EPA 744-S-98-002
June 1998
Cleaner Technologies Substitutes Assessment
for Professional Fabricare Processes:
Peer Review Process
U. S. Environmental Protection Agency
Office of Pollution Prevention and Toxics
Economics, Exposure and Technology Division (7406)
401 M Street SW
Washington, DC 20460
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DISCLAIMER
This is an official publication of the U.S. Environmental
Protection Agency. Mention of trade names, products, or services
does not convey, and should not be interpreted as conveying,
official U.S. EPA approval, endorsement, or recommendation.
This report is copied on recycled paper.
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ACKNOWLEDGMENTS
This document summarizes the results of the independent technical peer review of the
EPA document Cleaner Technologies Substitutes Assessment for Professional Fabricare
Processes, EPA 744-B-98-001. The overall peer review manager was Cindy Stroup.
The overall Project Manager for the development of the CTSA was Lynne Blake-Hedges.
Ms. Blake-Hedges chaired an EPA/OPPT Technical Workgroup responsible for the development
of the document and the Agency's response to peer reviewers' comments. Members of the
EPA/OPPT Technical Workgroup include:
Lynne Blake-Hedges, Workgroup Chair
Lois Dicker, Ph.D.
David Lai, Ph.D.
Elizabeth Margosches, Ph.D.
Fred Metz, Ph.D.
Mary Katherine Powers
Scott Prothero
The following EPA staff provided management support, and other general assistance to
the CTSA development:
Robert E. Lee, Ph.D.
Cindy Stroup
Mary Ellen Weber, Ph.D.
Vanessa Vu, Ph.D.
The peer review was conducted by Battelle Memorial Institute under contract to EPA.
Battelle was not involved in the preparation of the document undergoing peer review. The
current document was prepared by Battelle under EPA Contract number 68-D5-0008 under the
direction of Brandon Wood. The EPA Work Assignment Manager was Cindy Stroup.
To obtain a copy of this or other EPA/Design for the Environment Program publications, contact:
EPA's Pollution Prevention Information Clearinghouse (PPIC)
401 M Street SW (3404)
Washington, DC 20460
202-260-1023
fax: 202-260-4659
email: ppic@epa.gov
Any questions or comments regarding this document should be addressed to:
Cindy Stroup
Economics, Exposure and Technology Division (7406)
U.S. EPA/OPPT
401M Street S.W.
Washington, D.C. 20460
stroup. cindy(q),epa.gov
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TABLE OF CONTENTS
Page
1.0 INTRODUCTION 1
1.1 BACKGROUND ON CTSA 1
1.2 PEER REVIEW OBJECTIVES 1
1.3 OVERVIEW OF REPORT 2
2.0 METHODS 3
2.1 RECRUITMENT OF PEER REVIEW PANEL 3
2.2 CONFLICT OF INTEREST ISSUES 5
2.3 CONDUCTING THE REVIEW 6
3.0 RESULTS 12
3.1 COMPILATION OF COMMENTS 12
3.2 COMPLICATIONS AND FOLLOW-UP 12
3.3 ANALYSIS OF RESULTS 13
4.0 DISPOSITION OF COMMENTS 14
5.0 ADMINISTRATIVE PEER REVIEW RECORD 14
6.0 SUMMARY 14
APPENDIX A Office of Prevention, Pesticides and Toxic Substances "Standard Operating Procedures for
Peer Review of Major Scientific and Technical Documents, October 1, 1996 - September 30,
1997" A-1
APPENDIX B Correspondence with Peer Reviewers B-1
PACKET B-1 B-2
PACKET B-2 B-9
PACKET B-3 B-12
PACKET B-4 B-16
APPENDIX C Charge to Peer Reviewers C-1
APPENDIX D Peer Review Reference List D-1
APPENDIX E Indexto Administrative Record #199 E-1
LIST OF TABLES
Table 2-1. Stakeholders Asked for Nominations to Peer Review Panel 4
Table 2-2. All Nominated Candidate Reviewers 7
Table 2-3. Final CTSA Peer Review Panel 9
Table 2-4. Attendees at July 24, 1997 Teleconference Announcing CTSA Peer Review 10
Table 2-5. Record of CTSA Copy Numbers, Date Sent and Date Comments Received 11
Table 3-1. Summary Statistics on CTSA Comments from CTSA Peer Review Panel 13
IV
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1.0 INTRODUCTION
1.1 BACKGROUND ON CTSA
The Cleaner Technologies Substitutes Assessment (CTSA) is a tool developed by the
EPA Design for the Environment Program (DfE) for a technically-informed audience. The
CTSA presents a compendium of information on existing and new technologies in a given
industrial sector, compared across cost, performance, and risk parameters. The goal of the CTSA
is to provide business decision-makers with sufficient information to make environmentally-
sound choices. This particular CTSA, the Cleaner Technologies Substitutes Assessment for
Professional Fabricare Processes was developed by the DfE Garment and Textile Care Program
(GTCP) as part of an effort to explore opportunities for pollution prevention in the dry cleaning
industry. It presents information on existing drycleaning processes, such as perchloroethylene
(perc) and hydrocarbons, as well as new and emerging technologies including wetcleaning and
liquid carbon dioxide.
It is important to note that the focus of the fabricare CTSA is on relative risk, not absolute
risk. Further, the fabricare CTSA does not attempt to resolve all uncertainties in data cited nor in
methodology employed. These issues have been extensively debated by the scientific
community. The fabricare CTSA is intended to demonstrate a sufficient basis for concern, to
compare alternative exposure scenarios and performance information. The fabricare CTSA uses
readily available information and conventional models to provide general conclusions about
various cleaning technologies. It does not attempt to describe the absolute risk associated with
specific clothes cleaning operations. The CTSA recognizes that evaluations and judgements for
each setting need to be made individually.
The goal of the CTSA is to provide a comparative assessment of clothes cleaning
technologies available to cleaners. The assessment is intended to provide cleaners information
that can be used to assist them in making informed technology choices that incorporate
environmental concerns along with more typical considerations of cost and performance. The
CTSA is part of an effort to assist small cleaners who may have limited time or resources to
compare cleaning technologies. The primary audience for the CTSA is technically informed and
might consist of individuals such as environmental health and safety personnel, owners,
equipment manufacturers in the clothes cleaning industry, and other decision makers. As such,
the CTSA serves as a repository of information that can form the basis of a variety of
user-friendly information products designed specifically for small business cleaners who are
interested in choosing among cleaning technologies.
1.2 PEER REVIEW OBJECTIVES
In January 1993, responding to recommendations in the report Safeguarding the Future:
Credible Science. Credible Decisions. Administrator William Reilly issued an Agency-wide
policy for peer review. Administrator Carol Browner confirmed and reissued the policy on
June 7, 1994. As a result, EPA established standard operating procedures for the organization
and conduct of peer reviews. The primary objective of any peer review is to uncover technical
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problems or unresolved issues for use in revising the final work product so it will reflect sound
technical information and analyses. Peer review is considered a process for enhancing the
scientific integrity of the end product. Peer reviews are usually conducted by a panel of
independent experts in relevant scientific areas. Independent reviewers are not associated with
the generation of the specific work product, either directly by substantial contribution to its
development or indirectly by consultation during the development of the specific product.
The fabricare CTSA was identified as a major scientific and technical work product, and
as such required an independent peer review. The technical peer review of the fabricare CTSA
was conducted according to the SOP in place at the time, the Office of Prevention, Pesticides and
Toxic Substances (OPPTS) "Standard Operating Procedures for Peer Review of Major Scientific
and Technical Documents, October 1, 1996 - September 30, 1997" (Appendix A). The OPPTS
SOP set forth methods for: identifying work products for peer review, including the selection
process and mechanisms for peer review; planning and conducting a peer review, including
selecting reviewers and scheduling reviews; completing the review, including methods for
evaluating comments and recommendations; the final work product; and maintaining a peer
review record. The GTCP chose a balanced ad hoc panel of independent experts from outside
the Agency as the mechanism to assure an objective, fair, and responsible evaluation of the work
product. Information presented in the peer review was used to update and enhance the final
CTSA document. All requirements in the OPPTS SOP were met or exceeded.
1.3 OVERVIEW OF REPORT
The purpose of this report is to document the technical peer review of the Cleaner
Technologies Substitutes Assessment for Professional Fabricare Processes. The methods used
for planning and conducting the CTSA peer review are presented in Chapter 2. The information
provided in Chapter 2 summarizes recruitment and selection of the peer review panel, and
discusses initiation of the peer review process. Chapter 3 integrates the results of the CTSA peer
review process, providing information on the compilation of reviewer comments, complications
and follow-up during the review, and an analysis of the peer review results. Chapter 4 provides
discussion on the disposition of comments. The Administrative Peer Review Record (AR 199) is
described in Chapter 5. A summary of the peer review process is presented in Chapter 6.
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2.0 METHODS
This section describes the methods undertaken in planning and conducting the peer
review of the CTSA document. Section III of the OPPTS SOP document (Appendix A,
pages A-17 to A-22) was used for guidance in selecting peer reviewers, scheduling the review,
and developing information to provide to the peer reviewers.
2.1 RECRUITMENT OF PEER REVIEW PANEL
The OPPTS SOP for peer reviews (Appendix A, pages A-17 to A-19) lists several
important points of guidance to be followed when selecting a group of peer reviewers:
• Recommendations for potential peer reviewers can be identified from a number of
organizations.
Peer reviewers should be selected for independence and scientific/technical
expertise.
• Peer reviewers should be free of real or perceived conflicts of interest or there
should be a balancing of interests among peer reviewers.
Each of the peer reviewers should have recognized technical expertise that bears
on the subject matter under discussion.
• Taken as a whole, the peer reviewers of a work product should represent a
balanced range of technically legitimate points of view.
Generally, external peer reviewers are preferred.
Selected experts should have views that fall to either side of the centrist position
along the continuum, but not too far to either extreme.
The CTSA peer review strictly adhered to the OPPTS SOP guidance, and developed the
following strategy for convening an expert panel of peer reviewers:
1. Potential candidate peer reviewers were solicited from a well established group of
GTCP stakeholders.
2. A large panel of experts was convened so that all possible technical areas and
points of view could be covered.
3. Potential peer reviewers were recruited through a rigorous interview and review
process to ensure qualifications, independence, and timely availability.
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4. To ensure independence, most peer reviewers (all reviewers who requested
payment) were required to agree to a formal consulting contract which required
them to immediately disclose any real, or even potential, conflict of interest.
For the past six years, the EPA DfE GTCP collaborated with a group of key stakeholders,
including representatives of industry, research, environmental, labor and public interest groups.
At EPA's request, these stakeholders nominated technical peer reviewers that had expertise in
one or more of the main technical areas of the CTSA: technology and economics; exposure
assessment; hazard assessment; and risk assessment. Through a rigorous screening process,
40 reviewers were selected from the list. Stakeholders' first and/or second and/or third choice
nominees in each area of expertise who were available were selected for the formal peer review
panel.
The group of key stakeholders who were asked to nominate peer reviewers is listed in
Table 2-1. In the Spring and early Summer of 1997, stakeholders submitted candidate panelists
in order of preference, in each of the following categories: technology and economics; exposure
assessment; hazard assessment; and risk assessment. In addition, each proposed candidate peer
reviewer was required to have training and/or experience in one or more of the following areas:
(1) occupational and general exposure assessment; (2) exposure modeling techniques;
(3) chemical monitoring; (4) occupational health; (5) industrial hygiene; (6) toxicology, including
environmental (aquatic); (7) environmental epidemiology; (8) risk assessment; (9) economics,
finance, accounting; (10) marketing; (11) comparative cleaning technologies
Table 2-1. Stakeholders Asked for Nominations to Peer Review Panel
Stakeholder
Mr. Moon Jong Chun
Mr. Dave DeRosa and Mr. Jack Weinberg
Mr. Eric Frumin
Mr. Bob Gottleib and Ms. Jessica Goodheart
Ms. Janet Hickman
Ms. Sylvia Hoover-Ewing and
Mr. Anthony Star
Dr. David Ozonoff
Mr. Steve Risotto
Ms. Mary Scalco and Mr. Bill Fisher
Dr. Judy Schreiber
Mr. Bill Seitz
Ms. Jodie Siegel
Ms. Barbara Warren and Dr. Ned Groth
Dr. Manfred Wentz
Company
Federation of Korean Drycleaning Associations
Greenpeace
UNITE (Union of Needletrades, Industrial and Textile Employees)
ULCA, Pollution Prevention Education & Research Center
Dow Chemical
Center for Neighborhood Technology
Boston University School of Public Health
Center for Emission Control
International Fabricare Institute
New York State Department of Health
Neighborhood Cleaners Association International
Massachusetts Toxic Use Reduction Institution
Consumers Union
Fabricare Legislative & Regulatory Education Council / AATCC
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(e.g., wet methods, microwave); (12) the dry cleaning industry, including equipment and
processes used, practices employed, etc.; and (13) chemistry (product, engineering,
environmental fate). All stakeholders except the Federation of Korean Dry Cleaning
Associations and Consumers Union nominated peer reviewers.
Candidate reviewers were asked about their availability and/or interest in reviewing the
CTSA document, about their area of expertise, and whether they required payment for their
review. Potential reviewers who declined to participate were asked if there was anyone they
would recommend in their place. All nominated peer reviewers are listed in Table 2-2.
For each stakeholder group that nominated candidate peer reviewers, at least their first,
second, and third ranked nominees in each area of expertise were contacted during June and July
to determine their availability and willingness to take part in the peer review process. The CTSA
peer review panel consisting of 40 peer reviewers was finalized by EPA on Monday,
July 21, 1997 (Table 2-3). The panel incorporated a large and well-balanced independent panel
of experts from the drycleaning industry and the environmental and scientific communities.
2.2 CONFLICT OF INTEREST ISSUES
OPPTS SOP document states "Peer reviewers should be free of real or perceived conflicts
of interest or there should be a balancing of interests among peer reviewers." This was assured
several ways: (1) the nominees' resumes were reviewed to identify potential conflicts of interest,
(2) preliminary screening of all nominees was conducted, (3) the panel was balanced as a whole
and within each of the four key technical areas in the CTSA, and (4) each of the 28 paid
reviewers was subject to a contract containing a specific conflict of interest clause.
The potential peer reviewers listed in Table 2-2 were contacted to determine their
affiliation(s), qualifications, and availability. Reviewers were selected by EPA to ensure balance
across the four major technical areas covered by the CTSA. During recruitment, commitments of
the reviewers and their affiliations were considered to determine if significant conflicts of interest
were likely. In no cases were potential conflicts deemed to be sufficiently significant to preclude
the participation of any peer reviewers recommended by the GTCP stakeholders.
Of the 36 experts who ultimately reviewed the CTSA, 28 requested and received payment
for their services. Of these paid reviewers, 27 became subcontractors to Battelle, the contractor
who conducted the peer review for EPA, and formally agreed to the following conflict of interest
clause:
Seller (peer reviewer) will avoid and immediately notify BCO (Battelle) of any
activities, interests or relationships (past, present or planned) which place Seller in an
actual or apparent conflict of interest with the objectives of BCO or its Client under this
Contract. Seller must obtain BCO's prior written consent before engaging in any such
activities.
The other paid reviewer was a Battelle staff member, and as such, was subject to the conflict of
interest clause in Battelle's contract with EPA.
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EPA applied similar requirements of independence from the work product and lack of
conflict of interest when EPA contracted with Battelle Columbus Laboratories to conduct the
peer review. The OPPTS SOP for peer reviews states that "...the objectivity of the peer review
should not be improperly influenced or undermined by the contractor performing the review. To
identify and avoid or mitigate actual or potential conflict of interest, the contract should include
controls." (Appendix A, p. A-53) Battelle was well-known to EPA staff and known to be free of
any conflicts of interest. They were held to standard contractual requirements which ensured
their conduct of this peer review would not hinder the independence of the reviews. Battelle's
Contract 68-D5-0008, under which the CTSA peer review was conducted, has a specific
Organizational Conflict of Interest clause (H.2) which requires Battelle to diligently monitor all
work assignments under the contract and immediately inform EPA if an actual or potential
conflict of interest develops between the EPA work and other work Battelle is performing. No
conflicts of interest existed at any time while Battelle conducted the CTSA peer review,
compiled peer reviewer's comments, and delivered the comments to EPA.
2.3 CONDUCTING THE REVIEW
Battelle prepared two separate packets of documentation for each of the peer reviewers
(Appendix B). Packet B-l included a confirmation letter, contractual statement, and
non-disclosure agreement, and Packet B-2 included a confirmation letter and non-disclosure
agreement. Contractual agreements were sent only to those reviewers requesting to be paid for
their review. Packets were sent to all 40 peer reviewers by Federal Express on Monday,
July 21, 1997. All reviewers were requested to fax their signed non-disclosure agreements to
Battelle by COB Thursday, July 24, 1997. Those reviewers requesting payment were also asked
to submit a proposed hourly rate which is the lowest rate they charge any client.
The official peer review period began at 11:00 am on July 24, 1997, with a conference
call notifying stakeholders (Table 2-4) that the panel had been finalized and the CTSA work
products were being sent out for review. In the call, EPA announced that a well-balanced panel
was chosen and all of the stakeholders' first and/or second and/or third choice nominees in each
area of expertise were chosen for the review. The reviewers were to be given four weeks to
complete their review and return comments to Battelle by August 25, 1997.
On Thursday, July 24, 1997, the CTSA was sent to peer reviewers by Federal Express.
Enclosed in each package sent to the peer reviewer was a letter of transmittal and a reminder to
return their signed non-disclosure agreement to Battelle (Appendix B, Packet B-3), a charge to
peer reviewers (Appendix C), and an alphabetized list of CTSA references (Appendix D). The
peer review charge document attempted to properly focus the efforts of the peer reviewers and to
assist them in their review. Table 2-5 presents for each peer reviewer, the copy number and date
on which the CTSA was sent, and the date on which Battelle received each reviewer's comments.
Although only 40 peer reviewers were selected for the review, three copies of the CTSA were
sent to D. Votaw, bringing the total number of copies distributed to 42.
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Table 2-2. All Nominated Candidate Reviewers
Elden Dickinson
Michigan Department of Environmental
Quality
Kathleen Wolf, Ph.D.
Institute for Research and Technical
Assistance
Paul Dugard, Ph.D.
ICI Americas, Inc.
Charles Riggs, Ph.D.
Texas Women's University, Department of
Fashion & Textiles
Dr. Josef Kurz
Schloss Hohenstein
Mike Tatch
Tatch Technical Services
Noel Weiss, M.D., Dr. P.H.
University of Washington, School of
Health & Comm. Med.
Kenneth Mundt, Ph.D.
Umass, Dept. Of Biostatistics &
Epidemiology
School of Public Health & Health Sciences
Tom Starr, Ph. D.
Environ Corp.
D. Warner North, Ph.D.
Decision Focus Inc.
Rudolf Jaeger, Ph. D.
Environmental Medicine, Incorporated
Dr. Robert Squire
Mr. Todd S. Wong
Manager, Central Division
State of California Air Research Board
James Wilkin, Ph.D.
Mr. Richard H. Reitz
RHR Toxicology Consulting
Dr. Tom Armstrong
Univ. Of Michigan, School of Public
Health
Scott Earnest
NIOSH/Engineering Control Technology
Branch
Dr. Salvatore DiNardi
Umass/Environmental Health Sciences
Dr. Baruch Fischhoff/Dr. Mitchell Smalls
Carnegie Mellon University
Mr. Rory Connelly
Chemical Industry Institute of Technology
Joe McLaughlin, Ph.D.
International Epidemiology Institute
Dr. John Graham
Harvard University/School of Public Health
Dr. John Doull
Kansas University Medical Center
Joel Tickner
MSC/U Massachusetts Lowell
Pamela Christenson
Wisconsin Dept of Dev
Ellen Kirrane
Hunter College Center for Occup & Envir
Health
David Ozonoff, M.D., M.P.H.
Boston University School of Public Health
Dept of Environmental Health
DickClapp, Sc.D., M.P.H.
Boston University School of Public Health
Dept of Environmental Health
James Melius, M.D., Ph.D.
Director
NY State Laborer's Health & Safety Trust
Fund
Ms. Chris Hayes
Greater Chicago P2 Program, MWRD
Peter Orris, M.D.
Div. Of Occup. Med/Cook County Hospital
Frank Mirer, Ph.D.
Director, Health & Safety Dept., UAW
Diane Echeverria
Battelle Seattle Operations
Dale Hattis, Ph.D.
Center for Technology, Environment, &
Development (CENTED)
Clark University
Donald P. Gallo
Michael Best & Friedrich
Diane Weiser
Ecomat
Irv Markus
Kingsgard Cleaners
Amelia Gooding
DCCA, Small Bus Environ Asst Progam
Jim Ahearn
Polaroid
Ed Olmstead
NYCOSH (NY Committee for Occup Safety
& Health)
Dr. John Froines
UCLA
Henry Anderson, M.D.
Chief Medical Officer for Occupational and
Environmental Health
Div of Health
Dept of Health and Social Services
Nancy Kim
NYSHD/Div. Of Environmental Health
Dr. David Kriebel
Umass-Lowell, Dept. Of Work Environment
Dr. Margaret Quinn
Umass-Lowell, Dept. Of Work Environment
Philip Landrigan, M.D.
EPA Children's Health Initiative
Ethel H. Wise
Professor of Community Medicine
Chairman and Professor of Pediatric, Dept of
Community Medicine
Mount Sinai School of Medicine
Thomas Eggert
Wisconsin DNR Off Pollution Prev
George Alexeeff, Ph.D., D.A.B.T.
Chief, Air Toxicology & Environ Toxicology
Off of Environ Health Hazard Assessment
California Env. Protection Agency
Avima Ruder, Ph.D.
NIOSH/CDC, Chief, Industrywise Studies
Branch
Epidemiology 2 Section
Anne Marie Desmarais
Tufts Univ., Dept. Of Civil & Envir.
Engineering
Dr. Rafael Moure-Eraso
Umass-Lowell, Dept. of Work Environment
David Rail
former director, NIEHS
Aaron Blair
National Cancer Institute
Ken Geiser
Massachusetts Toxic Use Reduction Inst
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Table 2-2. All Nominated Candidate Reviewers (Continued)
Dr. John Peters/USC
Dept. of Occup. & Environmental
Medicine
Mark K. Enstrom
DCAA/Small Business Environ. Assn.
Program
Dennis F. Lekan
Cuyahoga Community College
Ron Kantor
Leather-Rich, Inc.
Ann Hacker
Northside Laundry & Cleaners
Rebecca Head, PhD
Washtenaw Co. Dept. Of Environment
Joanna Hoelscher
Citizens for a Better Environment
Stanley Liu
Environment Canada, P&Y Region
Jim Orlin
Morrison Suede & Leather Works
Jackie Peterson
International Acad. Of Merch. And Design
Merry Bering
M.I.L.D. Michigan
Tony Sasson
Ohio EPA Office of P2
Richard Simon
Business Habits (Ecoclean)
Ken Vandersnick
Wagners/Brix Cleaners
Dong Whang
HiTech Engineering
Allen L. White, PhD
Director, Risk Anal. Group
Adam Finkel, Ph.D.
Director, OSHA Health Standards
Directorate
US Department of Labor
Marthe Kent, Ph.D.
Office of Regulatory Analysis/Directorate
of Policy
DOL OSHA
David Votaw
Education and Information Division
National Institute for Occupational Safety
and Health
Jack Lauber
53 Fairlawn Dr.
Mr. Ken C. Adamson, General Manager
Langley Parisian
Manfred Wentz, Ph.D.
Chairperson, AATCC Research Committee
RA43: Dry Cleaning
Denny Hjeresen, Ph.D.
Los Alamos National Labs
Frank Arnold, Ph. D.
Andrew Persily, Ph.D.
NIST
Greg Traynor
T. Marshall Associates
Charlene Bayer, Ph.D.
Georgia Tech Research Institute
Clifford Weisel, Ph.D.
James Cone, M.D., M.P.H.
George Gray, Ph.D.
Harvard School of Public Health
Arthur Upton, M.D.
Environmental & Occupational Health
Sciences Inst.
Duncan Thomas
Univ. Of Southern California
Div. Of Preventative Medicine
Thomas Goldsworthy, M.D.
Claudia Miller, M.D.
Univ. Of Texas Health Sciences Center
Judy Schreiber, Ph.D.
NY Dept of Health
Kimberly Thompson, Sc.D.
Consultant
Arnold Brown. M.D.
Routt Reigart, M.D.
Medical University of South Carolina
Dan Krewski, Ph.D., MHA
Bureau of Chemical Hazards
Health Canada
Gary Carlson, Ph.D.
School of Health Sciences
Purdue
Ron Miller
Brad Leinhart, Ph.D.
MiCELL
Scott Lutz
Supervisor, Air Quality Engineer
Bay Area Air Quality Management District
Paul Lioy, Ph.D.
Robert Wood Johnson Medical School
Deborah Wallace
Consumers Union Technical Division
Marilyn Black
Air Quality Sciences
John Girman
Indoor Environments Division
Les Sparks
ORD, RTF
Betsy Howard
ORD, RTF
Dr. Ron Melnick
Linda Sheldon
RTI
Kevin Teichman
ORD
Lance Wallace, Ph.D.
US Environmental Protection Agency
Eula Bingham, Ph.D.
University of Cincinnati
Bernard Goldstein, M.D.
Director, Env & Occup Health Sciences Inst
Chairman, Dept of Community Medicine
University of Medicine and Dentistry of NJ
Robert Wood Johnson Medical School
Robert Taylor, M.D., Ph.D.
Howard University School of Medicine
Louise Ryan, Ph.D.
Dana Farber Cancer Institute
Adolfo Correa, M.D.
Johns Hopkins University
School of Public Health
Joel Mattsson, M.D.
Senior Associate Scientist
Health & Envir. Sciences
Dow Chemical Co.
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Table 2-3. Final CTSA Peer Review Panel
Ken C. Adamson
General Manager
Langley Parisian
Frank Arnold, Ph.D.
Consulting Economist
Charlene Bayer, Ph.D.
Georgia Tech Research Institute
Arnold Brown., M.D. - Retired
Professor Emeritus of Pathology
and Universal Medicine
Univ. of Wisconsin, Madison
Pamela Christenson
Wisconsin Dept. of Dev.
DickClapp, Sc.D.,M.P.H.
Boston University School of Public
Health
Dept of Environmental Health
James Cone, M.D., M.P.H.
Elden Dickinson
Michigan Department of
Environmental Quality
Paul Dugard, Ph.D.
Senior Vice President
ICI Americas, Inc.
Diane Echeverria, Ph.D.
Battelle Seattle Operations
Adam Finkel, Ph.D.
Director
OSHA Health Standards Directorate
U.S. Department of Labor
George Gray, Ph.D.
Harvard Center for Risk Analysis
Harvard School of Public Health
Dale Hattis, Ph.D.
Research Associate Professor
Center for Technology,
Environment, & Development
(CENTED)
Clark University
Ms. Chris Hayes
Greater Chicago P2 Program,
MWRD
Denny Hjeresen, Ph.D.
Los Alamos National Labs
Rudolf Jaeger, Ph.D.
Environmental Medicine,
Incorporated
Ellen Kirrane
Hunter College Center for
Occupational & Environmental
Health
Josef Kurz, Ph.D.
Schloss Hohenstein
Jack Lauber, P.E.-D.AA.E.E.
Consulting Engineer
James Melius, M.D., Ph.D.
Director
NY State Laborer's Health & Safety
Trust Fund
Frank Mirer, Ph.D.
Director
Health & Safety Dept., UAW
Kenneth Mundt, Ph.D.
University of Massachusetts
Department of Biostatistics &
Epidemiology
School of Public Health & Health
Sciences
D.Warner North, Ph.D.
Decision Focus Inc.
Peter Orris, M.D.
Division of Occupational Medicine
Cook County Hospital
David Ozonoff, M.D., M.P.H.
Boston University School of Public
Health
Department of Environmental
Health
Andrew Persily, Ph.D.
NIST
Routt Reigart, M.D.
Medical University of South
Carolina
Charles Riggs, Ph.D.
Texas Women's University,
Department of Fashion & Textiles
Judy Schreiber, Ph.D.
NY State Department of Health
Tom Starr, Ph. D.
Environ Corp.
Mike Tatch
Tatch Technical Services
Kimberly Thompson, Sc.D.
Consultant
Harvard Center for Risk Analysis
Joel Tickner
MSC/University of Massachusetts
Lowell
Greg Traynor
T. Marshall Associates
Arthur Upton, M.D.
Clinical Professor
Environmental & Occupational
Health Sciences Institute
David Votaw
Education and Information Division
(C15)
National Institute for Occupational
Safety and Health
Clifford Weisel, Ph.D.
Associate Professor
Deputy Director
Exposure Measurement and
Assessment Division
Environmental and Occupational
Health Sciences Institute
Noel Weiss, M.D., Dr. P.H.
Professor
University of Washington
School of Health & Community
Medicine
Department Of Epidemiology
Manfred Wentz, Ph.D.
Chairperson, AATCC Research
Committee RA43: Dry Cleaning
Kathleen Wolf, Ph.D.
Institute for Research and Technical
Assistance
Note: No known conflicts of interest existed with any peer reviewers.
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Table 2-4. Attendees at July 24,1997 Teleconference Announcing CTSA Peer Review
Name
Mary Scalco,
Bill Fisher
Bill Seitz
Ross Beard
Steve Risotto
Gary Baise
Eric Frumin
David DeRosa,
Jack Weinberg
Moon Jong Chun
Cindy Stroup,
Lynne Blake-Hedges,
Mary Ellen Weber
Melinda Armbruster,
Brandon Wood
Affiliation/Address
International Fabricare Institute
Neighborhood Cleaners Association, International
Fabricare Legislative & Regulatory
Centers for Emission Control
Baise & Miller
Union of Needletrades, Industrial and Textile Employees
(UNITE)
Greenpeace
Federation of Korean Dry cleaning Association
U.S. Environmental Protection Agency
Battelle Memorial Institute
10
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Table 2-5. Record of CTSA Copy Numbers, Date Sent and Date Comments Received
Copy
No.
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
Date Copy
Sent
7/24/97
7/24/97
7/24/97
7/24/97
7/24/97
7/24/97
7/24/97
7/24/97
7/25/97
7/25/97
7/25/97
7/25/97
7/25/97
7/25/97
7/25/97
7/25/97
7/25/97
7/25/97
7/25/97
7/25/97
7/26/97
Date
Comments
Received
8/27/97
Dropped
8/27/97
9/2/97 &
9/8/97
8/12/97
8/27/97
8/27/97
8/28/97
Withdrew
9/3/97
8/25/97
8/18/97
8/25/97
Withdrew
8/25/97
8/25/97
8/21/97 &
9/3/97
9/2/97 &
9/3/97
8/18/97
8/25/97
8/20/97
Reviewer
E. Dickinson
P. Dugard
P. Christenson
K. Adamson
A. Upton
D. Votaw
D. Votaw
D. Votaw
A. Persily
J. Schreiber
C. Riggs
J. Lauber
J. Tickner
J. Kurz
K. Wolf
J. Melius
M. Wentz
M. Tatch
D. Ozonoff
E. Kirrane
D. Hattis
Copy No.
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
Date Copy
Sent
7/26/97
7/26/97
7/26/97
7/26/97
7/28/97
7/26/97
7/26/97
7/26/97
7/28/97
7/26/97
7/28/97
7/28/97
7/28/97
7/29/97
7/29/97
7/29/97
7/29/97
7/29/97
7/29/97
8/1/97
8/1/97
Date
Comments
Received
8/15/97
8/19/97
8/25/97
8/7/97
8/27/97
9/11/97
8/25/97
8/27/97
8/6/97
8/25/97
9/3/97
8/22/97
9/2/97
9/17/97
8/25/97
8/22/97
8/26/97
9/4/97
9/5/97
8/25/97
Withdrew
Reviewer
R. Jaeger
K. Thompson
C. Hayes
N. Weiss
G. Traynor
D. Echeverria
J. Cone
C. Weisel
F. Arnold
C. Bayer
P. Orris
D. Clapp
F. Mirer
A. Finkle
D. Hjeresen
A. Brown
K. Mundt
T. Starr
G. Gray
W. North
R. Reigart
11
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3.0 RESULTS
3.1 COMPILATION OF COMMENTS
Thirty-six reviewers provided comments on the draft CTSA. In the course of the review,
three reviewers withdrew from the panel. Reasons for withdrawal from the peer review process
included not having enough time available to complete the review, and a mismatch between their
interests and the material presented in the CTSA. A fourth reviewer promised to but simply
never submitted comments, despite being granted an extension of the review period.
Battelle collected and compiled review comments and provided the EPA workgroup with
a list of comments for their consideration and response. Comments from peer reviewers were
compiled and sorted by reviewer and by CTSA chapter to which they referred. Attribution of
each reviewer's comments was kept anonymous. In a few cases, text was omitted from the
original comment (as indicated by "...") in order to ensure reviewer anonymity. Where a
comment cited a reference that was not complete, the reference was listed in square brackets
following the comment. In total, 1,855 comments were submitted which comprised 340
typewritten pages. The EPA Fabricare CTSA Workgroup reviewed all comments, determined
the appropriate changes in the CTSA as a result of the comments, and prepared the Agency's
Response to Comments document. That document, Cleaner Technologies Substitute
Assessment for Professional Fabricare Processes: Response to Peer Review Comments, EPA
744-P-98-001, will be published as an EPA Report and included in the Peer Review
Administrative Record #199.
In order to ensure accurate, verbatim transcription of all comments, Battelle enlisted the
proof-reading services of Key Office Services, an independent company. After the comments
were compiled, Key Office Services checked each comment against the original reviewer's
submission to ensure that the text remained unchanged, then returned the "proofed" list of
comments to Battelle for any necessary corrections.
Comments from 34 of the 36 reviewers were conveyed, without attribution, to EPA in a
report dated September 12, 1997. Any additional references or information that the reviewers
provided with their comments were also transmitted to EPA with the comments. An addendum
to the original report which included comments from the last two reviewers was submitted
October 2, 1997.
3.2 COMPLICATIONS AND FOLLOW-UP
In the course of the review, three reviewers withdrew from the panel. Dr. Routt Reigart
withdrew from the peer review process on August 1, 1997; Dr. Andrew Persily withdrew on
August 22, 1997; and Dr. Josef Kurz withdrew on August 28, 1997. Reasons for withdrawal
from the peer review process included not having enough time available for a complete review,
in spite of initially agreeing to be on the panel. Two reviewers felt they were not qualified to
review the CTSA after they saw it. Dr. Paul Dugard was dropped on January 1, 1998, because he
failed to provide any comments on the CTSA. As Dr. Dugard was a key reviewer in the hazard
12
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assessment area, he was given an extra four months to complete his review, but had to be
dropped from the panel to avoid delaying the overall CTSA schedule. In all cases it was too late
to replace the reviewers.
During the review, one fax was sent out to the peer reviewers as clarification on different
issues. The fax was sent out to all peer reviewers on August 6, 1997 (Appendix B, Packet B-4).
This was a clarification of EPA's evaluation of the carcinogenic potential of perchloroethylene.
The language in the peer review copy of the CTSA was revised, as per the fax, as part of the peer
review comment integration process.
During the review, one peer reviewer requested several of the papers referenced in the
peer review copy of the CTSA. These references were supplied to this reviewer on
August 14, 1997.
3.3 ANALYSIS OF RESULTS
Table 3-1 presents summary statistics on the number of comments and number of pages
of comments received by Battelle. These statistics are separated into the following categories:
general comments on CTSA document, comments on the executive summary, Chapters 1-8, and
Appendices A-D. There were a total of 1,855 comments submitted comprising a typed list of
340 pages. Of these 1,855 comments, there were a total 208 editorial comments. The editorial
comments included spelling changes and other minor structural modifications to the document.
Table 3-1. Summary Statistics on CTSA Comments from CTSA Peer Review Panel
Section
General
Executive Summary
Chapter 1
Chapter 2
Chapter 3
Chapter 4
Chapter 5
Chapter 6
Chapter 7
Chapter 8
Appendix A
Appendix B
Appendix C
Appendix D
Total
Complete Set of Comments
# of Pages of Comments
49
12
56
32
60
61
12
17
10
12
13
1
4
1
340
# of Comments
181
67
328
194
357
375
61
82
50
71
62
6
20
1
1855
13
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4.0 DISPOSITION OF COMMENTS
Peer review comments were compiled and sent, without attribution, to the EPA
Workgroup in charge of the disposition of comments. This workgroup drafted responses to every
peer review comment. The peer review comments and responses are included in a separate
document (Cleaner Technologies Substitute Assessment for Professional Fabricare Processes:
Response to Peer Review Comments., EPA 744-P-98-001). Based on the peer review comments,
significant revisions were made to the CTSA document (as per the OPPTS SOP, Appendix A,
Sections IV.A, and IV.B, pages A-22 to A-23).
5.0 ADMINISTRATIVE PEER REVIEW RECORD
As required in the OPPT Peer Review SOP, a public CTSA Peer Review Administrative
Record was established. AR-199 contains all the documentation and major products of the
CTSA technical peer review. The Index to Administrative Record #199 is included as
Appendix E. Administrative Record #199 was created and is maintained in accordance with
Section IV.C of the OPPTS SOP (Appendix A, p. A-23).
6.0 SUMMARY
As a major scientific and technical work product, the CTSA required an independent peer
review. The technical peer review of the fabricare CTSA was conducted according to the OPPTS
SOP, the Office of Prevention, Pesticides and Pollution Prevention "Standard Operating
Procedures for Peer Review of Major Scientific and Technical Documents,
October 1, 1996 - September 30, 1997". The GTCP chose a balanced ad hoc panel of
independent experts from outside the Agency as the mechanism to assure an objective, fair, and
responsible evaluation of the work product. As seen in Table 2-3, the peer review panel
encompassed a large, balanced independent panel of experts from the dry cleaning industry and
the environmental and scientific communities. The peer review panel was not only balanced by
the reviewers' areas of expertise, but also by the stakeholder groups who nominated reviewers
for the panel. None of the reviewers had any conflict of interest or other problems that may have
hindered their fair and objective review of the document.
The attrition of four reviewers during the review process did not affect the balance of the
panel nor the integrity of the review. Information presented in the peer review was used to
significantly update and enhance the final CTSA document. A response to comments document
has been prepared which addresses every comment provided by every peer reviewer. All
requirements in the OPPTS SOP were either met or exceeded.
14
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APPENDIX A
Office of Prevention, Pesticides and Toxic Substances
"Standard Operating Procedures for Peer Review
of Major Scientific and Technical Documents,
October 1,1996 - September 30,1997"
A-1
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Office Of Prevention, Pesticides and Toxic Substances
STANDARD OPERATING PROCEDURES
FOR PEER REVIEW OF MAJOR
SCIENTIFIC AND TECHNICAL DOCUMENTS
OCTOBER 1, 1996 - SEPTEMBER 30, 1997
A-2
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PREFACE
Overview
These Standard Operating Procedures (SOPs) provide guidance
to all staff and managers in OPPTS on the organization and
conduct of peer reviews pursuant to the Administrator's June 7,
1994 Peer Review Policy statement (Appendix A).
The guidance provides information and outlines procedures in
several different areas:
*• basic principles and definitions, including
distinctions between peer review and public
comment, and between peer involvement and peer
review;
*• preparing for peer review, including identifying
work products, identifying appropriate peer review
mechanisms, and identifying qualified experts;
and,
> conducting and completing peer reviews, including
materials required for peer review, creating a
peer review record, and utilizing peer review
comments.
In addition, appendices provide information on OPPTS staff and
management responsible for peer review activities and resources
for the upcoming fiscal year, work products selected for peer
review during the upcoming fiscal year, and detailed information
on budget, procurement, and legal considerations.
This SOP does not address, nor does it supersede,
established peer review practices or procedures of the selected
peer review mechanism. In fact, the SOP seeks to incorporate
existing mechanisms (e.g., professional journals for research
papers, Science Advisory Board and FIFRA Scientific Advisory
Panel, and research grant applications) as well as instituting
new ones.
Background
Peer review at the USEPA takes many different forms
depending on the nature of the work product, relevant statutory
requirements, and office-specific policies and practices, among
other things. In January 1993, responding to recommendations in
the report Safeguarding the Future: Credible Science, Credible
A-3
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Decisions, Administrator William Reilly issued an Agency-wide
policy for peer review. Administrator Carol Browner confirmed
and reissued the policy on June 7, 1994 and instituted an Agency-
wide implementation program. These SOPs constitute
implementation guidance for OPPTS.
These procedures are based on the central themes set forth
in the Administrator's policy statement:
Major scientifically and technically based work products related to
Agency decisions normally should be peer reviewed. Agency managers
within Headquarters, Regions, laboratories, and field components
determine and are accountable for the decision whether to employ peer
review in particular instances and, if so, its character, scope, and
timing. These decisions are made in conformance with program goals and
priorities, resource constraints, and statutory or court-ordered
deadlines. For those work products that are intended to support the
most important decisions or that have special importance in their own
right, external peer review is the procedure of choice. Peer review is
not restricted to the penultimate version of work products; in fact,
peer review at the planning stage can often be extremely beneficial.
As seen in the policy statement, one important task in
implementing the Peer Review Policy entails the identification of
"major scientific and technical work products." This decision is
based on several considerations and is discussed in Section II.
Another important task is using a peer review mechanism that is
suitable for the work product under review.
The goal of the Peer Review Policy is to ensure that
scientific and technical work products receive appropriate levels
of critical scrutiny from scientific and technical experts as
part of the overall decision making process. Generally, this
technical review will precede the customary, more broadly based
public review of the total decision.
OPPTS Peer Review Policy Overview
OPPTS recognizes that science and social science form the
basis for protection of the environment and public health. The
purpose of this SOP is to ensure that peer review is used
appropriately to enhance the credibility of OPPTS' decisions
while ensuring that OPPTS' peer review policies are in conformity
with Agency guidance. In general, OPPTS has traditionally
utilized peer review as well as peer involvement procedures with
much emphasis placed upon involving experts and interested
parties early and often in the development of a scientific or
technical work product. This allows an open exchange of data,
insights, and ideas throughout the life of a project, working
toward building consensus on the technical aspects of the work.
A-4
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Peer review mechanisms are typically selected based upon the
nature of the scientific or technical work product. In general,
scientific or technical work products will undergo an internal
peer review. However, for work products that are "major",
potentially costly, controversial, novel approaches, or have
cross-Agency implications, external peer review is recommended.
A-5
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TABLE OF CONTENTS
Preface i
I. Guiding Principles of Peer Review 1
A. General Principles 1
B. Definitions 3
II. Identifying Work Products for Peer Review 5
A. The Selection Process 5
B. Mechanisms for Peer Review 7
C. Categories of Office Products 9
III. Planning and Conducting a Peer Review 11
A. Selecting Peer Reviewers 12
B. Scheduling Peer Reviews 14
C. Materials 15
IV. Completing a Peer Review 17
A. Evaluating Comments and Recommendations 17
B. The Final Work Product 17
C. Maintaining the Peer Review Record 18
V. Accountability and Responsibility in the Office .... 20
A. Line Management 20
B. Office Coordination 21
C. Budget 24
D. Annual Reviews 24
A-6
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TABLE OF CONTENTS (continued)
Appendix A: Agency Peer Review Policy A-l
Appendix B: Key Personnel B-l
I. Individuals Involved in the Peer Review B-l
A. Line Management B-l
B. Office Coordination B-2
II. Legal Advice B-3
Appendix C: Listing of Representative Office Products in
Each Category Over the Past 3 Years C-l
Appendix D: Office Candidates for Peer Review in Upcoming
Fiscal Year D-l
Appendix E: Resources for Peer Review Services E-l
I. Acquisition of Peer Review Services E-l
A. Voluntary Services E-l
B. Contracts E-l
C. Small Purchases E-7
II. Travel E-9
A. Contracts and Purchase Orders E-9
B. Special Government Employees E-10
A-7
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I. GUIDING PRINCIPLES OF PEER REVIEW
This section offers some guiding principles for peer review,
defining certain terms, with emphasis on distinguishing between
several closely related concepts. In particular, this section
discusses the interrelationship between the broader concept of
peer involvement and its components: peer input and peer review.
A. General Principles
The purpose of peer review is to uncover any technical
problems or unresolved issues for use in revising a preliminary
product so that the final work product will reflect sound
technical information and analyses. It should be noted that peer
review is a process for enhancing the scientific or technical
work product.
Peer involvement occurs at different stages, involving
several related but different activities in the overall decision-
making process (e.g., an initial research protocol or work plan,
a preliminary review of an interim draft, and/or a later review
of a draft final work product). Peer involvement refers to both
peer input (ongoing discussions during the development of the
work product) and peer review (the critical, and usually, final
evaluation of the work product). Peer review can occur during
the early stages of project or methods selection, or as usually
defined, as part of the culmination of the work product, ensuring
that the final product is technically sound.
Subject matter experts who participate in the overall peer
involvement process can be expected to undertake one of three
related but different roles. First, they may work as paid or
unpaid consultants with a significant role as author or advisor
in developing a work product. Second, OPPTS may ask independent
experts to provide peer input by participating in early
developmental reviews or discussions of well-developed but
unfinished work products. In this case, the agency is inviting
and expecting expert suggestions that could lead to substantial
changes based on reviewer recommendations in the final product.
Third, experts may be asked to serve as peer reviewers, providing
critical evaluation and comments on work products nearing
completion.
Depending on the situation, peer review can be an iterative
process or a single event. Subject matter experts may review
several revisions of the same document, or they may comment only
A-8
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once on the document. Agency managers need to be aware of the
role a subject matter expert has played in earlier reviews and
make a determination -- on a case by case basis -- as to that
expert's independence for any further reviews.
The importance of the peer reviewer's independence and
technical expertise cannot be overemphasized as factors
influencing the value and credibility of any peer review.
Independence -- freedom from institutional, ideological, or
technical bias -- as to the issues under review is necessary for
objective, fair, and responsible evaluation of the work product
under review. However, if reviewers are selected to represent
any particular institution or technical perspective, balancing
the review with representatives of other institutions or
perspectives becomes a critical objective for the peer review.
Such perspectives and/or potential conflicts-of-interest (real or
perceived) should be fully identified to ensure a balanced and
credible peer review. Technical bias should also be considered.
An expert who serves as an author/advisor or early participant in
developmental reviews or discussions may also not be considered
independent and unbiased for a given work product.
The importance of scientific and technical expertise in the
subject matter is obvious, but there are several dimensions.
Knowledge in the subject matter is not equivalent to expertise in
the subject matter. For agency decisions, a multi-disciplinary
group of experts corresponding to the disciplines that contribute
to complex agency decisions is often necessary for a full and
complete peer review. For example, a risk assessment that relies
on both animal and human data often requires experts in both
areas for a complete review.
Peer review and public comment are not synonymous. Public
comment solicited from the general public through the Federal
Register or by other means is often required by the
Administrative Procedures Act, relevant statutes or both. Public
comment can also be solicited for policy purposes. The USEPA
takes public comment on some strictly scientific products and
almost all regulatory decisions. Public commentors usually
include a broad array of people with an interest in the technical
analysis or the regulatory decision; some are scientific experts,
some are experts in other areas, and some are interested non-
experts. The critical distinction is that public comment does
not necessarily draw the kind of independent, expert information
and analyses expected from the peer review process. Public
comment is open to all issues, whereas, the peer review process
is limited to consideration of technical issues. While an
important component of the review process, public comment does
not substitute for peer review.
A-9
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As part of each peer review, OPPTS must formulate a clear,
focused charge that identifies recognized problem areas and
invites comments or assistance. This request signals the
Agency's awareness of potential problems and its receptivity to
expert recommendations. The charge to peer reviewers usually
makes two general requests. First, it focuses the review by
presenting specific questions and concerns that the Agency
expects the reviewers to address. Secondly, it invites general
comments on the entire work product. Focused questions also
greatly simplify the task of collating, analyzing and
synthesizing peer review comments on a topical basis. Moreover,
written responses to these questions by peer reviewers help the
Agency create a peer review record.
Careful attention to all of these elements, singly and
together, assures a credible peer review process. Conversely,
inattention can nullify the peer review attempt. A well-planned
peer review applied to a reasonable quality starting work
product, followed by responsible, visible utilization of peer
review suggestions in the final product assures a credible
product for use in Agency decision-making.
B. Definitions
1. Peer Involvement - Peer involvement refers to
independent expert participation in the development and/or review
of a scientific and technical work product. Peer involvement
constitutes active outreach to and participation of the broad
scientific, engineering, and economics communities beyond the
USEPA (external) as well as within the USEPA (internal).
Typically, peer involvement takes two general forms, peer input
and peer review:
a. Peer Input - Peer input generally connotes an
interaction during the development of an evolving Agency
work product, providing an open exchange of data, insights,
and ideas. Peer input is characterized by a continued and
iterative interaction with scientific experts during the
early stages of peer involvement.
b. Peer Review - Peer review is an objective, critical
review of a specific Agency major scientific and technical
work product by an independent peer reviewer or reviewers.
Peer review can occur at several discrete points during the
peer involvement process. It is characterized by a one-time
interaction or a limited number of interactions by
independent peer reviewers.
A-10
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2. Independent Peer Reviewer - An independent peer
reviewer is an expert who was not associated with the generation
of the specific work product either directly by substantial
contribution to its development or indirectly by consultation
during the development of the specific product. The independent
peer reviewer, thus, can be objectively judgmental. This
individual has expertise in the subject matter required for the
review function.
3. Major Scientific and Technical Work Product -
Scientific, engineering, and economic documents or positions that
are used to support a research agenda, regulatory program, policy
position or other Agency decision that meet one or more of the
criteria found in Table 1 (in Section II.).
4. Peer Review Leader - A person who organizes and
oversees the peer review process for individual, specific work
products. Sometimes this individual is also the Project Manager
for the work product.
5. Peer Review Coordinator - The individual designated by
the AA to coordinate and monitor peer review activities.
6. Peer Review Group - The individuals who form the
working group that supports the Peer Review Coordinator.
II. IDENTIFYING WORK PRODUCTS FOR PEER REVIEW
The principle underlying the Peer Review Policy is that all
major scientific and technical work products (MSTWPs) normally
should be peer reviewed. The process for identifying major
products for review and then determining the mechanism of review
will take into account various criteria. The decision maker(s)
for peer review should consider the full field of possible work
products that could benefit from peer review as well as the full
spectrum of peer review mechanisms for each product.
A. The Selection Process
1. Major Scientific and Technical Work Product (MSTWP)
a) The determination that a scientific or technical product
is a "major" work product is based upon a thorough consideration
of a series of criteria. Work products that are used to support
a regulatory program or policy position and that meet one or more
of the criteria found in Table 1 are candidates for peer review:
A-11
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TABLE 1.
SOME CRITERIA FOR IDENTIFYING MAJOR
SCIENTIFIC AND TECHNICAL WORK PRODUCTS
1.
2.
3.
4.
5.
6.
7.
Supports major regulatory decisions or policy/guidance of
Establishes a significant precedent, model, or methodology
Addresses controversial issues
Focuses on significant emerging issues
Has significant cross-Agency/inter-agency implications
Involves a significant investment of Agency resources
Considers an innovative approach for a previously defined
process /methodology
major impact
problem/
8. Satisfies a statutory or other legal mandate for peer review
There are two specific circumstances when there does not
appear to be a rational for improving the work product with peer
review. First, additional peer review is not required for a
particular product that has a known peer review record by a
recognized expert or expert body. For example, a cancer risk
assessment methodology or an exposure modeling technique that had
been the subject of earlier peer review, would not require
additional review, even if the product supported a significant
Agency decision. Second, additional review is not required if a
new application of an adequately peer reviewed work product does
not depart significantly from its scientific or technical
approach.
b) Scientific or technical work products that do not meet
these criteria for "major" may be also considered candidates for
peer review depending upon the nature of these products, specific
program needs/goals, and potential benefits of the peer review
process (i.e., is value added to the work product?).
c) The need for and timing of peer review at various stages
in the development of the work product may greatly benefit that
product. The criteria in Table 1 may be used to help determine
if peer review is appropriate at a particular stage of work
product development (e.g., help an office/region decide which
direction/ methodology/technique is most appropriate from two or
more choices).
A-12
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d) Appendix D lists scientific/technical activities/products
identified in each category by OPPTS as candidates for peer
review for the upcoming fiscal year. Also listed is the
projected mechanism of peer review for each work product.
2. Special Circumstances Which May Constrain the
Use of Peer Review
a) Exploratory Analyses and Voluntary Risk Reduction: OPPTS
is involved with a number of activities that involve exploratory
scientific and technical analyses. For example, the Pollution
Prevention Program may collaborate with stakeholders, including
chemical manufacturers, formulators, users and others to
characterize the hazards, uses, exposure(s) and risks of a
substance, as well as economic considerations, to identify
pollution prevention opportunities. In other cases, alternative
chemicals or use practices (i.e., OPP's Special Review process)
may be considered that present lower risks or exploratory
analyses may be used to set priorities for additional testing or
information gathering. When such scientific and technical work
products are developed in anticipation of collaborative
activities with stakeholders, these scientific and technical work
products would not usually require peer review. If, however,
OPPTS were to determine that unilateral action is appropriate,
scientific and technical work products supporting such action
would be candidates for peer review.
b) Constraints: Statutory and court ordered deadlines and
other time constraints may limit or preclude peer review. Rarely,
resource availability may also limit peer review. OPPTS will
evaluate these circumstances on a case by case basis; decisions
will be based on consultations involving line management and the
Peer Review Coordinator. If no peer review is conducted, then
written justification to the peer review archive is needed to
explain the circumstance. The AA will notify the Science Policy
Council of the decision.
B. Mechanisms for Peer Review
1. Mechanisms List
Peer review for OPPTS takes many different forms. In OPPTS,
the most commonly used mechanisms are the FIFRA Scientific
Advisory Panel, the Biotechnology Science Advisory Committee,
workshops or symposia, outside experts, and the Science Advisory
Board. Table 2 lists 13 different types of peer review, ranging
from a single Agency expert to a twenty-person panel of external
experts. Familiarity with the method, advantages, resource
requirements, and logistics of the different forms, and their
variations, is an important aspect of peer review planning.
A-13
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TABLE 2
SOME MECHANISMS FOR OBTAINING PEER REVIEW
OF SCIENTIFIC AND TECHNICAL WORK PRODUCTS
INTERNAL PEER REVIEW
1. An independent expert from within the Agency
e.g., an ORD expert on non-cancer effects reviews a draft article
on benchmark dose.
2. An ad hoc panel of independent experts from (mostly) within the Agency
e.g., a group is convened to examine the case for the classification
for carcinogenicity for a chemical.
3. Office work group product reviewed for technical merit by scientist in
Agency laboratory
e.g., initial review of regional WTI risk assessment plan by RTF
scientists.
EXTERNAL PEER REVIEW
1. Independent expert(s) from outside the Agency
e.g., a peer reviewer for a journal to whom an Agency scientist has
submitted a paper for publication; a letter review by one or more
reviewers
2. An ad hoc panel of independent experts from (mostly) outside the Agency
e.g., a group is convened to reach consensus on the carcinogenicity of
formaldehyde.
3. Agency (including Risk Assessment Forum)-sponsored Peer Review
Workshops
e.g., review of indicators of ecosystem damage.
4. An Agency-based Federal Advisory Committee (other than SAB)
e.g., the Biotechnology Science Advisory Committee (BSAC) meets to
review technical aspects of the release of bioengineered
organisms.
5. Agency-appointed special Board or Commission
e.g., review of risk issued by the CAA Commission on Risk Assessment.
6. Agency Science Advisory Board (SAB)
e.g., review of drinking water criteria document for arsenic.
7. Interagency committee
e.g., review of research plans by Committee on the Environment and
Natural Resources (CENR) coordinated by the White House.
8. Committee of another agency
e.g., review of "dioxin" reassessment by HHS Committee to Coordinate
Environmentally Related Programs (CCERP).
9. Non USEPA-based groups
e.g., Society of Risk Analysis review of cancer guidelines.
10. National Academy of Science/National Research Council
e.g., review of children and pesticides.
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2. Selection of Appropriate Mechanism(s)
a) Determining an appropriate mechanism of peer review is
generally subjective. Science staff are responsible for
recommending and OPPTS managers for selecting peer review options
based upon the importance and impact of the work product, the
resources available (staff, budget, reviewers), the time
investment, and previous review history. The choice of mechanism
is based upon several criteria, as seen in Table 1. Also, the
extent of previous peer involvement and/or peer review helps
determine an appropriate mechanism of peer review.
b) Generally, the more nearly novel or complex the science
or technology, the greater the cost implications of the impending
decision, and the more controversial the issue, then the stronger
the indication for a more extensive and involved peer review and
for external peer review in particular. For example, certain
work products will clearly lend themselves to extensive external
peer review; generally these will be products with large impacts.
Other major work products may not need a large scale external
peer review and may utilize a less involved, less resource
intensive review. The peer review of some products may be better
served with some form of internal peer review or a combination of
internal and external peer review. Again, the choice is
subjective and will generally be dependent upon the experience
and assessment of the decision maker(s) dealing with peer review
issues. It is important to make this choice at the time that the
work is planned so that peer review costs and time can be
budgeted into the work plan.
C. Categories of Office Products
OPPTS is involved in a wide variety of activities that have
strong scientific and technical components. These activities
include hazard, dose-response, exposure, and risk assessments,
economic analyses and valuations, development of new assessment
methods, and surveys. Some activities (e.g., evaluations of new
chemical substances) are performed routinely using standardized
assessment methodologies.
Other activities involve breaking new ground or the use of
novel techniques or analyses (e.g., formaldehyde risk assessment,
acute dietary risk assessment methodology, assessment of
biological control agents). All OPPTS scientific and technical
activities benefit from peer involvement. The level of peer
involvement will differ depending on the scope of the effort, and
the significance of the potential outcome, among other factors.
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For purposes of discussion, major OPPTS scientific and
technical activities can be grouped into several categories.
Category #1: Products that support major regulatory decisions.
1) Risk assessments (including associated hazard, dose-
response and exposure analyses)
2) Benefits and cost (economic) assessments relevant to
some unreasonable risk determination under TSCA or
FIFRA
3) Data requirements for pesticide registration
4) Technical guidance documents for the regulated
community
Category #2: New approaches to the assessment of chemicals or
products of biotechnology. Issues having a major national impact
on public health and or ecosystem protection. Examples include:
1) issues associated with release of genetically
engineered organisms into the environment
2) application of new scientific principles in risk
assessment, e.g., the consideration of biological
mechanisms for induction of cancer in risk assessment
3) risk assessment methods development, e.g., risk
assessment methods concerning children exposed to
pesticide residues
4) risk mitigation proposals for eco-risk reduction
5) efficacy testing procedures for hospital disinfectants
and sterilants
Category #3: Products that result in generation of large
quantities of data or unusual data. Examples include
1) major surveys, e.g.,:
* national survey of lead-based paint in housing
* survey of pesticides in drinking water wells
* national food consumption survey
2) monitoring of chemicals in environmental components
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Category #4: New predictive tools or models of significance,
generic assessment methodologies to be used routinely in risk
assessment, novel approaches to economic valuation. Examples
include:
1) expert systems and quantitative techniques designed to
help predict hazards, chemical fate, etc., from
chemical structure, use, or toxicity/exposure data
2) significant models and other techniques designed to
predict exposure, simulate transport, etc.
3) precedent-setting methods for economic valuation
4) priority-setting tools, e.g., OPPT Use Cluster Scoring
System
Appendix C lists completed peer reviews initially listed in
prior Appendicies D plus representative scientific/technical
activities/work products peer reviewed prior to FY-95.
III. PLANNING AND CONDUCTING A PEER REVIEW
The success and usefulness of any peer review depends on the
quality of the peer review draft, the care given to the statement
of the issues or "charge", the match between the peer review
draft and the form of peer review, the match between the peer
review draft and the scientific/technical expertise of the
reviewers, and Agency use of peer review comments in the final
product. It is not enough simply to conduct a peer review; each
of the foregoing elements requires serious attention.
A. Selecting Peer Reviewers
1. Sources for Peer Reviewers
a) Recommendations for potential peer reviewers can be
identified from a number of organizations. These include
external groups such as the affected party(ies); special interest
groups; public interest groups; environmental groups; trade or
business associations; state organizations or agencies; the
National Research Council; and other Federal agencies with an
involvement in or familiarity with the issue. Internal groups
include the staff of the Science Advisory Board (SAB), BSAC, or
the Scientific Advisory Panel (SAP); relevant ORD scientific
staff; and other Program or Regional experts.
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b) In certain circumstances, existing peer review
organizations such as the SAB, BSAC or SAP may be used to conduct
a peer review. These groups establish their own criteria for
accepting work and coordination must be made directly with them.
Both conduct formal, public, external peer reviews.
c) Occasionally, a member of the scientific community will
offer his/her services for peer review during an ongoing peer
review. Disposition of these offers will be handled on a case by
case basis in consultation with the Peer Review Coordinator and
appropriate decision makers.
2. Selecting Peer Reviewers
a) Peer reviewers should be selected for independence and
scientific/technical expertise. The emphasis on independence and
expertise applies equally to government experts and experts from
the larger scientific community.
b) Ideally, peer reviewers should be free of real or
perceived conflicts-of-interest or there should be a balancing of
interests among peer reviewers.
c) Some peer reviews can be conducted with one or two
reviewers; others involve panels of peer reviewers. In either
case each of the peer reviewers should have recognized technical
expertise that bears on the subject matter under discussion.
Taken as a whole, the peer reviewers of a work product should
represent a balanced range of technically legitimate points of
view. In the face of equally qualified experts, cultural
diversity and "address" (e.g., industrial, academic, or
environmental community) are secondary factors that can play a
role.
3. Internal vs. External Peer Reviewers
Generally, external peer reviewers are preferred. For some
work products, either external or internal peer review may be
appropriate. Selection of internal peer reviewers should be
based upon technical expertise, available time and "address";
that is, they should not come from the immediate office or group
producing the product or have any other connection with the
product or document being peer reviewed.
4. Disciplinary Mix
a) A peer review panel or group can number from just a few
individuals to ten or more, depending on the issue, the time and
resources available and the broad spectrum of expertise required
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to treat the range of issues/questions in the charge (see Section
III.C. below). Naturally, experts whose understanding of the
specific technical area(s) being evaluated are critical;
nevertheless, it is also important to include a broad enough
spectrum of other related experts to completely evaluate the
relevant impacts on other less obvious concerns. For example,
for health related peer reviews, experts in such fields as
ecology and economics may provide very useful insights.
b) There is usually a continuum of views on any issue. To
the extent possible or practicable, selected experts should have
views that fall to either side of the centrist position along the
continuum, but not too far to either extreme. This will help
maintain a balanced viewpoint, while allowing all views to be
expressed and discussed. A balanced panel will allow consensus
building. As a general rule, experts who have made public
pronouncements on an issue (e.g., those who have clearly "taken
sides") have difficulty in reaching consensus positions and
should be avoided.
5. Constraints in Selecting Peer Reviewers
a) Peer review is not free. Regardless of the type of peer
review chosen, there is some cost to the Agency. This cost can
range from the time invested by a few Agency staff during an
internal peer review, to the total costs associated with a full,
formal, public external peer review; e.g., SAB review.
b) Sometimes the need for a peer review is accelerated due
to a court-ordered deadline or other time-sensitive requirements.
In such cases, it is difficult, if not impossible to conduct a
full external peer review. It may even be impossible to conduct
a small scale internal peer review using just a few individuals.
Mechanisms for identifying and using a small number of peer
reviewers should be included for OPPTS so that quick, effective
peer review can be included for even the most rapidly moving
products.
c) Care must be taken to reduce the possibility for real or
apparent conflicts of interest between the reviewers and the
OPPTS work product under review. Various tools are available to
identify and limit conflicts of interest (e.g., attention to the
employment, financial, and professional affiliations of the
participants; filing Confidential Financial Disclosure Forms (SF-
450) in the case of members of Federal Advisory Committees;
exploring directly the issue with each of the participants before
the review process takes place; and disclosing publicly at the
beginning of meetings any previous involvement with the issue).
The established peer review groups such as the Science Advisory
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Board and the Scientific Advisory Panel provide useful models for
addressing balance and conflict-of-interest issues. Assistance
in determining legal conflicts of interest can be obtained
through the Office of the General Counsel. In addition,
additional advice can be obtained from the Designated Agency
Ethics Officials. Appendix E has further discussion on conflict
of interest.
d) To evaluate OPPTS-generated studies properly, some peer
reviewers may need access to confidential business information
(CBI). However, unless the reviewers are Federal employees, it
is unlikely that the USEPA has the authority to disclose CBI to
them. Therefore, whenever contemplating the use of outside peer
reviewers, Agency staff should determine whether the reviewers
will need access to CBI. If so, the Office of the General
Counsel should be consulted on whether it is practical to obtain
the consent of CBI submitters to disclose the information to peer
reviewers.
e) Offices need to be aware of the requirements of the
Federal Advisory Committee Act (FACA) when establishing peer
review mechanisms. Federal advisory committees are subject to
chartering by the General Services Administration, hold meetings
that are open to the public, and have balanced membership
requirements. The Office of the General Counsel should be
consulted regarding the applicability of FACA to peer review
panels, see appendix E for additional information.
B. Scheduling Peer Reviews
The peer review schedule is a critical feature of the
process. The schedule must take into account the availability of
a peer review quality draft work product, availability of
appropriate experts, time available for using peer review
comments, deadlines for the final work product, and logistical
aspects of the peer review (e.g., contracting procedures).
The schedule for peer review should take into account the
overall rulemaking (or other decision-making) schedule. Peer
review sometimes leads to new information and analyses, or
recommendations for new research that would alter the work
product and thus modify the scientific/technical basis for the
action. For this reason, it is usually advisable to complete the
peer review before taking public comment, or at least before the
close of the public comment period.
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C. Materials
1. Information Provided to Peer Reviewers
a) Essential documentation for each peer reviewer includes:
1) A current copy of the work product to be peer
reviewed with associated background material. The work
product needs to be of the best possible
scientific/technical quality to ensure an adequate and
useful peer review.
2) A clear charge or statement of work seeking informed
comment on identified issues to properly focus the
efforts of the peer reviewers and ensure that their
individual efforts can be merged.
3) Some information concerning the process that OPPTS
is using for the peer review, including due date of
reviewer comments and the format of those responses.
Responses should be written and submitted to OPPTS by
an agreed upon deadline. In certain rare cases, oral
commentary may be sufficient. However, in such cases,
a follow-up written response for the record is
required.
4) OPPTS will make clear to the peer reviewers their
responsibilities. One of the major responsibilities of
peer reviewers is to ensure confidentiality of the peer
reviewed work product. Each peer reviewer must be
informed of the need for confidentiality with regard to
the release of OPPTS products that are stamped as
"DRAFT" or "DRAFT - Do Not Cite, Quote, or Release."
Premature release of draft Agency products, views, or
positions is inappropriate and can be damaging to the
credibility of the Agency or the peer reviewer. While
not having legal authority, such language will be
included in the charge to the peer reviewers. Other
mechanisms to use in discouraging premature release
include a disclaimer that appears in a separate section
at the front of the document and creating the document
with watermarks clearly delineating DRAFT status (or a
header or footer that states DRAFT status) on every
page. In addition, in any solicitation for peer
reviewers, the necessity for confidentiality and the
non-release of materials shall be emphasized.
b) Useful, but not critical materials that may be sent to
peer reviewers include:
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1) Unless a "Delphi" type process is being undertaken,
it is also useful for each peer reviewer to have the
name, address, and phone, fax, and/or Internet numbers
of each peer reviewer working on the specific review.
2) Any particularly relevant scientific articles from
the literature;
3) It is often more practical to provide comments on a
product that has line numbering added in the margin.
c) Peer Reviewers should be given what is needed to complete
their task -- they should not be overburdened with excess
material.
2. Peer Reviewer Responsibilities
The Peer Review Leader is responsible for ensuring that peer
reviewers understand and comply with these responsibilities:
a) Advise the USEPA of any real or perceived conflicts-of-
interest.
b) Provide written comments in specified format by the
specified deadline.
c) Comply with the request for not disclosing draft work
products to the public.
IV. COMPLETING A PEER REVIEW
Performance of the formal peer review is not the final stage
in the development of the work product. Rather, it is an
important stage in developing the work product, with the final
work product representing the true end of the peer review. As a
result, the peer review process closes with three major
activities: evaluating comments and recommendations, utilizing
peer review comments for completing the final work product, and
organizing and maintaining a record of the peer review.
A. Evaluating Comments and Recommendations
1. OPPTS must carefully evaluate and analyze all peer review
comments and recommendations. As discussed in Section III., a
carefully crafted charge to the peer reviewers simplifies
organizing and analyzing comments. Also, any other issues that
are raised need to be identified and evaluated.
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2. The validity and objectivity of the comments need to be
evaluated. Analyses include consultation with other
experts/staff within the Office and/or Agency.
3. Comments that have significant impact on time, budgetary,
and/or resource requirements need to be evaluated in consultation
with management. These comments may lead to allocation of
additional resources and a revised schedule for the completion of
the work product.
B. The Final Work Product
1. OPPTS must utilize technically sound and responsible peer
review comments and recommendations in completing the final work
product. The major issues raised by the peer reviewers need to
be identified in the front of the final work product, along with
information on how they were used or not used in the final work
product.
2. In the final work product, reference the location of the
peer review record where all comments and related peer review
information can be found. The peer review record should be
placed in any associated established public docket in addition to
the Office archive.
C. Maintaining the Peer Review Record
1. The Peer Review Leader will collect and maintain the
following materials for the peer review record, including at
least:
> the draft work product submitted for peer review
> materials and information given to the peer
reviewer(s)
*• comments, information, and materials received from
the peer reviewer(s)
> information about the peer reviewer(s) (e.g.,
names, affiliations, etc.)
* any logistical information (e.g., times;
locations; duration, etc.)
> the final work product
2. The peer review record must be indexed and maintained in
an office archive.
All peer review comments should be carefully evaluated and
used to revise work products where appropriate. As discussed in
III. C. (above) it is particularly useful to craft specific
questions for peer reviewers so that subsequent comment will be
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focussed. Focussing reviewers attention on issues of interest
will facilitate comment evaluation.
In some cases, preparation of a document that responds to
each comment may be appropriate. In other circumstances,
comments may be addressed in a more general manner. In any case,
a clear record must be maintained of the peer review process
employed, as well as the specific comments received.
Furthermore, the product itself must include some acknowledgment
of the peer review process.
The Agency may or may not agree with comments received.
However, it is important to reflect the nature of comments
received and the extent to which these comments affect the
scientific or technical product. In addition to revising the
technical product, if appropriate, it is particularly important
to communicate significant results of peer review to the decision
maker(s) as well as to others who may not be versed in the
technical discipline at hand. For example, a decision maker
might find a peer review summary very helpful. The summary could
present, in general terms, the scope of the peer review process
and the thrust of the comments received. A brief statement
discussing the kinds of comments received, how the comments were
reflected in the work product, and the impact on the scientific
or technical conclusion should be included. For example, a
hypothetical summary might include language such as:
Reviewers commented that the exposure analysis assumed no
chemical degradation as a result of treatment in a POTW.
Reviewers felt this was overly conservative and, as a
result, risks may be overestimated.
No information is available on the fate of the chemical in
POTWs. However, based on analogous chemicals for which data
are available, it is likely that less than 10% degradation
would occur. The risk characterization has been changed to
reflect risk as a range, thereby addressing the uncertainty
associated with our lack of information on fate of this
chemical in a POTW.
V. ACCOUNTABILITY AND RESPONSIBILITY IN THE OFFICE
Under the June 7, 1994 Peer Review Policy, the Administrator
has designated the Assistant Administrators and Regional
Administrators to be accountable for implementing the Policy in
their respective offices. This section provides information on
OPPTS' delegations of responsibility to (a) line management for
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individual peer reviews, and (b) an office-wide coordination
group for general assistance and advice.
A. Line Management
1. Decision maker(s)
a) The Assistant Administrator is accountable for the
decisions regarding the identification of major scientific and
technical work products and the mechanism(s) of peer review
utilized for each of the products. The AA designates the OPPTS
Division Directors, in conjunction with the Deputy Office
Directors, as decision makers. The AA and their designee(s) are
also responsible for ensuring that the peer reviews are performed
and fully completed. See Appendix B for the names (or positions)
of the designated decision maker(s).
b) Specific responsibilities of the decision maker(s) are:
> Designating a Peer Review Leader to organize the peer
review
* Providing advice, guidance, and support to the Peer
Review Leader in the preparation, conduct, and
completion of the peer review
*• Establishing a realistic peer review schedule (see
Section III)
* Designating the stage(s) of product development where
peer review is appropriate
> Ensuring that the results of peer review are carried
forward in the final work product
2. Peer Review Leader
a) The Peer Review Leader organizes and oversees the peer
review for a specific work product. This person(s) can be the
decision maker(s), but will usually be someone who is authorized
by the decision maker to prepare, perform, and bring to
completion the peer review. The Peer Review Leader will obtain
the assistance and support of the Peer Review Coordinator and
Peer Review Group (see below) as well as any others within the
Agency to help perform the peer review. The Leader will be
chosen on a case by case basis depending on the work product
needing peer review.
b) Specific responsibilities of the Peer Review Leader are:
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*• Coordinating the peer review of their assigned work
product with the Peer Review Coordinator and Peer
Review Group
*• Organizing, conducting, and completing the peer review
following the procedures outlined in this SOP,
particularly Sections III. and IV.
*• Selecting the peer reviewers in consultation with
others involved with the peer review (e.g., Peer Review
Coordinator)
*• Advising peer reviewers of their responsibilities
B. Office Coordination
1. Peer Review Coordinator
a) The Assistant Administrator for OPPTS will designate one
person to coordinate or lead coordination of peer review
activities for this office. The Peer Review Coordinator is
listed in Appendix B.
b) Specific responsibilities of the Peer Review Coordinator
are:
*• Leading the Peer Review Group as well as OPPTS peer
review activities
*• Reporting peer review activities to the AA
> Liaison with the Science Policy Council (SPC) and
Science Advisor:
1) Representing OPPTS before the SPC
2) Advising the SPC of any changes in SPC-reviewed
list of work products and peer review mechanisms
in Appendix D
3) Participating in SPC peer review training,
workshops, etc., as requested
4) Interfacing with the Administrator's Science
Advisor on peer review matters
*• Submit information on OPPTS peer review candidates for
each fiscal year on June 15 of the preceding year via
Appendix D reporting
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> Submit any SOP revisions on July 1 of each year for
review for incorporation in the SOP for the next fiscal
year
* Provide advice, guidance, and support to the various
Peer Review Leaders for the performance of the peer
reviews
*• Distribute Agency-wide peer review guidance and
materials to appropriate OPPTS personnel, as requested
2. OPPTS Peer Review Advisory Group
a) Each year, the Assistant Administrator may also designate
other persons and support staff to constitute the Peer Review
Advisory Group. The Group will assist the Peer Review
Coordinator either as special assignments or as a designated part
of their normal duties. The group members and support staff are
listed in Appendix B.
b) Specific responsibilities for the Peer Review Group are:
*• Assisting the Peer Review Coordinator in providing
advice involving peer review activities in OPPTS
> Assisting with logistical and technical peer review
needs in the office, e.g., acquisition and distribution
of resources
> If needed, providing advice to decision maker(s) and/or
help them with the identification of major work
products and selection of appropriate peer review
mechanism
*• Periodic review of the SOP and how it is being
implemented
> Provide advice during the planning and management of
OPPTS' peer review program, e.g., integrating peer
review plans into office workplans
3. Legal Advice
OPPTS staff and management work regularly with individual
OGC staff assigned to Agency activities. Peer Review Leaders
should continue to initially consult with their customary OGC
advisors for legal advice or referral. Headquarters attorneys
have specialties in specific areas and can be consulted as
needed. Appendix B lists these contacts for OPPTS.
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C. Budget
Both program offices within OPPTS (OPP and OPPT) have
rigorous planning processes. The planning process is the
appropriate forum to ensure that peer review-related activities
are appropriately budgeted, and that sufficient resources will be
available to effect a completed peer review.
The planning process articulates priority activities for the
coming year and provides opportunities for periodic evaluation of
project status, including opportunities for redirecting program
priorities. The planning process facilitates development of
project plans for priority projects, including identification of
scientific and technical products necessary to complete priority
activities.
The project planning process provides a natural forum for
discussing the nature of scientific and technical products that
will be developed to support various projects. This forum
provides an opportunity to discuss the mechanism of peer
involvement and/or peer review needed and how these peer
activities will be achieved. Discussing the scope of peer review
during the planing process provides the added benefit of ensuring
that timing and resource requirements associated with peer review
are included in the planning process and highlighted for senior
management attention.
D. Annual Reviews
1. The Peer Review Coordinator will organize an annual
preview of OPPTS' expected work products for the next fiscal year
and submit this information to the SPC by June 15 of each year as
required for Appendix D.
2. The Peer Review Coordinator will organize an annual
review to assess the function of the SOP in practice. The
Coordinator will consult with the SPC regarding any proposed
changes by June 15 for the next fiscal year.
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APPENDIX A
U.S. ENVIRONMENTAL PROTECTION AGENCY PEER REVIEW POLICY
PEER REVIEW AND PEER INVOLVEMENT
AT THE U. S. ENVIRONMENTAL PROTECTION AGENCY
This document establishes the policy of the United States
Environmental Protection Agency (EPA) for peer review of
scientifically and technically based work products that are
intended to support Agency decisions. Peer review is presented
in the context of the broader concept, peer involvement.
BACKGROUND
The report "Safeguarding the Future: Credible Science,
Credible Decisions"1 focused on the state of science at EPA. The
panel of experts who prepared the report emphasized the
importance of peer review, especially external peer review, and
the need for broader and more systematic use of it at EPA to
evaluate scientific and technical work products. Their specific
recommendation regarding peer review reads as follows:
"Quality assurance and peer review should be applied to
the planning and results of all scientific and
technical efforts to obtain data used for guidance and
decisions at EPA, including such efforts in the program
and regional offices. Such a requirement is essential
if EPA is to be perceived as a credible, unbiased
source of environmental and health information, both in
the United States and throughout the world."
In response to this recommendation, then-Administrator Reilly
directed staff to develop an EPA-wide policy statement, which he
issued in January, 1993. The paragraphs below preserve the core
of that earlier statement while updating it to specify the role
of the Science Policy Council in guiding further implementation
of the policy. Effective use of peer review is indispensable for
fulfilling the EPA mission and therefore deserves high-priority
attention from program managers and scientists within all
pertinent Headquarters and Regional Offices.
PEER INVOLVEMENT AND PEER REVIEW
EPA/600/9-91/050, March 1992.
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EPA strives to ensure that the scientific and technical
underpinnings of its decisions meet two important criteria: they
should be based upon the best current knowledge from science,
engineering, and other domains of technical expertise; and they
should be judged credible by those who deal with the Agency. EPA
staff therefore frequently rely upon peer involvement -- that is,
they augment their capabilities by inviting relevant subject-
matter experts from outside the program to become involved in one
or more aspects of the development of the work products that
support policies and actions.
One particularly important type of peer involvement occurs
when scientifically and technically based work products undergo
peer review -- that is, when they are evaluated by relevant
experts from outside the program who are peers of the program
staff, consultants, and/or contractor personnel who prepared the
product. Properly applied, peer review not only enriches the
quality of work products but also adds a degree of credibility
that cannot be achieved in any other way. Further, peer review
early in the development of work products in some cases may
conserve future resources by steering the development along the
most efficacious course.
Peer review generally takes one of two forms. The review
team may consist primarily of relevant experts from within EPA,
albeit individuals who have no other involvement with respect to
the work product that is to be evaluated (internal peer review).
Or the review team may consist primarily of independent experts
from outside EPA (external peer review).
POLICY STATEMENT
Major scientifically and technically based work products
related to Agency decisions normally should be peer-reviewed.
Agency managers within Headquarters, Regions, laboratories, and
field components determine and are accountable for the decision
whether to employ peer review in particular instances and, if so,
its character, scope, and timing. These decisions are made in
conformance with program goals and priorities, resource
constraints, and statutory or court-ordered deadlines. For those
work products that are intended to support the most important
decisions or that have special importance in their own right,
external peer review is the procedure of choice. Peer review is
not restricted to the penultimate version of work products; in
fact, peer review at the planning stage can often be extremely
beneficial.
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SCOPE
Agency managers routinely make regulatory and other
decisions that necessarily involve many different considerations.
This policy applies to major work products that are primarily
scientific and technical in nature and may contribute to the
basis for policy or regulatory decisions. By contrast, this
policy does not apply to nonmajor or nontechnical matters that
Agency managers consider as they make decisions. Similarly, this
policy does not apply to these ultimate decisions.
This policy applies where appropriate, as determined by the
National and Regional Program Managers, to major scientifically
and technically based work products initiated subsequent to the
date of issuance. Peer review should be employed to the extent
reasonable to relevant work products that currently are under
development. This policy does not apply to the bases for past
decisions, unless and until the relevant scientific and technical
issues are considered anew in the Agency's decision-making
processes.
Except where it is required by law, formal peer review (as
distinguished from the Agency's normal internal review
procedures) should be conducted in a manner that will not cause
EPA to miss or need extension of a statutory or court-ordered
deadline. Agency managers still may undertake peer review if it
can be conducted concurrently with necessary rulemaking steps.
LEGAL EFFECT
This policy statement does not establish or affect legal
rights or obligations. Rather, it confirms the importance of
peer review where appropriate, outlines relevant principles, and
identifies factors Agency staff should consider in implementing
the policy. On a continuing basis, Agency management is expected
to evaluate the policy as well as the results of its application
throughout the Agency and undertake revisions as necessary.
Therefore, the policy does not stand alone; nor does it establish
a binding norm that is finally determinative of the issues
addressed. Minor variations in its application from one instance
to another are appropriate and expected; they thus are not a
legitimate basis for delaying or complicating action on otherwise
satisfactory scientific, technical, and regulatory products.
Except where provided otherwise by law, peer review is not a
formal part of or substitute for notice and comment rulemaking or
adjudicative procedures. EPA's decision whether to conduct peer
review in any particular case is wholly within the Agency's
discretion. Similarly, nothing in this policy creates a legal
A-31
-------
requirement that EPA respond to peer reviewers. However, to the
extent that EPA decisions rely on scientific and technical work
products that have been subjected to peer review, the remarks of
peer reviewers should be included in the decision record.
IMPLEMENTATION
The Science Policy Council is responsible for overseeing
Agency-wide implementation. Its responsibilities include
promoting consistent interpretation, assessing Agency-wide
progress, and developing recommendations for revisions of the
policy as necessary.
The Science Policy Council will oversee a peer-review work
group, which will include representatives from program units
throughout EPA to effect a consistent, workable implementation of
the policy. The work group will assist the programs in (1)
formulating and, as necessary, revising standard operating
procedures (SOPs) for peer review consistent with this policy;
(2) identifying work products that are subject to review; and (3)
for each major work product, selecting an appropriate level and
timing of peer review.
In assisting the programs, the work group will take into
account statutory and court deadlines, resource implications, and
availability of disinterested peer reviewers. The group will
work closely with Headquarters offices and the Regional Offices
toward ensuring effective, efficient uses of peer review in
supporting their mission objectives. However, the Assistant
Administrators and Regional Administrators remain ultimately
responsible for developing SOPs, identifying work products
subject to peer review, determining the type and timing of such
review, documenting the process and outcome of each peer review,
and otherwise implementing the policy within their organizational
units.
Because peer review can be time-consuming and expensive,
Agency managers within Headquarters, Regions, laboratories, and
field components are expected to plan carefully with respect to
its use -- taking account of program priorities, resource
considerations, and any other relevant constraints as well as the
policy goal of achieving high-quality, credible underpinnings for
decisions. External peer reviewers should be chosen carefully to
ensure an independent and objective evaluation. The affiliations
of peer reviewers should be identified on the public record, so
as to avoid undercutting the credibility of the peer-review
process by conflicts of interest.
A-32
-------
This policy is effective immediately. The peer-review work
group mentioned above will identify the focal point to whom
comments and questions should be addressed and, from time to
time, will provide further information about implementation
activities.
A-33
-------
APPENDIX B
KEY PERSONNEL
I. Individuals Involved in the Peer Review
A. Line Management
1. Decision maker(s): OPPTS Division Directors in
conjunction with the Deputy Office Directors:
OPP Division Directors
Director, Program Management and Support Division
Director, Biological and Economic Analysis Division
Director, Biopesticides and Pollution Prevention Division
Director, Environmental Fate and Effects Division
Director, Field Operations Division
Director, Health Effects Division
Director, Registration Division
Director, Special Review and Reregistration Division
OPPT Division Directors
Director, Chemical Control Division
Director, Economics, Exposure and Technology Division
Director, Environmental Assistance Division
Director, Chemical Screening and Risk Assessment Division
Director, Chemical Management Division
Director, Health and Environmental Review Division
Director, Information Management Division
Director, Pollution Prevention Division
A-34
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OPPTS Deputy Office Directors
Deputy Office Director, Office of Pesticide Programs
Deputy Office Director, Office of Pollution Prevention and Toxics
B. Office Coordination
2. Peer Review Coordinator
Name: Michael Firestone
Position: Science Advisor/OPPTS
Telephone: (202) 260-2897
Term of service: continuing
3. Peer Review Group
Individuals serving on the Peer Review Group in FY95:
Chair: Susan H. Wayland
Position: Deputy Assistant Administrator/
OPPTS
Telephone: (202) 260-2910
Term of service: continuing
Co-chair: Penelope Fenner-Crisp
Position: Deputy Office Director/OPP
Telephone: (703) 305-7090
Term of service: continuing
Co-chair: Joseph S. Carra
Position: Deputy Office Director/OPPT
Telephone: (202) 260-1815
Term of service: continuing
Member: Michael Firestone
Position: Science Advisor/OPPTS
Telephone: (202) 260-2897
Term of service: continuing
Member: Robert B. Jaeger
Position: Designated Federal Official
for FIFRA Scientific Advisory Panel
Telephone: (703) 305-5369
Term of service: continuing
A-35
-------
Member: Elizabeth Milewski
Position: Designated Federal Official for
Biotechnology Science Advisory Committee
Telephone: (202) 260-6900
Term of service: continuing
Member: Amy Rispin
Position: Senior Science Advisor/PSPS/OPP
Telephone: (703) 308-2738
Term of service: continuing
Member: William T. Waugh
Position: Deputy Director
Chemical Screening and Risk Assessment Division
Telephone: (202) 260-3489
Term of service: continuing
II. Legal Advice
OPPTS works closely with OGC staff. Peer Review Leaders
should continue to initially consult with their customary OGC
advisers for legal advice or referral. The following individual
has been identified as the OPPTS contact in OGC for matters
relating to this SOP:
Robert Perils
Office of General Counsel
The headquarters attorneys listed below specialize in the
identified areas and may be consulted, as appropriate.
Donald Sadowski
Confidential Business Information
Office of General Counsel
Richard Feldman
Conflicts of Interest Disclosure
Office of General Counsel
Hale Hawbecker
FACA Issues
Office of General Counsel
A-36
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APPENDIX C - Part 1 of 2
PRODUCTS PEER REVIEWED SINCE 1991 (Pre-1995-Initiated Items are Representitive)
Candidate Work Product
Ecological Risk Assessment of Dioxins -
TS9101
Reduced Protocols for Carcinogenicity
Testing - TS9201
Ecological Quantitive Structure Activity -
TS9401
Analysis of HUD National Survey Data -
TS9402
Formaldehyde Risk Characterization -
TS9102
Design of Repair and Maintenance Study,
Lead - TS9202
Consumer Behavior Study - TS91 03
US EPA Regulatory Perpectives on the Use
of QSAR for New & Existing Chemical
Evaluations - TS9403
Green Chemistry Manuscripts TS9415
Region/
AAship
OPPTS
OPPTS
OPPTS
OPPTS
OPPTS
OPPTS
OPPTS &
OW
OPPTS
OPPTS
Program
Office
OPPT
OPPT
OPPT
OPPT
OPPT
OPPT
OPPT
OPPT
OPPT
Peer Review Leader/
Phone
John Bower, 260-1 771
David Lai, 260-6222
Richard Clements, 260-
5270
Manie Chen, 260-3910
Vanessa Vu, 260-1245
Susan Dillman, 260-5375
Lynne Blake-Hedges,
260-7241
Maurice Zeeman, 260-
1240
Tracy Williamson 260-
3960
Date of Peer
Review
Completion
10/91
1/94
1/95
9/94
7/92
4/92
4/94
5/95
3/96
Review
Mechanism
Workshop
Workshop
Public Literature &
Expert Panel
Independent Experts
SAB
Independent Experts
Independent Experts
Peer Review Journal
Independent Experts
Date of
Initial
Entry
9/94
9/94
5/95
9/94
Date Peer
Review
Initiated
6/91
9/92
1/94
4/94
6/91
4/92
9/91
9/94
3/95
Date Peer
Review
Comments
Received
10/91
12/92
6/94
5/94
12/91
4/92
12/91
4/95
3/96
Comments
Joint OW/OPPT
activity.
Received peer
input through
NACEPT. OW
asked that
OPPT publish
study ASAP for
additional
feedback.
Issued as ACS
Publications
CO
--J
-------
APPENDIX C - Part 1 of 2
PRODUCTS PEER REVIEWED SINCE 1991 (Pre-1995-Initiated Items are Representitive)
(Continued)
Candidate Work Product
LeadXRF and Test Kit Field Evaluation
Study TS9411
Pilot Testing Program for Protocals for
Lead-Based Paint Encapsalants TS9413
Pre-lntervention Data Collection from the
Lead Repair and Maintenance Study
TS9504
Effects of In-Home Education on Children's
Blood-Lead Levels in Milwaukee TS9505
Environmental Toxicology/Ecological
Effects Assessment by USEPA; OPPT
Under TSCATS9507
Environmental Toxicology Testing &
Screening Technologies TS9506
Region/
AAship
OPPTS
OPPTS
OPPTS
OPPTS
OPPTS
OPPTS
Program
Office
OPPT
OPPT
OPPT
OPPT
OPPT
OPPT
Peer Review Leader/
Phone
John Schwemberger
260-7195
Jill Hacker 260-3952
Ben Lim 260-1 509
Brad Schultz (608) 265-
4068
Maurice Zeeman 160-
1240
Maurice Zeeman 260-
1240
Date of Peer
Review
Completion
5/95
9/95
10/95
4/96
10/95
10/95
Review
Mechanism
Expert Panel
Expert Panel
Expert Panel
Expert Panel
OTA Symposium
OTA Symposium
Date of
Initial
Entry
9/94
9/94
5/95
5/95
5/95
5/95
Date Peer
Review
Initiated
11/94
6/95
7/95
8/95
4/95
4/95
Date Peer
Review
Comments
Received
1/95
8/95
8/95
10/95
8/95
8/95
Comments
Title of Work
Product Revised
Title of Work
Product Revised
Title of Work
Product Revised
CO
oo
-------
APPENDIX C - Part 2 of 2
PRODUCTS PEER REVIEWED SINCE 1991 (Pre-1995-Initiated Items are Representitive)
Candidate Work Product
Impact of Triazines on Water Resources -
PP9301
Small scale prospective ground-water
study guideline and protocol - PP9501
National Survey of Pesticides in Drinking
Water -PP9201
Assessment of environmental release of
transgenic cotton plants under an EUP -
PP9202
Proposed regulation of plant pesticides:
scientific issues - PP9203
Proposed regulation of plant pesticides
under FFDCA: scientific issues - PP9302
Proposed rule for plant pesticides:
scientific issues - PP9401
Assessment of plant pesticides containing
B.t. crylll delta endotoxin: scientific issues -
PP9501
Two generation reproductive toxicity test
guideline - PP9303
Developmental toxicity test guideline and
SEP - PP9304
Triphenyltin hydroxide cancer assessment
-PP9101
Triallate cancer assessment - PP9204
Quinclorac cancer assessment - PP9205
Region/
AAship
OPPTS
OPPTS
OPPTS/
OW
OPPTS
OPPTS
OPPTS
OPPTS
OPPTS
OPPTS
OPPTS
OPPTS
OPPTS
OPPTS
Program
Office
OPP-EFED
OPP-EFED
OPP-EFED
OPP-BPPD
OPP-BPPD
OPP-BPPD
OPP-BPPD
OPP-BPPD
OPP-HED/
OPPT
OPP-HED/
OPPT
OPP-HED
OPP-HED
OPP-HED
Peer Review Leader/
Phone
Hank Jacoby
703-305-5734
Betsey Behl
703-305-6128
Elizabeth Leovey
703-305-7328
Bill Schneider
703-308-8683
Bernice Slutsky
202-260-6900
Bernice Slutsky
202-260-6900
Bernice Slutsky
202-260-6900
W. Schneider
703-308-8683
Sue Makris/ Jennifer Seed
Sue Makris/ Jennifer Seed
Date Peer
Review
Completed
10/92
4/95
1/92
4/92
11/94
11/94
11/94
5/95
proj. 10/95
proj. 10/95
10/91
7/92
9/92
Review
Mechanism
Agency and outside
experts
workshop with
outside experts
SAP/EPA experts
SAP
SAP
BSAC
SAP/BSAC
SAP
SAP/SAB
SAP/SAB
SAP
SAP
SAP
Date of
Initial
Entry
9/94
9/94
9/94
Date
Peer
Review
Initiated
2/93
3/95
1/91
2/92
12/92
7/93
1/94
3/95
12/93
12/93
9/91
6/92
6/92
Date Peer
Review
Comments
Received
8/92
4/95
4/91
3/92
1/93
8/93
2/94
3/95
1/94
1/94
10/91
7/92
7/92
Comments
CO
CD
-------
APPENDIX C - Part 2 of 2
PRODUCTS PEER REVIEWED SINCE 1991 (Pre-1995-Initiated Items are Representitive)
(Continued)
Candidate Work Product
Dimethoate cancer assessment - PP9206
Bromoxynil cancer assessment - PP9207
Prodiamine cancer assessment - PP9102
Metolachlor cancer assessment - PP9103
ETU (ethylene thiourea) risk assessment -
PP9104
2,4-D weight of evidence for
carcinogenicity - PP9305
Agency proposed cholinesterase policy -
PP9208
Aldicarb and sulfone - PP9209
Immunotoxicity test screen - PP9306
Inhalation guideline revisions - PP9307
Cholinesterase methodology - PP9308
Dermal absorption test guideline - PP9309
Data requirements for pesticide registration
(40CFR.Part 158): draft proposed rule -
PP9402
Region/
AAship
OPPTS
OPPTS
OPPTS
OPPTS
OPPTS
OPPTS
OPPTS
OPPTS
OPPTS
OPPTS
OPPTS
OPPTS
OPPTS
Program
Office
OPP-HED
OPP-HED
OPP-HED
OPP-HED
OPP-SRRD
OPP-HED
OPP-HED
OPP-HED
OPP-HED
OPP-HED
OPP-HED
OPP-HED
OPP-PSPS
Peer Review Leader/
Phone
Amy Farrell
308-8054
R. B. Jaeger
R.B. Jaeger
703-305-5369
R. Sjoblad
Whalen/Redden
W. Sette
703-305-6375
R. Zendzian
703-305-5495
A. Rispin
703-305-5989
Date Peer
Review
Completed
9/92
9/92
11/91
11/91
3/92
5/93
12/92
proj. 10/95
proj. 10/95
proj. 10/95
proj. 1/96
Review
Mechanism
SAP
SAP
SAP
SAP
SAP
SAP/SAB
SAP/SAB
SAP/SAB
SAP/SAB
SAP/SAB
SAP/SAB
SAP/SAB
SAP
Date of
Initial
Entry
Date
Peer
Review
Initiated
6/92
6/92
9/91
9/91
9/91
4/93
11/92
11/92
12/93
12/93
12/93
12/93
11/94
Date Peer
Review
Comments
Received
7/92
7/92
10/91
10/91
10/91
3/94
4/93
11/92
1/94
1/94
1/94
1/94
12/94
Comments
.u
o
-------
APPENDIX D - Part 1 of 2
CANDIDATE PRODUCTS FOR FUTURE PEER REVIEW THROUGH FY-97
Candidate Work Product
Bioremediation Risk
Assessment - TS9403
Use Cluster Scoring System -
TS9404
Methods for Valuing Eco
Benefits - TS9404
Economic Analysis of Lead 403
Rule - TS9406
Cleaner Technology
Substitutes Assessment (Case
Study) - TS9407
TRI Indicator -TS9408
Source Ranking Database -
TS9409
Lead: Renovation and
Remodeling Study (Phase 1 &
II)-TS9410
Assessment of Risks from
Commercial Release of
Engineered Microorganisms -
TS9412
Ecological Tier-Testing
Schemes for Biotechnology -
TS9414
Region/
AAship
OPPTS
OPPTS
OPPTS
OPPTS
OPPTS
OPPTS
OPPTS
OPPTS
OPPTS
OPPTS
Program
Office
OPPT
OPPT
OPPT
OPPT
OPPT
OPPT
OPPT
OPPT
OPPT
OPPT
Peer Review
Leader/
Phone
Phil Sayre, 260-
9570
Dan Fort, 260-
1694
Lynne Blake-
Hedges
260-7241
Nishkam
Agarwal
260-1285
Linda Rusak,
260-5273
Nick Bouwes,
260-1662
Christina Cinalli,
260-3913
Darlene
Watford, 260-
3989
Mark Segal,
260-3389
Gwen McClung,
260-1272
Estimated Date
of Peer Review
Completion
7/96
10/96
4/97
11/96
5/97
10/97
9/97
5/96
7/97
8/96
Review
Mechanism
Workshop
SAB
Expert Panel
SAB
Expert Panel
SAB
SAB
Expert Panel
Expert Panel
Workshop
Date of
Initial
Entry
9/94
9/94
9/94
9/94
9/94
9/94
9/94
9/94
9/94
9/94
Estimated Date
of Peer Review
Initiation
6/93
10/94
11/96
9/96
9/96
12/96
9/96
2/96
8/94
2/94
Estimated
Date for
Receipt of
Peer Review
Comments
5/96
11/95
1/97
10/96
11/96
6/97
3/97
4/96
3/95
5/96
Comments
Parallel Review with
TS9503
Title of Work Product
Revised
Title of Work Product
Revised
-------
APPENDIX D - Part 1 of 2
CANDIDATE PRODUCTS FOR FUTURE PEER REVIEW THROUGH FY-97
(Continued)
Candidate Work Product
Economic Incentives Study -
TS9416
Thyroid Cancer -TS941 7
Proposed Test Guideline for
Fibrous Particles - TS9501
Concise International
Assessment Document
(Formaldehyde) - TS9502
Lead 403 Rule Technical
Analysis - TS9503
Estimation Programs Interface -
TS9508
Dermal Exposure Assessment
Methodology -TS9509
12-Month Report of the Lead
Paint Abatement and Repair
and Maintenance Study in
Baltimore - TS9601
Lead: Renovation and
Remodeling Study Phase III -
TS9602
Concise International
Assessment Document -
TS9603
Region/
AAship
OPPTS
OPPTS
OPPTS
OPPTS
OPPTS
OPPTS
OPPTS
OPPTS
OPPTS
OPPTS
Program
Office
OPPT
10
OPPT
OPPT
OPPT
OPPT
OPPT
OPPT
OPPT
OPPT
Peer Review
Leader/
Phone
Nishkam
Agarwal, 260-
1285
Richard Hill,
260-2894
Vanessa Vu,
260-1245
Oscar
Hernandez,
260-1832
Dave Topping,
260-7737
Gary Thorn,
260-3921
Cathy
Fehrenbacher,
260-0696
Ben Lim, 260-
1509
Dan Reinhart,
260-1585
Oscar
Hernandez,
260-1832
Estimated Date
of Peer Review
Completion
12/96
2/97
7/98
1/97
11/96
12/97
8/96
2/97
7/97
2/98
Review
Mechanism
Independent
Experts
SAB
SAB
WHO/IPCS
SAB
Independent
Experts
Independent
Experts
Expert Panel
Expert Panel
WHO/IPCS &
OECD
Date of
Initial
Entry
9/94
9/94
6/95
5/95
5/95
5/95
5/95
5/96
5/96
5/96
Estimated Date
of Peer Review
Initiation
8/96
4/96
6/97
1/96
9/96
1/97
6/94
9/96
4/97
6/97
Estimated
Date for
Receipt of
Peer Review
Comments
10/96
1/97
1/98
12/96
10/96
7/97
4/95
12/96
5/97
11/97
Comments
OPPTS Contribution to
international effort
Parallel Review with
TS9406
(Potentially Isopropanol)
-------
APPENDIX D - Part 1 of 2
CANDIDATE PRODUCTS FOR FUTURE PEER REVIEW THROUGH FY-97
(Continued)
Candidate Work Product
Cancer Expert System -
TS9604
Acute Exposure Guideline
Levels (AEGLs) - TS9605
Comparative Risk Guidance -
TS9606
Region/
AAship
OPPTS
OPPTS
OPPTS
Program
Office
OPPT
OPPT
OPPT
Peer Review
Leader/
Phone
Earnest V.
Falke, 260-3433
Rodger
Garrett.260-
4302
Rodger
Garrett.260-
4302
Estimated Date
of Peer Review
Completion
2/97
11/98
6/98
Review
Mechanism
Independent
Experts
MAS
Independent
Experts
Date of
Initial
Entry
5/96
5/96
5/96
Estimated Date
of Peer Review
Initiation
9/96
8/97
12/97
Estimated
Date for
Receipt of
Peer Review
Comments
12/96
2/98
3/98
Comments
Phase I
.u
CO
-------
June 13, 1996
APPENDIX D - Part 2 of 2
CANDIDATE PRODUCTS FOR FUTURE PEER REVIEW THROUGH FY-97
Candidate Work Product
Carbofuran flowable environmental risk -
PP9601
TBT Monitoring - PP9602
Extra 10-fold safety factor - PP9603
Small-scale Prospective Ground-water
Study Guideline and Protocol (PP9405)
Environmental Fate and Effects Corn
Cluster Risk Assessment (PP9501)
Report from the Aquatic Effects Dialogue
Group (PP9406)
Region/
Aaship
OPPTS
OPPTS
OPPTS
OPPTS
OPPTS
OPPTS
Program
Office
OPP-EFED
OPP-EFED
OPP-HED
OPP
OPP
OPP
Peer Review
Leader/
Phone
D. Bailiff
703-305-6108
Tony
Maciorowski
703-305-5988
Jim Rowe
703-305-5664
Betsy Behl
703-305-6128
Ingrid
Sunzenauer
703-305-5196
Tony
Maciorowski
703-305-5988
Estimated
Date of Peer
Review
Completion
«
«
*
7/96
Review
Mechanism
SAP
SAP
SAP
SAP
SAP
SAP
Date of
Initial
Entry
6/96
6/96
6/96
6/95
6/95
6/95
Date Peer
Review
Initiated
5/96
5/96
10/96
12/96
5/96
7/95
Date Peer
Review
Comments
Received
7/95
Comments
"Date of closure to be
estimated after peer
review comments are
received from the SAP
"Date of closure to be
estimated after peer
review comments are
received from the SAP
Carry over from
previous year. Delay
from FY96 due to
competing priorities
not anticipated when
dates originally
projected
"Date of closure to be
estimated after peer
review comments are
received from the SAP
Closure memo in
preparation
* Peer Review Standard Operating Procedures, Office Products for Peer Review in Upcoming Fiscal Year (Appendix D).
Science Policy Council/Peer Review Advisory Group, March 1995.
-------
APPENDIX D - Part 2 of 2
CANDIDATE PRODUCTS FOR FUTURE PEER REVIEW THROUGH FY-97
(Continued)
Candidate Work Product
Spray Drift Task Force Laboratory and
Field Data (PP9503)
Plant pesticides - final rule (PP9504)
Guideline for independent laboratory
validation of environmental chemistry
methods (PP9505)
Triazine benefits assessment (PP9506)
Pesticide usage monograph (PP9407)
Region/
Aaship
OPPTS
OPPTS
OPPTS
OPPTS
OPPTS
Program
Office
0 P P -
EFED/SRRD
OPP-BPPD
OPP-
BEAD
OPP-BEAD
OPP-
BEAD
Peer Review
Leader/
Phone
Arnett Jones
703-305-7416
and Jay
Ellenberger
703-308-8085
Flora Chow
703-308-8290
Don Marlow
703-308-8198
Steve Nako
703-308-8092
Arnold Aspelin
703-308-8136
Estimated
Date of Peer
Review
Completion
Review
Mechanism
Internal/external
review which
may include a
series of
workshops
SAP
SAP
SAP or other
external panel
SAP or other
external panel
Date of
Initial
Entry
6/95
6/95
6/95
6/95
9/94
Date Peer
Review
Initiated
6/96
9/96
5/96
12/96
12/96
Date Peer
Review
Comments
Received
Comments
Internal/external
review inserted prior to
SAP.
Waiver from SAP
review will be sought
because there have
been no science
changes since the
proposal was peer
reviewed
Carry over from
previous year. Delays
in completion of PD2/3
have meant that this
peer review will occur
in FY97
Carry over from
previous year. Key
staff time has not been
available to complete
this project, but much
of the report has been
developed.
.u
en
* Peer Review Standard Operating Procedures, Office Products for Peer Review in Upcoming Fiscal Year (Appendix D).
Science Policy Council/Peer Review Advisory Group, March 1995.
-------
APPENDIX D - Part 2 of 2
CANDIDATE PRODUCTS FOR FUTURE PEER REVIEW THROUGH FY-97
(Continued)
Candidate Work Product
Pesticide benefit analysis guidance
document (PP9507)
Physical Chemistry test guidelines
(PP9508)
Residue Chemistry test guidelines
(PP9509)
Nontarget Organism test guidelines
(PP9510)
Nontarget Plant test guidelines (PP9511)
Region/
Aaship
OPPTS
OPPTS
OPPTS
OPPTS
OPPTS
Program
Office
OPP-BEAD
OPP-HED.RD
OPP-HED/
OPPT
OPP-EFED/
OPPT
OPP-EFED,
OPPT
Peer Review
Leader/
Phone
Arnold Aspelin
703-308-8136
F. Griffith, R.
Boethling
R. Loranger
703-305-6192
L. Touart/R.
Morcock
703-305-
6134/202-260-
1265
R. Petrie/R.
Morcock
703-305-
7358/202-260-
1265
Estimated
Date of Peer
Review
Completion
6/96
6/96
12/96
12/96
Review
Mechanism
SAP or other
external panel
SAP/SAB
SAP/SAB
SAP/SAB
SAP/SAB
Date of
Initial
Entry
6/95
7/95
6/95
6/95
6/95
Date Peer
Review
Initiated
9/95
9/95
5/96
5/96
Date Peer
Review
Comments
Received
10/95
10/95
Comments
Carry over from
previous year. The
scope of this project
has been expanded to
include USDA/NPIAP
and stakeholder
involvement, taking
more time than
originally planned. The
need for SAP-type
involvement will be
reevaluated later in the
process.
Closure memo July '96
Closure memo June
'96
.u
CD
* Peer Review Standard Operating Procedures, Office Products for Peer Review in Upcoming Fiscal Year (Appendix D).
Science Policy Council/Peer Review Advisory Group, March 1995.
-------
APPENDIX D - Part 2 of 2
CANDIDATE PRODUCTS FOR FUTURE PEER REVIEW THROUGH FY-97
(Continued)
Candidate Work Product
Antimicrobial Product Performance test
guidelines (PP9512)
Toxicology test guidelines (PP9513)
Vertebrate Control test guidelines
(PP9514)
Region/
Aaship
OPPTS
OPPTS
OPPTS
Program
Office
OPP-RD
OPP-HED/
OPPT
OPP-RD
Peer Review
Leader/
Phone
Z. Vaitusis
703-305-7470
W. Sette/L.
Keifer
703-305-
6375/202-260-
1548
W. Jacobs
703-305-6406
Estimated
Date of Peer
Review
Completion
Review
Mechanism
SAP/SAB
SAP/SAB
SAP/SAB
Date of
Initial
Entry
6/95
6/95
6/95
Date Peer
Review
Initiated
9-12/96
10/96
12/96
Date Peer
Review
Comments
Received
Comments
Scheduling of these
guidelines is being
adjusted in order to
allow direct
harmonization with
Canada through
CUSTA. The goal is
now to issue a single
set of harmonized
guidelines with
Canada - an expanded
scope of this project.
Completion of residue
and product chemistry
guidelines was much
more resource
intensive than
anticipated due to
extensive industry
input and peer
involvement. Skill mix
problems led to the
delay in completion of
the vertebrate control
guidelines.
.u
--J
* Peer Review Standard Operating Procedures, Office Products for Peer Review in Upcoming Fiscal Year (Appendix D).
Science Policy Council/Peer Review Advisory Group, March 1995.
-------
APPENDIX D - Part 2 of 2
CANDIDATE PRODUCTS FOR FUTURE PEER REVIEW THROUGH FY-97
(Continued)
Candidate Work Product
Special Review/Draft Notice of Intent to
Cancel DDVP-PP951 5
Risk assessment for acute and
subchronic endpoints: less than lifetime
risk(PP9519)
Use of In utero cancer studies (PP9520)
Metabolism peer review process: plants
and animals (PP9521)
Region/
Aaship
OPPTS
OPPTS
OPPTS
OPPTS
Program
Office
OPP-SRRD
OPP-HED
OPP-HED
OPP-HED
Peer Review
Leader/
Phone
J. Housenger
308-8010
Jess Rowland
703-308-2719
Whang Phang
703-308-2723
Estimated
Date of Peer
Review
Completion
Review
Mechanism
SAP
SAP
SAP
SAP
Date of
Initial
Entry
6/95
6/95
6/95
6/95
Date Peer
Review
Initiated
FY97
9/96
FY97
Date Peer
Review
Comments
Received
Comments
Peer review of 4
special reviews did not
occur in FY96. Three
of the special reviews
originally planned for
peer review in FY96
(PP951 6,7,8) were
settled by negotiation
with the fourth, DDVP,
delayed to allow
incorporation of new
information.
Carry over from
previous year because
of changes in key
personnel and delays
due to furlough. This
will be reviewed at a
later meeting.
Carry over from
previous year. Too
many other tox
projects going to SAP
in Oct/96.
Carryover from
previous year.
Delayed because of
change in personnel.
.u
oo
* Peer Review Standard Operating Procedures, Office Products for Peer Review in Upcoming Fiscal Year (Appendix D).
Science Policy Council/Peer Review Advisory Group, March 1995.
-------
APPENDIX D - Part 2 of 2
CANDIDATE PRODUCTS FOR FUTURE PEER REVIEW THROUGH FY-97
(Continued)
Candidate Work Product
Subdivision K: Post-application test
guidelines (PP9522)
Development of a sorting scheme for
endocrine disrupters (PP9604)
Alachlorandvinclozilin
Bladder tumors (PP9523)
Ocular toxicity: visual system (PP9525)
Acute dietary data requirements and
methodology of risk assessment
(PP9526)
Guidelines for anticipated residues
(PP9527)
Cholinesterase as a measure of toxicity
(PP9528)
Region/
Aaship
OPPTS
OPPTS (ORD
involvement)
OPPTS
OPPTS
OPPTS
OPPTS
OPPTS
OPPTS
Program
Office
OPP-HED
OPPTS
OPP
OPP
OPP-HED
OPP-HED
OPP-HED
OPP-HED
Peer Review
Leader/
Phone
OREB
Denise
Keehner
703-3057695
HED
K. Baetcke
703-305-7712
K. Baetcke
703-305-7712
K. Baetcke
703-305-7712
Estimated
Date of Peer
Review
Completion
6/96
Review
Mechanism
SAP
To be determined
SAP
RAF
SAP
SAP
SAP
RAF
Date of
Initial
Entry
6/95
6/96
6/96
6/95
6/95
6/95
6/95
6/95
Date Peer
Review
Initiated
FY97or98
FY97
TBA
FY97
FY97
9/95
FY97
FY97
Date Peer
Review
Comments
Received
Comments
Loss of contract
funding to complete
guidelines will cause a
delay
Longterm project with
format to be
dtermined.
Carryover from
previous year due to
skill mix problems.
Carry over from
previous year. Too
many other tox
projects going to SAP
in Sept/96. This will
be reviewed at a later
meeting.
Carry over from
previous year because
of lack of funding.
Data to be
summarized were far
more extensive than
originally anticipated.
.u
CD
* Peer Review Standard Operating Procedures, Office Products for Peer Review in Upcoming Fiscal Year (Appendix D).
Science Policy Council/Peer Review Advisory Group, March 1995.
-------
APPENDIX E
RESOURCES FOR PEER REVIEW SERVICES
I. ACQUISITION OF PEER REVIEW SERVICES
A range of peer review services are available to the USEPA
including internal, external (voluntary, purchase order,
contractor employee), and Special Government Employee (SGE). The
mechanism selected is generally based on the nature of the
scientific or technical work product.
A. Voluntary Services
As a general matter, the USEPA can ask outside experts to
peer review Agency products without compensation. Several
environmental statutes authorize the USEPA to engage in
cooperative activities with "institutions, organizations, and
individuals." Accordingly, such groups may cooperate with the
USEPA in research and informational activities related to the
following statutes: Clean Air Act at 42 U.S.C. §7402; Clean
Water Act at 33 U.S.C. §1254; Resource Conservation and Recovery
Act at 42 U.S.C. §6981; and Safe Drinking Water Act at 42 U.S.C.
§300j-l.
However, if a person or organization wishes to cooperate
with the USEPA to perform some sort of voluntary activity,
program officials should ask them to sign a "Visitor/Guest
Worker" agreement, currently used at USEPA laboratories. This is
because the Anti-Deficiency Act at 31 U.S.C. §1342 prohibits so-
called "voluntary" services that could give rise to a claim for
compensation. Moreover, accepting "volunteers" to fill USEPA
employee "slots" might violate the personnel statutes and might
give rise to a valid claim for compensation in violation of the
Anti-Deficiency Act.
B. Contracts
The USEPA may contract for peer review services. The
contract may be written solely for peer reviews or be included as
part of an umbrella contract, which calls for performance of
other tasks as well.
For assistance in preparing the necessary pre-award
documents, program officials should consult The Cookbook: How to
Get Contracts Awarded in EPA and Chapter 2 of the Contracts
Management Manual (CMM). The following discussion identifies
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five key elements that should be considered in contracts for peer
reviews: Statements of Work (SOWs), Advisory and Assistance
Services (AAS) or Sensitive Activities, Management Controls,
Identification of Peer Reviewers, and Federal Advisory
Committees. Special considerations for small purchases are
discussed in section I.e. Small Purchases.
1. Statement of work (SOW)
The SOW must clearly specify that the contractor is
responsible for preparing peer review evaluations and set forth
guidelines for the peer review of scientific or technical
documents. The contractor may perform the peer review with in-
house staff, subcontractors or consultants. Any guidelines for
performing peer reviews to ensure soundness and defensibility
must be developed by the program office and made part of the
contract. The contractor would then ensure that the peer reviews
adhered to the guidelines.
The SOW cannot simply define the role of the prime
contractor as arranging for the services of others to perform
peer reviews and logistics for meetings. Unless the prime
contractor is clearly tasked with responsibility for performing
peer reviews, individual peer reviewers' fees and associated
travel expenses are not payable under the contract.
The USEPA may pay for the reviewer's comments or evaluation,
and also for attendance at a meeting with the Agency and other
reviewers to discuss the results of the peer review. If the SOW
calls for the preparation of comments or an evaluation, and
specifies a meeting with the Agency and other peer reviewers to
discuss the results of the peer review, payment is appropriate.
The peer reviewer's attendance at the meeting would then be part
of contract performance.
2. Advisory and assistance services (AAS) or sensitive
activities
Contracts that provide services that support or improve
Agency decision-making or policy development are subject to
special management controls. These services include: "...those
services acquired from non-Governmental sources by contract or by
personnel appointment to support or improve agency development,
decision-making, management, and administration, or to support or
improve the operation of management systems. Such services may
take the form of information, advice, opinions, alternatives,
conclusions, recommendations, training, and direct assistance."
For additional information on advisory and assistance services
A-51
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and sensitive activities, program officials should review EPA
Order 1900.2, Contracting at EPA and Chapter 2 of the CMM.
New contracts for these services require management
approvals prior to issuance of the solicitation. The following
thresholds have been established for approval of these
justifications:
Contract Amount Approved Concurrence By
$25,000,000 and over Both the Program Office Program Office
Assistant/Associate Senior
Administrator (AA) or Resource
equivalent and the Official
Deputy AA for Finance (SRO)
and Acquisition,
Office of Administration
and Resources Management
$5,000,000 to Both the Program Office Program
$24,999,999 AA and Office Director Office SRO
Office of Acquisition
Management
Under $5,000 Program Office AA Program
Office SRO
(See the June 30, 1993, Interim Procedures for Approval and
Documentation of Procurements Involving AAS.) Note, these
procedures and approval levels will be changed upon
implementation of Office of Federal Procurement Policy (OFPP)
Policy Letter 93-1, Management Oversight of Service Contracting
in Chapter 2 of the CMM.
3. Management controls
Contracting for peer review services is permitted. However,
because of the potential for improper use of these contracts,
special management controls are required.
a. Inherently governmental functions (IGFs)
OFPP Policy Letter 92-1, dated September 23, 1992,
describes (a) functions that are inherently governmental and
must be performed only by Government employees and (b)
functions that may be contracted, but so closely support
Government employees in their performance of IGFs that the
contract terms and performance require close scrutiny by
Federal officials.
A-52
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Peer reviews represent only a contractor's
recommendations, advice or analysis of a document. Agency
officials must make the official Agency decision regarding
acceptability of the document. To ensure that Agency
officials are not improperly influenced by recommendations
in the peer review, management controls must be included in
the contract. One possible control would be to require the
peer reviewers to submit with their evaluations or comments
a description of the procedures used to arrive at their
recommendations; a summary of their findings; a list of
sources relied upon; and make clear the methods and
considerations upon which their recommendations are based.
To the extent possible, the contract should set forth any
guidelines or criteria for performance of the peer review.
Agency officials should document their evaluations of the
quality and validity of the peer review.
b. Conflict of interest (COI)
Another important factor is that the objectivity of the
peer review should not be improperly influenced or
undermined by the contractor performing the review. To
identify and avoid or mitigate actual or potential COI, the
contract should include controls. Such controls might
require the contractor to report on prior and current work,
and prior clients that might create COI. Other controls
might include Agency review and placing limits or advance
approval on future work. There should also be procedures
implemented to assure that the contractor does not gain an
unfair advantage in future requirements as a result of their
performance of peer reviews. Program officials should
consult the Contracting Officer (CO) for special contract
clauses.
The EPA Acquisition Regulations (EPAAR) at 48 CFR
Subpart 1509.5 generally mandates conflicts of interest
solicitation provisions and contract clauses for contracts
over $25,000, but makes them optional for small purchases of
$25,000 or less.
See 48 CFR 1509.508(b) & (c)
48 CFR 1552.209-70, -71 & -72
Contract for peer review services: A USEPA contracting
officer will include conflicts of interest solicitation
provisions and contract clauses as a matter of course
without involvement by the USEPA project officer, if the
peer review services are obtained pursuant to a contract
A-53
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over $25,000. If the peer review services are subcontracted
pursuant to a prime contract (over $25,000), then the prime
contractor is ordinarily required to include a conflicts of
interest clause substantially similar to the conflicts of
interest clause in the primary contract in its subcontract
to the peer reviewer.
Although the USEPA contracting officer and/or prime
contractor has the primary responsibility to include the
required conflicts of interest provisions/clauses, the USEPA
project officer may nevertheless wish to:
1. Highlight the conflict of interest requirements in the
Scope of Work for the procurement of the peer review
services.
2. Develop a specific conflict of interest clause
regarding the peer review at issue as a substitute to
the standard conflicts of interest clause.
3. Review the solicitation/contract to make sure that the
required conflicts of interest clause has been
included.
Small purchase order for peer review services: Although
conflict of interests requirements are optional for small
purchases, they are nevertheless a good idea. Accordingly,
an USEPA project officer obtaining peer review services with
a small purchase order should request the purchasing
agent/contracting officer to include a conflict of interest
solicitation provision and contract clause in the purchase
order.
c. Confidential business information (CBI)/Privacy
Act protected information and other sensitive
information
When peer reviewers are not employees of the United
States Government, it is unlikely that the USEPA will have
authority to give reviewers access to confidential business
information in the absence of consent for such disclosure by
the CBI submitter. Therefore, all documents provided to
non-Federal reviewers must be screened for information
claimed as CBI. Even where business information has not
been explicitly claimed as CBI, if it is of a kind where the
submitter might be expected to object to its release, prior
to release the submitter must be asked whether it wishes to
assert a claim, unless the submitter has previously been
informed that failure to assert a CBI claim may result in
A-54
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disclosure without notice. Language should be included in
the contract to clearly identify any required procedures or
processes prior to release of any protected information,
including any requirements for confidentiality agreements,
as well as limits on use and disclosure of the data by
contractor personnel.
d. Personal services
Under contracts, the USEPA may not engage the peer
reviewers in any improper personal services relationships,
i.e., an arrangement under which contractor personnel are
subject to relatively continuous supervision and direct
control by an Agency official or employee. These
relationships are characterized as one where the contractor
employee interacts with the Agency in a manner similar to
that of a federal employee.
To avoid these improper relationships, program
officials should write well-defined SOWs. The SOWs should
set forth the requirements in detail for work to be
performed independently, including the manner in which it
will be evaluated. The SOW must set forth what work is to
be performed not how the work is to be performed. Technical
direction may be used to clarify ambiguous technical
requirements to ensure efficient and effective contractor
performance, and is not considered supervision or assignment
of tasks. For additional information, program officials
should consult EPA Order 1901.1A, Use of Contractor Services
to Avoid Improper Contracting Relationships.
4. Identification of peer reviewers
Program officials cannot interfere in a contractor's
ability to perform work by "selecting" who will perform the
peer review. The Federal Acquisition Regulation (FAR)
governs the CO's and program officials' relationship with
the contractor.
However, the CO does have the ability to review and
consent to subcontractors and consultants. The contract can
also specify which individuals are key personnel and include
peer reviewers. The FAR and Agency implementing regulations
set forth rules governing the use and replacement of key
personnel. Further, the contract can require workplans for
approval by the Agency, wherein the contractor will propose
the peer reviewers it is considering for selection.
A-55
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Program officials should identify the qualifications
required to perform the review work and the criteria for
technical acceptability. The USEPA may identify a pool of
qualified subcontractors and consultants to the prime
contractor, but cannot direct the use of any particular
subcontractor or consultant.
5. Federal Advisory Committees
The Federal Advisory Committee Act (FACA) requires that the
Agency develop a charter, maintain balanced membership, and hold
open meetings when it establishes an "advisory committee." An
advisory committee is any group established by the USEPA for the
purpose of providing advice as a group to the Agency. It does
not include advice coming from individual attendees at a meeting
or groups established by a non-federal entity such as an EPA
contractor. See, 41 C.F.R. §101-6.1004(1). If a contractor
convened peer review panel will provide advice and
recommendations to the USEPA as a group, then the group is
subject to FACA chartering requirements.
C. Small Purchases
The acquisition of supplies or nonpersonal services from the
open market and on a sole source basis when the aggregate amount
involved in any one transaction does not exceed $25, 000
constitutes a "small purchase". The USEPA has developed a guide
entitled Small Purchases, A Guide for Program Offices, which
provides basic information about small purchases and purchase
orders. The guide should be used in preparing a procurement
request (PR) for the purchase of peer review services under the
small purchase limitation.
The same considerations in the preceding discussion on IGFs,
COI, access to CBI, and personal services apply to small
purchases. Normally, the Government issues a small purchase
order directly to the individual peer reviewer, instead of to a
prime contractor who may subcontract for performance of the peer
review.
Approvals
All small purchases for peer reviews are considered AAS.
The approval level for small purchase AAS is at least one
organizational level above the initiating office. When award is
made during the fourth quarter of the fiscal year, approval must
be received from a program official at least two organizational
levels above the initiating office.
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Competition
The FAR requires competition for purchases in excess of
$2,500. To accomplish competition, Purchasing Agents will
solicit quotes from three vendors unless a requirement is
justified on a sole source basis. A sole source justification
must be detailed and fully describe the circumstances supporting
the justification. Program officials should refer to EPAAR
Subpart 1513.170-1 for more information on preparing
justifications. Poor planning does not constitute a valid basis
for a sole source justification. COs will make a small purchase
award to the vendor with the lowest offered price.
Procurement Requests
Program Officers should include the following in all PRs for
the purchase of peer reviews:
1. A fixed-price amount at or below the small purchase
limitation.
2. A detailed description of the requested services,
inclusive of:
a. Total quantity per line item;
b. Estimated unit price per line item;
c. Total cost per line item;
d. Specific deliverables for each line item; and
e. Total cost of the purchase request.
3. The name, address, and phone number of three
competitive sources if the value of the request is $2,500 or
more.
a. Reference FAR Subpart 3.6 and Environmental
Protection Agency Acquisition Regulation (EPAAR) Subpart 1503.601
regarding sources from Government employees or organizations
owned and controlled by them.
b. Provide sources from small businesses if
available.
4. If the request is a sole source purchase,
justification must be provided in accordance with the EPAAR
Subpart 1513.170-1.
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II. TRAVEL
A. Contracts and Purchase Orders
Funds obligated on a contract or purchase order are
available to pay for the costs of producing the peer review
including the travel costs and fee of the peer reviewer.
The USEPA acquires peer reviews through small purchases
issued directly to peer reviewers or through contracts with
companies, which then acquire the services of peer reviewers. By
issuing a purchase order or awarding a contract for a peer
review, the USEPA may pay not only for the peer reviewer's
comments, but also for his or her attendance at a meeting with
the Agency and other reviewers to discuss his or her comments.
The scope of work of the contract must include the organization
of peer reviews and indicate whether the contractor will be
required to discuss a specific peer review work product with the
Agency and/or with other peer reviewers. Attendance at a meeting
to discuss a peer review work product would then be part of the
contract's performance. Thus, the contract may serve as the
mechanism to pay for a peer reviewer's fee and associated travel
expenses to provide comments to the USEPA.
B. Special Government Employees
Travel and per diem expenses of experts hired as SGEs for
peer review may only be paid through the issuance of invitational
travel orders (5 U.S.C. §5703). These invitational travel and
per diem expenses should be charged to an appropriate USEPA
travel account.
Members of the SAB, SAP, and other FACA advisory committees
are hired as SGEs. It is not appropriate to reimburse travel or
per diem expenses of advisory committee members or other SGEs
through a contract.
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APPENDIX B
Correspondence with Peer Reviewers
B-1
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PACKET B-l
B-2
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July 21, 1997
Dear :
Thank you for your interest in participating in the formal technical peer review of EPA's Cleaner
Technologies Substitutes Assessment (CTSA)for Fabricare: Including Dry and Wet Cleaning
Technologies.
Prior to receiving the CIS A review package we request that you submit a brief letter proposal
with the labor rate you will charge to conduct this peer review. We are asking you to focus your
review on the area(s) in which you have particular expertise (i.e., economics and technology,
hazard assessment, exposure assessment, or risk assessment). Accordingly, we anticipate your
review and written comment preparation will require no more than 24 labor hours. In this
proposal, please include the following:
1. Your proposed labor rate, along with a statement that this is the lowest rate you currently
charge any client (required by Federal government contracting regulations);
2. A signed and dated copy of the enclosed Peer Reviewer Non-Disclosure Agreement
(required); and
3. A brief (one or two page) biographical sketch showing your educational training and recent
professional experience (unless already sent to Melinda Armbruster of Battelle).
Please submit your proposal (Items 1, 2, 3) to me by fax (614-424-4250) by Thursday, July 24,
1997, as well as the original of all of the above documents by regular mail (use enclosed pre-
addressed envelope). Please note that we cannot send you a copy of the CTSA review package
until we receive all three of the above requested documents. Upon acceptance of your proposal,
Battelle will issue a formal purchase order agreement; this agreement will also include the
attached Terms and Conditions.
Under separate cover on July 28th or 29th , you will receive, via Federal Express, a CTSA review
package including the CTSA, Charge to Peer Reviewers, and a list of available references, if
needed, to assist with your review. If you are not going to be at your office address on July 28th
or 29th, please inform us of the address to send the package to. Someone must be present to sign
for the package or Federal Express will not deliver it. In addition to your written comments
concerning the CTSA itself, we are also asking for your comments on the adequacy of the
supporting documents and key studies used in the development of the CTSA associated with
your area(s) of expertise. Further, if you are aware of any references or data sets that EPA has
not used, please indicate so in your submitted comments; copies of any such studies would be
appreciated. EPA is committed to getting this document out by September 1997 and in order to
B-3
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do that we need to receive your written comments by Monday August 25th. Please plan
accordingly.
Thank you again for your participation. We appreciate your interest and willingness to assist
EPA with this important document. If you have any questions, please feel free to contact me at
(614)424-4547.
Sincerely,
Bruce E. Buxton, Ph.D.
Program Manager
BEB:lnl
Enclosures
B-4
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Cleaner Technologies Substitutes Assessment (CTSA)
for Fabricare: Including Dry and Wet Cleaning Technologies
Peer Reviewer
Non-Disclosure Agreement
The CTSA document is an internal, preliminary work product developed by EPA.
Neither Battelle nor the peer reviewers are authorized to distribute, cite, quote or in
any manner release any portion of the CTSA or selected supporting material. All
copies of the CTSA and supporting materials will be returned to Battelle with the
written review comments.
I have read this non-disclosure statement and agree to its conditions.
Signature of Peer Reviewer Date
B-5
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ilBaltelle
. . . Putting Technology To Work
TERMS AND CONDITIONS- CLEANER TECHNOLOGIES SUBSTITUTES ASSESSMENT
(CTSA), PEER REVIEW
1. FORMATION OF THE CONTRACT
A) This Contract Purchase Order Number, dated 21 July, 1997 is Battelle Columbus Operations' (BCO) offer
to Seller, and acceptance by Seller is expressly limited to the terms of this offer. BCO objects to any
additional or modified terms stated in Seller's acceptance. Acceptance may be by prompt written
acknowledgment or by beginning performance.
B) Modifications. None of the terms and conditions of this Contract may be contradicted, modified,
supplemented, explained, waived or rescinded except as provided in the Contract or in written agreement
signed by both parties. Only a BCO Procurement Representative may sign on behalf of BCO.
C) Delegation and Subcontracting. Without SCO's written consent. Seller will not delegate any duty of
performance, or subcontract for the design, development or procurement of any substantial portion of goods
or services under this Contract This clause does not limit Seller's purchases of standard commercial
supplies, services or raw materials.
D) Waiver and Severability. Any action or inaction by BCO or the failure of BCO. on any occasion, to enforce
any right or provision of this Contract shall not be construed to be a waiver by BCO of its rights hereunder,
and shall not prevent BCO from enforcing such provision or right on any future occasion. A determination
that any portion of this Contract is unenforceable or invalid shall not affect the enforceability or validity of any
of the remaining portions of this Contact
E) Notice of Delay. Whenever Seller has knowledge of any delay or potential delay in the performance of work
under this Contract, Seller shall immediately give notice thereof, and all relevant information with respect
thereto, to the cognizant BCO Procurement Representative and shall notify the BCO representative of any
material changes in the information required hereunder. Seller's notification shall include the cause or
causes of such delay and Seller's plan to correct such cause(s) to recover such delay or potential delay.
F) Order of Precedence. If the various parts of this Contract are inconsistent, the following order of
precedence will apply: (1) special terms and conditions; (2) the terms and conditions in these General
Provisions; (3) specifications; (4) all other attachments incorporated in this Contract by reference.
G) Applicable Law. This Contract will be governed by and construed in accordance with the laws of the State
of Ohio with no consideration given to the state's conflict of laws rules, regardless of the places of execution
or performance of this Contract
H) Rights and Remedies. The rights and remedies of the parties set forth in this Contract are cumulative and
in addition to any other rights or remedies that they may have at law or in equity.
I) Independent Contractor. Seller is an independent contractor for all purposes. In no event shall Seller, its
agents, representatives, or personnel that it supplies to BCO under this Contract be deemed to be
employees of BCO. Seller's employees shall be paid exclusively by Seller for all services performed and
Seller shall be responsible for and shall actually comply with all requirements and obligations relating to such
employees under local, state or federal law, (or foreign law as applicable) including but not limited to
minimum wage, social security, unemployment insurance, state and federal income tax, and worker's
compensation. BCO has no responsibility for withholding any portion of salary or wages due employees of
Seller to comply with any of the aforementioned taxes or obligations.
J) Notice. Any notice or payment required to be given or made hereunder by either party to the other may be
given or made by depositing the same in the U.S. Mail, postage prepaid, addressed to BCO or Seller at the
addresses indicated on the face of the Purchase Order. Except where a specific notice period is provided
herein, any notice shall be deemed to have been given and any payment to have been made on the date of
the mailing thereof.
K) Successors in Interest This Contract shall be binding upon, inure to the benefit of, and be enforceable by
and against the successors, assignees, and transferees of the parties hereto.
I. DEVOTION OF REASONABLE TIME AND SKILL
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Putting Technology To Work
TERMS AND CONDITIONS- CLEANER TECHNOLOGIES SUBSTITUTES ASSESSMENT
(CTSA), PEER REVIEW
A) Seller shall provide the highest professional standard of services and devote Seller's full attention and efforts
the interests of BCO during all hours charged to BCO. Seller shall comply with appropriate legal, ethical and
professional standards of behavior and conduct
3. CONFLICT OF INTEREST
A) Seller will avoid and immediately notify BCO of any activities, interests or relationships (past, present or
planned) which place Seller in an actual or apparent conflict of interest with the objectives of BCO or its
Client under this Contract. Seller must obtain SCO's prior written consent before engaging in any such
activities.
4. INVOICE AND PAYMENT
A) Seller will submit invoices to the cognizant BCO Representative shown the face of this order on a monthly
basis. Invoices will include the following information:
i) A description of the services provided during the invoice period, including: the name of the individual
providing the service; dates of service; number of hours expended on that date; and the total amount
being billed for that service.
B) Reimbursable Expense. Invoices shall include only those expenses specified on the accompanying
Purchase Order as reimbursable.
5. DAMAGES
A) Indemnity. Seller agrees to indemnify, defend, and hold harmless BCO, its divisions, subsidiaries and
affiliates, officers, trustees, agents and employees from any and all liabilities, claims, suits, demands, and all
expenses and costs including reasonable attorney's fees and costs, arising out of the performance of Seller's
work hereunder that are caused, in whole or in part, by Seller's negligent or wrongful act or omission or that
of anyone employed by Seller for whose act Seller may be liable.
B) Consequential Damages. In no event shall either party to this Contract be liable for any special, incidental or
consequential damages of any type or nature whatsoever.
6. DELIVERY
A) Delivery of all items, reports or other defiverables required under this Contract will be made FOB Destination:
Battelle Memorial Institute, Columbus Operations, 505 King Avenue, Columbus OH 43201-2693 .
7. AUDIT
A) Until three years after final payment, Seller will maintain, and BCO will have the right to examine and audit,
books, records, document, and accounting procedures and practices sufficient to reflect properly all direct
and indirect costs of whatever nature claimed to have been incurred and anticipated to be incurred for the
performance of this Contract.
8. SELLER'S NONDISCLOSURE
A) Seller shall not, without the written consent of BCO, either during or after the performance of the work
required hereunder, use, other than for such performance, or disclose to any person other than a duly
authorized representative of BCO any information, data, material or exhibit created, developed, produced or
otherwise obtained in the course of the work required hereunder, or any information contained in reports,
drawings, documents, business plans or other records furnished to Seller by BCO. Seller further agrees that
it will not divulge any matter, the disclosure of which would be detrimental to the interests of BCO as
determined by BCO. Nothing contained herein shall prevent Seller from making proper use of its experience
gained in the performance of the work required hereunder. The restrictions of this provision shall not apply to
information in the prior possession of Seller or to information acquired by Seller from a source other than
BCO that has the right to disclose such information to Seller, and which Seller, in turn, has the right to
disclose, nor shall it limit any rights the Government may have in such information. Seller further agrees to
return to BCO all copies of any material provided to Seller.
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Putting Technology To Work
TERMS AND CONDITIONS- CLEANER TECHNOLOGIES SUBSTITUTES ASSESSMENT
(CTSA), PEER REVIEW
B) Seller further agrees to enter into a separate Peer Reviewer Non-Disclosure Agreement for the protection
of such information upon request by BCO.
9. CHANGES
A) BCO may, at any time, exclusively by written order signed by its authorized Procurement Representative,
and without notices to sureties, make changes within the general scope of this Contract which affect, among
other things, the services to be performed, and the time and place of performances thereof. If any such
change causes an increase or decrease in the cost of this Contract, and equitable adjustment shall be made
and the Contact shall be modified in writing accordingly. Any claim by Seller for adjustment under this Article
must be asserted in writing to BCO within 30 calendar days after the date of receipt by Seller of the written
change authorization, or within such extension as BCO may grant in writing. BCO may, in its sole discretion,
consider any such daim regardless of when asserted. Such claim shall be in the form of a complete change
proposal fully supported by factual information. Pending any such adjustment. Seller will diligently proceed
with the Contract as modified. BCO shall have the right to examine any of Seller's pertinent books and
records for the purpose of verifying Seller's claim.
10. TERMINATION
A) Upon 30 days written notification non-terminating party, either party to this Contract may terminate this
Contract in whole or in part any time and for any reason. In the event of termination, BCO shall be liable for
payments to Seller only for services performed by Seller to the effective date of the termination, and then
only in accordance with the payment provisions of this Contract
B) Force Majeure. Neither party is responsible to the other for nonperformance or delay in performance of the
terns and conditions herein due to Acts of God, acts of Government, wars, riots, and other causes beyond
the control or the performing party.
11. EXPORT OF DATA
A) Without the prior written consent of BCO and the U.S. Government (Department of Commerce), Seller will
not transmit directly or indirectly any technical data (as defined by Export Administration Regulations)
received from BCO or developed under this Contract, any immediate product of such technical data, or any
commodity produced by an immediate product of the technical data or any portion thereof to any country
outside of the United States.
12. RIGHTS AND REMEDIES
A) The right and remedies of the parties set forth in this Contract are cumulative and in addition to any other
rights or remedies that they may have at law or in equity.
13. COMPLIANCE WITH STATUTES AND REGULATIONS
A) Seller shall comply with all applicable statutes and governmental rules, regulations and orders.
14. APPLICABLE LAW
A) This Contract shall be governed by and construed in accordance with the laws of the State of Ohio
regardless of the place(s) of execution or performance of this Contract
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PACKET B-2
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July 21, 1997
Dear :
Thank you for your interest in participating in the formal technical peer review of EPA's Cleaner
Technologies Substitutes Assessment (CTSA)for Fabricare: Including Dry and Wetcleaning
Technologies. Under separate cover on July 28th or 29th , you will receive, via Federal Express, a
CTSA review package including the CTSA, Charge to Peer Reviewers, and a list of available
references, if needed, to assist with your review. If you are not going to be at your office address
on July 28th or 29th, please inform us of the address to send the package to. Someone must be
present to sign for the package or Federal Express will not deliver it. In addition to your written
comments concerning the CTSA itself, we are also asking for your comments on the adequacy of
the supporting documents and key studies used in the development of the CTSA associated with
your area(s) of expertise. Further, if you are aware of any references or data sets that EPA has
not used, please indicate so in your submitted comments; copies of any such studies would be
appreciated. EPA is committed to getting this document out by September 1997 and in order to
do that we need to receive your written comments by Monday August 25th. Please plan
accordingly.
Please submit a signed and dated copy of the enclosed Peer Reviewer Non-disclosure Agreement
to me by fax (614-424-4250) by Thursday, July 24, 1997, as well as the original of all the above
documents by regular mail (use enclosed pre-addressed envelope). We can not send to you a
copy of the CTSA until we receive your signed agreement.
Thank you again for your participation. We appreciate your interest and willingness to assist
EPA with this important document. If you have any questions, please feel free to contact me at
(614)424-4547.
Sincerely,
Bruce E. Buxton, Ph.D.
Program Manager
BEB:lnl
Enclosure
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Cleaner Technologies Substitutes Assessment (CTSA)
for Fabricare: Including Dry and Wetcleaning Technologies
Peer Reviewer
Non-Disclosure Agreement
The CTSA document is an internal, preliminary work product developed by EPA.
Neither Battelle nor the peer reviewers are authorized to distribute, cite, quote or in
any manner release any portion of the CTSA or selected supporting material. All
copies of the CTSA and supporting materials will be returned to Battelle with the
written review comments.
I have read this non-disclosure statement and agree to its conditions.
Signature of Peer Reviewer Date
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PACKET B-3
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July 25, 1997
Dear :
Thank you for agreeing to participate in the formal technical peer review of EPA's Cleaner
Technologies Substitutes Assessment (CTSA)for Fabricare: Including Dry and Wetcleaning
Technologies. As you know, EPA has been working with the dry cleaning industry and other
interested parties to evaluate current and alternative clothes cleaning technologies and controls to
reduce exposures to perchloroethylene and other solvents used in dry cleaning. As part of this
program, EPA has developed the CTSA. This CTSA is intended to be an analytical tool that
methodically assesses the comparative performance, costs, and human and environmental risks
associated with traditional and alternative chemicals, processes, and technologies in the clothes
cleaning industry. The goal of the CTSA is to develop accurate information for dry cleaners that
will enable the cleaning industry to make informed judgements on the products and technologies
used in their facilities.
We believe we have identified a peer review panel whose excellent and unbiased technical
reviews of the document will result in a high-quality final product. Every effort was made to
identify technical peer reviewers who are considered experts within their respective fields of
study and have specific knowledge gained through training or experience in one or more of the
following areas relevant to the CTSA:
• economics and technology,
• hazard assessment,
• exposure assessment, and
• risk assessment.
Please find enclosed a copy of the CTSA along with a guidance document and a list of available
references, if needed, to assist with your review. In addition to your comments on the CTSA
itself, we are also asking for your comments on the adequacy of the supporting documents and
key studies used in the development of the CTSA associated with your area(s) of expertise.
Further, if you are aware of any references or data sets that EPA has not used, please indicate so
in your submitted comments; copies of any studies would be appreciated.
We request that all your comments be summarized in a separate listing, with each comment
identified by the page number, and paragraph number to which it pertains. Please do not mark up
the CTSA itself with comments for EPA to consider. Due to the length of the CTSA, and the
number of reviewers, we cannot go through each copy of the CTSA and pick up marginal
notations. We have enclosed a detailed charge for your review and an alphabetized list of all
CTSA references. If you feel you need to see a particular reference as part of your review, and
you do not have access to it, please call me and we will send you a copy as soon as possible.
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EPA is committed to getting this document out by September 1997 and in order to do that we
need to receive your written comments no later than Monday August 25th. If you anticipate any
problem with this deadline, please let us know immediately.
Thank you once again for your participation. Please return to Battelle the entire CTSA review
package, including the CTSA, along with your comments. For your convenience, we have
enclosed a pre-paid pre-addressed Federal Express return package. You only need to enclose all
the materials and drop the package at any Federal Express drop box no later than Friday August
22nd. If you have any questions, please feel free to contact me at (614) 424-4547, or Brandon
Wood at (614) 424-7285.
Sincerely,
Bruce Buxton, Ph.D.
Program Manager
BEB:lnl
Enclosure
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REMINDER
Before beginning your review of the
CTSA, fax a signed and dated copy of
the Non-disclosure Agreement to
Dr. Bruce Buxton of Battelle at fax
(614)424-4250.
If you cannot locate your copy of the
Non-Disclosure Agreement, please call
Dr. Buxton immediately at
(614)424-4547.
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PACKET B-4
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August 6, 1997
CTSA Peer Reviewer
Sent via fax
Dear Peer Reviewer:
Clarification of Language on Carcinogenic Potential
EPA has asked us to provide you with the attached clarification of EPA's evaluation of the
carcinogenic potential of Perchloroethylene. The language currently in the CTSA will be
revised, as per the attached, as part of the peer review comment integration process. This applies
to statements on page 3 of the Executive Summary, on page 7 of Chapter 4, and on pages A-l
and A-13 in Appendix A.
If you have any questions on this, please call me on 614-424-4547.
Sincerely,
Bruce E. Buxton, Ph.D.
Program Manager
Statistics and Data
Analysis Systems
BEB:lnl
Enclosures
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August 6, 1997
Clarification for CTSA Peer Reviewers of EPA's Position on the
Carcinogenic Potential of Perchloroethylene (Perc)
The carcinogenic potential of Perc has been extensively investigated. Perc has been shown to cause
cancer in laboratory studies in rats and mice when given by ingestion or inhalation. There is also evidence
from several studies of workers in the laundry and dry cleaning industry suggesting a possible causal
association between exposure to Perc and elevated risk of cancer. The potential for an increased risk of
cancer depends on several factors, including the dose (how much), the frequency (how often), the duration
(how long), and how one comes in contact with it, as well as the state of health, age, lifestyle, family traits
etc. of the exposed individuals. Most people are likely to have a very low risk of getting cancer from
breathing air, drinking water, or eating food containing Perc. Workers and residents working and living
near dry cleaning establishments that send clothes to another location for cleaning are likely to be at low
risk. There is concern, however, for people working and living near dry cleaners that do use Perc on
premises located in an apartment building. Any potential increased health risk depends on the type of
machine used, what precautions are being properly employed, and conditions inside the facility.
The CTSA reflects scientific evaluations by the International Agency for Research on Cancer (IARC)
and the EPA regarding the human carcinogenic potential of Perc. In 1987, IARC reviewed the available
studies and concluded that Perc is "possibly carcinogenic to humans". Using the same body of data and its
own classification scheme, EPA's Office of Research and Development (ORD) concluded that Perc is "a
probable human carcinogen" primarily on the basis of sufficient evidence of carcinogenicity in laboratory
animals. This position was also taken by the EPA's Carcinogen Risk Assessment Verification Enterprise
(CRAVE) in December 1990. The EPA' Science Advisory Board (SAB), on the other hand, recommended
in 1991, that the human carcinogenicity of Perc lies between probable and possible. Subsequently, EPA-
ORD published its 1991 review on Perc and maintained its conclusion that Perc is a probable human
carcinogen (published in March 1995). Since then, new health effects information has become available.
IARC, in mid 1995, reevaluated the carcinogenicity of Perc and concluded that Perc is "probably
carcinogenic to humans", based on limited evidence of carcinogenicity in humans and sufficient evidence
in animals. At this time, the Agency plans to incorporate new information, finalize its evaluation, and
formally include the health effects assessment of Perc on its consensus database known as the Integrated
Risk Information System (IRIS).
The CTSA document itself is not intended to resolve all uncertainties in data cited nor in methodology
employed. These issues have been extensively debated by the scientific community. The document is
intended to demonstrate a sufficient basis for concern, to compare alternative exposure scenarios and to
provide alternative approaches in communicating risks. It uses readily available information, simplifying
assumptions, and conventional models to provide general conclusions about various cleaning technologies.
It cannot be used to describe the absolute risk associated with specific clothes cleaning operations, only to
permit evaluations, and judgments for each setting need to be made individually.
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APPENDIX C
Charge to Peer Reviewers
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Cleaner Technologies
Substitutes Assessment for Fabricare:
Including Wet and Dry Cleaning Technologies
CHARGE TO PEER REVIEWERS
July 1997
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DO NOT CITE, QUOTE, DISTRIBUTE OR RELEASE
TECHNICAL PEER REVIEW: Cleaner Technologies Substitutes Assessment
(CTSA)for Fabricare: Including Dry and Wetcleaning Technologies
Charge to CTSA Peer Reviewers
The following is intended to provide structure for your review and to enable the EPA to
address your comments directly in the final revision of the CTSA.
The CTSA document is intended to provide a flexible format for systematically
comparing the technical and economic tradeoff issues associated with traditional and alternate
products, processes, and technologies. The goal of the CTSA is to offer a detailed picture of the
environmental impacts, cost and performance issues associated with each option to assist users to
make informed decisions about which alternatives are best for a particular situation. The CTSA
document is not intended to resolve all uncertainties in data cited nor in methodology employed.
For example, this document is not intended to resolve the controversy on the carcinogenic
potential of perchloroethylene, nor on the appropriate slope factor. These issues have been
extensively debated by the scientific community. Rather, the document is intended to
demonstrate a sufficient basis for concern, to compare alternative exposure scenarios and to
provide alternative approaches in communicating risks. The EPA is seeking comment on the
presentations of science, technology and economic considerations in the document. Issues
related to policy considerations are beyond the scope of this peer review.
The information contained in the human health hazard sections was gleaned from existing
summaries, by the agency, its sister agencies or from professional groups taking positions in
accepted published sources, as well as supplemented by primary sources. They do not represent
primary research or a position based solely on primary sources. A summary appears in Chapter
2, with more technical presentation in Appendix B.
As you review the document, if you wish to comment or suggest specific changes, please
annotate directly in the text where the change or additional work is needed. If the provided space
is insufficient, please continue on a separate sheet of paper. After reviewing the document,
prepare a summary report that addresses your major issues. Please present your comments
constructively, be specific about the issues/changes suggested, and cite the page number where
the change should occur. If an issue has been omitted or addressed improperly, please give
specific information on how it should be addressed. If you are citing a new reference (that
has not been previously provided by the EPA), please provide a copy and indicate where in
the text it should be included.
The Office of Pollution, Prevention and Toxics of the EPA has prepared a series of issues
and questions relevant to each section and topic area. These items are deemed by EPA as areas
of concern to be considered and will aid in guiding your peer review. You may address these
issues along with any other concerns in your report. After you have completed your review,
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please return both the document and your comments, along with a copy of any new reference(s)
to the contractor (Battelle).
The CTSA document is an internal, preliminary work product developed by the EPA.
Neither the contractor nor the peer reviewers may distribute, cite, quote or in any manner release
any portion of the document. All copies of the document, support material, and comments will
be returned by Battelle to EPA.
I. GENERAL CTSA DOCUMENT CONCERNS
The following are several areas of concern that are applicable to the entire CTSA
document. These issues pertain to content, format, and presentation. Are you aware of any
enhancements which would improve the general presentation of information pertaining to the
following issues.
Chapters 1 through 8
1. Does each of these chapters clearly explain its purpose? If the chapter purpose is not clearly
articulated, indicate what you believe the purpose of the chapter was.
2. Is the text clear and well presented? Can you suggest other ways to present the information
to enhance its clarity?
3. Do tables/figures enhance understanding of the information presented in these chapters? If
not, how should the information be presented? Please provide an example.
4. Are there any inconsistencies between the data presented in the tables and text? Can you
suggest other ways to present the information? Please provide an example.
5. Are relevant references provided for the information contained in each of these chapters?
II. ECONOMIC ASSESSMENT
The Economic elements of the CTSA are found in Chapters 1, 6, 7, and 8.
A. Chapter 1. Overview of Dry cleaning
1. Does this chapter help set the stage for the comparative evaluation you understand will
follow?
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2. Are you aware of any specific sources where information is more current or different from
that quoted in this chapter?
B. Quantities where we would particularly appreciate your knowledge of newer or higher
quality data include:
1. Solvent mileage (solvent use per unit of clothes cleaned), by technology.
2. Maintenance costs for machines in use.
3. Volume of clothes cleaned, by technology.
4. Permitting costs, are these factored in to the trade off issues correctly?
5. Projected demand, by technology.
6a. Average site releases to H2O, each technology, total U.S. releases.
6b. Average site releases to air, each technology, total U.S. releases.
III. ENGINEERING ASSESSMENT
A. Process Descriptions
1. Are the proper primary equipment and operations included? If not, what has been omitted?
2. Do the technologies appear to have been properly categorized? If not, what categorization
would be more appropriate?
3. Are the descriptions accurate and adequate?
B. Environmental Release Estimates
1. Are release estimates reasonably accurate, keeping in mind that the relative differences
between technologies for a given solvent are the primary purpose for the estimates? If not,
please provide enough information, including bases, to calculate new estimates.
2. Are these release estimates adequate to properly distinguish the important differences
between the various technologies for each solvent?
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3. Have any important equipment or operational factors been omitted? If so, please provide a
basis for each new factor, if available, for quantification.
4. Are the assumptions reasonable? If not, please provide a basis for any new assumption.
5. Are the exposure characterizations in Chapters 3 and 4 consistent with one another? Do they
help the reader understand the context for evaluating risk?
6. Perc occupational and residential exposures have been measured in a number of disparate
settings by various protocols. Do the summarization measures and descriptions adequately
convey the variety and the contribution it has to the estimates of exposure and risk in
different scenarios? Should anything specifically be added to the text in Chapters 3, 4, and
8?
C. Environmental Release Assessments
1. Are the estimates reasonable? If not, what other estimates could be used? In providing other
estimates, please include the basis for each estimate and an example.
2. Are the data sets used for estimations reasonably representative of the industry as a whole? If
not, what data would be?
D. Exposure Estimates
1. Are the data sets used for inhalation exposure concentrations or potential dose rates
reasonably representative of the industry as a whole? If not, what data would be? Are the
data appropriate for the type and magnitude of exposure the EPA is trying to estimate?
2. Is the number of samples taken, in the case of the monitoring studies used in the assessment,
statistically significant [although a rigorous statistical analysis was not performed]? If not,
how should this be characterized in the text?
3. Are the assumptions reasonable? If not, what assumptions should replace them? Please
include a basis to support assumptions.
E. Pollution Prevention. Best Management Practices, and Control Options
1. Are there any other options for operational improvements? If so, what options are omitted?
Please provide relevant details.
2. Are there any errors/omissions in process substitutes provided?
3. Are the improvements presented clearly?
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IV. GENERAL POPULATION EXPOSURE ASSESSMENT
1. Is the information presented clearly?
2. Are the exposure scenarios realistic?
3. Have the exposed populations been adequately characterized?
V. HUMAN HEALTH HAZARD ASSESSMENT
The hazard information for the CTSA is found in Chapters 3 and 4. The health and
environmental hazards of Perc, one of the chemicals covered in the CTSA, have been studied
extensively. EPA's assessment of the hazards of Perc has been the subject of rigorous peer
review, including a review by EPA's Science Advisory Board. The hazards of Perc shall not be a
principle focus of this peer review.
A. Chapters 3 and 4. Perchloroethylene and Petroleum Processes, respectively
1. Is the discussion of perchloroethylene dose-response modeling straightforward? Are its
sources clear (for readers who want more detail)?
2. Are you aware of human health effects information pertaining to relevant exposures reported
on any substance in one of the described technologies that should have been included in the
summaries.
VI. RISK ASSESSMENTS
The Risk Assessments for the CTSA are found in Chapters 3 and 4 and Appendix G.
A. Chapters 3 and 4. Perchloroethylene and Petroleum Processes, respectively
The Agency is aware that other quantified assessments of perchloroethylene exist, and
that there is debate within the scientific community on the interpretation of several metabolic and
animal/human extrapolation issues, and these are pointed out in the text. However, the EPA has
not updated its earlier dose/response assessment of perchloroethylene, and such a revision is
beyond the scope of the CTSA. Also, an updated risk assessment is not considered essential for
the purpose of this document, which is to indicate ways users can make decisions about relative
risk, and alternative exposure reduction technologies.
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1. Does the risk assessment accomplish the objective of highlighting which sorts of situations
pose greatest risk of experiencing adverse effects from exposure to each cleaning process? If
not, please suggest ways that this objective could be accomplished.
2. Are the effects characterizations in chapter 2 and chapter 4 consistent with one another? Do
they help the reader understand the circumstances under which there may be risk?
3. Are the risk tables clear? If not, how might they be improved?
4. Are sources of uncertainty sufficiently covered in the Risk Assessment sections? If not, what
other uncertainties should be included?
5. Does the risk assessment for the petroleum solvents clearly convey the fact that there was a
disproportionate amount of information, specifically, toxicity information, that was available
for most of the cleaning processes in comparison to that available for perchloroethylene? Is
there a hidden bias in the assessment that could be corrected with clearer language as to the
respective amounts of information we were dealing with?
6. Recently the EPA's Science Policy Council released a final draft (1/6/95) of "Guidance for
Risk Characterization." All Agency risk assessments are supposed to adhere to the principles
detailed in this guidance document. Do the risk-related sections of the CTSA adhere to the
principles discussed in the guidance document? If not, what should be done to improve the
CTSA in this regard?
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APPENDIX D
Peer Review Reference List
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Cleaner Technologies
Substitutes Assessment for Fabricare:
Including Wet and Drycleaning Technologies
PEER REVIEW REFERENCE LIST
July 1997
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July 1997
DO NOT CITE, QUOTE, DISTRIBUTE OR RELEASE
TECHNICAL PEER REVIEW: Cleaner Technologies Substitutes Assessment (CTSA)for
Fabricare: Including Dry and Wet Cleaning Technologies
CTSA REFERENCES
1. Abt. 1994. Dry cleaning industry. Use cluster analysis. Final report. Prepared for the
U.S. EPA Office of Pollution Prevention and Toxics under Contract No. 68-D2-0175.
Abt Associates. Aprils.
2. ACGIH. 1986. American Conference of Governmental Industrial Hygienists.
Documentation of threshold limit values. ACGIH, Committee on Threshold Limit
Values. Cincinnati, OH.
3. ACGIH. 1994. American Conference of Government Industrial Hygienists. 1994-1995
Threshold Limit Values for Chemical Substances and Physical Agents and Biological
Exposure Indices, ACGIH.
4. Adam son, K. 1996a. Personal communication between Ken Adamson, Langley-Parisan
Cleaners, and Jonathan Greene, Abt Associates Inc. November 25.
5. Adamson, K. 1996b. The status of wet cleaning in Canada: Exploring the boundaries of
wet cleaning. Presented at Conf. on Global Experience and New Developments in Wet
Cleaning Technology. Schloss Hohenstein, Boennigheim, June. p. 15-20.
6. Adamson, K. 1997. Personal communication between Ken Adamson and Alice Tome,
Abt Associates Inc. January.
7. Ahlborg Jr., G. 1990. Pregnancy outcome among women working in laundries and dry-
cleaning shops using tetrachloroethylene. Am J Ind Med 17:567-575. [As cited in
ATSDR(1993).]
8. AIHA. 1990. Perchloroethylene exposure assessment among dry cleaning workers. Am
Ind Hyg Assoc J 51. October.
9. Alden, C.L. 1986. A review of unique male rat hydrocarbon nephropathy. Toxicol
Pathol 14:109-111. [As cited in ATSDR( 1995).]
10. Amato. 1994. Personal communication between sales representative of Amato Industries
and Michael Miiller of Abt Associates Inc.
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11. Amoore, I.E., and E. Hautala. 1983. Odor as an aid to chemical safety: odor thresholds
compared with threshold limit values and volatilities for 214 industrial chemicals in air
and water dilution. J of Appld Toxicol 3:272-90.
12. Anderson, C., K. Sundberg, and O. Groth. 1986. Animal model for assessment of skin
irritancy. Contact Dermatitis 15:143-151. [As cited in ATSDR (1995).]
13. Andersson, H.F., J.A. Dahlberg, and R. Wettstrom. 1975. On the formation of phosgene
and trichloroacetyl chloride in the nonsensitized photooxidation of perchloroethylene in
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products. J Environ Pathol Toxicol 2:1139-1150; as cited in Busch et al. 1983.
D-40
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APPENDIX E
Index to Administrative Record #199
E-1
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AR-199
September 4, 1998
INDEX to Administrative Record #199
of the
Technical Peer Review of the US EPA Report:
Cleaner Technologies Substitutes Assessment for Professional Fabricare Processes
EPA 744-B-98-001, June 1998
A. Office of Prevention. Pesticides and Toxic Substances STANDARD OPERATING
PROCEDURES FOR PEER REVIEW OF MAJOR SCIENTIFIC AND TECHNICAL
DOCUMENTS. October 1.1996 - September 30.1997. under which this technical peer
review was conducted.
B. The official technical peer review version of the Cleaner Technologies Substitutes
Assessment for Fabricare: Including Wet and Dry Cleaning Technologies, (CTSA)
July 1997. (NOTE: After the peer review was completed, the final document title was
changed to: Cleaner Technologies Substitutes Assessment for Professional Fabricare
Processes).
C. Materials and information sent to peer reviewers during course of peer review
1. July 21, 1997 letter from Bruce E. Buxton, Ph.D., Battelle Program Manager, mailed
to 29 peer reviewers who were to be paid for their review, requesting information and
transmitting a non-disclosure agreement and contracts information. With enclosures:
a. Peer Reviewer Non-Disclosure Agreement
b. Battelle's Special and General Provisions Technical Services for
Government Time and Material, Labor Hour Contracts
2. July 21, 1997 letter from Bruce E. Buxton, Ph.D., Battelle Program Manager, mailed
to 11 peer reviewers who were not to be paid for their review, requesting information
and transmitting a non-disclosure agreement. With enclosure:
a. Peer Reviewer Non-Disclosure Agreement
3. July 25, 1997 letter from Bruce Buxton, Ph.D., Battelle Program Manager, mailed to
40 peer reviewers and transmitting the official peer review version of the fabricare
CTSA. Specific guidance to the reviewers and a list of references cited in the CTSA
were bound into each official peer review copy of the CTSA:
a. Reminder page to return signed non-disclosure agreement to Battelle
b. Bound in the front of each peer review copy: July 1977 Charge to CTSA
Peer Reviewers
c. Bound at the end of each peer review copy: July 1997 Peer Review
Reference List of all references that were cited in the peer review version
of the fabricare CTSA.
E-2
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4. August 6, 1997 letter from Bruce Buxton, Ph.D., Battelle Program Manager, faxed to
40 peer reviewers, clarifying carcinogenic potential of perchloroethylene. With
enclosure:
a. August 6, 1997 Clarification for CTSA Peer Reviewers of EPA's
Position on the Carcinogenic Potential of Perchloroethylene (Perc)
5. August 14, 1997, letter from Brandon Wood, Battelle CTSA Task Leader, to
Kimberly Thompson, Dr.S., transmitting requested references from peer review
version of CTSA. With the following list of enclosures (see AR Section C3c for
actual references):
a. List of references sent to K. Thompson
D. Comments, information, and materials received from the peer reviewers
1. Signed Non-Disclosure Agreements from 40 peer review panelists
2. Proposals from panelists that were to be paid for their review
3. Invoices submitted to Battelle from panelists that were to be paid for their review
4. Original comments and additional materials as submitted by the 36 peer reviewers
that responded
5. List of additional materials submitted by each peer reviewer
E. Information about the peer reviewers
1. List of 40 technical peer reviewers on the panel and their affiliations
2. Biosketches submitted by peer reviewers
3. Table of the 113 nominated candidate reviewers and detailed information on their
technical expertise, who nominated them, and why they were or were not on the
panel.
F. Cleaner Technologies Substitutes Assessment for Professional Fabricare Processes:
Peer Review Process. EPA 744-S-98-002. June 1998. (NOTE: This EPA report
summarizes the entire process that was followed for the technical peer review of the
fabricare CTSA, how the panel was selected, all logistical information, and the results.
This report was prepared for stakeholders and other interested parties, and to document
the peer review process from start to finish as part of this Administrative Record.)
G. Cleaner Technologies Substitutes Assessment for Professional Fabricare Processes:
Response to Peer Review Comments. EPA 744-P-98-001. June 1998
H. Final CTSA and related documents
1. Cleaner Technologies Substitutes Assessment for Professional Fabricare
Processes, EPA 744-B-98-001, June 1998 (final CTSA)
2. Cleaner Technologies Substitutes Assessment for Professional Fabricare
Processes: SUMMARY, EPA 744-S-98-001, June 1998 (summary version abstracted
directly from the full CTSA)
3 Federal Register Notice of Availability of CTSA and Summary CTSA
4. Fact Sheet: Cleaner Technologies Substitutes Assessment for Professional
Fabricare Processes, EPA 744-F-98-011, June 1998
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5. Frequently Asked Questions About Dry cleaning, EPA 744-K-98-002, June 1998
I. Indexed list and a copy of each of the 404 references cited in the final published
report: Cleaner Technologies Substitutes Assessment for Professional Fabricare
Processes, EPA 744-B-98-001, June 1998
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50272-101
REPORT DOCUMENTATION 1. REPORT NO. 2.
PAGE EPA 744-S-98-002
4. Title and Subtitle
Cleaner Technologies Substitutes Assessment for Professional Fabricare
Processes: Peer Review Process
7. Author(s) Brandon J. Wood, Melinda Armbruster
9. Performing Organization Name and Address
Battelle Memorial Institute
505 King Avenue
Columbus, Ohio 43201-2693
12. Sponsoring Organization Name and Address
U.S. Environmental Protection Agency
Office of Pollution Prevention and Toxics (7401)
401 M Street, S.W.
Washington, D.C. 20460
3. Recipient's Accession No.
5. Report Date: June 1998
6.
8. Performing Organization Rept. No.
10. Project/Task/Work Unit No.
G003470-0108
1 1 . Contract(C) or Grant(G) No.
(C) 68-D5-0008
(G)
13. Type of Report & Period Covered
Final Report
14.
15. Supplementary Notes
16. Abstract (Limit 200 words)
This report presents the general approach and considerations taken into account for conducting the peer review of the
Cleaner Technologies Substitutes Assessment for Professional Fabricare Processes, EPA 744-B-98-001 . The objective of the
peer review was conducted to uncover any technical problems or unresolved issues for use in revising the preliminary work
product so that the final work product reflects sound technical information and analyses and enhance the scientific technical
work product.
The review process began with a conference call between CTSA stakeholders and EPA on July 24, 1998. The peer
review panel consisted 40 reviewers, each of whom was specialized in at least one of the four following categories: Technology
and Economics, Exposure Assessment, Hazard Assessment, and Risk Assessment. The panel encompasses a large, balanced
independent panel of experts from the dry cleaning industry and the environmental and scientific communities. Peer reviewers
of the CTSA document submitted a total of 1,855 comments comprising 340 pages.
The EPA Technical Workgroup in charge of developing and revising the CTSA document based on reviewers' comments
drafted responses to every peer review comment. Additional investigations and revisions were made to the CTSA document
based on the peer review comments.
17. Document Analysis
a. Descriptors: drycleaning, wetcleaning, perchloroethylene, PCE
?
b. Identifiers/Open-Ended Terms: Possible carcinogens, pollution prevention
?
c. COSATI Field/Group: Not applicable
18. Availability Statement 19. Security Class (This Report)
EPA Docket AR-1 99 Unclassified
NCEPI: (800)490-9198
20. Security Class (This Page)
Unclassified
21. No. of Pages
146
22. Price
(SeeANSI-239.18)
OPTIONAL FORM 272 (4-77)
(Formerly NTIS-35)
Department of Commerce
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