1 Summary Minutes of the

U.S. Environmental Protection Agency (EPA)

Clean Air Scientific Advisory Committee (CASAC)

L e ad Review Panel

Public Meeting

February 5

- 6, 2013

Date and Time : Tues d ay

, February 5 , 201 3

, 8 : 30 AM

– 5:3 0 PM ET ; Wedn e sday, February 6

, 201 3

,

8:30 AM

– 12 :30 P M ET

Location : Hilton Garden Inn Raleigh

- Cary

, 101 Columbus Avenue

, Cary , North Carolina 27 518

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

Assessment for Lead (Third External Revi ew Draft, November 2012) and Policy

Assessment for the Review of the Lead National Ambient Air Quality Standards

(Ex ternal Review Draft, January 2013 ).

Participants : Lead Review Panel (for full panel, see roster 1 )

Dr. H. Christopher Frey, CASAC Chair

Mr. George Allen

Dr. Herbert Allen

Dr. Richard Canfield

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. Michael Rabinowitz

Dr. Ian von Lindern

Dr. Gail Wasserman

Dr. Michael Weitzman

M r. A aron Yeow , Designated Federal Office (DFO)

M r. Christopher Zarba

, EPA Science Advisory Board Staff Office

Mr. Thomas Brennan

, EPA Science Advisory Board Staff Office

D r

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

Dr. Ellen Kirrane , EPA NCEA

Ms. Lydia Wegman, EPA Office of Air Quality and Planning Standards (OAQPS)

Dr. Deirdre Murphy

, EPA OAQPS

Ms

. Ginger Tennant , EPA OAQPS

O ther Attendees (See Attac hment A )2

Tues day

, February 5 , 201 3

Opening Remarks

M r

. A aron Yeow , DFO

, 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 2 , and the meeting minutes will be made publicly available after the meeting. H e noted

that the Panel did not receive any written public comments nor any requests to make oral statements. He

did note that there would be a dditional opportunities fo r the public to provide clarifying comments

. H e

sta ted that the SAB Staff Office reviewed information provided by the panel and determine d that there

were no issues with conflict

- of

- interest n or any issues with an appearance of a lack of impartiality

. He

n oted that Dr. Christopher Frey had been appointed by the Administrator to be the Chair of the

Chartered CASAC. H e t hen turned the meeting over to M r. Thomas Brennan , the Deputy Director of the

SAB Staff Office, welcomed everyone, noted that Dr. Vanessa Vu had retired as Director of the SAB

Staff Offices and introduced Mr. Christopher Zarba, Acting Director of the SAB Staff Office

. Mr. Zarba

welcomed everyone and discussed the importance of the role that the SAB and the CASAC had in

ensuring sound science in Agency documents and the importance of achieving balance in SAB and

CASAC panels. H e then turned the meeting over to Dr. Christopher Frey

, Chair of the C ASAC

.

Dr. Frey welcomed everyone and gave an overview of the Agenda 3

. He had the panel introduce

them selves, and then discussed the charter of the CASAC, the role of the CASAC, and ways that the

CASAC could streamline reviews of NAAQS documents. He then introduced D r

. John Vanden berg

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

.

EPA Presentation on the Integrated Science Assessment

D r

. John Vandenberg, EPA NCEA

, made a presentation 4 to the Panel. He thanked the Panel members

and the pub lic for their comments on the 2nd draft Lead Integrated Science Assessment (ISA) and

highlighted some of the changes made in the 3rd draft ISA. He then turned it over to Dr. Ellen Kirrane

, who continued with the presentation, providing an overview of the key revisions to the document

.

Public Comments on the ISA

There were no public comments so the panel proceeded to the next item on the agenda.

Panel Discussion of the ISA

Preamble, Legislative and Historical Background; Executive Summary ( Chapter 1 ) and Integrative

Summary ( Chapter 2 )

The panel discussed the causality framework an d the differences between the “likely to be a causal

relationship” and “suggestive of a causal relationship”. The panel recommended that it should be made

clear when animal data is the basis for the determination as opposed to epidemiological data. There w as

discussion about the causal designation for the association between lead (Pb) exposure and renal effects

and suggested that it should be changed from “likely to be a causal relationship” to “suggestive of a

causal relationship”.3

Chapter 3

– Source t o Concentration

The panel thought that the Agency did a good job revising the 2 nd Draft ISA and encouraged the EP A to

continue the development of a new high

- volume Total Suspended Particulates (TSP) air sampler for Pb.

There was discussion about the appro priate cut size for the sampler. The members generally agreed that

15 micrometers was appropriate because inefficiencies in sampling occurred at sizes above 15

micrometers.

Chapter 4

– Exposure, Toxicokinetics and Biomarkers

The panel found that the EPA was responsive in addressing the panel’s comments on the 2 nd Draft ISA.

Although the consumer products section was a nice addition, the discussion about the health effects from

exposure to them and the importance of them is not adequate. The panel found th e presentation and

discussion of air

- to

- blood relationships to be thorough, but that c onclusions or summary statements

regarding the utility of the relationships for current Pb exposures (and even lower) would be helpful.

Chapter 5

– Integrated Health E ffects of Lead

The panel commended the EPA in doing an incredible job of trying to tackle a lot of complicated issues

and that the chapter was an improvement over the previous version. There was discussion about the need

for more transparency between the determinations made between the “likely to be a causal relationship”

to “suggestive of a causal relationship” designations.

The panel found that the revised grouping according to health effects was a major improvement.

However, there was some discussion regarding the classification of certain effects as internalizing or

externalizing behaviors.

Chapter 6

– Potentially At

- Risk Populations

The panel found the chapter to be much improved in terms of the reorganization, better delineation of

the sources of risks, and better discussion of at

- risk vulnerability and susceptibility. However, the panel

found that additional discussion of the magnitude of the impact of these risk factors (e.g., effect

modifiers) would be helpful

.

Chapter 7

– Ecological Effects o f Lead

The panel thought that the EP A did a good job in revising the chapter and that the standardized

concentration units made it easier to make comparisons between studies. However, the panel found that

a critical loads approach would help in establishi ng the relationship between ecological effects and Pb in

air, water, and soil.

Clarifying Comments from the Public on the ISA

Mr. Yeow read a clarifying comment 5 from Anita Meyer, Department of Defense Chemical and Material

Risk Management Program

.4

EP A Presentation on the Policy Assessment

Ms. Lydia Wegman, EPA OAQPS, made a presentation 6 that provided an overview of the Pb NAAQS

review. Dr. Deirdre Murphy then continued the presentation, which provided an overview of the PA

document.

Public Comment s

There were no public comments so the panel proceeded to the next item on the agenda.

Panel Discussion on the PA

Chapter 1

– Introduction

The panel thought that the EPA did a nice job on Chapter 1 and provided a good foundation for the rest

of the doc ume nt. The panel pointed out that Pb is a very unique environmental success story compared

to any other pollutant. However, it also has the biggest legacy problem of any pollutant and that the lack

of information on human exposures to the legacy Pb is a pr oblem. Although some panel members found

the PA to be adequate for its intended purpose, they found the scope to be too narrow and that there was

not any mention of the global impacts of Pb

.

Chapter 2

– Ambient Air Lead

The panel generally found that th e relevant information on emissions, air quality and Pb concentrations

in other media was appropriately characterized and clearly communicated. There was discussion of the

need for inclusion of more monitoring data, especially for aviation gasoline. The pa nel was supportive

of the EPA developing a new air sampler for Pb and there was discussion about various cut sizes for the

sampler. There was discussion of the uncertainty surrounding exposure to legacy Pb through

resuspension of soil , dust, diet, and wate r.

Chapter 3

– Health Effects and Exposure/Risk Information

The panel found that the PA generally captures the key aspects of the health effects evidence presented

in the ISA . There were suggestions that the PA could be made more concise and clear by pro viding

summary conclusions regarding the health effects evidence at the beginning of the sections. The y found

that the risk and exposure information fro m the previous Pb NAAQS review wa s adequately presented

and concluded that a new risk and exposure asses sment (REA) wa s not needed.

The panel was a little ahead of schedule and Dr. Frey suggested beginning the discussion on Chapter 4.

Chapter 4

– Review of the Primary Standard

The panel generally found that the application of the evidence

- based framework and the use of the

health risk and exposure information from the previous Pb NAAQS review seemed appropriate. They

generally agreed with the EPA that the evidence did not support a revision to current primary standard.

They found that the PA lacked discus sion of the rationale behind the averaging time and form of the

current primary standard.

The panel recessed for the day at 5:3 0 pm.5

Wedn e sday

, February 6 , 201 3

The meeting was reconvened at 8:30 am.

Panel Discussion on the P A (cont'd.)

Chapter 5

– W

elfare E ffects and Risk Information

The panel generally found that the chapter did a good job summarizing the welfare effects and risk

information. However, they noted that they had concerns with the risk assessment performed in the

previous NAAQS review. The EPA judged that four out of the five case studies in that risk assessment

had limited or no value for the purposes of the PA. The panel recommended a robust critical loads

approach as a research priority to fill in this need.

Chapter 6

– Review of th e Secondary Standard

The panel generally agreed with the EPA that the scientific evidence did not support a revision to the

current second ary standard. There was further discussio n about research needs , particularly a detailed

discussion about the critica l loads approach.

Dr. Frey asked the lead discussants to summarize the main points of their consensus responses. There

was then discussion about the research agenda. The members stated that the main human health research

needs were a better understanding of air Pb to blood Pb relationship, a better understanding of the

pathways of Pb exposure, particu larly to young children, and a better understanding of effects of low

level Pb exposure in children.

Due to declining U.S. Pb emissions and the possibility t hat lowering the Pb NAAQS might not provide

any additional health benefit, some panel members suggested that EPA should consider delisting Pb as a

criteria pollutant in the future. There was no clear consensus and the panel discussed the benefits of

keepin g Pb as a criteria pollutant and the benefits of maintaining a Pb NAAQS.

Clarifying Comments from the Public on the PA

There were no clarifying comments from the public so the panel proceeded to the next item on the

agenda.

Summary and Action Items

Dr . Frey discussed the writing assignment deadlines as well as the remaining schedule for the review,

including a follow

- up teleconference on April 1, 2013 from 1:00

– 4:00 PM ET to discuss the draft

reports.

With the panel business concluded, t he meeting was adjourned by M r. Yeow at 11:30 am.6

Respectfully Submitted: Certified as Accurate :

/Signed/ /Signed/

Mr. Aaron Yeow Dr. H. Christopher Frey

Designated Federal Officer Chair

EPA SAB Staff Office CASA C

NOTE AND DISCLAI MER: 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 Pan el members. The reader is cautioned to

not rely on the minutes to represent final, approved, consensus advice and recommendatio ns offered to the

Agency. Such 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.7

Materials Cited

The following meeting materials are available on the CASAC website: http://www.epa.gov/casac , at the

February 5

- 6, 2013 CASAC Lead Review Panel Meeting page :

1 Roster

2 Federal Register Notice Announcing the Meeting

3 Agenda for February 5

- 6 , 201 3 Public Meeting

4 EPA Presentation of Revisions t o Draft Lead Integrated Science Assessment

5 Public Comments from Anita Meyer, Department of Defense Chemical and Material Risk Management Program

6 EPA Presentation

- Review of the National Ambient Air Quality Standards for Lead

- Draft Policy AssessmentA

- 1 ATTACHMENT A

– Other Attendees

CASAC Lead Review Panel Public Meeting

Tuesday, February 5, 2013

Name Affiliation

Brown, James USEPA

Buonanduci, Michele* ARCADIS U.S., Inc.

Cakir, Halil USEPA

Cavender, Kevin USEPA

Datko

- Willliams, Laura USEPA

Dubois, Jean Jacques USEPA

Hines, Erin USEPA

Hopkinson, Jenny* Inside EPA

Hoyer, Marion USEPA

Kotch am, DJ USEPA

Lassiter, Meredith USEPA

Lorenz, Alyson* USEPA

Madden, Meagan USEPA

Martin, Karen USEPA

McDow, Steve USEPA

Meacham, Connie USEPA

Meyer, Anita* US Army Corps of Engineers

Nichols, Jennifer USEPA

Nystrom, Marci* California Air Resources Board

Oakes, Michelle USEPA

Orlin, David USEPA

Owens, Beth USEPA

Peddle, Meredith USEPA

Pekar, Zachary USEPA

Pugh, Barbara* ARCADIS U.S., Inc.

Puthrath, Resha* Navy and Marine Corps Public Health Center

Rak, Drew* Noblis

Richmond

- Bryant, Jen USE PA

Ross, Mary USEPA

Sipon, Kaylan USEPA

Stevens, Tina USEPA

Svendsgaard, David USEPA

Tennant, Ginger USEPAA

- 2

Vinikoor

- Imler, Lisa* USEPA

Weinstock, Lewis USEPA

Wilkie, Adrien USEPA

Wilson, Linda* New York State Office of the Attorney General

Young, Brianna USEPA

*via teleconference

Wednesday, February 6, 2013

Name Affiliation

Blase, Kurt* Holland & Knight

Buonanduci, Michele* ARCADIS U.S., Inc.

Cavender, Kevin USEPA

Hines, Erin USEPA

Hopkinson, Jenny* Inside EPA

Hoyer, Marion USEPA

Lassi ter, Meredith USEPA

Lorenz, Alyson* USEPA

Martin, Karen USEPA

Meacham, Connie USEPA

Orlin, David USEPA

Owens, Beth Osterling* USEPA

Peddle, Meredith USEPA

Pugh, Barbara* ARCADIS U.S., Inc.

Rak, Drew* Noblis

Ross, Mary* USEPA

Ryman, Jessica Inter national Lead & Zinc Research Organization

*via teleconference