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Tiêu đề Understanding, Managing, and Reviewing Environmental Risk Assessment Reports
Tác giả Sally L. Benjamin, David A. Belluck
Trường học Not specified
Chuyên ngành Environmental Risk Assessment
Thể loại Guide
Năm xuất bản 2001
Thành phố Boca Raton
Định dạng
Số trang 42
Dung lượng 739,22 KB

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A Practical Guide to Understanding, Managing,and Reviewing Environmental Risk Assessment Reports... Belluck A Practical Guide to Understanding, Managing, and Reviewing Environmental Risk

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A Practical Guide to Understanding, Managing,

and Reviewing

Environmental Risk Assessment

Reports

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LEWIS PUBLISHERS

Boca Raton London New York Washington, D.C.

Edited by

Sally L Benjamin David A Belluck

A Practical Guide to Understanding, Managing,

and Reviewing Environmental Risk Assessment

Reports

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This book contains information obtained from authentic and highly regarded sources Reprinted material

is quoted with permission, and sources are indicated A wide variety of references are listed Reasonable efforts have been made to publish reliable data and information, but the author and the publisher cannot assume responsibility for the validity of all materials or for the consequences of their use.

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The consent of CRC Press LLC does not extend to copying for general distribution, for promotion, for creating new works, or for resale Specific permission must be obtained in writing from CRC Press LLC for such copying.

Direct all inquiries to CRC Press LLC, 2000 N.W Corporate Blvd., Boca Raton, Florida 33431.

Trademark Notice: Product or corporate names may be trademarks or registered trademarks, and are used only for identification and explanation, without intent to infringe.

Visit the CRC Press Web site at www.crcpress.com

© 2001 by CRC Press LLC Lewis Publishers is an imprint of CRC Press LLC

No claim to original U.S Government works International Standard Book Number 1-56670-448-0 Library of Congress Card Number 00-048667 Printed in the United States of America 1 2 3 4 5 6 7 8 9 0

Printed on acid-free paper

Library of Congress Cataloging-in-Publication Data

A practical guide to understanding, managing, and reviewing evironmental risk assessment reports / Sally L Benjamin, David A Belluck, editors.

p cm.

Includes bibliographical references and index.

ISBN 1-56670-448-0 (alk paper)

1 Environmental risk assissment I Benjamin, Sally II Belluck, David.

GE145 P73 2000

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We wish to thank the 31 other professionals, who shared our vision of a prehensive, general guide to environmental risk assessment, for their dedication tothe idea and for their patience as our manuscript went through several iterations

com-We owe special thanks to Ruth Hull, who gave freely of her ideas, professionalcontacts, and support Without her, this book would not have been possible Wethank our peer-reviewers and readers, most especially Dr Hiai Rothmann We alsoacknowledge the contribution of Steven David, who has successfully implementedmany of the ideas in this book

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Extreme care has been taken in preparation of this work However, neither thepublisher, editors, nor authors shall be held responsible or liable for any damageresulting in connection with or arising from the use of any of the information inthis book

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George Anderson, B.A., M.A., C.H.M.M., is the Director of EnvironmentalCompliance & Safety at US Filter Recovery Services Inc., 2430 Rose Place,Roseville, Minnesota 54701, one of Minnesota's largest hazardous waste recycling,treatment, and storage facilities Mr Anderson has a Bachelors degree in Biologyand Chemistry and a Master’s degree in Biology from St Cloud State University

Mr Anderson has 29 years of professional experience in industry, consulting, ernment, and utilities He currently serves as the President of the Minnesota Chem-ical Technology Alliance, the Chemical Manufacturers Association, State of Min-nesota Affiliate Mr Anderson has testified on hazardous waste management issuesbefore the Wisconsin State Legislature, the Minnesota Waste Management Board,and has represented the waste management industry before the U.S EPA and theU.S Congress

gov-Carol Baker, M.S., M.A is Senior Consultant at ENTRIX, Inc., 5252 ter, Suite 250, Houston, Texas 77005 She is Manager of Environmental Sciencesand, for the past 10 years, she has worked in human health risk assessments underCERCLA, RCRA, UST and Voluntary Cleanup Programs Ms Baker earned herBachelor of Arts degree in Wildlife Management from North Carolina State Uni-versity, a Master of Science in Fisheries Science/Aquaculture from Louisiana StateUniversity, and a Masters of Arts in Science Education from North Carolina StateUniversity

Westches-David A Belluck, B.S., Ph.D., is a toxicologist and risk assessor with morethan 30 years experience in public health and environmental science Dr Belluck isprincipal toxicologist for Risk Writers, Ltd., 3108 46th Avenue South, Minneapolis,Minnesota 55406 Dr Belluck provides expert services for litigation in the areas oftoxicology, environmental risk, and the history of science Dr Belluck publishesextensively on risk assessment, toxicology, and groundwater protection His currentresearch interests include historical toxicology of manufactured gas plants andimproved project management techniques for risk assessment and public decision-making He is a member of the National Advisory Committee to the U.S EPA onAmbient Exposure Guideline Levels (AEGLs) Dr Belluck earned his Bachelor ofScience degree from Cornell University and his Ph.D from the University of Illinois

Sally L Benjamin, M.S., J.D., is an environmental scientist and attorney withmore than 25 years of professional experience in environmental policy, naturalresources management, and public dispute resolution Ms Benjamin’s firm, RiskWriters, Ltd., 3108 46th Avenue South, Minneapolis, Minnesota 55406, conductshistorical and technical research for environmental litigation and provides expertservices in toxicology, environmental science, and the history of science Ms Ben-jamin earned her Bachelor of Arts in Biology, Mansfield State College, Pennsylvania,her Master of Science from the Institute for Environmental Studies, University ofWisconsin-Madison, and her Juris Doctorate from the University of Minnesota She

is a member of the Hennepin County Bar and of the Minnesota and the WisconsinState Bar Associations Her research interests include environmental impacts of localland use planning, interrelationships of transit, traffic and urban air quality, manu-

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factured gas plant history, and the role of environmental science in litigation, publicpolicy, legislation, and regulation.

Bruce Braaten, P.E., J.D., works for the Minnesota Pollution Control Agency

in Winona, Minnesota, and he teaches environmental law at the University of nesota Mr Braaten earned his Juris Doctorate from the William Mitchell School ofLaw and his Bachelor of Science and Master of Science degrees in engineering fromthe University of Minnesota

Min-Jan W Briede, Ph.D (New Mexico State University) is a biologist with Dames

& Moore, 644 Linn Street, Suite 501, Cincinnati, Ohio 45203 He has more than

20 years of experience in ecology and ecosystem modeling world-wide (Africa, theMiddle East, Asia, Europe, and the U.S.) Presently, Dr Briede supports clients infields such as: project management, ecological risk assessments, decision supportsystems, ecological inventories, wetland issues, ecosystem restoration, permitting,and environmental site assessments

Gary J Burin, Ph.D., D.A.B.T., Associate Director of the Toxicology Division,Technology Sciences Group, Inc., 1101 17th Street, N.W., Suite 500, Washington,D.C 20038, earned his Bachelor of Science in Biology and M.P.H in Toxicologyfrom the University of Michigan and his Ph.D in Biology, with a Pharmacologyminor, from George Washington University He coordinated much of the interna-tional work surrounding OECD, WHO and the EC, particularly the harmonization

of data requirements, study interpretation, and risk assessment Dr Burin authoredthe WHO document, “Environmental Health Criteria Document 104 — Principlesfor the Toxicological Assessment of Pesticide Residues in Food,” and the U.S EPA’s

“Standard Evaluation Procedures” for the evaluation of chronic reproductive anddevelopmental toxicity studies He has served on national committees under theNational Toxicology Program and the Office of Science and Toxicology and haslectured at the Universities of Sienna, Italy, and Surrey, England, as a Diplomate ofthe American Board of Toxicology

Rick D Cardwell, Ph D., Parametrix, Inc., 5808 Lake Washington Blvd N.E.,Kirkland, Washington 98052, is an ecotoxicologist with 30 years experience studyingthe fate and effects of chemicals and wastes in the environment He has authoreddozens of ecological risk assessments, including two primers on ecorisk assessmentmethodologies

Robert Craggs, M.S., J.D., is Senior Director of Environmental Services forR.W Beck, Minneapolis Office, 1380 Corporate Center Curve, Suite 305, St Paul,Minnesota 55121 Mr Craggs earned his Juris Doctorate and Master of Sciencedegrees from the University of Iowa

John P Cummings, Ph.D., C.H.M.S., R.E.A., R.E.P., J.D., P.O Box 2847,Fremont, California 94536, is a chemist, environmental engineer, teacher, andattorney with over 30 years of experience in environmental project management,remedial design, and implementation of environmental programs and policies Hehas a strong background in hazardous/toxic waste management, UST work, includ-ing pollution abatement implementation, solid waste management, resourcesrecovery and recycling, asbestos assessment, lead audits and clean-up, and legalaspects of OSHA and U.S EPA litigation and product liability He also has an

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extensive technical background in chemistry, ceramic, paper, and plastic materials.

He is a patentee and author of more than 40 papers

Maxine Dakins, Ph.D., is an Assistant Professor of Environmental Science atthe University of Idaho, Idaho Falls, Idaho, 83402 Dr Dakins teaches courses inuncertainty analysis, the sampling and analysis of environmental contaminants, andnatural resources policy Her research interests include various aspects of uncertaintyanalysis including Bayesian Monte Carlo Analysis and uncertainties related to mea-suring contaminants at trace levels

Clifford S Duke, M.A., Ph.D., a Senior Environmental Analyst at The ronmental Company, Inc., 1611 North Kent Street, Suite 900, Arlington, Virginia

Envi-22209, earned his Bachelor of Science degree in Biology at the University of Vermontand graduate degrees in public policy analysis (M.A.) and botany (Ph.D.) at DukeUniversity He has prepared ecological risk assessments and managed NationalEnvironmental Policy Act documents for Department of Energy and Department ofDefense facilities nationwide Dr Duke is a past-president of the Ohio Valley Chapter

of the Society of Environmental Toxicology and Chemistry and is an active ipant in risk assessment standardization efforts of the American Society for Testingand Materials

partic-Nava C Garisto, Ph.D., is Senior Scientist at SENES Consultants Limited, 121Granton Drive, Unit 12, Richmond Hill, Ontario, Canada L4B 3N4 Dr Garisto has

20 years of scientific and consulting experience and has published more than 60journal publications and reports relating to environmental model development, masstransport of radionuclides and toxic contaminants and environmental risk assessment

Guy L Gilron, M.Sc., R.P.Bio., is a Senior Project Manager (Ecotoxicology)with ESG International Inc., 361 Southgate Drive, Guelph, Ontario, Canada, N1G3M5 Mr Gilron has conducted environmental effects assessment of naturalresources in North America, the Caribbean, South America, and the Middle East.Moreover, he has conducted ecotoxicological valuations in large- and small-scaleenvironmental programs He is an experienced environmental biologist, with a focus

on aquatic toxicology and ecology, and with expertise in ecological risk assessments,aquatic community structure analyses, toxicological research, ecological inventories,and water quality assessments for aquaculture

Michael E Ginevan, Ph.D., is president of M.E Ginevan & Associates, 307Hamilton Avenue, Silver Spring, Maryland 20901 Dr Ginevan’s firm providesinterdisciplinary statistical consultation for the health and environmental sciences.301-585-4951; Fax: 301-585-1350; e-mail: mginevan@cais.com or MGINE-VAN@worldnet.att.net

Laura C Green, Ph.D., D.A.B.T., is a Senior Scientist and President of bridge Environmental, Inc., 58 Charles Street, Cambridge, Massachusetts 02141,and Lecturer in the Division of Toxicology at the Massachusetts Institute of Tech-nology Dr Green has performed original research, published, and consulted in theareas of chemical carcinogenesis, toxicology and pharmacology, food chemistry,analytical chemistry, risk assessment, and regulatory policy Prior to founding Cam-bridge Environmental, Dr Green was Senior Vice President at Meta Systems Inc.and the founder and director of Meta’s Environmental Health and Toxicology group

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She also served as Research Director of the Scientific Conflict Mapping Project atthe Harvard University School of Public Health, during which time she coauthoredthe text, In Search of Safety: Chemicals and Cancer Risk Dr Green currentlyspecializes in: performing qualitative and quantitative assessments of health andenvironmental risks; providing toxicologic and other technical expertise designed toaid in regulatory compliance and in decision-making; providing and directing sci-entific support for litigation and other matters; and teaching toxicology Dr Greenholds a B.A from the Department of Chemistry at Wellesley College (1975) and aPh.D from the former Department of Nutrition and Food Science (currently theDivision of Bioengineering and Environmental Health) at the Massachusetts Institute

of Technology (1981) She is a diplomate of the American Board of Toxicology(D.A.B.T.)

Carol “Griff” Griffin, M.S., Ph.D., is an Assistant Professor in NaturalResources Management at Grand Valley State University, 218 Padnos Hall, Allen-dale, Michigan 49401-9403 Professor Griffin teaches courses in natural resourcepolicy, water resources, environmental policy, environmental science, and environ-mental ethics Her research interests include public participation in natural resourcemanagement, nonpoint source pollution modeling, and the role of error in GISmodeling Dr Griffin earned her M.S and Ph.D in Environmental Science from theState University of New York — College of Environmental Science and Foresty

Donald R Hart, M.S., Ph.D., Senior Ecologist at Beak International rated, 14 Abacus Road, Brampton, Ontario, Canada, L6T 5B7, has 15 years of postdoctoral research and consulting experience and over 30 journal publications andreports in aquatic ecology, ecotoxicology, and ecological risk estimation Dr Hartearned his Ph.D in Environmental Biology from Tulane University and both hisMaster of Science and Bachelor of Science degrees in Zoology from the University

Incorpo-of Manitoba

Ruth N Hull, M.Sc., is a Risk Assessment Specialist at CANTOX MENTAL INC., 2233 Argentia Road Suite 308, Mississauga, Ontario, Canada, L5N2X7 Ms Hull earned a Masters of Science in Ecotoxicology from ConcordiaUniversity and a Bachelor of Science in Biology from the University of Waterloo,Waterloo, Ontario Ms Hull oversaw contractor-produced risk assessment reportswhile working for the State of Minnesota's Pollution Control Agency and Oak RidgeNational Laboratory (ORNL) She has been the lead ecological risk assessor onseveral risk assessments for contaminated sites across North America

ENVIRON-Colleen J Dragula Johnson, M.S., D.A.B.T., 5815 Redford Drive, #E, field, Virginia 22152, provides general toxicology services relating to the Food andDrug Administration and the U.S EPA, including summarizing toxicity data forinvestigation of new drug applications

Spring-Wendy Reuhl Jacobson, B.S., M.S., of Colorado Springs, Colorado, earned herdegrees in Natural Resources from the University of Wisconsin in poultry geneticsand in Natural Resources Management from the University of Alaska, Fairbanks,where she investigated the readability and graphic content of federal environmentalimpact statements Ms Jacobson’s research article, "The Typography of Environ-mental Impact Statements: Criteria, Evaluation, and Public Participation" was pub-lished in Environmental Management in January 1993

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Robert A Kreiger, M.S., Ph.D., 9414 North 84th Street, Stillwater, Minnesota

55082, earned his Master of Science Degree in Epidemiology from the University

of Michigan and a Doctor of Philosophy in Environmental Health from the University

of Minnesota Dr Kreiger has over a decade of experience in risk assessment andhas conducted epidemiological studies of worker cohorts and residential populations,and has researched the use of chromosomal damage biomarkers to characterizeoccupational and public exposures and the use of immunoassay methods for screen-ing worker exposure to pesticides

Jeanette H Leete, Ph.D., is the Supervisor of the Technical Analysis Group inthe Ground Water Unit of the Minnesota Department of Natural Resources in St.Paul Minnesota 55155 Dr Leete is a Licensed Professional Geologist in the State

of Minnesota, a certified Professional Hydrogeologist (American Institute of ogy) and a Certified Professional Geologist (American Institute of ProfessionalGeologists) Dr Leete received her doctoral degree from the University of Minnesota

Hydrol-Kathy Malec, M.S., is an environmental librarian with more than a decade ofexperience in technical library research Ms Malec earned her Master of Sciencedegree in Library Science from the University of Minnesota She is a Librarian/Infor-mation Specialist with the Minnesota Pollution Control Agency and has worked as

a librarian for private consulting firms and in academia, prior to entering state service

Wayne Mattsfield, B.S., has over a decade of professional experience in stategovernment, as a Minnesota Department of Health environmental laboratory analyst,laboratory certification officer and quality assurance officer, and Minnesota PollutionControl Agency quality assurance coordinator for federal and state Superfund sites

Mr Mattsfield earned his Bachelor of Science degree in Biology, with emphasis inMicrobiology, from St Cloud State University Mr Mattsfield is currently in privateconsulting and can be reached at 16123 Harvard Lane, Lakeville, Minnesota 55044

William Phillips, B.A., M.S., is Senior Project Director & General Manager,Environmental Strategies Corporation, 123 North 3rd Street, Suite 706, Minneapolis,Minnesota 55401 Mr Phillips is widely experienced in environmental and regulatorytoxicology, risk assessment, environmental claims, investigation and remediation ofhazardous waste sites, environmental fate and transport, and evaluation of environ-mental impairment He earned his Master of Science in Environmental Toxicologyfrom the University of Minnesota and his Bachelor of Arts degree in Biology andHistory from Macalester College He publishes in environmental remediation andprovides expert services for environmental litigation

Mark W Rattan, J.D., is an attorney with Litchfield Cavo, 303 West MadisonStreet, Suite 200, Chicago, Illinois 60606 Mr Rattan practices insurance coverageand insurance defense litigation He earned his Juris Doctorate from Loyola Uni-versity He is licensed to practice in Wisconsin and Illinois He is a member of theState Bar of Wisconsin, the Chicago Bar Association, and the Milwaukee BarAssociation

Bruce T Rodgers, M.Sc., P.Eng., Senior Environmental Engineer, Beak sultants Limited, 14 Abacus Road, Brampton, Ontario, Canada, L6T 5B7 Mr.Rodgers specializes in the analysis of natural receiving water systems He has beeninvolved extensively in environmental impact assessments, numerical model studies,and field monitoring planning for marine and freshwater environments In particular,

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Mr Rodgers has been involved in the application and interpretation of sional numerical models for predicting physical, hydraulic, thermal, and water qual-ity characteristics of receiving waters He earned his Bachelor of Science in Geo-technical Engineering from the University of Toronto and his Master of Science inCoastal Engineering from Queen’s University.

multi-dimen-Richard A Rothstein, C.C.M., Q.E.P., is Senior Air Quality Consultant forRAR Associates, 46 Liberty Street, North Andover, Massachusetts 01845 Mr Roth-stein earned his Bachelor of Science in Meteorology from Rutgers University, andhis Master of Science in Meteorology and Air Resources Engineering from NewYork University He has more than 25 years of diversified project management andtechnical expertise in air quality impact assessment; environmental pollution controland permitting; facility siting and design; and regulatory review, compliance plan-ning and agency negotiation for waste processing, power generation, and industrialprojects

Bradley E Sample, Ph.D., is a Senior Wildlife Toxicologist and Ecological RiskAssessor with CH2M HILL (2485 Natomas Park Dr., Suite 600, Sacramento, Cal-ifornia 95833) Dr Sample holds a Bachelor of Science in Wildlife Biology fromWest Virginia University, a Master of Science degree in Entomology from theUniversity of Delaware, and a Doctorate of Philosophy in Wildlife Toxicology fromWest Virginia University Dr Sample has more than a decade of experience in wildlifetoxicology and ecological risk assessment emphasizing development of models andmethods for estimation of bioaccumulation, exposure, and effects in birds andmammals, as well as other ecological receptors

David Weitz is a Public Affairs Manager with the Wisconsin Department ofNatural Resources, N902 910th St., Mondovi, Wisconsin 54755 Mr Weitz workedfor thirteen years as a newspaper reporter During more than two decades as a publicinformation officer and public affairs manager he has managed communications onnumerous emergency response efforts, including large train derailments, massivetire fires, and chemical releases He has served as information officer for the Wis-consin Law Enforcement Task Force on tribal fishing and for the U.S Forest Service

on major forest fires and Texas Forest Service in emergency fire prevention programs

Jeanne C Willson, Ph.D., D.A.B.T., M.B.A, is a toxicologist with her own firm,Global Environmental Strategies, P.O Box 3492, Englewood, Colorado 80155,

http://www.mindspring.com/~jwillson Dr Willson earned her Ph.D at Cornell versity and her M.B.A (International Business) at the University of Colorado,Denver She has over 15 years of experience in toxicology, chemical safety, riskassessment, and risk management Her work at mining, smelting, and metals disposalsites has included metals risk assessment, blood lead and urinary arsenic studies,metals bioavailability, IEUBK (lead) model evaluation and application, plant uptake

Uni-of metals, quantitative uncertainty analysis, and evaluation Uni-of ecological benchmarksand measurements She is also experienced in radiological risk assessment (espe-cially radon), air emissions and deposition modeling, groundwater quality, andcarcinogen risk assessment Dr Willson has managed or reviewed hundreds of humanhealth and ecological risk assessments of hazardous waste and occupational chemicalexposure at Superfund and RCRA sites and operating facilities of all types, includinglandfills and incinerators Her interest in international environmental policy has taken

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her to Russia many times, including a visit for a NATO conference on air pollution.

an M.S (1985) and Ph.D (1989) from the Massachusetts Institute of Technology,all in the field of Mechanical Engineering

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Human Health Risk Assessment 29

David A Belluck and Sally L Benjamin

Chapter 3

Ecological Risk Assessment 79

Ruth N Hull and Bradley E Sample

Chapter 4

Risk Assessment Project Planning (Phase I) 99

David A Belluck and Sally L Benjamin

Chapter 5

Managing Risk Assessment Report Development (Phase II) 173

David A Belluck and Sally L Benjamin

Chapter 6

Concluding a Risk Assessment Contract (Phase III and IV) 221

David A Belluck and Sally L Benjamin

Risk Assessment Contract Formation 245

Robert Craggs and Sally L Benjamin

Chapter 9

Ecological Risk Assessment Review 257

Clifford S Duke and Jan W Briede

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Chapter 10

Environmental Chemistry 265

John P Cummings and Sally L Benjamin

Chapter 11

Analytical Quality Assurance/Quality Control for Environmental Samples

Used in Risk Assessment 277

Wayne Mattsfield and David A Belluck

Chapter 12

Environmental Sampling Design 301

Rick D Cardwell

Chapter 13

Sampling for Ecological Risk Assessments 319

Jan W Briede and Clifford S Duke

Chapter 14

Ecotoxicity Testing in Risk Assessment 325

Guy L Gilron and Ruth N Hull

David Weitz and Sally L Benjamin

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Chapter 22

Clear Communication in Risk Assessment Writing 439

Wendy Reuhl Jacobson

Chapter 23

Scientific Library Risk Research for Risk Assessment 447

Kathy Malec and David A Belluck

Chapter 24

Risk Assessment of Airborne Chemicals 465

Jeanne C Willson

Chapter 25

Radiation Risk Assessment 479

Nava C Garisto and Donald R Hart

International Health Risk Assessment Approaches for Pesticides 527

Colleen J Dragula Johnson and Gary J Burin

Chapter 30

Historical Toxicology and Risk Assessment 537

David A Belluck, Mark W Rattan, and Sally L Benjamin

Chapter 31

Special Topics in Risk Assessment: Models and Uncertainties 551

Stephen G Zemba and Laura C Green

Appendix: Risk Assessment Resources Guide 563LA4111/frame/FM Page 19 Thursday, December 28, 2000 2:09 PM

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PART I The Risk Assessment Process

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Introduction

David A Belluck and Sally L Benjamin CONTENTS

I Introductory Remarks 4

II You Need This Book 4

III Introduction to Environmental Risk Assessment 6

A Common Terms 6

B Risk Assessment Controversy 7

IV Who is Technically Qualified to Produce a Risk Assessment? 12

A Different Risk Assessments Need Different Experts 12

B Technical Credentials Needed to Perform Expert Tasks 12

V Risk Assessment as a Multidisciplinary Endeavor 13

A Mandated Science 13

B Team Work in Risk Assessment 13

C Roles in Risk Assessment Teams 15

D Teams Establish Performance Standards 17

VI An Overview of the Risk Assessment Process 20

A Phase One — Planning a Risk Assessment 20

B Phase Two — Managing a Risk Assessment (Including Iterative Review) 23

C Phase Three — Accepting a Risk Assessment (Including Iterative Review) 24

D Phase Four — After a Risk Assessment 25

E Risk Assessment Planning Form 25

VII Conclusion 25

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4 A PRACTICAL GUIDE TO ENVIRONMENTAL RISK ASSESSMENT REPORTS

I INTRODUCTORY REMARKS

This is a very different risk assessment book Many risk assessment books targetrisk assessment practitioners exclusively, providing them with greater technicalinsights and complex methodologies to aid in professional practice Other riskassessment books provide brief overviews of the risk assessment process and tech-nical inputs for a lay audience

In contrast, this book is intended to introduce environmental risk assessment and

to also provide sufficient technical, procedural, and methodological knowledge toempower every reader with tools and information to participate in a risk assessmentteam, communicate effectively with colleagues, manage a risk assessment report,direct work of expert consultants, and critically review a completed risk assessmentreport How is this done?

This book is essentially divided into two functional parts Part One begins byintroducing risk assessment as a process Next, it discusses team building to plan arisk assessment report and hire a consultant to perform risk assessment work Then,

it discusses managing a consultant to prepare a risk assessment report Finally, PartOne concludes by discussing how to formally complete a risk assessment project.Part Two, presents a series of primers, succinct treatments of key risk assessmenttopics, to assist readers in conversing knowledgeably with risk assessment teammembers Reviewing the risk assessment, in its parts and as a whole, is discussedthroughout this book

II YOU NEED THIS BOOK

You need this book if you are not an expert in every facet of risk assessmentgeneration and review While you may be expert in certain fields, you are likely tostill need to understand, communicate, and work with other disciplines to complete

a successful risk assessment One of the great weaknesses of risk assessment is thelack of interdisciplinary linkage among its components

It is common when preparing risk assessment reports for one expert to hand off

a work product to another expert in a different field Since each part of a riskassessment hinges on earlier parts, this is logical Unfortunately, one great weakness

of risk assessment originates when work products of one discipline are used byanother, without the technical result of the exchange being checked For example,

an emissions expert produces a table listing those chemicals the emissions expertbelieves to be important, based solely on emission rates However, a toxicologistmight add or delete chemicals from the list, based solely on toxicity The end-product

of each discipline’s independent view of important chemicals for the risk assessment

is insufficient A better approach, is for these experts to collaborate and arrive at ajoint, shared vision of the important chemicals list

It is, therefore, critical for all experts involved in a risk assessment to understandeach other’s decision logic, so where work intersects, they can collaborate success-fully When collaboration does not occur at the borders of disciplines involved in arisk assessment, erroneous results can propagate throughout a report, producing false

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INTRODUCTION 5

risk findings This book is intended for persons who want to better collaborate on

a risk assessment process to reduce preventable errors

It is also intended for persons who want an introduction to risk assessment Riskassessment literature is extensive Excellent technical papers, guidance documents,and treatises exist for each scientific discipline involved in environmental risk assess-ment Nevertheless, a gap exists No single book presents a comprehensive treatment

of practical issues routinely encountered by people who develop, review, or useenvironmental risk assessment reports

Why was this book written? It is intended as a plain English discussion of what

it takes to prepare a risk assessment report on time, within budget, and with sufficienttechnical credibility to be defensible It provides step-by-step instructions on how

to push through technical “smoke-and-mirrors” to determine whether risk assessorsmake a technically defensible case for their risk findings

We intend this book to fill a gap in environmental risk assessment literature bypresenting a comprehensive discussion of this important process and offering strat-egies for developing credible risk assessment reports on-time and within budget.Toward this end, we attempt to explain the risk assessment process in simple terms,introduce basic tools of project management, and offer concepts and techniques formanaging many problems routinely encountered on risk assessment projects Thisbook is no substitute for technical risk assessment publications It provides guidance

on how to integrate documents on technical guidance, management and review, inorder to develop a high quality risk assessment report

This book is written by risk assessment practitioners for anyone who wants tounderstand, manage, or review a human health or ecological risk assessment report.While certain information in this book might be found in other documents, no bookbrings it all together as a single publication aimed at making every reader conversant

in risk assessment

As noted earlier, literature on the risk assessment process, and its componenttechnical disciplines, is voluminous Scattered across government publications(including websites, formal and informal guidance documents, library catalogues,and microfiche collections), academic writing (journals, books, theses, and confer-ence publications), practical handbooks and field references, and trade publications,all this information cannot possibly be collated into a single source However, wehave compiled one of the most extensive collections of reference materials to befound in one book Specifically, practitioners and general readers alike should refer

to the Appendix (additional resources include Chapter 23, Scientific Library RiskResearch for Risk Assessment, and the end of each chapter for a collection coveringboth recent materials and seminal works in risk assessment-related disciplines) Use

of these book sections should save a reader enormous amounts of time, may lead

to resources rarely listed by other finding tools, and will provide some indication

of the vast reach of the risk assessment field, with all its multifaceted parts

A novice risk assessor and risk assessment reviewer may encounter certaintechnical areas that they are uncertain how to even start researching This book easesthe learning curve by providing the process, discipline, and data categories necessary

to consider when performing, understanding, managing, or reviewing a risk ment report and indicating where essential information can be found

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6 A PRACTICAL GUIDE TO ENVIRONMENTAL RISK ASSESSMENT REPORTS

As you will see repeated again and again throughout our book, it is our intention

to help our readers understand how to start from zero and build and manage opment of an acceptable risk assessment report or review a completed report We

devel-do not hope to supplant or compete with the numerous technical risk assessmentvolumes currently in print First, we will introduce the concepts of environmentalrisk assessment

III INTRODUCTION TO ENVIRONMENTAL RISK ASSESSMENT

A Common Terms

The term “risk assessment” refers to both the risk assessment process and documentsthat result from that process Procedurally, risk assessment is “an organized processused to describe and estimate the likelihood of adverse health outcomes from envi-ronmental exposures to chemicals The four steps of risk assessment are hazardidentification, dose-response assessment, exposure assessment, and risk character-ization.”* In risk assessment, risk assessors use data of known quality in a standard-ized analytical framework to estimate type and degree of risks posed by environ-mental contaminants These estimates are referred to as “risk estimates” or “riskfindings.” The result of the risk assessment process is a document, also termed arisk assessment, which presents risk findings and describes how they were generated(see Chapters 2 and 3)

“Risk assessors,” usually experts in toxicology or a related scientific discipline,are responsible for technical aspects of producing risk assessments Risk assessorswork closely with a project manager to ensure that data, assumptions, methods, andanalytical framework used to generate environmental risk estimates meet currenttechnical and regulatory standards “Project managers” are responsible for managing

a risk assessment project They may have a science background, but need not betechnical specialists Instead, good project managers understand leadership, politics,and negotiation They can work with a diverse set of technical and scientific experts,

as well as with parties with opposing interests

The primary purpose of environmental risk assessment is to provide risk agers with all available information in a form that facilitates scientifically informeddecisions “Risk managers” are those persons responsible for making a decisionregarding environmental risk “Risk management is the process of identifying, eval-uating, selecting, and implementing actions to reduce risk to human health and toecosystems The goal of risk management is scientifically sound, cost-effective,integrated actions that reduce or prevent risks, while taking into account social,cultural, ethical, political, and legal considerations.”** Risk managers use risk esti-mates, derived through risk assessment, to determine whether a process, activity, orsite poses significant risks to human health or the environment Risk managers may

man-* From the Presidential/Congressional Commission on Risk Assessment and Risk Management, 1997, Framework for Environmental Health Risk Management, Final Report, vol 1, p 61.

** From the Presidential/Congressional Commission on Risk Assessment and Risk Management, 1997, Framework for Environmental Health Risk Management, Final Report, vol 1, p 61.

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