1 Summary Minutes of the U.S. Environmental Protection Agency (EPA) Clean Air Scientific Advisory Committee (CASAC)

Lead Review Panel

Public Meeting July 20

- 21 , 201 1

Date and Time : W e dne sd ay
, July 20 , 2011

, 9:00 AM

– 5:30 PM ET ; Thursday, July 21, 2011,

8:30 AM

– 12:30 PM ET

Location : Marriott at Research Triangle Park, 4700 Guardian Drive, Durham, NC, 27703

Purpose : The purpose of the meeting was to conduct a peer review of EPA’s Integrated

Science Assessment for Lead (First External Draft

- May 20 11) and a

consultation on EPA’s Review of the National Ambient Air Quality Standards for Lead: Risk and Exposure Assessment Planning Document (June 2011)

.

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

Dr. H. Christopher Frey , Chair

Mr . George Allen

Dr. Herbert Allen Dr. Deborah Cory

- Slechta

Dr. Cliff Davidson Dr. Philip Goodrum Dr. Sean Hays

Dr. Chris Johnson

Dr. Susan Korrick

Dr. Michael Kosnett

Dr. Roman Lanno

Mr. Richard Poirot

Dr. Joel Pounds

Dr. Michael Rabinowitz

Dr. William Stub blefield

Dr. Ian von Lindern

Dr. Gail Wasserman

Dr. Michael Weitzman

Mr. Aaron Yeow, Designated Federal Officer (DFO)

D r

. John Vandenberg, EPA National Center for Environmental Assessment (NCEA) Dr. Ellen Kirrane, EPA NCEA Ms. Debra Walsh, EPA NCEA

D r. Bryan Hubbell , EPA Office of Air Quality and Planning Standards Dr. Zachary Pekar, EPA OAQPS

Other Attendees (See Attachment B)2

Wedne s day

, July 20 , 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 advanced 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 receive d one request from the p ublic to present oral comments

, and received one set of written public comments

. 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. Vanessa Vu, the Director of the SAB Staff Office, who welcomed everyone and thanked them for their public

service. She indicated that the purpose of the meeting was for the Panel to peer review EPA's Integrated Science Assessment for Lead (First External Draft

- May 2011) 2 and to provide

consultative advice on EPA’s Review of the National Ambient Air Quality Standards for Lead: Risk and Exposure Assessment Planning Document (June 2011) 3

. She then turne d the meeting

over to Dr. Chris Frey

, Chair of the C ASAC Lead Review Panel

.

Dr. Frey welcomed everyone

, and had the Panel introduce themselves. He reiterated the purpose of the meeting and the expectations of the results from the meeting. H e reviewed the Agenda 4

, and introduced D r

. John Vanden berg , from EPA’s National Center for Environmental Assessment (NCEA) for h is presentation

.

EPA Presentation

D r

. John Vandenberg, EPA NCEA

, made a presentation 5 to the Panel. He provided a description of the Integrat ed Science Assessment (ISA) document, the National Ambient Air Quality Standard (NAAQS) review process, and reviewed the schedule for the current NAAQS review.

He then turned it over to Dr. Ellen Kirrane, who provided an overview of the ISA and the charge questions. Ms. Debra Walsh then provided an overview of the Health and Environmental

Research Online (HERO) system.

Public Comment

D r. Craig Boreiko

, International Lead Zinc Research Organization , made an oral statement and

indicated that he also submitt ed written comments 6

. He indicated that the causality criteria set forth in the ISA were not rigorously applied. He noted that little attention was paid to the causality criteria, particularly with respect to confounders in the lead epidemiology studies.

Charge Question 1

- Causal Framework / Study Selection

The Panel members generally agreed that the criteria of using epidemiological studies within one order of magnitude at the general population blood lead range was reasonable, especially for a

documen t that intends to focus on environmental lead exposures. The members found the Health and Environmental Research Online (HERO) system to be helpful. One member expressed concern that limiting the analysis to just one order of magnitude of current exposure excludes3

90% of the world. There was discussion on the NAAQS process and that the role of the ISA is to aid the development of the Lead NAAQS for the United States.

Charge Question 3

- Ambient Air

The Panel members generally found the document to be we ll written and comprehensive. Some of the Panel members noted that there was not any discussion on what EPA is doing to develop a better high

- volume sampler. Although the ISA might not be the best place to discuss the development of a new high

- volume sampl er, the members wanted to reiterate CASAC’s previous recommendations for the need for such a sampler, early on in the NAAQS review process, and not wait until the implementation stage, at which point it would be too late to develop it. It was

also noted t hat the shutdown of the Herculaneum smelter presents an opportunity to prospectively study the impacts of air lead to soil lead. Other members recommended that the chapter needs to briefly summarize the current state of the science to provide context to th e new studies. The Panel members had several issues with the accuracy of some of the particle size Pb comparisons and recommends that EPA screen the data for very low concentrations that may have poor precision and re

- check the calculations. The members al so had concer ns about several aspects of the reported Pb emissions inventory data, including the relative importance of resuspended Pb from soils near historical sources (including roadways), and emissions from aviation gasoline combustion.

Charge Questi on 4

– Exposure, Biomarkers, Toxicokinetics Charge Question 4a

– Exposure and Toxicokinetics

The Panel members noted that this chapter was pretty well

- put together and found that the discussion of the effects of the reduction in air lead levels from the p hase out of gasoline to be good. However, little emphasis is given to attributing the reductions in air lead levels to the shutdown of stationary sources throughout the country that was occurring at the same time. The members also thought it would be usefu l for the chapter to include a summary of how lead concentrations in other media have changed over the years.

Following the lunch break, EPA provided some clarification of the NAAQS process and the roles of the ISA and Risk and Exposure Assessment (REA).

Charge Question 4b

– Biological Markers

The Panel recommended that the ISA provide greater distinction in the definition of the terms absorption and bioavailability and to use the terms consistently according to that distinction. The

members also recomme nded defining the distinction between validation and application of biomarkers for exposure, body burden, dose, and risk. There was discussion regarding several figures pertaining to biokinetic modeling and it was recommended that greater explanation be gi ven to the biokinetic modeling assumptions and comparisons to epidemiological data as

validation.4

Charge Question 4c

– Empirical Modeling

The Panel members found that inclusion of additional studies from which to estimate air Pb to

blood Pb slope facto rs wa s a positive advancement from the previous NAAQS, which relied on just one or two studies , but would like to see how these slope factors compared to the one used in the previous NAAQS review. One member develop e d several figures to illustrate the pote ntial change (reduction) in blood Pb concentrations as a function of reductions in the current NAAQS and recommended that the ISA contain similar figures.

Charge Question 5

– Integrated Health Effects of Lead Exposure Charge Questions 5a and 5e

– Modes of Action and Dose

- Response

The Panel members generally found that the discussion of the potential modes of action underlying the health effects of Pb exposure was thorough and inclusive of the current scientific

literature and that no known modes of action have been left out. They found that some cases studies were not presented in sufficient detail to make conclusions regarding the mechanisms of

action. They found that the additional evidence since 2006 for a non

- linear dose

- response curve was appropriatel y cited and provides further support for the non

- linearity of the dose response curve. They noted that the non

- linear dose

- response curve is also supported by the animal

literature.

Charge Questions 5band 5c

– Health Endpoints

The Panel members generall y found the discussion of specific health endpoints in this chapter to
be sufficiently broad in scope, and inclusion of additional health endpoint s wa s not required. The

members recommended a more rigorous and transparent “weight of the evidence” analysis to establish the extent of any causal relationship and that the analysis should devote more attention to the limitations of the existing studies with respect to consistency, reproducibility, bias, control for confounders, and shortcomings in statistical m ethodology.

Charge Question 5d

– Integration of Epidemiological and Toxicological Evidence

The members found the c hapter provided a comprehensive review of the human epidemiologic and toxicological evidence of Pb ’s health effects but recommend ed a number of modifications to the chapter and identified several ways to improve the application of causal determination criteria to the Chapter’s conclusions.

Charge Question 7

– Ecological Effects of Lead

The Panel members generally found the ecological effects chapter to be an excellent synthesis of the available environmental toxicity data for Pb. The chapter focused on post

- 2006 data, but

some of the values that are relied upon are somewhat dated (e.g., the 1985 Ambient Water Quality Criteria and the 2003 ter restrial ecological soil screening level values). It was suggested

that high quality data might be availab le from non

- published sources, such as data generated for the European Registration, Evaluation, Authorisation and Restriction of Chemicals ( REACH )

re gulations and recommendations were made that these be evaluated. The members5

recommended consistent use of the terms bioconcentration factor (BCF) and bioaccumulation factor (BAF) and also noted that BCF is an inappropriate measure to assess the haz ard of Pb.

Causal conclusions we re only weakly supported by limited exposure data and thus should be

reevaluated.

Charge Question 6

– Susceptible Populations and Life Stages

The members generally found t hat the ISA’s discuss ion on susceptible populations was we ll written and useful. However, they recommend that EPA be very clear on the strength of the

literature and cautious in inferring causality

. The y found that the ISA would be strengthened with more discussion of nutritional aspects that serve to increase su sceptibility, differences in effects by gender, more discussion of gene

- environmental interactions, and more mention of epigenetic implications. They noted that although early development is a vulnerable time period, significant data also show that later p eriods in life are associated with significant adverse effects.

Charge Question 2

- Integrative Health and Ecological Effects Overview

The members generally supported the integrated summary being placed towards the beginning of

the ISA as opposed to the end of the document

. Overall, they found the integrated overview to be very helpful and well written , and the framework for characterizing the degree of causality is particularly useful . They recommended that c are be taken to ensure that the most important points and key features from the health effects chapter are mentioned in this overview chapter

.

Dr. Frey discussed action items and the DFO recessed the meeting until the next day.

Thursday

, July 21, 2011

The Panel reconvened at 8:30 am and Dr. Frey w ent over some scheduling items related to the draft letter on EPA’s ISA that the Panel will be developing. He then went over the agenda and turned it over to EPA for their presentation.

EPA Presentation

Dr. Zachary Pekar and Dr. Bryan Hubbell from EPA’s OAQPS presented an overview 7 of the Risk and Exposure Assessment Planning Document. Some of the topics discussed included the purpose of the document, an overview of the of the prior Lead NAAQS review, key areas of uncertainty and limitations in the prior review, and an overview of key observations in the current planning document.

There was some discussion between the Panel members and EPA about whether there was going to be an REA document. EPA indicated that they did not plan on producing an REA documen t because the recent scientific information did not warrant a new quantitative risk assessment. They explained that this would be documented in the policy assessment document (PAD).

Several members indicated that the documentation in the PAD is too late in the process and wanted to see something sooner. Several members also indicated that they would like to see6

additional modeling, particularly in regards to an airport case study to assess the impact of aviation gasoline

.

Public Comment

There were no publi c comments on the REA Planning document.

Health Risk Assessment Issues

The Panel proceeded to discuss their comments on the human health risk assessment issues in the REA Planning Document. Several members commented that the document was well

- written a nd coherent. Some members agreed with EPA that there is not sufficient new data to warrant a new quantitative risk assessment. Other members raised the issue of airports and aviation gasoline and perhaps the need for some additional case studies/modeling.

Welfare Assessment Issues

The members generally found the document to be well

- written and well

- organized. Some members pointed out that there is a huge difference in terms of perspective of the importance of lead in health risk assessment versus ecologi cal risk assessment. They did not consider lead to be in the top list of things that reduce the functioning of ecosystems and the production of

e cosystem services . Some members agreed that the critical loads approach was the way to go,

but were concerned t hat there would ever be enough sufficient data. Another member indicated that the weakest link in the risk assessment was the linkage between air concentrations of lead

and media concentrations of lead.

Summary and Action Items

With the discussion on the REA Planning Document concluded, Dr. Frey then proceeded with a summary of the Panel’s consensus responses to the charge questions on the ISA. He presented a summary of the major points discussed and agreed upon by the Panel. He then discussed the next

st eps and action items.

With the business concluded, the Designated Federal Officer adjourned the meeting at 11:55 A M

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 Panel7

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 meeti ng. 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 recommendatio ns offered to the Agency. S uch advice and recommendations may be found in the final advisories, commentaries, letters or reports prepared and transmitted to the EPA Administrator following the public meetings.8

Materials Cited

The following meeting materials are available on the CAS AC website: http://www.epa.gov/casac , at the July 20

- 21, 2011 CASAC Lead Review Panel Meeting page :

1 Federal Register Notice Announcing the Meeting

2 Integrated Science Assessment for Lead (First External Draft

- May 2011)

3 Review of the National Ambient Air Quality Standards for Lead: Risk and Exposure As sessment Planning Document (June 2011).

4 Agenda for July 20

- 21 , 201 1 Public Meeting

5 EPA Presentation on the Lead Integrated Science Assessment (ISA)

6 Public Comments from Craig Boreiko, International Lead Zinc Research Organization (ILZRO)

7 E PA Pre sentation on the Lead Risk and Exposure Asse ssment (REA) Planning DocumentA

- 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 University, 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 Environ mental Engineering, University of Delaware, Newark, 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 Rochester, 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, Dep artment of Civil and Environmental Engineering , 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. Mich ael Kosnett , Associate Clinical Professor, Division 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 Evolutio n, 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 Po unds

, Laboratory Fellow , Cell Biology & Biochemistry, Biologica l Sciences Division, Pacific Northwest National Laboratory, Richland, WA

Dr. Michael Rabinowitz , Geochemist, Marine Biological Laboratory , Newport, RI

Dr. William Stubblefield , Senior Researc h Professor, Department 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 Ch ild Psychiatry, Division 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 part icipate in this review.

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 Meeting

July 20

, 201 1

Name Affliation
Boreiko, Craig International Lead Zinc Research Organization
Brightwell, Holly* Texas Commission on Environmental Quality

Brown, James E PA

Datko, Laura EPA

Davis, Allen EPA
Dietert, Rodney Cornell University

Dubois, Jean

- Jacques EPA

Dutton, Steve EPA

Dzubow, Rebecca* EPA

Fairbrother, Anne Exponent
Gandy, Jay University of Arkansas for Medical Sciences
Gonick, Harvey UCLA

Hines, E rin EPA
Hoyer, Marion EPA

Hubbard, Heidi ICF
Johns, Doug EPA

Kotchmar, Dennis EPA

Lassiter, Meredith EPA
Long, Thomas* EPA
Lorang, Ellen EPA

McDow, Steve EPA

Meacham, Connie EPA

Mendez, Bill ICF
Murphy, Deirdre EPA
Nystrom, Marci* California Ai r Resources Board

Orlin, David EPA

Owens, Beth EPA

Parker, Stuart* InsideEPA

Patel, Molini EPA

Pedde, Meredith* EPA
Pinto, Joseph EPA
Rajan, Pradeep EPA

Richmond

- Bryant, Jennifer EPA
Ross, Mary EPA
Rothenberg, Stephen National Institute of Public HealthB

- 2

Selgrade, Mary Jane ICF
Sheedy, Keith* Texas Commission on Environmental Quality

Shumake, Katie EPA
Siporin, Kaylyn EPA
Stanek, Lindsay EPA
Svendsgaard, Dave EPA
Tennant, Ginger EPA
Tonne, Jay* Texas Commission on Environmental Quality

Van derpool, Robert EPA

Vinikoor

- Imler, Lisa EPA
Volpe, Rosalind ILZRO

Walsh, Debra EPA
Weaver, Virginia Johns Hopkins University
Wiesskopf, Marc EPA

Wise, John University of Southern Maine
Wright, Robert Harvard University
Wright, Rosalind Harvard Uni versity
Young, Brianna EPA

*Participated via teleconference

July 21, 201 1

Name Affliation
Boreiko, Craig ILZRO
Brightwell, Holly* Texas Commission on Environmental Quality
Deitert, Rodney Cornell University

Dubois, Jean

- Jacques EPA

Dzubow, Rebecc a* EPA

Fairbrother, Anne Exponent

Hines, Erin EPA
Hoyer, Marion EPA

Hubbard, Heidi ICF

Kotchmar, Dennis EPA

Lassiter, Meredith EPA
Long, Thomas* EPA

Mendez, Bill ICF
Murphy, Deirdre EPA
Nystrom, Marci* California Air Resources Board

Orlin, David EPA

Owens, Beth EPAB

- 3

Parker, Stuart* InsideEPA

Patel, Molini EPA

Pedde, Meredith* EPA
Rajan, Pradeep EPA

Richmond

- Bryant, Jennifer EPA
Ross, Mary EPA
Rothenberg, Stephen National Institute of Public Health
Sheedy, Keith* Texas Commission on Enviro nmental Quality
Tennant, Ginger EPA
Tonne, Jay* Texas Commission on Environmental Quality
Volpe, Rosalind ILZRO
Weaver, Virginia Johns Hopkins University

Wise, John University of Southern Maine

*Participated via teleconference