DRAFT



## Peer Reviewer Selection Report for the

External Peer Review of EPA’s Technical Approach Document Approach for Estimating Exposures and Incremental Health Effects from Lead due to Renovation, Repair, and Painting Activities in Public and Commercial Buildings

EPA Contract No . EP

- C

- 12

- 045

Task Order No. 39

September 3 , 201 4

Prepared for: U.S. Environmental Protection Agency

Office of Pollution Prevention and Toxics

1 200 Pennsylvania Aven ue, NW Washington DC 20460 Prepared by:
Versar, Inc.

6850 Versar Center Springfield, VA 22151Draft Peer Reviewer Selection Report for the External Peer Review of EPA’s Technical Approach Document Approach for Estimating Exposures and I ncremental Health Effects from Lead due to Renovation, Repair, and Painting Activities in Public and Commercial Buildings

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iDraft Peer Reviewer Selection Report for the External Peer Review of EPA’s Technical Approach Document Approach for Estimating Exposures and I ncremental Health Effects from Lead due to Renovation, Repair, and Painting Activities in Public and Commercial Buildings

Table of Contents

EXECUTIVE SUMMARY

................................ ................................ ................................ ............ 1

I Identification of Experts

................................ ................................ ................................ ... 3

I. 1 Experts Nominated by the Public

................................ ................................ ........... 3

I.2 Experts Identified by Versar

................................ ................................ ................... 4

II Conflict of Interest Screening Process

................................ ................................ ............. 5

III Selection of Candidates on Proposed List

................................ ................................ ........ 5

III.1 Credential Evaluation

................................ ................................ .............................. 5

III.2 COI Information Evaluation

................................ ................................ ................... 6

III.3 Compilation of Results

................................ ................................ ........................... 6

IV Selection of Final 10 to 12 Peer Reviewers

................................ ................................ ...... 7

V EPA Guidance Materials Used for the Peer Review Selection Process

........................... 8

FIGURE

Figure ES

- 1 Flow Chart Summarizing the Peer Reviewer Selection Process

TABLE

Table 1 Versar Ratings Assigned to Candidates Based on their Qualifications

APPENDICES

Appendix A Conflict of In terest (COI) Screening Questionnaire

Appendix B COI Certification Letter to EPA

Appendix C Informat ion on the Candidate Reviewers

Appendix D Biosketches of the Proposed Candidate Reviewers

iiDraft Peer Reviewer Selection Report for the External Peer Review of EPA’s Technical Approach Document Approach for Estimating Exposures and I ncremental Health Effects from Lead due to Renovation, Repair, and Painting Activities in Public and Commercial Buildings



### EXECUTIVE SUMMARY

On August 6, 2014 , EPA announced in the Federal Register the release of the draft document Approach for Estimating Exposures and Incremental Health Effects from Lead due to Renovation, Repair, and Painting Activities in Public and Commercial Buildings (Technical Approach Document) for the purposes of public review and comment ( http://www .gpo.gov/fdsys/pkg/FR

- 2014

- 08

- 06/pdf/2014

- 18357.pdf ) . Consistent with guidelines for the peer review of influential scientific assessments, Versar, Inc., an EPA contractor, was tasked with assembling 10 to 12 scientific experts to evaluate the T echnical Ap proach

D ocument

. The objective of this report is to describe Versar’s selection process for external peer

reviewers of the T echnical A pproach D ocument

.

The peer review selection process was initiated with a three

- week public nomination period that

was held from June 2 7 , 2014 to July 18 , 2014 , as documented in the Federal Register ( http://www.gpo.gov/fdsys/pkg/FR

- 2014

- 06

- 27/pdf/2014

- 15123.pdf ) . D uring this period

, members o f the public were able to nominate scientific experts with knowledge and experience in one or more of the following areas: (1) m ultimedia routes of human exposure to lead ; (2) m odeling of multimedia human exposures ; (3) l ead exposure pathway assessment; (4) l ead uptake/absorption ; ( 5 ) i nternal biokinetic distribution and physiological effects of lead; ( 6 ) t issue

concentrations of lead ; (7) h um an growth and activity patterns; (8) e xposure assessment modeling ; (9) l ead

- induced health effects ; and (10) risk assessment and uncertainty

characterization

. A total of 18 experts were nominated by the public.

Following the nomination period

, Versar conducted an independent search for qualified scientific experts to augment the list of public ly

- nominated candidate s. Altogether, Versar contacted 63

experts (18 p ublicly

- nominated, 45 Versar

- identified). Of these, 31 were interested and available (12 p ublicly

- nominated , 19 Versar

- identified )

. CVs for each of these 31 candidates are available at the following link: https://downloads.versar.com/data/public/592325.php

.

Versar considered and screened all 31 candidates against the selection criteria described in the Federal Register dated June 27

, 2014, which included : (1) having demonstrated expertise in the

areas described above, based on information in their submitted resume, biographical sketch and/or current publications ; (2) being free of any conflict of interest (COI) and the appearance of the lack of impartiality ; and (3) being available to participate in

- person in a two

- day peer r eview meeting in the Washington DC area

. In addition, candidates were queried on their availability in the December 2014 to January 2015 ti meframe, with the exact date for the meeting to be

determined at a later time.

Following completion of the screening process, which narrowed the list of poten tial reviewers to

15 candidates . Versar provided to EPA the names of the 15 experts on the draft proposed list of

candidate reviewers

. After consultation with the EPA Office of the Science Advisor, the names

of the 15 candidates and their professional affiliations will be published in the Federal Register. The Federal Register will also announce that additional information on the candidates, including education and professional experience, will be made available on Versar’s peer review website ( https://www.peerreview.versar.com/epa/lead/ ). The Federal Register will provide a 21

- day period for the public to submit relevant information or documentation on the proposed list of

1Draft Peer Reviewer Selection Report for the External Peer Review of EPA’s Technical Approach Document Approach for Estimating Exposures and I ncremental Health Effects from Lead due to Renovation, Repair, and Painting Activities in Public and Commercial Buildings

candidates that Versar should c onsider during the evaluat ion process of selecting the final 10 to

12 reviewers

.

Following the close of the public comment period on the proposed list of reviewers, Versar will

re

- evaluate each proposed can didate’s credentials to select the 10

- 12 experts who, collectively, provide expertise spanning the multiple subject matter areas covered in the T echnical Approach

D ocument and, to the extent feasible, best prov ide a balance of perspectives.

A flow chart summarizing the peer reviewer selection process is provided in Figure ES

- 1

. T he

final list of reviewers will be published on Versar’s website ( https://www.peerreview.versar.com/epa/le ad/ ) in late

- October 2014

.

Figure ES

- 1

. Summary of the Peer Reviewer Selection Process Selected Peer Reviewers (n= 10 to 12) Candidates Excluded (n= 32 ):

• Unavailable

• Did not Respond

Candidates Excluded (n= 16 ):

• Not best qualified

• Potential or Actual CO I Candidate Reviewers
Nominated by Public (n= 18)

Candidate Reviewers Interested and Available (n=31)

Proposed List of Candidate Reviewers (n= 15) Candidate Reviewers Identified by Versar (n= 45)

2Draft Peer Reviewer Selection Report for the External Peer Review of EPA’s Technical Approach Document Approach for Estimating Exposures and I ncremental Health Effects from Lead due to Renovation, Repair, and Painting Activities in Public and Commercial Buildings

I Identification of Experts

I.1 Experts Nominated by the Public

As documented in the Federal Register ( http://www.gpo.gov/fdsys/pkg/FR

- 2014

- 06

- 27/pdf/2014

- 15123.pdf ) a public nomination process was held from June 27, 2014 to July 18,

2014 to allow members of the public to nominate scientific experts to be considered as peer

reviewers. Nominations were submitted to the Federal eRulemaking Portal ( http://www.regulations.gov ), by mail, and by hand delivery

. The nominators were requested to provide the following i nformation on the peer reviewer candidates : nominee's full name, address, affiliation, telephone number, email address, and a statement on the nominee's expertise.

I nformation was collected to determine if the candidates had the appropriate scientific crede ntials in one or more of the following areas: (1) m ultimedia routes of human exposure to lead ; (2) m odeling of multimed ia human exposures ; (3) l ead exposure pathway assessment; (4) l ead uptake/absorption ; ( 5 ) i nternal biokinetic distribution and physiological effects of lead; ( 6 ) t issue

concentrations of lead ; (7) h um an growth and activity patterns; (8) e xposure assessment modeling ; (9) l ead

- induced health effects ; and (10) risk assessment and uncertainty

characterization

.

Versar received a total of 18 unique public nominations from both individuals submitting self

nominations and individuals submitting nominations for other scientific experts. Of the 18 nominees contacted by Versar, 12 responded that they were interested and available to participate in this peer review

. The names and affiliations of t he publicly

- nominated individuals are provided below (interested and available nominees in italics ):

1. Karyn Bischoff , D .V.M. | Cornell University

2. Asa Brad man
, Ph.D. | University of California, Berkeley

3. C. Scott Clark , Ph.D., CIH | University of Cincinnati (Emeritus)

4. Gary Diamond , Ph.D. | Syracuse Research Corporation

5. David Dorman , D.V.M., Ph.D. | North Carolina State University

6. Phillipe Glorennec , Ph.D. | EHESP School of Public Health, France

7. Wendy Heiger

- Bernays , Ph.D. | Boston University

8. David Jacobs , Ph.D., CIH | Nation Center for Health Housing/University of Illino is

9. Bruce Lanphear , M.D., M.P.H. | Simon Fraser University

10. Patricia McLaine , Dr.Ph., M.P.H., R.N. | University of Maryland

11. Paul Mushak , Ph.D. | PB Associates

12. Richard Rabin , M.S. | Massachusetts Coalition for Occupational Safety and Health

13. Andrew Rooney

, Ph.D. | National Institute of Environmental Health Sciences

14. Anne Steenhout , Ph.D. | Unive rsité Libre de Bruxelles, Belgium

3Draft Peer Reviewer Selection Report for the External Peer Review of EPA’s Technical Approach Document Approach for Estimating Exposures and I ncremental Health Effects from Lead due to Renovation, Repair, and Painting Activities in Public and Commercial Buildings

15. Richard Troast , Ph.D. | Troast Environmental Consulting, LLC

16. David Vearrier

, M.D., M.P.H. | Drexel University

17. Jennifer Vogel , B.S. | Georgia Environmental Protection Division

18. Kathleen Vork , Ph.D., M.P.H. | California Environmental Protection Agency

I.2 Experts Identified by Versar

Versar conducted an independent search for scientific experts to augment the list of publicly

nominated candidates. The se experts were identified through search ing scientific journa ls, professional societies, scientif ic meetings and Versar’s database of expert scientists and engineers . As a result of this search, Versar identified and contacted a total of 45 potential scientific experts. Of the 45 experts contacted, Versar received 1 9 positive responses expressing interest and availability to participate in the December 2014 or January 2015 timeframe

. The remaining 2 7 candidates were either not available du ring the peer review timeframe or did not respond to our invitation. Interested candidates provided the same information as the publicly

nominated experts, which included their name, contact information, CV containing their education, employment history, a rea(s) of expertise, and research activities, as well as recent service on advisory commi ttees, publications, and awards

. The names and affiliations of the 1 9

interested and available Versar

- identif i ed individuals are provided below:

1. Deborah Cory

- Slechta

, Ph.D. | University of Rochester

2. Panos Georgopoulos , Ph.D. | Rutgers University

3. Phillip Goodrum , Ph.D. | Integral Consulting, Inc.

4. Dale Hattis , Ph.D. | Clark University

5. Andrew Hunt , Ph.D. | University of Texas, Arlington

6. Naila Khalil , Ph.D., M.B.B.S, M.P.H

. | Wright State University

7. Andy Menke , Ph.D., M.P.H. | Social & Scientific Systems , Inc.

8. William Menrath , M.S. | Great Lakes Regional OSHA Center

9. Howard Mielke , Ph.D. | Tulane University

10. Sheryl Milz , Ph.D. | University of Toledo

11. Barbara Peterse n , Ph.D., M.P.H. | Exponent

12. Rosalind Schoof , Ph.D. | ENVIRON

13. Joel Schwartz , Ph.D., M.D. | Harvard University

14. Kyle Steenland , Ph.D. | Emory University

15. Kenneth Unice , M.S. | Ca r dno ChemRisk

16. Ian von Lindern , Ph.D., PE | Terra Graphics Environmental Engineering, Inc.

17. C lifford Weisel , Ph.D. | Rutgers University

4Draft Peer Reviewer Selection Report for the External Peer Review of EPA’s Technical Approach Document Approach for Estimating Exposures and I ncremental Health Effects from Lead due to Renovation, Repair, and Painting Activities in Public and Commercial Buildings

18. Charles Wilkes , Ph.D. | Versar, Inc.

19. Stephanie Yendell , D.V.M. | Minnesota Department of Health

II Conflict of Interest Screening Process

Versar initiated COI screening on 31 ( 1 2 publicly

- nominated and 1 9 Versar

- identified ) experts to

ensure that the experts had no COI or appearance of the lack of impartiality. The screening was

conducted in accordance with EPA guidance ( see Section V ) and involved each expert completing a screening questionnaire with 18 questions to determine if they were involved with any other work and/or organizations that might create a real or perceived COI for the current

task. The COI questionnaire provided to the candidates is included in Appendix A

. Additionally,

each expert was requested to sign a form certifying that, to the best of their knowledge, they did not have any COI related to this peer review

, and that they were not arranging any new professional relationship with, or obtaining any new financial holdings in, an entity that could be viewed as related to the topic

. Versar also conduct ed an internet search to determine if the

candidate s had previously made any publi c statements related to this peer review topic or participated in any other activities that may be considered a COI or indicate the appearance of

the lack of impartiality

. More detail regarding the review of information collected during the COI screening p rocess is included in Section III.2.

III Selection of Candidates on Proposed List

Versar was charged with selecting 12 to 1 5 candidates for a proposed list of potential reviewers, with the intent of selecting 10 to 12 final reviewers from this list. For each candidate, the

se le ction process involved evaluation of credentials, COI, and availability, in accordance with

the June 27, 2014 Federal Register Notice ( http://www.gpo.gov /fdsys/pkg/FR

- 2014

- 06

- 27/pdf/2014

- 15123.pdf ).

III.1 Credential Evaluation

The first step in the selection process was to evaluate each candidate’s credentials based on their scientific and technical expertise in the following key areas: (1) epidemiology, (2) m ultimedia routes of human exposure to lead ; (3) m odeling of multimedia human exposures ; (4) l ead exposure pathway assessment; (5) l ead uptake/absorption ; (6) i nternal biokinetic distribution and physiological effects of lead; (7) t issue concentrations of lead ; (8) h um an growth and activity patterns; (9) e xposure assessment modeling ; (10) l ead

- induced health effects ; and (11) risk assessment and uncertainty characterization

. To facil itate evaluation of credentials , a rating

system was deve loped by Versar to allow compari son of the relative strength of candidates’ experience within a discipline/ area of expertise. The rating system consisted of three graphic symbol s, which are shown in Table 1

. The solid black circle is considered the highest possible rating, the half

- filled circle represents the next lower rating, and the empty circle is considered the lowest rating. A rating was not assigned if a candidate did not possess experience in the specific area of expertise being evaluated

. The tabl e in Appendix C shows the ratings assigned for each of the 15 proposed candidate reviewers in the categories listed above.

5Draft Peer Reviewer Selection Report for the External Peer Review of EPA’s Technical Approach Document Approach for Estimating Exposures and I ncremental Health Effects from Lead due to Renovation, Repair, and Painting Activities in Public and Commercial Buildings

A Versar staff member w as assigned to review each candid ate’s CV and list of publications in

order to designate a rating for each category based on their qualifications in the disciplines/ areas of expertise

. Upon completion of this initial review, a secondary review of the information was conducted by another Versar staff member.

Table 1

. Versar Ratings Assigned to Candidates Based on their Qualifications

Symbol Definition



#  This symbol was used to indicate that a candidate had performed work and/or research in a key area that was directly relevant to the disciplines/areas of expertise as well as t he chemical of concern (i.e.,

lead ). Out of the three symbols, t his i s considered the highest possible rating.



# ◒ This symbol was used to indicate that a candidate had performed work and/or research in a key area, some of which was relevant to th e disciplines/areas of expertise

. However, t he candidate did not have

direct or extensive experience with lead

. Therefore, this symbol was used to represent a lower rating than the symbol above.



##  This symbol was used to indicate that some of the candidate’s work and/or research was in a key area,

but that it was less relevant to the disciplines/areas of expertise . The candidate also did not have direct

or extensive experience with lead

. Therefore, this symbol i s considered the lowest rating.

III.2 COI Information Evaluation

Following the review of each candidate’s qualifications, Versar staff review ed the professional and financial information collected during the COI screening process. This involved reviewing the responses to the COI questionnaire

, as well as the results of the internet search conducted on

the candidates regarding publications or statemen ts that might indicate the appearance of the lack of impartiality . Versar staff also verified that the candidates signed the form provided during the

COI screening process. A letter certifying that the 15 proposed candidate reviewers adequately passed the COI evaluation process and that Versar has found no significant evidence to trigger a COI finding for any of the proposed candidate reviewers listed in Section III.3, below is included in Appendix B of this report.

In addition to the COI screening that h as been completed, Versar will also obtain updated COI information from the peer reviewers one week prior to the initial peer review conference call, two weeks prior to the in

- person meeting, and at the start of the meeting, to confirm that the

individuals are still eligible to serve as peer reviewers.

III.3 Compilation of Results

Once evaluation of the 31 candidate s’ scientific credentials and COI information was completed

, results were compiled and recorded in a table to document the evaluation process ( provided in Appendix C ) . The table includes the names of the candidates along with their affiliation, education information, and ratings assigned for each discipline/ area of expertise. Comments on the candidates’ qualifications and COI status w ere summar ized and included in the table to assist the Versar team in narrowing the proposed list to 15 candidates.

6Draft Peer Reviewer Selection Report for the External Peer Review of EPA’s Technical Approach Document Approach for Estimating Exposures and I ncremental Health Effects from Lead due to Renovation, Repair, and Painting Activities in Public and Commercial Buildings

Based on Versar’s review of the responses received during the COI process, 16 of t he 31

candidates were eliminated from further consideration due to the availability of stronger candidates in the required areas of expertise or potential COI

. Information on candidates’ expertise and potential COI can be found in Appendix C

. T he remaining 1 5 candidates were evaluated using the selection criteria and rati ng system developed for this peer review. After

careful consideration and discussions on the candidates ’ credentia ls

, Versar selected all 15 qualified candidates for the draft proposed list of candidate reviewers. These experts cover ed the areas of expertise desired, were generally available to attend the public peer review meeting in the December or January timeframe

, provided a balance of perspectives, and had no real or apparent COI related to this peer review or the appearance of th e lack of impartiality

.

Once the evaluation of experts was complete, Versar provided to EP A the proposed list of 15 candidate reviewers, along with their b iographical sketches (Appendix D)

. The draft list of proposed reviewers is as follows:

1. Deborah Cory

- Slechta , Ph.D. | University of Rochester

2. Panos Georgopoulos , Ph.D. | Rutgers University

3. Phillip Goodrum , Ph.D. | Integral Consulting, Inc.

4. Dale Hattis , Ph.D. | Clark University

5. Andrew Hunt , Ph.D. | University of Texas, Arlington

6. Naila Khalil , Ph.D., M .B.B.S., M.P.H. | Wright State University

7. Andy Menke , Ph.D., M.P.H. | Social & Scientific Systems, Inc.

8. Howard Mielke , Ph.D. | Tulane University

9. Paul Mushak , Ph.D. | PB Associates

10. Rosalind Schoof , Ph.D. | ENVIRON

11. Joel Schwartz , Ph.D., M.D. | Harvard University

12. Anne Steenhout , Ph.D. | Université Libre de B r uxelles

13. Kenneth Unice , M.S. | Cardno ChemRisk

14. Ian von Lindern , Ph.D., PE | Terra Graphics Environmental Engineering, Inc.

15. Kathleen Vork , Ph.D. , M.P.H. | California Environmental Protection Agency

I V Selection of Final 10 to 12 Peer Reviewers

A Federal Register notice to be published in late

- September will invite the public to submit comments on the proposed list of peer reviewers for Versar ’s consideration prior to sele ction of

the final reviewers. Along with consideration of the public comments, Versar will re

- evaluate

each proposed candidate’s credentials to select the 10 to 12 expert s who, collectively, best cover the areas of expertise needed f or this peer review, have no rea l or apparent COI or appearance of

7Draft Peer Reviewer Selection Report for the External Peer Review of EPA’s Technical Approach Document Approach for Estimating Exposures and I ncremental Health Effects from Lead due to Renovation, Repair, and Painting Activities in Public and Commercial Buildings

the lack of impartiality , and who are available to attend a two

- day meeting in the Washington

DC area in the December 2014 to January 2015 timeframe

.

V EPA Guidance Materials Used for the Peer Review Selection Process

All activities conducted during the peer review selection process were in compliance with the following peer r evie w and conflict of i nterest guidance documents , as specified in Task Order

2013

- 06 , under EPA Contract No. EP

- C

- 13

- 010

.

• Conflicts of Interest Review Process for Contractor

- Managed Peer Reviews of EPA

HISA and ISI Documents (March 13, 2013). Memo from EPA Science and Technology Policy Council, available at http://www.epa. gov/osa/pdfs/epa

- process

- for

- contractor.pdf

.

• EPA Peer Review Handbook : Third Edition ( http://www.epa.gov/peerreview/pdfs/peer_review_handbook_2012.pdf )

• December 2009 Addendum to the EPA Peer Review Handbook ( http://www.epa.gov/peerreview/pdfs/spc_peer_rvw_handbook_addendum.pdf )

• EPA COI S creening Q uesti onnaire template provided in the contract

8Draft Peer Reviewer Selection Report for the External Peer Review of EPA’s Technical Approach Document Approach for Estimating Exposures and I ncremental Health Effects from Lead due to Renovation, Repair, and Painting Activities in Public and Commercial Buildings

Appendix A

Conflict of Interest (COI) Screening QuestionnaireDraft Peer Reviewer Selection Report for the External Peer Review of EPA’s Technical Approach Document Approach for Estimating Exposures and I ncremental Health Effects from Lead due to Renovation, Repair, and Painting Activities in Public and Commercial Buildings

Conflict of Interest Screening Questions

1. To the best of your knowledge and belief, is there any connection between the document, Approach for Estimating Exposures and Incremental Health Effects from Lead due to Renovation, Repair, and
Painting Activities in Public and Commercial Buildings, and any of your and/or your spouse's
compensated or uncompensated employment, including government service, during the past 24

months? ___Yes* ___No

*If yes, please describe.

2. To the best of your knowledge and belief, is there any connection between the document, Approach for Estimating Exposures and Incremental Health Effects from Lead due to Renovation, Repair, and
Painting Activities in Public and Commercial Buildings, and any of your and/or your spouse's research
support and project funding, incl uding from any government, during the past 24 months? ___Yes* ___No

*If yes, please describe.

3. To the best of your knowledge and belief, is there any connection between the document, Approach for Estimating Exposures and Incremental Health Effects from Lead due to Renovation, Repair, and
Painting Activities in Public and Commercial Buildings, and any consulting by you and/or your spouse,
during the past 24 months? ___Yes* ___No

*If yes, please describe.

4. To the best of your knowledge and belie f, is there any connection between the document, Approach for Estimating Exposures and Incremental Health Effects from Lead due to Renovation, Repair, and
Painting Activities in Public and Commercial Buildings, and any expert witness activity by you and/or
your spouse, during the past 24 months? ___Yes* ___No

*If yes, please describe.

5. To the best of your knowledge and belief, have you, your spouse, or dependent child held, in the past 24 months, any financial holdings (excluding well diversified mutu al funds and holdings with a value less than $15,000) with any connection to the document, Approach for Estimating Exposures and Incremental Health Effects from Lead due to Renovation, Repair, and Painting Activities in Public and
Commercial Buildings ?

__ _Yes* ___No

*If yes, please describe.

6. Have you made any public statements or taken positions on or closely related to the document, Approach for Estimating Exposures and Incremental Health Effects from Lead due to Renovation, Repair,
and Painting Act ivities in Public and Commercial Buildings ? ___Yes* ___No

A

- 1Draft Peer Reviewer Selection Report for the External Peer Review of EPA’s Technical Approach Document Approach for Estimating Exposures and I ncremental Health Effects from Lead due to Renovation, Repair, and Painting Activities in Public and Commercial Buildings

*If yes, please describe.

7. Have you had previous involvement with the development of EPA’s Approach for Estimating Exposures and Incremental Health Effects from Lead due to Renovation, Repair, and Painting Activities in Public and Commercial Buildings you have been asked to review? ___Yes* ___No

*If yes, please describe.

8. To the best of your knowledge and belief, is there any other information that might reasonably raise a
question about an actual or potential personal conflict of interest or bias? ___Yes* ___No

*If yes, please describe.

9. To the best of your knowledge and belief, is there any financial benefit that might be gained by you or your spouse as a result of the outcome of this review? ___Yes* ___No

*If yes, please describe.

Supplemental Information for Conflict of Interest Screening

EPA has developed enhanced COI requirements that require Versar to obtain relevant information from individuals who are selected to serve as a peer reviewer of Highly Influential Scientific Assessments (HISA) or Influential Scientific Informatio n (ISI). The information collected, with respect to you, your
spouse, and dependent child, will be held in confidence and will only be used to determine if a COI exists. Please provide the following information (a response must be entered for each item):

1 0

. Compensated and uncompensated employment (for panel member and spouse): list sources of compensated and uncompensated employment, including government service, for the preceding two years, including a brief description of the work.

1 1 . Research Fundin g (for panel member): list sources of research support and project funding, including from any government, for the preceding 24 months for which the panel member served as the Principal Investigator, Significant Collaborator, Project Manager, or Director. For panel member's spouse, provide a general description of research and project activities in the preceding two years.

1 2

. Consulting (for panel member): list sources of compensated consulting activities during the preceding two years, including names of clients, if compensation provided 15% or more of your annual compensation. For panel member's spouse, provide a general description of consulting activiti es for the
preceding two years.

13

. Expert witness activities (for panel member): list sources of compensated expert witness activities and a brief description of each issue and testimony [during the preceding 24 months.] For panel
member's spouse, provid e a general description of expert testimony provided in the preceding two

years.

A

- 2Draft Peer Reviewer Selection Report for the External Peer Review of EPA’s Technical Approach Document Approach for Estimating Exposures and I ncremental Health Effects from Lead due to Renovation, Repair, and Painting Activities in Public and Commercial Buildings

14. Assets: Stocks, Bonds, Real Estate, Business, Patents, Trademarks, and Royalties (for panel member, spouse, and dependent children): list specific financial holdings that collectively had a fair market value greater than $15,000 at any time during the preceding 24

- month period (excluding well diversified mutual funds, money market funds, treasury bonds, and personal residence).

1 5

. Liabilities (for panel member, spouse, an d dependent children): list liabilities over $10,000 owed at
any time in the preceding twelve months (excluding a mortgage on personal residence, home equity loans, automobile and consumer loans).

16. Public Statements: provide a brief description of any public statement made and/or positions taken
on or closely related to the matter under review by the panel member.

1 7

. Involvement with document under review: provide a brief description of any previous involvement of the panel member in the development of the document (or review materials) the individual has been

asked to review.

1 8

. Other potentially relevant information: provide a brief description of any other information not
mentioned above that might reasonably raise a question about an actual or perceived bias, lack of impartiality, or personal conflict of interest including, but not limited to, associatio n with any groups,
companies, local governments, or state governments that have previously made a public statement, taken a position (for or against) on issues, or participated in litigation related to lead

- based paint

hazards.

A

- 3Draft Peer Reviewer Selection Report for the External Peer Review of EPA’s Technical Approach Document Approach for Estimating Exposures and I ncremental Health Effects from Lead due to Renovation, Repair, and Painting Activities in Public and Commercial Buildings

Appendix B

COI Certification Letter to EPACOI CERTIFICATION LETTER TO EPA

Date: September 3, 2014

To: Ernest Falke, Stan Barone, Mark Cranley

RE: Contractor ’ s COI Certification Letter to EPA

From: David Bottimore
Versar, Inc. Subj ect: Selection of Peer Review Panelists for the External Peer Review of EPA’s Technical Approach Document Approach for Estimating Exposures and Incremental Health Effects from Lead due to Renovation, Repair, and Painting Activities in Public and Commercial Buildings , under TO 39, Contract EP

- C

- 12

- 045

Prior to potentially entering into any arrangement with a peer revie wer, Versar has conducted a thorough evaluation to determine if the candidate reviewers pose a conflict of interest or an appearance of a lack of impartiality. Each candidate peer reviewer has provided answers to all questions of conflict of interest to date and all written information that Versar collected shall be retained

in Versar ’ s files including an explanation of the s uitability and rationale for including or excluding each final proposed panelist. In addition to the collection of written information, Versar staff have conducted Internet searches for public comments made by

each candidate reviewer.

With this letter, V ersar concludes and certifies that all pro posed peer review panelists have adequately passed the COI evaluation process signifying that, i n Versar ’ s judgement, there is no significant evidence to trigger a COI finding for any of the proposed panel members listed below. Versar shall select and enlist the services of reviewers from the list of proposed panelists below.

Through Versar ’ s continuing obligation to identify and report any actual or potential conflict of interest or an appearance of a lack of impartiality, Versar ’ s files will document the results of each panelist’s recertification. If any actual or potential conflict of

inte rest or appearance of a lack of impartiality is found, disclosure shall be made to the EPA.

Proposed Candidate Panel Members:

1. Deborah A. Cory

- Slechta , Ph.D. University of Rochester School of Medicine and Dentistry 9

. Paul Mushak, Ph.D.

PB Associates

2. Panos G. Georgopoulos, Ph.D. Rutgers University

– Robert Wood Johnson Medical School, Environmental and Occupational Health Sciences Institute (EOHSI) 10

. Rosalind A. Schoof, Ph.D., DABT ENVIRON Corporation

3. Philip E. Goodrum, Ph.D. Integral Consulting Inc. 11 . Joel Schwartz, Ph.D., M.D.

Harvard School of Public Health

4. Dale Hattis, Ph.D. George Perkins Marsh Institute, Clark University 12

. Anne Steenhout, Ph.D.

Université Libre de Bruxelles 5. Andrew Hunt, Ph.D. University of Texas at Arlington 13. Kenneth M. Unice, MS

Cardno ChemRisk

6. Naila Khalil, M.B.B.S., MPH., Ph.D. Center for Global Health Boonshoft School of Medicine, Wright State University 14. Ian H. von Lindern, Ph.D., PE TerraGraphics Environmental Engineering, Inc

.

7. Andy Menke, MPH, Ph.D. Social & Scientific Systems, Inc. 15. Kathleen L. Vork, MPH, Ph.D. California Environmental Protection Agency, Office of Environmental Health Hazard Assessment (OEHHA) 8. Howard W. Mielke, Ph.D. Tulane University School of Medicine

________________________________ ________________________Date: September 3, 2014 (Contractor Official Signature)

David Bottimore, Director

_______________________________________________________________________ (Print Contractor Name and Title)

B

- 1This written certification has been

has certified that

(Print COR Name)

'A Peer Review Signature) 

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Peer Review By signing this letter EPA acknowledges that the contractor

of a lack of impartiality, or all conflicts of interest

EPA Peer Review Record.



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B-2 have been rep6ed. A ofDraft Peer Reviewer Selection Report for the External Peer Review of EPA’s Technical Approach Document Approach for Estimating Exposures and I ncremental Health Effects from Lead due to Renovation, Repair, and Painting Activities in Public and Commercial Buildings

Appendix C

Information on the Candidate ReviewersKey:Work/research includes this area, less relevant to topic and leadN= Publicly-nominated Candidates◒Work/research in this area & some relevant to topic, but not directly to leadV= Versar-identified CandidatesWork/research in this area & directly relevant to topic and leadNo. Name Affiliation Education/CertifcationsCandidateType Epidemiology Exposure Routes Exposure Modeling (Uptake/Absorption) Exposure Modeling (Ambient/Indoor) Air and/or Soil Exposure Pathways Uptake/Absorption Biokinetic Distribution / Physiological Effects Tissue Concentrations Human Growth / Activity Patterns Lead-induced Health Effects Risk Assessment / Uncertainty CharacterizationComments on Qualifications Comments on COIProposed List of Candidate Reviewers1 Deborah Cory-Slechta University of RochesterPh.D., ExperimentalPsychology/Pharmacology (1977)V ◒Served on CASAC for lead and has served as chair ofseveral scientific committees/panels. Has more than 30years of work on the impact of lead on learning andattention and associated neurochemical mechanismshas participated in numerous national and internationalcommittees/review panel/workshops on lead.2 Panos Georgopoulos Rutgers UniversityPh.D., Chemical Engineering(1986)V◒◒◒◒◒◒◒ ◒◒◒Expertise in areas of exposure and PBPK, mathematicalmodeling, computational toxicology, and human healthrisk assessment. Research includes development ofcomputational models of toxicokinetic andtoxicodynamic processes at the cellular, tissue andwhole body levels.3 Phillip Goodrum Independent ConsultantPh.D., EnvironmentalEngineering (1999)VStrong Pb risk assessor with expertise in exposuremodeling and probabalistic uncertainty analysis. Hasserved on SAB and CASAC for lead.4 Dale Hattis Clark University Ph.D., Genetics (1974) V ◒Pb expertise related to occupational exposure. Hasexperience with risk assessment/PBPK. His work hasfocused on the development of methodology toincorporate interindividual variability data andquantitative mechanistic information into riskassessments for both cancer and non-cancer endpoints.5 Andrew HuntUniversity of Texas,ArlingtonPh.D., Mineral Magnetism (1988) V Expertise in evaluating exposure to lead; lead in dustand soil resulting from renovations. Some experiencewith bioavailability of lead. Knowledge of health effects.6 Naila Khalil Wright State UniversityPh.D., EnvironmentalEpidemiology (2007), M.B.B.S.,M.P.H.V Epidemiologist who has studied the relationshipbetween lead exposure and skeletal changes in oldermen and women, as well as mortality, andneurocognitive function.7 Andy MenkeSocial & ScientificSystems, Inc.Ph.D., Epidemiology (2010),M.P.H.,V◒◒Epidemiologist with lead-specific experience, as well asexpertise in statistical methods. Has examined bloodlead levels as related to cardiovascular mortality.8 Howard Mielke Tulane University Ph.D., Geography (1972) V  Expertise in characterizing lead exposure and theeffects of lead exposure on human populations.9 Paul Mushak PB AssociatesPh.D. Metalloorganic/OrganicChemistry and Biochemistry(1970)N◒Expertise in lead toxicity. Has studied lead andpregnancy/childhood development; lead in bone, blood,brain, neurotoxicological effects of lead, modelingimpacts of lead on human populations10 Rosalind Schoof Environ Ph.D., Toxicology (1982), DABT V  Risk assessor with expertise in measurement of bloodlead levels associated with abatement; lead exposure;collection of dust, soil, drinking water, slag samples forlead analysis; knowledge of health effects &bioavailability of lead.TO 39 - Information on Candidates for Peer Review ofEPA's Technical Approach Document on Lead-based Paint HazardsSeptember 3, 2014C-1Key:Work/research includes this area, less relevant to topic and leadN= Publicly-nominated Candidates◒Work/research in this area & some relevant to topic, but not directly to leadV= Versar-identified CandidatesWork/research in this area & directly relevant to topic and leadNo. Name Affiliation Education/CertifcationsCandidateType Epidemiology Exposure Routes Exposure Modeling (Uptake/Absorption) Exposure Modeling (Ambient/Indoor) Air and/or Soil Exposure Pathways Uptake/Absorption Biokinetic Distribution / Physiological Effects Tissue Concentrations Human Growth / Activity Patterns Lead-induced Health Effects Risk Assessment / Uncertainty CharacterizationComments on Qualifications Comments on COITO 39 - Information on Candidates for Peer Review ofEPA's Technical Approach Document on Lead-based Paint HazardsSeptember 3, 201411 Joel Schwartz Harvard UniversityPh.D., Theoretical Physics(1980), M.D. (2010)V  ◒Lead epidemiologist with health effects/modelingexpertise. Has served on EPA’s SAB Ad Hoc All AgesLead Committee, EPA’s Lead CASAC, and the NASCommittee on Assessing Lead Exposure in CriticalPopulations.12 Anne SteenhoutUniversité Libre deBruxellesPh.D., Ecotoxicology (1986) N  Expertise in environmental epidemiology,toxicokinetics/dynamics. Has studied accumulation of Pbin hard tissues (bone, teeth), developed a leadbiokinetic model (all-age) and exposure model (allsources).13 Ken Unice Cardno ChemRiskM.S., Environmental Engineering(1998)V◒ ◒◒◒◒◒◒◒◒Fifteen years experience of quantitative human healthrisk with expertise in areas of environmental modeling,biokinetic modeling, indoor air modeling, occupationalexposure assessment, human health risk assessment,and environmental fate and transport analysis.14 Ian von LindernTerraGraphicsEnvironmentalEngineering, Inc.Ph.D., Environmental Scienceand Engineering (1980), PEV  Has served on several SAB panels and CASAC panelrelated to lead. Strong experience in lead related riskassessment and exposure.15 Kathleen Vork CalEPAPh.D., Environmental HealthSciences (2003), M.P.H.N◒ ◒Has knowledge of health effects related to lead,exposure from lead-based paint abatement/construction,using PBPK to determine air/blood lead relationships,and blood lead monitoring.Not Best Qualified or Potential COI16 Karyn Bischoff Cornell University D.V.M. (1995) NVeterinary Toxicologist. Lead poisoning in livestockincluding from improper remediation of lead paint onfarm buildings and improper feed storage. Food-chainexposure.17 David DormanNorth Carolina StateUniversityPh.D., VeterinaryBiosciences/Toxicology (1990)NToxicologist with publications on pharmacokinetic andneurotoxicology of metals. Served as chairman of theNRC Committee on Potential Health Risks fromRecurrent Lead Exposure to DOD Firing RangePersonnel.18 Phillipe GlorennecEHESP School of PublicHealthPh.D., Université de Rennes 1(2006)NRisk assessor with expertise in exposure of children tolead.19 Wendy Heiger-Bernays Boston University Ph.D., Biochemistry (1987) NExpertise in risk assessment with some lead specificwork. Not as strong as other available candidates.20 William MenrathGreat Lakes OSHAEducaton CenterM.S., Population Biology (1975) VExcellent practical experience dealing with lead,however, does not have the specific types of expertiselisted in the PWS.21 Sheryl Milz University of ToledoPh.D., Public HealthServices/Industrial Hygiene(1994)VExpertise in exposure modeling, indoor air quality, andepidemiology, expertise not as broad (relative to PWScategories) as other candidates.C-2Key:Work/research includes this area, less relevant to topic and leadN= Publicly-nominated Candidates◒Work/research in this area & some relevant to topic, but not directly to leadV= Versar-identified CandidatesWork/research in this area & directly relevant to topic and leadNo. Name Affiliation Education/CertifcationsCandidateType Epidemiology Exposure Routes Exposure Modeling (Uptake/Absorption) Exposure Modeling (Ambient/Indoor) Air and/or Soil Exposure Pathways Uptake/Absorption Biokinetic Distribution / Physiological Effects Tissue Concentrations Human Growth / Activity Patterns Lead-induced Health Effects Risk Assessment / Uncertainty CharacterizationComments on Qualifications Comments on COITO 39 - Information on Candidates for Peer Review ofEPA's Technical Approach Document on Lead-based Paint HazardsSeptember 3, 201422 Barbara Petersen ExponentPh.D., Biochemistry (1976),M.P.H.VDoes not have specific types of expertise listed in PWS.23 Richard Rabin MassCOSHM.S., Public HealthAdministration (1983)NExcellent practical experience dealing with lead,however, does not have the specific types of expertiselisted in the PWS.24 Andrew RooneyNational ToxicologyProgram/NIEHSPh.D., Zoology (1998) NProject lead for NTP Monograph on Health Effects onLow- level Lead, which along with EPA's ISA on Lead,was used as resource by CDC and CalEPA for settingreduced lead levels.Over 20 years of experience intoxicology and human health risk assessment.25 Kyle Steenland Emory University Ph.D., Epidemiology (1985) VEpidemiologist. Expertise not as broad in PWScategories as other candidates.26 Richard TroastTroast EnvironmentalConsulting, LLCPh.D., Environmental Scienceand Public Policy (2006)NDuring tenure at EPA served as Chair of TechnicalWorkgroup for Lead. Managed development of IEUBKmodel. Preparation of guidance documents on lead.Chaired numberous conferences and public meetings.27 David Vearrier Drexel University M.D. (2005), M.P.H. (2013) NClinical effects of lead in > 80 years of age, especiallybone lead concentrations. Limited expertise in notedareas.28 Jennifer VogelGeorgia EnvironmentalProtection DivisionB.S., Industrial Engineering(2001)NPractical experience with lead and lead-based paint(manages the GDEP's lead-based paint program).Expertise does not fit areas specified in PWS.29 Stephanie YendellMinnesota Departmentof HealthD.V.M. (2011) VPrincipal epidemiologist for the MN Lead and HealthyHomes Program.30 Cliff Weisel Rutgers UniversityPh.D., Chemical Oceanography(1981)VExpertise in multiple exposure routes.31 Charles Wilkes Versar, Inc.Ph.D., Civil and EnvironmentalEngineering (1994)VEngineer with more than 15 years of experience indeveloping and implementing mass-balance models toestimate indoor-air pollutant concentrations andsubsequent human exposures resulting from numeroussources.Perceived conflict of interest as anemployee of Versar.C-3Draft Peer Reviewer Selection Report for the External Peer Review of EPA’s Technical Approach Document Approach for Estimating Exposures and I ncremental Health Effects from Lead due to Renovation, Repair, and Painting Activities in Public and Commercial Buildings

Appendix D Biosketches of the Proposed Candidate ReviewersD-1 DRAFT

Deborah A. Cory-Slechta, Ph.D. , University of Rochester School of Medicine and Dentistry

i. Education: University of Minnesota, Ph.D. in Experimental Psychology (1977)

ii. Professional Experience: Dr. Cory-Slechta is a Professor in the Department of Environmental Medicine and the Department of Pediatrics at the University of Rochester School of Medicine and Dentistry, where she also serves as co-directo r of the Behavioral Sciences Facility Core and director of the Animal Behavior Core. Dr. Cory -Slechta received her Ph .D. from the University of Minnesota in 1977 and worked as a junior staff fellow of the National Center for Toxicological Research beginning in 1979. She was appointed to the faculty of the University of Rochester Medical School in 1982 and was appointed Chair of the Department of Environmental

Medicine and Director of the NIEHS Environmental Health Sciences Center at the University of Rochester in 1998. From 2000 to 2002, she was the D ean for Research and Director of the AAB Institute for Biomedical Sciences. Following her appointment as Dean, she concurrently served until 2007 as the Chair of the Department of Environmental and Occupational Medicine at

Robert Wood Johnson Medical School and as Di rector of the Environm ental and Occupational Health Sciences Institute, a joint Institute of the Robert Wood Johnson Medical School and Rutgers. Dr. Cory-Slechta’s research has fo cused largely on environmental neurotoxicants as

risk factors for behavioral disorders and neur odegenerative disease. Specifically, this has included more than 30 years of work on the im pact of lead on lear ning and attention and associated neurochemical mechanisms, and th e participation in numerous national and international committees/review panel/workshops on lead. These research efforts have resulted in over 170 papers and book chapters to date. Dr. Cory-Slechta has served on and chaired numerous national research review and advisory panels, including committees of the National Institutes of Health, the National Institute of Environmental Health Sciences, the Food and Drug Administration, the National Center for Toxicolo gical Research, the Environmental Protection Agency Science Advisory Board, the National Acad emy of Sciences, the Institute of Medicine, and the Agency for Toxic Substances and Dis ease Registry, Centers for Disease Control and Prevention. In addition, Dr. Cory-Slechta has served on the editorial boards of several journals including Environmental Health Perspectives

, Neurotoxicology

, Toxicology

, Toxicological

Sciences

, Fundamental and Applied Toxicology

, Neurotoxicology and Teratology , and American Journal of Mental Retardation . She has held the elected pos itions of President of the Neurotoxicology Specialty Section of the Societ y of Toxicology, President of the Behavioral Toxicology Society, and been named a Fellow of the American Psychological Association.D-2 DRAFT

Panos G. Georgopoulos, Ph.D., Rutgers University – Robert Wood Johnson Medical School, Environmental and Occupational He alth Sciences Institute (EOHSI)

i. Education: California Institute of Technology, Ph.D. in Chemi cal Engineering (1986)

ii. Professional Experience: Dr. Georgopoulos is Professor of Environmental and Occupational Medicine at Rutgers University – Robert Wood J ohnson Medical School. He is also a member of

the Graduate Faculties of Chemical and Bioche mical Engineering, Biomed ical Engineering, and of Environmental Sciences at Rutgers Universi ty, and a member of the Rutgers Environmental and Occupational Health Sciences Institute (EOHSI). Dr. Georgopoulos received his Ph.D. in Chemical Engineering from the California Inst itute of Technology. At EOHSI, he established and directs the Computational Chemodynamics Laborat ory (CCL), a state-of-the-art facility for informatics and modeling of complex environmenta l and biological systems. Furthermore, he codirects the Center for Exposure and Risk Modeling (CERM) at EOHSI. Dr. Georgopoulos’ research areas involve the development and a pplication of mathematical and computational methods for diagnostic and mechanistic studies of multipathway physicochemical processes taking place in interacting environmental and biologi cal systems. The aim of this research is to improve the understanding and quantification of human exposure and biological mechanismbased dosimetry and risk for environmental toxics; this is being accomplished through the ongoing development of a consistent mechanistic multiscale modular co mputational framework for source-to-dose-to-effect modeling of toxicant dynamics. Outcomes of this research include integrative computational models of toxicokinetic and toxicodynamic processes at the cellular, tissue and whole body levels. Dr. Georgopoulos has published more than 125 peer-reviewed articles and chapters in scientific journals , books and proceedings, and has authored or coauthored several state and Federal government documents and numerous technical reports. He has served on editorial boards of scientific jour nals and currently serves as member of various

national and international scientific and t echnical committees on environmental issues.D-3 DRAFT

Philip E. Goodrum, Ph.D., Integral Consulting Inc.

i. Education: SUNY College of Environmental Science and Forestry, Ph.D. in Environmental Engineering (1999)

ii. Professional Experience: Dr. Goodrum is a Senior Managing Scientist at Integral Consulting

Inc. and a Senior Consultant at Cardno ENTRIX. He received his Ph.D. in Environmental Engineering from SUNY College of Environm ental Science and Forestry in 1999. Prior to joining Integral Consulting Inc. in 2013, Dr. Goodrum was employe d at Environmental Resources Management (ERM), ARCADIS-US, In c., and SRC, Inc. where he conducted and reviewed numerous quantitative risk assessments. Dr. Goodrum ha s 23 years of experience in quantitative risk assessment and environmental m odeling, specializing in applications to human health and ecological risk assessment, se diment remediation, groundwater compliance monitoring, and natural resource damage assessme nt. He is a recognized national expert in probabilistic modeling, quantitative uncertainty analysis, lead (Pb) risk assessment, and statistical methods. Dr. Goodrum served for appr oximately 10 years as a consultant for EPA’s Technical Review Workgroup for Lead, manage d EPA’s “Lead Hotline,” which assisted the public with applications of both the IEUBK mo del and the interim A dult Lead models, coauthored numerous platform presentations, tech nical white papers and guidance documents, and actively participated in the re search and development of EPA’ s All Ages Model for Lead. Dr. Goodrum served on EPA’s Science Advisory Boar d for lead and on EPA’s Clean Air Scientific Advisory Committee (CASAC) - Lead Review Pa nel. He is a member of the Interstate Technology and Regulatory Council (ITRC) wo rkgroup on Incremental Sampling Methodology and the Society for Environmental Toxicology and Chemistry.D-4 DRAFT

Dale Hattis, Ph.D., George Perkins Marsh In stitute, Clark University

i. Education: Stanford University, Ph.D. in Genetics (1974)

ii. Professional Experience: Dr. Hattis is a Research Profes sor with the Center for Technology Environment and Development (CENTED) of the George Perkins Marsh Institute at Clark University. He received his Ph.D. in Genetic s from Stanford University in 1974 and an undergraduate degree in Biochemistry from the Un iversity of California at Berkeley in 1967. For the past thirty years he has been engaged in the development and application of methodology to assess the health, ecological and economic impact s of regulatory actions, including those related to the occupational exposure to lead. His work has focused on the development of methodology to incorporate interindividual variability data an d quantitative mechanistic information into risk assessments for both cancer and non-cancer endp oints. Specific stud ies have included quantitative risk assessments, as sessment of reproductive effects, neurological effects, and chronic lung function impairment , four pharmacokinetic-based ri sk assessments for carcinogens, an analysis of uncertainties in physiologically based pharmacoki netic (PBPK) modeling and an analysis of differences among species in processes related to carcinogenesis . Recent research has also explored age-related differences in sensitiv ity to carcinogenesis and other effects. Major current research projects include PBPK modeling and mechanism-based dose response modeling of carcinogenic effects. Dr. Hattis has published more than 200 articles and chapters in scientific journals, books and proceedings. He is a member of the Environmental Health Committee of the EPA Science Advisory Board, and for several ye ars he has served as a member of the Food Quality Protection Act Science Review Board. He has also served as a member of the National Research Council Committee on Estimating the Hea lth-Risk-Reduction Benefits of Proposed Air Pollution Regulations. Dr. Hattis has been a coun cilor and is a Fellow of the Society for Risk Analysis, and serves on the edito rial board of its journal, Risk Analysis

.D-5 DRAFT

Andrew Hunt, Ph.D. , University of Texas at Arlington

i. Education: University of Liverpool, England, Ph.D. in Atmospheric Science (1988)

ii. Professional Experience: Dr. Hunt is on the faculty of the Department of Earth And Environmental Sciences at the University of Te xas at Arlington where he teaches courses in Human Health Risk Assessment/Probabilistic Risk Assessment, Global Environment and Human Health, and Toxicology. He previ ously was on the faculty of the Pathology Department of the State University of New York Health Science Ce nter in Syracuse, NY. (14 years) and held a position in environmental consulting for four years. For the past 25 years, Dr. Hunt’s research

has addressed health and environmental hazards in urban and indoor environments. He has

conducted a number of studies concerned with characterizing and apportioning the sources of lead in indoor dust, and with mapping the distribution of lead in dust across urban environments (funded by the U.K. Department of the Environm ent, EPA, HUD, and NSF). His work has also repeatedly focused on lead contamination of urba n soil. Dr. Hunt has also published in the areas of lung disease associated with inhaled par ticles, and pediatric as thma in relation to environmental exposures. Dr. Hunt has served on various committees and panels, including the Executive Board of the Society for Environmenta l Geochemistry and Health and EPA’s Science Advisory Board peer review of lead dust technical analyses. He has published more than 50 peerreviewed articles and chapters in scientific journals, books and proceedings. In addition, Dr.

Hunt has served on the editorial bo ards of several journals including Air & Water Borne

Diseases and Journal of Environmental Geochemistry and Health

.D-6 DRAFT

Naila Khalil, M.B.B.S., MPH., Ph.D., Center for Global Health Boonshoft School of Medicine, Wright State University

i. Education: University of Pittsburgh, Ph.D. in Environmental Epidemiology (2007); Quaid-e-Azam University, MPH in Public Health (2000); University of the Punjab, M.B.B.S. in Medicine and Surgery (e quivalent to MD) (1986)

ii. Professional Experience: Dr. Khalil is an Assistant Profe ssor in Community Health at Wright State University, Boonshoft School of Medicine , Center for Global Hea lth. She received her Ph.D. in Environmental Epidemiology from th e University of Pittsburgh in 2007. She is a physician and also holds an MPH from Pakist an. In Pakistan, Dr. Khalil was the national program manager for the National Institute of Envi ronmental Health, a collaborative effort with World Health Organization. Before joining the Cent er for Global Health as Assistant Professor, Dr. Khalil was a post-doctoral researcher at the Li fespan Health Research Center at Wright State University Boonshoft School of Medicine where her research focused on cardiovascular disease epidemiology. Dr. Khalil’s doctoral dissertation focused on multiple health outcomes associated with environmental lead exposures in older people. She is currently working on a project involving the association of blood lead concentration with fa lls and bone density in older men. Dr. Khalil has a number of peer-reviewed publications on lead exposure including the

association of blood lead levels with bone fr actures and mortality in older women and the association of occupational cumulative lead and neurocognitive function. Dr. Khalil is on the

editorial board and serves as a re viewer for journals such as the Journal of Family Medicine & Community Health and Environmental Health Perspectives . She is a member of the American Society of Bone and Mineral Research.D-7 DRAFT

Andy Menke, MPH, Ph.D., Social & Scientific Systems, Inc.

i. Education: Johns Hopkins University, Bloomberg School of Public Health, Ph.D. in Epidemiology (2010); Tulane University, School of Public Health and Tropical Medicine, MPH, (2005)

ii. Professional Experience: Dr. Menke is a Senior Research Analyst at Social & Scientific Systems, Inc. He received his Ph.D. in Epidemiology from Johns Hopkins University, Bloomberg School of Public Health in 2010 and his MPH from Tulane University, School of Public Health and Tropical Medicine in 2005. Pr ior to his position at Social & Scientific Systems, Inc., Dr. Menke was a research assistan t in the Department of Epidemiology and Welch Center for Prevention, Epidemiology and Clinical Research at the Johns Hopkins Bloomberg

School of Public Health. Dr. Me nke’s research experi ence includes the conduc t and analysis of epidemiologic studies, focusing on the epidemio logy of diabetes, sex steroid hormones, iron metabolism, and environmental exposure to he avy metals. Specific studies on lead and

associated blood lead levels in U.S. adults a nd cardiovascular mortalit y, stroke, and end-stage renal disease. Dr. Menke has published more th an 35 peer-reviewed journal articles and has made presentations at more than 15 scientific mee tings. He serves as a reviewer for journals such

as American Journal of Kidney Diseases; Americ an Journal of Preventive Medicine; Annals of Epidemiology; Cancer Epidemiology, Biomar kers & Prevention; Environmental Research; and Environmental Science and Technology. Dr. Menke is a member of the American Heart Association, the Society for Epidemiologic Rese arch, and the American Diabetes Association.D-8 DRAFT

Howard W. Mielke, Ph.D., Tulane University School of Medicine

i. Education: University of Michigan , Ph.D. in Geography (1972)

ii. Professional Experience: Dr. Mielke is a Professor in the Department of Pharmacology at the Tulane University School of Medi cine. He received his Ph.D. in Geography from the University of Michigan in 1972 and his undergraduate degree in biology, chemistry and geography from Macalester College in 1963. Prior to his current appointment at Tulane University, Dr. Mielke held a joint appointment in the Department of Chemistry and the Center for Bioenvironmental

Research at Tulane and Xavier Universities. Dr. Mielke began hi s urban geochemistry research

in 1971 and his research has focused on accumula ted environmental sources of lead and its

association with childhood lead poisoning in inner city environments. He has published numerous articles on the topic of exterior me tal accumulation in many cities including New Orleans where he conducted a multi-media study of metals in urban and rural areas. This study was followed by a pilot project wh ereby clean soils were brought in to reduce the potential for childhood exposure to lead and othe r toxins that had accumulated in the soil. Dr. Mielke also studied multiple metal contamination from house paints as a result of power sanding and paint scraping that changed the regulations for house painting in New Orleans. His research has influenced policy for the removal of lead from gasoline, and supported revised lead laws in New Orleans, Michigan, Canada, Mexico, Peru, the European Union, and Norway. Dr. Mielke has published more than 100 peer-reviewed articles a nd chapters in scientif ic journals, books and proceedings and has served on editorial boards of scientific journals. He served on EPA’s Science Advisory Board to conduct a consultatio n and peer review of EPA’s draft lead dust technical analyses. Dr. Mielke is a full member of the Society of Toxicology and a member of the board of the Society of Envir onmental Geochemistry and Health.D-9 DRAFT

Paul Mushak, Ph.D., PB Associates

i. Education: University of Florida, Ph.D. in Orga nometal and Biological Chemistry (1970)

ii. Professional Experience: Dr. Mushak is a Senior Partner at PB Associates where he is a Toxicologist and Human Health Risk Assessment Specialist, prin cipally working in the area of environmental lead and other metals, metalloids, and organometals. He received his Ph.D. in Organometal and Biological Chemis try from the University of Florida in 1970. Dr. Mushak also had extensive training and rese arch experience in metal and analytical toxicology in the Department of Pathology, University of Florid a School of Medicine. Hi s post-doctoral training was at the Yale University Department of Molecu lar Biophysics and Biochemistry in the area of biochemical toxicology and enzy mology of certain toxic and e ssential metals. Prior to his partnership at PB Associates, Dr . Mushak was a visiting professor at the Albert Einstein College of Medicine and a faculty member from 1971 to 1993 at the University of North Carolina - Chapel Hill School of Medicine, Pathology Departme nt. Dr. Mushak has more than 45 years of education, training, and experience in the areas of exposures and their determinants, analytical pediatric toxicology, toxicokinetics , modeling and health risk asse ssments. He was the author of the book, Lead and Public Health: Science, Risk and Regulation (2011), 180 research articles, conference abstracts, and book chapters, and ha s served on approximately50 expert advisory national and international committees including EP A’s Science Advisory Board Panel for the All Ages Lead Model and EPA’s Clean Air Scie ntific Advisory Comm ittee (CASAC) – Lead

Review Panel. Dr. Mushak has co-authored more than two dozen risk assessment documents for various Federal and international agencies on lead, arsenic, cadmium, mercury, etc. He has testified before Congressional committees on tw o occasions about childhood lead poisoning. Dr. Mushak has been qualified as an expert on lead and other metals risk assessment before six

Federal and six state courts. He is a member of the Society of Occupational and Environmental Health, the Society for Risk Analysis, and the Society of Toxicology, among others.D-10 DRAFT

Rosalind A. Schoof, Ph.D., DABT , ENVIRON Corporation

i. Education: University of Cincinnati , Ph.D. in Toxicology (1982)

ii. Professional Experience: Dr. Schoof is a Principal at ENVIRON where she is a board certified toxicologist (Diplomate of the Amer ican Board of Toxicology (DABT)). Prior to joining ENVIRON in 2010, she was a Principal and Senior Toxicologist at Integral Consulting, Inc., Gradient Corporation, and Exponent. Dr. Sc hoof received her Ph.D. in Toxicology from the University of Cincinnati in 1982 and has more th an 25 years’ experience assessing human health effects and exposures from metals and other chemical substances for a variety of projects, such as contaminated site remediation; commercial, industrial, agricultural and residential exposure assessments; product uses; and dietary exposures. Her projects have included numerous health

risk assessments conducted under various U.S. and international regulatory settings, as well as regulatory, research and litigati on projects. Dr. Schoof has direct ed evaluations of chemical toxicity, derivation of risk-based exposure le vels, health risk assessments for cancer and noncancer end points and multimedia exposure asse ssments. Dr. Schoof is an internationally recognized expert on evaluation of arsenic and othe r metals (including lead) in the environment, as well as in the human diet, and on the bioavailab ility of metals from soil. Her experience with lead has included numerous exposure studies and ri sk assessments for mine and smelter sites; risk assessments for manufacturing, landfill, and waste combustion sites; regulatory and research projects for/cited by Health Canada, EPA, State of Montana; and litigatio n projects (e.g., former shooting range; mining and smelting site). Dr. Schoof has published more than 40 peer-reviewed articles and chapters in scientific journals, books and proceedings. She has served on numerous peer review panels for U.S. agencies (e.g., EPA, ATSDR) and Canadi an ministries, and on

several National Research Council committees. She ha s also served as a member of the British Columbia Contaminated Sites Science Advisory Board, the Expert Advisory Panel for the

Canadian Metals in the Human Environment- Research Network, and the Washington Model

Toxics Control Act Science Panel. Dr. Schoof wa s certified as a DABT starting in 1986 and is a Fellow of the Academy of Toxicol ogical Science. She is a member of the Society of Toxicology, Society for Risk Analysis and the International Soci ety for Exposure Science.D-11 DRAFT

Joel Schwartz, Ph.D., M.D., Harvard School of Public Health

i. Education: Brandeis University, Ph.D. in Theoretic al Physics (1980); University of Basel, Switzerland, M.D. (2010)

ii. Professional Experience: Dr. Schwartz is Professor of Environmental Epidemiology at the

Harvard School of Public Health and Director of the Harvard Center for Risk Analysis. He received his Ph.D. in Theoretical Physics from Brandeis University in 1980 and his M.D. from the University of Basel, Switzer land, in 2010. His research intere sts are in epidemiology and the health consequences of exposure to pollutants, focusing on the health e ffects of lead and air pollutants. Prior to his academic appointment at the Harvard School of Public Health, Dr.

Schwartz was a Senior Scientist at EPA until 1994. Dr. Schwartz has studied the cardiovascular effects of lead exposure in adul ts, neurological/cognitive effects in children, auditory effects in children, and effects of lead on children’s grow th. He has also done work on sources of lead exposure, including establishing gasoline lead as the major source of lead exposure in the U.S.

Dr. Schwartz has studied both acute and chroni c effects of air pollution exposure and recently established that the exposure to fine combustion particles in ai r at concentrations well below current standards are associated with a range of a dverse health effects, le ading to a tightening of the U.S. air quality standards. He is also experienced in the mode ling of continuous covariates in epidemiologic studies, both for better covari ate control and to more accurately assess the relationship between exposure and response. Dr . Schwartz has published more than 600 peerreviewed articles and chapters in scientific journals, books and proceedings. In addition, Dr.

Schwartz has served on the editorial boa rds of several jour nals including the International Journal of Biometeorology and the American Journal of Respiratory and Critical Care

Medicine . He has served on EPA’s Science Advisory Board Ad Hoc All Ages Lead Committee, EPA’s Lead Clean Air Science Advisory Commi ttee, and the National Academy of Sciences’ Committee on Assessing Lead Expos ure in Critical Populations.D-12 DRAFT

Anne Steenhout, Ph.D., Université Libre de Bruxelles

i. Education: Université Libre de Bruxelle s, Ph.D. in Sciences (1986/87)

ii. Professional Experience: Dr. Steenhout is a Professor at the Institute for Environmental Management and Physical Planning (IGEAT) a nd Director of the Research Unit "Group for Ecotoxicological Evaluation on Po llutants, Safety and Impacts on Humans" (GEEPSIH) at the Université Libre de Bruxelles (ULB) in Brussels , Belgium. She received her Ph.D. in Sciences

from ULB in 1986/87 and her research focuses on the assessment of chemical risks and vulnerable groups for both inor ganic and organic contaminan ts. Dr. Steenhout’s experience includes environmental epidemiology, exposure a ssessment, toxicokinetics and toxicodynamics, and variability and uncertainty analysis for l ead and other contaminants. In addition, she has experience on the accumulation of lead in hard ti ssues (bone, teeth) in children and adults, and developed a lead biokinetic model (all-age) and exposure model (all sources). The models evaluated a variety of sources in cluding lead paints and comparisons with IUBK performances.

Dr. Steenhout also cont ributed to EPA’s Working Group on Lead Models. She has also served on the European Union Scientific Committee for Health and Environmental Risks (SCHER). Dr. Steenhout has published more than 50 peer-r eviewed papers and book chapters, 150 grant reports, and 120 presentations.D-13 DRAFT

Kenneth M. Unice, MS , Cardno ChemRisk

i. Education: University of Arizona, MS. in Environmental Engineering (1998)

ii. Professional Experience: Mr. Unice is a Science Advisor at Cardno ChemRisk, He received his MS in Environmental Engineering from the University of Arizona in 1998 and has 15 years of quantitative human health risk, exposure assess ment, and database experience. Prior to joining Cardno ChemRisk in 2005, Mr. Unice was employed at AMEC as an Environmental Engineer and Health Scientist. Mr. Unice’s expertise is in the areas of environmental modeling, biokinetic modeling, indoor air modeling, occupa tional exposure assessment, hu man health risk assessment, environmental fate and transport analysis, com puter programming and database design. He has been involved in a number of projects involving exposure and risk/dose-response assessments for metals including an analysis of exposures to l ead-based paint, refinement of a biokinetic model

for cobalt which was based on a framework or iginally developed for the International Commission on Radiological Prot ection (ICRP) age specific biokine tic model for lead, and an

assessment of the adverse health effects associ ated with cobalt exposure. Mr. Unice has coauthored more than 35 journal articles on th e topics of biokinetic modeling, biomonitoring, environmental fate and transport models, meta ls exposure, pathogen risk assessment, and exposure reconstruction. Mr. Unice has served as an external p eer reviewer for EPA and as a peer reviewer on behalf of the Pennsylvania Depa rtment of Environmental Protection. He is a

member of the International Society of Exposure Science (IS ES) and the Society for Risk Analysis (SRA).D-14 DRAFT

Ian H. von Lindern, Ph.D., PE, TerraGraphics Environmen tal Engineering, Inc.

i. Education: Yale University, Ph.D. in Environm ental Science and Engineering (1980)

ii. Professional Experience: Dr. von Lindern has been Chief Executive Officer and Principal Scientist of TerraGraphics Environmental Engi neering since co-founding the firm in 1984. He

received his Ph.D. in Environm ental Science and Engineering from Yale University in 1980 and has nearly 40 years of national and internati onal environmental engin eering/science experience that includes a variety of environmental assessmen ts; studies in air, water, and soil pollution; toxic and hazardous materials investigations; re medial and cleanup plans; human health risk assessments; and application of statistical analysis techniques to multi-disciplinary environmental problems. He has directed over 40 major health/environm ental investigations involving primary and secondary lead smelters and battery processors, landfills, and uranium mill tailings at several major mining/smelting site s in the U.S., as well as internationally. Dr. von

Lindern has worked for the State of Idaho on various projects involvi ng the Bunker Hill/Coeur d’Alene Basin Hill Superfund Site for more than 35 years as the head Risk Assessor and Project Manager. In that capacity he had extensive ex perience in applying exposur e and biokinetic lead modeling in assessing human health risk, deve loping cleanup criteria and remedial design. TerraGraphics conducted site-specific quantitative analysis of the relatio nship between observed

blood lead levels and environmenta l variables, and one of the most extensive evaluations of lead paint as an additional source of exposure at a CERCLA site. Blood lead data relative to yard and house dust lead levels were analyzed to evalua te the effectiveness of the yard remediation program. Dr. von Lindern has a number of peer -reviewed publications on the reduction of

childhood blood lead levels and remedial activities at this site. Dr. von Lindern has served as an EPA Science Advisory Board Member on five occasions: (1) Review Subcommittee for Urban Soil Lead Abatement Demonstration Project, 199 3; (2) Subcommittee Assessing the Consistency of Lead Health Regulations in U.S. EPA Pr ograms, 1992; (3) Review Subcommittee Assessing the Use of the Biokinetic Model for Lead Absorption in Children at RCRA/CERCLA Sites, 1988; (4) the Ad Hoc All-Ages Lead Model (AALM) Review; and (5) National Ambient Air Quality Standard for lead Panel (2006-2008). He also served on the EPA Clean Air Scientific Advisory Committee (CASAC) Subcommitt ee on Exposure Assessment Methodology, 1988,

and was a member of the EPA Criteria Assessment Committee for Lead in the Ambient Air from

1975-1986 and 2006-2008.D-15 DRAFT

Kathleen L. Vork, MPH, Ph.D., California Environmental Protection Agency, Office of Environmental Health Hazard Assessment (OEHHA)

i. Education: University of California at Berkeley, Ph.D. in Environmental Health Sciences (2003); University of Minnesota, MPH in Occupational and Environmental Health

ii. Professional Experience: Dr. Vork is a Staff Toxicologist for the Office of Environmental Health Hazard Assessment (OE HHA) at the California Environmental Protection Agency. She

received her Ph.D. in Environmental Health Sc iences from the University of California at Berkeley in 2003 and her MPH degree in Occu pational and Environmental Health from the University of Minnesota, School of Public Hea lth in 1988. Prior to her position at OEHHA, Dr. Vork worked for the California Childhood Lead Poisoning Prevention Program. Dr. Vork has extensive experience and expertise relating to exposure pathways and the pharmacokinetics of lead in worker and general adul t populations. Dr. Vork has imple mented various statistical and mathematical modeling methods to estimate, adjust and check the accuracy and consistency of predictions from models combining expos ure pathways with physiologically-based pharmacokinetic (PBPK) and biokine tic models. She is the primary author of the report entitled “Estimating Workplace Air and Worker Blood Lead Concentration using an Updated Physiologically-based Pharmacokinetic (PBP K) Model” (2013). She has conducted work involving the derivation of human lactation transfer coefficients for various chemicals including

lead for the “Risk Assessment Guidelines Technical Support Documents for Exposure Assessment and Stochastic Analysis” (2012) and contributed work publishe d in “The Derivation of Non-cancer Reference Exposure Levels” (2007 ) for the California Air Toxics Hot Spots program. Dr. Vork has worked collaboratively with multiple agencies and the public. She has served on California’s Advisory Committee for Tr aining Regulations for Lead Paint Abatement, the California Lead Poisoning Prevention Program , and was Chair of the Alameda County Lead Poisoning Prevention Program Cour se Planning Committee. Dr. Vork is currently a member of the Genetic and Environmental Toxicology Association of Northern California.