1 Summary Minutes of the

U.S. Environmental Protection Agency (EPA)

Clean Air Scientific Advisory Committee (CASAC)

Lead Review Panel

Public Teleconference

September 1 5 , 201 1

Date and Time : T hur sd ay

, September 1 5 , 2011

, 1 2 :00 P M

– 3 : 0 0 PM ET

Location : Teleconference Only

Purpose : The purpose of the teleconference was t o discuss the Panel’s draft letter on

EPA’s Integrated Science Assessment (ISA)

.

Participants : C ASAC Lead Panel (for full roster, see Attachment A)

Dr. H. Christopher Frey , Chair

Mr. Ge orge Allen

Dr. Herbert Allen

Dr. Deborah Cory

- Slechta

Dr. Cliff Davidson

Dr. Sean Hays

Dr. Philip Hopke

Dr. Chris Johnson

Dr. Susan Korrick

Dr. Michael Kosnett

Dr. Roman Lanno

Mr. Richard Poirot

Dr. Joel Pounds

Dr. William Stubblefield

Dr. Gail Wasserman

D r. Michael Weitzman

Mr. Aaron Yeow, Designated Federal Officer (DFO)

D r

. John Vandenberg, EPA National Center for Environmental Assessment (NCEA)

Dr. Bryan Hubbell , EPA Office of Air Quality and Planning Standards

Other Attendees (See Attachment B)2

Thurs day

, September 1 5 , 2011

Opening Remarks

Mr

. Aaron Yeow , the DFO for the CASAC Lead Review Panel , opened the meeting

. H e noted

that as required under the Federal Advisory Committee Act (FACA) , the Panel ’s deliberations

are held in public with advance d notice given in the Federal Register 1 , and the meeting minutes

will be made publicly available after the meeting. H e noted that the Panel did not receive any

public comments and did not receive any requests for oral public statements

. H e also no ted that

the Panel m embers are subject to compliance with federal ethics regulations and conflict

- of

inter est laws that pertain to them. He t hen turned the meeting over to Dr. Chris Frey

, Chair of the

C ASAC Lead Review Panel

.

Dr. Frey welcomed everyone and indicated t hat the purpose of the meeting was to review the

Panel’s letter on EPA’s ISA 2

. H e reviewed the Agenda for the meeting 3

, and turned it over to

EPA for their remarks

.

EPA Remarks

D r

. John Vandenberg, EPA NCEA

, expressed EPA’s appreciation for the work unde rtaken by

the Panel. He had one clarifying question regarding the Panel’s recommendation in the response

to charge question #7 for EPA to evaluate nonpublished data, such as data generated for the

European Registration, Evaluation, Authorisation and Restri ction of Chemicals ( REACH ). He

asked for the Panel’s clarification on how to go about doing that, noting the difficulty in

obtaining as well as evaluating the quality of the data. He stated that doing so would represent a

departure from what NCEA typically does, which is to evaluate only published, peer

- reviewed

data.

One of the panel members indicated that the data submitted to REACH have been reviewed for

quality and data in the dossiers are peer reviewed according to the Clemish process. He indicated

th at at the July 20

- 21, 2011 meeting, the representative from the International Lead Zinc

Research Organization (ILZRO) stated that industry would provide this data to EPA.

Dr. Bryan Hubbell, EPA OAQPS, discussed the Lead NAAQS process and schedule. He

indi cated during the spring 2012 CASAC meeting on the second draft ISA, EPA will brief the

panel on aspects of the Policy Assessment Document (PAD) related to risk, such as aviation

gasoline.

Response to Charge Questions

For the response to charge question 1 , there was discussion regarding clarification of the Panel’s

statement regarding high does in toxicology and/or in vitro studies. It was agreed that Dr.

Davidson would provide some revised language to clarify the statement.

There were not many changes th at needed to be made to the response to charge question 3, aside

from minor editorial changes.3

For the response to charge question 2, there was discussion on providing further detail on what

specific key features from chapter 5 were missing from chapter 2, as well as clarifying the

Panel’s statement regarding clinical significance/magnitude of effects. Furthermore, there was

discussion about how the causal framework was not applied well in the document and how the

Panel’s response needs to make this point c lear. It was agreed that Dr. Korrick , with input from

Dr. Kosnett would make these revisions.

Dr. Kosnett mentioned some missing text that he provided to the lead author of the response to

charge question 4 and agreed to send it again for inclusion. There was discussion about the

definition of absorption and bioavailability and it was agreed to remove these definitions and

recommend to EPA to clearly define these terms and use them consistently. It was agreed that

Dr. Hays would make all the revisions disc ussed.

For the response to charge question 5, it was agreed to make the language pertaining to clinical

significance consistent with the revisions that will be made to the response to charge question 2.

There was discussion over item 8 on page B

- 13 regard ing modes of action and it was agreed that

Dr. Cory

- Slechta and Dr. Kosnett would work on revised language to send to Dr. Wasserman,

who would make all the revisions for the response to charge question 5.

Dr. Cory

- Slec h t a agreed to revise lines 5

- 9 of p. B

- 16 to clarify the Panel’s statement regarding

the document’s emphasis of various age groups.

Dr. Lanno agreed to make revisions to the response for charge question 7, incorporating the

earlier discussion regarding REACH and to fully answer all the subqu estions within the charge

question.

Letter to Administrator

One member commented that perhaps the more minor comments could be excluded from the

letter so that the major points are not buried. Another member mentioned that one major point

that does not c ome through is that the causal framework was not adequately applied throughout

the document. It was agreed that any revisions made to the response to charge questions would

be reflected in the letter as well.

Dr. Frey discussed next steps and action items

. With the business concluded, the Designated

Federal Officer adjourned the meeting at 3 :0 0 PM ET

.

Respectfully Submitted: Certified as Accurate :

/Signed/ /Signed/

Mr. Aaron Yeow Dr. H. Christopher Frey

Designated Federal Officer Chair

EPA SAB Staff Office CASA C Lead Review Panel4

NOTE AND DISCLAIMER: The minutes of this public meeting reflect diverse ideas and

suggestions offered by Panel members during the course of delib erations within the meeting. Such

ideas, suggestions and deliberations do not necessarily reflect consensus advice from the Panel

members. The reader is cautioned to not rely on the minutes to represent final, approved, consensus

advice and recommendations offered to the Agency. Such advice and recommendations may be

found i n the final advisories, commentaries, letters or reports prepared and transmitted to the EPA

Administrator following the public meetings.5

Materials Cited

The following meeting materials are available on the CASAC website:

http://www.epa.gov/casac , at the September 15, 2011 CASAC Lead Review Panel Meeting page :

1 Federal Register Notice Announcing the Meeting

2 CASAC Review of EPA’s Integrated Science Assessment for Lead (First External Review Draft

– May 2011)

3 Agenda for September 1 5 , 201 1 Public MeetingA

- 1 ATTACHMENT A

- ROSTER



### U.S. Environmental Protection Agency

Clean Air Scientific Advisory Committee

CASAC Lead Review Panel (2010

- 2013)

CHAIR

Dr. H. Christopher Frey , Professor, Department of Civil, Construction and Environmental

Engineering, College of Engineering, North Carolina State Univers ity, Raleigh, NC

MEMBERS

Mr. George A. Allen , Senior Scientist, Northeast States for Coordinated Air Use Management

(NESCAUM), Boston, MA

Dr. Herbert Allen , Professor Emeritus, Department of Civil and Environmental Engineering,

University of Delaware, N ewark, DE

Dr. Richard Canfield * , Senior Research Associate, Division of Nutritional Sciences, Cornell

University, Ithaca, NY

Dr. Deborah Cory

- Slechta , Professor, Department of Environmental Medicine, School of

Medicine and Dentistry, University of Roches ter, Rochester, NY

Dr. Cliff Davidson , Professor, Civil and Environmental Engineering, Syracuse University,

Syracuse, NY

Dr. Philip E. Goodrum , Senior Project Manager, Environmental Resources Management

(ERM), Dewitt, NY

Dr. Sean Hays , President, Summit Toxicology, Allenspark, CO

Dr. Philip Hopke , Bayard D. Clarkson Distinguished Professor, Department of Chemical and

Biomolecular Engineering, Clarkson University, Potsdam, NY

Dr. Chris Johnson , Professor, Department of Civil and Environmental Engineerin g , Syracuse

University, Syracuse, NY

Dr. Susan Korrick , Assistant Professor of Medicine , Department of Medicine, Brigham and

Women's Hospital, Channing Laboratory, Harvard Medical School, Boston, MAA

- 2

Dr. Michael Kosnett , Associate Clinical Professor, Di vision of Clinical Pharmacology and

Toxicology, Department of Medicine, University of Colorado Health Sciences Center, Denver,

CO

Dr. Roman Lanno , Associate Professor and Associate Chair, Department of Evolution,

Ecology, and Organismal Biology, Ohio State University, Columbus, OH

Mr. Richard L. Poirot , Environmental Analyst, Air Pollution Control Division, Department of

Environmental Conservation, Vermont Agency of Natural Resources, Waterbury, VT

Dr. Joel Pounds , Scientist, Cell Biology & Biochemistry, Biological Sciences Division, Battelle

- Pacific Northwest National Laboratory, Richland, WA

Dr. Michael Rabinowitz , Geochemist, Clinical Instructor in Neurology, Harvard University,

Newport, RI

Dr. William Stubblefield , Senior Research Professor, Depart ment of Molecular and

Environmental Toxicology, Oregon State University, Corvallis, OR

Dr. Ian von Lindern , President, TerraGraphics Environmental Engineering, Inc., Moscow, ID

Dr. Gail Wasserman , Professor of Clinical Psychology in Child Psychiatry, Div ision of Child

and Adolescent Psychiatry, College of Physicians and Surgeons, Columbia University, New

York, NY

Dr. Michael Weitzman , Professor, Pediatrics; Psychiatry, New York University School of

Medicine, New York, NY

*Did not participate in this rev iew.

SCIENCE ADVISORY BOARD STAFF

Mr. Aaron Yeow , Designated Federal Officer, U.S. Environmental Protection Agency, Science

Advisory Board (1400R), 1200 Pennsylvania Avenue, NW, Washington, DC, Phone: 202

- 564

- 2050, Fax: 202

- 565

- 2098, (yeow.aaron@epa.gov)B

- 1 ATTACHMENT B

– Other Attendees

CASAC Lead Panel Public Teleconference

September 1 5, 201 1

Name Affiliation

Bertrand, Charlotte EPA

Brown, James EPA

Burkett, Jeff Empire District Electric Co.

Campleman, Sharan Electric Power Research Insti tute (EPRI)

Corrales, Mark EPA

Curry, Bridgid EPA

Davis, Charles North Carolina Department of Environment and Natural

Resources

Diamond, Gary SRC

Hawkins, Bernard F., Jr. Nelson Mullins Riley & Scarborough LLP

Kirrane, Ellen EPA

Kotchma r, Dennis EPA

Lassiter, Meredith EPA

MacDonald, Stephen Health Canada

Macey, Kristin Health Canada

McAngus, Jess Spirit Environmental, LLC

McMahon, Bobby InsideEPA

Miksad, Roger Wiley Rein LLP

Nystrom, Marci California Air Resources Board (CARB)

Orlin, David EPA

Osterling Owens, Beth EPA

Patel, Molini EPA

Rak, Drew Noblis

Richmond

- Bryant, Jennifer EPA

Ross, Mary EPA

Sexton, Will Florida Department of Environmental Protection

Smith, Kathleen Missouri Coalition for the Env ironment

Steichen, Ted American Petroleum Institute (API)

Sun, Gulan Texas Council of Environmental Quality (TCEQ)

Vinikoor

- Imler, Lisa EPA

Volpe, Rosalind I nternational L ead Z inc R esearch O rganization (ILZRO)

Walsh, Debra EPA

Weaver, Virginia Johns Hopkins University

Wichers

- Stanek, Lindsay EPA

Wilson, Linda New York State Attorney General's Office