examine the information presented, weight each piece according to facility and community
characteristics, and develop an independent choice.

       The analysis is further developed in the following sections, beginning with summaries of
the potential risks of the substitute and baseline blanket washes. Associated Costs provides a
summary of the  financial costs of the baseline and the alternative blanket washes, Costs  and
Benefits by Formulation compares the benefits and costs of using the substitute blanket wash
products instead of the baseline wash, and Potential Benefit of Avoiding Illness Linked to
Exposure to Chemicals Commonly Used in Blanket  Washing provides an indication of the
minimum benefits per affected person that would accrue to society if switching to substitute
blanket wash products reduced cases of certain adverse health effects.
 TABLE 1-6: COSTS AND BENEFITS OF BASELINE AND SUBSTITUTE BLANKET WASHES
 Formula
 Number
                Private Cost'
          Average Cost/Press    %
                            Change
             Private Benefits
     Worker Risk
      Trade-offs
                                   Low to moderate concern for
                                   dermal and inhalation
                                   exposure/
                                   Overall concern is low for
                                   dermal and inhalation
                                   exposure."1
Flammability
   Riskb
                       High risk
                       Low risk
voc
             99%
             30%
                      External
                      Benefits
Environmental
     Risk
      No estimated risk
      No estimated risk
                                   Concern for dermal exposure
                                   and inhalation.
                       Moderate risk
             91%
      Aquatic species
      risk
                  Not tested
Concern for dermal exposure
and very low concern for
inhalation exposure.
Moderate risk
 89%
No estimated risk
                                           1-14

-------
DATA SUMMARY AND SOCIAL BENEFITS/COSTS ASSESSMENT
TABLE 1-6: COSTS AND BENEFITS OF BASELINE AND SUBSTITUTE BLANKET WASHES
5
6

7
8
9

10
11
12
14
16
17
19
20
Not tested
Alternative: 3.28
Baseline: 2.80
Alternative: 3.08
Baseline: 2.00
+17
+54
Not tested
Not tested
Alternative: 8.32
Baseline: 3.64
Alternative: 3.68
Baseline: 2.00
Alternative: 2.28
Baseline: 8.80
Alternative: 8.80
Baseline: 3.40
Alternative: 5.16
Baseline: 2.36
Alternative: 2.72
Baseline: 2.12
Alternative: 3.96
Baseline: 3.20
Alternative: 3.32
Baseline: 3.20
Alternative: 4.28
Baseline: 1.84
Alternative: 3.28
Baseline: 2.64
+129
+84
+4
+159
+119
+28
+22
+4
+133
+24
Not tested
Not tested
Alternative: 6.64
Baseline: 2.48
Alternative: 3.56
Baseline: 2.12
Alternative: 4.52
Baseline: 2.80
Alternative: 6.32
Baseline: 3.24
+168
+68
+61
+95
Concern for dermal exposure
and very low concern for
nhalation exposure.
Concern for dermal exposure
and very low concern for
nhalation exposure.
Concern for dermal exposure
and very low concern for
nhalation exposure.
Concern for dermal exposure
and very low concern for
nhalation exposure.
Very low concern for dermal
exposure and no concern for
nhalation exposure.11
Very low concern for dermal
exposure0 and no concern for
nhalation exposure."1
Concern for dermal exposure
and very low concern for
inhalation exposure.
Concern for dermal exposure
and low concern for inhalation
exposure.0
Low concern for dermal and
inhalation exposure.0
Concern for dermal exposure
and very low concern for
inhalation exposure.
Possible concern for dermal
exposure and very low
concern for inhalation
exposure.11
Low concern for dermal and
inhalation exposure.0

Concern for dermal exposure
and low concern for inhalation
exposure.0
Moderate Risk
^ow risk
jOW risk
Moderate risk
Low risk
Low risk
Low risk
Moderate risk
Low risk
Moderate risk
Low risk
Low risk
Low risk
30%
47%
36%
41%
10%
2%
61%
20%
12%
99%
0.6%
22%
35%
Aquatic species
isk
Aquatic species
isk
No estimated risk
Aquatic species
isk
No estimated risk
No estimated risk
Aquatic species
risk
No estimated risk
No estimated risk
No estimated risk
No estimated risk
No estimated risk
Aquatic species
risk
           1-15

-------
APPENDIX I
TABLE 1-6: COSTS AND BENEFITS OF BASELINE AND SUBSTITUTE BLANKET WASHES
21
22
23
24
25
26
27
29
30

31

32

33
Alternative: 4.04
Baseline: 1.84
Alternative: 2.32
Baseline: 1.64
Alternative: 3.28
Baseline: 3.24
Alternative: 6.04
Baseline: 3.20
Not tested
Alternative: 3.88
Baseline: 2.64
Alternative: 3.52
Baseline: 1.64
+120
+41
+1
+89

+47
+115
Not tested
Alternative: 2.92
Baseline: 2.20
Alternative: 1.88
Baseline: 2.00
+33
-6
Not tested
Alternative: 3.72
Baseline: 2.28
Alternative: 3.56
Baseline: 2.20
Alternative: 4.04
Baseline 2.48
Alternative: 2.48
Baseline: 2.12
Alternative: 6.36
Baseline: 2.28
Alternative 2.36
3aseline: 2.20
Alternative: 5.24
Baseline: 2.36
Alternative: 1.72
Baseline: 2.12
+63
+62
+63
+17
+179
+7
+122
-19
Not tested
Concern for dermal exposure
and very low concern for
inhalation exposure.
Moderate concern for dermal
exposure0 and low concern for
inhalation exposure.1*
Possible concern for dermal
exposure and very low
concern for inhalation
exposure.
Concern for dermal exposure
and very low concern for
inhalation exposure.
Concern for dermal exposure
and very low concern for
inhalation exposure.
Concern for dermal exposure
and no concern for inhalation
exposure.11
Concern for dermal exposure
and very low concern for
inhalation exposure.
Low concern for dermal
exposure" and no concern for
inhalation exposure.*1
Concern for dermal exposure
and low concern for inhalation
exposure.0
Concern for dermal exposure
and low concern for inhalation
exposure.0
^ow to moderate concern for
dermal and inhalation
exposure.0
Concern for dermal exposure
and very low concern for
nhalation exposure.
Moderate risk
Low risk
Moderate risk
Moderate risk
Low risk
Low risk
Moderate risk
Low risk
Moderate risk
Vloderate risk
Low risk
Vloderate risk
47%
17%
6%
19%
55%
18%
93%
30%
7%
99%
99%
46%
No estimated risk
No estimated risk
No estimated risk
No estimated risk
No estimated risk
No estimated risk
No estimated risk
No estimated risk
No estimated risk
No estimated risk
No estimated risk
••To estimated risk
                                    1-16

-------
                                 DATA SUMMARY AND SOCIAL BENEFITS/COSTS ASSESSMENT
TABLE 1-6: COSTS AND BENEFITS OF BASELINE ANJ> SUBSTITUTE BLANKET WASHES
34
35
36
37
38
39
40
Alternative: 3.56
Saseline: 2.36
Alternative: 3.80
Baseline: 2.12
+51
+79
Not tested
Not tested
Alternative: 1.92
Baseline: 2.20
Alternative: 3.16
Baseline: 3.40
Alternative: 4.32
Baseline: 2.12
Alternative: 4.44
Baseline: 3.40
Alternative: 2.76
Baseline: 2.20
Alternative: 3.20
Baseline: 2.20
Alternative: 3.16
Baseline: 2.36
Alternative: 3.48
Baseline: 3.64
-13
-7
+104
+31
+25 1
+45
+34
-4
Concern for dermal exposure
and low concern for inhalation
exposure."
Concern for dermal exposure
and low concern for inhalation
exposure.
Concern for dermal exposure
and low concern for inhalation
exposure.0
Low to moderate concern for
dermal exposure and low
concern for inhalation
exposure.0
Low to moderate concern for
dermal exposure and low
concern for inhalation
exposure.0
Concern for dermal exposure
and very low concern for
inhalation exposure.
Concern for dermal exposure
and low concern for inhalation
exposure.*1
Moderate risk
Moderate risk
Low risk
High risk
Low risk
Low risk
Low risk
39%
99%
48%
14%
65%
52%
52%
No estimated risk
No estimated risk
No estimated risk
No estimated risk
No estimated risk
No estimated risk
No estimated risk
£^i V^iJHL CUlCll V oJLo Uaa&U. tll-'fJ.l LM.VJVIVI.WV JLVX/JLJL w-i. j-iiw-jn-w v*u Mw>>Ma. **»**«.—•—. ** j -..-.— j-—• -. — —	,	              ^
facilities and pricing submitted by the product supplier. See Chapter 4 for a more in-depth description of the cost
analysis and descriptions of the testing facilities.
b) Flammability risks are defined as follows: (1) High Risk: products with a flash point less than 100 °F; (2)
Moderate Risk: products with a flash point greater than 100 °F but less than 150 °F; and (3) Low Risk: products with
a flash pouit greater than 150 °F.
c) Risks for this chemical could not be quantified; therefore, the level of concern for this chemical is based upon a
structure-activity analysis.
d) Risks for this chemical could not be quantified; therefore, the level of concern for this chemical is based solely
upon estimated exposure levels.

Potential Benefits

       The potential social benefits associated with the use of a substitute blanket cleaner versus
the baseline wash include: reduced health risks for workers and the general public, reduced risk
of fire and explosion due to lower flammability, reduced ecological risks, reduced use of energy
and natural resources, and reduced VOC emissions. In order to assess the risk to workers, the
EPA risk assessment combines hazard and exposure data for individual chemical components of
the substitute as well as the baseline products into a single qualitative expression of risk.  This
qualitative expression of risk provides the basis for comparing the relative worker exposure risks
associated with the use of the substitute blanket wash products as compared with the baseline.
                                               1-17

-------
 APPENDIX I
 While members of the general public are also potentially at risk from blanket wash chemicals
 that are released to air and water, the EPA risk assessment identified no concerns for the general
 public through ambient air, drinking water, or fish ingestion. Due to data limitations, the
 exposure assessment does not estimate cumulative exposures from landfill releases or septic
 system releases. The relative risks of fire and explosion are determined by comparing the flash
 point of each blanket wash, using the OSHA definition of a flammable liquid as well as EPA's
 definition of an ignitable waste as a benchmark. In addition to the risks faced by workers and the
 general public, the risk assessment considers the potential ecological risks of using each of the
 alternative products and the baseline blanket wash. Several of the substitute formulations were
 found to present a risk to aquatic species. The energy and natural resource requirements of the
 substitute and the baseline blanket wash vary and a full life-cycle assessment, which was beyond
 the scope of this CTSA, would be needed to determine the requirements. The risks associated
 with VOC releases were not examined within the risk assessment; however, the relative VOC
 contents of the substitute formulations are discussed below since VOC releases are the primary
 driving factor behind current regulations affecting printers.

 Reduced Worker Health Risks

       Reduced risks to workers can be considered both a private and an external benefit.
 Private worker benefits include reductions in worker sick days and reductions in health insurance
 costs to the printer. External worker benefits include reductions in medical costs to workers as
 well as reductions  in pain and suffering associated with work related illnesses. The EPA risk
 assessment considers two paths of worker exposure: inhalation and dermal. Inhalation exposure
 results from the volatilization of blanket  wash chemicals from the blanket during washing and
 from the rags used to wipe down the blanket. Dermal exposure results from direct contact with
 the blanket wash chemicals during blanket cleaning. Worker dermal exposure to all products can
 be easily minimized by using proper protective equipment such as gloves or barrier creams
 during blanket cleaning.  Worker health risks associated with the use of any blanket wash
 product are a function of both the product's toxicity as well as the degree of worker exposure
 which occurs during blanket cleaning.  For example, the worker health risks associated with the
 use of a more toxic blanket wash may be reduced by the product's low volatility (i.e., reduced
 inhalation exposure) or workplace practices such as the use of automatic blanket cleaning
 technology (i.e., reduced dermal exposure). The exposure assessment estimates worker exposure
 (dermal and inhalation) for each of the blanket wash products. The risk assessment evaluates the
 toxicity of the individual blanket wash components for the substitute and baseline products and
 integrates the hazard  and exposure information into a single qualitative  expression of risk. The
 risk assessment does  not provide a single measure of risk for the products overall, making it
 difficult hi some cases to determine the relative risk from one product to another. For example,
 Blanket Wash 22 contains heavy aromatic solvent naphtha and fatty acid esters which were
 determined to posses moderate dermal concern and low dermal concern, respectively.

 Reduced Public Health Risk

      In addition to  worker exposure, members of the general public may be exposed to blanket
wash chemicals due to their close physical proximity to a printing facility or due to the wide

                                          1-18

-------
                               DATA SUMMARY AND SOCIAL BENEFITS/COSTS ASSESSMENT
dispersion of chemicals. Such releases impose an external cost on society that is typically not
considered by printing facilities in selecting their blanket wash. For example, people may breath
blanket wash vapors that have been released from a printing facility or people may drink
water containing blanket wash residues discharged by a facility. Individuals in the general public
that are exposed to blanket wash chemicals are therefore potentially subject to health risks. The
EPA risk assessment identified no concerns for the general public through ambient air, drinking
water, or fish ingestion. Using the model facility approach, the general population exposure
assessment predicted that exposure levels would be extremely low for all media examined.
Because of the low exposure levels, no concerns were identified for the general public from the
use of blanket wash chemicals.

Reduced Flammability Risk

       Some blanket wash chemicals in this assessment present risks of fire and explosion
because of their flammability and high volatility (Tables 1-2 and 1-3). Reduced flammability risk
may result in both private and external benefits. Private benefits may accrue to the printer in the
form of lower risk of fire damage to the print shop. The population surrounding the print shop
may experience external benefits in the form of lower risks of fire damage to their homes.
In order to assess the relative fire hazard of the substitute and baseline blanket washes, the flash
points of each product is compared to OSHA and EPA definitions of flammable liquids.4
Flammable liquids are defined by OSHA as having a flash point less than 141 °F.  Similarly, EPA
defines RCRA  ignitable wastes (40 CFR 261.21)  as having a flash point of 140 °F or less. The
baseline product has a flash point of 50 °F, well below OSHA and EPA standards. Several of the
substitute blanket washes have flash points below the OSHA and EPA thresholds: Blanket
Washes 3,4, 5, 8, 12, 21, 23, 24, 30, 31, 33, 34, 35, and 37.

Reduced Ecological Risk

       Blanket wash formulations are potentially damaging to terrestrial and aquatic ecosystems,
resulting in external costs borne by society. The EPA risk assessment evaluated the ecological
risks of the substitute products as well as the baseline blanket wash; however, only the risks to
aquatic species were considered. Reductions in aquatic species risks may create external benefits
by increasing the catch per unit effort for commercial fishers as well as by increasing
catch and participation rates of recreational fishers. The following formulations were found to
pose a risk to aquatic species: Blanket Washes 3, 5, 6, 8,11,18, and 20. All the chemicals of
concern are amine salts of an alkylbenzene sulfonate. Switching to these substitutes would likely
increase aquatic risks rather than decrease them.  The baseline product was not identified as
creating an aquatic species risk.
        4  Flash point is defined as the lowest temperature at which a liquid gives off vapor within a test
 vessel in sufficient concentration to form an ignitable mixture with air near the surface of the liquid.

                                           1-19

-------
 APPENDIX I
 Energy and Natural Resource Conservation

       Benefits may accrue to society (external) as well as the printer (private) in the form of
 energy and natural resource savings if substitute blanket washes are substituted for the baseline
 wash. For example, Blanket Wash 34 was found to require fewer impressions to get back to
 acceptable print quality than with the baseline wash, thereby consuming less paper and energy.
 A similar situation may occur with press wipes.  By switching to the substitute blanket wash, the
 printer might experience lower energy and resource costs.  At the same time, society would also
 benefit from the printer's reduction in energy and natural resource use. However, the analysis of
 energy and resource conservation did not estimate the individual energy and natural resource
 requirements of the substitute and baseline washes due to various data limitations.  A thorough
 quantitative evaluation of each life-cycle stage was beyond the scope of the CTSA.

 Reduced VOC Releases

       The reduction of VOCs within the pressroom can potentially result in private benefits
 including lower compliance costs and savings on insurance premiums, as well as external
 benefits including a safer work environment and reduced health effects outside of the facility.5
 VOCs are currently regulated under clean air legislation as well as toxics use and release
 reporting laws and, therefore, were not re-evaluated as part of the risk assessment.  Because there
 are several sources of VOCs within any given print shop, no attempt was made to quantify the
 benefits associated with an incremental reduction in the release of blanket wash VOCs.
 However, case studies are available documenting the potential benefits of VOC reduction
 throughout the pressroom. For example, the Commonwealth of Massachusetts Office of
 Technical Assistance found that Hampden Papers of Holyoke, Massachusetts experienced
 savings by reducing VOCs (97 percent reduction over a ten year period).6 Hampden Papers, by
 adopting a source reduction strategy, has avoided the need to purchase VOC collection and
 control equipment or explosion-proof mixers for inks and coatings containing VOCs. In
 addition, they have incurred significant savings in fire insurance premiums, and reduced their
 liability under Superfund, air regulations, OSHA, RCRA, and other laws (OTA, no date).  VOC
 content of the baseline as well as the alternative formulations, as measured by the GATF
 laboratory, are presented in Table 1-3.  VOC content ranges from a low of 2 percent to a high of
 99 percent. The baseline product and Blanket Wash 31 have the highest VOC content (99
percent).
       5  A successful VOC reduction strategy cannot be limited to blanket washes. All sources of VOC
releases (i.e., inks, coatings, etc.) within the print shop must be evaluated in order to design and
implement an efficient emissions control plan.

       6  For a copy or further information about this case study, contact: Office of Technical
Assistance (OTA), Executive Office of Environmental Affairs, 100 Cambridge Street, Boston, MA
02202, or phone OTA at (617) 727-3260.

                                          1-20

-------
                               DATA SUMMARY AND SOCIAL BENEFITS/COSTS ASSESSMENT
Associated Costs

       As discussed previously, in comparing the cost data for the alterative and the baseline
products, the costs of using the alternative blanket cleaners exceed the cost of using the baseline
product in nearly all cases. Some cases required smaller quantities of wash or less cleaning time,
resulting in a cost savings when using the substitute instead of the baseline wash. (Blanket
Washes 26, 32, 37, and 40 resulted in costs savings relative to the baseline product.  Overall,
however, the costs of using the substitute blanket washes exceed the costs of using the baseline
wash in the large majority of cases.  Costs of the using the substitute blanket washes range from
a low of $1.72 to a high of $8.80 per press.  Costs of using the baseline product range from $1.64
to $3.64 per press. Where costs of the alternative blanket washes exceed the baseline, percentage
cost increases range from 1 percent to 179 percent.)

Costs and Benefits by Formulation

       The objective of a social benefit/cost assessment is to identify those products or decisions
that maximize net benefits. Ideally, the analysis would quantify the social benefits and costs of
using the substitute and baseline blanket wash products in terms of a single comparable unit (i.e.,
dollars) and calculate the net benefits of using the substitute instead of the baseline product. Due
to data limitations, however, the analysis presents a qualitative description of the risks associated
with each product compared to the baseline. Table 1-7 compares the relative risks and costs of
each substitute blanket wash to the baseline. While this table presents a comparison between the
blanket washes and the substitutes, it is important to keep in mind that not all of the risk
assessments are based on risk (comprised of both exposure and hazard) but that some of the
assessments are based solely on a hazard call based upon a structure-activity analysis. A
frowning face (©) indicates an increase in cost, worker health risks, flammability, risk to aquatic
species, or VOC content when using the substitute blanket wash instead of the baseline product.
A smiling face (©) indicates a reduction in cost, worker risk, flammability, aquatic species risk,
or VOC content when using the substitute instead of the baseline product. A zero (o) indicates
that the risk assessment identified no difference in relative risks when using the substitute
blanket cleaner instead of the baseline. Because the risk assessment evaluated individual blanket
wash components, the relative worker health risks are based upon the component that poses the
highest degree of concern.  For example, components of Blanket Wash 32 were determined to
pose no or low concern (propylene glycol ethers) and concern (aromatic and petroleum distillate
hydrocarbons); therefore, the overall dermal risk of Blanket Wash 32 is one of concern. Blanket
Wash 32 is shown to have similar relative dermal risks to workers when compared to the
baseline because the baseline product's component of highest concern poses concern (i.e.,
petroleum distillate hydrocarbons).7

       In nearly every case the substitute product costs more to use than the baseline. There
were several products whose used was determined to decrease dermal worker health risks; these
       7 The risk classification scheme should be interpreted as follows: no/low concern < low to
 moderate concern< concern.

                                           1-21

-------
APPENDIX I
were Blanket Washes 13 9, 10, 14,17,19,22, 23, 29, 37 and 38. Formulation 10 was found to
increase costs by less than 10 percent for one of the facilities. The few products that did show
evidence of reduced costs, had mixed results in terms of their relative health risks. For example,
Blanket Wash 37, which was found to be less expensive to use than the baseline, was found to
reduce worker dermal risks but was neutral in terms of relative inhalation risk. Blanket Washes
26 and 40 showed evidence of reduced costs; in addition, the risk assessment found that worker
dermal risks were similar for both products over the baseline. In addition, while Blanket Wash
32 was less expensive than the baseline at one facility, it was found to present increased
dermal and inhalation risks over the baseline. All of the substitute products had lower flash
points and, therefore, reduced flamniability risk when compared to the baseline. Finally, three
Blanket Washes (6,11, and 20) had higher aquatic risks than the baseline.
TABLE 1-7: RELATIVE BENEFITS AND COSTS OF SUBSTITUTE VS BASELINE
BLANKET WASH8
Formula
Number
1
3
4
5
6
7
8
9
10
11
12
14
16
17
18
19
20
21
22
23
24
Cost/Press
Facility #1
©
Facility #2
©
Not tested
Not tested
Not tested
©
©
Not tested
Not tested
©
©
®
©
©
©
©
©
©
©
Not tested
Not tested
Not tested
©
©
©
©
©
©
©
©
Not tested
©
©
Worker Health Risk
Dermal
©
0
o
o
o
o
o
©
©c
0
o
©<=
o
©
o
©<=
o
o
©<=
©
0
Inhalation
0°
©
o
o
o
o
o
o
o
o
0
o
o
o
o
o
o
o
0
o
o
-.( ' •> !
Flammability
Risk
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Risk to
Aquatic
Species
o
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o
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o
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0
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                                          1-22

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                               DATA SUMMARY AND SOCIAL BENEFITS/COSTS ASSESSMENT
TABLE 1-7: RELATIVE BENEFITS AND COSTS OF SUBSTITUTE VS BASELINE :
BLANKET WASH8 ;
25
26
27
29
30
31
32
33
34
35
36 :
37
38
39
40
Not tested
®
©
Not tested
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©
©
©
©
©
©
©
Not tested
©
©
Not tested
Not tested
©
©
©
©
©
©
©
©
o
o
o
©
o
o
©
o
o
o
0
o
©
©
o
o
0
o
o
o
o
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0
o
o
o
o
o
o
o
©
©
©
©
©
©
©
©
©
©
©
©
©
©
©
o
o
o
o
o
o
o
o
0
o
o
o
0
o
0
©
©
o
©
©
o
o
©
©
o
©
©
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Potential Benefit of Avoiding Illness Linked to Exposure to Chemicals Commonly Used
in Blanket Washing

       As mentioned above, the risk assessment did not link exposures of concern to adverse
health outcomes.  Data do exist, however, on the cost of avoiding or mitigating certain illnesses
that are linked to exposures to blanket wash chemicals.  Such cost estimates indicate potential
benefits associated with switching to less toxic products. Health endpoints potentially associated
with blanket wash chemicals include: eye irritation, headaches, nausea, and asthma attacks.  The
following discussion presents estimates of the economic costs associated with each illness. To
the extent that blanket wash chemicals are not the only factor contributing toward the illnesses
described, individual costs may overestimate the potential benefits to society from substituting
alternative blanket cleaners; also, this is not a comprehensive list of the potential health effects of
exposure to blanket washes. For instance, inks and other pressroom chemicals may also
contribute toward adverse worker health effects. The following discussion focuses on the
external benefits of reductions in illness: reductions in worker medical costs as well as reductions
in pain and suffering related to worker illness.  However, private benefits, accrued by the
decision-maker, may be incurred through increased worker productivity and a reduction in
liability and health care insurance costs. While reductions in insurance premiums as a
result of pollution prevention are not currently widespread, the opportunity exists for changes in
the future.
                                          1-23

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APPENDIX I
       Often adverse health effects are experienced when working with chemicals.  For example,
press operators at facility 12 experienced nausea and dizziness when using Blanket Wash 20, a
petroleum based blanket wash containing petroleum distillates and aromatic hydrocarbons. In
addition, Blanket Wash 20 aggravated a previously existing respiratory condition in one press
operator. The economic literature provides estimates of the costs associated with eye irritation,
headaches, nausea, and asthma attacks, each of which may result from exposure to blanket wash
chemicals. An analysis summarizing the existing literature on the costs of illness estimates
individual willingness-to-pay to avoid certain acute effects for one symptom day (Unsworth and
Neumann, 1993). The estimates for eye irritation, headaches, nausea, and asthma attacks are all
based upon a survey approach designed to illicit estimates of individual willingness-to-pay to
avoid a given illness. Such surveys, when properly designed, should capture direct treatment
costs, indirect costs, and costs associated with pain and suffering.  As eye irritation, headaches,
nausea, and asthma attacks typically occur  as short-term, discrete incidents, cost estimates
represent an individual's willingness-to-pay to avoid a single incidence and not the average
lifetime cost of treating a disease. Table 1-8 presents a summary of the low, mid-range, and high
estimates of individual willingness-to-pay to avoid each of these health endpoints. These
estimates provide an indication of the benefit per affected individual that would accrue to society
if switching to a substitute blanket wash product reduced the incidence of eye irritation,
headaches, nausea, and asthma attacks.
TABLE 1-8: ESTIMATED WILLINCNESS-TO-PAY TO AV0TO MOBmWTY EFFECTS
FOR Om SYMPTOM DAY (1995 DOLLARS)
Health Eudpoint
Eye Irritation"
Headacheb
Nausea*
Asthma Attack0
Low ($)
20.79
1.67
29.11
15.62
Mid-Range ($)
20.79
13.23
29.11
42.96
High ($)
46.14
66.72
83.66
71.16
a) Tolley, G.S., et al. January 1986. Valuation of 'Reductions in Human Health Symptoms and Risks. University of
Chicago. Final Report for the U.S. EPA. As cited in Unsworth, Robert E. and James E. Neumann, Industrial
Economics, Incorporated, Memorandum to Jim DeMocker, Office of Policy Analysis and Review, Review of
Existing Value of Morbidity Avoidance Estimates: Draft Valuation Document. September 30, 1993.
b) Dickie, M., et al. September 1987. Improving Accuracy and Reducing Costs of Environmental Benefit
Assessments.  U.S. EPA, Washington, DC and Tolley, G.S., et al. Valuation of Reductions in Human Health
Symptoms and Risks. January 1986.  University of Chicago.  Final Report for the U.S. EPA. As cited in Unsworth,
Robert E. and James E. Neumann, Industrial Economics, Incorporated, Memorandum to Jim DeMocker, Office of
Policy Analysis and Review, Review of Existing Value of Morbidity Avoidance Estimates: Draff Valuation
Document.  September 30, 1993.
c) Rowe, R.D. and L.G. Chestnut. March 1985.  Oxidants and Asthmatics in Los Angeles: A Benefit Analysis.
Energy and Resource Consultants, Inc.  Report to U.S. EPA, Office of Policy Analysis. EPA-230-07-85-010.
Washington, DC. Addendum March 1986. As cited in Unsworth, Robert E. and James E. Neumann, Industrial
Economics, Incorporated, Memorandum to Jim DeMocker, Office of Policy Analysis and Review, Review of
Existing Value of Morbidity Avoidance Estimates: Draft Valuation Document. September 30, 1993.
                                             1-24

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            APPENDIX J
COST OF ILLNESS VALUATION METHODS

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        Several approaches are available to estimate the economic benefits of reduced morbidity
effects associated with pollution releases, including: contingent valuation, averting behavior,
hedonic valuation, and cost of illness approaches.  Table J-l provides a brief summary of each.
                  TABLE J-l: COST OF ILLNESS VALUATION METHODS
        Valuation Method
                         Description
 Contingent Valuation Approach
The contingent valuation approach uses a survey to illicit
estimates of individual willingness-to-pay to avoid a given illness.
The contingent valuation technique, when properly designed,
should capture direct treatment costs, indirect costs, and costs
associated with pain and suffering.
 Cost of Illness Approach
The cost of illness approach estimates the direct medical costs
associated with an illness and will sometimes include the cost to
society resulting from lost earnings. Cost of illness studies do not
account for pain and suffering, the value of lost leisure time, or the
costs and benefits of preventive measures.
 Hedonic Valuation Approach
Hedonic valuation studies use regression analysis to estimate the
relationship between environmental improvement or reduced
worker risk and other independent variables. For example, a
hedonic wage study may attempt to describe the relationship
between wage rates and job related risks (i.e., what is the premium
required to compensate workers for the added risk they incur from
their occupation). The weakness of the hedonic approach is based
upon the difficulty in separating illness effects from other
independent variables.
 Averting Behavior Approach
The averting behavior method examines preventive measures
undertaken to avoid exposure or mitigate the effects of illness.
Investments made in preventive measures are then used as a proxy
for individual willingness-to-pay to avoid a particular illness.
Source: Unsworth, Robert E. And James E. Neuman, Industrial Economics, Incorporated, Memorandum to Jim
DeMocker, Office of Policy Analysis and Review, Review of Existing Value of Morbidity Avoidance Estimates:
Draft Valuation Document. September 30, 1993.
                                              J-l
                                                           * U. S. GOVERNMENT PRINTING OFFICE: 1997-422-460/60549

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  ISBN 0-16-048959-8
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