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Cleaner Technologies Substitutes Assessment for Professional Fabricare Processes: Peer Review Process
TABLE OF CONTENTS
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.
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)
1200 Pennsylvania Ave. NW (7407-T)
Washington, DC 20460-0001
202-566-0799 (phone)
202-566-0794 (fax)
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
401 M Street S.W.
Washington, D.C. 20460
stroup.cindy@epa.gov
Back to Contents
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 Partnership (GTCP) as part of an effort to explore opportunities for pollution prevention in the drycleaning 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 OBJECTIVESIn 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 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 REPORTThe 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.
Back to Contents
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.
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 (Continued following Table 2-1.)
Table 2-1. Stakeholders Asked for Nominations to Peer Review Panel
|
Stakeholder |
Company |
|
Mr. Moon Jong Chun |
Federation of Korean Drycleaning Associations |
|
Mr. Dave DeRosa and Mr. Jack Weinberg |
Greenpeace |
|
Mr. Eric Frumin |
UNITE (Union of Needletrades, Industrial and Textile Employees) |
|
Mr. Bob Gottleib and Ms. Jessica Goodheart |
ULCA, Pollution Prevention Education & Research Center |
|
Ms. Janet Hickman |
Dow Chemical |
|
Ms. Sylvia Hoover-Ewing and |
Center for Neighborhood Technology |
|
Dr. David Ozonoff |
Boston University School of Public Health |
|
Mr. Steve Risotto |
Center for Emission Control |
|
Ms. Mary Scalco and Mr. Bill Fisher |
International Fabricare Institute |
|
Dr. Judy Schreiber |
New York State Department of Health |
|
Mr. Bill Seitz |
Neighborhood Cleaners Association International |
|
Ms. Jodie Siegel |
Massachusetts Toxic Use Reduction Institution |
|
Ms. Barbara Warren and Dr. Ned Groth |
Consumers Union |
|
Dr. Manfred Wentz |
Fabricare Legislative & Regulatory Education Council / AATCC |
(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.
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-1 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.
Table 2-2. All Nominated Candidate Reviewers
|
Elden Dickinson Kathleen Wolf, Ph.D. Paul Dugard, Ph.D. Charles Riggs, Ph.D. Dr. Josef Kurz Mike Tatch Noel Weiss, M.D., Dr. P.H. Kenneth Mundt, Ph.D. Tom Starr, Ph. D. D. Warner North, Ph.D. Rudolf Jaeger, Ph.D. Dr. Robert Squire Mr. Todd S. Wong James Wilkin, Ph.D. Dr. Tom Armstrong Scott Earnest Dr. Salvatore DiNardi Dr. Baruch Fischhoff/Dr. Mitchell Smalls |
Mr. Rory Connelly Chemical Industry Institute of Technology Joe McLaughlin, Ph.D. Dr. John Graham Dr. John Doull Pamela Christenson Ellen Kirrane David Ozonoff, M.D., M.P.H. Dick Clapp, Sc.D., M.P.H. Director NY State Laborer's Health & Safety Trust Fund Ms. Chris Hayes Greater Chicago P2 Program, MWRD Peter Orris, M.D. Frank Mirer, Ph.D. Diane Echeverria Dale Hattis, Ph.D. Donald P. Gallo Diane Weiser Irv Markus Amelia Gooding |
Jim Ahearn Polaroid Ed Olmstead Dr. John Froines Henry Anderson, M.D. Nancy Kim Dr. David Kriebel Dr. Margaret Quinn Philip Landrigan, M.D. Ethel H. Wise Thomas Eggert George Alexeeff, Ph.D., D.A.B.T. Avima Ruder, Ph.D. Anne Marie Desmarais Dr. Rafael Moure-Eraso David Rall Aaron Blair Ken Geiser |
Table 2-2. All Nominated Candidate Reviewers (Continued)
| Dr. John Peters/USC Dept. of Occup. & Environmental Medicine Mark K. Enstrom Dennis F. Lekan Ron Kantor Ann Hacker Rebecca Head, PhD Joanna Hoelscher Stanley Liu Jim Orlin Jackie Peterson Merry Bering Tony Sasson Richard Simon Ken Vandersnick Dong Whang Allen L. White, PhD Adam Finkel, Ph.D. Marthe Kent, Ph.D. Education and Information Division National Institute for Occupational Safety and Health Jack Lauber |
Mr. Rory Connelly Mr. Ken C. Adamson, General Manager Langley Parisian Manfred Wentz, Ph.D. Denny Hjeresen, Ph.D. Frank Arnold, Ph.D. Andrew Persily, Ph.D. Greg Traynor Charlene Bayer, Ph.D. Clifford Weisel, Ph.D. James Cone, M.D., M.P.H. George Gray, Ph.D. Arthur Upton, M.D. Duncan Thomas Thomas Goldsworthy, M.D. Claudia Miller, M.D. Judy Schreiber, Ph.D. Kimberly Thompson, Sc.D. Arnold Brown. M.D. Routt Reigart, M.D. Dan Krewski, Ph.D., MHA School of Health Sciences Purdue Ron Miller Brad Leinhart, Ph.D. Scott Lutz |
Paul Lioy, Ph.D. Robert Wood Johnson Medical School Deborah Wallace Marilyn Black John Girman Les Sparks Betsy Howard Dr. Ron Melnick Linda Sheldon ORD Lance Wallace, Ph.D. Eula Bingham, Ph.D. Bernard Goldstein, M.D. Robert Taylor, M.D., Ph.D. Louise Ryan, Ph.D. Adolfo Correa, M.D. Joel Mattsson, M.D. |
Table 2-3. Final CTSA Peer Review Panel
| Ken C. Adamson General Manager Langley Parisian Frank Arnold, Ph.D. Charlene Bayer, Ph.D. Arnold Brown., M.D. - Retired Pamela Christenson Dick Clapp, Sc.D., M.P.H. James Cone, M.D., M.P.H. Elden Dickinson Paul Dugard, Ph.D. Diane Echeverria, Ph.D. Adam Finkel, Ph.D. George Gray, Ph.D. Dale Hattis, Ph.D. Ms. Chris Hayes Denny Hjeresen, Ph.D. |
Rudolf Jaeger, Ph.D. Environmental Medicine, Incorporated Ellen Kirrane Josef Kurz, Ph.D. Jack Lauber, P.E.-D.A.A.E.E. James Melius, M.D., Ph.D. Frank Mirer, Ph.D. Kenneth Mundt, Ph.D. D. Warner North, Ph.D. Peter Orris, M.D. David Ozonoff, M.D., M.P.H. Andrew Persily, Ph.D. Routt Reigart, M.D. Charles Riggs, Ph.D. Judy Schreiber, Ph.D. |
Tom Starr, Ph. D. Environ Corp. Mike Tatch Kimberly Thompson, Sc.D. Joel Tickner Greg Traynor Arthur Upton, M.D. David Votaw Clifford Weisel, Ph.D. Noel Weiss, M.D., Dr. P.H. Manfred Wentz, Ph.D. Kathleen Wolf, Ph.D.
|
Note: No known conflicts of interest existed with any peer reviewer.
Table 2-4. Attendees at July 24, 1997 Teleconference Announcing CTSA Peer Review
|
Name |
Affiliation/Address |
| Mary Scalco, Bill Fisher |
International Fabricare Institute |
| Bill Seitz | Neighborhood Cleaners Association, International |
| Ross Beard | Fabricare Legislative & Regulatory |
| Steve Risotto | Centers for Emission Control |
| Gary Baise | Baise & Miller |
| Eric Frumin | Union of Needletrades, Industrial
and Textile Employees (UNITE) |
| David DeRosa, Jack Weinberg |
Greenpeace |
| Moon Jong Chun | Federation of Korean Drycleaning Association |
| Cindy Stroup, Lynne Blake-Hedges, Mary Ellen Weber |
U.S. Environmental Protection Agency |
| Melinda Armbruster, Brandon Wood |
Battelle Memorial Institute |
Table 2-5. Record of CTSA Copy Numbers, Date Sent and Date Comments Received
|
Copy No. |
Date Copy Sent |
Date Comments Received |
Reviewer |
Copy No. |
Date Copy Sent |
Date Comments Received |
Reviewer |
|
1 |
7/24/97 |
8/27/97 |
E. Dickinson |
22 |
7/26/97 |
8/15/97 |
R. Jaeger |
|
2 |
7/24/97 |
Dropped |
P. Dugard |
23 |
7/26/97 |
8/19/97 |
K. Thompson |
|
3 |
7/24/97 |
8/27/97 |
P. Christenson |
24 |
7/26/97 |
8/25/97 |
C. Hayes |
|
4 |
7/24/97 |
9/2/97 & 9/8/97 |
K. Adamson |
25 |
7/26/97 |
8/7/97 |
N. Weiss |
|
5 |
7/24/97 |
8/12/97 |
A. Upton |
26 |
7/28/97 |
8/27/97 |
G. Traynor |
|
6 |
7/24/97 |
8/27/97 |
D. Votaw |
27 |
7/26/97 |
9/11/97 |
D. Echeverria |
|
7 |
7/24/97 |
8/27/97 |
D. Votaw |
28 |
7/26/97 |
8/25/97 |
J. Cone |
|
8 |
7/24/97 |
8/28/97 |
D. Votaw |
29 |
7/26/97 |
8/27/97 |
C. Weisel |
|
9 |
7/25/97 |
Withdrew |
A. Persily |
30 |
7/28/97 |
8/6/97 |
F. Arnold |
|
10 |
7/25/97 |
9/3/97 |
J. Schreiber |
31 |
7/26/97 |
8/25/97 |
C. Bayer |
|
11 |
7/25/97 |
8/25/97 |
C. Riggs |
32 |
7/28/97 |
9/3/97 |
P. Orris |
|
12 |
7/25/97 |
8/18/97 |
J. Lauber |
33 |
7/28/97 |
8/22/97 |
D. Clapp |
|
13 |
7/25/97 |
8/25/97 |
J. Tickner |
34 |
7/28/97 |
9/2/97 |
F. Mirer |
|
14 |
7/25/97 |
Withdrew |
J. Kurz |
35 |
7/29/97 |
9/17/97 |
A. Finkle |
|
15 |
7/25/97 |
8/25/97 |
K. Wolf |
36 |
7/29/97 |
8/25/97 |
D. Hjeresen |
|
16 |
7/25/97 |
8/25/97 |
J. Melius |
37 |
7/29/97 |
8/22/97 |
A. Brown |
|
17 |
7/25/97 |
8/21/97 & 9/3/97 |
M. Wentz |
38 |
7/29/97 |
8/26/97 |
K. Mundt |
|
18 |
7/25/97 |
9/2/97 & 9/3/97 |
M. Tatch |
39 |
7/29/97 |
9/4/97 |
T. Starr |
|
19 |
7/25/97 |
8/18/97 |
D. Ozonoff |
40 |
7/29/97 |
9/5/97 |
G. Gray |
|
20 |
7/25/97 |
8/25/97 |
E. Kirrane |
41 |
8/1/97 |
8/25/97 |
W. North |
|
21 |
7/26/97 |
8/20/97 |
D. Hattis |
42 |
8/1/97 |
Withdrew |
R. Reigart |
Back to Contents
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 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 |
Complete Set of Comments |
|
|
# of Pages of Comments |
# of Comments |
|
|
General |
49 |
181 |
|
Executive Summary |
12 |
67 |
|
Chapter 1 |
56 |
328 |
|
Chapter 2 |
32 |
194 |
|
Chapter 3 |
60 |
357 |
|
Chapter 4 |
61 |
375 |
|
Chapter 5 |
12 |
61 |
|
Chapter 6 |
17 |
82 |
|
Chapter 7 |
10 |
50 |
|
Chapter 8 |
12 |
71 |
|
Appendix A |
13 |
62 |
|
Appendix B |
1 |
6 |
|
Appendix C |
4 |
20 |
|
Appendix D |
1 |
1 |
|
Total |
340 |
1855 |
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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).
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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).
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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 drycleaning 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.