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Appendix B

Correspondence with Peer Reviewers

PACKET B-1

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 CTSA 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 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


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


Terms and Conditions


Terms and Conditions cont.


Terms and Conditions cont.


PACKET B-2

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


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


PACKET B-3

 

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.

    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


    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.


    PACKET B-4

     

    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-1 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


    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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