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 U.S. ENVIRONMENTAL PROTECTION AGENCY

 + + + + +

 CLEAN AIR SCIENTIFIC ADVISORY COMMITTEE

 OZONE REVIEW PANEL

 + + + + + 

 PUBLIC MEETING

 + + + + +

 THURSDAY, SEPTEMBER 13, 2012

 + + + + +

 The meeting convened in State

Ballrooms A and B of the Marriott City Center,

500 Fayetteville Street, Raleigh, North

Carolina, at 8:30 a.m., Jonathan Samet, CASAC

Chair, presiding.

CASAC MEMBERS PRESENT:

JONATHAN M. SAMET, Chair

GEORGE A. ALLEN

ANA DIEZ-ROUX

HELEN SUH (via telephone)

KATHLEEN WEATHERS
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PANEL MEMBERS PRESENT:

ED AVOL

MICHELLE BELL

DAVID CHOCK

WILLIAM MICHAEL FOSTER 

DAVID GRANTZ

JACK HARKEMA

DANIEL JACOB (via telephone)

FREDERICK J. MILLER

HOWARD NEUFELD

JAMES ULTMAN

SVERRE VEDAL

PETER WOODBURY

U.S. ENVIRONMENTAL PROTECTION AGENCY STAFF

PRESENT:

ANGELA NUGENT, Designated Federal Officer

VANESSA VU, Director, SAB Staff Office

BRYAN HUBBELL, OAQPS

SCOTT JENKINS, OAQPS

KAREN MARTIN, OAQPS

VICKI SANDIFORD, OAQPS

SUSAN STONE, OAQPS

KAREN WESSON, OAQPS
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 C-O-N-T-E-N-T-S

 PAGE

Agency Presentation on Policy Assessment

Overview by Karen Martin. . . . . . . . . . . 10

 by Ms. Susan Stone. . . . . . . . . . . 24

 by Dr. Scott Jenkins. . . . . . . . . . 31

 by Ms. Vicki Sandiford. . . . . . . . . 44

Public Comments

 by Jon Heuss. . . . . . . . . . . . . . 72

 by Roger McClennan. . . . . . . . . . . 78

Panel Discussion on Policy Assessment

Chapter 1 - Introduction

 by Dr. Daniel Jacob . . . . . . . . . . 84

 by Mr. George Allen . . . . . . . . . . 89

 by Dr. David Chock. . . . . . . . . . . 91

Chapter 2 - Overview of Health

 by Dr. Michael Bell . . . . . . . . . . 93

 by Dr. Sverre Vedal . . . . . . . . . . 96

 by Dr. Jack Harkema . . . . . . . . . . 99

 by Dr. Joe Brain

Chapter 3 - Health Exposure and Risk

Assessments

 by Dr. Helen Suh. . . . . . . . . . . .112

 by Dr. Michael Foster . . . . . . . . .114

 by Dr. James Ultman . . . . . . . . . .116

Chapter 4 - Preliminary Conclusions on the

Primary NAAQS

 by Dr. Chris Frey . . . . . . . . . . .123

 by Mr. Ed Avol. . . . . . . . . . . . .134

 by Dr. Fred Miller. . . . . . . . . . .138

 by Dr. Ana Diez-Roux

Chapter 5 - Welfare Evidence

 by Dr. Kathleen Weathers. . . . . . . .155

 by Dr. Peter Woodbury . . . . . . . . .157

 by Dr. Howard Neufeld . . . . . . . . .160
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Chapter 6 - Welfare Exposure and Risk

Assessments

 by Dr. Kathleen Weathers. . . . . . . .165

 by Dr. Peter Woodbury . . . . . . . . .167

 by Dr. Howard Neufeld . . . . . . . . .170

 by Dr. David Grantz . . . . . . . . . .174

Ch. 7 - Preliminary Conclusions on the

Secondary NAAQS

 by Dr. Kathleen Weathers. . . . . . . .180

 by Dr. Peter Woodbury . . . . . . . . .181

 by Dr. Howard Neufeld . . . . . . . . .181

 by Dr. David Grantz . . . . . . . . . .182
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1 P-R-O-C-E-E-D-I-N-G-S

2 (8:30 a.m.)

3 DR. NUGENT: Again, this is Angela

4 Nugent, and it's my pleasure to reconvene the

5 CASAC Ozone Review Panel for this last day of

6 its meeting.

7 Two administrative items, the

8 first one is, I think, our Chair is going to

9 comment on the plans for the day, and when we

10 might wrap up.

11 But, keeping that in mind, I know

12 many of you are heading for other destinations

13 this afternoon. And our contractors outside

14 are ready to see if they can assist you to get

15 a taxi to the airport.

16 So at the break, if you have the

17 desire for a taxi or transportation, sign up

18 with them. And if you have any special needs

19 about when you're leaving, let them know that

20 too. So that's one thing.

21 And the other item is for members

22 of the public, who have an interest to provide
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1 additional clarifying comments, no more than

2 three minutes. After today's Panel

3 deliberations, please, contact me, if you have

4 not already done so.

5 And we ask members of the public,

6 who wish to do that to stay tuned to our

7 agenda and how we're working through it,

8 because the clarifying comments from the

9 public may happen a little earlier than 12:30. 

10 So those were my two thoughts. I know Vanessa

11 has an important administrative item.

12 DR. VU: Good morning. As you may

13 know, this CASAC Meeting is the last meeting

14 that is chaired by Dr. Jonathan Samet. And I

15 would like to take this opportunity to, you

16 know, it's my honor and privilege to present

17 to Dr. Jon Samet a tribute of appreciation

18 from Administrator Lisa Jackson.

19 With that, Jon, here it is for

20 you. I hope you can hang it on your wall in

21 your office back home. The tribute, basically

22 says that, "U.S. EPA tribute of appreciation
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1 presented to Dr. Jonathan M. Samet, in

2 recognition of public service on the EPA's

3 Science Advisory Board and Chair of the EPA

4 Clean Air Scientific Advisory Committee 2008

5 to 2012, signed Lisa P. Jackson,

6 Administrator." Thank you.

7 (Applause.)

8 DR. VU: In addition to the

9 Certificate of Appreciation, Administrator

10 Jackson also wrote you a letter, a personal

11 letter, thanking you.

12 And just an inscription on the

13 letter, she also said thank you for, you have

14 done great service to EPA and to our Nation. 

15 Thank you again.

16 CHAIR SAMET: Okay. Thank you,

17 Vanessa. And this has been great fun. Don't

18 worry, I'm not going to make a speech.

19 And I have one prediction for you. 

20 There will be another Chair of CASAC. This

21 may be picked at random, in fact, so watch

22 out. But I think this has actually been great
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1 fun.

2 I'm impressed by the tremendous

3 amount of work that we all do together, the

4 EPA, this Committee, the Public, who provide

5 comments.

6 And I think the challenge and the

7 fun for me has been trying to put together so

8 many different pieces of so many kinds of

9 information and see what the story is. 

10 Sometimes the story is clear, sometimes it's

11 not.

12 But, you know, I think our job,

13 CASAC's is to help make that story as clear

14 and as strong possible. So I will certainly

15 be watching what happens as you move forward,

16 and we'll see whether I'm sitting around the

17 table with you back here.

18 So, thanks, and thank the

19 Administrator, and I'll find a nice spot for

20 this tribute. So, thank you very much, and

21 let's get on with the work.

22 And just a comment, I think, from
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1 the number of people who've come up to me,

2 which is like everybody who doesn't live in

3 North Carolina, you've all said that you're

4 leaving before the meeting actually ends.

5 Let's see, who is in sort of the

6 pre-getting out of here before noon group? Or

7 roughly noon? Yes, so, okay. So I think

8 that's helpful. I think we'll certainly

9 target getting done before noon, and I suspect

10 that we can. So why don't we get on with

11 hearing from EPA then?

12 MS. WEGMAN: Okay. Great. Good

13 morning, everybody. And let me add my thanks

14 to what Vanessa said, Jon, for all the work

15 you've done.

16 We're so appreciative of your

17 leadership with CASAC over these past several

18 years. We are pleased that this morning Karen

19 Martin feels well enough to join us.

20 And she will be kicking off the

21 presentation on the Policy Assessment and then

22 we have also Susan Stone, Scott Jenkins, and
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1 Vicki Sandiford up here to talk about

2 different parts of the Policy Assessment, as

3 we go through the presentation and the

4 discussion. So I'm going to turn it over to

5 Karen.

6 DR. MARTIN: Okay. Good morning. 

7 While I wasn't here in person the last couple

8 of days, I listened to all your discussions,

9 so at least I come armed with understanding

10 what you all have been talking about.

11 Let me begin by just providing the

12 overview for the Policy Assessment. And this

13 next slide is showing the overview, as you've

14 all seen, as to how the Policy Assessment is

15 organized.

16 And what I want to do is just

17 discuss a little bit about Chapter 1, and then

18 I'm going to turn it over to the rest of the

19 team, Susan, Scott, and Vicki, to discuss the

20 rest.

21 What I want to do is take just a

22 little bit of time on the first bullet on this
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1 page about the introductory chapter. And

2 that's to provide some context for a lot of

3 the discussion that's gone on the last couple

4 of days with regard to our favorite subject of

5 background, and how it's come into play in the

6 past, how it might be considered in this

7 review, and the whys of why it's been done how

8 it was in the past, and why we might change in

9 how we approach it in this review.

10 And it struck me that, while the

11 opening remarks on Tuesday, that Bryan offered

12 about this had something to say on that topic,

13 it might not have gone into enough background

14 to make it as understandable as would have

15 been helpful.

16 So I thought I'd just talk a

17 little bit about some of the things we might

18 have said in that introductory part of the

19 chapter, but we didn't, but we will certainly

20 consider adding to the second draft of this

21 document.

22 And in that regard, I'd like to
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1 take a step back in time and reflect upon the

2 issue of considering attainability and setting

3 the standard, and the extent to which the case

4 law that arise from the litigation following

5 most all of the Agency's decisions on the

6 NAAQS has addressed that issue.

7 And for that, we need to go back

8 to 1979 for the ozone decision when the one

9 hour 0.12 part per million Standard was set. 

10 That standard was challenged for many reasons. 

11 One of which was that, we should have, but

12 didn't, consider whether or not that standard

13 would be attainable.

14 And a finer point was put on that

15 in that litigation by one petitioner saying,

16 furthermore, in my area, in my city, it

17 wouldn't be attainable just because of natural

18 sources of emissions, precursory emissions.

19 And the court very specifically

20 engaged in those arguments, and the court said

21 that, it would defeat congressional intent of

22 the Act to allow attainability to be a
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1 relevant consideration.

2 That basically, the legislative

3 history makes clear that the Act intended

4 these NAAQS to be not lowest common

5 denominator standards as to what everyone

6 could meet everywhere at all times, but

7 rather, standards that were truly defined to

8 be what is protective of public health with an

9 adequate margin of safety from the health side

10 and standards that are intended to protect

11 welfare from known and anticipated adverse

12 effects.

13 So that the court recognized that

14 attainability would defeat that purpose and

15 therefore it wasn't a relevant consideration.

16 It engaged further, even on the

17 natural issue. And it made the point that a

18 national standard, like the NAAQS intended to

19 broadly protect public health, wasn't

20 appropriate to tailor that standard to address

21 circumstances in any one particular area.

22 And this, obviously, has resonance
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1 in looking at our much more sophisticated

2 understanding of the issue of background today

3 than certainly what we had in time gone by,

4 where we can observe peak levels occurring in

5 individual locations at infrequent points in

6 time.

7 And to suggest that somehow those

8 peak concentrations should in some way form a

9 constraint on what the Agency defines to be a

10 standard that is broadly protective of public

11 health would again, not be consistent with the

12 intent of the Act.

13 So that's sort of the long-term

14 history. In bringing us up a little more

15 recently to look at the '97 Ozone Review. In

16 that Review, the Agency brought in the issue

17 of background, both in the concept of looking

18 at calculating risks in excess of background.

19 And it also explicitly brought in

20 background as part of the factors in reaching

21 a final decision on the level of the standard.

22 With regard to the issue about
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1 looking at risk above background in that

2 review, I'll note a couple things. At that

3 time, there was a very simplistic

4 understanding of background. We didn't have

5 the global models to apply, and it was defined

6 to be one level everywhere at all times.

7 And further, and importantly, I

8 think, in looking at the much more limited

9 epidemiologic evidence and clinical evidence

10 in that review, we were faced with a situation

11 where we had absolutely no clinical evidence

12 below a level of 0.08, and the epi evidence we

13 had was interpreted expressly by CASAC as

14 providing evidence of effects that likely

15 extend down to background. And that's a quote

16 from the CASAC advice in that review.

17 So what happened in that review

18 was there was an interpretation by the Agency,

19 by the CASAC Panel advising the Agency, that

20 it was reasonable to interpret the evidence as

21 providing associations down to background.

22 And that set up the notion that it
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1 was therefore reasonable to estimate risk in

2 excess of background. And that when the

3 Agency then engaged in the question of asking:

4 is the then current standard adequate, and

5 looking not only at the evidence, but also at

6 the risk estimates, and asking the question:

7 what is the risk remaining upon attaining the

8 current standard? It seemed reasonable enough

9 to estimate that risk as risk in excess of

10 background.

11 In addition, in reaching that

12 final decision, the Agency was faced with

13 looking at three different levels, 0.09, 0.08,

14 0.07, that was the range the then staff paper

15 had set up. That was the range that the CASAC

16 Advisory Panel, at that time, felt was

17 appropriate to consider.

18 And the Agency addressed all of

19 the evidence-based reasons and the risk-based

20 reasons for why 0.08 was more appropriate than

21 0.09.

22 And then it engaged in the
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1 question of: should we go down to 0.07? And

2 there were three reasons articulated why the

3 Administrator, at that time, decided it was

4 not appropriate to go down to that level.

5 And the three reasons very

6 succinctly are: first of all, not one member

7 of the CASAC Panel supported going to that

8 level.

9 Second of all, it talked about the

10 most certain evidence was the least serious. 

11 There was no evidence from clinical studies

12 below 0.08 and that the more serious effects

13 were much more uncertain.

14 And the third point, in the face

15 of that scientific uncertainty, the Agency

16 also observed that a level of 0.07 was closer

17 to peak background levels that infrequently

18 occurred in some places.

19 And for all those reasons taken

20 together, the Agency made the decision to set

21 the standard at the level of 0.08 that it did.

22 The court engaged in litigation on
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1 that decision, and I'm sure you're aware,

2 there was a tremendous amount of litigation on

3 this decision. But some of the points

4 specifically took on the issue of: were they

5 valid considerations to use as the basis for

6 the standard? And the court decided that in

7 fact they were.

8 The court decided that the most

9 compelling information was the science

10 information and the uncertainty and the

11 absence of evidence below a certain level.

12 But it allowed as to how that in

13 the face of that uncertainty, it wasn't

14 unreasonable for the Agency to consider the

15 other factors, that it was certainly

16 appropriate for Agency to put weight on

17 CASAC's views.

18 And it was not inappropriate to

19 consider the other issues about background,

20 again, in the face of the scientific

21 uncertainty.

22 So when we think about how to take
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1 background into consideration in reviews, our

2 understanding of it is informed by this

3 history of how it is evolved through Agency's

4 thinking and through litigation and court

5 opinions on the reasonableness of that

6 thinking.

7 So, sorry for that diversion, but

8 it just seemed appropriate, given everything

9 I had been listening to, to sort of lay that

10 out.

11 Now, when we come to this review,

12 the question is, why wouldn't we do things the

13 same way? Why wouldn't we continue to

14 estimate risks above background like we did

15 before?

16 Well, I'd make the observation,

17 that in this particular case, we don't have an

18 ISA, or a CASAC Panel saying, we only having

19 evidence effects down to background.

20 We have science evaluation and

21 interpretation saying, we don't discern a

22 threshold, and it's likely that these
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1 associations extend down to the lowest levels

2 that we see.

3 So we're not faced with the same

4 kind of interpretation of the science, that in

5 the first place would have set us up to do

6 risk above background.

7 And therefore, we would judge it's

8 more appropriate, based on the current

9 interpretation of the much, much broader body

10 of epidemiologic evidence available today, to

11 think about calculating total risk and not

12 truncating it at some background level, which

13 we now understand to be quite a complex

14 spatially and temporally variable

15 consideration.

16 And one last point I would like to

17 make about that, is that when you look at the

18 rationales for NAAQS' decisions, not just in

19 ozone, but in other reviews as well, where

20 background isn't really particularly relevant,

21 but where we have to parse the risk

22 information.
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1 What those decisions typically do

2 is they look at the question first of, what

3 does the risk information tell us about the

4 adequacy of the current standard?

5 And there in the past, and whether

6 you define it as risk above background or

7 total risk, you still want to look at what is

8 the risk remaining upon meeting the current

9 standard.

10 But to the extent the Agency then

11 concludes that that information calls into

12 question the adequacy of the current standard,

13 and therefore looks at alternative standards.

14 The way in which we've

15 historically used that risk information is to

16 look at what is the reduction in risk

17 associated with going to an alternative

18 standard, relative to the risk we observe with

19 the current standard?

20 And once you start using the risk

21 information to look at reduction in risk, the

22 differences in risk, then it matters very
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1 little whether your risk calculations were

2 done looking at total risk, or looking at risk

3 above background.

4 Because when you subtract those

5 numbers, the risk attributable down to the

6 lower levels or down to background basically

7 subtract out.

8 In other words, that difference in

9 risk is not substantially sensitive to whether

10 or not you estimated risk down to some very

11 low level, or down to a background level.

12 And that was the point that was

13 being made. In discussing the risk assessment

14 before, that the primary focus is on risk

15 reduction, once we start looking at

16 alternative standards, and therefore it's not

17 particularly sensitive to this question.

18 So I didn't want to belabor that

19 point any more, but it seemed worth trying to

20 bring that history in. Because that's

21 certainly a context that frames our

22 considerations of how we approach the task we
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1 have in terms of doing risk assessments and

2 doing the policy assessment. And it became

3 clear, listening, that that history hadn't

4 been brought into this policy assessment and

5 perhaps would be worth touching upon here.

6 Let me just finish my remarks by

7 completing the information on this chart. And

8 that's just to say that that first chapter

9 does now include a discussion of air quality

10 and focuses very heavily on background.

11 And just to summarize how one

12 would generally interpret the information

13 presented there, is to say that, oh, in

14 general, background concentrations are

15 relatively low across much of the U.S.,

16 including the more heavily populated areas in

17 the East and particularly,\ California.

18 That anthropogenic emission

19 sources are the dominant contributors to eight

20 hour daily max concentrations on days where

21 ozone concentrations are the highest.

22 And where background
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1 concentrations are highest, in the Western

2 U.S. and particularly at higher elevations,

3 key sources contributing to those episodic

4 peak concentrations include wildfires,

5 stratospheric intrusion, and intercontinental

6 transport. So with that, I'll turn it over to

7 Susan.

8 MS. STONE: Thank you, Karen. In

9 considering the policy-relevant evidence to

10 pull forward into the Policy Assessment, we

11 look to the weight of evidence conclusions

12 regarding causality in the ISA.

13 The primary focus is on those

14 health end points for which the ISA concludes

15 the relationship is causal, or likely to be

16 causal.

17 And these include respiratory

18 morbidity and mortality effects following

19 short and long-term exposures and total

20 mortality following short-term exposures.

21 What this means with regards to

22 controlled human exposure studies, is we
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1 focused on the large body of evidence

2 available in the last review.

3 This is evidence primarily above

4 80 parts per billion, which showed lung

5 function decrements, respiratory symptoms,

6 pulmonary inflammation, increased airway

7 responsiveness, and decreased lung host

8 defenses.

9 There was also evidence of lung

10 function decrements down to 60 parts per

11 billion. These were, of course, the Adams

12 studies.

13 When we looked at new studies we

14 focused on studies that evaluated effects

15 below the level of the current standard. And

16 these provided additional information about

17 lung function decrements at 60 parts per

18 billion. And new information about pulmonary

19 inflammation and respiratory symptoms at 60

20 and 70 parts per billion, respectively.

21 As we did in the last review, we

22 considered not only the group mean lung
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1 function decrements, but also the proportion

2 of subjects who experience moderate lung

3 function decrements greater than or equal to

4 a ten percent decrement in FEV1.

5 These are decrements that could be

6 clinically relevant in people with lung

7 disease. And the ISA reports that at 60 parts

8 per billion, on average ten percent of

9 subjects experienced these decrements of ten

10 percent or greater in FEV1.

11 The ISA concludes that across the

12 end points, not only lung function decrements,

13 but also pulmonary inflammation and

14 respiratory symptoms, that studies conducted

15 in healthy subjects likely underestimate the

16 magnitude and seriousness of effects in at

17 risk populations.

18 With respect to epidemiological

19 studies, studies of short-term exposures,

20 these are hours to weeks. In the 2006 Air

21 Quality Criteria document, it was concluded

22 that there was a causal relationship between
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1 ozone exposure and the respiratory morbidity

2 effects that you see listed here and a likely

3 causal relationship between ozone and total

4 non-accidental mortality.

5 The new multi-city and single city

6 studies reinforce the previous evidence. 

7 Reporting ozone respiratory morbidity and

8 mortality effects, including hospital

9 admissions and emergency department visits.

10 And the recent studies continue to

11 report no evidence of a discernable threshold

12 down to levels that are common in the U.S. in

13 the ozone season. These are levels greater

14 than 20 parts per billion, supporting

15 associations between the ozone and these

16 effects at levels below the current standard.

17 The Policy Assessment discusses

18 key issues related to the interpretation of

19 Epidemiologic studies, including confounding

20 by co-pollutants, effect modification, the

21 biological plausibility of the lag structure,

22 and the shape of the concentration response
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1 function.

2 Important new evidence in this

3 review is evidence of effects of long-term

4 exposures. These are exposures of 30 days or

5 greater.

6 In the last review, there was

7 limited evidence of this, primarily from

8 toxicology studies. In this review there is

9 new evidence from epidemiologic studies, which

10 reports associations with respiratory effects.

11 Many with effects related to

12 asthma, including new onset asthma, first

13 asthma hospitalization, asthma prevalence,

14 asthma severity and control, as well as

15 decrements in pulmonary function, changes in

16 lung structure, and respiratory mortality.

17 Several studies report

18 gene/environment interactions. And these

19 studies of susceptibility genes help shed

20 light on the biological pathways most relevant

21 to the disease.

22 And toxicology studies continue to
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1 support the biological plausibility and

2 coherence of the epidemiologic evidence. And

3 so, because, as Lydia and Bryan mentioned, the

4 Policy Assessment does not re-evaluate the

5 science, our charge questions to you are along

6 the lines of, is the presentation of the

7 evidence in the Policy Assessment, does it

8 appropriately reflect the assessment of the

9 science in the ISA? Is it technically sound,

10 clearly communicated and balanced?

11 And so, after we look at the

12 health effects, we consider the public health

13 implications. Thank you, Lydia. I'll turn it

14 over to Scott.

15 And in this we characterize the

16 adversity of the effects, for many effects,

17 clearly they are adverse. The question comes

18 into play when you look at lung function

19 decrements and respiratory symptoms.

20 We used exactly the same criteria

21 for adversity that we did in the last review. 

22 These are the American Thoracic Society
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1 Adversity Guidelines from 1985 and 2000, and

2 the recommendations of the CASAC Panel in the

3 last two reviews, especially.

4 The discussion of the populations

5 at increased risk focuses on the factors for

6 which the ISA concludes there is adequate

7 evidence of increased risk.

8 This results in the same

9 populations at risk as in the last review,

10 except for the addition of diet as a factor. 

11 The ISA concludes that diets with reduced

12 intake of Vitamin C and E increase risk.

13 We have estimated the size of

14 these populations using 2010 data from the

15 U.S. Census and the Bureau of Labor

16 Statistics. And the size of the at risk

17 population is quite large.

18 We have an example here of two

19 non-overlapping groups, children and older

20 adults, which together total more than 110

21 million people in the United States, which is

22 37 percent of the population.
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1 In the Policy Assessment there's a

2 short discussion of the new evidence for the

3 impact averting behaviors. The ISA concludes

4 that this evidence suggests that these

5 averting behaviors may effect risk estimates

6 in short-term epi studies in the United

7 States. And now I'd like to turn it over to

8 Scott.

9 DR. JENKINS: Thanks, Susan. So I

10 am aware that we're pushing our time limit

11 here, so I'm going to try to go quickly

12 through the next few slides so Vicki will be

13 able to talk through the welfare slides, as

14 well, before our time runs out.

15 So I'm going to talk through

16 Chapters 3 and 4. And Chapter 3 is, of

17 course, where we bring in the preliminary

18 results of the first draft of the REA.

19 And I won't belabor the slide,

20 just noting that our focus in bringing forward

21 these results is on the preliminary estimates

22 of ozone related exposures and risks that
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1 remain after simulating just meeting the

2 current standard.

3 We have the list of exposure and

4 risk end points listed there as sub-bullets. 

5 And ranging from the benchmark exceedances to

6 estimates of ozone attributable mortality,

7 hospital admissions, emergency department

8 visits, and respiratory symptoms.

9 As we look forward to the second

10 draft of the Policy Assessment, in addition to

11 these exposure and risk end points we're going

12 to be bringing forward also estimates of the

13 population at risk for ozone-induced lung

14 function decrements.

15 And this is, of course, Chapter 6

16 of the first draft REA, which was sent to the

17 Panel at the same time as the Policy

18 Assessment. So we weren't able to incorporate

19 those estimates into the first draft.

20 In addition to that, we will be --

21 so the first draft, of course, looks at

22 estimates of exposures and risks with the
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1 current standard.

2 In the second draft, we will be

3 looking at exposures and risks remaining after

4 simulating just meeting different alternative

5 standards, as well as what Karen alluded to,

6 which is the incremental changes in risks as

7 you go from one alternative standard to

8 another.

9 In soliciting input from the Panel

10 on this chapter, we are looking for input not

11 only on the way in which we brought forward

12 these estimates of exposures and risks, but

13 also on the utility of the chapter as a whole. 

14 Whether it's in part or in whole redundant

15 with what's in Chapter 4 and what's in the

16 REA. And so any feedback from the Panel on

17 that issue would be appreciated.

18 Okay, the next three slides I'm

19 going to be talking through Chapter 4. And

20 Chapter 4 is, of course, when we get to the

21 final Policy Assessment Chapter 4 is where we

22 will be drawing conclusions, staff conclusions
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1 on the adequacy of the current standard and on

2 the range of alternatives that are appropriate

3 for consideration by the Administrator.

4 So in the first draft of the

5 Policy Assessment we really deal with three

6 main issues. And I'm going to go through

7 those three issues quickly on the next three

8 slides.

9 The first issue is the adequacy of

10 the current primary NAAQS. So bottom line is

11 that when we look at the available scientific

12 evidence from the third draft ISA, including

13 evidence for effects below the level of the

14 current standard, when we look at the

15 exposure/risk information, particularly the

16 evidence for ozone-related exposures and risks

17 that remain after simulating just meeting the

18 current standard.

19 And when we consider the CASAC

20 advice that we received in the last review and

21 in the reconsideration, all of those together,

22 we considered all of those together, and we
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1 reached the preliminary conclusion that they

2 support consideration of revising the current

3 standard in order to increase public health

4 protection against short-term exposures,

5 especially for at risk populations.

6 So as we look forward to the

7 second draft of the Policy Assessment, an

8 additional issue that, I think, we will be

9 spending a lot more time on is the extent to

10 which the current short-term standard provides

11 protection against effects that have been

12 associated with long-term exposures.

13 So, again, we're looking for 

14 feedback from the Panel on this conclusion, as

15 well as on the basis for reaching the

16 conclusion.

17 Okay, the second issue I'm going

18 to raise with regard to Chapter 4 is the

19 preliminary conclusions that we reached

20 regarding the additional analyses that

21 appropriate for the second draft of the REA.

22 So just to clarify, what we're not
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1 doing here is we're not identifying a range of

2 alternative standards that are appropriate for

3 consideration by the Administrator. What we

4 are doing is reaching conclusions regarding a

5 range of levels that are appropriate for

6 analysis in the REA.

7 So when we get to the second draft

8 of the Policy Assessment, which will, of

9 course, be pulling from the second draft of

10 the REA, we will be able to consider those

11 estimates of exposures and risks with the

12 alternative levels and we will actually be

13 reaching preliminary conclusions regarding the

14 range of alternative standards that are

15 appropriate for consideration by the

16 Administrator.

17 When we talk about alternative

18 ozone levels, we're talking about levels

19 within the context of essentially the current

20 indicator averaging time and form.

21 And when we look at the evidence

22 and when we think about CASAC advice that
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1 we've received in the past, what we've

2 concluded or what we noted at first was, in

3 the last review, and in the reconsideration,

4 CASAC recommended that we focus on levels from

5 70 to 60.

6 When we look at the evidence

7 available in the current review, we reached

8 the preliminary conclusion that the new

9 evidence reinforces support for this range, 70

10 to 60. And that, in addition, it supports

11 considering analyzing standard levels somewhat

12 below 60.

13 And so, obviously, this is an

14 issue that we are looking for feedback from

15 the Panel on, you know, to what extent is it

16 appropriate to focus on this range of 60 to

17 70?

18 And to what extent should we go

19 think about analyzing levels below 60, and if

20 so, how far below 60? So those are key

21 issues, obviously, for us as we think about

22 moving to the second draft.
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1 And then the last topic I'm going

2 to touch on with regard to Chapter 4 is, it

3 really relates to how we think about air

4 quality information and epidemiologic study

5 locations within the context of making

6 decisions on alternative standard levels that

7 are appropriate.

8 We've got a couple of different

9 approaches that we put forward and that we

10 talk about in the current first draft of the

11 Policy Assessment. And the first approach is

12 to look at ozone design values and study

13 locations.

14 And if you think about this

15 approach in the context of the current

16 standard, it's actually designed to answer a

17 very straightforward, very simple, simplistic

18 question, and that is, do we have associations

19 with mortality or morbidity that have been

20 reported in locations that meet the current

21 standard?

22 You can ask the same question for
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1 alternative standards. If the answer to that

2 question is yes, you can imagine that it

3 provides some very compelling evidence

4 regarding the adequacy of the current

5 standard, or the appropriateness of different

6 alternative standards.

7 So this design value approach is

8 really designed to answer that sort of very

9 straightforward and simple question. Now we

10 have gotten some comments, and the pre-meeting

11 comments, to suggest that we have understated

12 the utility of looking at studies, the broader

13 distributions of ozone concentrations and

14 studies in areas that would have violated the

15 current standard.

16 And I think we generally agree

17 with those comments. I think there are some

18 areas where we do sort of paint too stark a

19 picture in terms of the utility of those

20 studies.

21 So I do think as we go forward to

22 the second draft, that's something we will
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1 definitely be looking to improve the way we

2 discuss those studies.

3 Because one of the other

4 approaches that we're looking at, is looking

5 at these broader air quality distributions in

6 locations where we have studies that have

7 evaluated concentration response

8 relationships.

9 And so we put forward a couple of

10 examples in this first draft Policy

11 Assessment. And we are looking to refine the

12 approaches that we put forward and expand on

13 these approaches as we move to the second

14 draft.

15 And when we get to the final

16 Policy Assessment, I think our goal is that we

17 will have an approach that builds on what

18 we've learned doing the fine particle review.

19 For those of you who have been

20 involved in that, we do have consideration of

21 these broader PM distributions, as part of a

22 basis for informing decisions on alternative
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1 standards.

2 And so building on what we've

3 learned for PM, we are planning to, well, our

4 plan is to try to build on what we've learned

5 for the ozone assessment.

6 Now we have a couple of issues

7 that I'll just raise here really quickly, that

8 complicate the way in which we consider air

9 quality and these distributions and study

10 locations.

11 And the first one is, how do we

12 interpret confidence intervals? So, given

13 that as we go down to lower and lower ozone

14 concentrations, and we have characterizations

15 of associations at lower and lower ozone

16 concentrations, the confidence intervals get

17 wider and wider.

18 And that's not necessarily

19 reflective of a lack of an association down at

20 lower concentrations so much as decreasing

21 data density. And so, how should we think

22 about those confidence intervals as you get
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1 down to lower and lower ozone concentrations? 

2 The second issue that I'll raise 

3 is really related to the fact that we are

4 dealing with studies that often average across

5 monitors.

6 And yet, we are thinking of those

7 studies within the context of a standard that

8 is based on concentrations measured at the

9 highest ozone monitor.

10 And so, you know, we have to think

11 about the relationships between those average

12 ozone concentrations and the studies and the

13 concentrations that are more relevant for

14 comparison to the standard.

15 And so, you know, and this is an

16 issue that we're grappling with. We,

17 obviously, grappled with it in the first

18 draft, and we'd be looking for any feedback on

19 that issue as we move forward into the second

20 draft.

21 And then finally, I'll just note

22 that for some studies we don't have all of the
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1 data available that we would like, and that

2 necessitates use of surrogates for things like

3 study areas, in some case, or air quality

4 metrics. And so that can introduce some

5 uncertainties into these comparisons.

6 So as we move forward into the

7 second draft, I think I've already implied

8 that we're going to be looking to refine and

9 potentially expand the approach that we have

10 laid out in the first draft for considering

11 distributions of ozone air quality.

12 And then on a slightly different

13 note, we'll also be looking at protection

14 provided. Even though we're talking about

15 short-term standards in this first draft,

16 we'll be looking at the extent to which those

17 short-term standards can provide protection

18 against exposures to long-term concentrations.

19 And so that was a rather quick

20 overview of Chapter 4. I'm going to now turn

21 it over to Vicki, and she's going to talk

22 through the welfare chapters.
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1 MS. SANDIFORD: Thank you, Scott. 

2 As was done in the human health effects side

3 of the Policy Assessment, we also focused on

4 the weight of evidence conclusions developed

5 by North Carolina and the ISA.

6 Primarily focusing on those

7 vegetation and ecosystem level effects for

8 which there was found a causal or likely to be

9 a causal relationship.

10 The vegetation effects published

11 since the 2006 Criteria document supports,

12 strengthens, and is consistent with key

13 conclusions drawn from previous reviews

14 regarding visible foliar injury, growth,

15 productivity, and carbon storage.

16 This new evidence also increases

17 the coherence in the weight of evidence based

18 on new mechanistic studies in the areas of

19 genomics and proteomics.

20 And it reinforces previous

21 conclusions regarding the importance of

22 cumulative seasonal peak weighted exposures
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1 and selecting biologically relevant exposure

2 indices.

3 The vegetation effects evidence is

4 also useful for assessing the adequacy and

5 appropriateness of the current standard, and

6 for considering potential alternative

7 standards to be assessed in the second draft

8 REA.

9 It includes information that helps

10 us determine what the appropriate forms,

11 levels and averaging times would be for

12 further assessment.

13 In considering the public welfare

14 implications of the evidence, staff determined

15 that the adversity paradigm described in the

16 last review was still appropriate, with the

17 addition in this review of impacts on

18 ecosystem services.

19 We did look at impacts on other

20 welfare effects, such as climate and UDB. 

21 However, the information was determined to be

22 insufficient to inform judgments regarding the
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1 adequacy of the current standard at this time,

2 although some of these effects are described

3 qualitatively.

4 The primary focus of Chapter 6 is

5 on the assessments that were conducted in the

6 Welfare Risk and Exposure Assessment, and

7 include preliminary estimates of national

8 scale ozone exposures and vegetation risk in

9 terms of relative biomass loss that remain

10 after simulating just meeting the current

11 secondary NAAQS.

12 In the second draft REA -- second

13 draft Policy Assessment, excuse me, we will

14 look at assessment of other effects that have

15 been discussed here in this meeting, as well

16 as additional analyses on visible foliar

17 injury and crop yield loss, and taken into

18 account, excuse me, recommendations from this

19 Committee.

20 The second draft Policy Assessment

21 will also consider the preliminary results of

22 analyses that have been made available in
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1 terms of the FASOM model and i-Tree models, as

2 well as information that will be added on the

3 forest health monitoring and FIA Data.

4 Chapter 7 is also our chapter to

5 focus on preliminary conclusions regarding the

6 adequacy of the current standard and

7 additional analyses that should be done in the

8 second draft.

9 Regarding the range of alternative

10 standards that would be appropriate for

11 consideration, the first draft Policy

12 Assessment presents our conclusions in regard

13 to form, averaging time and level.

14 And this chapter concludes that

15 it's appropriate to continue focusing on the

16 Cumulative Peak Weighted Exposure Index W126

17 to continue looking at the 12-hour daytime

18 diurnal exposure period, maximum consecutive

19 three months seasonal exposure period, and

20 three year average.

21 With regard to level, in the last

22 review and in the 2010 reconsideration, CASAC
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1 recommended a range of seven to 15 parts per

2 million hours.

3 In this review, we re-evaluated

4 that and came to the preliminary conclusion

5 that the new evidence reinforces support for

6 analyzing levels with that same range, seven

7 to 15.

8 That's it. Thank you, and look

9 forward to your comments.

10 CHAIR SAMET: You're finished? 

11 Okay. All right, good. Thank you, and I

12 think just as a comment, Karen, I think your

13 explanation was very helpful.

14 Sort of thumbing back through what

15 was in Chapters 1 and 4, I think much of what

16 you said is not actually reflected in the

17 current language, and I think it would be

18 helpful if it were augmented, particularly

19 some of the earlier case history.

20 I think that would be helpful to

21 the document. Let me ask if other members

22 have questions or concerns.
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1 DR. VEDAL: I agree, that whole

2 discussion was very helpful. And Karen's

3 perspective was also helpful and has

4 implications for what we do.

5 I just want to make a couple of

6 points. One is a small one. So the first one

7 is that, you know, this issue of the 

8 background not being relevant for the delta,

9 is true, if I understand it, if you're looking

10 at absolute reductions.

11 But proportional or percentage

12 reductions in fact are sensitive to whether

13 you include background or not.

14 The bigger issue has to do with

15 what we do in our deliberations with respect

16 to background. And we had a lot of discussion

17 yesterday about the utility of estimating

18 risk. Not down to zero, but in addition down

19 to some definition of background.

20 And many of us thought there was

21 utility in that and that it would be useful if

22 the Administrator had that information.
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1 Now, after listening to you, I'm

2 not sure that's the path, I'm not sure, I'm

3 not as confident that that's a path that we

4 should go down.

5 So, I guess I wanted to hear your

6 perspective on that whether we should persist

7 in that, with that recommendation.

8 DR. MARTIN: It's hard to argue

9 that a fuller characterization of air quality

10 and understanding more fully what sources

11 contribute to it, isn't in general useful to

12 understand, at least as a backdrop for

13 understanding the context of the levels that

14 you're looking at. On the other hand, it's

15 also hard to argue, in this particular case,

16 that assessing risk above any one particular

17 definition of background, there's no one right

18 way to do it, obviously.

19 And to what extent does that

20 better inform an understanding of the extent

21 to which the current standard is adequate when

22 their primary focus is on broad measures of
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1 national public health?

2 So I don't have a more specific

3 answer to your question, but it depends, in

4 part, upon the purpose for doing it, if it's

5 a general characterization for broad context,

6 that's one thing.

7 If it's intended because for some

8 reason the decision has to hinge on that

9 particular metric of risk, then I fail to see

10 that there's any particular utility to that.

11 DR. VEDAL: I guess we viewed it

12 as it was information that might be useful,

13 couldn't hurt, but not in the sense that she

14 would, you know, that it would be entirely

15 based on that sort of perspective.

16 CHAIR SAMET: Okay, Fred?

17 DR. MILLER: Well, Sverre

18 identified exactly where I've been coming

19 from, and that is, what is the percentage

20 reduction in risk?

21 And I think it is relevant. And

22 I'd like to ask you a couple questions. And
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1 I totally agree that some of the strength in

2 my written preliminary comments would have

3 changed had the chapters, you know, included

4 the kind of discussion that you've just

5 presented.

6 So, I wanted to ask if the

7 attainability that you mentioned in terms of

8 the 1979 part, and the fact that you're using

9 a single value for background, does that

10 violate or aggregate what's being proposed

11 now, with having more region-specific in the

12 ability of the models to take this into

13 account, that in fact, in your risk analyses,

14 you should still be -- I don't think it does,

15 but I just want to make sure, because you

16 didn't mention any subsequent precedent about

17 whether or not, how that ought to be

18 considered.

19 DR. MARTIN: I can see no earthly

20 reason not to take advantage of all the new

21 work that's been done to develop more

22 sophisticated models to allow us to
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1 characterize air quality and background, in

2 particular, in a much more nuanced way. I

3 mean, why wouldn't we use that new

4 information?

5 And even to some extent in the

6 last review that ended in 2008, again, it was

7 risk in excess of background, but even there,

8 it wasn't just a constant level of background,

9 but there was some encompassing of the new

10 model value --

11 DR. MILLER: Okay. All right. And

12 then --

13 DR. MARTIN: So how we approach it

14 as an analytic matter has changed as new tools

15 and data become available to us.

16 DR. MILLER: Okay. And then in

17 your discussion about the 1997 and this aspect

18 of no threshold, the game is changed relative

19 to FEV1 changes.

20 The McDonnell paper absolutely

21 shows it's only one chance in more than 36,000

22 that there is not a threshold for FEV1
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1 changes.

2 So your comment relative to

3 attainability, I think, becomes extremely

4 relevant to that particular risk analysis for

5 that end point.

6 And the other thing is, the

7 epidemiology studies have examined models that

8 have a threshold, don't have a threshold, and

9 it's kind of like the mega mouse experiment

10 where, for the kinds of things that we're

11 involved, you can't say, you can't prove it

12 one way or the other.

13 And so that's why I keep coming

14 back to having additional information on the

15 percent. I totally endorse the strategy you're

16 talking about, the zero risk scenario, and

17 then your alternative standards, how much does

18 it take you.

19 But, in judging between, having

20 the information that the Administrator may

21 need to judge what's the delta in that

22 interval that they can sustain, that's where
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1 the percent reduction in risk comes into play.

2 And I feel like you're going to be

3 asked for and I don't see why you can argue

4 that more information isn't. But it doesn't

5 change the strategy that you're taking of

6 examining the alternative levels, it's just

7 one more piece on a graph or a table

8 somewhere. So that's why I will come back to

9 the percent reduction.

10 CHAIR SAMET: Okay, to be

11 continued.

12 DR. MILLER: Yes.

13 CHAIR SAMET: Ana.

14 DR. DIEZ-ROUX: Yes. I think

15 those comments were also very helpful. I just

16 wanted to make a few comments, to make sure

17 that I'm understanding exactly what is being

18 done in the REA.

19 So, as I said yesterday, and I

20 agree with what Karen was saying, I think it

21 makes total sense when estimating the total

22 deaths attributable to ozone, to use all the
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1 information we have, and extrapolate that to

2 wherever we feel is reasonable, and therefore

3 not use the background as the lower level, if

4 we have evidence that suggests that the dose

5 response curve goes below that.

6 And, of course, there may be some

7 uncertainty about that, and that's true. So

8 that's one point. The second point in this,

9 hypothetically, one might want to estimate the

10 maximum potential benefit of reducing a

11 standard, ignoring the background as well. 

12 What's the maximum potential benefit?

13 However, as I understand it, in

14 the current risk reduction estimates that you

15 have in the REA, you know, where you're

16 estimating both the absolute and percent

17 reduction in risk associated with just meeting

18 the standard, or in the future with

19 alternative standards, you are taking

20 background into account.

21 Because you are, as I understand

22 it, you're setting, you're using background as
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1 the lower bound. So in a sense, the

2 calculations that we have in the document

3 right now are achievable, assuming that

4 reductions below a given background are not

5 possible.

6 I just want to make sure that

7 that's correct, that interpretation is

8 correct. Because that's what you have in the

9 REA right now.

10 And as I understand it, that's

11 what you're proposing to do with the other

12 standards as well. So it is achievable

13 benefit, assuming reductions below background

14 are not possible, is that correct?

15 DR. MARTIN: Right. Because the

16 emission changes that go into simulating just

17 meeting --

18 DR. DIEZ-ROUX: That's right.

19 DR. MARTIN: -- the alternative

20 standards are only changing anthropogenic --

21 DR. DIEZ-ROUX: That's right.

22 DR. MARTIN: -- U. S. emissions.
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1 DR. DIEZ-ROUX: That's correct.

2 DR. MARTIN: As far as that takes

3 them, yes.

4 DR. DIEZ-ROUX: So background is

5 taken into consideration in that portion of

6 the analysis. So I think we have, you know,

7 addressed, you know, we are addressing some of

8 the concerns that people have.

9 DR. MARTIN: It's not truncating

10 some overall estimate of risk at a background

11 level.

12 DR. DIEZ-ROUX: Right.

13 DR. MARTIN: But it does, as Bryan

14 alluded to, take into account --

15 DR. DIEZ-ROUX: That's right. 

16 It's geographically varying and --

17 DR. MARTIN: Yes.

18 DR. DIEZ-ROUX: Now, what that

19 raises, also, is what is it that is being used

20 for the background, right? Because you're

21 going to get different results, depending, we

22 have all these backgrounds, on which
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1 background and which model.

2 So that introduces a whole range

3 of uncertainties in that domain, as well,

4 which it may be important to say something

5 about.

6 CHAIR SAMET: In terms of

7 presentation, I mean, I think, if you had the

8 right pictures to show this. I mean, if you

9 had a circle that comprised total ozone risk,

10 i.e., down to zero.

11 And then you began to fractionate

12 that into that attributable to not meeting the

13 current standard, to meeting a potential

14 alternative standards. The difference between

15 actual and background. Whatever it is, I

16 think something like that would be helpful. 

17 Because, you know, I think part of the

18 confusion here is simply one of terminology.

19 And just sort of getting all this

20 straight in a way that when everybody talks

21 about this, you know, we're all talking about

22 the same thing.
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1 And I think some of our confusion

2 over the last day has simply reflected the

3 complexities of the terminology And as Ana,

4 I think, just made very clear, what the models

5 are doing in the case of background, and how

6 the analysis, how the modeling truncates at

7 the background.

8 So I think those, if you could

9 capture that in a way that everybody could see

10 it, I think it would be extremely helpful.

11 There's both the level of the

12 concentrations and the associated burden of

13 risks that are important to show. Fred.

14 DR. MILLER: Ana asked the

15 question in the right way, and I appreciate

16 it. Because I think that clarifies. However,

17 the way the current material is written, it

18 implies that you just stopped your

19 calculations for the alternative when they

20 were below the LML.

21 And the LMLs are four to five

22 times lower than the U.S. background, the
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1 North American -- whatever background you want

2 to put in.

3 And so I got the impression that

4 you were not terminating it at whatever was

5 the background level in that region, in terms

6 of that, because it's clearly -- you said that

7 you, in the presentations earlier about the --

8 you truncated it only when it dropped below

9 the LML.

10 So if you're doing what Ana asked,

11 and you just implied now, changes

12 tremendously. And I agree, that incorporates

13 what we're, what I'm trying to get at in this

14 percent risk. So I'm confused to how that

15 came across.

16 DR. MARTIN: One observation I

17 would make about the comparison between LML,

18 the lowest measured level in a given study

19 that we're drawing a response function from,

20 and background.

21 The background estimates that are

22 generally presented are longer term average
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1 estimates. They're median values of the whole

2 distribution of background values that occur,

3 that change hour by hour, day to day

4 throughout the year.

5 So the low end of those background

6 estimates are very low, relative to those

7 median values. So the question about: how can

8 a lowest measured level be lower than

9 background?

10 Well, if you're focused on the

11 median background you're not taking into

12 account the whole lower half of the

13 distribution of background values.

14 So the lowest measured level in

15 any given study on the lowest day will clearly

16 be well below that median value of background. 

17 So that would explain why there's such a

18 difference there.

19 DR. HUBBELL: I need to clarify

20 that, because I think there's still a

21 fundamental misunderstanding, to make sure we

22 get this straight.
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1 What Ana was referring to and what

2 you're referring to are different aspects of

3 the analysis. When we do the absolute risk

4 calculations, the total risk associated with

5 a given concentration of ozone, we are going

6 all the way back to the LML or down to zero.

7 What Ana's referring to is: when

8 we are simulating just attaining the

9 standards, when we're moving the air quality

10 distribution down to just attain the

11 standards, the amount that we move the air

12 quality distribution down is limited by U.S.

13 background.

14 So we don't allow for there to be

15 changes in the air quality distribution beyond

16 what would be accomplished by reducing U.S.

17 emissions.

18 But we're still calculating the

19 total risk, all the way down to zero or to the

20 LML. So your concern that you keep raising

21 about what's the percent comparison point,

22 that has not changed from what we talked about
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1 yesterday. All right?

2 So you're still taking the percent

3 of total risk. And so, when you look at the

4 reduction in risk that's occurring between

5 current conditions and just meeting the

6 existing standard.

7 What you're seeing is a percent

8 reduction relative to total risk down to zero. 

9 Not a percent of total risk down to background

10 levels.

11 CHAIR SAMET: So, Bryan, just one

12 point of clarification. So the background, 

13 U.S. Background is where you truncate?

14 DR. HUBBELL: In this particular

15 case, yes.

16 CHAIR SAMET: So I think,

17 actually, I think we don't want to belabor

18 this. I think the point probably is that if

19 we're confused --

20 DR. HUBBELL: Yes, I'm agreeing,

21 we've got to do a better job of laying those

22 out, but --
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1 CHAIR SAMET: Yes, this just has

2 to be better explained. I mean, that's --

3 DR. HUBBELL: Yes, absolutely.

4 CHAIR SAMET: -- probably the

5 bottom line here.

6 DR. HUBBELL: Yes. And I agree, a

7 diagram would probably be most helpful in

8 laying out the different components and the

9 different aspects of the analysis, both in

10 calculating absolute risk and then in

11 calculating the reductions in risk.

12 And I think we just need to

13 clarify that. But I just don't want there to

14 be confusion there.

15 DR. DIEZ-ROUX: You now, a good

16 place where this could go is in that framework

17 chapter --

18 DR. HUBBELL: Yes.

19 DR. DIEZ-ROUX: --in the REA.

20 DR. HUBBELL: Yes.

21 DR. DIEZ-ROUX: That's exactly

22 where this should go.
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1 DR. HUBBELL: No, I've made a very

2 large note saying that we will do that. It

3 looks Chris has got a figure for us.

4 DR. CHOCK: Another issue is the

5 definition of PRB, this adds more confusion to

6 the issues --

7 DR. DIEZ-ROUX: Yes.

8 DR. CHOCK: -- so maybe you have

9 the --

10 DR. HUBBELL: Yes. And again,

11 also to be perfectly clear, while I'm up here,

12 is that while we looked at U.S. Background on

13 this initial calculation of just meeting the

14 current standard, it does not mean that we

15 would limit ourselves to just looking at U.S.

16 Background as one potential definition we

17 would use than looking at alternative

18 standards that might require us to go lower.

19 CHAIR SAMET: Okay. Let me ask,

20 if there are any other questions, because we 

21 probably need to move on. Particularly, since

22 some of you want to truncate this meeting as
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1 background. Anything else?

2 DR. BRIAN: I would just echo what

3 you said at the outset. Karen, your

4 commentary was extremely helpful, and the only

5 request is, you know, to have the same clarity

6 in the document.

7 CHAIR SAMET: Okay. Great. Thank

8 you. And so, we'll move on to the public

9 comment period. And we have two public

10 commenters, George Wolff, by phone on behalf

11 AIR Improvement Resources. Let's see, George,

12 are you on?

13 DR. JACOB: -- can hear me, but I

14 don't think they can hear us.

15 CHAIR SAMET: Yes.

16 DR. JACOB: Yes.

17 MR. HEUSS: This is Jon Heuss. 

18 I'm also on, and hopefully, they'll open up a

19 mic or something and then hear me. Then they

20 can hear you folks too.

21 CHAIR SAMET: So do you want to

22 comment, Ana?
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1 DR. NUGENT: Hello, this is Angela

2 Nugent, the DFO. I ask everybody on the

3 phone, except the public speakers, who are

4 speaking right now, to put their phones on

5 mute.

6 And the public speakers to use a

7 land line, or, and a headset not a speaker

8 phone, please. That makes a big different for

9 audibility.

10 DR. SUH: Actually, Angela, this

11 is Helen. Daniel's been trying to have a

12 comment, and somehow it's been tough to hear

13 us.

14 CHAIR SAMET: No, we haven't heard

15 you at all. So, actually, if, Daniel, if you

16 want to go ahead and make a comment or

17 something, please, go ahead, before we move on

18 to something --

19 DR. JACOB: Yes, and so in the

20 interest of it will be really brief, can you

21 hear me now?

22 CHAIR SAMET: We really can.
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1 DR. JACOB: Okay. So my first

2 comment was, with regard to the consideration

3 of a U.S. Background, of a North American

4 Background, and is, whether that would

5 actually very severely limit you in order, in

6 the expiration of lower standards.

7 For example, you know, if you go

8 to border areas, the U.S. Background can be

9 really high. And so you may not be able to

10 achieve 70 ppb standard, or 65 ppb standard

11 until you had time to get to the 65 or 60 ppb

12 standard, you may not be able to achieve that

13 in that in locations in the inter-mountain

14 west.

15 So at that point, you are not

16 really able to quantify your risk reduction

17 associated with the particular standard,

18 because you cannot meet that standard in parts

19 of a country.

20 And I'm sure you've thought about

21 this, but I wanted to have your thoughts on

22 this. The second question I had was with
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1 regard to the implementation, and it's a

2 little bit connected to that, is that, I

3 understand that the background may not be

4 relevant in terms of quantifying risk

5 reduction, but it's highly relevant in terms

6 of the implementation of the standard.

7 And so the kind of emission

8 reductions that one might have to seek in

9 order to meet the standard, and I was

10 wondering whether that's relevant to the

11 Policy Assessment? Not just setting the

12 standard, but how would you go about meeting

13 it?

14 CHAIR SAMET: Let's see, where's

15 Lydia, or Karen, or, Karen's coming.

16 DR. MARTIN: To address the

17 question of, is it relevant? It's obviously

18 relevant in the broad sense, because setting

19 standards necessarily leads to the

20 implementation of standards, which was one of

21 the reasons why we engaged in this in the

22 context of the Policy Assessment.
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1 But it is clearly not the role of

2 the Policy Assessment to take on a discussion

3 of implementation issues, because those issues

4 aren't relevant to setting the standard.

5 But clearly, the Agency will

6 engage in those issues as a separate, but very

7 related matter, as we proceed to the rule8 making in this review.

9 CHAIR SAMET: Okay. And I think

10 your first question we'll take as a comment,

11 and leave that. Helen, actually, I'm sorry,

12 we ignored you too, do you have anything you

13 want to add?

14 MS. SUH: Well, not at this time,

15 but thank you.

16 CHAIR SAMET: Okay. All right,

17 good. Then we'll move on to the public

18 comment period. Let's see, George, are you

19 on?

20 MR. HEUSS: This is Jon Heuss. 

21 I'm going to be speaking for George. He's not

22 available this morning.
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1 CHAIR SAMET: Okay, Jon, then go

2 ahead.

3 MR. HEUSS: Thank you. We at AIR

4 really have three major comments. The first

5 one, obviously, has to do with background. 

6 And would point out that yours being not NAB

7 is more appropriate for background for most of

8 the U.S., and these comments that the AIR made

9 on the first couple drafts of the ISA.

10 The other comments we made at that

11 point were that the analysis of USB on days of

12 high end of ozone were needed and the impact

13 of USB on observed concentrations rather than

14 USB itself should be considered because of the

15 non-linearities in the ozone formation

16 process.

17 We emphasize that EPA can't

18 eliminate or even reduce emissions in Canada

19 or Mexico, and that the use of NAB instead of

20 USB would penalize the states effected by the

21 Canadian-Mexican emissions.

22 And that the use of NAB instead of
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1 USB would overestimate the risk reduction

2 achieved by lowering the NAAQS. Third Draft

3 ISA was much improved.

4 It endorsed the use of USB,

5 included the most recent GEOS-Chem and CAMx

6 results, included a discussion of days in the

7 high end of ozone distribution, recognized the

8 important distinction between background and

9 contributions to background, and acknowledged

10 that further work is needed to help determine

11 the contributions of background sources to

12 urban concentrations.

13 However, when we started looking

14 at the PA, the first draft, there's a

15 disconnect between the Third Draft ISA and the

16 First Draft PA.

17 The PA only mentions USB in

18 passing. All the analyses shown or done there

19 use NAB not USB. And no attempt to estimate

20 the background impact on urban ozone

21 concentrations has been made yet.

22 So the PA, will not reflect the
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1 state of our knowledge on background ozone or

2 below the risk until these elements are

3 included.

4 Second comment we have relates to

5 the way the consistency of epi associations is

6 stated in the draft. We find many places

7 where the consistency is overstated.

8 I'll give you one example, and

9 it's an important one. EPA talks about

10 consistent positive associations for

11 respiratory mortality in the APHENA study.

12 However, the HEI Review Committee

13 said in all year analyses associations between

14 ozone and respiratory mortality generally

15 close to zero, and not significant in any of

16 the regions or in the combined estimate for

17 all three regions.

18 The APHENA investigators also said

19 they found little evidence for effective ozone

20 on respiratory mortality in any center. This

21 is a huge study, as you know.

22 Now while the associations were
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1 generally higher in the summer-only analyses,

2 only two of the 12 model combinations they

3 evaluated were statistically significant.

4 And when they control for PM10

5 none of the eight model combinations that are

6 presented in the APHENA Report were

7 statistically significant.

8 We'll provide other examples of

9 the way the PA overstates consistency in our

10 written comments. The third major area is the

11 fact that dose plausibility for the more

12 severe effects is not rigorously evaluated and

13 discussed in the PA. It should be.

14 From the control studies, clearly

15 a threshold for the first physiological

16 effects, whether it's FEV1 symptoms,

17 inflammatory markers.

18 And we also know that exercise is

19 very important in terms of how low the

20 concentrations are when these are first

21 perceived.

22 We also know that personal
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1 exposures are very, very below ambient levels

2 90 percent of the time when people are

3 indoors.

4 And all these factors raise

5 questions about the very low concentrations

6 that are implied is causing premature

7 mortality.

8 And if we look at the epi, then we

9 see several studies now that measurement error

10 can give a false linear result. And then we

11 look at the pattern in the individual city

12 associations, it's biologically impossible.

13 When Bell, et al. (2007)

14 restricted -- that asked the says with ozone

15 less than 0.02 ppm, the range in individual

16 city and mortality associations for a ten part

17 per billion increase was widened. It went

18 from minus 20 percent to plus 30 percent.

19 DR. NUGENT: Mr. Heuss, you have

20 one minute.

21 MR. HEUSS: Thank you. Well, with

22 this wide range of individual city
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1 associations, it calls into question, how you

2 can combine these two to understand that there

3 might be a small effect or not.

4 And we would hope that the PA

5 would rigorously evaluate dose plausibility,

6 and consider that as we move forward. Thank

7 you, much.

8 CHAIR SAMET: Okay. Thank you. 

9 Any questions or comments?

10 (No response.)

11 CHAIR SAMET: Okay. Thank you. 

12 We'll move on to our second public speaker,

13 Roger McClellan. Roger.

14 DR. McCLELLAN: Good morning. 

15 It's a pleasure to again address the CASAC

16 Panel. I appreciate the importance of your

17 public service and hard work.

18 I understand the commitment having

19 personally served as Chair of CASAC and on

20 numerous CASAC panels. The challenges you

21 face today are very substantial, as a result

22 of the major improvements in air quality that
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1 have been achieved over the last four decades

2 and the increasing narrow margin between the

3 standards in ambient background ozone.

4 In the brief time I have available

5 today, I want to make several points. First,

6 it's important to recognize your central role

7 in reviewing the adequacy of the current ozone

8 NAAQS as assuring the quality of the science

9 and scientific judgments that will inform

10 policy judgments, that are the exclusive

11 responsibility of the EPA Administrator.

12 The current process is an exercise

13 in using ever changing science to inform

14 policy judgments on the four elements of each

15 NAAQS, the indicator, averaging time, level,

16 and statistical form.

17 Despite efforts by many

18 individuals to streamline the process, the

19 process has become more complex and

20 cumbersome.

21 In my opinion, the process is

22 clearly flawed. Even the most ardent follower
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1 of the process is challenged to keep track of

2 the changing landscape of what has been

3 assembled and interpreted.

4 I submit, that one of the

5 difficulties with the current process, is that

6 it is inappropriately expecting the science to

7 provide public policy decisions.

8 Scientific knowledge can and must

9 inform public policy decisions. However, it

10 is not possible for science to establish what

11 is an acceptable or unacceptable public health

12 or welfare risk.

13 Without clear evidence for an

14 absence of harm, every decision as to a level

15 and form of the NAAQS is a policy decision as

16 to an acceptable level of risk.

17 In my opinion, the current ozone

18 NAAQS process being driving by a view, that if

19 enough effort is expended a wall of ozone

20 science will be created that is so solid and

21 consistent the level informed in the NAAQS

22 will be clear to any observer of the law.
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1 This is a misguided view of the

2 role of science in informing public policy

3 decisions. In my opinion, the EPA staff and

4 CASAC are not neutral, impartial participants

5 in the review process.

6 Each individual brings to the

7 process their professional expertise, their

8 personal ideologies and, in some cases, even

9 preferences for a final rule. I ask you to

10 set aside your personal preferences and focus

11 on the science.

12 It's apparent that the policy

13 judgments involved in the review and setting

14 of NAAQS have been heavily influenced by the

15 results of a few published studies.

16 The importance of these studies is

17 exemplified by EPA obtaining from the

18 investigators information that did not appear

19 in the original publications or supplement. 

20 All such requests and data should be contained

21 in the Ozone Docket and preferably be

22 traceable to the ISA.
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1 Moreover, I urge, that if the

2 results of any particular study are to be used

3 to inform public policy judgments, the

4 original data under-girding those publications

5 and releases should be made available to all

6 qualified scientists.

7 In my opinion, the present draft

8 policy assessment is largely a place holder. 

9 The document contains a Section 4.3 additional

10 analyses to inform second draft policy

11 assessment.

12 In my opinion, the additional

13 analyses are an attempt to giving an answer

14 that may and is indeed beyond the role of

15 science. The specific level --

16 DR. NUGENT: Excuse me, Dr.

17 McClellan, one minute.

18 DR. McCLELLAN: -- inform of the

19 revised NAAQS. It's my view, that in this

20 particular review, current background ozone

21 levels are playing a key role.

22 We have much better information. 
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1 That information deserves to be clearly laid

2 out and analyzed and interpreted. In

3 conclusion, it is well-recognized that science

4 must be used to inform the judgments that the

5 Administrator must make.

6 However, it's important to

7 recognize that the science alone cannot

8 identify the specific level and form of the

9 Ozone NAAQS.

10 Determining how low is low enough

11 involves identifying an acceptable risk target

12 level and form, and I emphasize the importance

13 of the statistical form. These are policy

14 judgments that must be made by the EPA

15 Administrator.

16 It is important that the Policy

17 Assessment document clearly layout the

18 guidelines as to how the science is going to

19 be used to inform those policy judgments. 

20 Thank you for your attention.

21 CHAIR SAMET: Okay. Thank you. 

22 Comments, questions? To those on the phone,
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1 Helen, Daniel?

2 DR. SUH: No.

3 DR. JACOB: No.

4 CHAIR SAMET: No. David?

5 DR. GRANTZ: Does this imply that

6 a series of well-reasoned qualitative risk

7 assessments would be either preferable or

8 sufficient in this process?

9 DR. McCLELLAN: They certainly

10 would have a role. And I'm not arguing that

11 quantitative assessments do not have a role. 

12 In fact, I think I was probably one of the

13 earliest advocates of quantitative risk

14 assessments informing these judgments.

15 What I'm concerned about is the

16 fact we've moved to a process where we keep,

17 by analogy, grinding the flower finer and

18 finer. As my wife once told me, the finer the

19 flower gets the less useful it is for baking. 

20 I think we have a similar situation here

21 today.

22 CHAIR SAMET: Okay. Anyone else? 
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1 Okay. Thank you, Roger. So I think what

2 we'll do is get started and perhaps take a

3 break. Some of you may need to check out.

4 So why don't we get started with

5 Chapter 1 of the Policy Assessment. So let's

6 see, we have Daniel, George, and David. Let's

7 see, Daniel, do you want to go ahead with

8 comments on Chapter 1?

9 DR. JACOB: Yes, sure. Can you

10 hear me?

11 CHAIR SAMET: Yes, yes.

12 DR. JACOB: Okay. So, you know,

13 Chapter 1 is a good start, but it's got some

14 weaknesses that I think should be corrected. 

15 And there's a number of technical points in my

16 preliminary comment. I'm not going to go over

17 this.

18 The one sentimental point, and

19 this is again sounding like a broken record,

20 is about the description of the ozone

21 background. But this is really important, of

22 course, in this Chapter of the PA, to convey
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1 to the reader a good understanding of what

2 does background really represent.

3 And right now, I think that this

4 draft fails to do so. It fails to convey a

5 very important point, which is, that this

6 background doesn't really represent high

7 events associated with stratospheric

8 intrusions, intercontinental transport, or

9 fires.

10 No, that background is really a

11 uniform, fairly invariant, moderately high

12 level of ozone that you get in places like the

13 inter-mountain west.

14 And that uniform background cannot

15 be easily tied to a specific source. It

16 reflects, as I point out in previous comment,

17 just a general behavior of ozone in the 

18 troposphere that ozone increases with

19 altitude.

20 And the PA, right now, it kind of

21 conveys that maybe we should be able to

22 recognize background events in the same way
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1 that we had recognized exceptional events.

2 Well, no, we really can't. And

3 this is, I think, the big challenge in

4 accounting for the background in this

5 assessment.

6 Anyway, there's other points

7 that's, well, okay, another point that I

8 wanted to make that should be really in the

9 PA, is that when it comes to occurrences of

10 high background, and those do happen, so we

11 have this moderate background, you know, that

12 increases with altitude, so background is

13 pretty low at sea levels and it's relatively

14 high at elevated sites.

15 And then, on top of that, yes, we

16 do have occasional events of elevated

17 background. And I think an important point is

18 that the models failed to reproduce them.

19 And they fail for reasons that are

20 very much intrinsic to the transport structure

21 in the models, and that are not easily

22 addressed by simply increasing resolution, or
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1 anything.

2 It really has to do with the fact

3 that the transport say of plumes or of

4 stratospheric layers is very filamented. And

5 this filamented structure is not something

6 that you can probably describe in models that

7 intrinsically do a significant amount of

8 spatial averaging.

9 Finally, I think that the chapter

10 spends too much space on ozone production from

11 fires. And it conveys a notion that fires are

12 a really big deal in terms of the ozone

13 background, in terms of occurrences

14 availability to background.

15 I would say that this is mainly a

16 model result, and like the hot spots over

17 central Idaho is a model result. And, in

18 fact, in the observations you don't see this.

19 And the times where you see

20 elevated ozone associated with fire plumes, it

21 seems to be when those fire plumes are mixed

22 with urban influence.
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1 There's a lot of uncertainty over

2 this, and clearly, you know, we don't yet have

3 a firm knowledge of the contribution of fires

4 to ozone.

5 But we have pretty clear idea that

6 models like CMAQ and also GEOS-Chem, over7 estimate the amounts of ozone that's generated

8 by wild fires.

9 And there's some papers in the 

10 literature to that effect. And I think that

11 they should be cited, and I give references in

12 my comments, in the PA.

13 Right now, the impression one gets

14 from the PA, that the fires make a lot ozone,

15 and I think that should be taken with a grain

16 of salt. That's it.

17 CHAIR SAMET: Okay. Thank you. 

18 George?

19 MR. ALLEN: All right. I have

20 some good news for you. I'm not going to

21 mention background ozone. I think Daniel

22 covered that one sufficiently.
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1 Chapter 1 is really an overview. 

2 It starts out with a pretty detailed overview

3 of the history of the NAAQS and the process of

4 the ozone NAAQS, which I think is very useful.

5 Section 1.2.3, Page 1-7 covers the

6 reconsideration of the '08 Reg. A fascinating

7 chapter in the ozone NAAQS history.

8 It stops short though, in pointing

9 readers to the 2011 Rule that wasn't, which

10 actually is posted on the EPA website,

11 EPA.gov/G-L-0, for ground level ozone.

12 And under there you just click

13 under regulatory actions and there's the

14 entire rule that was sent to OMB, EPA's final

15 take on it, as well as the regulatory, all the

16 other related documents.

17 And it's interesting reading to

18 see where EPA was at in Summer of 2011, just

19 in some piece of the final chapter of that

20 story. I don't know if it needs to be in

21 there, but it's certainly a piece of the final

22 chapter of that story.
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1 Other comments, the chapter really

2 is, it's just a brief summary of the Ambient

3 Monitoring Network. It's four pages. It's

4 pretty much overview of what's in Chapter 3 of

5 the ISA, and that's fine.

6 It has appropriate references. 

7 There is a concise description of the ozone

8 chemistry again, with appropriate references

9 to Chapter 3.

10 And then the rest of it really is

11 the Ozone Background Summary, which I said I

12 wouldn't mention, so I wont. I'm done.

13 CHAIR SAMET: Thanks. David?

14 DR. CHOCK: I only have two

15 points. First, I think the chapter was very

16 succinct, very well written. The title

17 Background, primarily accounts for historical

18 background.

19 I certainly hope that the

20 description by Karen could be incorporated in

21 this section, expand it, so that we can

22 understand the evolution of thoughts on the
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1 approach by EPA.

2 The second point is that I feel

3 that we have been emphasizing the health

4 aspect, but not very much on the welfare

5 aspect. So maybe you ought to expand more to

6 this W126 et cetera, in the write up as well. 

7 That's basically it.

8 CHAIR SAMET: Okay. Thank you. 

9 And I notice that so far you've escaped. 

10 Would you be the summarizer for the comments

11 on this one?

12 DR. CHOCK: Okay.

13 CHAIR SAMET: Thank you. Let's

14 see, and then I think there was, here I think

15 we all probably feel is where you need to very

16 clearly layout what we were talking about

17 before, where we are, background zero North

18 American, you know, the whole bit.

19 Perhaps Chris is going to solve

20 this with a figure, but certainly, that figure

21 ought to have its origins going back to the

22 ISA and the descriptions of ozone production,
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1 generation, air, natural background, and so

2 on.

3 Let's see, who else would like to,

4 other comments on Chapter 1?

5 DR. WEATHERS: I just want to

6 underscore what David said. I think this is

7 an appropriate place to lay out the difference

8 between the W126 and the primary standard, and

9 to make clear some of the differences in

10 justifications for consideration of a standard

11 that has to do with exposure.

12 CHAIR SAMET: Okay. Anyone else? 

13 Let's try Chapter 2 then, before break. 

14 Michelle.

15 DR. BELL: All right, so I don't

16 have a whole lot of comments. I thought this

17 was a very good summary. I also really liked

18 how it focused on being an extension of the

19 2006 document, rather than kind of repeating

20 everything.

21 As is the case with many early

22 drafts, some of the text was a bit unclear. 
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1 And I'll put some more specifics in the

2 comments.

3 Just a couple of examples, it

4 talks about a focus on policy relevant

5 studies. It doesn't talk about what that

6 means, and how those receive special

7 attention.

8 And then there's some other

9 specific information in there. We were asked

10 to think about the level of detail. I thought

11 overall, the level of detail was okay.

12 There were a few places where I

13 thought it would be useful to have some

14 additional information and more clarification,

15 like text on the limitations, even though

16 there was a really nice start talking about

17 limitations.

18 And I put some specifics in my

19 comments, but I won't go over now, but in

20 general, I thought the information on

21 confounding could be better. I thought the

22 language was not strong enough in thinking
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1 about confounding.

2 Information on adaptation and

3 averting behavior was not particularly well4 covered. And at the same time, the document

5 seemed almost a little lengthy. Even though

6 I realize I just suggested adding a lot of

7 things. So as a suggestion of ways to kind of

8 make it more concise in other ways, I thought

9 it should really focus on more clearly on key

10 specific points.

11 This document, I thought, could

12 really take advantage of citing other

13 documents and citing other sections as a way

14 to kind of just pull it down and make it more

15 focused. And I also have Joe's comments, Jon,

16 just to let you know.

17 CHAIR SAMET: Okay. Why don't you

18 go ahead and --

19 DR. BELL: You want me to do those

20 now?

21 CHAIR SAMET: Yes, sure.

22 DR. BELL: Okay. So I have read
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1 his comments, and what I'm going to talk about

2 here, are just things that are different from

3 my comments.

4 So he had a lot of comments that

5 were very similar to mine, so that's good

6 news, that we're on the same page. He also

7 would like more detail on the definitions of

8 the levels of causality and they need to be

9 agreed upon definitions.

10 He spent a lot of time talking

11 about the issue of adaptation and how that

12 needs to be better dealt with. But he did,

13 also overall, think it was a very nice

14 document.

15 He also wanted it to be crisper

16 and more focused. And said that parts of the

17 document seemed more theoretical and

18 philosophical, rather than actually laying out

19 alternatives and their consequences.

20 And thought it would be useful if

21 in the discussion of evidence that if the

22 choices were more explicit and the positive
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1 and negative aspects described, just to be

2 more laid out rather than having it be kind of

3 theoretical. And then the rest of his

4 comments I already covered in my comments.

5 CHAIR SAMET: Okay. Thank you. 

6 Sverre.

7 DR. VEDAL: Yes, I mean,

8 obviously, this chapter's entirely, not

9 entirely, very dependent on the ISA. And

10 we've had a lot of discussion about the ISA

11 already and things that we would take some

12 exception with.

13 And things that we would take

14 exception with are necessarily transferred to

15 the policy assessment. And I won't belabor

16 those, but I will itemize some of the things.

17 In terms of the, you know,

18 appropriately reflecting the ISA, I have a

19 paragraph there. It's not very important. In

20 terms of sort of the balance and whether it's

21 technically sound and scientifically sound,

22 again, it's because of reliance, total
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1 reliance on the ISA.

2 So the things that I have touched

3 on in my written remarks include new onset

4 asthma and the emphasis that's placed on that.

5 You have a section, again, on

6 respiratory symptoms and medication use and

7 you used descriptors like, clearly

8 demonstrate, and then that's followed by three

9 paragraphs, in which it looks like it's

10 anything but clear.

11 And similarly terms like,

12 consistently associated with, again, in the

13 context of respiratory symptoms and medication

14 use where you have ignored the multi-city

15 studies, which provide the information, that

16 it's anything but consistently associated

17 with.

18 There's reference to PFT responses

19 in asthma and non-asthma. I think some of

20 that is appropriate. It's not appropriate

21 when you reference that to FEV1 changes, where

22 they're really, the evidence and the
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1 distinction between asthma and non-asthma is,

2 in my opinion, nonexistent.

3 And that also translates to this

4 charge question regarding human exposure

5 studies. I thought, Michelle has addressed

6 the issue about the confounding issue, and

7 embellishing upon that, somewhat making that

8 more substantial.

9 The last comment I have had to do

10 with as you get to the discussion of

11 adversity. I mean, clearly, that's a tough

12 nut. We all have different opinions on

13 adversity, and by necessity, you've had to

14 rely on the American Thoracic Society

15 statements and the updates to that.

16 One specific thing that I was a

17 little puzzled by was that table of grading

18 responses, where these responses are

19 stratified by normal subjects and subjects

20 with disease.

21 And they have, the diseased

22 subjects' table has some rows in it that are
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1 unique to disease subjects, and that's

2 appropriate.

3 But everything that's common

4 between the two tables are identical. And that

5 puzzled me. And that is something that is

6 graded as a response of, you know, being minor

7 in a normal subject is also graded the same

8 way in a diseased subject. And on the face of

9 it, that seemed to be, that was puzzling. So

10 that's all I have to say.

11 CHAIR SAMET: Okay. Jack?

12 DR. HARKEMA: I agree with all the

13 comments that have been stated. I guess, I

14 was more on the side that I think the emphasis

15 should be placed more on key studies and the

16 ISA and to really limit the amount of the

17 text. But just to focus really on those key

18 studies and not to reiterate everything in the

19 ISA.

20 One area of discussion that was in

21 the ISA over the past couple of meetings here

22 have been cardiovascular effects, and why the
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1 ISA decided not to change the causality on

2 that.

3 And I think that should be

4 captured some how in the document, given the

5 rationale why that, why it is what it is. And

6 there are, I just reiterate what Sverre said

7 about, you have to go back to that ISA now and

8 some things have been included in there that

9 you want to really carefully make sure that

10 that's documented, especially also in relation

11 to the health REA, and the discussion that we

12 had on the threshold model and everything. 

13 It's all captured succinctly in the document.

14 But overall, it captured

15 everything pretty well in here. It's just

16 making sure that the key points aren't lost,

17 the key studies aren't lost in there.

18 And I really liked what Susan

19 presented this morning on her slide. And if

20 you follow that format, I think the next draft

21 will be great.

22 CHAIR SAMET: And Jack, you've
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1 escaped as well, would you be the summarizer?

2 DR. HARKEMA: No I didn't.

3 CHAIR SAMET: You didn't?

4 DR. HARKEMA: I didn't escape, but

5 I will do it if you want me to.

6 CHAIR SAMET: Thank you. Thank

7 you. Sverre, you escaped, didn't you? Okay.

8 DR. VEDAL: You know, I --

9 DR. HARKEMA: On the other hand,

10 if he's --

11 CHAIR SAMET: Thank you, Jack. 

12 You know, just on this point about revisiting

13 the cardiovascular, it seems to me that the

14 logic for a decision sits with the ISA, and

15 that you want to stop there.

16 And certainly, we don't want a

17 revisiting of causal determinations in the PA,

18 having done so in the ISA. I guess the

19 question, whether you want to say, you know,

20 here's what we're advancing for consideration

21 in and around health effects, and we're

22 stopping short on cardiovascular because of a
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1 decision in the ISA. Perhaps, that's how I

2 would have phrased this.

3 But I don't think there's a need

4 to repeat the actual argumentation about why

5 the level of --

6 DR. HARKEMA: You know, what I

7 meant is that why they came to that

8 determination that clearly.

9 CHAIR SAMET: Okay. All right,

10 let's see, Chris.

11 DR. FREY: You know, I've been

12 thinking a lot about David's comment two days

13 ago, about trying to shorten or consolidate. 

14 And, you know, even Dr. McClellan's comments

15 today about, you know, maybe this is getting

16 to be kind of a big, a big process.

17 Do we need Chapter 2 in the Policy

18 Assessment? I mean, if the role of Chapter 2

19 is to say that the ISA reached some

20 conclusions, then that could probably be done

21 in two pages.

22 And if there's some policy
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1 relevant interpretation, maybe that's another

2 five or ten pages. But I guess I wonder, why

3 does it need to be 75 pages of material, and

4 how repetitive is it of the ISA?

5 CHAIR SAMET: And we had a little

6 bit of that discussion yesterday, of course,

7 around these documents and the need for them

8 to be self-contained or not.

9 I mean, I think in theory you

10 could say, based on the ISA here's the causal

11 classification, and here's what we view this

12 from the public health perspective and what

13 we're going to emphasize in the policy

14 analyses and have a very brief chapter.

15 On the other hand, you know, if

16 you feel that you need to describe key

17 studies, which was one suggestion. I mean, I

18 think, it's hard to bound what you get into,

19 I guess.

20 DR. FREY: Yes. I think, well, I

21 know from, maybe it was the PM Panel we had a

22 similar discussion. And if I recall, I think,
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1 and I'm sure Karen can speak to this better

2 than I remember it, but there may be a reason

3 to write some of this, because this ultimately

4 could help be text for the notice of a

5 proposed rule. And that notice would have to

6 be a stand alone document.

7 So there may be some other benefit

8 to it. But, you know, just from, I guess, all

9 of us who publish papers, if we cite a

10 reference, you know, we don't have to

11 summarize everything about that reference.

12 And, you know, if we agree with

13 it, we can simply say we agree with it, an

14 interested reader can go read it, and it's not

15 necessary to defend it extensively.

16 So, you know, maybe there's

17 another purpose here. But for our purpose as

18 CASAC it just seems kind of redundant to

19 review those.

20 DR. GRANTZ: Well, I'm going to

21 make the same comment about Chapter 5. And I

22 agree. And we were told on day one that it
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1 was our role to suggest how these documents go

2 and that it was not required that they be

3 standalone.

4 And I think I would pay some real

5 attention to the comments that Chris has made,

6 because in a sense, there's so much text and

7 so much repetition and obfuscation almost, in

8 these two chapters in particular, that the

9 punchiness of this document, which, I think,

10 it really has to have to be effective, is

11 lost, or is partially lost.

12 It's a very good document. And

13 I'll get to that when I talk about Chapter 5. 

14 But I think this important.

15 CHAIR SAMET: Fred?

16 DR. MILLER: I think if the Agency

17 listens to the comments of the primary

18 reviewers it would work. It serves a useful

19 purpose, and I would not eliminate it.

20 And the reason for that is, there

21 are people who are going to only look at this

22 document and just eliminating and requiring
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1 them to go to the others. I think if this is

2 more succinct and incorporates the comments,

3 it serves a purpose, and I would not endorse

4 totally eliminating it.

5 DR. SUH: This is Helen.

6 CHAIR SAMET: Helen, go ahead.

7 DR. SUH: Okay. You know,

8 actually, I was thinking about this also in

9 relation to the next chapter that we're going

10 to talk about, Chapter 3.

11 I guess, I think that the summary,

12 a targeted summary could be useful and helpful

13 in providing some background information for

14 the subsequent Chapter 4.

15 But I do think that the summary

16 really has to be targeted to the key questions

17 in Chapter 4. And I saw that that was done in

18 Chapter 2 with the Public Health

19 considerations.

20 But I'm wondering, if perhaps, the

21 summary might be made tighter where some of

22 the key findings and maybe other key
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1 associated findings are brought forward from

2 the ISA.

3 And then those, especially the

4 ones that are going to come through again in

5 Chapter 4, but really have that summary be

6 targeted to some of the key policy questions.

7 Now how that gets divided with

8 Chapter, you know, between Chapter 2, 3, and

9 4, you know, it's a little bit tricky. But I

10 do think there is a real possibility of having

11 a much, much more succinct and targeted

12 summary towards the key questions that come

13 out of Chapter 4, about the form and averaging

14 time, and things like that.

15 So I think there is a need for a

16 summary, but I think it could be a lot more

17 crisp. Not crisp so much, but is targeted to

18 the questions at hand in the PA.

19 CHAIR SAMET: Let me check,

20 Daniel, do you have any comments on this point

21 before I forget that there are people on the

22 phone? Okay, guess not. Chris?
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1 DR. FREY: Yes, I'm happy with the

2 idea of not eliminating it, just to follow up

3 on Fred's comments. But I think also, if we

4 think about the ISA, I mean, we have

5 encouraged EPA to write, you know, a preamble,

6 an executive summary, an integrative chapter.

7 And so someone who, you know,

8 reads a short summary of the ISA here can go

9 to a fairly short summary in the ISA itself,

10 that is a little bit more detailed. And then,

11 if they really want the full thing they can

12 read all the chapters.

13 So I think we have a kind of

14 layered approach to, you know, if the

15 reader's really interested, it's not that hard

16 to go. And, you know, if these are on the Web

17 and hyperlinked it would be easy to bring

18 people to the more detailed content.

19 CHAIR SAMET: So, I think you've

20 had a range of opinions. I think with the

21 idea of a quote targeted summary, I think one

22 problem with what is here, it's not clear why
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1 it's here.

2 And whether you've picked the most

3 important things and studies that you're going

4 to rely on most heavily, or whatever.

5 And then, you know, there's text

6 here that just doesn't need to be here. Page

7 268, future studies of these and other genes

8 and human populations will be important for

9 determining the role of each genotype and its

10 effect on risk, as well as finding coherence

11 across the disciplines. Strike it out.

12 I mean, you know, there's, just go

13 back and, you know, this is certainly not the

14 place to speculate about what might be needed

15 in the future.

16 So, I mean, I think there's a lot

17 of people commenting on this already, just at

18 this point, loose writing here that needs to

19 be fixed.

20 But I think, you know, you're

21 going to decide what you need to do, but I

22 think this needs to read in a way that says,
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1 okay, here's Chapter 2. You have this huge

2 ISA, and here's some things we're bringing

3 forward to discuss more importantly, to

4 discuss in the PA, because of blank, because

5 these are the most important, because these

6 are critical studies, because these are the

7 new advances. Whatever it is, so the reader

8 actually knows why the material's here.

9 And, I think, when I read this

10 it's just, it's very hard to understand why

11 you picked one thing and not another. I

12 think, which is the basic problem. Fred?

13 DR. MILLER: I don't know who

14 provided the comment, but I think the idea of

15 making sure that this sets up for the kinds of

16 analyses that are done in Chapter 4, it really

17 ought to be the thrust of this.

18 And a lot of this other is extra

19 verbiage, as you're indicating. And so if

20 they take it that way, then the Chapter really

21 becomes not only shorter, more focused, but

22 also underpins what kind of analyses and why
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1 they need to be done.

2 CHAIR SAMET: Okay. So let's do

3 Chapter --

4 (Off microphone comment).

5 CHAIR SAMET: Okay. Yes, Peter.

6 DR. WOODBURY: I'd just like to

7 register my agreement with this. And we

8 discussed yesterday sort of this cone idea

9 that we're going from the large ISA to the

10 risk assessments, to the policy documents.

11 So, I think, you know, that

12 narrowing down would imply that the policy

13 document is resting most heavily on the risk

14 assessments, and should not be spending so

15 much time on the ISA. I think I may be trying

16 to summarize a few recent comments here.

17 CHAIR SAMET: Okay. Thanks. Is

18 everybody okay with moving to Chapter 3? 

19 Okay. So let's do Chapter 3, because we're

20 going to lose Helen.

21 DR. NUGENT: Do you have to leave

22 right after Jack?
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1 CHAIR SAMET: We do, Jack.

2 DR. NUGENT: Jack.

3 CHAIR SAMET: He volunteered. 

4 Chapter 3, Helen.

5 DR. SUH: Okay. So can you hear

6 me?

7 CHAIR SAMET: Yes.

8 DR. SUH: So, actually, in some

9 ways Chapter 3, the comments echo what's been

10 voiced for Chapter 2. So Chapter 3 is really

11 a overview of the REA, the findings.

12 And I thought, actually, that the

13 summary was fine. And that it was clear and 

14 it brought forward the major findings from the

15 exposure and the risk assessment.

16 And there were two parts to the

17 charge question. One was, was it clear; but

18 two, was it necessary. I guess, you know, it

19 is just a very strict summary of the findings.

20 And there's no interpretation or

21 no discussion about how those findings pertain

22 to later judgments. And I guess, as it is,
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1 you know, then you start to question about

2 whether or not it's really necessary.

3 And I think, just as I had said

4 for the previous chapter, I think that such a

5 chapter is important, but perhaps at the

6 beginning of the chapter there could be a

7 overview about what the summary's intended to

8 do.

9 And instead of being a summary of,

10 really just a flat summary of the results,

11 it'd be a summary of what is being brought

12 forward and why.

13 And then perhaps at the end there

14 could be a discussion about how these findings

15 might be related, will be related or will be

16 used in the subsequent Chapter 4.

17 So I think, perhaps, a targeted

18 summary with more contexts about its

19 importance would, I think, be helpful. So, as

20 it is now, I don't think it's that useful, you

21 know, and I would maybe argue that maybe it

22 could be dropped.
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1 But I think that if it became a

2 targeted summary, with some more

3 interpretation and explanation of why this is

4 related to the PA, and why these findings, the

5 ones that are being brought forward, I think,

6 then it would be a very important and useful

7 addition.

8 CHAIR SAMET: Okay. Thank you. 

9 Mike?

10 DR. FOSTER: So I agree with

11 everything Helen has said so far, in terms of

12 redundancy, of some of the information. But

13 I think, Scott, in your introduction, you

14 emphasized that you wanted to bring in at the

15 preliminary results were good estimates of

16 exposure, estimates of mortality, hospital

17 administrations and respiratory effects based

18 on epidemiology studies.

19 And I think this is a really good

20 summary, the way you've approached it from the

21 ISA, which as other people have said, it's

22 been through its third iteration, so there's
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1 plenty of discussion of that. And I think

2 you've folded it in fairly well. It's

3 informative kind of background for the policy.

4 But, the other part of the, a

5 little bit on risk assessment and risk

6 exposure, is out of my kind of area of

7 expertise. But it is alluded to the fact that

8 in the next iteration of the policy you'll be

9 spending time on pulmonary function per se,

10 and obviously, I'll be able to weigh in much

11 more heavily on that.

12 The other thing is, I think,

13 intentionally, sometimes people intentionally

14 do redundancy because you're trying to drive

15 home an impact.

16 But there's clearly, as you

17 probably know, in Chapter 4 and Chapter 3,

18 there's clearly pages that are absolutely,

19 it's in my notes to you earlier, that are

20 completely identical.

21 So there's a reason for that, I'm

22 presuming, but from wordsmithing, you could,
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1 you've heard already, that you could probably

2 be more economy. Thank you, Jon.

3 CHAIR SAMET: Okay. Jim?

4 DR. ULTMAN: Yes, I didn't really

5 have much to add to what, I agree with what

6 was said before. The only additional comment

7 I had was that, there was a use of text where

8 I think tables, or I'm sorry, yes, where

9 tables could be more effective.

10 And for example, some of the

11 bullet items you used to summarize the risk

12 assessment on Page 3.7 and 3.8, for example. 

13 It's just kind of bullet items listing

14 results.

15 But if you can put them in a

16 table, it makes it easier to appreciate them. 

17 And then you can bring in a little bit more

18 information instead of just talking about just

19 one population, for example. You could

20 compare two populations in the same table.

21 So I would just go to some tables

22 and that will cut down on maybe in the text a
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1 little bit as well. And obviously, this

2 direct redundancy, it's bothersome.

3 You know, if you're going to put a

4 table in Chapter 3, and you want to use the

5 information in Chapter 4, just refer back to

6 the table, don't repeat it. The other thing

7 I thought were that some figures would help

8 explain the risk assessment process, it might

9 help people a little bit.

10 So you can see exactly what the

11 input data is and what the output data is and

12 how that data is being processed. Some type

13 of a table.

14 There's already figures in the

15 REA, Example 3.1 and 3.2 are currently in

16 there or something along those lines,

17 explaining this process. And that's about it.

18 CHAIR SAMET: Okay. Thanks. 

19 Mike, I would like to bestow on you the honor

20 of summarizing for Chapter --

21 DR. FOSTER: Graciously accept.

22 CHAIR SAMET: Thank you. Other
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1 comments on Chapter 3? Fred?

2 DR. MILLER: Just like with

3 Chapter 2, setting up 3, to me, the third

4 charge question for Chapter 4 would greatly

5 benefit by looking at some of the

6 distributions that you're talking about in a

7 subsections of them and laying this out in

8 Chapter 3.

9 Because that is one of the areas

10 where you're talking about the studies where

11 the dose metric was above the standard and how

12 to partition out.

13 And so, to me, this is where you

14 do the set up for what kind of information. 

15 And in Chapter 4 in the current draft, you

16 just elude to some numbers and postulating and

17 wanting feedback.

18 But as you do the analyses that

19 would maybe support that, they belong in this

20 Chapter, and that would give it the focus

21 that, again, setting up for what needs to

22 underpin what you want to do in Chapter 4.
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1 CHAIR SAMET: Okay. Anyone else,

2 anyone on the phone, Daniel? Maybe not there. 

3 Any other comments? Just, I'll point out on

4 the Page 314, you have this discussion of

5 quote key sources and variability and

6 uncertainty, which, first of all, it's just

7 cribbed. We've seen this about seven times. 

8 It appears in every chapter.

9 But, second, this is probably not

10 the right place for it. And certainly, if

11 this is the set up for discussing variability

12 and uncertainty, that would probably be better

13 placed in Chapter 1 and offer better framing

14 of the concept. Okay, other comments here?

15 Okay, so, I would suggest, that we

16 take a quick break till 10:30 a.m., and give

17 everybody a chance to check out. So let's try

18 to get back by 10:30 a.m.

19 (Whereupon, the above-entitled

20 matter went off the record at 10:19 a.m. and

21 resumed at 10:30 a.m.)

22 CHAIR SAMET: If everybody could
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1 take their seats, we're going to get going. 

2 So, if everybody could take their seats. The

3 taxicabs are lining up and people are getting

4 antsy.

5 All right, a couple of quick

6 comments. One is that, those of you who are

7 doing the response on the charge questions

8 that have been designated on the chapter

9 reviews, remember that you need to develop the

10 answer to the charge questions based on what

11 you and your colleagues have written,

12 amplified by the discussion here.

13 So if you could remember, that's

14 what you need to do. So we do need to respond

15 to the charge questions and shape that.

16 And then, I think, when we talk

17 about this on the phone, the important points

18 that we want to bring forward to the letter,

19 letters, in fact, we will need to pull those

20 out. And I think those have been some of the

21 major topics of discussion around the table

22 today.
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1 I think the other, usually I'll

2 turn to Angela for this, would be the schedule

3 for getting these, and again, following usual

4 practice.

5 We'd like to get these in quickly. 

6 And we will, of course, have a follow-up phone

7 call to review the first draft's letter and

8 comments to the Administrator.

9 DR. NUGENT: Right. So we'll be

10 in touch about follow-up teleconference likely

11 to happen some time in October. But, you

12 know, I'm one of these people who like things

13 to happen quickly.

14 And, you know, would it be

15 unreasonable to ask for your comments within

16 the week, you know, while it's fresh in your

17 mind for the write ups? Hearing that's okay,

18 and no disagreement, let it be. So thank you. 

19 A week from today, next Thursday.

20 You can, the SAB Staff Office is

21 going to kind of work together on the next

22 step, so I may not be your point of contact,
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1 but you can send the comments to me, and I'll

2 make sure that the right people get them.

3 CHAIR SAMET: Go ahead.

4 DR. MILLER: One clarifying

5 question is, as we're working with the

6 subgroup that is charged with, you know,

7 integrating like per se, Chapter 7 comments,

8 do we have to copy the DFO on all of us, or

9 you just want the final thing from the first

10 in charge, which is it?

11 DR. NUGENT: Please copy me on all

12 the --

13 DR. MILLER: Okay.

14 DR. NUGENT: -- communications

15 related --

16 DR. MILLER: All right.

17 DR. NUGENT: -- toward this Panel.

18 DR. MILLER: Okay. I hope you

19 have a large email box.

20 (Laughter)

21 CHAIR SAMET: Okay, let's go to

22 Chapter 4. Chris?
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1 DR. FREY: Okay. Let's see,

2 Chapter 4, I think there were several charge

3 questions, if I'm correct. And so, in

4 answering the charge questions, I'll focus on

5 that and then I'll say some other things.

6 So, I think for the first one,

7 basically is how does this chapter

8 characterize and consider available health

9 evidence and so on, in reaching the

10 conclusions about the adequacy of the current

11 standard?

12 I think the material is there for

13 the reader to come away with the idea there's

14 a strong justification for the conclusion that

15 the current standard is not adequate.

16 And the term preliminary is used

17 in front of conclusion, the preliminary could

18 be deleted throughout. But I think the

19 rationale is not clear. And the chapter

20 really needs a conceptual framework to help

21 the reader understand why things are in the

22 chapter, or why things are not in the chapter.
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1 So, I mean, clearly, the

2 determination has to do with weight of

3 evidence. It has to do with short-term risk

4 assessment. It has to do with long-term risk

5 assessment, and so some overview of that.

6 And a preview of, you know, which

7 were the most significant considerations among

8 say those three categories, or maybe there's

9 better ways to catagorize it. And then within

10 those categories there's additional

11 considerations.

12 And it seems to me, that the

13 chapter spends a lot of time, and is very

14 repetitive about epidemiologic studies from

15 the perspective of whether the conditions of

16 the air quality data for those studies were in

17 compliance with the standard or not, and

18 what's the design value.

19 And, as a reader, I really could

20 not figure out why that was there. I think I

21 could invent reasons for why it was there, but

22 it was never articulated.
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1 So I found it a very frustrating

2 chapter to read. And as I will say later,

3 it's very repetitive. Parts of it are well4 written, but parts of it, or aspects of it are

5 very poorly written.

6 It was to the point where if a

7 student had turned that into me I would have

8 just given it back and said, you know, do this

9 over.

10 So I hate to be that harsh, but

11 for something that goes to a panel of 20

12 really busy people, it just, to me, was not an

13 acceptable piece of writing.

14 So, you know, for example, in the

15 epidemiological thing, there's discussions

16 about what seems to be implied as an exclusion

17 criteria for maybe not considering epi

18 studies, which is that, the design value of

19 air quality during the time period of the epi

20 study was above the standard.

21 And there's a lot of discussion of

22 that, and with regard to short-term epi
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1 studies. And I couldn't figure out, why do we

2 care for a short-term epi study about a design

3 value, which, by the way, the definition of

4 that is based on a three year average of

5 fourth highest annual, you know, daily maximum

6 eight hour values.

7 So what epi study uses that as the

8 metric of exposure? I don't think any epi

9 study ever has used the design value. So I

10 couldn't figure out, why is that relevant to

11 looking at the validity of the concentration

12 response function at levels either above the

13 standard, or particularly below the standard.

14 I think the relevant scientific

15 question is, is there adequate data in the epi

16 study at the averaging time of interest that

17 is below the levels of the current standard,

18 and can we use that in risk assessment?

19 Now I could imagine, if there were

20 epi studies at areas with design values below

21 the current standard, that would give us more

22 direct empirical evidence as to the health
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1 effects below the standard, but the document

2 never says that very clearly. I couldn't find

3 that.

4 So I could see why it would nice

5 if we had such studies, but the fact that we

6 don't have such studies by in large, to me,

7 doesn't, it's not a significant shortcoming of

8 the scientific evidence.

9 So I have a lot of comments on

10 this point, just because it comes up over and

11 over and over again in the chapter, which is

12 also just another indication it's not well13 organized.

14 This issue should be addressed

15 once and, you know, dispatched, and then move

16 on to something else. John, you want to do

17 all the charge questions? I'll do the other

18 charge questions here, okay.

19 So then, the second charge

20 question, to what extent does the PA help

21 inform looking at alternative standards?

22 So, I think, you know, it's very
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1 clear, I thought it was extremely clear that,

2 you know, 70 ppb is a level that ought to be

3 looked at. It's been looked at before.

4 Evidence is still there that

5 that's probably more health protective than

6 the current standard, which is not adequately

7 protective, which I think, is well-established

8 in the PA.

9 And 60 ppb also makes sense as a

10 level to look at. I think there's some places

11 where the document talks about 80 ppb. I

12 think there's no need to address 80 ppb

13 anymore.

14 Maybe there was some other reason

15 for that, but again, there's no conceptual

16 framework for the chapter, so I don't know why

17 that was there.

18 The Policy Assessment provides,

19 but doesn't state, and again, you know, if EPA

20 wants our reaction to things, I would rather

21 they propose what they want to do.

22 What is it that they want to do
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1 below 60, if anything? I think an argument

2 could be made to look at 55. An argument

3 could be made to look at 50. That would be an

4 interesting discussion to have. I don't know

5 if that's a discussion we want to have today. 

6 But, anyway, I think there's information there

7 as far as a short-term health standard.

8 There's a preliminary conclusion

9 that there's not a need to consider a long10 term average for a new health standard. And,

11 I couldn't really figure out the rational for

12 that conclusion. And not that I necessarily

13 disagree with it, but just as it was stated,

14 I didn't really get why that was a conclusion.

15 You know, there is likely, I think

16 it was likely to be causal for long-term

17 effects from the ISA for long-term. And, you

18 know, there is a significant body of evidence

19 related to that. So it wasn't clear that that

20 could easily be dismissed.

21 And I'm not arguing that it should

22 be included, but I guess, I'm arguing for a
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1 clear articulation of why it's implied that

2 that's not going to be pursued.

3 Now there is some other language

4 in this chapter that says, to the effect that,

5 well, setting a short-term standard could also

6 be protective of longer term average related

7 health effects, and that there would be some

8 analyses of air quality relationships to look

9 at that.

10 And I think that's good and I

11 certainly support that analysis. But, I

12 guess, I would just like more clarity on EPA's

13 thinking behind why not consider a longer term

14 standard.

15 Okay. Then, moving on to the

16 third charge question. So, I guess I won't

17 read the whole thing, but as far as the

18 question, you have it up on the screen.

19 My general thought was that this

20 chapter, this section of the document was

21 generally reasonable. But that, I really

22 think the key factors to consider, when
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1 looking at the relevance of these epi studies,

2 more important than whether the design value

3 was above or below a standard, was the extent

4 to which they're based on air quality data

5 with concentrations that are below the

6 standards, such that we can develop with

7 confidence, concentration response functions

8 that allow us make predictions of health

9 effects below the standard.

10 And something about the level of

11 confidence in those concentration response

12 functions and a range of interest, I suspect

13 50 to 75 ppb is going to be a key range of

14 interest.

15 Below 50, that, we may be

16 interested in, and I think, as Fred as talked

17 about, maybe looking at what is the risk

18 associated with background concentration, so

19 that might be roughly 30 to 50 ppb down to

20 zero.

21 But, I think, in terms of what I

22 understood Bryan Hubbell to describe, looking
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1 at the incremental risk reduction of the

2 current standard to alternative levels, that's

3 likely to be in the range of 75, as the

4 current standard looking at 70, 60, 50, 55. 

5 It's not clear what might happen below 60 in

6 this analysis.

7 But I think if we have epi studies

8 that are, you know, have good empirical bases

9 in those concentration ranges, whether it was

10 the design value of the current standard or

11 not, to me, seems irrelevant.

12 I have a lot of detailed comments,

13 which I am not going to go through. I am

14 going to say, just, I know Vanessa doesn't

15 want us to spend our time editing, but I just,

16 I have tremendous respect for OAQPS, but this

17 is the worst written chapter I've ever read in

18 my time on CASAC.

19 And I have a lot of suggestions

20 for how to improve it. I think it could be

21 much better and much shorter. And I put in a

22 few examples, just to illustrate, you know,
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1 when I say, you could cut things by 90

2 percent, I really mean it.

3 I mean, you could take five lines

4 of text and replace it with the word

5 therefore, and no loss of content. So I

6 really encourage someone to do some editing of

7 this chapter. Because it's going to lose its

8 punch if it's way too long and wordy and

9 repetitive.

10 You know, to me, a policy

11 assessment should be the most accessible, easy

12 read of all of these documents, because this

13 is going to go on beyond our technical

14 community to decision-makers, and it's really

15 critical that it be easy to read. That's it.

16 CHAIR SAMET: Okay. Thanks. 

17 Chris, loved it. Okay, Ed?

18 MR. AVOL: I just have a couple of

19 things, one of the advantages of going after

20 Chris. I think a lot of the elements are in

21 place here, but some of them are just

22 promised, about to be delivered, but not
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1 delivered on here.

2 And then, as it had been

3 mentioned, there's a lot of repetition and a

4 lot of extra stuff. There are a couple of

5 things that I want to comment on, because in

6 some cases, I think, the wrong perspective is

7 given, or potentially, maybe it's just not as

8 neater, maybe it's a little too sloppy.

9 And so on one case, for example,

10 at the end of Page 4.4 there was talking

11 about, the end of the paragraph, it talks

12 about recognizing that a zero risk standard is

13 not required by the Clean Air Act. And that's

14 true, but the tenor or it, I think, is not

15 quite right.

16 For me, the issue is not so much

17 that zero risk standard, which is true, but

18 rather that the public's health with an

19 adequate margin of safety is the issue. And

20 so, I think, that it's maybe just a

21 perspective, but I think it's a different way

22 of sort of how it's presented.
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1 And there's a section in there

2 where it talked about some of the information

3 on lung function results and use of the word

4 normal. Now I'm from California, so the use

5 of the word normal has no context for me.

6 (Laughter)

7 MR. AVOL: But, you know, in

8 health effects studies and research, the only

9 way I could qualify the use of normal would be

10 if it was, you know, age, height, gender, race

11 adjusted, and so, I think, you can't just sort

12 of throw around normal. That's just another

13 example, I think, of where the wording is sort

14 of a little loose.

15 There's a comment later on Page

16 4.40, about the likelihood that the serious

17 adverse responses to ozone exposure's likely

18 relate to frequency of exposures. And to some

19 extent that's true, but I don't want you to

20 forget that, you know, there is a phenomena

21 known as toleration or adaptation.

22 And so, for out of seasonal, one
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1 exposure in the early Spring has been shown to

2 be pretty effective in terms of the listening

3 response, if you haven't been previously

4 exposed.

5 So it's not just the case that the

6 long exposure effects, there's been

7 information that data has shown that

8 repetitive exposure sometimes blunts the

9 response. So I think, take a look at that and

10 sort of look at that.

11 Finally, not to beat on something

12 that we've already beat on for a couple days,

13 but I mention it, at Page 453 there's this

14 conversation about long-range transport and

15 background and exceptional events and so

16 forth.

17 And again, in the context of the

18 background discussion and what's in and what's

19 out, and I think you should take a look at

20 that and sort of try to tighten it up. But as

21 Chris mentioned, probably tightening up the

22 whole chapter, I think, would be something
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1 that would be well done.

2 CHAIR SAMET: Okay. Thanks. 

3 Fred?

4 DR. MILLER: Well, I hardly know

5 where to begin, because I'll make the analogy

6 to the political Republican and Democratic

7 views.

8 I am as far away from Chris on

9 this chapter as you could possibly get. I

10 have read lots of policy documents and things

11 and this is the most well-written chapter that

12 I have ever read.

13 (Laughter)

14 DR. MILLER: For example, Section

15 4.2.1, you couldn't write a better legal brief

16 than what this has. If I had to make the

17 analogy to Perry Mason and to Matlock, all the

18 evidence about how you put it out, you say

19 what you need to have and then you go and you

20 interpret and you say how you're going to use

21 it.

22 It's all here, and then Matlock
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1 comes in and explains it in common language

2 such that we the jurors can follow it. So I

3 am absolutely totally at the other end.

4 And I don't know, maybe this is a

5 function of how many of these I've read, or

6 what, but I just cannot agree with you in

7 terms of what is the goal.

8 And one of the things that you put

9 on in terms of concentration response

10 functions, I don't think is an understanding

11 of how with the metric being in the particular

12 study, how they have to incorporate that

13 concentration response and are trying to look

14 at the segments of the over all time series

15 analysis and the ozone concentrations, and get

16 out the portion that are relevant when they

17 are talking about going to alternative

18 standard levels. So it's just an absolute

19 requirement.

20 So, and there's sections in terms

21 of, that are more difficult to explain, like

22 4.2.2. It's concisely written, but the topic
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1 is much more difficult to convey.

2 The draft on the integrative

3 consideration of the risk, they only need two

4 pages to totally define what's going on about

5 the first draft exposure and the available

6 information and the reasonableness of

7 considering a range of possible alternative

8 standards.

9 I can tell you, there are other

10 documents where this rambled for pages. So

11 I'm just, I don't know where we were when we

12 read that, but I still just can't agree with

13 you there.

14 In terms of the second charge

15 question, staff clearly present the support

16 for looking at alternative ranges between 60

17 and 70. But when they then go into the

18 consideration of levels below, the pros and

19 cons of this, I thought we would need

20 discussion here, and basically, in my opinion,

21 the scientific weight of the evidence is not

22 sufficient to go below 60 parts per billion at
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1 this time.

2 The recent McDonnell Paper clearly

3 establishes a threshold for changes in FEV1

4 that to ozone exposure. There are only a few

5 epi studies where the design value is below

6 the current standard. Okay? And one of

7 those is the Mar and Koenig Study at .71.

8 And so you clearly have a full

9 blown epi study that shows that the current

10 standard is not protective. Now you have to

11 extract out from that the portions so you can

12 get to the alternative risk estimates.

13 And the other part of it is the

14 fact that as you go to lower and lower

15 alternative standards, then the delta from the

16 background to non-anthropogenic sources, it

17 becomes much more of an issue.

18 And so, looking at the science and

19 the weight of the evidence, I still see that

20 60 is the lowest level that I see the science

21 having a worthwhile investment of their time

22 for exploring alternative in the range of 60
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1 to 70.

2 In terms of the third charge

3 question about what they can do in terms of

4 extracting data from these different studies,

5 and they explain how the confidence limit

6 widens in the range of the 30 to 50 ppb.

7 And I think this is likely a

8 function of the smoothing function that was

9 used in the study. So, for example, in the

10 Bell, et al., they used a cubic spline. 

11 Others used difference.

12 And in terms of the statistical

13 distribution and the mean's central tenancies,

14 these become factors as you take segments of

15 the thing.

16 So it's not surprising to me, but

17 it does become problematic when you pose the

18 question, how could you use subsets of the

19 percentiles of the distributions in the CR

20 functions that you have to examine for the

21 alternatives.

22 And I offer the suggestion that
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1 you could take five to ten ppb intervals, and

2 then use the variance of the observations in

3 the time series in your air quality data in

4 those ranges as a weighting function in your

5 CR functions. 

6 And then you can check the

7 reasonableness of this by contrasting what you

8 get when you're now estimate risk compared to

9 what in the, and I would take specifically the

10 Mar and Koenig Study, because there it's

11 below, the design value's below, and I would

12 compare for your different weighting and

13 alternative weights that you may come up with.

14 How you aggregate up compared to

15 what's in the total risk that you estimate

16 from that study.

17 And that gives you a very good

18 idea of the statistical robustness of the

19 schemes that you're talking about and being

20 able to then sub-fractionate in terms of the

21 distributions in that.

22 So whatever you do, you're going
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1 to need to identify how that fits in, because

2 that's going to put these alternative

3 standards that we could be proposed into a

4 better assessment of things.

5 CHAIR SAMET: Fred, just, I think

6 in the next five minutes or so we need to move

7 on to the other chapters, because we're going

8 to lose some of our colleagues. So I just

9 wanted to --

10 DR. MILLER: Okay, I'll do one

11 last --

12 CHAIR SAMET: -- call for brevity. 

13 Okay.

14 DR. MILLER: Is that okay?

15 CHAIR SAMET: Yes.

16 DR. MILLER: Okay. It has to do

17 with on 447.3, I don't think that I've read

18 anything in the ISA, the REA, or others, that

19 convinces me that the statistical form of the

20 standard should not be revisited to examine

21 its robustness as you go to alternative level

22 standards. And so I offer that as something
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1 I think needs to be explored.

2 CHAIR SAMET: I will say, just on

3 this counterpoint between Chris and Fred. 

4 There may be, maybe you're saying the right

5 things, but it's perhaps also a matter of how

6 you say it.

7 And if you look, for example, at

8 the first paragraph on Page 412, there's an 11

9 line sentence that probably deserves to be

10 four sentences. And there are many, many

11 examples of that.

12 And I think that, you know, so

13 maybe the right stuff is there, which is kind

14 of what Fred is saying. But I do think it's

15 a little bit impenetrable in places.

16 And that's just one example I bring to your

17 attention. Ana?

18 DR. MILLER: And that's the kind

19 of thing I'm willing to overlook at this

20 point. But I agree with you. I know what you

21 meant.

22 DR. NUGENT: Okay. So, I read
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1 this very much as a draft. So, I think the

2 chapter has a lot of good stuff in it. I

3 think I agree with others, that perhaps, one

4 of the issues is to establish what the focus

5 and objective is, very clearly.

6 And I think, primarily, this

7 chapter, I think, needs to state what the key

8 points that are crucial to revisiting the

9 standard are, and what new evidence relevant

10 to these points makes this revision necessary. 

11 So that's kind of, I think, what you want to

12 transmit.

13 What are the key points that one

14 would have to consider if one were thinking

15 about revising a standard, and do we have

16 evidence on those points that suggests that we

17 need to revisit it and what it is.

18 I think what you don't want to do

19 is revisit conclusions that were previously

20 arrived at in the other documents. And you do

21 a little bit of that, and I think that's, you

22 know, can be problematic.
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1 So I think the document probably

2 has to have some synthesis. And actually, I

3 thought some of the syntheses that was in it

4 was actually quite good. Perhaps it needs to

5 be even more synthetic.

6 I mean, I found the PA better

7 written than the previous documents, actually. 

8 I found it easier to read. I don't know if

9 I'd got used to reading the stuff, or what,

10 but --

11 (Laughter)

12 DR. NUGENT: But I think you need

13 to have some synthesis, because people who

14 read the PA, aren't going to go back and wade

15 through the ISA, but I think it needs to be

16 very synthetic and to the point.

17 You know, what's crucial for,

18 what's the decision going to be based on and

19 what's the new point that we need to

20 highlight?

21 I think the, I also found the

22 whole issue of the design values not very
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1 useful, because of this issue that, yes, I

2 mean, even epidemiologic studies that have a

3 median value, or whatever, above the standard

4 can be informative, because they may have

5 distributions that go way down. So I found

6 that confusing.

7 So that's in terms of the first

8 point. In terms of the second point, the

9 second question, you know, I agree with, I

10 think, previous reviewers that, you know,

11 certainly, looking at 60 makes a lot of sense.

12 I think for comparison purposes,

13 and that this, I'm sure we'll talk about,

14 maybe looking somewhat lower than that might

15 also be useful, even if it's only for

16 comparison purposes.

17 In terms of the third point,

18 you're asking for some guidance on how the

19 epidemiologic data can be used. Again, I

20 think you don't want to, I mean, supposedly

21 the ISI reaches some conclusions, based on the

22 epidemiologic data and the REA, just some
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1 analyses that use the epidemiologic data to

2 help us understand the impact of changing the

3 standard.

4 So I don't think you want to kind

5 of reopen that whole thing up here. And I was

6 a little bit confused about whether that's

7 what you wanted to do or not.

8 But in any case, in terms of the

9 general question, I think it's important to

10 remember that what the goal of the

11 epidemiologic studies is.

12 And I think the goal of the

13 epidemiologic studies, and my epidemiologic

14 colleagues may want to chime in on this, but

15 from my perspective, it's really to establish

16 whether there is a causal relation between

17 ozone and certain outcomes, and what the form

18 of that relation is, and what the strength of

19 that relation is.

20 So I think it's rare that you're

21 going to be able to take an epidemiologic

22 study and use it to determine this should be
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1 the standard, or even a collection of

2 epidemiologic studies.

3 I think the best you can do, and I

4 think it's what you're doing, is to, you know,

5 simulate population changes in exposures under

6 varying standards and these varying standards

7 could be varying levels, in forms, in

8 averaging periods, whatever, simulate what the

9 new continuous distribution would be.

10 And I emphasize continuous,

11 because of this, you know, apparently linear

12 relation, what the new continuous distribution

13 that we would observe would be.

14 And I would do that with the

15 lowest level aggregation possible in the time. 

16 So, you know, with the lowest common

17 denominator.

18 And then from that distribution

19 derive the measures that were used in the

20 Epidemiologic studies, eight-hour averages,

21 24-hour averages, whatever, and combine those

22 with the dose response function to predict the
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1 deaths and then use that to estimate how many

2 deaths were saved on various scenarios.

3 And I think that's really the best

4 you can do in terms of how to use the

5 epidemiologic data. And, you know, if you can

6 simulate the changes in the population

7 distribution using the lowest common

8 denominator, then you can aggregate up in

9 different ways and predict using, you know,

10 taking the dose response functions directly

11 from epidemiologic studies that use different

12 averaging periods, or whatever, and you don't

13 need to worry about matching everything up.

14 I'm not sure if I'm being clear,

15 but, so, have the lowest common denominator

16 for the distribution so that then you could

17 aggregate up and use it in various ways, and

18 use that to compare various standards.

19 So that's my suggestion of how the

20 epidemiologic data can be used to inform the

21 actual level of the standard through that kind

22 of, the level and the form of the standard
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1 through that kind of comparison. I think

2 that's it.

3 CHAIR SAMET: Okay. Thanks. And

4 actually, would you take on the role of

5 summarizing, because I'm afraid to ask Chris

6 or Fred.

7 (Laughter)

8 DR. NUGENT: Okay.

9 CHAIR SAMET: We need a neutral

10 person. If you don't mind, I think, we could

11 come back to this, if needed, but I would

12 really like to make sure we have time while

13 our welfare team is here.

14 So I think we should move to

15 Chapter 5, Kathy, and that's you, let's lead,

16 or start.

17 DR. WEATHERS: Okay.

18 DR. ULTMAN: Do we have time,

19 short time for one comment on Chapter 4, or

20 no?

21 CHAIR SAMET: If you could hold

22 it, we'll come back, I promise, we'll come
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1 back to Chapter 4.

2 DR. ULTMAN: Oh, okay.

3 CHAIR SAMET: Okay. Are you

4 leaving too?

5 DR. ULTMAN: At 11:45 a.m.

6 CHAIR SAMET: A short comment on

7 Chapter 4?

8 DR. ULTMAN: A short comment. The

9 most concise part of the chapter was Section

10 4.2.2.2 on estimates of ozone induced lung

11 functioning impairment. Because it hadn't

12 been done yet, so it's not in here.

13 (Laughter)

14 DR. ULTMAN: It took up four

15 sentences. At any rate, the ISA Group is

16 moving in the direction of using McDonnell's

17 2012 model for exposure response for FEV1 in

18 the risk assessment.

19 And that model does have an

20 intercept to it. I don't know if you want to

21 call it a threshold or not, but it does have

22 an intercept associated with it.
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1 So some of the ideas of what we

2 did in the past with respect to the FEV1

3 conceptually is going to change a little bit. 

4 And I'm sure that'll all get filtered into the

5 next document.

6 But my point has to do really with

7 the fact that that model is indeed used for

8 risk assessment, has a much better, has a

9 better fit, I won't say a much better fit, has

10 a better fit at low concentrations and affords

11 the opportunity to calculate some background

12 risks using that model, with more confidence

13 than we've had before. And this is just for

14 FEV1.

15 So my suggestion was going to be

16 that you consider doing some calculations to

17 compare, you know, the risk assessment under

18 no background situation to the risk

19 assessment, to compare that to just with the

20 background would do.

21 Because I really feel like there

22 has to be some context when you show that, you
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1 know, reducing the standard by a certain

2 amount is going to save so many lives. You

3 need some context for that too, to see what

4 the, well, I'm sorry. You do a calculation

5 that shows that so many lives are going to be

6 lost at some level of the standard.

7 We need some context for that, for

8 people to appreciate then with what, if you

9 lower the level, how much of a difference it's

10 really going to make. So I'm just saying,

11 there's a proved opportunity to do that with

12 this document.

13 CHAIR SAMET: Okay. And, Jim, 

14 make sure that's, presuming that's reflected

15 in your written --

16 DR. ULTMAN: Pardon me?

17 CHAIR SAMET: Reflected, what you

18 just said is --

19 DR. ULTMAN: Okay.

20 CHAIR SAMET: -- reflected in your

21 written comments.

22 DR. ULTMAN: I will do that.
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1 CHAIR SAMET: Okay. Kathy?

2 DR. WEATHERS: Okay. So, going

3 down the questions, I think that the first

4 question we've talked about a little bit in

5 regards to some of the chapters, that this

6 chapter seemed a little bit long and unwieldy

7 and it wasn't clear what the point was.

8 And so refining that, making sure

9 that the chapter points out what's new and

10 what supports the Policy Assessment will be

11 important.

12 It seemed to me that there was too

13 much detail in Section 5.2. It was okay

14 detail in Section 5.3. Again, this falls

15 along the over-arching comments about the

16 level of detail in this chapter.

17 In terms of the focus on the W126

18 Form, I was actually compelled by the history

19 there, and found that section to be useful,

20 and thought it might even be pulled up into

21 the beginning part of the PA document. So, I

22 thought that was quite useful.
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1 In terms of Question Number 4, it

2 occurred to me that, in terms of looking at

3 ecosystem effects, yesterday we talked about

4 using some modeling techniques and that PnET

5 might actually be used or some other model to

6 look at potential for water effects, ecosystem

7 level of water effects. So that wasn't

8 identified at all in this version.

9 In terms of Number 5, it seems

10 that here's a place where it's not clear why

11 crop yield and Ag effects weren't considered

12 more fully in terms of adversity.

13 And then, in terms of Question

14 Number 6, it seems okay. It's speculative, in

15 terms of the feedbacks and the chemical soup

16 of the atmosphere and how ozone, tropospheric

17 ozone might interact.

18 But I do think it's important to

19 point out that there are these feedbacks and

20 it is a chemical sympathy atmosphere. So

21 those are my responses to the questions.

22 CHAIR SAMET: Okay. Peter?
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1 DR. WOODBURY: Thank you. I have

2 many of the same general concerns for the

3 Policy Assessment that I brought up yesterday

4 for the Risk Analysis.

5 I'm not going to repeat those

6 general points here, but they are in my

7 written comments. And I do have some detailed

8 comments both for Chapters 5 and 6, and I'm

9 not going to try to go through all of those.

10 For Question 1, there's a lot of

11 good material in this chapter that does

12 reflect the ISA. But again, echoing that I

13 think it can be condensed and clarified.

14 And in particular, trying to

15 clarify which points are fairly well-known and

16 where there are areas that really aren't that

17 well-known.

18 There's a lot that we don't know,

19 but there's a lot that is well-known. And

20 just as an example of that from today, the

21 presentation, Vicki, that you made, Slide 11,

22 that language was exceedingly clear and brief.
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1 And so, so maybe if you start by,

2 you know, working with some of your slides and

3 other brief presentations and bringing that

4 back in, that will help.

5 For Question 2, I had pretty much

6 the same response. It's, the information's

7 appropriate, but some more effort to clarify

8 what's well-known from what isn't will be

9 helpful.

10 For Question 3, I had some

11 specific comments that I won't go over

12 verbally. For Question 4, I think I, again,

13 I have some specific comments that I won't go

14 over.

15 And I would also echo what Kathy

16 just mentioned, that there are some modeling

17 studies that provide quantitative estimates of

18 some of these effects, how that may be worth

19 mentioning.

20 For Question 5, again, this is

21 helpful and should be retained, but again,

22 clarifying, focusing on the information that's
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1 relevant to the rest of this document.

2 In other words, this chapter is

3 supporting the remainder of the document,

4 rather than trying to summarize everything. 

5 I think that's it. Thanks.

6 CHAIR SAMET: Okay. Thank you. 

7 Howie?

8 DR. NEUFELD: I have very brief

9 comments, because I agree with everything

10 that's been said before. But I also want to

11 put in my voice that, I think, that both the

12 welfare and the PA, should be much shorter and

13 less redundant.

14 I think it dilutes from the actual

15 mission of each of those documents to simply

16 repeat all those ISI things, ISA things.

17 I only want to concentrate on two

18 things. Question 3, I just want to emphasize

19 the utility and the need, okay, and I

20 emphasize the word need to use the W126 Metric

21 for the welfare effects.

22 And then in Question 5, I just
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1 want to say that I appreciate the distinction

2 between injury and damage. I liked that

3 discussion there.

4 And also expanding on the adverse

5 effects at the ecosystem level. And I thought

6 this was an illuminating section. Other that,

7 I just had very other brief comments, which

8 you can read. Thanks.

9 CHAIR SAMET: Okay. Thank you. 

10 Other comments on Chapter 5?

11 DR. GRANTZ: Yes.

12 CHAIR SAMET: David.

13 DR. GRANTZ: When I first read

14 through this chapter, I was really quite

15 pleased with it. And --

16 CHAIR SAMET: You can summarize

17 it.

18 DR. GRANTZ: -- until I got to

19 actually Question 3 for the next chapter,

20 which asked if Chapter 6 might be removed from

21 the document.

22 At that point, I went back and
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1 thought about what I really thought about

2 Chapter 5. So it's not adequately reflected

3 in the written comments for Chapter 5.

4 But I agree with the discussion

5 we've had previously, that there's way too

6 much, you know, regurgitation of what's in the

7 ISA.

8 And if could be brought together

9 in a few focused points, I think it would be

10 much more powerful. So that's been said, and

11 I won't go over it too much.

12 I think, if this whole process is

13 going to be science-based, either the

14 agricultural data really needs to be featured,

15 because we know an awful a lot about it, or

16 the agency needs to write a very clear

17 paragraph as to why not.

18 I mean, it's just incomprehensible

19 to me that all of that NCLAN data and all of

20 the chamber data with trees and all that kind

21 of stuff is not integrated more fully. I just

22 don't understand that, I can't see it.
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1 I think it's not a science-based

2 question, and it needs to be put in some kind

3 of science-based terms. Okay. I think that's

4 really all I need to say there.

5 I agree with Howie, that we need

6 to carry it forward the strong recommendation

7 regarding accumulative weighted standard, that

8 needs to be emphasized at every step in this

9 process and it needs to come out in the letter

10 as it was done previously.

11 CHAIR SAMET: Okay. Thank you. 

12 Peter?

13 DR. WOODBURY: So one of my over14 arching comments yesterday was on this topic. 

15 That there really needs to be a greater

16 analysis and inclusion of effects on crop

17 yield loss.

18 So I will repeat that and just

19 echo what Dave just said. Except that I would

20 differ in that I don't think there's any

21 rational for excluding that information and

22 for excluding analyses, additional analyses of
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1 crop yield loss.

2 I think the exposure response

3 functions are available. There are reasonable

4 estimates for much of the country of exposure

5 patterns, and that's quantifiable.

6 So there's no reason not to,

7 again, expand that analyses in the welfare

8 assessment. And then, obviously, that gets

9 brought forward here.

10 I would also echo the comments

11 that we definitely need the accumulative

12 seasonal standard and that the W126 Form is

13 useful and appropriate.

14 CHAIR SAMET: Howie?

15 DR. NEUFELD: Just to echo the

16 comments on crops, I just say Ibid.

17 CHAIR SAMET: Okay. Kathy.

18 DR. WEATHERS: I just wondered

19 whether there was actually a reason, from the

20 EPA's perspective, so turn around and ask the

21 question, is there a particular reason why the

22 crop assessments were not highlighted?
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1 MS. SANDIFORD: Just as Karen

2 Martin gave a very long history lesson

3 earlier, we could do the same for the rational

4 on the crops, but I don't think it's worth

5 going into here. We do appreciate your

6 comments.

7 DR. GRANTZ: Can you summarize

8 whether that is a science-based decision?

9 MS. SANDIFORD: It's a policy10 based decision.

11 DR. GRANTZ: This is, at least the

12 first two of these documents are not policy

13 documents.

14 MS. SANDIFORD: Chapter 5, I

15 definitely agree could be expanded to include

16 the crop information in Chapter 6, whatever is

17 added to the Risk and Exposure Assessment. 

18 Once we get to Chapter 7, I don't think I can

19 speak to that at this point.

20 CHAIR SAMET: Okay. And, Kathy,

21 you've agreed to summarize that?

22 DR. WEATHERS: Yes.
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1 CHAIR SAMET: Yes. Okay, other

2 comments on Chapter 5?

3 (No response.)

4 CHAIR SAMET: Okay. On to 6? 

5 That's your --

6 DR. WEATHERS: I think I'll make

7 some general comments on 6, and one is,

8 actually specific to yesterday's conversation,

9 as well, which is where fusion models are

10 introduced.

11 I think, in all places where they

12 show up it would be very useful to have just

13 a very short explanation about what that

14 means. I think there's some confusion about

15 fusion.

16 This is, I think, a question as

17 well, looking at the analyses of the W126

18 Standard, I wonder what other comparisons

19 might be made beyond looking at, you know,

20 just occurrence.

21 So, it's kind of a question for

22 you all. What source of analyses would be
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1 useful to inform a policy decision about the

2 form of this standard?

3 So, I don't know the answer to

4 that, but this chapter brought up that

5 question for me. Again, there was a lack of

6 focus on the agricultural symptoms. We just

7 talked about that.

8 And as with our conversation

9 yesterday, that at some point we'll have to

10 deal again with looking at sensitive species

11 versus lumping species together.

12 So in general, it wasn't clear to

13 me what this added beyond Chapter 5, or some

14 combination of Chapter 5 and 6 might be a way

15 to move forward.

16 CHAIR SAMET: Okay. Peter?

17 DR. WOODBURY: Well, there are

18 definitely some continuing themes here. I

19 think this chapter's useful and well-written

20 and appropriate, but the narrow focus on Class

21 1 areas is not appropriate.

22 So, again, expanding the Risk
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1 Assessment to include effects on yields of

2 sensitive crops in areas with higher ozone is

3 needed to reflect literally decades of vary

4 solid science.

5 Question 2, about the qualitative

6 discussion, I think most of my comments here

7 echo similar comments that I made yesterday

8 for the Welfare Assessment, so I don't think

9 I have anything additional add, except to

10 refer my written comments here and what I

11 presented yesterday.

12 For Question 3, certainly this

13 Chapter is useful and should be retained. And

14 again, we've talked about, you know, this, the

15 policy document needs to be understandable on

16 its own with, obviously, with reference to

17 supporting information elsewhere.

18 So just to elaborate slightly on

19 that, I think presenting the main conclusions

20 of the supporting document here, and then

21 again, I don't think, you know, how much of

22 the supporting evidence needs to be here.
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1 I'm not sure there needs to be a

2 lot of discussion of individual studies, even

3 if they're new here. I think the summary

4 statements that are made in the supporting

5 documents need to be brought forward.

6 And I guess, as far as the

7 quadratic rollback or any other approach used

8 to examine the potential for reduces ozone

9 levels, I think it is appropriate to

10 acknowledge that that is -- it's an

11 appropriate approach, and it reflects the real

12 world and the current emissions.

13 But there is the potential for

14 increased emissions due to industrial

15 development or anything else in regions that

16 are currently not exceeding the current

17 standard. And I think some acknowledgment of

18 this potential is important. And I'll stop

19 there.

20 CHAIR SAMET: Okay. Thanks. 

21 Dave?

22 DR. GRANTZ: I would only speak to
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1 Question 2 in Chapter 6, and I think it's very

2 important to keep this concept to the

3 Ecosystem Services going. And I think that,

4 as a sort of analytical rubric ought to be

5 expanded if anything.

6 So I think, to the extent that you

7 can, well, just link the ecological effects

8 that are discussed through out the document

9 into this framework, I think, is very useful.

10 CHAIR SAMET: Howie?

11 DR. NEUFELD: After the previous

12 speakers, I can't add anything new. I'd just

13 say I agree with what has been said at this

14 point.

15 CHAIR SAMET: Okay. Other --

16 MS. WEGMAN: Jon, could we take

17 one moment just to respond a little further to

18 Kathy's question about ag?

19 CHAIR SAMET: Sure.

20 DR. MARTIN: I would direct your

21 attention to the last two times we have looked

22 at this secondary standard, both in the final
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1 role in 2008, as well as in the proposed

2 consideration.

3 In both cases, both of the

4 Administrators expressing their views on the

5 secondary standard, made it clear that in

6 looking at crop information on impacts on

7 crops, they recognized how heavily managed

8 crops are.

9 And there's discussions in both of

10 those rule-making documents expressing the

11 policy views of both of the Administrators, as

12 to how difficult the heavily managed aspect of

13 agricultural crops makes determining what the

14 impact on crops is from a public welfare

15 perspective.

16 And as a matter of policy,

17 therefore, they both felt that it was

18 appropriate to focus the secondary standard on

19 other aspects of environmental impacts, other

20 than managed agricultural crops.

21 So when Vicki gave the answer that

22 it was a policy decision, that's what she was
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1 eluding to. There's no question that the

2 fundamental science that exists over the

3 decades on crops, that has led to and help

4 support everything we know about other types

5 of vegetation, is clearly important from a

6 science perspective.

7 And I think we could clearly add

8 more of that to Chapter 5. But, to the extent

9 Chapter 7 is intended to take into account the

10 policy perspective that we are left with as a

11 follow on to past decisions, we would then be

12 adding information into 5, that wasn't going

13 to be particularly policy relevant when we got

14 to Chapter 7.

15 And that's the dilemma we find

16 ourselves in, not to disregard the importance

17 of that science, but along the lines that you

18 all are saying, let's make sure what we

19 include in 5 or in 2, on the case of health,

20 is directly relevant to the policy aspects

21 we're going to be discussing in the later

22 chapters. We really have a conundrum in
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1 dealing with the crop information.

2 DR. NEUFELD: I'd have to take

3 exception to that, because you're implying

4 that the management is eliminating the

5 problem, right? And that's not true.

6 DR. MARTIN: I'm stating the

7 rationales that have been presented as the

8 basis for the final and proposed decisions

9 that the last two Administrators have

10 presented.

11 DR. NEUFELD: But it's clearly

12 stated in the ISA --

13 DR. MARTIN: I'm debating the

14 merits of that, I'm just saying that has been

15 the policy view presented.

16 DR. NEUFELD: But it's clear from

17 the ISA, which is the science, that the

18 current agricultural practices today are not

19 preventing crop field losses, either by the

20 planting of resistant varieties, or by the

21 actual agricultural practices in planting.

22 Because you still get the same
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1 yield losses you did today, that you did 20,

2 30 years ago. So the whole basis for

3 excluding it seems unattainable.

4 CHAIR SAMET: Yes. I think what

5 I've, you know --

6 DR. NEUFELD: And this is despite

7 management.

8 CHAIR SAMET: I think just a

9 comment. I mean, maybe what I'm hearing, let

10 me just summarize this. Is Chapters 5 and 6

11 should not be written in light of what the

12 Administrator has done in the past or might do

13 in the future.

14 I think the call is layout the

15 science, and I think in this case, the concern

16 is that something has been omitted based at

17 this point on the past record and how you

18 think that might influence future decision19 making.

20 I think what I'm hearing is that

21 should be --

22 DR. GRANTZ: Right, and I think
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1 it's completely inappropriate to cast actual -

2 -

3 CHAIR SAMET: Yes.

4 DR. GRANTZ: -- what some

5 Administrator may or may not have done in the

6 past for whatever reasons, which we might want

7 to ask about, if we really pursue this, is

8 immaterial to me.

9 We have a science document. We

10 have a risk based on the best available

11 science. And then we have what you folks, you

12 know, advised by us believe would be the best

13 policy options.

14 I don't see that what the

15 Administrator did in the past has anything

16 much bearing on me, it probably does on you,

17 I'm sure.

18 (Laughter.)

19 DR. GRANTZ: But I still think

20 that our role here to be, you know,

21 appropriately executed is to carry that

22 science-based information as far forward in
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1 this as we can.

2 DR. MARTIN: I'm not suggesting

3 your comments are inappropriate, I'm

4 suggesting it leaves us with a dilemma, that's

5 all. But we will certainly take your comments

6 into consideration.

7 DR. GRANTZ: Well, our role is to

8 advise you, and I think we are advising you on

9 how to resolve that dilemma.

10 CHAIR SAMET: Peter?

11 MS. WEGMAN: That's fine, and we

12 certainly will add the scientific studies into

13 the Chapters 5 and 6.

14 DR. WOODBURY: Well, there's a big

15 difference here between Chapter 5 and 6. 

16 Chapter 5, I'm not hearing any reason why we

17 can't all agree that Chapter 5 should

18 adequately cover the science that's been done.

19 And there's plenty of it. It's

20 been well-summarized in previous documents. 

21 And these documents do a fine job of bringing

22 in the new information and demonstrating how
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1 it confirms older results.

2 I think the more critical, or more

3 challenging question is, what will you do in

4 the Risk Assessment? And I think there is a

5 very strong scientific basis for assessing

6 risks of crop yield loss for sensitive crop

7 species throughout many parts of the country.

8 The scientific data are very

9 strong, because we've been able to do

10 experiences that actually measure yield loss

11 in the fields.

12 And those of you who are familiar

13 with this, you know, I don't need to emphasize

14 this, but it's, you know, we're actually

15 measuring in the field under realistic field

16 conditions, yield losses. We're not

17 extrapolating, we're measuring a real effect.

18 There's some discussion of whether

19 a ten percent yield loss has been suggested as

20 a cutoff value. I would suggest that a five

21 percent yield loss is extremely economically

22 important.
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1 It's difficult to measure in an

2 individual field, but it's not difficult to

3 make robust predictions for many fields across

4 a county or state, given the good information

5 we have about ozone exposure and the good

6 information we have about exposure response

7 functions.

8 I spent quite a bit of time in my

9 comments yesterday explaining why, in my view,

10 it's useful to look at a sectoral wide

11 approach to crop yield loss, but it's

12 inadequate simply to do that.

13 Because, I think there's very

14 strong scientific evidence of crop yield loss

15 for sensitive species over large parts of the

16 country. And I think that's a welfare impact,

17 in my view.

18 So I think, anyone's allowed to

19 say anything they like about something being

20 a policy judgment, but as scientists, I think,

21 we also need to say what we think is well22 supported by the scientific evidence. And you
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1 have to decide whether you want to ignore the

2 scientific evidence.

3 CHAIR SAMET: Well, I think the

4 word is not ignore, I think the question is

5 actually how it figures into the policy

6 judgment at the end. But I think the message

7 should be very clear by now that it should be

8 included. I think that was --

9 DR. WOODBURY: Let me clarify the

10 word ignore. I think leaving out assessment

11 of crop yield loss for areas, for sensitive

12 crops in areas with elevated ozone, leaving

13 that out of the Risk Assessment would be

14 ignoring the science, in my view.

15 CHAIR SAMET: All right. So I

16 think the call is to include it. Let's see,

17 anything else on this point, because we still

18 have one more chapter to get through on this,

19 on Chapter 6.

20 (No response.)

21 CHAIR SAMET: Okay. And actually,

22 Peter, would you be the summarizer for this
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1 one, Chapter 6?

2 (No response.)

3 CHAIR SAMET: Thank you. So,

4 Chapter 7, Kathy.

5 DR. WEATHERS: Okay, so Chapter 7,

6 I have just a couple of comments, obviously,

7 since this is the first draft and there are

8 many analyses left to do. There are extensive

9 comments.

10 One is, that it's clear that

11 you'll have to deal with a western anomaly

12 that was talked about yesterday, in terms of

13 the ozone surfaces.

14 And the other question that I had,

15 I think this is a fairly well laid out chapter

16 to the extent that it's complete. It has to

17 do with the use of case studies again and the

18 Class 1 wilderness areas.

19 Many of them, as we said

20 yesterday, are high elevation. The diurnal

21 part of the standard, when you're looking at

22 12 hours, and you're not looking at night time
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1 ozone may turn out to be a challenge.

2 It's one of the few places where

3 it actually may matter that ozone is looked at

4 through a 24-hour period rather than a 12-hour

5 standard.

6 So once again, it's just a

7 question to you about focusing on these areas

8 and what kinds of challenges may provide in

9 terms of thinking about the PA.

10 CHAIR SAMET: Okay. Peter?

11 DR. WOODBURY: Well, this is the

12 summary in conclusions chapter. I think it's

13 a bit premature for us to be commenting on

14 this.

15 So, I did provide responses to the

16 questions and some detailed comments, but

17 basically, they reflect my previous comments

18 on the need for augmenting the Risk Analyses

19 and then the subsequent discussion, obviously,

20 the synthesis would then include that

21 information as well.

22 CHAIR SAMET: Okay. Howie?
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1 DR. NEUFELD: And just to build on

2 the comments from the others, that generally

3 it's a well-written chapter. The justification

4 for switching away again, I'm going to

5 emphasize it again, from the eight hour index

6 to the cumulative weighted index is based on

7 strong evidence in the ISA, and also in the

8 Welfare REA. So, I just wanted to re9 emphasize that.

10 With regard to Question 2, I think

11 this does a good job of justifying the range

12 of levels that you were proposing for the

13 secondary standard.

14 And there were concise summaries

15 and conclusions there, you could read that

16 fairly easily. But I will again, emphasize

17 that if you're going to propose a secondary

18 standard and not consider half of the data,

19 and some of it the strongest data, is just an,

20 I don't want to use too strong a word,

21 abrogation of your responsibilities to

22 consider all of the evidence.
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1 CHAIR SAMET: Okay. Dave?

2 DR. GRANTZ: Well, I can't add

3 much to that, but I agree. I thought that

4 this chapter was pretty nicely laid out,

5 actually. I liked it.

6 I thought it did a good job of

7 looking at the form and the averaging period. 

8 But I thought when it got to 7.3.3, I guess I

9 disagree a little bit with Howie, I didn't get

10 a feel really for the levels that were being

11 recommended or why.

12 So I thought that, since that's

13 kind of the key issue, one of the key issues

14 anyway, that that needed to be beefed up a

15 little bit. And then in my written comments

16 I mentioned again this business of

17 agricultural data.

18 CHAIR SAMET: Peter.

19 DR. WOODBURY: Just pull out --

20 I'd like to just pull out one comment that I

21 made and elaborate on that a little bit from

22 my written comments.
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1 I mentioned recommending

2 consideration of a five percent yield loss

3 level for crops that over a wide area, not an

4 individual field.

5 And for a tree species, you know,

6 one to two percent yield loss doesn't sound

7 like much. The focus here is on two percent.

8 If you go back to the document,

9 the so-called consensus, or meeting document

10 that was cited, it actually says one to two

11 percent. That's a large difference, actually.

12 And this doesn't sound like much,

13 one or two percent, but we're talking about

14 perennial plants, so if you do, Howie just did

15 a nice compounding exercise. You can do this

16 yourself on the Web, from any number of

17 compounding tools.

18 And that that kind of a growth

19 decrease compounds very quickly for a plant

20 that might live for 100 years. So, I think,

21 making sure to include that kind of

22 compounding example will help indicate why,
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1 you know, something that looks only like one

2 or two percent is actually much, much more

3 substantial than that.

4 And in addition, there can be the

5 subsequent impacts that there are effects on

6 competition as well. That would be an

7 additional separate type of additional effect.

8 CHAIR SAMET: Thanks. Okay,

9 Howie?

10 DR. NEUFELD: Just to emphasize, a

11 one percent loss over 75 years is more than a

12 50 percent growth loss over that 75-year

13 period. So it can, it's really a small

14 difference over a large period, long time.

15 CHAIR SAMET: Okay. And, Howie,

16 would you be the summarizer? I think that

17 will lead to an equitable distribution of the

18 summarizing goal.

19 DR. NEUFELD: I keep getting

20 Chapter 7 --

21 CHAIR SAMET: And if you don't

22 want to do it, get Sverre to do it. But --
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1 (Laughter)

2 CHAIR SAMET: Other comments on

3 Chapter 7? There's just a few other things

4 I'd like to move on to, and I think we still

5 have one person, who wants to make clarifying

6 comments. So Chapter 7, Chris.

7 (Off microphone comment).

8 CHAIR SAMET: Okay. Okay. So, I

9 did say we would actually go back to Chapter

10 4, so let's see, are there comments to Chapter

11 4, let's do that real quick.

12 DR. FREY: Yes, I just, I, you

13 know, one of the charge questions is, what

14 range of alternative ozone levels would be

15 appropriate for further exposure and risk

16 analyses in the second draft.

17 This is a question on the Policy

18 Assessment, but it's asking what would be a

19 good, good levels for the REA Second Draft

20 that would inform the second Policy

21 Assessment.

22 I don't feel like, as a Panel,
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1 we've really answered that. I know we had a

2 couple of people comment on it. But it just

3 seems like an important point we ought to give

4 EPA the Panel feedback on.

5 CHAIR SAMET: Okay. I guess the

6 discussion that we've had is largely been in

7 a sense, I mean, there are some fairly obvious

8 points of concentration to consider. I guess,

9 probably the more most important question is

10 will there be a recommendation to go below 60

11 ppb, is that not correct?

12 So, I think that there's lots of

13 numbers from 60 to 75 that you know, and can

14 pick. But it seems to be the more critical

15 question is probably this question of whether

16 we would recommend considering scenarios below

17 60 ppb.

18 And I think we heard differing,

19 somewhat differing views on that at least from

20 you, and possibly others, if I remember right,

21 about numbers like 55 versus, Fred, who

22 suggested stopping at, I think, not going
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1 below 60.

2 And then we have others who would

3 like to comment on this point of guidance. 

4 Sverre?

5 DR. VEDAL: Just as a precedent,

6 we were at a time when we had the lung

7 function data, which showed effects at 80. 

8 And it was argued, because we were seeing

9 effects at 80, that we should go below that.

10 We're now in a situation where we

11 see effects at 60. So in parallel and

12 symmetry, one could make an argument, that if

13 we're seeing effects at 60, we should consider

14 looking at considering a standard of 50.

15 CHAIR SAMET: I mean, these are

16 analyses to essentially inform the

17 Administrator and judgment when they go back

18 to the PA. I mean, they're not, these are

19 not, I guess, bright lines defining what a

20 standard might be. These are scenarios for

21 analyses, and I think we need to remember

22 that.
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1 So I don't know that we have a

2 Panel view about this, and I don't

3 particularly want to take a vote, but let me

4 just get a sense of how others feel about

5 really whether some of the analyses should

6 extend below 60, and probably 55 seems like at

7 least one point that might be considered. Ed,

8 is that a yes?

9 DR. AVOL: Yes.

10 CHAIR SAMET: That's a yes. 

11 Anyone else want to venture into this

12 territory?

13 (No response.)

14 CHAIR SAMET: Okay. I think you

15 just had a weak opinion from us. But I, I

16 mean, at least, to me, it does not seem

17 unreasonable to consider 55 is going to be

18 useful for, really in forming the analyses.

19 I mean, again, I don't think this

20 is a commitment to anything, except some

21 scenarios to explore to try and understand

22 where risk gets generated and that total risk. 
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1 Fred, do you have, you want to --

2 DR. MILLER: Yes, I guess, I just

3 don't think that the overall weight of the

4 evidence going beyond the FEV1 changes support

5 it.

6 But, given that, at this point in

7 time, you could go to 55 parts per billion. 

8 But it's like, to me, it's the last thing you

9 do to add into the document, because all the

10 other things we've discussed in terms of

11 priority of what you ought to be doing for

12 this next go around.

13 If you still have time, then I

14 might look at some of that, but I think it's

15 extremely unlikely to be able to really shed

16 enough light that that would be a value in the

17 final interval that we might recommend.

18 CHAIR SAMET: Okay. Before the

19 room empties, and we still have one person on

20 the phone to hear from. I think one issue,

21 and perhaps this will have to come up in our

22 follow-up phone calls. And perhaps, one that
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1 more pertains to the charter CASAC than the

2 panel in full is, some discussion of sort of

3 the process that is playing out now around

4 sort of what I'll call incremental and

5 evolutionary review of documents.

6 Clearly, I think, in our view, the

7 Third Draft ISA is done. I would hope that

8 there's not a need, on the part of any of us,

9 I assume, that we would ever want to see the

10 Fourth Draft ISA brought to us for formal

11 discussion.

12 So that's done. Okay, but with

13 the REA about to, and probably particularly

14 the REA, you know, it seems like we're acting

15 in sort of a let's say an advisory or

16 consultant role as some key decisions are

17 being made in sort of what seems to be a

18 sequential process of development,

19 essentially, the machinery of the REA.

20 And maybe, and that's just fine, 

21 I mean, the purpose of CASAC is to advise, but

22 this is somewhat different from some of the
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1 approaches of the past when, and particularly

2 since we now have the REA in a sense rather

3 than sort of the CD and the staff paper, that

4 you are doing a lot of work that takes time to

5 accomplish as you move forward there are

6 decisions to be made.

7 You're clearly not bringing a

8 completely done REA to the Committee, rather

9 we're seeing it in pieces, giving guidance and

10 sort of bringing Template 1, Template 2, and

11 so on, and getting guidance.

12 I think this makes for a different

13 kind of review, because what we're looking at

14 is always moving, and you know, we're seeing

15 it at different stages.

16 And again, I think that this needs

17 some discussion on, I think, how the process

18 will work, at what point CASAC appropriately

19 comments. And, in particular, how we in the

20 end get a look at the final product and make

21 sure that the final product is right.

22 And, you know, I think we had the
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1 discussion on Tuesday about the schedule that

2 was put before us, that had one more CASAC

3 meeting on the entire set of documents. And

4 when, I'm remembering correctly.

5 And I think the single Spring

6 meeting, this really seems unlikely to be

7 satisfactory, in terms of either where you

8 are, or allowing CASAC to provide the review

9 that it needs to. Especially since, you know,

10 again, as I said, we're seeing a product in

11 development.

12 So, you know, among other things

13 you might want to think about what a realistic

14 time frame is. I know you have deadlines that

15 come from elsewhere, and you want to do the

16 best job possible and try and meet those

17 deadlines, as there may be some problems now

18 with the amount of time available, what you

19 have to do. And what do you have to do and

20 bring to CASAC to have reviews.

21 So I think this is a topic that

22 merits being highlighted, perhaps in our
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1 letter on the REAs. And perhaps, if we meet

2 by phone will be something that we should

3 discuss.

4 And, you know, I think I

5 understand exactly why we're having these

6 interactions as they are, but I think we

7 should acknowledge that and then look and

8 consider implications.

9 So I don't think we have time to

10 go into this further, but I think this is an

11 important enough issue that it merits some,

12 you know, full discussion. That's, yes, Fred.

13 DR. MILLER: Jon, would you

14 anticipate that the two pages we reviewed and

15 gave our high low and that would be

16 incorporated in our response to this review,

17 and that sort of really helps them jumpstart,

18 you know, their allocation and resources and

19 time in that, so --

20 CHAIR SAMET: Right.

21 DR. MILLER: That could be

22 formalized, you know --
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1 CHAIR SAMET: Right. Right. No,

2 actually, I think this should be an appendix,

3 or something, to our letter. But, I mean,

4 it's a good example of exactly what I was

5 talking about and our sort of engagement,

6 involvement in this ongoing process.

7 So I'm not sure we, you know, just

8 highlight this issue for further discussion

9 while we're here together. Let me ask, I

10 think we do have one person on the phone for -

11 -

12 DR. NUGENT: Actually, he's here

13 in the room.

14 CHAIR SAMET: Oh. Here in the

15 room.

16 DR. NUGENT: And I wonder if you

17 could -- if he could speak to --

18 CHAIR SAMET: Mr. Ted Steichen,

19 who's going to make clarifying comments, which

20 you have for three minutes.

21 MR. STEICHEN: Yes. Thanks to

22 those of you from the Panel that were able to
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1 stay for this last comment. And I think Dr.

2 Samet was just speaking about what I was

3 interesting in making a clarifying comment

4 about, which dealt with the schedule.

5 And again, I think it's very

6 important to recognize, I think, as Dr. Martin

7 went through, is a history that often CASAC

8 has come into play as it relates to issues in

9 the court.

10 And since there may very well be

11 an activity soon in the court, in terms of

12 trying to speed up the review of ozone to make

13 the five-year schedule.

14 If, in your letter, you identified

15 the need for you to get your work done

16 required a certain amount of time, that may

17 weigh into the time the Administrator would be

18 able to provide that as additional information

19 to the court to explain why perhaps this

20 process needs to take longer.

21 You know, it's very clear, as an

22 observer, I've certainly been watching these
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1 meetings for the last five years myself. API

2 has been involved in it from the beginning.

3 We have always seen a tremendous

4 amount of public service by the part of CASAC,

5 and certainly professionalism on the part of

6 the EPA Staff.

7 So I'm sure it's very

8 disheartening to have to make comments like

9 chapters aren't very well written. And we

10 know it's probably not very nice to get those

11 comments either.

12 So there's something about the

13 process that needs to change to be able to

14 allow qualified people to get work done in a

15 qualified way. So that was that comment.

16 And then the last one was, I asked

17 Dr. Nugent to hand out the first page of the

18 Charter for CASAC again. And I just wanted to

19 hit on Number D, which references the fact

20 that you are chartered to identify

21 anthropogenic and natural emission sources.

22 So that's an important role for
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1 you. And, again, you may have a role beyond

2 simply responding to the charge questions that

3 you received from the Administrator.

4 Your charge came from a Congress. 

5 And you also have a Charge E here, where

6 you're to look at the impacts of different

7 approaches to attain these standards.

8 And again, if there was an

9 investigation of the work that's going on with

10 CASAC, I don't think there would be a lot of

11 evidence, right now, that these issues have

12 been worked.

13 So, again, I would just ask Dr.

14 Samet, in his final letter to the

15 Administrator, to perhaps point out how all of

16 these charter requirements are handled, and

17 also to look at the schedule for this current

18 ozone review. Thank you.

19 CHAIR SAMET: Okay. Thank you. 

20 Any questions or comments?

21 DR. GRANTZ: I didn't, in the

22 introduction, I didn't catch for whom.
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1 MR. STEICHEN: Yes, that's my

2 question.

3 DR. GRANTZ: Who are you speaking

4 for?

5 MR. STEICHEN: I'm Ted Steichen,

6 I'm with the American Petroleum Institute.

7 DR. GRANTZ: Thank you.

8 CHAIR SAMET: Okay. Thank you. 

9 Let's see, we are down in numbers. The

10 stalwarts are here. Anything else that we

11 need to do? I don't think so. So, Angela,

12 any, or Vanessa, any last minute instructions?

13 So, rapid turnaround on your

14 summaries. There will be a conference call,

15 probably at least one conference call, and

16 we'll see what else may be necessary. And a

17 meeting this Spring comes to North Carolina.

18 DR. NUGENT: Right. And, Vanessa,

19 do you have anything to add?

20 (No response.)

21 DR. NUGENT: No?

22 DR. VU: I just want to thank the
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1 members of the Ozone Review Panel for your

2 hard work and provide very useful advice to

3 the Agency, very much appreciate your time

4 being here the last three days. And, of

5 course, once again, I just want to extend our

6 sincere thanks to our Chair, Dr. Jon Samet.

7 I know, I think Dr. Samet asked me

8 earlier about how many letters are there, so

9 I just want to remind you that the Agency

10 requests you to review the ISA. That is the

11 ISA's Paper Office and Research Development,

12 so we'll have a separate letter to go to ORD.

13 And then the REAs, the two reports

14 in the REAs, one separate letter and the PA is

15 the last letter. So you actually have three

16 letters.

17 And you will receive a follow-up

18 email from Angela and Aaron Yeow. Aaron will

19 be the DFO to put all the reports together.

20 Even though Aaron is not here

21 today, but he's been listening on the phone

22 and working closely with Angela to develop
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1 that. And with that, I want to thank you

2 again, and have a safe journey home.

3 CHAIR SAMET: Okay. And thanks,

4 and good luck.

5 DR. NUGENT: Right. So we're all

6 adjourned.

7 CHAIR SAMET: Adjourned.

8 (Whereupon, the above-entitled

9 matter went off the record at 11:50 a.m.)

10

11

12

13

14

15

16

17

18

19

20

21

22
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A

Aaron 199:18,18

199:20

ability 52:12

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36:10 69:9,12,16

85:21 115:10

142:20 148:21

176:9 189:15

194:22 195:18

196:13

above-entitled

119:19 200:8

abrogation 181:21

absence 18:11

79:14

absolute 49:10

56:16 63:3 65:10

138:18

absolutely 15:11

53:20 65:3 115:18

138:3

accept 117:21

acceptable 79:11

79:16 82:11

125:13

accessible 133:11

accomplish 191:5

accomplished

63:16

account 46:18

52:13 56:20 58:14

62:12 171:9

accounting 86:4

accounts 90:17

accumulative

162:7 163:11

achievable 57:3,12

achieve 69:10,12

achieved 73:2 78:1

acknowledge

168:10 193:7

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acknowledgment

168:17

Act 12:22 13:3

14:12 134:13

acting 190:14

actions 89:13

activity 195:11

actual 59:15 102:4

150:21 159:14

172:21 174:1

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adaptation 94:2

95:11 135:21

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116:5 167:9

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175:12 182:2

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184:7,7 195:18

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123:10

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126:15 134:19

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114:17

administrative 5:7

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Administrator

6:18 7:6,9 8:19

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49:22 54:20 78:11

82:5,15 121:8

173:12 174:5,15

187:17 195:17

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Administrators

170:4,11 172:9

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advances 110:7

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advantage 52:20

94:12

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29:17 135:17

160:4

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98:13 156:12

advice 15:16 34:20

36:22 199:2

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advocates 83:13

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161:16 199:3,9

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142:14 150:8,17

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104:13,22 114:10

116:5 138:6

139:12 144:20

145:3 147:9 159:9

161:4 162:5

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175:17 182:3

agreed 95:9 164:21

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agreement 111:7

agricultural 161:14

166:6 170:13,20

172:18,21 182:17

ahead 68:16,17

72:2 84:7 94:18

106:6 122:3

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67:11 72:3,8

77:22 92:1 124:16

125:19 130:8

131:4 134:13

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Allen 1:19 3:11

88:19

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allow 12:22 52:22

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177:18

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alluded 33:5 58:14

115:7

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21:17 22:16 33:4

33:7 36:2,12,14

36:17 38:6 39:1,6

40:22 45:6 47:9

54:17 55:6 56:19

57:19 59:14 60:19

66:17 127:21

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139:7,16 140:12

140:15,22 142:13

143:2,21 185:14

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86:12

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154:2 192:18

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Ana 1:20 3:22

55:13 60:3,14

61:10 63:1 67:22

144:17

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137:5,17

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103:14 110:16,22

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48:6

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Angela 2:13 5:3

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198:11 199:18,22

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anomaly 179:11

answer 38:16 39:1

39:8 51:3 81:13

120:10 166:3

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23:18 57:20

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antsy 120:4

anymore 128:13

anyone's 177:18

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74:10,13,22 76:12

76:16 77:1

assume 190:9

assuming 57:3,13

assuring 78:8

asthma 28:12,12,13

28:13,14 97:4,19

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atmosphere 156:16

156:20

attain 63:10 197:7

attainability 12:2

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attainable 12:13,17

attaining 16:7 63:8

attempt 73:19

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attributable 22:5

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audibility 68:9

augmented 48:18

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availability 87:14

available 20:10

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average 26:8 42:4

42:11 47:20 61:22

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averages 149:20,21

averaging 36:20

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87:8 107:13

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averting 31:3,5

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Avol 2:2 3:21

133:18 135:7

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aware 18:1 31:10

awful 161:15

a.m 1:13 5:2

119:16,18,20,21

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B

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basis 18:5 35:15

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bearing 174:16

beat 136:11,12

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began 59:11

beginning 113:6

155:21 196:2

behalf 67:10

behavior 85:17

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behaviors 31:3,5

belabor 22:18

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believe 174:12

Bell 2:2 3:13 76:13

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belong 118:19

benchmark 32:5

benefit 56:10,12

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best 149:3 150:3

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bestow 117:19

better 50:20 64:21

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beyond 63:15

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big 68:8 86:3 87:12

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bigger 49:14

billion 25:4,11,18

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biological 27:21

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biologically 45:1

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biomass 46:9

bit 10:17,22 11:17

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108:10 115:5

116:17 117:1,9

144:15 145:21

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155:6 177:8

180:13 182:9,15

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blank 110:4

blown 140:9

blunts 136:8

Board 7:3

body 20:9 25:1

129:18

border 69:8

bothersome 117:2

bottom 34:10 65:5

bound 57:1 103:18

box 122:19

Brain 3:15

break 5:16 84:3

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brevity 143:12

BRIAN 67:2

brief 68:20 78:4

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bright 187:19

bring 22:20 31:17

108:17 114:14

116:17 120:18

144:16 192:20

bringing 14:14

31:20 32:12 110:2

158:3 175:21

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brings 80:6

broad 50:22 51:5

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broader 20:9 39:12

40:5,21

broadly 13:19

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broken 84:19

brought 14:16,19

23:4 33:11 107:1

112:14 113:11

114:5 157:3 161:8

163:9 166:4 168:5

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Bryan 2:16 11:11

29:3 58:13 64:11

131:22

build 41:4 181:1

building 41:2

builds 40:17

bullet 10:22 116:11

116:13

burden 60:12

Bureau 30:15

business 182:16

busy 125:12

C

C 30:12

calculate 153:11

calculating 14:18

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calculation 66:13

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calculations 22:1

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California 23:17

135:4

call 121:7 143:12

152:21 173:14

178:16 190:4

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calls 21:11 77:1

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CAMx 73:5

Canada 72:18

Canadian-Mexic...

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capture 60:9

captured 100:4,13

100:14

carbon 44:15

cardiovascular

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care 126:2

carefully 100:9

Carolina 1:13 9:3

44:5 198:17

carry 162:6 174:21

CASAC 1:13,15

5:5 6:13 7:20

9:17 15:13,16,19

16:15 17:7 19:18

30:2 34:19 36:22

37:4 47:22 77:15

77:19,20 80:4

104:18 132:18

190:1,21 191:18

192:2,8,20 195:7

196:4,18 197:10

CASAC's 8:13

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case 12:3 19:17

43:3 48:19 50:15

60:5 64:15 92:21

134:9 136:5 148:8

171:19 173:15

179:17

cases 80:8 134:6

170:3

cast 174:1

catagorize 124:9

catch 197:22

categories 124:8,10

causal 24:15,16

26:22 27:3 44:8,9

101:17 103:10

129:16 148:16

causality 24:12

95:8 100:1

causing 76:6

CD 191:3

Census 30:15

center 1:12 74:20

central 78:6 87:17

141:13

certain 17:10 18:11

148:17 154:1

195:16

certainly 8:14 9:8

11:19 14:3 18:15

22:21 83:9 89:21

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101:16 109:13

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108:19 111:2,5,17

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175:10 178:3,15

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184:21 185:2,8

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198:8 199:6 200:3

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chaired 6:14

challenge 8:6 86:3

180:1

challenged 12:10

79:1

challenges 77:20

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challenging 176:3

chamber 161:20

chance 53:21

119:17

change 11:8 55:5

62:3 100:1 153:3

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changed 52:3 53:14

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changes 28:15 33:6

53:19 54:1 57:16

61:11 63:15 97:21

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189:4

changing 57:20

78:13 79:2 148:2

chapter 3:10,13,16

3:19,23 4:8 10:17

11:1,19 23:8

31:16 32:15 33:10

33:13,15,19,20,21

35:18 38:2 43:20

46:4 47:4,4,14

65:17 84:5,8,13

84:22 87:9 89:1,7

89:19,22 90:1,4,9

90:15 92:4,13

102:17,18 103:14

104:21 105:13

106:9,10,14,17,18

107:5,8,8,13

108:6 110:1,16,20

111:3,18,19 112:4

112:9,10,10 113:4

113:5,6,16 115:17

115:17 117:4,5,20

118:1,3,4,8,15,20

118:22 119:8,13

120:8 122:7,22

123:2,7,19,22,22

124:13 125:2

127:11 128:16

130:4,20 132:17

133:7 136:22

137:9,11 145:2,7

151:15,19 152:1,7

152:9 155:6,9,16

157:11 159:2

160:10,14,19,20

161:2,3 164:14,16

164:18 165:2

166:4,13,14

167:13 169:1

171:8,9,14 175:15

175:16,17 178:18

178:19 179:1,4,5

179:15 180:12

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184:20 185:3,6,9

185:10

chapters 31:16

43:22 48:15 52:3

105:8 108:12

143:7 155:5 157:8

171:22 173:10

175:13 196:9

chapter's 96:8

166:19

characterization

50:9 51:5

characterizations

41:14

characterize 29:15

53:1 123:8

charge 29:5 98:4

112:17 118:4

120:7,10,15

122:10 123:2,4

127:17,18,19

130:16 139:14

141:2 185:13

197:2,4,5

charged 122:6

chart 23:7

charter 190:1

196:18 197:16

chartered 196:20

check 84:3 107:19

119:17 142:6

chemical 156:15,20

chemistry 90:8

children 30:19

chime 148:14

Chock 2:3 3:12

66:4,8 90:14

91:12

choices 95:22

Chris 3:21 66:3

91:19 102:10

105:5 107:22

122:22 133:17,20

136:21 137:8

144:3 151:5 185:6

circle 59:9

circumstances

13:21

cite 104:9

cited 88:11 183:10

citing 94:12,13

city 1:12 12:16 27:5

76:11,16,22

clarification 64:12

93:14

clarified 157:13

clarifies 60:16

clarify 35:22 62:19

65:13 157:15

158:7 178:9

clarifying 6:1,8

122:4 158:22

185:5 194:19

195:3

clarity 67:5 130:12

Class 166:20

179:18

classification

103:11

Clean 1:3 7:4

134:13

clear 8:10,13 13:3

23:3 60:4 66:11

79:13,22 88:5

92:9 97:10 108:22

112:13,17 123:19

128:1,1 129:19

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195:21

clearly 29:10,17

61:6 62:15 71:1,5

75:14 78:22 82:1

82:17 88:2 91:16

94:9 97:7 98:11

102:8 115:16,18

124:1 127:2

139:15 140:2,8

145:5 171:5,7

172:11 190:6

191:7

click 89:12

climate 45:20

clinical 15:9,11

17:11

clinically 26:6

close 74:15

closely 199:22

closer 17:16

CMAQ 88:6

coherence 29:2

44:17 109:10

colleagues 120:11

143:8 148:14

collection 149:1

combination

166:14

combinations 75:2

75:5

combine 77:2

149:21

combined 74:16

come 9:1 10:9 11:5

19:11 55:8 107:4

107:12 123:13

142:13 151:11,22

151:22 162:9

189:21 192:15

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commenting

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55:16 72:4,8,10

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commitment 77:18

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common 13:4

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149:16 150:7,15

communicated

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communications

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community 133:14

compare 116:20

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153:17,19

compared 142:8,14

comparison 42:14

61:17 63:21

147:12,16 151:1

comparisons 43:5

165:18

compelled 155:18

compelling 18:9

39:3

competition 184:6

complete 179:16

completely 115:20

174:1 191:8

completing 23:7

complex 20:13

78:19

complexities 60:3

compliance 124:17

complicate 41:8

components 65:8

compounding

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compounds 183:19

comprised 59:9

concentrate 159:17

concentration

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126:11 131:7,11

131:18 132:9

138:9,13 186:8

concentrations

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24:1,4 39:13

41:14,16,20 42:1

42:8,12,13 43:18

60:12 72:13 73:12

73:21 75:20 76:5

131:5 138:15

153:10

concept 14:17

119:14 169:2

conceptual 123:20

128:15

conceptually 153:3

concern 63:20

173:15

concerned 83:15

concerns 48:22

58:8 157:2

concise 90:7 94:8

152:9 181:14

concisely 138:22

concluded 26:21

37:2

concludes 21:11

24:14 26:11 30:6

30:11 31:3 47:14

conclusion 35:1,14

35:16 37:8 48:4

82:3 123:14,17

129:8,12,14

conclusions 3:19

4:16 24:11 33:22

33:22 35:19 36:4

36:13 44:4,13,21

47:5,12 102:20

123:10 145:19

147:21 167:19

180:12 181:15

condensed 157:13

conditions 64:5

124:15 176:16

conducted 26:14

46:5

cone 111:8

conference 198:14

198:15

confidence 41:12

41:16,22 131:7,11

141:5 153:12

confident 50:3

confirms 176:1

confounding 27:19

93:21 94:1 98:6

confused 61:14

64:19 148:6

confusing 147:6

confusion 59:18

60:1 65:14 66:5

165:14

Congress 197:4

congressional

12:21

connected 70:2

cons 139:19

consecutive 47:18

consensus 183:9

consequences

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consider 11:20

12:12 16:17 18:14

18:19 29:12 34:19

36:10 41:8 46:21

77:6 123:8 129:9

130:13,22 145:14

153:16 181:18,22

186:8 187:13

188:17 193:8

consideration 13:1

13:15 19:1 20:15

34:3 35:2 36:3,15

40:20 47:11 58:5

69:2 92:10 101:20

139:3,18 170:2

175:6 183:2

considerations

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124:7,11

considered 11:6

25:22 34:22 52:18

72:14 156:11

188:7

considering 12:2

24:9 37:11 43:10

45:6,13 125:17

139:7 186:16

187:14

consistency 74:5,7

75:9

consistent 14:11

44:12 74:10 79:21

consistently 97:12

97:16

consolidate 102:13

constant 53:8

constraint 14:9

consultant 190:16

contact 6:3 121:22

contained 80:20

contains 81:9

content 108:18

133:5

context 11:2 22:21

36:19 38:5,15

42:7 50:13 51:5

70:22 97:13 135:5

136:17 153:22

154:3,7

contexts 113:18

continue 19:13

27:10 28:22 47:15

47:17

continued 55:11

continuing 166:18

continuous 149:9

149:10,12

contractors 5:13

contrasting 142:7

contribute 50:11

contributing 24:3

contribution 88:3

contributions 73:9

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contributors 23:19

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controlled 24:22

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correct 57:7,8,14

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corrected 84:14

correctly 192:4

counterpoint 144:3

country 69:19

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county 177:4

couple 10:7 11:3

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41:6 49:5 51:22

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134:4 136:12

179:6 186:2

course 25:11 31:17

32:15,21 33:20

36:9 56:6 84:22

103:6 121:6 199:5

court 12:19,20

13:13 17:22 18:6

18:8 19:4 195:9

195:11,19

cover 175:18

covered 88:22 94:4

96:4

covers 89:5

co-pollutants 27:20

CR 141:19 142:5

created 79:20

cribbed 119:7

crisp 107:17,17

crisper 95:15

criteria 26:21

29:20 44:11

125:17

critical 110:6

133:15 176:2

186:14

crop 46:17 156:11

162:16 163:1,22

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172:1,19 176:6,6

177:11,14 178:11

crops 163:16 164:4

167:2 170:7,8,13

170:14,20 171:3

178:12 183:3

crucial 145:8

146:17

cubic 141:10

cumbersome 78:20

cumulative 44:22

47:16 181:6

current 16:4,8 20:8

21:4,8,12,19

25:15 27:16 32:2

33:1 34:1,10,14

34:18 35:2,10

36:19 37:7 38:10

38:15,20 39:4,15

45:5 46:1,10 47:6

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66:14 78:7,12

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118:15 123:10,15

126:17,21 128:6

132:2,4,10 140:6

140:9 168:12,16

172:18 197:17

currently 117:15

168:16

curve 56:5

cut 116:22 133:1

cutoff 176:20

C-O-N-T-E-N-T-S

3:1

D

D 196:19

daily 23:20 126:5

damage 160:2

Daniel 2:5 3:10

68:15 83:1 84:6,7

88:21 107:20

119:2

Daniel's 68:11

data 30:14 41:21

43:1 47:3 53:15

80:20 81:4 117:11

117:11,12 124:16

126:15 131:4

136:7 141:4 142:3

147:19,22 148:1

150:5,20 161:14

161:19,20 176:8

181:18,19 182:17

187:7

Dave 162:19

168:21 182:1

David 2:3,4 3:12

4:14,22 83:4 84:6

90:13 92:6 160:12

David's 102:12

day 5:5,9 60:2 62:3

62:3,15 104:22

days 10:8 11:4

23:20 28:4 72:11

73:6 102:12

136:12 199:4

daytime 47:17

deadlines 192:14

192:17

deal 34:5 87:12

166:10 179:11

dealing 42:4 172:1

dealt 95:12 195:4

deaths 55:22 150:1

150:2

debating 172:13

decades 78:1 167:3

171:3

decide 109:21

178:1

decided 17:3 18:6,8

100:1

decision 12:8 14:21

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79:15 101:14

102:1 146:18

164:8,10 166:1

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decisions 12:5

20:18 21:1 38:6

40:22 79:7,9 80:3

171:11 172:8

190:16 191:6

decision-makers

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decrease 183:19

decreased 25:7

decreasing 41:20

decrement 26:4

decrements 25:5

25:10,17 26:1,3,5

26:9,12 28:15

29:19 32:14

defeat 12:21 13:14

defend 104:15

defenses 25:8

define 21:6 139:4

defined 13:7 15:5

defines 14:9

defining 187:19

definitely 40:1

163:11 164:15

166:18

definition 49:19

50:17 66:5,16

126:3

definitions 95:7,9

deleted 123:18

deliberations 6:3

49:15

delivered 133:22

134:1

delta 49:8 54:21

140:15

Democratic 137:6

demonstrate 97:8

demonstrating

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NEAL R. GROSS

COURT REPORTERS AND TRANSCRIBERS 

1323 RHODE ISLAND AVE., N.W. 

(202) 234-4433 WASHINGTON, D.C. 20005-3701 www.nealrgross.com 

C E R T I F I C A T E

This is to certify that the foregoing transcript 

In the matter of: 

Before: 

Date: 

Place: 

was duly recorded and accurately transcribed under 

my direction; further, that said transcript is a 

true and accurate record of the proceedings. 

 

 ----------------------- Court Reporter 

228

Clean Air Scientific Advisory

Committee Ozone Review Panel

US EPA

09-13-12

Raleigh, NC