OSHA: Proposed Standard For Indoor Air Quality: ETS Hearings, January 19, 1995

OSHA: Proposed Standard For Indoor Air Quality: ETS Hearings, January 19, 1995




Thursday, January 19, 1995

Department of Labor

Washington, D.C.

The above-entitled matter came on for hearing, pursuant to notice, at 9:00 a.m.


Administrative Law Judge



R.J. Reynolds
Christopher R. E. Coggins
Michael W. Ogden
Paul R. Nelson
Stephen B. Sears
Michael W. Ogden
Christopher R. E. Coggins
Hoy R. Bohanon, Jr.


Dr. Glantz 11848
Ms. Sherman 12000
Mr. Herman 12024
Mr. Dinegar 12121
Mr. Myers 12151

Allan Hedge


Ms. Sherman 12170



239 12021 12021

240 12022 12022

241 12022 12022

9:05 a.m.

JUDGE VITTONE: We resume our hearings into the proposed rule by the Occupational Safety and Health Administration for indoor air quality.

Before we resume our examination by the OSHA staff, let me repeat my admonition of yesterday. I would like to see questions more specific. I would like to see the answers more direct and specific to the question. There will be ample opportunity to clarify and amplify any answer in this proceeding. We made good progress, I thought, yesterday afternoon. If we can move along in that same mode all day, we should all be talking to each other by the time five o'clock or six o'clock rolls around.

DR. GLANTZ: In our effort to reduce the questions, a page got deleted by accident. Hold on a moment.

MR. GROSSMAN: While they're looking, Your Honor, Mr. Bohanon had an answer to a question that was posed yesterday.

JUDGE VITTONE: Okay. What question was that?

MR. BOHANON: The question had to do with the incident rates. I checked with our safety and industrial hygiene people and they inform me that the incidence rate is based on OSHA 200 type incidents and applies to all employees.

MS. SHERMAN: Hourly and salaried?

MR. BOHANON: Hourly and salaried. All employees.

MS. SHERMAN: Thank you.

MR. BOHANON: So that's the way that would be interpreted. If Dr. Coggins as a salaried employee had turned his ankle, then that would be counted as an incident.

MS. SHERMAN: Thank you.

JUDGE VITTONE: Thank you very much.

Ms. Sherman?

MS. SHERMAN: Yes. Dr. Glantz has some questions to ask and then I need to revisit some economic issues, Your Honor.


DR. GLANTZ: Good morning. What I would like to do in the interests of trying to move quickly is first begin with some sort of general scientific issues and then once you set that, I think that will help us get through other questions more quickly.

Would you agree that properly applied mathematical modeling is a legitimate technique for use in science?

DR. COGGINS: I'll take a first stab at that. Properly applied --

DR. GLANTZ: I would hope you could say yes or no. I mean, I'm going to ask some more questions where you can elaborate.

DR. COGGINS: I really don't think that's a yes or no answer. It's a very big question. Properly applied and what kind of mathematical modeling.

DR. GLANTZ: Well, I'll get to that. I'd like to talk about mathematical modeling as a general approach to science. I mean, people teach courses in that. And then I want to get to the question of what properly applied means but would you agree that properly applied mathematical modeling is a legitimate technique in science?

DR. COGGINS: It may be.

DR. GLANTZ: Well, do you think it is or isn't?

MR. GROSSMAN: I think you got an answer. Why don't you move ahead?

DR. COGGINS: There are models that work and models that don't work.

DR. GLANTZ: Well, I want to get to how you decide a model works or doesn't work.

JUDGE VITTONE: Let me ask you this. Is this a technique that is used, has been used in the past, by scientists or mathematicians or whatever?

DR. COGGINS: I'm still not sure exactly what the question is. There's a number of mathematical models that's been used for example in Mr. Bohanon's area. We've talked about Dr. Nelson's area.

DR. GLANTZ: I'm not talking about a specific model yet. I'm trying to establish some general principles rather than getting bogged down in a lot of -- we'll get to the specific models. But, as the judge said, is that a general technique which properly applied is accepted in science? I take it is since you're using it in some cases and you would deem those to be proper applications.

MR. GROSSMAN: Maybe to clarify this, are you asking whether mathematical modeling properly applied is accepted in all scientific disciplines or in some scientific disciplines?

DR. GLANTZ: In scientific disciplines where it's used. This is -- you're making a very straightforward question very complicated. It's not a trick question. I promise.

DR. COGGINS: Well, I understand it's not a trick question. But you're now saying is mathematical modeling a technique in areas where it's applied. I mean, that seems to be a circular kind of question.

DR. GLANTZ: No, there are some people who would say -- I mean, I know a few people who say that you can never do mathematical modeling, that it's ridiculous. But I'll try to --

It's going to be a long day, Your Honor, I'm afraid.

JUDGE VITTONE: No, it won't. No, it won't.

Why don't you go directly to your question?

DR. GLANTZ: In getting to the question of how one determines if a model is properly applied, is one of the things you need to make that judgment an understanding of the assumptions that are in the model?

DR. COGGINS: I think that's a much better question. I think yes.

DR. GLANTZ: Okay. And --

DR. COGGINS: Just a second. I really need to finish that because obviously there are a great deal of a number of assumptions in any model and you've got to know all of those.

The other part you need to also be aware of is are there other assumptions that you haven't taken into account.

DR. GLANTZ: Yes. In order to judge whether a mathematical model is properly applied, do you need to know the precise equations in the model or computer code that's used to implement the model if there are no explicit equations written down?

DR. COGGINS: Do we need to know the precise equations to go into the model?

DR. GLANTZ: In order to judge whether or not you think it's a correct model or proper model.

DR. COGGINS: Can you help me on this, Steve?

DR. SEARS: Yes, I'd be happy to.

In my opinion, Dr. Glantz, yes. The answer is yes. In order for me to evaluate both the validity of the model and the application of the model, I would need to see the equations and whatever coding has been performed to execute it.

DR. GLANTZ: Would you say that in order to judge whether or not a mathematical model is an accurate model properly applied you need to see the data that was used to validate the model and how well the model fit that data?

DR. COGGINS: I think I would like to see both sets of those.

But, again, Steve, you're more the expert in this area.

DR. SEARS: Yes. I would like to see both of those. However, I can think of some exceptions where that may not be possible.

MR. BOHANON: Certainly in the engineering field there are cases where there are applied models in control theory where it's not necessary to understand the data that generated that control model but simply necessary to understand that the control works in the applied situation.

DR. GLANTZ: So to just clarify what you said, would it be then -- you're saying that still to use a control system you would want to verify that it behaves the way you would hope it would, if you're dealing -- I mean, if it's a simple control system, but if it's a complex control system, people usually do some sort of testing to verify that it's behaving as expected, wouldn't you say?

MR. BOHANON: Yes. And that can be a judge of the performance in that field of application.

DR. GLANTZ: And then would you say that it's fair to say that after you have gone through these -- well, I'm getting ahead of myself.

If one develops a model for one situation, would you say that it is fair to conclude that very often the conditions in which the model is applied, you need to be careful not to go beyond the areas that the model was originally developed for? Maybe a little bit beyond but not very far afield. If you're being very careful. Would you agree with that?

DR. COGGINS: I think that in many situations where you have multiple parameters in your model minor changes in one parameter can have wild effects on the overall conclusion.


DR. SEARS: Certainly there are models where extrapolation is appropriate and interpolation. And, of course, there are models where not even interpolation is appropriate.

MR. BOHANON: And in the engineering field there are cases certainly where you go beyond the parameters that the control was designed for and the system becomes unstable.

DR. GLANTZ: Okay. Well -- okay. Thank you.

We'll come back to this in some specifics later but I want to just go through some general science at the beginning.

I would like to just address some general principles of toxicology. Have you by any chance read the August 5th Notice of Intent to Appear by the Washington Technical Information Group? Any of you.

DR. COGGINS: I glanced at it. It's been a while. I haven't read it recently.

DR. GLANTZ: It's my understanding -- actually, I read it myself, they submitted a chapter from the Cassaret and Doull toxicology textbook in that submission. Are you familiar with that book or the chapter the put in there?

DR. COGGINS: There are four separate editions. I don't know which -- presumably the most recent.

DR. GLANTZ: But you are generally familiar with the book.

DR. COGGINS: Absolutely.

DR. GLANTZ: Okay. Would you say it's an authoritative text?

DR. COGGINS: It's a toxicology text. There are many others.

DR. GLANTZ: Well, in any event, the Washington Technical Information Group characterized it as, "The most authoritative text" and perhaps the most authoritative textbook in the field. So they at least were impressed with it.

In chapter two of the book by Claussen and Eden, they describe the presence of a dose response relationship as "the most fundamental concept in toxicology." Would you agree with this principle or with this statement?

DR. COGGINS: Not necessarily. I think it is a general principle of toxicology, that you would expect a dose-response relationship but that there are many other factors that are involved in toxicology than just a simple relationship between dose and response. I think that's an oversimplification.

DR. GLANTZ: Well, briefly, what are some of the other principles that you think are important? We're all trying to be brief.

DR. COGGINS: Well, that's again a very big question. The main point I think I would make in terms of general toxicology is something we've heard a lot of and that's the statement by Paracelsus that the dose makes the poison, which is the inverse, if you like, of your statement of dose-response, but that anything could be made into a poison, it's just a question of supplying enough dose. That's certainly one founding principle of toxicology, one that's been with us for 400 years.

There are many other aspects. We could talk about toxicology textbooks for a long time.

DR. GLANTZ: Okay. When was this statement you made about the dose made the poison, when was that statement made?

DR. COGGINS: Paracelsus made it, I believe, 1567.

DR. GLANTZ: Was he a cancer toxicologist?

DR. COGGINS: He was a German pharmacologist. I don't think the word toxicologist was around then.

DR. GLANTZ: Well, getting back to the textbook we were talking about, there's a chapter there, chapter 5, titled "Chemical Carcinogenesis." Are you familiar with that?

DR. COGGINS: I have probably read it but not recently, certainly.

DR. GLANTZ: Well, in chapter 5 under the section "Quantitative Aspects of Carcinogenesis" it says, "Thus, with DNA reactive genotoxic carcinogens, a given dose can result in permanent abnormalities of cells. Subsequent dosages can add to such changes." Do you agree with this statement?

DR. COGGINS: I think the operative work in there is can. There are many other factors that are involved. The textbook that you are referring to is, of course, a textbook and is therefore upon the day it was printed is probably out of date.

One of the statements I was making yesterday, there is some very recent work on DNA repair, I think something we would want to make as a very strong adjunct to the statement that you have just made.

DR. GLANTZ: But as far as -- I didn't make it, the textbook made it. But do you agree? I still don't understand if you agree or disagree with this statement. It's obviously not everything that could possibly be said but is this statement a correct statement as far as it goes?

DR. COGGINS: Well, I think I will stick with the statement I made, the key word is can.

DR. GLANTZ: Okay. The same section in this textbook which was published in 1991 says, and I'm quoting, "Thus, time as well as dose is a factor in assessing the properties of chemical carcinogens." Do you agree with that statement?

DR. COGGINS: Yes. I think that particularly in the field of inhalation toxicology, which is, of course, my expertise, that the equation C times T is of major significance.

DR. GLANTZ: The same section further states, "A number of small doses may give no immediate evidence of their action but in time they could yield neoplasms within the life span of the host." Do you agree with this statement?

DR. COGGINS: I don't want to sound obstructive, but, again, that word may, it may, it may not. It seems to me a very narrow statement with that word may in the middle. In some circumstances, yes, in others, probably not.

DR. GLANTZ: The same section also states that when a chemical "is administered as smaller doses over a longer period of time it can actually be more effective than when it is given as larger yet fewer individual doses in a shorter period of time." Do you agree with that?

DR. COGGINS: This is starting to sound like a litany. May, can -- in certain circumstances, yes. Under other circumstances, no.

DR. GLANTZ: What are the circumstances in which you would agree and disagree with this statement from this textbook?

DR. COGGINS: We could take a simple example, not necessarily referring to neoplasia but for example one of the classic sets of equations, and I guess it comes back to your very first point about mathematical modeling, would be for the uptake of carbon monoxide, that if you gave an absolutely massive dose of carbon monoxide, let's say 10,000 parts per million and you gave it for five minutes, clearly everybody would die. If you gave 2 parts per million for 20 days, nobody would die. And yet you could develop a mathematical model for C times T, concentration of CO and the time that you expose those people and, indeed, the Coburn-Foster-Kane equation has been derived for different concentrations, different times of how that would result in the ultimate problem of cause of death. So that is an example of where you need to develop a mathematical relationship between C and T, concentration and time.

DR. GLANTZ: Okay. But could you give us an example of a carcinogen where you think the statement here was correct and true and if you would like one word isn't correct?

DR. COGGINS: No, you've used a word in a way that I don't use it and I want to define my usage before I can even continue on that question.

A carcinogen is not a carcinogen. It is not an inherent property of a material like molecular weight or boiling point. You can only define the carcinogenicity of a compound by correct reference to four different parameters. That's the test species, that's the dose of administration, that's the dose used, and the target organ.

Now, only when you have defined those four parameters for me can I answer any questions on carcinogenicity.

DR. GLANTZ: Okay. Well, I'd like you to give me an example of a carcinogen where you think the statement that administered as smaller doses over a longer period of time it could be more effective than when given as larger yet fewer individual doses in a short period of time. Using your definitions.

DR. COGGINS: Given time, I could come up with such an example but under these glaring lights I can't think of one off hand.

DR. GLANTZ: Having been under the glaring lights, I would ask you to submit that as a post-hearing comment. And I am particularly interested in an example of a carcinogen which administered as a smaller dose over a long period of time is actually more effective than when given as larger yet fewer individual doses over a short time. And when I say more effective, I mean more likely to end up inducing a cancer.

If you would like to also submit an example where that isn't true, that would also be interesting, but I am most interested in one where you think those conditions are met. And you could submit that as a post-hearing comment.

DR. COGGINS: Could I just confirm, then, you want me to give you an example of a known carcinogen, which I will define with the four parameters that I've just given you, that given in small concentrations over a long period of time can produce a higher or lower response than a carcinogen given in high doses over a short period of time?

DR. GLANTZ: No, I want one which will -- well, you'll have a transcript to work from but I want one which, and I'll read the quote from the book again, it says there are chemicals which "administered as smaller doses over a longer period of time can actually be more effective," and by effective they mean effective at inducing cancer, "than when given as larger yet fewer individual doses in a short period of time."

And that's what the textbook says and what I would like is an example of a chemical where you believe this statement is a true statement with regard to that chemical using your definitions, which I think are acceptable for this.

DR. COGGINS: I'll do that but I will add to that the comments that I made earlier of the problems that you have when you have low dose administrations where you can have a massive amount of DNA repair that is overwhelmed by the higher concentrations. This concept of linear extrapolation from high dose to low dose as I mentioned in testimony yesterday is under severe examination in toxicology circles, so I'll add that to my comment.

DR. GLANTZ: Well, that's fine but I think you understand what we're asking for --


DR. GLANTZ: -- so I'm going to move on.

Then the last sort of general questions, or actually there are two more, let's suppose we're doing a laboratory as you do in college where I'm going to give you a vial with some purple substance in it and I know what it is and you don't and I know that it is a carcinogen by your definition, let's just say to make it relevant to the proceedings that it's a lung carcinogen when inhaled, and I know that for a fact, okay?

And I give this vial to you and say, Dr. Coggins, I want you to figure out whether this is a carcinogen when inhaled over a long period of time at relatively low doses but I know it is, we'll call it Glantzium.

How would you go about determining that? I know what the outcome is, you don't, but what set of experiments, and as briefly as you can although I realize it's a difficult question, what series of steps as a toxicologist would you go through to reach the conclusion that this purple fluid is in fact carcinogenic?

DR. COGGINS: Well, of course, this is a hypothetical question.

DR. GLANTZ: Yes, that's correct.

DR. COGGINS: And as such maybe I shouldn't answer it but you didn't mention one important aspect. You say it's a known lung carcinogen by inhalation. You didn't mention the species.

DR. GLANTZ: Well, let's just say in rats.

DR. COGGINS: Okay. So you're omniscient.

DR. GLANTZ: But I'm not telling you the rats. I'm omniscient, I know it is, I've just handed you this vial of material and I'm saying to you, Dr. Coggins, as a toxicologist, you tell me is this a carcinogen, a lung carcinogen, when inhaled. But beyond that, I've told you nothing. And so how -- I mean, if you were teaching a toxicology course, you know, and this is a laboratory exercise, what series -- there's a series of steps I think most toxicologists would go through to evaluate this purple thing when you aerosolize it or something and I'd like you to as briefly as you can go through the series of steps that you would take. You don't know it's a carcinogen. I know it is. So I know ultimately you could get a positive result but what would you do?

DR. COGGINS: This is a fairly long question. I now have Glantzium in a jar.


DR. COGGINS: And I've been asked to perform a carcinogenicity assay? Or what --

DR. GLANTZ: I've come to you. I don't know anything about toxicology. I say I got this stuff and I want to spray it into the air because it's a perfume or something and I have crazy environmentalists out there saying that this is bad. Tell me whether it's bad or not, whether or not this causes cancer.

DR. COGGINS: Okay. Now that you've narrowed it down, that makes more sense.


DR. COGGINS: The very first thing I would do, I would take Glantzium and I would give it to my colleagues the chemists and I would ask them to tell me what's in it. And they would analyze this material and come back and say it contains compounds X, Y and Z at concentrations A, B and C.

I would then ask you of the sponsor the route of administration because if I was to swallow Glantzium, I would take a very different set of tests --

DR. GLANTZ: It's inhaled. It's inhaled as an aerosol.

DR. COGGINS: So you're now telling me that I would be involved in inhalation of the compounds that I now know are present in Glantzium.

I would then go back to the database of toxicology and say are compounds A, B and C at concentrations of X, Y and Z, I transposed it, are there any data on those, what are the toxicological responses obtained in these compounds in these materials that are present in Glantzium and I would then at that point make a decision as to whether any further studies were needed.

If there were data in the literature that indicated carcinogenic effects or non-carcinogenic effects, I would then be at a decision point in my tree, my decision tree. If there were hard and fast data, I would come back to you and say take it back. So it's a lung carcinogen.

If there were no data, which I think is the point of your question, I would then probably, depending on how much time and money we had, initiate a series of toxicological studies to determine what exactly the responses of Glantzium would be in experimental animals. Probably the first study, the first experimental design, would be very similar to the 14-day study I described yesterday. But, again, I would have to work very closely with my colleagues the chemists who would tell me exactly how much material that I have presented to the animals, whether or not the material can be inhaled under the circumstances that I had defined. And then I would look at those responses and see what my colleagues as toxicologists would think of the results of the examination of Glantzium.

At the same time, while I'm doing this, I think I would be looking around and talking to colleagues such as epidemiologists to say are there examinations of Glantzium in the epidemiological sense. In other words, are there, for example, work situations where people have been exposed to Glantzium.

DR. GLANTZ: Would you then --

DR. COGGINS: I'm not finished.

DR. GLANTZ: I thought you were done.

DR. COGGINS: We're a long way off.


DR. COGGINS: So what I'm trying to build here would be a consensus of opinion to arrive at the word that we used yesterday, cause. Because I'm now building up the consensus of opinion from the epidemiologists, from the chemists and from the toxicologists, we'd be moving forward on, if you like, three parallel paths to obtain information on Glantzium.

I would probably at this stage initiate -- depending on the results of the earlier studies, some longer term studies, depending on the results, as I say. We would be possibly considering a long-term inhalation study depending on the results of the earlier term studies.

So that hopefully when we've got the information back from my colleague the epidemiologist who would say there's a link or there isn't a link, the chemist would say there's something in here, there isn't something in here, looking back at the database, there's something in here, there isn't something in there, and, of course, depending on the results of the toxicology assays, I'd come back to you and give you my consensus opinion as to the toxicological activity of Glantzium.

I'm sorry it's such a long winded answer but it was a big question.

DR. GLANTZ: No, I appreciate that. I would just like to, despite the long answer, ask you to elaborate one or two points.

Could you give me a little more details on how you would do the toxicological testing? And, in particular, let me try to ask you a few specific questions.

Would you determine an LD-50? Again, you know nothing about this to begin with.

DR. COGGINS: The concept of LD-50 in inhalation is not really applicable because of the C times T concentration thing I was just describing, for example, with CO.

DR. GLANTZ: Well, how would you -- since all I've given you is this vial of stuff, how would you decide what doses what you might want to use in your inhalation experiments?

DR. COGGINS: I would look at the database of toxicology results.

DR. GLANTZ: You can't find -- nobody's done it, it's a new -- you don't -- you can't -- there's nothing in the database.

DR. COGGINS: We're getting more and more hypothetical as we go on. You're narrowing me down. I'm saying that I would look at the information from my chemist colleagues, and I think it's pretty unlikely -- they aren't going to come back and say you've got a new compound here. I'm sure there's going to be some information on comparable compounds or families of compounds. I'm going to look at those data and from those perhaps construct a dose range finding study and that basically was what the 14-day study that I described yesterday was, was a dose range finding study to see what the approximate toxicological end points were in a study with a material that had not been examined in the literature.

Just now getting back onto the point here, when we performed the 14-day study almost six years ago now, there were very few references in the literature to inhalation studies with real ETS. In fact, there weren't any. So we were effectively working in the dark under that very same set of hypothetical statements that you've just made. And we decided that based on these chemists and their ideas of what would be a reasonable exposure to perform exposures of that and ten and hundredfold exaggerations.

So when we were doing the 14-day study with ETS, we had no idea what the responses were likely to be at those concentrations, although we had a rough idea compared to mainstream smoke but, of course, we've heard from again the chemists, it's very different.

DR. GLANTZ: Okay. Thank you.

I'm going to try to ask you a few pointed questions that I hope you can give much shorter answers to.

Would you say that an accepted toxicological procedure is to determine an LD-50 for a compound and then based on that back off from that and determine what exposures would be appropriate in a long-term inhalation study?

DR. COGGINS: I think the concept of LD-50s is outdated, outmoded and is not really of great relevance to toxicology. It's perhaps of relevance to acute toxicology but I don't think that an LD-50 is necessarily of major importance in the armamentarium that toxicologists have.

DR. GLANTZ: Now, yesterday when we were talking about some of these same issues, we were talking about long-term studies, the 24-month studies. You made the point that sometimes you people even do 30-month studies now. Would you say that it is common practice to do a long-term study, 24, 30 months if you're talking about a rodent, and then back off the exposure duration? That that's often the way people do toxicological bioassays or cancer bioassays, is to begin with a long-term exposure study and then work their way back down to shorter terms?

DR. COGGINS: No, the exact opposite. You start with a short-term study and see what the responses are and see if they warrant further attention. You have a kind of a battery approach. You would start off with a short-term study, an acute study, say like a 14-day dose range finding. Depending on what you saw there, what the indications were, you would go to a longer term study, which is exactly what we did with ETS. Then when you've got the 90-day data, you look at that and say, well, are there any indications here based on my information as a toxicologist and on the information that I have seen in the literature that those changes would warrant a longer term study.

And, in the case of our 90-day study, that one change that we saw, hyperplasia, which I'm sure you'll agree is a very minor change, in a tiny portion of one area of one organ only, we just felt that that was not, and I feel today that that is not the kind of lesion that is going to progress to a carcinogenic end point in a two-year study or to any other kind of response in a two-years study.

DR. GLANTZ: Well, I didn't want to get into that specific study quite yet but in terms of the statement that you just made, that was your belief, though. You don't have any data to demonstrate that that's a true statement, that's just what you believe based on your best scientific judgment, is that a correct statement on my part?

DR. COGGINS: Based on my scientific judgment and on that of my colleagues, the fact that the response that we saw in the 90-day study was the same as that seen after four days and based on my previous statements that responses after 90 days are the same as after two years, we felt that there was no real reason to move into the next stage of the battery. Because then --

DR. GLANTZ: Okay. You've answered the question.

When people are doing bioassays for chemical carcinogenicity, is it common to administer doses that are thousands of times above ambient levels, sometimes tens of thousands of times? I'm not asking whether it's controversial in some circles but is that a common practice?

DR. COGGINS: Ambient? I'm not sure what you mean by that.

DR. GLANTZ: Well, let me define that, then. I do a lot of work for the State of California on air pollution and we are presented with animal data and risk assessments from time to time when assessing a pollutant in the outdoor air, methylene chloride that comes to mind. And people do animal bioassays where the animals are exposed to very high doses compared to ambient levels, sometimes 10,000 times, even 100,000 times above ambient. And then you're stuck with a high dose to low dose extrapolation problem.

But would you say that in bioassays for chemical carcinogenicity that that's a procedure which is often followed by reputable organizations?

DR. COGGINS: I think that the procedure that is currently recommended is to establish the maximum tolerated dose and back off slightly from that. And that may well represent in some cases tens, hundreds, thousandsfold over ambient. It depends on the compound of interest. But that's the way it's done. It's not let's take the ambient concentration and multiply by 10 or by 100. You go the other way around. You look at the MTD and come back.

DR. GLANTZ: Right. I agree. That's a much better statement than I made.

Well, let me ask you this. Did you follow that procedure in any of your experiments looking at ETS or ADSS?

DR. COGGINS: Clearly the concept of a maximum tolerated dose is not necessarily applicable to a 90-day study. But let's assume that it were. I think and several other scientists that I have discussed would argue that a blood carboxyhemoglobin of 6 percent is in excess of the MTD.

DR. GLANTZ: But in terms of the studies you've done on ETS or ADSS, you didn't follow the procedure that you outlined which we were talking about earlier in terms of assessing carcinogens in the air, ambient air. By ambient, that means outdoor air in air pollution lingo.

DR. COGGINS: We weren't doing carcinogenicity assays. We were doing a toxicology study.

DR. GLANTZ: Okay. Okay. Well, having gone through these general things, I'm now going to get specific to your testimony and hopefully the groundwork we laid will speed things up.

Now, in Dr. Chang's submission to the docket and also in one of the presentations a couple of days ago, you presented the results of a pharmacokinetic model to calculate peak plasma nicotine levels in people exposed to ETS. Is that correct?

DR. COGGINS: Dr. Nelson was involved in this work. Yes.

DR. NELSON: And what I presented were some results of some pharmacokinetic modeling performed by Dr. Chang.

DR. GLANTZ: Okay. Now, in figure 2 of her submission, she reported a peak concentration of plasma nicotine of .006 nanogrms per milliliter in a 70 kilogram person resulting from breathing 2 micrograms per cubic meter of nicotine. This was the page that got confused.

Okay. Let me back up again. She said that she got a plasma nicotine concentration of .006 nanograms per milliliter in a 70 kilogram person resulting from breathing 2 micrograms per cubic meter of nicotine for eight hours a day, five days a week.

What was the respiration rate used in the modeling to get this number?

DR. NELSON: I do not have that information with me. I was reporting on some modeling work that she did. I did not perform the modeling myself.

DR. GLANTZ: Is that something you could submit as a post-hearing comment?

DR. NELSON: I'm sure that we could. Before you go on, let me make a not of that.

DR. GLANTZ: Yes. Although it will be in the transcript.

Now, you said in your presentation a couple of days ago that that pharmacokinetic model was actually developed to study the effects, I believe, of nicotine in active smokers. Is that correct?

DR. NELSON: That is correct.

DR. GLANTZ: Can you tell us more about the purposes for which that model was developed?

DR. NELSON: I was not part of the development of the model. As I say, I'm merely reporting some results from that model that were relevant to my testimony and based on discussions but I don't know the actual reason why that model was developed.

DR. GLANTZ: When one develops a pharmacokinetic model, you usually develop it specifically to model end effects on target organs, at least in the pharmacokinetic models I'm familiar with. Do you know what target organs were modeled in that model?

DR. COGGINS: I'm not sure that necessarily it has to go to a target organ but what we can do -- I believe we have published the data on the PBPK model for nicotine, Toxicology, Applied Pharmacology. If it's not in the record, I'll put it in but I think that will give you the answer as to why we performed that work.

DR. NELSON: And one other point is, at least I'm not aware it's not necessarily to determine end effects but I know that the model determines concentrations in various organs. I'm not sure whether or not it was -- what the intent of the particular model was.

DR. GLANTZ: Would you be willing based on our discussion of mathematical models earlier to put the full model into the record? Because most models I'm aware of is they get published, for reasons that you discussed earlier you often have to really cut things down when you write a paper. And so that OSHA can fully assesses the appropriateness and applicability of the model, would you be willing to put into the record a full description of the assumptions in that model, the equations or computer code as appropriate, probably the computer code would be best, to implement the full model and the results of all validation studies that you've done?

DR. NELSON: I can't speak for the modelers but I can them. I suspect the answer will be yes.

DR. GLANTZ: Well, we heard a lot about we're speaking to RJR as the panel and I'm asking RJR to put this information in as a post-hearing comment so that OSHA can apply the standards that you outlined earlier in your testimony to that model.

DR. NELSON: As far as I know, as I said, the answer is yes but I can't speak for everyone.

DR. OGDEN: Excuse me. Could I interject here? I believe that the reason the information on the modeling was submitted to OSHA in the first place is because OSHA requested information on PBPK modelling but as the data show I'm not sure how that's relevant to what OSHA's charge is and that is understanding ETS exposure in the workplace.

DR. GLANTZ: We would appreciate it if you would submit that as a post-hearing comment and you appear to have agreed to so let's move on.

DR. NELSON: Yes, but let me do point out that although that model will show nicotine concentrations in various organs of the body, it does not show concentrations of any other component associated with environmental tobacco smoke and could not be used to predict any effects due to other components of environmental tobacco smoke that will behave very differently than nicotine in the body.

DR. GLANTZ: I appreciate the information. In the interests of time, we had already gotten to the end of this line of questioning.

Now, as you said the other day and as we have just been discussing, I would anticipate the validation data that you would be sending would be for active smokers, since the model was developed for active smokers. Is that correct?

DR. NELSON: Again, I'm not involved directly with the model so I can't answer that question.

DR. GLANTZ: Well, based on, again, the discussion of modeling that we had earlier and assuming that it was a competently done, appropriately applied model I would presume the validation data would be for active smokers, so we would be interested in that.

But since you are applying the model to passive smokers, which as you've pointed out receive much lower doses and as you've pointed out, there might be a serious extrapolation problem in the use of that model, we would also appreciate any additional validation you've done to show that it applies to passive smokers as well, for the reasons you outlined in your testimony. That takes care of that part.

DR. NELSON: Although I guess I could point out -- excuse me. I really would like to finish clarifying my answer and try to be as full for the record as possible.

Many of those assumptions that were made in extrapolating the model from smokers to non-smokers are indeed also outlined in Dr. Chang's submission and I think that that is an important point to reiterate, that those assumptions are, I believe, outlined in her submission to the docket.

DR. GLANTZ: I just realized a missed a question. I missed one question here. I have to go back to the toxicology textbook for two more questions. I apologize.

In the chapter on carcinogenesis, it also states that DNA reactive carcinogens vary greatly in their potency. Is that something you would agree with?

DR. COGGINS: I'm sure there's a range of responses, just like I said earlier, even for any one component the dose will make a poison.

DR. GLANTZ: And, again, I apologize for kind of having to come back to this but in going over the general principles of toxicology as outlined in this textbook, would you agree that those principles should be applied when assessing the toxicity of environmental tobacco smoke?

DR. COGGINS: I think that the most up-to-date set of principles should be applied. As I say, that book you just told me was published in '91. The concepts in it, I was involved in writing some of that book and some of my colleagues were, too -- I'm sorry, wrong textbook. You're talking about Cassaret and Doull?


DR. COGGINS: It was published in '91 and so with publication delay, probably most of the manuscripts were submitted in '89. I think there's been a great deal of change, especially since as mentioned earlier the molecule of the year. I would apply the most modern techniques rather than those from a textbook published many years ago.

DR. GLANTZ: I understand what you're saying, that science is a dynamic process but, for example, F has equalled MA for a long time, since Newton, and so some things don't change. And would you say that the principles outlined -- well, actually, I just got handed a better question.

Which of the principles that we outlined from the textbook do you think have changed since the book was written?

DR. COGGINS: Have changed?


DR. COGGINS: Well, I think the comment that I made yesterday on the concept of understanding of repair systems. I have the quote again from Science, December 1994, where virtually the whole issue was talking about molecule of the year, the DNA repair enzyme where at low levels of dose the DNA repair mechanism can overwhelm any insult. Larger doses overwhelm the DNA response, the DNA repair response.

Also, the concept that we're now realizing, and here's another quote, the spontaneous errors resulting from intrinsic DNA chemistry in the human body, endogenous changes, are usually many times more dangerous than chance injuries from environmental causes.

There are huge changes that have arrived in the carcinogenesis field in the last few months and I believe that as scientists it behooves us and I'm sure you would agree to use the most modern technology.

DR. GLANTZ: Now, environmental tobacco smoke is a mixture, it's not Glantzium, it's some complicated mixture of things. When you have a mixture of -- and some of the elements of the smoke at appropriate doses are toxic, would you agree with that? At high enough doses, the benzene or formaldehyde would be toxic, do you agree with that?

DR. COGGINS: Anything can be toxic. It's a question of the dose.

DR. GLANTZ: Is the fact that it's a mixture affect the toxicology and the toxicologic assessment and how?

DR. COGGINS: That's an excellent question. I don't know how we would work that out. Clearly it's a mixture. A chemist can tell you how many compounds there are. We're aware of the concept of toxicology of mixtures, the difficulty in understanding how they interrelate. I don't know how to answer your question other than to say it is a mixture and we exposed animals to that mixture. So whatever the contributing agents and contributing chemicals might be, if any, all we did in our study is say, okay, we know it's a mixture, we presented animals with a good surrogate, whatever the responses are, those are the responses of animals exposed to ETS.

DR. GLANTZ: Okay. Well, on slide 12 of your presentation, Dr. Coggins' presentation, there's a little picture of it on page 10 of your handout, you have a schematic representation of your laboratory, the inhalation laboratory.


DR. GLANTZ: And you showed us a photograph also. As I understand it, you have a box with a smoke generator in it and then there's a tube that connects -- that goes from that box and the smoke is pumped into the exposure chambers where the animals are and this takes a half hour or so.

Could you tell me a little bit about the tube? How big is it? What's it made out of? How long is it?

DR. COGGINS: In the interests of time, I would refer you to our manuscript, American Industrial Hygiene Association Journal, Volume 55, 1994, page 806. The full set of details are there.

DR. GLANTZ: Okay. But how long is the tube?

DR. COGGINS: How long is the tube?

DR. GLANTZ: How long is the tube?

DR. COGGINS: From where to where?

DR. GLANTZ: From the smoke generation box, say, the mean length to the exposure chambers. It's going to be variable lengths, obviously, but roughly how long is it?


DR. COGGINS: Actually, in our publication we only have the diameter of the tube, which was 76 millimeters diameter PVC tubing. As I recall, the lab was 20 cubic meters, so it would be approximately -- midpoint would be perhaps six to eight meters.

DR. GLANTZ: Okay. So it's around six to eight meters, so that's around 20 or 25 feet long for people who don't speak metric. And you said it was -- what was the diameter?

DR. COGGINS: Three and a half inch.

DR. GLANTZ: And what was it made of again? I didn't hear you.


DR. GLANTZ: Okay. Was any deposited in the tube?

DR. COGGINS: Yes. As we say in our paper -- it's in here somewhere but there was depositional material throughout the PVC. It didn't appear to change with the continuing days of the experiment. We had a number of pressure drop manometers cross different sections of the tubing to make sure that there were no blockages. Clearly with three and a half inch it would take a lot of blocking. Was that what you were referring to?

DR. GLANTZ: Well, I was not so much thinking of blocking the tube but we've done some similar experiments, as you know, and had a similar tube and over a period of a few days there was quite a lot of tobacco tar deposited on that tube. Is that what you found also?

DR. COGGINS: Yes. And that's one reason why we made measurements in the chamber, to ensure that we hadn't had any selective depositional materials in the tubing. That's why Dr. Ogden and his team made measurements of the amount of smoke presented to the animals, not what was in the chamber, not was normally generated, what animals were exposed to.

DR. GLANTZ: Did you do any toxicological testing on what was in the tube?


DR. GLANTZ: What color did the tube turn over time?

DR. COGGINS: It was a dark brown color.

DR. GLANTZ: Did you have any concern at all that the large particulate matter may have been preferentially settling out in the tube and so the model that you used could be underexposing the rats to certain compounds in the ETS?

DR. COGGINS: Again, the rate of flow through the tube, I think preferential settling out because we had information on the particle size distribution was unlikely. Remember, our mass median aerodynamic diameter was less than one micron, actually more like half a micron. So at the flow rates we were using, the diameters of the tubes, we don't think that there was any selective deposition in the tubing. Difficult to prove, of course. The main point is that the animals were presented with an aerosol that was completely respirable.

DR. GLANTZ: But you didn't do any kind of toxicological testing on the part of the sidestream smoke that settled out in the tube.

DR. COGGINS: No, as I say, we made --


DR. COGGINS: We didn't. Okay.

DR. GLANTZ: That's the answer.

Have you heard or read Professor Idle's testimony?

DR. COGGINS: Neither.

DR. GLANTZ: Okay. Well, Professor Idle criticized OSHA for citing studies using rats. He claims that he had known since 1972 that the rat is not a good model to use for tobacco studies. He cites differences in nicotine metabolism between rats and humans to support this position.

You used rats in your study so you must not agree with him. Is that correct?

DR. COGGINS: No, as I say, I haven't read his testimony.

DR. GLANTZ: Well, the general assertion that he made was that the rat was not a good model to use for studying ETS because it has metabolic differences in the way it handles nicotine from humans. Do you agree with that statement?

DR. COGGINS: No, I'm not sure whether rats have different metabolism. I'm sure that different animals will have different metabolic profiles. But we didn't expose animals to study metabolic profiles. We exposed animals to obtain toxicological information. As I said right in the beginning of my presentation, there weren't any such studies around. Rats and to a lesser extent mice are the animal of choice in inhalation studies. You can expose large numbers of them, there's a large database. And, indeed, for tobacco smoke, there is a very large database of mainstream studies. And we felt it behooved us to use the animal of choice. We could be criticized for any species we used but I think we would be criticized less for using rats than for any other animal model.

DR. GLANTZ: So would it be fair that you and OSHA are on the same side on this one, that you think that rat data is a reasonable thing to consider when assessing ETS?

DR. COGGINS: I think the rat is probably the animal model that has the best inhalation set of data behind it. But remember also we do have a second species. We have the information from the Gem study in the Syrian golden hamster that showed no responses whatsoever. So we have good information from two species.

DR. GLANTZ: Now, why didn't you use mice? You mentioned mice. Why did you use rats and not mice?

DR. COGGINS: I think there are two problems with using mice. One is which mouse do you use. There are hundreds of strains. Hundreds of strains. Which one do you pick?

DR. GLANTZ: Well, there are many, many strains of rats, too.

DR. COGGINS: That's a separate question. Let's go back to the mice. There are hundreds of strains of mice. A bigger concern was -- first of all, we had a concern over which biostrain we would use. The second concern we had was we wanted to prove, as I showed from my text, that animals that actually inhaled the smoke. There would be people out there that would criticize our work who have said that, okay, you have presented them with smoke but they didn't breathe it. We wanted to prove that the animals had inhaled the smoke. To do that, we needed biomarkers. To do that, we needed to take blood samples repeatedly from animals over different periods of time. You can't do that with mice. We used the rat because you can obtain easily large volumes of blood that can be examined for carboxyhemoglobin, plasma nicotine, plasma cotinine. That was one main reason in our overall choice, although really the rat is, I believe, the default position.

DR. GLANTZ: But you certainly aren't saying that the rats -- that you had to do the blood samples to make sure the rats were breathing. I mean, the rats were in a controlled chamber and they had no choice. They either breathed the ETS or they suffocated. I'm sorry. Well, would you agree with that? I mean, they had to breathe in the exposure chamber.

DR. COGGINS: Clearly.

DR. GLANTZ: Okay. They couldn't go to the non-smoking section or something.

Okay. Moving on.

In 1993, you and Dr. Doolittle published a manuscript entitled "90-Day Inhalation Study in Rats Using Aged and Diluted Sidestream Smoke from a Reference Cigarette, DNA Adducts and Alveolar Macrophage Cytogenics."

Also in 1992, you and Doolittle published a manuscript "14-Day Inhalation Study in Rats Using Aged and Diluted Sidestream Smoke in Reference Cigarettes, DNA Adducts and Alveolar Cytogenics."

Did you use the same animals from the histopathology study in both --

I'm sorry, these got edited a lot, Your Honor, late at night.

Did you use the same animals for both of these studies? Wait a minute.

DR. COGGINS: The 14-day animals were killed.

DR. GLANTZ: No, I'm sorry. Just a minute.


DR. GLANTZ: Oh, I understand. Excuse me. Let's back up. Okay. I apologize. Let's scratch the previous questions because --

JUDGE VITTONE: The rats are dead.

DR. GLANTZ: The rats are coming back. Rats will take over the world.

Okay. See, these were questions written for Dr. Doolittle and then he isn't here, right? Okay.

In 1993, Dr. Doolittle published a manuscript, right? Not you and Dr. Doolittle, Dr. Doolittle, published a manuscript entitled "90-Day Inhalation Study in Rats Using Aged and Diluted Sidestream Smoke from Reference Cigarettes, DNA Adducts and Alveolar Macrophage Cytogenics," okay? That's a paper that he published.

DR. COGGINS: No, actually, the first author, the principal investigator was Dr. Lee and Dr. Doolittle and I were co-authors.

DR. GLANTZ: On that study.




DR. GLANTZ: Then there was another paper studied --


JUDGE VITTONE: Take two minutes.

JUDGE VITTONE: Back on the record.

DR. GLANTZ: It's a simple question.

JUDGE VITTONE: Good. Go ahead.

DR. GLANTZ: Dr. Doolittle and you published the two papers I mentioned earlier which were on DNA adducts. Now, you've presented here the results of your 90-day and 14-day histopathology studies. Were they the same rats?


DR. GLANTZ: Okay. That's all.

DR. COGGINS: The reason being that --

DR. GLANTZ: Well, that's all we needed to know.

JUDGE VITTONE: Okay. Next question.

DR. GLANTZ: One other thing that I forgot to ask you back on the PBPK model of nicotine, another thing that's important in assessing the appropriateness of the use of a mathematical model is whether or not you're using it for the purpose for which it was developed and I would appreciate it if in your submission as a post-hearing comment you would provide details on the purposes for which the nicotine model was developed.

Now, if I could have the overhead?


DR. GLANTZ: And we're going to enter this as an exhibit, this slide, and I believe --

Have we given them copies, too? Okay.

This up on the screen which will be an exhibit, do you want to give it a number now?

JUDGE VITTONE: No, we'll do it later.

DR. GLANTZ: Is Figure 2 from a paper by Lee, Doolittle and I believe Dr. Coggins. Is that correct?


DR. GLANTZ: And this is a paper in which -- the slide is presenting DNA adduct maps of lung, heart, larynx, tissues of Sprague-Dawley rats exposed to aged and diluted sidestream smoke for 13 weeks.

Would it be correct to say that these little blobs that we're looking at which have been circled, the blob size is more or less a measure of the number of DNA adducts produced?

DR. COGGINS: Roughly speaking, that's the concept. Yes.

DR. GLANTZ: Now, in this paper, it says that you only demonstrated DNA adduct formation, statistically significant DNA adduct formation in the 10 milligram group. That's the high level. The bottom line on the graph. Is that true?

DR. COGGINS: That's correct.

DR. GLANTZ: Is it also true that from simply looking at the graph here, or not the graph, at the figure here, that these scanned images of the TLC plates, that there was also some DNA adduct formation at the .1 and the 1 milligram group in the 90-day study?

DR. COGGINS: No, I think that your photocopying of the original, which I have in front of me, has introduced artifacts into the picture. I have the original here and clearly the act of photocopying the original had the action of apparently introducing enlarged DRZs in the low medium for lung, and certainly also for medium in heart. I'd like to have the original put into the docket and not the photocopy because this is a black and white picture that has under photocopying been modified.

JUDGE VITTONE: Is that already in the record?


DR. GLANTZ: Did Reynolds submit an original copy or a photocopy to the record?

DR. COGGINS: An original. I have one with me if we --

DR. GLANTZ: No, in terms of the submission to the docket, was an original submitted or a photocopy?

DR. COGGINS: An original.

DR. GLANTZ: Could I just have a look at that?


DR. GLANTZ: Well, when I look at this, I see -- it gets progressively more intense as the dose goes up but the plates are not clear for the sham, low and medium doses.

DR. COGGINS: Correct. And that's why we didn't use the pictures. We used the scanned pictures using the Ambis technology to produce actual numbers rather than pictures which can be distorted by simple photocopying errors. We used the radio-analytical scanning technique to produce the number of DNA adducts per billion nucleotides which were the data I presented on Tuesday. We didn't rely on these pictures.

DR. GLANTZ: Because there is some concern about the interpretation of these results and in order to speed things up, would you be willing to submit the raw data that was used in the analysis of this figure for OSHA's consideration? Otherwise, I think we're going to spend a long time discussing this.

DR. COGGINS: These are the raw data.

DR. GLANTZ: Well, they're -- the raw counts.

DR. COGGINS: Shouldn't be a problem.

JUDGE VITTONE: Okay? Do you still need this thing on?


JUDGE VITTONE: Okay. Are you going to have any other sides?

DR. GLANTZ: I think we're done. We don't need any others.


DR. GLANTZ: Your Honor, I'm informed this thing I was going to enter as an exhibit is already in the record, so it's unnecessary.


DR. GLANTZ: Is it true that in your rat DNA adduct study, the one that we're discussing here and also the one you presented on the first day, that you exposed some mice to benzo(a)pyrine and called that your positive control group?

DR. COGGINS: Yes. On page 395 of Dr. Lee's document, there are pictures of the TLC maps.

DR. GLANTZ: Okay. Actually, just yes is adequate.

DR. COGGINS: Okay. Yes.

DR. GLANTZ: Is this a standard toxicological protocol, to use mice as a positive control for rats?

DR. COGGINS: I think I'll get Dr. Doolittle to answer that. I think he just had some mice that had been already treated. I'm not sure of the actual answer to that.

DR. GLANTZ: Would you say that by the fact that you did this, because your name is on that paper and so you're an author of the paper --


DR. GLANTZ: -- that effectively you were assuming that there is no difference between mice and rats in terms of ETS toxicology?

DR. COGGINS: No, no. We used the mouse here injected with benzo(a)pyrine to prove that our DNA adduct technique was working. That's the only reason we use it, to produce the gels that are given on page 395.

DR. GLANTZ: Why didn't you inject a rat?

DR. COGGINS: I think Dr. Doolittle already had some liver tissue from mice that were pre-treated and that was the reason but I'll check on that.

DR. GLANTZ: Would you say -- we've heard a lot in these hearings about high scientific standards and doing everything to very high levels of scientific care. Doesn't it seem a little strange to you that they were using mice instead of rats, given that you can buy rats as easily as you can buy mice.

DR. COGGINS: I don't think that's got anything to do with scientific standards. It clearly states here that we used the B6C3F1 mouse. It clearly states here that in the animal study we used Sprague-Dawley rats. That's not a question of scientific standards.

DR. GLANTZ: As a co-author, you didn't say, gee, shouldn't we have used rats for our positive control since the whole rest of this study is done with rats?

DR. COGGINS: Perhaps to have been completely complete we should have done that.

DR. GLANTZ: Have you done any studies with mice on cigarette smoke and effects of cigarette smoke on mice? By "you" I mean Reynolds.

DR. COGGINS: Yes, I have done some. Not with ETS. I have done a couple of inhalation studies with mice. Yes.

DR. GLANTZ: When you did these inhalation studies, how was what they inhaled different from an ETS study? What was it about the mouse studies that differed from the rat studies in terms of how you administered the smoke?

DR. COGGINS: You're asking me to compare my mouse mainstream with my rat ETS?


DR. COGGINS: The mouse mainstream was effectively the same concept of a rodent restraint tube, the mouse was placed directly into the tube. In the mainstream experiments, that tube was placed directly into a smoking machine. In the ETS studies, the tube was placed inside a chamber into which ETS was administered.

DR. GLANTZ: Now, was the smoke that was being put into the exposure chamber in the mouse studies, was that out of the -- that was from the exhaust port of the smoking machine? How was it hooked up to the smoking machine?

MR. GROSSMAN: Let me register a quick objection here. Before coming to R.J. Reynolds, Dr. Coggins worked for a laboratory in Europe where he did proprietary work for other tobacco companies. I direct him not to respond to any question that deals with proprietary work he did for other tobacco companies.

DR. GLANTZ: Has the work that we're discussing now been published?


DR. GLANTZ: Is it in the record?

DR. COGGINS: I'll introduce it right now.

DR. GLANTZ: You can just submit it as a post-hearing comment. Just put it in as a post-hearing comment.

Did you find any differences between mice and rats? The mainstream smoke mice and the sidestream smoke rats? Or the ADSS rats?

DR. COGGINS: Did we see a difference between the responses in the mainstream mice --

DR. GLANTZ: To the mice -- the study we've just been discussing and the rats, the ADSS rat study you discussed earlier?

DR. COGGINS: So we're not only comparing two species, we're comparing two test materials.


DR. COGGINS: Briefly, the study that we described in mice that we published showed a very different set of responses from the rats exposed to ETS.

DR. GLANTZ: And could you briefly summarize those differences?

DR. COGGINS: The mouse study that we published was of 14 days duration and used a reference cigarette and used another cigarette where the tobacco was only heated and not burned. I'll refer my comments here solely to the cigarette that burned tobacco. Responses that we saw in the mice were largely restricted to the nasal passages where we saw hyperplasia and some metaplasia. We saw some laryngeal metaplasia as I discussed yesterday that we did not see in the ETS rat study and I believe, although I don't have the mouse paper in front of me, we may have seen some lung macrophage induction. Quite different responses but that's because we're using very different materials at very different doses.

DR. GLANTZ: Have you done any comparisons of the chemical makeup of ADSS, ETS, sidestream smoke and mainstream smoke?

DR. COGGINS: I personally have not.

DR. GLANTZ: By "you" I mean RJR.

DR. COGGINS: Let me check with my colleagues.

DR. OGDEN: There's a substantial amount of information in the literature about the chemical composition of mainstream smoke. There has been, I would say by comparison, a smaller amount of work done with sidestream smoke, and then again by comparison, a much smaller amount of work done with ETS.

My direct experience is in measuring ETS, both in chamber experiments, as Dr. Coggins has described, and also in field situations in workplaces, which I'm assuming we'll get around to that eventually.

DR. GLANTZ: I guess what I'm interested in is what positive evidence you have about differences in the toxicology of mainstream smoke, sidestream smoke, ETS and ADSS. You've asserted in your testimony here and in many of the submissions, that there are major differences. I've read pretty much all of the stuff you've submitted. I couldn't find any information, any data demonstrating that there was a difference in the toxicity of these different things. That there were differences in the details of the chemical makeup.

Do you have any data showing a difference in toxicity of ETS, sidestream smoke, and what you're calling ADSS? We'll leave mainstream smoke aside.

So let's just look at sidestream smoke, which we'll define as the smoke coming off the lit end of the cigarette, what you're calling ADSS which is created by the device that you've described in your testimony, and ETS which is the smoke that's in the air people are breathing.

What evidence do you have that these are toxicologically different?

DR. SEARS: Dr. Glantz, before he proceeds to that, I want to correct something in your question, please. You said that there are chemical differences. That's only part of it. There are also very profound physical differences in the three types of smoke as well. Particle diameter, evaporative processes, temperature, and not least of all, the hundreds to thousands of times dilution.

DR. COGGINS: Simply put, we have a large number of studies on mainstream smoke, and many of them...

DR. GLANTZ: Let's set aside mainstream smoke. I shouldn't have mentioned that. Let's just look at sidestream smoke, ETS, and ADSS. What evidence do you have that there are any significant differences in the toxicological properties of those three things?

DR. COGGINS: We have only studied, as far as I know, aged and diluted sidestream smoke.

DR. GLANTZ: So would it be fair to say the statements that you're making, that there's a big difference between these in terms of their biological activity. That's something you believe, but you don't have any data to support that.

DR. COGGINS: Clearly, my biological data only refer to aged and diluted sidestream smoke. They don't refer to anything else.

DR. GLANTZ: On the point that was just raised about the physical differences, would you make an equally strong statement if we eliminate mainstream smoke, if we're comparing sidestream smoke, ADSS, and ETS? Do you see dramatic differences in the chemistry and physics of those three compounds?

DR. COGGINS: Dr. Sears?

DR. SEARS: Let me address the physical aspect since that's what I'm most familiar with, and then I'll let my more chemical-minded colleagues address the other.

I think it's fair to say that the dilution effect alone is an incredible physical difference of great magnitude. That effect alone would drive, logically, many other physical differences as well.

DR. GLANTZ: If you were to have the same concentration of ETS, sidestream smoke, and ADSS in a box, would then you find, would you think they were quite similar?

DR. OGDEN: That's an illogical question because part of the definition of ETS is dilution.

DR. GLANTZ: No, but we're going to dilute them all to the same...

DR. OGDEN: Oh, dilute them down?

DR. GLANTZ: We're going to take sidestream smoke, ATSS, and ETS, and we're going to put them all at the same concentration. Then would say that they're all the same thing?

DR. OGDEN: That's still an illogical question. You can't do that. The fundamental definition of ETS is that it has been allowed to age and dilute. You can't concentrate ETS and compare it to sidestream because they're not comparable. I wouldn't know how to answer that question.

DR. NELSON: And likewise, as you dilute sidestream smoke, it ceases to be sidestream smoke, and becomes aged and diluted sidestream smoke.

DR. GLANTZ: Could you submit for the record as a post-hearing comment, a detailed discussion of the physical and chemical differences between ETS and ADSS?

MR. GROSSMAN: Let me see if I understand you. You want not a pre-existing work, but you want Reynolds to...

DR. GLANTZ: No. Statements have been made that ADSS and ETS are different. I'd like to just see the evidence to support that statement. I'm not requesting a research project be undertaken, and if there's no such data, then you can simply say there's no data.

MR. GROSSMAN: Okay I understand...

DR. GLANTZ: But I'd ask that that be put into the record.

We've heard a lot about solanesol as what you view as the preferred marker for RSPs related to ETS. Are there any portable, commercially available, real-time solanesol monitors available?

DR. COGGINS: It might not be very useful, but I think Dr. Ogden can answer that.

DR. OGDEN: No, there's not.

DR. GLANTZ: Can you very briefly describe what you have to do to do a solanesol measurement?

DR. OGDEN: Certainly. What we do is we take a sample for RSP on a teflon filter, which is a standard technology, readily available commercial equipment. We take the filter that it in... Of course we draw air through the filter and collect RSP. Then we extract the filter in three milliliters of methanol and we inject an aliquot of that extract into readily available HPLC or high performance liquid chromatography equipment, and we determine solanesol by HPLC.

DR. GLANTZ: If you were doing this as a commercial venture, say as a lab that did solanesol determinations to make a living, what do you think you'd charge for that?

DR. OGDEN: In fact we've done that. We've thought about it.

DR. GLANTZ: Well, then what did you charge?

DR. OGDEN: I'm saying we thought about what we would charge for doing such a thing. In our estimation, the methodology and the protocol for determining solanesol is actually easier than for determining nicotine. I would say a true commercial venture would probably charge $35, $40 per sample.

DR. GLANTZ: That includes everything. That includes the teflon sampler and...

DR. OGDEN: That wouldn't include the collection of the samples, which would not be performed in an industrial hygiene...

DR. GLANTZ: Not counting the time it takes to collect the sample, but if someone were to come to you and say we want to do a solanesol, you'll give them the sampling device, they'll take it to wherever they take it, give it back to you, and you'll give them back a number. What would that cost? About $40, you think? Fifty dollars?

DR. OGDEN: Oh yeah, certainly.

DR. GLANTZ: What's the limit of detection for solanesol using this method?


DR. OGDEN: The current limit of detection for solanesol that we have determined for solanesol is .005 micrograms per sample.

DR. GLANTZ: Is that in one of your publications?

DR. OGDEN: This number is in a manuscript that has been submitted for publication.

DR. GLANTZ: Is that in the docket?

DR. OGDEN: No, it's not.

DR. GLANTZ: Could you submit that in a post-hearing comment?

DR. OGDEN: I'd be happy to.

DR. GLANTZ: Thank you.

Who has used solanesol as a tracer for ETS outside of Reynolds and its organizations associated with Reynolds?

DR. OGDEN: I don't know what organizations associated with Reynolds you mean.

DR. GLANTZ: For example, the Oak Ridge study.

DR. OGDEN: I think that's not a fair characterization.

DR. GLANTZ: I'm looking for people who are using it who have no connections at all to the tobacco industry.

DR. OGDEN: Let me just name who I'm aware has used it and published it in the literature, and you can decide for yourself whether you trust them or not.

The Oak Ridge team has looked at solanesol. Professor Etaugh at Brigham Young University has measured
solanesol. Hazelton Europe, Hazelton England as a laboratory has used solanesol. There are certainly other tobacco researchers who have used solanesol.

DR. GLANTZ: Thank you.

I'd like to go on now and talk, go back to a couple of basic principles very briefly. Let's suppose you're interested in assessing whether or not exposure to a compound has adverse effects in humans. I'd like to ask you some of the aspects of a good study.

Do you think it would be good to have a population-based study as opposed to just a laboratory study?

DR. COGGINS: I think you're talking of epidemiology rather than inhalation toxin. Maybe, Dr. Sears, you could comment?

DR. SEARS: Sure, let me have the first go.

The question is in conducting a quality epidemiology study?

DR. GLANTZ: Let me rephrase the question. You'll see where I'm going to. It's sort of half toxicology, half epidemiology.

If one is interested in assessing the potential toxicology of a compound in humans, would you consider it a good thing if the study was based on a broadly drawn sample from a population as a whole? The humans that you were observing. Would you consider that a good thing or a bad thing?

DR. SEARS: Let me address the epidemiological component of that which, I believe, if I understand your question properly, is only one component of your answer.

Certainly a large randomly selected population base would be superior to a pre-determined, informed population base. That's for the epidemiology part.

DR. COGGINS: I've never done toxicology studies in humans. I wouldn't know where to start.

DR. GLANTZ: Would you say that it would be a good thing if the exposures that people experienced in these studies were at realistic levels?

DR. COGGINS: Same answer for me. I wouldn't know what to do.

DR. GLANTZ: Would you consider it an important thing if the subjects really didn't know the purpose of the study?

DR. SEARS: Once again, epidemiologically, yes. I would say...

DR. GLANTZ: Would you say it would be a good thing if other variables that were thought to affect the outcome were also measured?

DR. SEARS: Epidemiologically, yes.

DR. GLANTZ: If you looked at these other variables, so-called confounding variables, and found very little change in the effect of the toxin estimated before and after taking these confounders into account, would you think the confounders weren't a problem?

DR. SEARS: No, I think that's an incorrect inference, Dr. Glantz.

DR. GLANTZ: Could you explain why?

DR. SEARS: Certainly.

Taking confounders into effect, and if one were to design a study in which confounders were taken into effect say in the analysis of the study, one could conclude from that, having found no effect, that the confounder happened to be balanced, in the exposed group and the unexposed group for that particular study. That's the only thing that one could infer. Certainly not that the confounders are unimportant.

DR. GLANTZ: But it certainly wouldn't represent positive evidence that the confounders were important, would you agree with that?

DR. SEARS: You're asking me if the absence of an effect would lead me to conclude that they were not important?

DR. GLANTZ: No. The absence of an effect is certainly not evidence that they are important.

DR. SEARS: By definition, that's true. But of course, Dr. Glantz, I certainly don't need to tell you this. It's impossible to prove a negative. That's counter to not only epidemiological and toxicological scientific practice, but it's counter to the entire history of Western science for hundreds of years.

JUDGE VITTONE: Let's take a five minute break.

JUDGE VITTONE: Back on the record.

DR. GLANTZ: I have a paper here that I'd like to...

DR. COGGINS: Excuse me. We have a point of clarification on a statement one of our scientists made in the last go-round. Could we just do that?


DR. OGDEN: At the break I was recalling the iterative discussion of the mainstream/sidestream ETS in a box, a hypothetical situation. Our answers, I think, were clear in what we intended when we were discussing mainstream, sidestream, and ETS. Somehow toward the end of that discussion, ADSS crept into the picture, and I want to make clear that the discussions we were talking about, the differences we were talking about, were among mainstream, sidestream, and ETS. We do consider ADSS and ETS to be certainly more close, if not identical, than sidestream.

DR. GLANTZ: Let me just ask one clarification of the clarification.

As we discussed in the 20 or 25 foot long tube that goes from the smoking machine to the exposure chambers, there was deposition of materials. Are you saying that what went into that tube and what came out of that tube were the same in terms of the pure mass of what went in and what came out?

DR. COGGINS: I'll give my answer, then see if Dr. Ogden has any comments. What we took was fresh sidestream smoke and entered into the tube. There was deposition throughout the tube. We didn't make any measurements of that. All we took measurements of was what the animals were exposed to, and we then compared that in terms of the different ratios of solanesol to TPM and TPM to nicotine and all of that. It was Dr. Ogden who did the analysis, and said is this approximately what you'd expect from that cigarette under experimental conditions? We used the 1R4F, of course, and I believe the ratios were about what you'd expect.

DR. OGDEN: Exactly. That's the point. What goes into that tube, in your words, is not what comes out of the tube. What went into the tube was sidestream smoke. What came out of the tube was ADSS. And that's the point.

DR. GLANTZ: Let's say that you, instead of having that tube, let's assume that you had the smoking machine sitting out in the middle of the lab with a whole bunch of fans so that you could get perfect mixing, and you didn't have to worry about... And the rats were sort of running around, uniformly distributed in the room, so that you didn't have problems with...


These are serious issues.

For the record, Ms. Sherman giggled.

There are no problems with the cages distributing air patterns or any of that. Are you saying that what came out of the 25 foot tube is the same as what you would measure if you had had a large box with the smoking machine in it and perfect mixing?

DR. OGDEN: In terms of what we know about it then yes, we've not demonstrated any substantial differences. Ratios between components were more or less what we would expect to find from real measurements of ETS in real places. Nicotine was in the vapor phase and not in the particulate phase like it would be in sidestream smoke, and it was in the vapor phase like we would expect it to be in ETS. So for what we know, it appears as if it's close to ETS.

MR. BOHANON: Certainly there would be deposition on the walls of the box as we observe in real environmental tests. There are depositions on surfaces. So for the smoke that's actually in the environment there is a deposition process that goes on, and that's what we're talking about here, which is environmental tobacco smoke.

DR. COGGINS: Just to add to that, the study by Von Meyerinck from the German consortium of cigarette manufacturers, had an experiment described very similar to the one you've just described. I think toxicologically it has got its shortcomings, but they basically just had a room full of rats and a room full of hamsters, and blew smoke in under very much the conditions you just described. I think toxicologically that's got some problems, and that's why we went the route we did.

DR. GLANTZ: In the...

I'm sorry, Your Honor, but actually these are some things we were going to get to later, anyway.

It's correct, isn't it, that cigarettes are manufactured in order to obtain different nicotine yields? You would agree with that, wouldn't you? I'm not asking you for any brand information or any proprietary information, Mr. Grossman.

MR. GROSSMAN: None of these members of the panel is a cigarette designer, and what you are asking for in a way is proprietary information. What you're also asking for is material that relates to pending lawsuits.

DR. GLANTZ: No, I'm not. I'm asking you for material that relates to one of the slides that was shown yesterday, Mr. Grossman.

MR. GROSSMAN: No, the question...

DR. GLANTZ: Mr. Grossman, please. I'm trying to get through this as quickly as I can.

JUDGE VITTONE: Let him get the question out, and then...


Let me rephrase the question.

Based on claims made in advertising published in magazines, is it an accurate statement to say that cigarettes are designed to yield different yields of nicotine?

MR. GROSSMAN: The problem with your question, and this will speed it up, is the phrase designed to yield as opposed to yield. Different cigarettes yield...

DR. GLANTZ: Okay, let me try rephrasing it one more time.

Is it a correct statement to say that different brands of cigarettes yield different levels of nicotine?

DR. COGGINS: I think that's definitely a question for Dr. Nelson who presented just such information.

DR. NELSON: I guess your question would still take...

DR. COGGINS: Some clarification before we get... Are we talking mainstream?

DR. GLANTZ: I'm talking about sidestream.

DR. NELSON: I can't speak to sidestream. But in terms of environmental tobacco smoke chemistry, different cigarettes do appear on the basis of the information which I presented yesterday, to generate different amounts of nicotine when consumed, into environmental tobacco smoke.


DR. COGGINS: You mentioned magazine ads...

DR. GLANTZ: I was trying to deal with Mr. Grossman's objection. There are nicotine levels advertised for different brands of cigarettes.

MR. GROSSMAN: That doesn't matter.

DR. GLANTZ: My question's been answered, Your Honor.

JUDGE VITTONE: Okay, move on.

DR. GLANTZ: Are the presence of differences in the manufacturing of a cigarette, such as the kind of paper that was used, the presence of catalysts in the paper or the tobacco, the physical construction of the cigarette in terms of the density of tobacco, any of these factors. Do they have an effect on the amount of sidestream smoke generated?

DR. COGGINS: I'm not a cigarette designer. I'm not sure...

DR. GLANTZ: Well, maybe you can refer that.

DR. COGGINS: Just a second. I'm not a cigarette designer, and I'm not sure if any of the rest of the panel are cigarette designers, but let me see what comments we can elicit.

DR. NELSON: You've listed a number of factors, and not being a cigarette designer, I do not know whether some of those factors that you describe are even used, whether or not they're used.

What we see experimentally is that we know that different cigarettes are manufactured differently, and what we see experimentally is that different cigarettes in terms of environmental tobacco smoke, generate differing amounts of nicotine. The factors that I mentioned in my submission are at least some of the factors that I know differ among the cigarettes. But I can't speak directly to cigarette design questions, because I'm not involved in that process.

DR. GLANTZ: R.J. Reynolds has marketed one so-called low sidestream cigarette, the Premier. Some people would argue whether it was a cigarette or not, but that was marketed and there were recent news stories about another one, Eclipse, which is similar to Premier.

Has R.J. Reynolds done any research on how you could modify the manufacturing of a cigarette in order to change the amount or the chemical makeup or the visibility of the sidestream smoke? In a conventional type cigarette.

DR. COGGINS: We're all tobacco scientists. We have no skills, no training in cigarette design.

MR. GROSSMAN: Let me once again register an objection as to proprietary information of R.J. Reynolds. There is a great deal of research that Reynolds does that its competitors would like to have, and we're not going to divulge it in these proceedings.

DR. GLANTZ: Could I request that to the extent that Reynolds could make the information available to OSHA as a post-hearing comment without violating proprietary issues, that you provide any information you have on how the amount of sidestream smoke can be changed in a conventional cigarette by changes in the way the cigarette is manufactured.

MR. GROSSMAN: You may request it, but I don't think it has anything to do with the burden of whether OSHA has by substantial evidence shown that sidestream smoke or ETS causes injury in the workplace in the United States.

DR. GLANTZ: I'm requesting that to the extent possible, that information be put into the record.


DR. GLANTZ: Yesterday there was some discussion of Dr. Nelson's slide that we put up showing the relationship production, and I believe it was RSP production, and you showed a great deal of scatter in that. Am I recalling the slide correctly? For the 51 cigarettes.

DR. NELSON: In terms of environmental tobacco smoke nicotine yield, and environmental tobacco smoke RSP yield, that is correct.

DR. GLANTZ: Do you believe, and this is where I've been leading with all these questions, Mr. Grossman, do you believe that those differences are simply kind of random differences that occur just because there's no relationship, or could one of the things that's contributing to what you characterize as wide differences between different brands of cigarettes be a reflection of the fact that the way cigarettes are manufactured in a way which affects the nicotine yield, and perhaps could affect the sidestream smoke yield, is actually what's accounting for all that scatter?

DR. NELSON: Again, I cannot speak in any way to the design of cigarettes which is sort of the second part of your answer, but I can try to, perhaps, give you a better feel for the basis of some of that information.

If we look at a single cigarette, and I'll pick the 1R4F cigarette for example, we can very reproducibly, within certain boundaries, and they have been described in other presentations...

DR. GLANTZ: Excuse me...

DR. NELSON: No, please. Let me finish answering the question.

JUDGE VITTONE: Wait a minute. Let him finish answering the question. Then you can ask something else.

DR. NELSON: Getting back to my train of thought.

DR. GLANTZ: I'm sorry.

DR. NELSON: We can very reproducibly, under the same environmental conditions, generate approximately, within a few percent, not within... It's more reproducible than the range that you saw on my slide, I believe it was seven and nine. You can much more reproducibly generate the same amount of nicotine or determine the same yield of environmental tobacco smoke nicotine and the same yield of environmental tobacco smoke RSP. There are other factors which can lead to some distribution, but we, to the extent possible, tried to account for those factors in the study that was described in those slides.

DR. GLANTZ: Thank you. You've almost clarified the point I was confused on.

You've done replicate measurements, as you've just said. Can you recall how repeatable the measurements are? Is that something you can put into the record if you don't recall the number?

DR. NELSON: The answer depends on the type of experiment that's being done. As I stated, if we put in, as I've reported in a conference, if you put different individuals in the environmental chamber and ask them to smoke one cigarette, you can get a fairly, and I'm talking about very different individuals in terms of the number of characteristics of those individuals, you can get a very wide distribution of yields of some environmental tobacco smoke constituents, particularly respirable suspended particles. Other constituents tend to be much more reproducible. The same individual may smoke cigarettes, if you reproducibly test an individual in the environmental chamber, you find that some individuals provide very tight, perhaps less than one or two percent variation between cigarettes, and this is three cigarettes over different days, and some individuals may have five or ten or maybe even 20 percent variation in the generation of some environmental tobacco smoke constituents.

A single individual does not show the sort of variation that was seen in those slides.

DR. GLANTZ: Okay. Of the variation that you showed in the slide, how much of that is variation, you could call between cigarette variation. Well, there's three sources of variation here. That's variation, if the same person's smoking the same cigarette several times, there's going to be some variability there.

DR. NELSON: Very small.

DR. GLANTZ: There's going to be some variation which is between brands. And there's going to be variation between people, for the reasons you just outlined, correct? So those ar three distinct...

DR. NELSON: Correct. And they each have different magnitudes of effect. Variations within an individual tend to be fairly small. Across people. People tend to group, but they can be larger, and then variations across cigarettes as I've shown, and I believe I've said I would provide to OSHA, or I could provide to OSHA the brand, a brand on a brand basis, not an individual experiment basis. You'd still get a very wide variety across brand.

DR. OGDEN: There's two important sources of variants that you've left out for the real world scenario. Actually three. That is the surface characteristics of the room in which the cigarettes are smoked, the ventilation characteristics of the room in which the cigarettes are smoked, and then an analytical estimate of variants. If you're asking about repeatability of the analytical estimate, that is something I can give you. That's the only piece I have.

DR. GLANTZ: What I would appreciate you putting in as a post-hearing comment because I'm a little bit confused now is, I'd like to know, there's, I guess, five components of variability. I was most interested in the first three, but the other two are of interest, too. How much variability is there within a brand, smoked in a standard way... You can just submit...

DR. NELSON: Some of that has already been submitted to the record. IF you would check the record I believe you would find that information.

DR. GLANTZ: Well, there's thousands of pages in the record.

MR. GROSSMAN: Yes, but don't ask for material if you haven't read it.


DR. GLANTZ: I would appreciate it if you would at least assist us in finding in the record, because I read the material, Mr. Grossman, and I couldn't find this.

To move on, let me just tell you what it is we need, and then we can move on and you can submit it later.

JUDGE VITTONE: Gentlemen, you can identify the material for him at a later time. All right?

DR. GLANTZ: I want to be very clear. I would like to know how much variability there is within a brand of cigarette, the same brand of cigarette smoked in a standard way, the amount of between brand differences, and the amount of differences between individual subjects. Those three... Because of the total variability we saw in the slide, I'd like to be able to separate those three component out, and you can submit it later.

DR. NELSON: Let me explain one thing to start with. When you say variability within a brand, I'm presuming you mean the same cigarette smoked over a long time period. I'm not aware of any information that exists on that.

DR. GLANTZ: You said you had two or three times you smoked the same cigarette as part of...

DR. NELSON: But that's variations among smokers that lead to those variations. That variation is due to a number of factors. As much as possible we tried to minimize the variation among smokers of that brand of cigarette in the chamber, but that is a source of that variation.

When you're doing an experiment where you have people smoking cigarettes in an environmental chamber, it's impossible to separate out the difference between people, and maybe the difference between one and another cigarette in the same pack of cigarettes.

DR. GLANTZ: Well, I'd just ask you to do the best you can.

DR. OGDEN: You asked for a cigarette smoked in a standard way. You're not referring to a machine. You're talking about humans.

DR. GLANTZ: I'm talking about the slide that we were shown.

DR. OGDEN: Now we're talking about humans, and I don't know that we can define "smoked in a standard way."

DR. GLANTZ: Dr. Nelson showed us a slide yesterday which we discussed, and I'm trying to better understand that slide.

Let's move on.

Well actually, there's one question left. That is if the nicotine is not generated in a fixed proportion to components during smoking, and the ratio of ETS yield of nicotine to the other constituents varies so widely as a function of brand and smoker, then why is it relevant to do research with a reference test cigarette? How do you know that has anything to do with real exposures and real cigarettes?

DR. OGDEN: Let me take the first piece of that. You said it's not generated in a standard way. The data, as I read the data that Dr. Nelson presented, says nothing about the generation of nicotine. Again, we're stepping a little closer to reality. It's what's actually measurable in that space. We need to make sure whether you're talking about generated or what's results from the generation.

DR. NELSON: Two other points I would like to bring up here. First of all, that the reference cigarette is near the center of that distribution that was shown in the slide. Second of all, you're saying if things are variable, why ever use a standard.

The reason that you use a standard is so that you can make comparisons among different laboratories. It's no different for cigarettes nor is it, I suspect, for any other issue in chemistry. You use a standard so that everybody is speaking from the same point of reference.

DR. GLANTZ: What evidence do you have that the reference cigarette you used is a standard which is typical of all cigarettes in terms of the issues you're studying?

DR. NELSON: As I stated yesterday, I don't have the data with me so I can't cite for you where it falls relative to the sales-weighted average. I can represent to you that it is very near the sales weighted average... University of Kentucky 1R4F reference cigarette does sit near the center of the distribution of cigarettes in terms of ETS. Nicotine yield and ETS RSP yield.

DR. OGDEN: Are you aware of any evidence that they're not?

DR. GLANTZ: I'm asking questions today. Not answering them.

DR. OGDEN: I just wanted to clarify.

JUDGE VITTONE: Ask your next question.

DR. GLANTZ: Is the mass of tobacco in the cigarette the primary determinant of the amount of ETS which is produced?

MR. GROSSMAN: This is totally irrelevant, Your Honor, and it's now ten after 11:00. Could we move on?

JUDGE VITTONE: Why is it irrelevant?

MR. GROSSMAN: OSHA is not going to regulate the kinds of cigarettes sold. It has nothing to do with the rule that's been proposed by this agency. The question is, does smoking in the workplace injure non-smoking workers?

JUDGE VITTONE: Okay. As I understand it, the question asked was does the mass of tobacco affect the level of ETS. Is that right?

DR. GLANTZ: The question was...

MR. GROSSMAN: He's asking...

DR. GLANTZ: ...mass of tobacco in a cigarette a primary determinant of the amount of ETS generated. That's very relevant.

MR. GROSSMAN: He's asking...

DR. GLANTZ: I'm not asking about any specific brands, Mr. Grossman. I'm asking a general scientific question that is important. If it wasn't, believe me, Your Honor, we have whacked out a huge number of questions, and this is one that survived.


The mass of tobacco affect the level of ETS.

DR. GLANTZ: The amount of ETS.

JUDGE VITTONE: The amount of ETS. I think it's relevant.

MR. GROSSMAN: Okay. It's their time.

DR. COGGINS: The simple answer is, I don't think I know. It seems to me that would be very much a cigarette design parameter. Anybody else on the panel got any answers?

DR. OGDEN: We have done some experiments that, looking at tar categories, if you will, to see if there is a differing amount of ETS delivered by full flavor, full flavor low tar, and ultra low tar cigarettes. In general, there's not.

The weight of tobacco is, as I understand it, only one variable. There may be more, but the overall conclusions, as I recall, I'm not sure where... You may be headed somewhere else with this, and we may be able to answer more specifically, but...

DR. GLANTZ: Let me ask one quick clarifying question from that, and then we'll move back to where we were before, before we got off on this.

When you use the terms full flavor and all that, it's basically nicotine yield.

DR. OGDEN: No. No, it's not. Those are based on the "tar yield" as defined by the FTC.

DR. GLANTZ: If one were to... Never mind. I think we've got what we need.

I'd like to get back to where I was before we had this minor point of clarification. I'd like to give this to the panel to take a look at. This is a paper that was recently published, and I'd like to put this into the record.

(Document handed to Dr. Coggins)

It's entitled "Active and passive smoking are associated with increased carotid wall thickness." The atherosclerosis risk in community study.

This paper reports the results of a population-based trial in several cities. Incidentally, including Winston-Salem, North Carolina, where a group of cardiologists measured the thickness of carotid arteries. That's an artery in the neck which you can visualize with ultrasound.

They studied smokers, former smokers, passive smokers, and what they called true non-smokers, and measured the thickness of their carotid arteries.

If you look on page 1279, you'll see I've underlined a section there at the top of the first column. It says, "Lifestyle associated factors." They adjusted the results for lifestyle associated factors and known cardiovascular risk factors, and then go on for the rest of the paragraph listing these factors. They're the ones we've talked about -- weight, body mass index, alcohol intake, things like that.

If you look at the bottom of that... They measured the thickness of the carotid artery. What they found, if you look at the bottom of page 1279 on the right hand column, statistical adjustment for lifestyle factors or lifestyle factors plus major cardiovascular risk factors, did not substantially affect the difference between ETS and past smokers in terms of how thick their carotid arteries were.

Would you say that, all things being equal, that that could be interpreted as saying that the difference which was observed associated with ETS, was probably due to the ETS exposure.

If you want to take a minute and look at the paper, that's why I've underlined the relevant parts for you.

DR. COGGINS: It's a large paper for us to read and answer questions on. I'm aware of a couple of papers that have shown increased carotid wall thickness with a number of different materials, not just exposure to ETS. For example, high fat diet, which is another...

DR. GLANTZ: They controlled for that.

DR. COGGINS: No, I'm not talking of the control in this group. I'm talking of another group, part of ARIC, that have shown increased carotid wall thickness, and I haven't got the paper with me, as a result of a high fat consumption. However, we looked at this paper in a superficial way before, although we haven't brought any of our reviews with us today.

Mr. Steichen has got a couple of comments on it, I think.

DR. GLANTZ: Could I suggest the following thing to speed things up and probably build a better record. Let's put this aside and maybe we can briefly come back to it after lunch. That will give you a chance to look at it. I think that will be much fairer than just trying to have them read what I've underlined.

MR. STEICHEN: I don't think looking at it will change what I have to say.

DR. GLANTZ: So you are familiar with the paper.

MR. STEICHEN: Quite awhile back we did...

DR. GLANTZ: Okay, then we can proceed.

MR. STEICHEN: In fact I think we saw it before it was actually published, when it was first done as a report to some meeting.

We do know George Howard, he is from Winston-Salem. In fact he presented some of this material at Reynolds one time.

We looked at this data and we also looked at some of their previous papers where they looked at the basic method they were doing. One of those previous papers considered whether or not, actually how reproducible the same measurement on the same carotid artery was. They did, as I said then, repeat samples of the same artery.

We also then looked at the kind of numbers they have in this paper, the sample sizes they had in back calculated, to say are the differences that they're observing here reasonable considering the replication ability of the method. They're right dead on the same kind of magnitude. So we can't distinguish here whether these differences are due to differences in any exposure, or just to replication error.

DR. OGDEN: You asked us as a panel to comment. Again, I have not seen this paper, but there's one thing that immediately strikes me as a very potential bias in the paper, and that's the misclassification of smoking status that is relevant to all of the epidemiology, as I discussed yesterday. I don't see here any measurement of cotinine to try to determine misclassification status. They used fairly standard definitions of reported smoking status. As we've seen from the literature and certainly more recent literature citations, in a clinical setting by Epsiloff, this misclassification of smoking status could be as high as 16 percent. That just strikes me as a very relevant and very important bias that may affect all the conclusions in this paper.

DR. GLANTZ: Getting back to the point earlier by Mr. Steichen, when you do a large study like this, though, the precision of your mean estimates is better than your individual replicate observations, isn't it?

MR. STEICHEN: That's correct. That was considered in making that statement. We looked at the sample sizes that were involved, the differences that they had, and observed whether they were then consistent if you back calculate, to what kind of measurement differences would have been applicable at an individual level.

DR. GLANTZ: Sir, are you saying that this paper, their statistics are wrong?

MR. STEICHEN: I'm not saying his statistics are wrong. We raised these questions with Mr. Howard and he did not respond to us.

DR. GLANTZ: If you look at the paper as it finally appeared in print which in science, as you know, is the bottom line, do you think this paper is seriously flawed in terms of the statistical analysis?

MR. STEICHEN: In terms of the statistical analysis? No. I didn't say that. I said that the methodology that was used I don't think has the precision based on the numbers that they've reported elsewhere, to reliably generate these kinds of differences.

DR. GLANTZ: Then do you think the reviewers made a mistake in accepting this paper, because if the observations are worthless, as you know ,you can do all the statistics you want on numbers that are meaningless, and...

MR. STEICHEN: I don't think they considered the issue.

DR. OGDEN: Then obviously there's one major bias that they didn't consider. I think that...

DR. GLANTZ: Excuse me. I'm trying to move quickly. Let me...

DR. OGDEN: I'm trying to answer your question.

DR. GLANTZ: Let me raise specific issues...

JUDGE VITTONE: Hold it. You're asking questions, you're asking them for a reaction. You've hit them with a paper that they obviously haven't had for awhile. You wanted to give them a couple of minutes to read it. Give them a couple of seconds to respond to it. That's it.


DR. OGDEN: To make my point...

JUDGE VITTONE: I think you've already done that.

DR. OGDEN: Okay. I'd be happy to make it again.

DR. GLANTZ: Your Honor, just to be fair with this, I'd like to try to focus the questions, and then at the end maybe we can say, I can ask is there anything else we missed, and you can add anything else you want.

If you look on page 1280 in the second column, you'll see I've underlined a sentence there, the number of hours of ETS exposure was significantly associated with IMT which is the carotid wall thickness in men.

Is the presence of a statistically significant dose response effect evidence that ETS is causing this thickening?

DR. COGGINS: It may. It may not. It's only one parameter in the whole exercise. As I say, a separate paper from the ARIC group show similar responses for a high fat diet. The word "cause," as we've discussed many times in these hearings, means different things to different people. I can't tell from the paper as we have it in front of us, if we can really answer that.

MR. BOHANON: Again, you pointed out another important point. As I read it, the passage that you underlined, this is another significant problem with this piece of ETS research in that they've apparently asked the subjects to guess how much ETS they're exposed to. As we've shown and the studies cited in the proposed rule show, people can't guess. They don't know. So to use that as the surrogate for exposure, in my mind, as a person who measures exposure, that would be highly questionable.

DR. COGGINS: Dr. Sears?

DR. SEARS: I'd also like to point out that once again, we're not dealing with exposure here. Even what Dr. Howard has reported is duration of exposure which, of course, is only half of the critical equation.

DR. OGDEN: As I think the CAP Study showed, it may, in fact, just be potential duration. It may not even be potential exposure.

DR. GLANTZ: On page 1282 at the bottom of the first column, in the part I've underlined, they say at age 55 years, "arbitrarily chosen as the middle age of the population, the magnitude of the association between passive smoking and IMT, again, which is intermediate wall thickness corresponded to 23 percent of that observed for active smoking."

It goes on to say a bit more.

Would you say that this large effect in comparison to the dose. I don't know if it's been said in the last couple of days, but it's been said many times, the dose that a passive smoker gets is much smaller than the dose that an active smoker gets. Is this relatively large effect in a passive smoker, something that you think supports the relatively large effect found in epidemiological studies in terms of cardiac death and non-fatal cardiac events among passive smokers.

DR. COGGINS: I would read back to you, parrot the sentence after the part you've underline. "Although no causal inference can be drawn from this cross-sectional study."

DR. GLANTZ: No, I agree with that. I should have underlined that, too, because I figured you'd bring it up. But I'm not asking that. That's not the question I'm asking. The question I'm asking, and let me try to rephrase it more succinctly is, does the presence of a relatively large effect -- 23 percent of that observed in active smokers, does that strengthen the confidence one can have in the comparably large effects compared to active smokers, that you see in the epidemiology studies of coronary disease? Whether you look at death or non-fatal end points.

I'm not addressing the issue of causality here at all.

DR. COGGINS: I don't think it strengthens that lack of association. Isn't that right, Dr. Sears? There isn't an association.

DR. SEARS: I'll answer that, first of all, as an academic question. The answer is, if it were a valid increase, then certainly that would strengthen my comments.

However, Dr. Glantz, as I pointed out before, we're not measuring exposure. So the existence of a statistic and this paper that shows an increase is practically meaningless from that point of view.

I think I would also like to remind you and the OSHA panel that Dr. Neil Benowitz made the point in his testimony that although self-assessment of exposure may be useful under certain limited circumstances it is, and I forget his exact word, it's either "useless" or "worthless" for determining degree of exposure.

MR. BOHANON: I would like to enter a comment. The selective underlining that's been done here may be somewhat misleading. You're talking about the significant exposure with men. The following sentence in the paragraph says, "Despite the larger sample of ETS women, the increase in IMT," and so forth "was a difference that proved statistically insignificant."

So a larger sample doesn't correspond to this smaller sample of self-report. I'm not sure what that means.

DR. GLANTZ: I think we need to move on. I'm putting the whole thing in as an exhibit. Obviously, you're in a position to comment further. I wasn't meaning to quote things out of context. I was meaning to... There are other statements in here saying they felt the difference because men had more work site exposure, too, but that's not the point of the question.

JUDGE VITTONE: The report says what it says. You both can use it for whatever....


I'd like to return very briefly to an issue that Dr. Samet raised yesterday when he asked Dr. Coggins if there was anything where he thought carcinogenicity had, or that a subject that caused cancer, and you said asbestos.

Could you just outline briefly why you think the evidence that asbestos causes cancer is strong enough to say the word "cause" and why you don't think we can make a similar statement about active smoking.

JUDGE VITTONE: Didn't we get into that in a fairly detailed discussion yesterday?

DR. GLANTZ: If that was dealt with, I must have been out of the room.

The next question related to that is, do you believe that people who are exposed to asbestos and smoke have a higher risk of cancer than if they were non-smokers?

DR. COGGINS: Again, I'm not sure...

DR. GLANTZ: For lung cancer.

DR. COGGINS: Again, I'm not sure how this gets back to substantial evidence of the significance of material impairment of health, but I've read some papers that would indicate that there is somewhat of a synergistic effect. I've seen other papers that have not shown such an effect between smoke exposure, asbestos exposure, and an epidemiological link with lung cancer.

DR. GLANTZ: Do you think that it exists? Is it real?

DR. COGGINS: As I say, I've seem some that do and some that don't. The data don't, in my opinion, converge on that issue. It may and it may not. I don't know.

DR. GLANTZ: What is it about smoking and being exposed to asbestos that can increase your risk of lung cancer?

DR. COGGINS: There may be any number of factors, but remember, we're not talking of absolutes here. WE're only talking of increases in the strength of the statistical association. We're not talking of individuals. We're talking here of populations, and that when you see different sets of data from different studies, it must behoove ourselves to look at the whole set of data before we can make any overall toxicological inference.

DR. GLANTZ: When you talk about misclassification errors, you discussed at some length that misclassification errors can bias risk estimates upward.

It's correct, isn't it, that misclassification can also bias errors in the other direction too, isn't it?

DR. COGGINS: I'm going to let Dr. Ogden answer that.

DR. OGDEN: Let me start, because I think your question may not be the issue that I was raising at all. We need to be specific. The only misclassification that I was dealing with was the misclassification of smoking status. I'm not aware that there's any substantial evidence that would indicate that that bias is not upward.

DR. GLANTZ: If you were to -- this is a new line of questioning. If you were to, say, classify -- no, wait. I have to think a second.


DR. GLANTZ: If you were to classify non-smokers as smokers in an epidemiological study of, say, passive smoking and lung cancer, wouldn't that have the effect of biasing your estimate down?

DR. OGDEN: If you were to classify non-smokers as smokers? That seems to me more of a hypothetical question that the other end of the table might answer better.

DR. SEARS: If you're asking that as an academic possibility, then, yes. The answer is yes.

DR. GLANTZ: That would bias the estimate down.

DR. SEARS: Academically, yes. But, as Dr. Ogden has said, there is absolutely no evidence of that.

DR. GLANTZ: If you were to count an ever smoker as a smoker, would that bias the estimate down?

DR. SEARS: It would be the same hypothetical answer.

DR. GLANTZ: If someone did a study where they counted an ever smoker as a smoker, do you think that would be a real problem with the study, to the point that you would say this is just fatally flawed?

DR. SEARS: Your question is if one did a study in which an ever smoker were classified as a smoker, the study would be seriously flawed? There are too many unanswered questions that I would have to see before I could say that. See the answer to before I could say that. How long are we talking about, what --

DR. GLANTZ: Okay. Well, let me -- we had a study put in the record --

DR. SEARS: Excuse me.

DR. GLANTZ: I'm sorry.

DR. SEARS: Excuse me. How long ago was it that the misclassification occurred? How heavy a smoker was it? There are many questions that need to be answered before your primary question could be answered.

DR. OGDEN: And also an ever smoker can be correctly defined -- includes the subset of current smokers. Ever smoker would include former and current.

DR. GLANTZ: When you're trying to get an accurate measure of exposure misclassification, do you think you're better off if you're using interview techniques, which we've heard your views of interviews but if we're using an interview, are you better off with a direct interview or a proxy interview regarding ETS exposure?

DR. OGDEN: Let me clarify one part of your statement. You said you've heard our opinions. Those aren't our opinions. I'm simply restating for OSHA what the original authors said in their original papers about the limitations.

DR. GLANTZ: Okay. Let me rephrase the question. I don't want to get into a general discussion of whether or not interviewing per se is a good idea. If we limit ourselves to interview assessment of ETS exposure, is a direct interview or a proxy interview better?

DR. OGDEN: I can't answer that.

DR. COGGINS: I don't know.

MR. STEICHEN: I think it's generally accepted that a direct interview would be a better approach.

DR. GLANTZ: So all things being equal, would you say that a study with a higher percentage of direct interviews would tend to give more accurate results?

MR. STEICHEN: It would certainly give more consistent results, internally consistent results.

DR. GLANTZ: Do you think they would be more accurate?

MR. STEICHEN: Well, if we're talking about ETS exposure in the workplace, it certainly makes sense that someone who is there has a better chance to get some idea of how much exposure they had than someone who wasn't even there. Yes. So it would be more accurate in that respect. Whether it's adequate to then assess ETS exposure, that's a different question.

DR. GLANTZ: Just for the judge's notice, I'm crossing out a page.

MR. GROSSMAN: Would you like a marker?


DR. GLANTZ: Okay. Just a second. It's a long day for everyone.

Do you think that dose response information is necessary in order to determine causality?

DR. COGGINS: We discussed causality a lot yesterday. I didn't include dose response in that. I think we would expect to see dose response in both the animal part and in the epidemiology part. I think you would expect to see both of those in the two of the three patterns and hopefully that would be perhaps included in the mechanism part.

Dr. Sears, would you comment on the epi part?

DR. SEARS: Yes. I'm happy to give you a short answer. The answer is yes, it's necessary.

DR. GLANTZ: On to the much-discussed Fontham study. You criticized the study on page 17 of -- which submission -- well, I believe it's Dr. Sears -- the August 13th submission. As not being representative of the non-smoking U.S. female population.

Are there any studies that by your definition are representative of the non-smoking U.S. female population?

DR. COGGINS: Dr. Sears?

DR. SEARS: I can give you a short answer to that as well. The answer is no, but there are studies that are better than others.

DR. GLANTZ: Doesn't Fontham's 1994 report report statistically significant exposure response relationships for spousal, workplace, social and total adult and lifetime exposure to ETS?

DR. SEARS: You'll have to give me a moment to check those.



DR. SEARS: Would you repeat the categories that you're interested in?

DR. GLANTZ: Yes. Doesn't Fontham's 1994 paper report statistically significant exposure response relationships for spousal, workplace, social and total adult and lifetime exposure?

MR. BOHANON: The paper reports for occupational exposure a significant trend test. It does for social exposure. For household exposure, it does not report a significant trend. And I don't know if you're referring to spousal -- let's see. Where was that --


DR. NELSON: And, again, they asked for spousal exposure, it does report a significant trend test. I don't know what all exposures is, your definition.

DR. GLANTZ: Okay. Well, if you want to put in any further -- you'll get the transcript. If you want, you can put further clarification in as a post-hearing comment.

Did Fontham control for dietary cholesterol and antioxidants in her analysis?

MR. STEICHEN: She claimed she did. Yes.


MR. STEICHEN: I think we'd like to clarify a few things, though.


MR. STEICHEN: Fontham, of course, did not measure exposure. She asked some certain questions about how much smoking was around them. Secondly, this is a trend test which doesn't necessarily reflect true dose response testing and so there's questions there.

I think we also raised in our submission a series of questions about Fontham's paper and whether or not trend tests are important. You need to take into account all those other issues first.

DR. GLANTZ: All right. Now, you said --

DR. SEARS: Excuse me.

DR. GLANTZ: I'm sorry.

DR. SEARS: There's one more clarification here that needs to be made. The reason that I'm making this is because you asked for individual categories, Dr. Glantz. I want to make sure you understand that the populations of those categories overlapped. There wasn't a clean distinction between occupation, spousal, et cetera. They're all mixed up.

DR. GLANTZ: Now, you had said that when I asked the question about Fontham controlling for cholesterol and antioxidants, you gave sort of an ambiguous answer that implied you didn't believe she really did that. Is that what you meant to say? She didn't do what she said she did?

MR. STEICHEN: The answer was somewhat ambiguous because I believe Fontham's effort is somewhat ambiguous. Yes, she had certain measures of parts of what might represent dietary factors but our ability to adjust for them depends on how accurately you represent those variables and even whether even the questionnaire responses that you got really properly represented what was there.

That's one aspect of whether you can properly adjust for it. The second aspect is do we understand what the model is between these and are we applying them in a proper model. Clearly the technique used -- I guess you would say it would be linear in the log and in that respect somewhat of a first order approximation. Whether or not that's good enough to represent the effect of dietary variables, I don't know. That's why I was ambiguous.

DR. GLANTZ: But you weren't meaning to imply that Fontham falsified her data or somehow misrepresented things, were you?

MR. GROSSMAN: Let me respond briefly. If you will recall, Dr. Glantz, on the very first day of these hearings we asked that the data underlying the Fontham study be -- let me continue, Dr. Glantz -- be placed in the record by OSHA. I heard you in the audience say "They finally got a good idea."

DR. GLANTZ: That wasn't one of them. For the record.

MR. GROSSMAN: Dr. Glantz, let me just finish this. We all agree that the Fontham study is relevant to this proceeding. In fact, OSHA has relied exclusively on the Fontham study in defining its risk analysis. You've asked for so much of Reynolds today, much of which is irrelevant. There is nothing more relevant than the data underlying the Fontham study and I assume that OSHA will be placing that in the record in the post hearing comments.


DR. GLANTZ: I'd like to get back to the question that I asked.

MR. STEICHEN: The question was was I trying to say that I believe that they were falsifying data. No, I was not saying that.

DR. GLANTZ: So it would be fair to say you had some concerns about maybe the way they chose to do it but you're not accusing them of anything nefarious, is that correct?

MR. STEICHEN: No, I'm not.


MR. STEICHEN: In fact, I would like to go on a little bit, why I raised some of those questions.

If you say why were dietary variables included in the assessment, the answer, of course, is because most researchers consider that these dietary factors would falsely raise the risk estimate for ETS. But if you actually look at this particular paper, it went the opposite direction and that's very inconsistent with what's expected for these variables. And when that happens, yes, I do have questions about why that's going on in a particular study.

DR. GLANTZ: But those are legitimate scientific issues, not accusations of fraud or anything.

MR. STEICHEN: Most certainly.

DR. GLANTZ: Is it correct that R.J. Reynolds sponsored a group that's been associated in various places with either McGill University or Rockefeller University that did an analysis of the ETS epidemiology database and was published in the Journal of Clinical and Investigative Medicine in 1990 by Dr. Spitzer, et al.?

DR. COGGINS: I know of the paper by Spitzer. I know something of the McGill symposium. Whether we had anything to do with it or not, I don't know.

Anybody else?

DR. GLANTZ: Well, the paper credits R.J. Reynolds with funding the project. This is not the McGill symposium that was the book, this is a paper.

Have you submitted this paper to the docket?

DR. COGGINS: First of all, if it was funded by us, it was funded by us, if it says so. We haven't submitted it to the docket, meaning we here, I don't think.

DR. GLANTZ: Well, I mean "we" R.J. Reynolds who you are speaking on behalf of.

DR. COGGINS: I don't know.

DR. GLANTZ: If you haven't, we would appreciate it if you would submit it, together with any comments you have as to why in your very extensive submissions you missed that one.

DR. COGGINS: Spitzer 1990?

DR. GLANTZ: It's Spitzer 1990, Clinical and Investigative Medicine. I was sort of -- given the thoroughness of your submissions, I was surprised to not be able to find it, although perhaps I missed it.

You criticized OSHA for inferring causality on the basis of spousal studies alone. Do you believe it's like that ETS could cause lung cancer or cardiovascular disease in spouses of smokers but not people receiving comparable exposures in the workplace?

DR. COGGINS: With caveats on the use of the word "cause" because we are still talking only about epidemiology here, Dr. Sears?

DR. SEARS: I think speaking from the point of view of the epidemiology, Dr. Glantz, there is no evidence for either.

DR. GLANTZ: Pardon me? Could you repeat it?

DR. SEARS: Yes. In my opinion, the epidemiology reveals no evidence of increased risk either for spousal exposure or for occupational exposure and I think it's worth emphasizing that the occupational studies, studies that directly influence or have direct impact on OSHA's considerations, by pooling reveal a relative risk identically of 1.0.

DR. OGDEN: If I could, the trailing end of your question I disagree with. You stated that home exposures were comparable to exposures in the workplace.

DR. GLANTZ: No, I said if they were.

DR. OGDEN: Well, clearly they're not.

DR. GLANTZ: Right. But I was -- the question I was trying to get at --

DR. OGDEN: Oh, we're in hypothetical again.

DR. GLANTZ: Yes. The question -- if someone was exposed to the same level of ETS at home or at work, would the effects be the same? I'm asking that as a question.

MR. STEICHEN: Could I respond to that?

DR. GLANTZ: Whatever the effects are.

MR. STEICHEN: The issue has to come down, though, to whether you can measure those effects in the same way. When we're talking about epidemiology studies, those measured in the home may not be measuring the same things as those measuring in the workplace are measuring. It does come down to the issue of you're dividing people into two groups. One group you're saying is exposed to something, the other group is not exposed to something. You put a label on it. But we've talked also a lot about confounders which are potential risk factors that are not in balance between those two groups. And so you're not just separating these people especially in the spousal situation by the exposure factor alone. You have all these other variables going with. So that's what you're measuring in the home.

In the workplace you may have a different set of confounders that are also going with the exposure factor of interest. Clearly there's been a lot of discussion about spousal confounding. There's not nearly that same volume of discussion concerning confounders in the workplace and the discussion in the spousal situation suggests that the great majority of those confounders increase the relative risk or the observed relative risk and you need to try to correct for them. Whether you can correct for them or not is another question.

We are seeing in the spousal situation for lung cancer, we'll pick on, EPA reported a 1.19 for the studies that they claimed they had in their possession at that time. The ones that they chose to report upon. After that, of course, there were other studies that were published, some before the actual publication date of the EPA report, but if you look at them now you get a 1.11 and it's non-significant.

And, in fact, if you look historically at meta-analyses of the U.S. spousal lung cancer studies, the only point in time that they were significant was with the group of studies that EPA used. That's not the same situation when you get to the workplace where we think that the number of confounders is probably less and certainly not as important. There those set of studies for lung cancer, as Dr. Sears said, uniformly, well, almost uniformly, come up with a relative risk of one. Even if you include Fontham, you get a relative risk of one. It's the only one that's an outlier from the rest of the data when you're going to talk about workplace lung cancer.

DR. GLANTZ: You criticized OSHA's inclusion of non-U.S. studies in the risk assessment, both in the written submission, I believe, and your oral presentation. At other points in the written submissions you criticized OSHA for not including five Chinese studies. Which way do you want OSHA to do it?

DR. SEARS: Can you identify those two positions in the written submissions?

DR. GLANTZ: They'll have to dig them up. Let's come back to this, then, because I don't have those at my fingertips. We'll come back to that.

DR. SEARS: Let me give a preliminary answer to that, just on the basis of memory. I believe it was two entirely different types of criticism. In one case, I believe that we criticized OSHA for failing to find and include in their documentation of all ETS studies, the Chinese studies simply because that is what OSHA chose to do in one of their tables.

In the other case, it was a criticism of relevance, what is relevant to OSHA's task of finding substantial evidence of significant risk for ETS in the workplace.

DR. GLANTZ: Well, overall, do you think as a general principle that those studies should be considered or shouldn't be considered?

DR. SEARS: In my opinion, all evidence should be considered but the most weight should be placed on the most relevant studies and, in my opinion, that is the workplace studies.

DR. GLANTZ: If I were to do a statistical test and it came up with a P value of .06, would you call that a negative study?

DR. COGGINS: I think I'm going to pass that to Mr. Steichen. I think there are other factors you need to take into account other than statistical significance. Mr. Steichen's got, I'm sure, a better answer than that.

MR. STEICHEN: I think Dr. Coggins is correct. There are many factors you have to consider. There does come a point, though, where you have to decide what criteria you're going to use. The scientific literature has chosen the 95 percent significance level as pretty much the standard and there's good reasons for trying to pick a standard so we all have some basis to judge things on. And to take that consensus opinion then you would probably conclude that, no, that study is not significant.

DR. GLANTZ: So you would say a P value of .06 you would call a negative. You'd draw a negative conclusion from that.

MR. STEICHEN: Again, it goes back to where we started from. It depends on the actual situation.

DR. SEARS: May I interject? The prudent judgment of the medical community would say that's not a significant study. And I'll also draw your attention to a quote by I believe it was Dr. Sander Greenland yesterday who in recent publication has said all confidence intervals, and I assume he means by inference P values as well, should be taken as a minimum, a most conservative measure of the uncertainty in a study.

DR. COGGINS: Could I just give you a quote? I think it's relevant here. That's from Tox Forum, 1993, Professor Alvin Feinstein and he's summing up comments. He'd been talking a lot about this issue, the .05, the one-tailed, the two-tailed, and he had made the point just like Mr. Steichen that these are the established principles although admitting that they weren't completely sacrosanct, he made the final statement, this is page 334, "The decisions for public policy should depend on the goals of public policy and the scientific evidence used in public policy should depend on the standards of science," which is what we all agree, 5 percent unless proven otherwise, "but neither science nor public policy is well served if the integrity of science is sacrificed to meet the goals of public policy. "

I think we would all agree that we are moved away from the standard of 5 percent. If you came up with a P .06, all other things considered, I think we would all say it's negative.

DR. GLANTZ: Okay. You state in your submission that six of the studies that were classified by OSHA, and the six were Brownson, Correa, Garfinkle, Inouye, Pershagen and Stockwell, that were classified by OSHA as positive, and this is for lung cancer, right? Yes.

MR. STEICHEN: Can you lead us to the page?


MR. STEICHEN: Is it page eight? I think I've found it.

DR. GLANTZ: Okay. If you've found it, I'll trust that you've found it.

MR. STEICHEN: Well, repeat your question and we'll know.

DR. GLANTZ: Okay. You state that six of the studies, the ones I listed, that were classified by OSHA as positive -- it is page eight, yes.

Let me start over again. You state that six of the studies that were classified by OSHA as positive were only positive for the highest exposure groups. Isn't that what you would expect if there is a dose-response effect of ETS increasing the risk of lung cancer, depending on dose, with larger doses producing larger effects?

DR. COGGINS: First of all, none of our studies measured dose, so we don't know whether the highest exposure group were exposed to higher amounts, so we can't really use the word dose.

Dr. Sears?

DR. SEARS: Actually, I haven't been able to find the quote yet. Page eight?


DR. GLANTZ: You say for the reasons presented below the following are misclassified by OSHA. And it's the list, the first bullet there is what led to the question.

DR. SEARS: I think that we've answered this question in different forms before but certainly an important aspect of the answer is what Dr. Coggins just told you. Dose-response has no meaning unless dose has been measured. And in these studies, Dr. Glantz, not even exposure has been measured. And let me repeat to you the warning of Dr. Benowitz before this panel which was that self-report of exposure is not useful for determining degree of exposure.

MR. STEICHEN: I believe our purpose in making that statement was to look at OSHA's original table and point out which ones were not in the proper column. And in particular, Brownson '92 we can pick on it since that's the first one in the list, yes, you can find significantly elevated subsets of the data. You can also find many more significantly decreased subsets in the data.

The important issue, though, is the Brownson overall risk estimate is 1.0 and to begin to classify this as a positive study is just not consistent with what I would consider standard principles.

DR. SEARS: Mr. Steichen, your mention of the Brownson study reminded me of something pertinent as well. I believe that in the Brownson study there are two indices of exposure measured, one a more general index, something like high, medium and low, and the other an attempt at a more quantifiable index, that being cigarettes per day. And the two dose-response trends contradict each other. That is, one is significant and one is not significant.

DR. GLANTZ: Brownson in his paper concluded that his study "suggests that exposure to high levels of ETS in adulthood increases the risk of lung cancer in non-smokers." Was Brownson misinterpreting his own data?

DR. COGGINS: I think that's a statement in the abstract. I think that the data, when you have a closer look, do not support the statement that he's made in the abstract.

Isn't that right, Dr. Sears?

DR. SEARS: I'm aware of that statement and the only answer I can give is the data speak for themselves.

DR. GLANTZ: You state in your submission that the Kabat and Wynder study, lung cancer study, is "archaic" because the cases were accrued in the 1970s and the ETS exposure goes back into the '40s.

Isn't it necessary to study individuals exposed for 20 to 30 years or more in the past because of the long latency period expected between ETS exposure and development of lung cancer?

DR. COGGINS: First of all, you're sort of assuming that there has been a link shown between ETS and lung cancer and I don't think we've established that. In fact, I think we've established the exact opposite.

Archaic -- I don't remember that word.

Did we use that?

MR. STEICHEN: I believe we did use the word although I don't know exactly what page it's on. It is an old study. No question about it. And the type of cigarettes, well, just plainly the type of cigarettes that were smoked then may be very different from what's smoked now.

DR. OGDEN: If I could interject, bringing it back to what OSHA's responsibility is, they're attempting to regulate smoking in the workplace now and what's relevant is exposure in the workplace now. Not what it may have been 50 years ago.

MR. STEICHEN: That's correct. And that may then raise the question about whether smoking levels have decreased in general and in particular in workplaces.

The other issue, of course, it is the theory that lung cancer may be a long-term disease and it's just that yet, a theory. I don't think anybody knows the answer to that.

DR. GLANTZ: You criticized the Fontham study for not using tobacco-related cancer controls as they did in their earlier study. I'm sorry, I read this wrong.

You criticized the Fontham study for not using non-tobacco-related cancer controls as they did in their earlier study. Isn't it true that in their earlier study the relative risk for lung cancer associated with ETS only changed from 1.29 to 1.28 when population controls or colon cancer controls were used respectively?

DR. COGGINS: Mr. Steichen, can you handle that?

MR. STEICHEN: Yes. I have the earlier paper. Let me look up the numbers.

DR. COGGINS: This was Fontham '91 you were talking about?

DR. GLANTZ: Comparing Fontham '91 and Fontham '94.


MR. STEICHEN: That is correct. If you're speaking specifically of all lung carcinomas, any type of tobacco, that is the difference that they observe there. That is one of the differences they observed, all of which, if you look at the colon cancer controls, all of which are smaller when you look at colon cancer controls than when you look at the population controls.

DR. GLANTZ: Is this difference, from 1.29 to 1.28, large enough difference to have any practical significance?

MR. STEICHEN: I don't know what practical means in that sense. It's a small difference. It's one of many small differences that may be important in this particular study.

JUDGE VITTONE: Would this be a convenient time?


JUDGE VITTONE: Ms. Sherman, did you want to say something?

MS. SHERMAN: Well, I wanted to try to give you some indication as to the amount of questioning remaining.


MR. GROSSMAN: Your Honor, we've arranged to have a shorter lunch period for us if it's appropriate and necessary to move this on.

MS. SHERMAN: That would be good.


MS. SHERMAN: We are going faster. Dr. Glantz has --

DR. GLANTZ: Probably an hour, maybe a little bit less.

MS. SHERMAN: Let's say less. And I think I have about 20 minutes of questions on economic aspects of the Reynolds submission.


MS. SHERMAN: And we have no objection at all to a shorter lunch hour. In fact, I think it's a great idea.

DR. GLANTZ: For the record, could we point out that Mr. Grossman and I both agree this is a great time to break?


JUDGE VITTONE: For the record, we'll use the government prescribed standard of 30 minutes. Twelve-thirty.


12:40 p.m.


DR. GLANTZ: You stated that the use of the HCFA, the Health Care Financing Administration, files to identify controls in the Fontham study was likely to result in younger controls than cases within the age categories and resulted in inflated risks. What empirical evidence do you have to support this statement?

DR. COGGINS: Mr. Steichen, please?

MR. STEICHEN: I don't believe that is what we said. What we said was that while they were using random digit dialing controls what clearly occurred is that they were getting too many younger subjects and that's reflected in the fact that they had to go out and look for another source for older controls. It's also reflected in the fact that they changed their protocol which is documented in the Freedom of Information Act material that you can get from the National Cancer Institute. That they stopped adding controls to the youngest age group, the under 50 age group, because they had too many. That's all we said.

DR. GLANTZ: If you're trying to get a balanced control group, is that an unusual procedure that they used?

MR. STEICHEN: I don't know what is usual.

DR. GLANTZ: You criticized the Fontham study for failing to match on Chinese-speaking and suggest this biased the results toward inflating the risk. What was the percentage of non-English-speaking Chinese women included in the Fontham study?

MR. STEICHEN: We don't know. That's not documented. That's why we raised the question, because we think it ought to be documented. And possibly that Fontham ought to put that information forth so we can look at that and find out whether that is in fact an important factor in this study.

DR. GLANTZ: Do you have any empirical evidence that Chinese speaking is associated with lung cancer in the United States?

DR. COGGINS: Could you give that again? I'm sorry.

DR. GLANTZ: Do you have any empirical evidence that being a native Chinese speaker is associated with lunge cancer in the United States?

DR. GLANTZ: Dr. Sears?

DR. SEARS: I think that Mr. Steichen is looking up some direct references but to give a cursory answer to begin with, yes. There are several studies in which the population of Chinese women has been identified as having a high incidence rate of lung cancer and there are other studies which show that that incidence rate persists when the native Chinese migrate to other areas. I am thinking of the work of Dr. Linda Koo primarily in this regard.

MR. STEICHEN: I would like to add a little bit to that. Earlier in these hearings Dr. Samet spoke and actually in questioning by Mr. Grossman he was asked about the Chinese women and the questions evolved to whether immigrants or first-generation Chinese in the United States would possibly have different risks. And he was asked would it be a factor to consider and the answer was it could be a substantial confounder. Excuse me. He said it would be a factor to consider. And when he was asked would it be a substantial confounder he said it would depend on patterns in the data, so I can't answer that but certainly a potential confounder. And so empirically at least Dr. Samet seems to agree with what we're saying.

DR. GLANTZ: Well, could you submit whatever evidence you have beyond that that you've already cited in a post-hearing comment?

You criticized the Fontham study, and this actually was raised, you made this point again in your answer to a question earlier today, you criticized the Fontham study for controlling for confounders using a log linear scale or a log linear adjustment. Isn't this the method that's commonly used in case control studies to control for confounders?

MR. STEICHEN: It is a method that's commonly used.

DR. GLANTZ: You criticized the Helsing study because the adjustment for confounding by age reversed the direction of the relative risk of ETS-induced heart disease from .6 to 1.24. Doesn't this simply demonstrate that adjusting for a confounding variable can increase as well as reduce the risk estimate?

MR. STEICHEN: I think it's quite oversimplifying it to say that's the only thing it suggests. It has to suggest more than just that it can go in either direction. We did raise some concerns about what happened in Helsing and in particular with that adjustment. And age, of course, can be looked at as a confounder, just a demographic variable, and it's often adjusted for. And should be adjusted for, from what we can tell.

But there, I believe, were three other variables that they adjusted for, none of which would be considered very important, of the more important of the confounding variables for heart disease.

We do expect confounders to move the data some, the results some, but you don't expect to go from a significantly positive effect to a significantly negative effect when you're dealing with variables that are that minor in certain aspects. The only one that's not minor, of course, is the H variable. And then that raises the question of, well, did they have a reasonable group to adjust from in the first place relative to the target population they were trying to represent. There are important questions to ask about that data set.

DR. GLANTZ: I just want to clarify because i'm a bit confused. Do you think age is or is not an important determinant of risk of heart disease?

DR. COGGINS: I'm not sure how to answer that.

Do you guys know the answer to that?

DR. SEARS: My opinion is, yes, it's an important determinant. But if you ask me to give you a citation on the spot, I don't think I can, Dr. Glantz.

DR. GLANTZ: No, that's fine.

You criticized the Helsing study for relying on death certificate information. Isn't the potential misclassification of disease resulting from death certificate information more likely to bias the study towards not observing an increased risk?

DR. COGGINS: I don't know the answer to that one either.

DR. SEARS: I don't think I would conclude that. I don't see any reason to believe that it would go in that direction.

DR. GLANTZ: Could you cite any empirical evidence or any data on which to base that opinion?

DR. SEARS: The opinion that I expressed was that I don't have any reason to believe it would go one way more than another way, other than the statement that I have come across in the literature that death certificate information is not one of the more accurate ways of determining the outcome.

DR. GLANTZ: Would you say that a study of, say, ETS based on death certificate information in general, that's a very serious flaw in the study?

DR. SEARS: It's certainly a source of uncertainty that should be accounted for.

DR. COGGINS: Are you familiar with the paper by Judd Wells published, I believe, in August of last year on passive smoking and heart disease? It's in the record.


DR. GLANTZ: In the paper, Wells did an EPA-style meta-analysis in which he grouped the studies with the ones that were the best studies, defining best as controlling for the most confounders and then he had a middle tier and a bottom tier. And what he found was that if you limited your analysis to what were the best studies, you got a higher risk estimate and then the risk estimates dropped as you added in the studies that controlled for fewer confounders. Do you think it would be reasonable to conclude that in the case of ETS and heart disease confounders can actually be masking an effect of ETS rather than inducing one?

DR. SEARS: Let me have a first go at that.

It's been some time since I read Dr. Wells' paper but as I recall you correctly characterized it as having a categorization of epidemiology studies based on one criterion, that one criterion being the simple count of confounders, that is, the number of confounders controlled for in each study.

In my opinion, Dr. Glantz, that's a totally inadequate way of determining the quality few the study. And even if one were to base a categorization, a quality categorization, on confounders alone, as I recall, in fact, I'm sure, since I'm familiar with the literature, it's a mixed bag of confounders. Some confounders were controlled for in one study, a completely different set of confounders were controlled for in another study. So to categorize them on the basis of that hodgepodge of counted confounders I think is essentially meaningless.

In addition, Dr. Glantz, I would say that the proper way to do that would be to systematically add the same confounders to studies and then determine whether or not they have an effect.

DR. GLANTZ: Would you agree, though, that at least from the position -- the kind of analysis based on existing publications that Wells did, that's basically impossible to do? Retrospectively.

DR. SEARS: My opinion is that that is impossible to do, based on the poor quality publications that are currently available.

DR. GLANTZ: You criticized OSHA for using the CPS-II study for estimating background rates. What do you think OSHA should use to estimate background rates in lung cancer? Which specific data set or study?

DR. SEARS: Can you direct me to a page here?

DR. GLANTZ: It's in the August 13th submission, I'm told. Just to help you out, I have a series of questions and they're all based on the August 13th submission.


DR. SEARS: I believe I've found that.

DR. GLANTZ: Perhaps you could tell us what page.

DR. SEARS: Try 35.


DR. GLANTZ: Do you want me to repeat the question?

DR. SEARS: Please.

DR. GLANTZ: You criticized OSHA for using the CPS-II study to estimate the background rates for lung cancer. What study or data set do you think OSHA should use to estimate the background rates for lung cancer?

DR. SEARS: I believe the basis of our criticism was that OSHA mixed populations, for using the incidence rate from population while using a relative risk from another population in their computation of their quantitative risk assessment.

DR. GLANTZ: Well, the statement that you have here, you say "CPS-II is not representative of the U.S. working population because subjects were recruited from families of American Cancer Society members, their friends and relatives." And then you go on to explain why you believe that. The question is what do you think OSHA should use if they don't use the CPS-II data set?

DR. SEARS: Well, I believe I partially answered that question. OSHA should be consistent in applying incidence rates from one population to relative risks from the same population. That's good statistical practice and, of course, it's good epidemiological practice.

My criticism of the CPS-II data stands as you have pointed out. I have outlined the reasons that I disagree with that.

DR. GLANTZ: Well, I'm still -- then are you saying that we should be using incidence rates from the Fontham study, assuming that OSHA goes forward and uses the Fontham study for their relative risk? Which I'm not saying they're going to do that but if they were to do that, do you think it would be preferable for them to use the incidence rates from the Fontham study?

DR. SEARS: Categorically OSHA should not go ahead with a quantitative risk assessment using the Fontham study, in my opinion. And for that reason, your question is moot.

DR. GLANTZ: Okay. You criticized the use of the Framingham study as a source of background rates for heart disease. What do you think OSHA should be using to get the heart disease background rates? What data set?

DR. SEARS: Dr. Glantz, I believe we could go through the same litany for that series of questions.

DR. GLANTZ: Are you aware of the fact that some of the other witnesses at this hearing who have testified at the request of the tobacco industry have actually said this is the best study to use to get population rates?

DR. SEARS: Can you refer me to that testimony? I'm unaware of that.

DR. GLANTZ: We'll just move on in the interests of time. I mean, I recall -- I was here for a couple of them, Springall, I believe, was one. I think Laird may have been one.

DR. SEARS: Well, simply to the OSHA panel, I would say that my comments stand.

DR. GLANTZ: OSHA used data from the Cummings study and the National Health Interview Survey to construct a range of anticipated prevalence rates for ETS exposure in the workplace. Do you disagree with OSHA's choice?

DR. COGGINS: Dr. Ogden, I think.

DR. OGDEN: Yes. I think that was outlined in some detail in my presentation of two days ago. The lower bound for population exposure that OSHA used was obtained from the NHIS study. My reading of that study would indicate, and also in comparison to the quality of the other studies would indicate that to me that's the best estimate of central tendency.

For the upper bound of the prevalence of exposure, OSHA used a number obtained from the Cummings study and we've outlined a number of criticisms as to why that number is unlikely to be accurate and principally those are first of all the Cummings study is a very unusual population. Its subset was restricted to people who attended a cancer screening clinic but also more importantly the subjects were informed at the outset or they were asked if they wished to participate in a study on ETS. So I don't see how you could take that as anything be representative of the U.S. workforce. Knowing the intent of the study as I indicated in my testimony, it would seem to me that if you didn't think you were ETS exposed why would you volunteer to participate in a study on ETS?

DR. GLANTZ: Well, do you think that they should base their estimates of exposure including the confidence intervals for that estimate just on the NHIS estimates? Would that be what you would view as the preferable approach in order to construct a range of exposures?

DR. OGDEN: I'm not sure I can answer that question in total detail. Again, what I would see as the most logical first step, the outcome of the NHIS study would seem to be the best available estimate of central tendency. As for confidence intervals from that study I couldn't speak to that.

DR. GLANTZ: Well, how could it be a good estimate of central tendency but not a good estimate of variability?

DR. OGDEN: Well, that's more of a statistical issue. I think certainly you'd have to consider other parameters rather than just a central estimate.

DR. GLANTZ: Does anyone else want to comment?

DR. SEARS: May add something to that?

Certainly I agree with you that the variability around whatever parameter that you choose to use in any sort of calculation should be the variance that's appropriate for that particular variable. This does allow me to comment, though, that I don't believe OSHA propagated error at all in their calculation of either annual risk or lifetime occupational risk.

DR. OGDEN: And also the NHIS study, as is the Cummings study and the Emmons study and the CAP study and all of those cited by OSHA as information relevant to that particular piece of the risk assessment in terms of how many workers are exposed don't include any measure of exposure, so they are at best -- they're estimates of potential exposure. At best. And in many of those, that's even dubious.

DR. GLANTZ: Well, if we were -- I don't want to get back into that whole discussion of exposure versus potential exposure but if OSHA decides to try to use a survey method to estimate whatever it ends up being called, because I'm a bit confused, are you saying you think the NHIS is the best source of that information?

DR. OGDEN: Is the best estimate of the number of people who are potentially exposed?


DR. OGDEN: From the studies I'm aware of, yes. I would say that's the best estimate.

DR. GLANTZ: And it would also then, and perhaps Dr. Sears would be the one who might speak to this although it's up to you, if the study is good as a measure of central tendency, it has to be good as a measure of variability. It can't be good for one without the other. Would you agree with that?

DR. SEARS: I certainly would agree with that. I feel the need to clarify one thing. That, of course, is not the only parameter in that calculation and an error band should be used around the other parameters as well.

DR. GLANTZ: Now, if you could look at -- this is Dr. Ogden's presentation, comments on -- I'm sorry. I'm sorry. I've got too many pieces. This is Dr. Nelson's presentation, slide 12.

DR. NELSON: If you'll give me just a moment to come to the same slide.


DR. NELSON: All right. I've found that slide.

DR. GLANTZ: This will be a slightly hypothetical question, I will warn you.

When I look at these graphs for site 1, 3, 4 and 5, what I see is a reasonably linear trend with one point falling off the curve in each case. That's not what the question is about. For the sake of argument, I'd like to just say suppose that's the case, that you've just got one outlyer, a weird point there. In that case, if you're just using the eyeball technique, draw a line through the remaining data, you end up with a reasonable straight line with a non-zero intercept.

DR. NELSON: I would not use the eyeball technique to do that. I would actually perform the regression and determine whether or not that point was an outlyer before I actually went --

DR. GLANTZ: Okay. Well, let's presume -- let's presume -- and if I hadn't been so tired I would have picked the points off and done the regression but the point I'm trying to make, assuming that what you just said occurs, that you can through good statistical practice or by going back and double checking the data you ended up deciding that those were outlyers and that you could fit a good straight line, if you look at them, you're going to have an intercept greater than zero on all of those, on those four curves or at least three, 1, 4 and 5.

DR. NELSON: Perhaps the best thing to do, and it is done in my submission to the docket, and really in slide 13, if you want to do that sort of thing, is go ahead and perform the regression equation on the entire data set. Now, that is described in the docket and the regression equation is in there.


DR. NELSON: And in that case I believe you will find that the intercept was not significantly different.

DR. GLANTZ: Well, again, when I look at slide 13 -- this becoming longer than I had hoped. You know, most of the points look to me like they fall on a line and there's about six points that seem to fall below the line. But let's just say -- we're going off into a debate about a peripheral issue. If there was a non-zero intercept, would the interpretation of that be that there is some simply background level?

DR. NELSON: Not necessarily.


DR. NELSON: Let me explain why. This is -- let me --

DR. GLANTZ: I'll rephrase the question.

DR. NELSON: No, please let me answer the question that you asked.


DR. NELSON: This is really not a peripheral issue. What you are doing and what you are saying is assuming that there is a good, direct, linear relationship between ETS nicotine concentration in this particular environment and ETS RSP concentration in this particular environment. That is an assumption that has not been validated and what you are passing off as a peripheral issue is really not a peripheral issue, it's a very important issue.

The next point I would say is say you make these assumptions in your graphs. Another question might be even though the line doesn't pass through zero, is that intercept statistically significantly different than zero? And, again, only eyeballing you aren't going to be able to get that information. You're going to have to perform the analysis.

And the third thing I would say, as you say, it looks like a straight line. Actually, to me, it looks kind of like a curve, not a straight line. And so, again, linear first order regression statistics would not apply to something that's a curved linear relationship.

DR. GLANTZ: Well, there's another -- wait. We're going off. I'm trying to-- let me just try to -- we're going off into a discussion of something different than what I was trying to find out. I mean, I can -- we can just keep going but --

JUDGE VITTONE: Okay. What's your question?

DR. GLANTZ: Let me try to rephrase the question because I'm leading you not to the information I'm seeking.

Let's say given all the things you said that there was a non-zero intercept. What would the interpretation of that be? Okay? Do you understand -- I'm trying to understand what a non-zero intercept would mean.

DR. COGGINS: So a non-zero intercept for the UVPM.


DR. COGGINS: Dr. Ogden.

DR. GLANTZ: Not asserting that it is there, I'm just asking you what it would mean.

DR. OGDEN: Strangely enough, that was what I was going to answer previously.

DR. GLANTZ: Okay. Great.

DR. OGDEN: One potential interpretation of this particular graph, which is slide 13 in Dr. Nelson's presentation, would be that that's simply the background of ultraviolet absorbing material in the universe, in this case, indoor air in an office. Because this is using UVPM as a surrogate for RSP that's attributable to ETS. It's not perfect. And, as we've shown and we've published, and it is in the docket, for instance in one restaurant study, UVPM actually over-estimated the ETS contribution to RSP by about 25 percent. That simply could be the residual UVPM from other non-tobacco sources. Could be.

DR. NELSON: Let me go one step further because rather than talking about hypothetical data, let's talk about real data.

And in that case, by the way, I mischaracterized what I wrote in the submission and I would like to clarify that as well. We have performed a regression of UVPM versus nicotine in 471 United States workplaces and what we do see here is that we do have a significant intercept. I would not characterize that intercept as -- it's a little difficult for me to perhaps characterize that intercept but a number of things we do find. We find that the slope is one, not 10, and I could go into some other areas on that. For your sake, I won't at the moment. But another important consideration is not just in determining a relationship between two species, it's not just the intercept or the slope of the line, but the precision of predictions made with that line.

In the case of the 471 workplaces, all but about a small handful in which smoking was known to occur, the R-squared value is 0.05. That regression does a very poor job of predicting tobacco-specific RSP in workplaces on the basis of measured nicotine concentrations. Nicotine, although is certainly associated in some way with tobacco-specific particles, when you smoke a cigarette you generate both nicotine and particles, an association should not be surprising. But that association is not quantitative. That is to say the association cannot be used to predict one species from the other.

DR. GLANTZ: Now, first of all, would you submit the material you were just describing in a post-hearing comment?

DR. NELSON: It's submitted on page 12 of my submission to the docket already.

DR. GLANTZ: Oh, okay. I'm sorry.

Now, if there is a positive intercept, just from pure mathematical considerations, should the ratio of UVPM to nicotine be constant?

DR. NELSON: I'm just kind of rattling through my head, not necessarily. But that is not the only factor, as I demonstrated in my testimony, it's not the only factor that would lead to this variety and ratio between RSP and nicotine. Although you are right, it does make it very difficult to pick a simple number, 10, 1, 15, 3, and apply that number uniformly in all spaces. That and the fact that the correlation between the two species -- air, nicotine, and tobacco specific particulate matter, is very poor.

DR. GLANTZ: Just to make sure, because I think I understand, but I want to make sure. You would agree, if you fit a straight line and the intercept is at zero and the line is Y=MX+B, then if you take Y over X, that ratio's going to be B+M/X, which is a hyperbole, right?

DR. NELSON: I disagree with that. That is the basis of my statements on Slides 7 and 9, that you cannot explain the ratio between RSP and nicotine with a single, simple ratio.

DR. GLANTZ: But that fact doesn't mean that there isn't a relationship.

DR. NELSON: As I stated, there is almost certainly a relationship between RSP and nicotine. You generate both when you smoke cigarettes. The question, as is put forth, or the idea as it's put forth in the OSHA NPR is not is there a relationship between them, is there a predictive, a quantitative relationship between them. And there is not in this case, a good quantitative or predictive relationship between nicotine and any other environmental tobacco smoke component that we have looked at.

DR. GLANTZ: OSHA would appreciate it if any additional data you have on the variability in these measurements could be submitted as a post-hearing comment. For the various different techniques that you've described.

These next series of questions were drawn from Carl Joseph Smith's submission, but there's material that Dr. Coggins also presented that relates to these. This is just to orient you.

On page seven of this submission you, and by you I mean Reynolds, I guess, stated that four of the heart disease epidemiological studies have 95 percent confidence interval, the lower bound of which "approaches one." Then go on and suggest that these really shouldn't be considered as positive.

Do you agree that these four studies do reach statistical significance in the conventional 95 percent confidence interval excluding one?

DR. COGGINS: I haven't got Dr. Smith's testimony with me. Mr. Steichen, do you?

MR. STEICHEN: I don't have it either.

By the way, just for the record, his name is Carr, C-A-R-R. Not Carl.

DR. GLANTZ: Thank you.

JUDGE VITTONE: They don't have the testimony.

DR. GLANTZ: I have a copy of it.

MS. SHERMAN: I think that the issue is, do you feel you can answer questions on the submission by Carl Joseph Smith?

DR. COGGINS: I don't.

MS. SHERMAN: I'm sorry. Do you think you can answer questions on the submission of Carl Joseph Smith?

DR. COGGINS: I don't think I could, no.

MS. SHERMAN: Is there anybody on the panel?



JUDGE VITTONE: I guess the answer is no.

DR. GLANTZ: Let me then redo the question to...

Would you agree that an epidemiological study whose 2-tailed 95 percent confidence interval excludes one is, by conventional statistical criteria, statistically significant.

DR. COGGINS: I'd say statistically that's the case. Gentlemen?

MR. STEICHEN: Yes, by standards that would be a statistically significant study.

DR. GLANTZ: Well then would you agree or disagree with the statement that something where the lower bound approaches one shouldn't be counted as a positive study.

DR. COGGINS: I guess it would depend how much it approached. I'm not sure what the values are.

MR. STEICHEN: I think this follows directly from some of the earlier discussions that were held here. Dr. Sears quoted Sander Greenland, and states again that a confidence interval is just a minimum variability that's really present in the study. Again, what we're talking about there is whether random chance alone would have resulted in a result as high as we're seeing.

The answer there is no. But that doesn't mean we understand exactly what did cause it, and I think that may be what Dr. Smith is referring to.

DR. GLANTZ: As a general issue, when you say there's a statistically significant difference, and I'm not talking about epi, I'm talking about any statistics, when you say P is less than .05, what does that mean?

DR. COGGINS: To me it's a one in 20 chance of it being due to chance, but we have a statistician. He's got a much longer answer, I'm sure.

DR. GLANTZ: Well I'll accept a short answer.


MR. GROSSMAN: Why don't we move on?

DR. GLANTZ: Is that acceptable? Okay.

What are the chances of getting four studies, each of which yields a P value of less than .05 just by chance if there is, in fact, no treatment effect?

DR. COGGINS: That's a much more complicated question. I will have to get Mr. Steichen to answer that.

MR. STEICHEN: I'm sure we can calculate that as an appropriate power. It's small.

DR. GLANTZ: It would be .05 to the fourth power, correct?


DR. GLANTZ: Which is, for the record, .000006.

Do you think it's likely that you would get four studies that reached statistical significance by chance if ETS wasn't affecting the risk of heart disease, given that that's only a probability of I think six in a million or so?

DR. COGGINS: Dr. Sears can go first. We're lining up on this one.

DR. SEARS: This, of course, is a variation of the coin tossing problem, a binomial distribution type problem. The answer to your question is that statistic that you've computed, I'm sure accurately, Dr. Glantz, has no relevance. The reason it has no relevance is because studies are not judged on the basis of the toss of a coin. They're based on the quality of the study and many other factors, including confounders and biases.

As I've tried to make clear in my oral and written testimony, the studies that you're referring to are rife with confounding factors and biases. So no, your statistic does not apply.

DR. GLANTZ: If one did a study and ended up with a statistical significance at the 99 percent level, would you think that was compelling evidence of an association?

DR. COGGINS: Then instead of having a one in 20 chance you have a one in 100 chance.

DR. GLANTZ: Would you consider that pretty strong evidence?

DR. COGGINS: Much stronger.

DR. GLANTZ: ...conclude that there is a relationship?

DR. COGGINS: I'd say it's much stronger, but again, relationship is something else. Right Steve?

DR. SEARS: The answer is how close is close. That's the question you're asking. So by definition, the relationship would be stronger, by definition. But would it be more convincing in the case of ETS? No.

DR. GLANTZ: What if it was 99.9 percent? If you had a P value, what's that, .0001, would that do it?

DR. NELSON: I think we're chasing the same
issue that gets involved with, when we're talking about meta-analysis, that we can increase the statistical precision all we want, and it really doesn't change our ability to look at the confounders that may be involved. We still don't know whether the label that's been attached is the correct label.

DR. GLANTZ: In your submission you list several potential confounding variables for heart disease which we've discussed -- diet, exercise, age, perhaps, and several others. What empirical evidence can you cite to demonstrate that these potential confounders actually explain the observed increase in risk of heart disease with passive smoking?

DR. COGGINS: Dr. Sears?

DR. SEARS: I believe that in our written testimony we provided several references to that effect. But in addition to that, I would draw the panel's attention to the submissions of Dr. William Butler, and Dr. Peter Lee on that subject. I would also say that Dr. Matanowski's submission to the docket, her analysis of the NHANES data, I believe it is, is also relevant to that question.

DR. GLANTZ: I don't recall Dr. Butler's submission, but I did read Dr. Lee's very carefully. All that he presents is a list of I believe 33 potential confounders. He doesn't present any affirmative evidence that those actually explain the effects which have been observed of ETS. Do you have any data that demonstrates...

There are long lists of potential confounders that have been created. Do you have any data demonstrating that these confounders actually explained the elevated risk observed with ETS?

DR. SEARS: First of all, my answer was based on my memory on the spot here. I could be wrong about Dr. Lee's. I'm firmer about Dr. Butler's, though. So I do draw your attention to that. I believe that those lists of confounders universally come from prior studies that have identified those in one way or another as being a potential confounder.

DR. GLANTZ: Right, but my question is slightly different. It's one thing to be a potential confounder. It's another thing to be a real confounder. All of the evidence that I've seen put in front of using these hearings, including Layard's work, the National Death Followback Survey, the work we just discussed today from the carotid thickness study, show that adjusting for those variables really doesn't make a whole lot of difference. I'm not saying one shouldn't adjust for them.

So what I'm asking for you is direct evidence, which you can put in as a post-hearing comment, that these things actually explain the observed elevation and risk, rather than our potential problems.

To move on, could I just ask that you put that in as a post-hearing...

DR. SEARS: Let me give you one concrete example that has come to mind.


DR. SEARS: The sister paper to the Brownson study, that is the paper who's first author is Alavanja, does identify several variables that I think would qualify according to your criteria.

In reference to that paper I would also say that Alavanja states that ETS had no effect on that population.

DR. GLANTZ: Heart disease is clearly a multifactorial disease. We've been discussing several of the variables that account for it. Is the fact that say having high blood pressure or high cholesterol or a bad family history mean that ETS couldn't be a cause of heart disease?

DR. COGGINS: Dr. Sears?

DR. SEARS: Could you please repeat that?

DR. GLANTZ: There are many things which are well accepted risk factors for heart disease. Having a bad family history, high blood pressure, cholesterol, smoking, a lot of people would think, active smoking, does the presence of these other causes of heart disease mean that ETS couldn't be a cause?

DR. SEARS: Once again, this is the question of proving a negative. I believe we've addressed that earlier.

DR. GLANTZ: In the RJR submission, some of the other variables which are discussed are differences in dietary intake of beta carotene between passive smokers and true non-smokers. What empirical evidence do you have that this difference is sufficient to explain the differences in observed death rates and heart disease rates between non-smokers and passive smokers?

DR. COGGINS: Dr. Sears?

DR. SEARS: First of all, as I pointed out, a careful examination of the studies reveals that the relative risk is not significantly different from one. So your reference to a death rate is inappropriate and incorrect. However, there is also another misconception in the premise to your question. That is that a single dietary factor or a single confounder is necessary to account for an observed effect.

As I believe I pointed out earlier, ETS is a marker for an aggregate of confounders or potential confounders, so it could very well be any of a group that could result in any observed association.

DR. GLANTZ: Do you have any biological evidence that changes in dietary intake of beta carotene produces effects on the cardiovascular system at a mechanistic level?

DR. COGGINS: I think that most of the studies on beta carotene have been largely epidemiological. There are some studies I believe more involved with the carcinogenic end point. I'm not aware of any with a cardiovascular end point.

DR. SEARS: Not at the mechanistic level.

DR. GLANTZ: In the animal studies of passive smoking and heart disease, such as the work by Zhu et al that we did at UC San Francisco, and also the work by Penn using cockerels. Dose response relationships were observed between exposure to what the authors considered ETS and the development of atherosclerosis or atherosclerotic type lesions. How can you explain this dose response relationship if it wasn't the ETS that was causing it?

DR. COGGINS: The Zhu study first, in the cholesterol fed rabbits. I don't think you can have a dose relationship when the two test materials are very different. As I understand it in this particular study, and this is the Journal of American College of Cardiology in 1993. There claim to be two ETS groups, and in fact, one group was given fresh mainstream, and as I read this, the other group... Sorry, fresh aged mainstream.

DR. GLANTZ: Aged and diluted mainstream.

DR. COGGINS: Potentially diluted mainstream, and the second group was given a high dose of fresh sidestream. Neither of these were ETS. You should not play in the dose relationship when you're not using more than one, preferably more than two concentrations of the same material.

DR. OGDEN: There's a comment that I made in my written submission regarding the Zhu paper. As I looked at it, and of course I can't judge health effects from a standpoint of analytical chemistry, but as a person who measures ETS, but the clean air in that experiment is actually higher in nicotine and RSP and CO than you would expect to find in real ETS situations, and particularly with respect to the RSP in nicotine. They're higher than the levels reported at these hearings by Oak Ridge from the recent studies conducted in the workplace.

DR. COGGINS: In fact on Table 1, page 228, total particulates, not respirable. The control value is higher than our low exposure. .13 milligrams a cubic meter control, and yet our low dose was .1 milligrams per cubic meter. That was, admittedly, total particulates. If you look at respirable it drops, for some peculiar reason, down to .07.

DR. GLANTZ: What about the Penn study?

JUDGE VITTONE: What about it?

DR. GLANTZ: The Penn study also found a dose response relationship. Would you give an alternative explanation for that?

DR. COGGINS: You're talking of the Penn...

DR. GLANTZ: There are two studies, actually. Both published in circulation.

DR. COGGINS: I only have two. Penn and Snyder in '93.

DR. GLANTZ: And there's a Penn and Snyder '94.

DR. COGGINS: I have a Penn and Snyder '94. I don't have a third one.

DR. GLANTZ: Did I say three? I meant two.


So in Penn and Snyder '93, there was only one smoke concentration, so there can't be a dose response.

DR. COGGINS: There are two papers of two different concentrations with the same preparation.

DR. COGGINS: Okay, so combining studies is something I don't normally do.

DR. GLANTZ: Well they were done by the same people in the same lab with the same preparation. The only difference between the two studies was the dose.

DR. COGGINS: Maybe. There may have been other differences.

But again, the problem with the Penn studies, again, I think is that they are again using the wrong material. In this case they're using fresh sidestream, and to a large extent, undiluted sidestream.

DR. GLANTZ: In another of the Zhu papers, the rat study, where rats were exposed to what you would call fresh diluted sidestream smoke at two different levels, we also found a dose response relationship between the level of smoke exposure and the size of myocardial infarction.

DR. COGGINS: This was the Zhu 1993 in rats?

DR. GLANTZ: Yes, in circulation.

DR. COGGINS: This is circulation '94.

DR. GLANTZ: Maybe it was '94 then.


DR. GLANTZ: How can you explain the dose response relationship we found there?


DR. COGGINS: You didn't have a dose response. You only used one dose.

DR. GLANTZ: There was one where we had two different durations of exposure. Dose, as we heard earlier, is concentration times duration.

DR. COGGINS: Right. You had three days, three weeks, and six weeks.


DR. SEARS: I'm sorry, Chris. Exposure is concentration times...

DR. GLANTZ: I'm sorry.

DR. COGGINS: There are, again, problems with this paper that I think the wrong test material was used, and that over longer periods of time you appear to have got some changes that may have been due to the smoke, almost certainly were due to other factors.

For example, I mentioned in my submission the problem of oral and dermal absorption of material. You may well have had significant amounts of smoke actually being ingested by these animals.

DR. GLANTZ: So are you saying smoke, tobacco smoke constituents are toxic when ingested?

DR. COGGINS: As I said earlier, everything can be made toxic one way or another. It's a question of...

DR. GLANTZ: At the levels they would have licked it off their coats.

DR. COGGINS: No, I'm not suggesting that at all. I'm saying that the wrong test material was used, and that the wrong route of administration was used. I think the study is very difficult to interpret.

DR. GLANTZ: Let me ask one last question about this. Putting all of that aside, if we were to write a very precisely written conclusion, calling the smoke that these rats were exposed to smoke with the appropriate modifiers in front of it, do you think that paper produces evidence that smoke, whatever that smoke was in those exposure changes, smoke produces a dose dependent increase in infarct size?

MR. GROSSMAN: I have to object to that question as ambiguous.

DR. GLANTZ: Then let me ask the following question.

Would you please characterize what was in the air using your terminology in that experiment? It's thoroughly described in the paper.

DR. COGGINS: I would say it was fresh sidestream and it wasn't particularly well characterized.

DR. GLANTZ: Would you say that the evidence in that paper, a reasonable interpretation would be exposure to fresh sidestream smoke produces a dose dependent increase in infarct size in rats?

DR. COGGINS: No, again. Even if we're interested in fresh sidestream, which we're not. We're interested in aged and diluted sidestream as a surrogate for ETS, you're still using the wrong route of administration. We just don't know the potential effects of those dermal and oral through preening effects of the smoke exposure.

DR. GLANTZ: Would you say that we have shown that exposure to sidestream smoke through whatever modes of administration occurred in these rats, produced a dose dependent increase in infarct size?

DR. COGGINS: No. There were two caveats up front. Now you've given a third statement of dose.

DR. GLANTZ: Okay, lets move on.

As you know, OSHA cited a wide variety of epidemiological clinical and animal studies which it interpreted as all consistent with the hypothesis that ETS caused heart disease. You've criticized the epidemiological and experimental studies one at a time. We haven't talked about the clinical studies, but my guess is it would have been a similar discussion.

Can you offer an alternative global hypothesis that can be used to explain the breadth of scientific data that is in the literature on the subject of ETS exposure and heart disease? An alternative to the hypothesis that the ETS is causing the heart disease.

DR. COGGINS: You've used that word "cause" again. We've got problems with that word. I don't think there is the overall breadth of information.

Will you agree, Dr. Sears?

DR. SEARS: Once again I'll address the epidemiological data.

I can't explain why there are so many papers that have been done, in my opinion, as poorly as they have been executed. I'm not able to explain that. But I can say that the overall evidence is one of no statistically significant effect, and in the workplace the effect of ETS has been demonstrated to be 1.0 exactly.

DR. GLANTZ: In your submissions you attached a list, and you alluded to it earlier, of 246 risk factors for heart disease. Do you know of a single epidemiological study that has adequately controlled, and this is any aspect of heart disease, that has adequately controlled for all 246 risk factors?

DR. SEARS: Dr. Glantz, I've reviewed the ETS literature. I haven't reviewed a broader heart disease literature than that, and my testimony is addressed to environmental tobacco smoke.

DR. GLANTZ: You're familiar with the list I'm talking about, the list of 246, is that true?

DR. SEARS: Actually, I've seen lists of 100 up to 300.


Do you think that there are 246 or 100 or 300 independent risk factors for heart disease?

DR. SEARS: I'm not qualified to answer that question.

DR. GLANTZ: I think that's everything I have. Thank you.


DR. GLANTZ: Oops, I've got one more. I'm sorry.

JUDGE VITTONE: You know, doctor, lawyers learn that sometimes you just don't ask the last question.


DR. GLANTZ: This is, I promise, the last question, and this has to do with Michael Ogden's Slide 15 from Exhibit 235, whichever that one is. That's this one here, the ETS meta-analysis relative risk.

DR. OGDEN: This is from the testimony?

DR. GLANTZ: Yes, from your testimony the other day.

DR. OGDEN: What's the title of...

DR. GLANTZ: "ETS meta-analysis relative risk estimates for lung cancer versus RS misclassification rate."

DR. OGDEN: I can find it based on that.

DR. GLANTZ: I can just give it to him.

DR. OGDEN: I'll find it. You said Slide 15?


DR. OGDEN: I have it.

DR. GLANTZ: Could you tell me where, at what misclassification rate, the upper end of the confidence interval crosses one?

DR. OGDEN: Not from this graph, no.

DR. GLANTZ: Can you submit that as a post-hearing comment, please?

DR. OGDEN: Certainly. Realize that Slide 15 depicts the EPA meta-analysis and their misclassification adjustment with, of course, the adjustment of only one of the many parameters.

DR. GLANTZ: Right. I'd appreciate it if you could give the rest of the graph...

MR. STEICHEN: Could I add...


MR. STEICHEN: That, of course, was based on the 1992 publications without Brownson, Stockwell, and the 1994 Fontham. That whole graph would slide down a fair amount. I think at the 1.09 misclassification rate that EPA used, they had a 1.19. At that same rate, you'd now have a 1.11, and the whole thing would slide down.

Do you prefer the updated one?

DR. GLANTZ: I'd like both of them as a post-hearing comment, please.

Thank you.



We were having a discussion yesterday on some of your economic submissions. I'd like to ask you a series of questions so that we can better know how to factor in your predictions into our regulatory impact analysis.

You've presented us, I believe we were dealing with business paper number six yesterday, and you've presented us with a series of numbers, but you haven't given us any detail about your assumptions in deriving these numbers. So the questions I'm going to ask you deal in large part with the assumptions.

I also need to know generically, the number of units of each thing that you're predicting is going to cost you something there will be, and also the unit costs, so that we can better work with your numbers.

I assume that you have determined that some air intakes would have to be relocated as part of the compliance with the proposed indoor air quality standard. Is that correct?

MR. BOHANON: Yes. Yes, that is correct.

MS. SHERMAN: And how many are you predicting would have to be relocated?

MR. BOHANON: We did not specify how many. I can submit that, go back and check. There's one of them in particular that would be very expensive to relocate and I would think that that's going to be a large piece of the cost. And, again, it's subject to interpretation so in making an estimate conservatively, we estimated anywhere where we might have problems with uptake of auto exhaust or those sorts -- you know, intakes of that type, we had better allow for in an estimate costs to relocate those.

MS. SHERMAN: Do you have underlying documents that you used to derive or to generate this table that might help us understand where these numbers come from? I think yesterday you mentioned a spreadsheet.

MR. BOHANON: Yes, there is a backup spreadsheet. I don't know that that --

MS. SHERMAN: Would that help us?

MR. BOHANON: That probably would be helpful and I would be glad to provide that to you. I'm not sure that it in total would explain the underlying assumptions. However, in cases where we have used unit costs time a number of units, that would give you exactly the kind of information --

MS. SHERMAN: Okay. Well, we would appreciate that and perhaps we can also uncover some of the assumptions that wouldn't be derived in the spreadsheet in our hopefully short discussion which will follow.

MR. BOHANON: Okay. Yes. I just think the part on the relocation is entirely clear how that might be interpreted, so it could be very costly or it could be that we could have a meeting with an OSHA representative and they would say, no, you'll never have to move that and that would just knock that off the list. But I don't know to do that --

MS. SHERMAN: Do you recall the assumptions that you were using? You said that there was one air intake in particular that was going to be very costly to move.


MS. SHERMAN: So do you recall enough about the situation to recapitulate it here? To give us an example of what your reasoning was.

MR. BOHANON: Well, that situation is a high-rise office building with the air intake located at street level. The air intake -- by the configuration of the building, as you know, what happens many, many times and happened in this case, you put or the architects put, let's blame somebody, the architects --

MS. SHERMAN: Architects are good people to blame.

MR. BOHANON: -- put the air intakes in the loading docks back behind the building where it's not seen by the passersby and so we do have that situation. I believe that it's a situation that we have managed around but it's a situation where the air intake clearly is at street level and clearly at times can have an uptake of diesel truck exhaust. It's a possibility. We try and minimize that through procedural means and we don't feel justified in spending the money to relocate that air intake, which would be very expensive. It would involve building out some sort of intake to get elevated about the diesel and this is a building where we have an economizer cycle so you're talking about a capacity of, say, 160,000 cfm. It's a pretty large intake that would have to be then somehow relocated and reducted in a suitably attractive manner. I guess there wouldn't be any attractive manner to do that but in a suitable manner on the back side of the building.

MS. SHERMAN: Well, we wouldn't want to offend the architects, of course, but when you were looking at your various air intakes, did you consider any alternative to relocation such as some sort of filtration system or cleaning system or any other alternatives that might seem likely?

MR. BOHANON: No. The answer to that is no, we didn't and I think we made a relatively literal interpretation of what we read into the proposed rule, which I believe used the word relocate.

MS. SHERMAN: Yes. I think you also estimate $100,000 for construction compliance, I guess which you characterized as similar to asbestos abatement.


MS. SHERMAN: Is this cost estimate for OSHA's proposed Section F that describes renovation and reconstruction activities?

MR. BOHANON: I believe that's correct. Let me find Section F very quickly and just confirm that.



MR. BOHANON: Yes. Yes, it was. I know it does apply to Section F. There may be another section that there's some costs in there also.

MS. SHERMAN: And what were your assumptions for developing this cost estimate?

MR. BOHANON: Okay. I think that is listed on the other sheet. I can read you those pretty quickly. Having a meeting prior to any construction activity to develop a compliance program; performing mitigation measures during construction; isolating or containing the work areas under negative pressure which involves some sort of containment and some sort of a fan system for every project; the potential to have to use some sort of auxiliary filtration system where we couldn't get negative pressurization; constructing barriers near any of the return air systems and depending on the specific location, there are times when the entire ceiling is a return air system and there are multiple penetrations, it would be very hard to actually seal off the whole ceiling during every project but -- not very hard, it just would be expensive, that's the point. And then the notification. All of those factors are included and anticipated. Then to apply those to all the multiple projects that we have during the year and that was the estimate for all projects in total for one year.

MS. SHERMAN: On the spreadsheet it will show us how many projects you contemplate per year?

MR. BOHANON: I believe that it will. We have a lot of minor moving and reconstruction projects that go on just continuously. There's always something.

MS. SHERMAN: I'm sure most large companies do.

How often would you foresee testing for carbon dioxide in your buildings?


MR. BOHANON: It's been a while since we put this together. I don't know the assumptions. I'll have to look that up.

MS. SHERMAN: Perhaps you could submit that as a post hearing comment.

MR. BOHANON: Okay. I'll have to look up what we assumed on that.

MS. SHERMAN: Also, could you give us the cost breakdown for the $1500 per building figure that you list for this? In other words, what component of it is labor, what component of it is equipment?

MR. BOHANON: Yes. I'm sure that that's a unit cost times some assumed labor and material cost.

MS. SHERMAN: Do you think that will be in the spreadsheet?

MR. BOHANON: Yes. I believe the assumption will be back in that detailed spreadsheet.

MS. SHERMAN: What's the basis for the $30 per hour figure given for the RJR employee training costs?

MR. BOHANON: We just used that as a representative wage and fringe cost for our entire workforce population.

MS. SHERMAN: So this is their time or the trainer's time?

MR. BOHANON: No, this is their time. This is production workforce time that would be involved in training exercises as opposed to production activity.

MS. SHERMAN: So this would not be for office workers?

MR. BOHANON: I believe it would be for all workers.

MS. SHERMAN: So you think it represents all of your workers?

MR. BOHANON: Then we get to the 6000 number. I'll have to explain what that number is. I don't know offhand how we arrived at that number. We do have training programs for other training that is required by the agency and this would just be additional training that would be on top of that.

MS. SHERMAN: Do you currently provide your employees with indoor air quality information?

MR. BOHANON: I think the answer to that is, no, we don't have a program nor to my recollection have we made any publication to our employees about indoor air quality. I did explain the other day that we take the preventive measures and that when someone perceives that there is a problem with indoor air we are very responsive to that and we feel that that's a good policy and procedure.

MS. SHERMAN: Did you contemplate in coming up with these estimates that all employees would go through training each year?

MR. BOHANON: I believe that we did. I do think that's in the assumption, as evidenced by the way the number is carried out.

MS. SHERMAN: Okay. Well, in your chart, in business paper number 6, I notice that the costs of the training didn't seem to increase each year as the other program elements did. Is that true?

MR. BOHANON: Yes, that is true.

MS. SHERMAN: Is there a reason?

MR. BOHANON: Not that I can explain right now. I'll have to check on the assumptions. I don't know why that's different than the others and it wasn't inflated. I don't know. I'll need to check. That may be an error in the calculation.

MS. SHERMAN: In your business paper number 7, what was the source of the multipliers used in the table titled "Developing a Smoking Lounge"?

MR. BOHANON: Source of the multipliers?


MR. BOHANON: You're talking about --

MS. SHERMAN: I'm talking about the note at the bottom of the table.

MR. BOHANON: For the different geographic regions.

MS. SHERMAN: Yes. I think you list 16 different cities.

MR. BOHANON: Yes. That was provided to us by Raytheon Engineers, by their estimator department so I assume that that's their data. That may also be the same as somebody else's data, like Means data or someone else's but I don't know. This is the data they provided to us.

MS. SHERMAN: Could you check the source of this?

MR. BOHANON: It may be their own corporate database.

MS. SHERMAN: Okay. I assume it's somehow based on some cost of living data but I can't tell from looking at it.

MR. BOHANON: Well, in general construction cost data, it is not based on cost of living data. There are actual construction cost surveys that are taken throughout different regions in the country and they do not -- they may be related in some way to cost of living but they're directly looking at actual construction costs in different regions.

MS. SHERMAN: Okay. Well, if you could let us know and if it is Raytheon's proprietary program, then we should know that also. Also, do you know what year these were for? Should we assume it's 1994?

MR. BOHANON: I would assume that they would give us current information, that all this is from their current database. Estimating is an art unto itself within the construction trades and those that don't keep current information get left behind in that business. It does change dynamically. So I would feel safe in assuming that all of these represent their best estimate of the costs as of the date they prepared the document.

MS. SHERMAN: I notice also in business paper number 7 that your labor time estimate for engineering and architecture services varies from $900 to $270. What's the rate per hour and how many hours are required for existing or for new construction?

MR. BOHANON: Okay. I don't know what formula the estimator used. He has it listed as one lot, so implicit in that is not any rate, it's just a fee. And I guess since those guys do know a lot about the architectural and engineering trades there are multiple rates so what you're really looking at is a unit of work and many times in these small amounts of work it's traditional just to do that on a bid basis or just a lump sum basis, so the estimator is making an allowance that in one of these cases $1200, he can get all the engineering and architectural services he needs and that's just a lump basis without actually rates entering into the equation. And many times it doesn't in these small jobs.

MS. SHERMAN: Is there any way we can get more insight into this rate to know how to use these figures in our own analysis?

MR. BOHANON: I can ask the estimator if he would like to comment on that. Usually these are the judgments of the estimators based on their perception of how the work goes on. Those things are -- like I say, it's one lot or one unit of work, not based on a lot of other details but based on their past experience of the kinds of costs and fees associated with these types of jobs.

MR. GROSSMAN: Your Honor, I don't know how much more Ms. Sherman has. I've received a request from the panel, it's not absolutely urgent, it says, for a break.

MS. SHERMAN: I would not stand in the way of their break. I have a few more questions but I would want everybody to be comfortable.

JUDGE VITTONE: Five minutes.

JUDGE VITTONE: Mr. Myers, do you want to do that right now?

MR. GROSSMAN: Mr. Grossman.

JUDGE VITTONE: I'm sorry, Mr. Grossman.

I apologize to both of you.

I called Mr. Gross who was here before, I called him Mr. Myers. I called Mr. Myers Mr. Gross and I called Mr. Gross Mr. Myers.

I'm sorry.

MR. GROSSMAN: That's all right, Your Honor.

Your Honor, we know that the Court has throughout this proceeding maintained even and fair standards as to all the parties with regard to the TV cameras. The same standards have applied to everyone. Today for the first time, and I understand it may not be at Your Honor's request, a camera has come down to change the standards, under new standards that are different from the standards that have applied in the last few days and throughout the remainder of the proceeding. The camera has been standing there with its face down throughout the questioning by the OSHA panel since lunch, now it's pointed up and at the lectern.

We believe that that's inappropriate for a number of reasons. The next questioners are people who are deeply involved in litigation against R.J. Reynolds in which they have an enormous monetary investment, as they characterize it, and it would appear that the use of the camera is an injection into this regulatory and administrative proceeding of their personal litigation.

This panel has appeared now for two and a half days, it's going on three days, which is far longer than any other panel or any other testifying group that has appeared before this agency. It has submitted itself to rigorous scientific questioning and will continue to do so. And the injection of extraneous personal litigation into this, and perhaps political considerations into this, outside the purview of this panel or Your Honor or R.J. Reynolds is totally inappropriate. We would ask that the camera be moved back under the rules that were established before.

JUDGE VITTONE: I permitted the camera to be moved where it is right now. Is it still there? Okay. And to be kept stationary. This objection, your concern was raised to me during the break. I have directed that the camera be only used to photograph the person at the podium and not to photograph anybody else.

I should say that this is in keeping with a number of other cases in which I have had cameras, that whenever an individual objected to being photographed I would not permit that person to be photographed and I can think of several different proceedings where that was the requirement.

The rules governing this proceeding encourage the use of cameras and any other means to inform the public, since it is a public meeting with the restrictions I have placed on it.

I understand your objection and I think I have accommodated it. My understanding is that the camera will remain there but it will only photograph -- unless any of the people making questions have objections and if they have objections to being photographed, I will have the camera turned off for them, too.

MR. GROSSMAN: If I could just clarify, Your Honor, my objection, I don't know what was said during the break but my objection, the one that I am voicing, is not on the camera being trained on this panel. It's rather that the people at the podium may use that opportunity to promote causes that have nothing to do with the question of whether there is substantial evidence on the record before OSHA that ETS presents a significant risk in the workplace. And that it will be used for purposes unrelated to this administrative process and related to the private litigation in which they have made an investment.

JUDGE VITTONE: If I get any hint of that or see anything like that, I will have the camera turned off.

Mr. Myers, very quickly. We are chewing up time here.

And you won't have to ask me to do it, I'll do it on my own.

MR. MYERS: Your Honor, I just think the record absolutely needs to be set straight here on a couple of issues. One is that while I'll be part of the group of people who have just a few hours after this to ask some questions, that camera has nothing to do with any of the individuals who are asking any questions whatsoever.

As you know well, I represent a group of public health organizations who have no financial interest in this whatsoever. It's my understanding that that camera is a network TV camera, that none of the people who are asking questions whatsoever have had anything to do with that camera or any other camera that's currently sitting in this courtroom. So that the notion that somebody is trying to use this hearing --

The second question that needs to be made perfectly clear because it keeps getting said and that is that people are asking questions because they have a financial interest, there is no group here that has a greater financial interest in every single thing that's been said than the RJR panel which is up here.

Now, to assert that the people who are going to subsequently be asking questions will alter what they're doing because of financial interest as opposed to what has been a pure public health approach through the last two to three months of this hearing is in fact scandalous and shouldn't go uncontested.

We have had nothing to do with that camera. We didn't request that camera. We don't have any control over that camera. That camera will be irrelevant as far as we're concerned and we certainly don't object if the news media thinks that there's a different angle that will better serve its purpose.

JUDGE VITTONE: All right. Thank you, Mr. Myers.

As I said, if something happens that I think is not in keeping with proper decorum within this proceeding, I will tell the cameraman to turn it off. But my direction is that it photograph only the individual asking the questions.

All right. Ms. Sherman, you had several more questions, I understand.


I believe you submitted some information from the Washington Consulting Group, and this is in Exhibit 8 in the Bohanon submission.


MS. SHERMAN: There was an estimate of $15,000 for the construction of a 150 square foot smoking room and there was an estimate of $100,000 for the construction of a 1000 square foot smoking room. This is correct, isn't it?


MS. SHERMAN: It's on page 12.

MR. BOHANON: I'm trying to find it.


MR. BOHANON: Yes. Yes, that is correct.

MS. SHERMAN: The paper wasn't very clear as to what elements were included in these cost estimates, so I'd like to know what the assumptions were for these estimates, whether it includes labor time and rates, et cetera.

MR. BOHANON: Okay. Well, the two numbers you were talking about, the number in business paper 7 by Raytheon Engineers was prepared at the same time Washington Consulting Group was putting together their estimate, so they used a different source. They didn't take the numbers from this paper 7.

MS. SHERMAN: We know that. But now we're trying to understand what the source is in this Washington Consulting Group estimate.

MR. BOHANON: Okay. The source they have cited is a New York Post article by the head of the New York City Restaurant Association, June 6, 1994. Beyond that, I don't know anything else about it.

MS. SHERMAN: Well, okay. Were these estimates taken from the New York Restaurant Association?

MR. BOHANON: It was taken from a New York Post article, June 6, 1994.

MS. SHERMAN: Okay. So what you're saying is you don't know anything other than what is written right here.

MR. BOHANON: No, I do not.

MS. SHERMAN: Is there any way for you to find out some of the assumptions that the Washington Consulting Group used?

MR. BOHANON: I suppose I could. I would comment that they're not really out of bounds with the range that is in the engineering estimate.

MS. SHERMAN: Well --

MR. BOHANON: The 15,000 would be a good representative number.

MS. SHERMAN: The 15,000 perhaps is. However, there is quite a difference between the 15,000 and the 100,000 and we want to understand how we can possibly make use of these figures in a meaningful way. I mean, we're appreciative of all cost data that comes to us. However, we have to understand it in order to be able to use it.

MR. BOHANON: Okay. So you're asking me if I can find out from the --

MS. SHERMAN: Washington Consulting Group.

MR. BOHANON: Yes. Okay. I will ask them. I would suppose they're going to say they just got the article.

MS. SHERMAN: Well, if that's what they say, that's what they say and we'll have to give it that weight but --

MR. GROSSMAN: Isn't the Washington Consulting Group sponsored by someone else?

MS. SHERMAN: Mr. Grossman, Mr. Bohanon submitted these figures and I don't know if they're sponsored by somebody else. There are several other groups in this proceeding with similar names and you may be referring to them or maybe they are sponsored by somebody else. I'm not sure.

Do you think that a cost estimate for a New York establishment would be typical of U.S. costs?

MR. BOHANON: No. In fact, I don't and that's why in the detailed engineering summary we gave a range that would apply for different locations. There are geographic factors that do need to be considered in any cost estimate, especially one that's going to apply nationwide.

MS. SHERMAN: You also mentioned that hospitality places face significantly different circumstances than other industry and I think you're talking about loss of revenue and loss of customers. Could you identify the basis for this statement? This is on page ES-II.

MR. BOHANON: Is in one of my attachments?

MS. SHERMAN: It is in an attachment called "Critique of OSHA's Notice of Proposed Rulemaking, Economic Aspects of Preliminary Regulatory Impact Analysis" and I think it is by this Washington Consulting Group. Would you like me to just show you this?

MR. BOHANON: It's identified -- I can't find any pages numbered ES. Please, if I may take a look.


MR. BOHANON: Oh, okay. I'm sorry. Yes. This is the paper prepared by the Washington Consulting Group. And the question was?

MS. SHERMAN: I hope I quoted something accurately from it. I think it says something along the lines of hospitality places face significant different circumstances than other industries.

MR. BOHANON: Yes. That is exactly what it says.

MS. SHERMAN: Okay. Can you identify the data on which this is based or the statement?


MR. BOHANON: Well, the statement merely goes on to explain what some of the factors are that are different in the hospitality industry and then concludes that the proposal fails to provide reasonable compliance cost estimates for those individual industries.

MS. SHERMAN: So then would it be fair to say that the statement should just be read the way it is and that there is not any sort of a big body of empirical evidence underneath it? In other words, we should just take it at face value?

MR. BOHANON: I believe so. There is no evidence I know of that's -- it certainly isn't cited on this page and I would need to go through the whole report to see if he's done anything else but there is not anything that I'm aware of as far as an extensive survey.

MS. SHERMAN: Okay. If you have any other thoughts on this issue, if you want to make them available to us in a post-hearing comment, that's fine.

MR. BOHANON: All right.

MS. SHERMAN: I think that that concludes my questions, Your Honor. However, I would note that during some of the questioning we referred to chapter 5 by Gary Williams and John Weisberger called "Chemical Carcinogenesis" and I thought -- and this is from Casseret and Doull's book on toxicology, fourth edition. I thought perhaps we should put this in the record.

JUDGE VITTONE: For the record, the one chart that was used yesterday during the examination called "RSP Versus Nicotine for 51 Cigarettes," it's the chart with a lot of dots on it and some handwriting at the bottom, is Exhibit 239.

(The document referred to was marked for identification as Exhibit 239 and was received in evidence.)

JUDGE VITTONE: The report "Active and Passive Smoking Are Associated with Increased Carotid Wall Thickness" by Howard et al., June 13, 1994, is Exhibit 240.

(The document referred to was marked for identification as Exhibit 240 and was received in evidence.)

JUDGE VITTONE: And the report just referred to by Ms. Sherman called Casseret and Doull's Toxicology: The Basic Science of Poisons, Fourth Edition, chapter 5, will be Exhibit 241.

(The document referred to was marked for identification as Exhibit 241 and was received in evidence.)

MS. SHERMAN: I would like to thank the panel for their time.

JUDGE VITTONE: Okay. As I understand it, we have several people, other participants who wish to ask questions.

Mr. Dinegar, you told me what, 15, 20 minutes? Or was it longer?

MR. DINEGAR: Twenty minutes to a half hour.

JUDGE VITTONE: Twenty minutes to a half hour?

Mr. Herman, how long?

MR. HERMAN: Couple hours.

JUDGE VITTONE: Couple hours.

Mr. Dinegar, I'm going to go with Mr. Herman first.

Mr. Herman?


JUDGE VITTONE: Mr. Herman, what are you doing?

MR. HERMAN: Just putting the names in front of the gentlemen. My concern is that having watched this that the record is going to be somewhat garbled and jumbled as to who was saying what and when and if that's incorrect, that's fine. I don't need the names up there.

JUDGE VITTONE: We haven't been able to garble the record from that point of view. The gentlemen will identify themselves.

MR. GROSSMAN: And pursuant to the instructions and the order that the Court has already entered, all questions will be addressed to Dr. Coggins who will decide who on the panel will answer.

MR. HERMAN: Mr. Grossman, I'm going to let them all answer whatever they want to answer.

MR. GROSSMAN: Well, we have an order of the Court. Direct them, please, to Dr. Coggins.

MR. HERMAN: I will direct my questions to the panel as I believe I should and I will certainly abide by whatever the judge rules in terms of my questioning.

JUDGE VITTONE: All right. Direct the questions to the panel in general. Dr. Coggins can identify the person he believes to be the most appropriate person to answer, depending upon what the subject is, I assume.


MR. GROSSMAN: If I may, Your Honor, while Mr. Herman is getting ready, a moment ago Mr. Myers came up, I think, to deflect consideration of words that I said about monetary interest in the litigation.

Mr. Herman has a significant investment in litigation, isn't that right, Mr. Herman?

JUDGE VITTONE: All right. Gentlemen, Mr. Herman is going to identify who he represents in this proceeding, okay?

MR. HERMAN: While I'm looking for the list, it is almost comical to hear these gentlemen complain about lawyers who are doing this on a pro bono basis, particularly in light of the fact that they're the only lawyers in this room, I think, for the tobacco industry, the only lawyers in this room that I know of, the ones from the tobacco industry, that are getting paid.

JUDGE VITTONE: All right, gentlemen. I want this discussion ended. I want to hear some questions, I want to hear some answers on ETS.

MR. HERMAN: I'd like to do the same thing, Your Honor. I don't want to deflect this from issues that have no moment here at all.

We represent the AMA, three ETS victims, this is on file already, Your Honor, previously. Do you want me to go through them?

JUDGE VITTONE: Just run through them quickly, please.

MR. HERMAN: Dr. Hirze Shapiro, J.D. Lee, the Association of Flight Attendants, Virginia Group to Alleviate Smoking in Public, Maryland Group Against Smokers Pollution, Service Employees International Union and we are also here on behalf of the Heart Association, Cancer Society and the Lung Association. The list is the same for the last couple of months that we've been here.


MR. HERMAN: Just in general, gentlemen, how many of you smoke?

DR. COGGINS: I will answer that first. I don't smoke but I think a more relevant question given today's meeting, do you work with smokers and are you concerned about that.

MR. HERMAN: We're going to get to that.

DR. COGGINS: I do not smoke. I do work with smokers and that's not a concern that I have in my workplace.

I'm going to ask my colleagues. And let's go from right to left.

Dr. Ogden?

DR. OGDEN: My answer would be very much the same as Dr. Coggins. I do not currently smoke. I do work with smokers freely.

MR. HERMAN: You're Dr. Ogden?

DR. OGDEN: Dr. Ogden. That's correct.

MR. HERMAN: Dr. Coggins first answered?

DR. OGDEN: That's correct.

DR. COGGINS: Mr. Bohanon?

MR. BOHANON: I smoke on occasion and I also work with smokers.

DR. COGGINS: Dr. Nelson?

DR. NELSON: I do not smoke and I do work with smokers in the workplace and have no problem with that at all.

MR. HERMAN: Did you say you smoked or you didn't smoke?

DR. NELSON: I stated that I do not smoke.

MR. HERMAN: Mr. Grossman?

MR. GROSSMAN: I'm the lawyer.

MR. HERMAN: I'm sorry. I forgot. I forgot.

DR. COGGINS: Mr. Steichen?

MR. STEICHEN: I do not smoke.

DR. COGGINS: And Dr. Sears?

DR. SEARS: I also don't smoke.

MR. HERMAN: Do all of you work with smokers in the workplace.

DR. COGGINS: Let me handle that for everybody. We all work with smokers in the workplace. Yes.

MR. HERMAN: Are there any rules in the workplace? Do you provide a special place for smokers to smoke?

MR. GROSSMAN: Perhaps, Your Honor, I could direct counsel's attention to the testimony elicited by Ms. Sherman yesterday extensively on the smoking regulations at Reynolds.

MR. HERMAN: Are you the lawyer or are you testifying, sir?

MR. GROSSMAN: I am the lawyer.

JUDGE VITTONE: He's making an objection, I assume.

MR. HERMAN: Oh, okay.

JUDGE VITTONE: We did get into this yesterday. Ms. Sherman asked a number of questions about the R.J. Reynolds smoking policy at their workplaces.

MR. HERMAN: I just want a brief answer. Is there such a smoking policy?

JUDGE VITTONE: Repeat it quickly.

DR. COGGINS: I'm going to ask Mr. Bohanon to repeat that.

MR. BOHANON: Our policy regarding smoking in the workplace really has two parts. One is that we properly ventilate all of our workplaces, therefore, levels of all contaminants, including any that may come from environmental tobacco smoke, are very, very low.

The second part is that as a policy our company encourages accommodation of both smokers and non-smokers alike within work situations.

DR. NELSON: One additional point I should perhaps bring up here is --

MR. HERMAN: Your name is Dr. Nelson?

DR. NELSON: That is correct. One additional point that I should bring up here also is that our company obeys rules, for example, regulating smoking in the laboratories as directed by OSHA.

MR. HERMAN: Those of you who -- do any of you work in labs which allow smoking?

DR. COGGINS: Let's go through it again.

I don't work in a lab.

Dr. Ogden?

DR. OGDEN: I do work in a lab. I am laboratory scientist and smoking is not allowed in the laboratory.

MR. HERMAN: And why is that, sir?

DR. OGDEN: Because there are flammable liquids, flammable gasses.

MR. HERMAN: Are you telling me it has nothing to do with the contamination aspects of ETS?

DR. OGDEN: We comply with good laboratory practice in terms of any flammable material around any combustible source.

MR. HERMAN: You are Dr. Ogden, correct?

DR. OGDEN: I was a minute ago and still am. Yes, sir.

MR. HERMAN: Does your policy of non-smoking in the lab have anything to do with the contaminant nature of sidestream smoke or environmental tobacco smoke?

DR. OGDEN: We do many sensitive chemical analyses. We do many sensitive biochemical analyses. That question really doesn't come up because smoking is not allowed in the laboratory in general but if there were not such a prudent practice to not smoke around flammable liquids, like you wouldn't smoke around a gasoline pump, there would be many reasons, for some of the reasons proposed by Dr. Nelson and demonstrated by Dr. Nelson about the unusual effects or decay properties of nicotine, if we're doing a sensitive nicotine assay, we would want to eliminate that as a problematic consideration in analytical chemistry, yes.

DR. COGGINS: Mr. Bohanon?

MR. HERMAN: Anybody else? Anybody you want.

MR. BOHANON: Yes. I would like to comment that, no, I do not work in a laboratory but our policies about places where smoking is allowed in laboratories are based upon safety standards and good practices of safety.

MR. HERMAN: Yes, you wrote about safety standards and good practice in one of these papers that was submitted, didn't you, Dr. Bohanon?

Are you a doctor? Are you a Ph.D.?


MR. HERMAN: I want to address you properly.

MR. BOHANON: I put it on the record. No, I am not a doctor. I am a professional engineer, which is the usual credentials for practice of engineering.

DR. COGGINS: Dr. Nelson?

DR. NELSON: You've asked several questions since the beginning of this. Just so I can answer it completely, could you re-ask your initial question?

MR. HERMAN: Do you smoke?

DR. NELSON: No, no.

MR. HERMAN: Is the reason that smoking is not allowed in a scientific lab related to the contaminants in ETS and sidestream smoke?

MR. GROSSMAN: And I believe you predicated that before with a question of whether each of the panelists works in a laboratory.

MR. HERMAN: That's correct.

DR. NELSON: Let me answer the predicate first.

MR. HERMAN: Your name is Dr. Nelson?

DR. NELSON: That is correct.

In the laboratory where I was previously located, as Dr. Ogden indicated, there are flammable chemicals and gasses present and OSHA regulations prohibit smoking in that area. In the current laboratory space where I am located, that is not the case, and the safety and health officer has checked out the area and said that as far as OSHA's definition of laboratory space was concerned, smoking could be permitted in that area. However, when we are doing studies, when we're trying to look at various types of studies in our environmental chambers, we do not permit smoking in the laboratory area so that we can eliminate problems with essentially background or incidental contamination of samples with background levels of environmental tobacco smoke. We want to maintain a very high quality of analytical results out of our laboratory.

DR. COGGINS: Mr. Steichen?

MR. STEICHEN: I do not work in a laboratory.

DR. COGGINS: And Dr. Sears?

DR. SEARS: I also don't work in a laboratory although I have in the past where smoking was restricted.

MR. HERMAN: For whom were you working at the time, sir?

DR. SEARS: For R.J. Reynolds and according to the same practices that you've already heard elaborated on here, smoking was restricted.

MR. HERMAN: Do you have a corporate policy that encourages your co-workers to smoke?

DR. COGGINS: I am not aware of any such policy.

And, again, I'll ask my colleagues if they are.

DR. OGDEN: I am not aware of any corporate policy, no, sir. And I have never been encouraged to smoke.

MR. BOHANON: I am not aware of any such policy of encouraging co-workers to smoke.

DR. COGGINS: I think -- the rest of the panel have indicated to me that none of us are aware of any such policy.

MR. HERMAN: Do any of you allow smoking in your home?

DR. COGGINS: I have no problems with my friends smoking in my home.

MR. HERMAN: So you do allow smoking in your home? Yes or no. I'm just trying to move it along. It's a little silly, if you get right down to it. Just answer the question.

JUDGE VITTONE: Mr. Herman, that was a yes. I mean, anybody can interpret that as a yes. Do you want to hear from the rest of the panel?


DR. OGDEN: I do allow smoking in my home, as I do in my office and I also regularly visit homes of smokers.

MR. HERMAN: You have two young children, Dr. Ogden?

DR. OGDEN: That's correct.

MR. HERMAN: Three and five years old? Whatever age they are, they're young children.

DR. OGDEN: Right.

MR. HERMAN: Are you concerned when they're in the room with someone smoking?

DR. OGDEN: No, sir, I'm not.

MR. HERMAN: Do you view smoking as a health hazard? Dr. Ogden?

MR. GROSSMAN: Are you referring to secondhand smoke, ETS?

MR. HERMAN: Smoking in general.

MR. GROSSMAN: Well, it's unclear --

MR. HERMAN: Active smoking.

Dr. Ogden?

DR. OGDEN: You're asking me if I believe that active smoking --

MR. HERMAN: Is a health hazard.

DR. OGDEN: -- is a health hazard. From my professional opinion and what I'm trained to observe, I can't judge health hazard from a position of analytical chemistry. I would concur with --

DR. COGGINS: Let me try to answer that on behalf of the --

MR. HERMAN: Wait. Wait. Wait. Excuse me. Dr. Ogden was answering. You can say anything you want when he's finished.

MR. GROSSMAN: All right. And when he's finished, the questions are to be directed to Dr. Coggins, pursuant to the Court's order.

MR. HERMAN: Unless the judge says that I need to follow up a question to the same witness who had answered a previous question and I want to direct a question to that witness who has already had the floor, unless the judge tells me that I must first go to Dr. Coggins, I'm not going to do that.

MR. GROSSMAN: Well, let me just say, if I may --

JUDGE VITTONE: Mr. Grossman. Okay. He was asking a follow-up question.

Are you finished with your answer, Dr. Ogden?

MR. HERMAN: He didn't start.

JUDGE VITTONE: I thought he had.

DR. OGDEN: You asked me if I believe that active smoking causes health problems, health effects? I'm not sure how you characterized it.

MR. HERMAN: Is a health hazard.

DR. OGDEN: Is a health hazard.

MR. HERMAN: Is injurious to health.

DR. OGDEN: Again, I'm speaking from listening to my colleagues testify and from what little I have read. I believe that in terms of being able to prove causation of disease, there is not the convergence of data that the toxicological community would require as evidence or proof of causation.

MR. HERMAN: Does that mean, no, you do not believe active smoking is a health hazard?

DR. OGDEN: I don't believe that it's been shown definitively. It may or it may not be.

MR. HERMAN: I'm just asking for your opinion. Do you have an opinion as to whether active smoking is injurious to health?

DR. OGDEN: I've stated my opinion. I don't know whether it is or not. I don't believe that's been demonstrated.

MR. HERMAN: Your field is limited to ETS?

DR. OGDEN: My qualifications are as an analytical chemist.

MR. HERMAN: A what?

DR. OGDEN: Analytical chemist.

MR. HERMAN: Yes. Do you have a specialty in smoke, analyzing smoke from cigarettes?

DR. OGDEN: No, my specialty is chromatography, which is ways of identifying or separating complex mixtures. It's particularly applicable to smoke chemistry, as it would be in many other --

MR. HERMAN: Do you do anything at RJR except chemical analysis of cigarette smoke?

DR. OGDEN: Cigarette smoke, I'm presuming you mean mainstream smoke. I do not analyze --

MR. HERMAN: Mainstream, sidestream, ETS, the whole -- any of the three.

MR. GROSSMAN: Your Honor, about a month ago we were before the Court on the question of the ground rules under which the questioning of Reynolds would be conducted.

Previously in questioning of OSHA, NIOSH and the AMA, who I understand is one of the participants that's purportedly represented here, we were not allowed to ask questions of individual panel members as to individual beliefs, as to individual background, as to even what part of the statement of the agency was written by the individuals.

Reynolds has come forward and has given the authors of each part of its statement. As part of the hearing a month ago or a month and a half ago on the ground rules for Reynolds Your Honor made it very clear that the same ground rules would bear here, that all questions would be addressed to Dr. Coggins as chairman of the panel, that he would decide who would answer the questions. And I ask that those ground rules that were so clearly stated and as to which Your Honor said there would be no reconsideration when Mr. McNeely, Mr. Herman's colleague, asked for reconsideration, be kept today and followed today.

JUDGE VITTONE: Okay. I think we've been following that.

Mr. Herman, quite truthfully, I don't think that personal questions about their family life are relevant to this proceeding. Questions about what they do in front of their children or what they don't do in front of their children, I don't think are relevant to this proceeding. I said this once before, whether a person smokes or not smokes is not relevant as far as I can see to this proceeding. If you have that question, ask another.

MR. HERMAN: Your Honor, I got off that question.

JUDGE VITTONE: Okay. All right. Let's move along.

Dr. Ogden has stated his qualifications, he's stated for two days what he works on. I think we've got an ample discussion in the record on what he does for R.J. Reynolds.

MR. HERMAN: Well, I have heard, with all due respect, and my last question to Dr. Ogden had to do with his job, what he does for RJR which directly relates to the submissions that he has made in this proceeding and that's all I'm trying to find out and I don't --

JUDGE VITTONE: But he's described that job and what he has done with respect to those submissions a good deal of the time for the last several days now.

Let's move on, please. What's your next question?
If I recall correctly, we were having these kinds of discussions about who was being directed to ask questions. Okay?

MR. HERMAN: Your Honor, that whole process, I've watched what's going on here.

JUDGE VITTONE: Mr. Herman, I don't think you were here when the AMA was testifying.

MR. HERMAN: No, sir. I didn't. I've watched the process over the last three days and certainly the OSHA panelists who ask questions did not funnel all of their questions through Dr. Coggins or Mr. Grossman.

JUDGE VITTONE: They are not...

MR. HERMAN: It's a silly waste of time.

JUDGE VITTONE: Okay. Let's...

(Brief pause)

JUDGE VITTONE: Did any of you gentlemen do original research?

DR. COGGINS: I think all of us do original research, whether it be laboratory, such as Dr. Ogden and these colleagues, whether it be review of written papers such as some of the other colleagues. Or even research in buildings, such as Mr. Bohanon.

I think all of us do research. I don't see how you can do, to a certain extent, non-original research. We are all scientists. We're all researchers. And we're all active in our field.

MR. HERMAN: Dr. Coggins, are you required when you do research to first have the protocol reviewed by legal counsel?

MR. GROSSMAN: Your Honor, once again, counsel for OSHA covered exactly this question. And almost to the word. And this is simply redundant.

JUDGE VITTONE: Was it directed to Dr. Coggins?

MR. GROSSMAN: Yes, it was.

JUDGE VITTONE: I don't think that specific question was asked, though. She asked questions about the process that R.J. Reynolds goes through in approving research programs or research proposal.

If you have an objection to that question, move to something else.

Go ahead, Mr. Herman. You ask your question.

Do you understand the question, Dr. Coggins?

DR. COGGINS: Yes. The simple answer is, the research protocols that the individual scientists come up with are reviewed by a number of different people. Clearly, legal stuff are involved in that research proposals initiated by scientists may well have legal ramifications, may well have patent ramifications.

MR. HERMAN: I'm sorry. What kind of ramifications?

DR. COGGINS: Patent.

MR. HERMAN: Patent. Oh, I'm sorry.

DR. COGGINS: That's all right.

MR. HERMAN: I thought that was a scientific term. I'm sorry.

MR. HERMAN: It comes up every so often. Legal, patent, a number of other potential ramifications beyond that that the individual scientist may be aware of. And so, as an example, the study that I described here today -- two days ago -- once I had arrived at a scientifically acceptable protocol in my mind it went through a review by a number of different scientists, management and lawyers within the R&D department.

All right. Dr. Ogden has a comment.

DR. OGDEN: I've done many research projects, many of which have not been reviewed by my legal counsel.

DR. COGGINS: Anybody else, any comments?

MR. HERMAN: But that wasn't my question. Do you have or have you performed projects where the protocols were first reviewed by lawyers before you produced? Went in the lab and did your alchemy, whatever it is you do.

DR. OGDEN: I don't practice alchemy, but... I can't recall any project that was carried out in the laboratory that I've done where legal counsel was involved in reviewing a protocol.

MR. HERMAN: Anyone else?

DR. COGGINS: Anyone else? Dr. Nelson.

DR. NELSON: I can... Your original question was actually, I believe, "Does all your research go through, get funneled through lawyers." No. For the most part the work that I do does not go through lawyers. There are certain proprietary types of research that I do that may have some legal involvement.

MR. HERMAN: Did any of you perform any kind of research on ETS where the results of that research were reviewed by legal counsel and changed by legal counsel.

Two questions. Where the results were reviewed by legal counsel, pre-publication.

DR. COGGINS: Absolutely not. Your line of questioning means to me that somehow or other we could be persuaded as scientists to change our data.

MR. HERMAN: Well, I didn't say that.

DR. COGGINS: I object strenuously. Well, that was the implication. And I object to that implication. As a scientist my job is to be objective, to collect my data according to my protocols, and to write the data up so that the interpretation of the data are correct.

I object strongly to the implication that my data could somehow be changed by someone else. This is an important question for a scientist, and I'd therefore just to check with the rest of the panel, if you don't mind.

DR. OGDEN: When you say the results are reviewed by counsel. Now, you're talking... You said pre-publication. I'm not sure I fully understand that. It was asked and answered in response to, I believe, Ms. Sherman's question about what our publication policy was.

Manuscripts are typically reviewed before they are submitted to journals, but I would echo Dr. Coggin's sentiment that absolutely in no way have I ever changed any result at the request of anyone, and that includes legal counsel.

DR. COGGINS: Mr. Bohanon.

MR. BOHANON: I am Mr. Bohanon, and my answer is that a number of people review papers before I seek to have them published. However, at no time have I changed any results in any of my papers or publications regarding environmental tobacco smoke upon the request of a legal counsel.

DR. COGGINS: Dr. Nelson.

DR. NELSON: As was described in our answers for the OSHA panel yesterday, pre-publication documents or a paper would be reviewed as part -- as a small part -- of the review process by lawyers. There may be confidentiality issues involved. There may be patentability issues involved. You wouldn't necessarily want to give out any of our secrets to our competitors that would allow them to better compete with us.

On the second part of your question, has a lawyer ever suggested changes in my results, I can tell you two things. One, that a change in my results has never been suggested, and as scientist nor would I ever allow anybody make me change my results, or change the results, or inaccurately restate the results of any research that I have performed.

DR. COGGINS: Mr. Steichen.

MR. STEICHEN: Yes. I agree with what's been said before. The policy of Reynolds is that the scientists do write their own work, do their own work, and it's not changed by lawyers.

DR. COGGINS: And Dr. Sears.

DR. SEARS: The policy is as has been stated before. I personally have never been asked to make any changes in my scientific work.

MR. HERMAN: Now, these proceedings primarily concern, as I gather and as I read, smoking in the workplace, and how sidestream and ETS affects non-smokers primarily.

Do you all agree or disagree with that comment?

MR. GROSSMAN: Well, that is a legal question. And I agree that the question here is whether OSHA has shown by substantial evidence on the record that ETS -- not sidestream smoke, but ETS -- presents a significant risk of material impairment to the health or functional capacity of employees in the American workplace.

MR. HERMAN: And I believe Mr. Bohanon, in your submission you set forth what appeared to me to be some kind of a middle ground somewhere in order to provide a place within the business or the manufacturing plant or wherever for smokers to go where they can smoke. Is that correct?

MR. GROSSMAN: I object to the question.

JUDGE VITTONE: What is your objection?

MR. GROSSMAN: Your Honor, Mr. Bohanon submitted a paper that was part of Reynolds' submission. The paper made specific scientific findings. It did not make a policy statement of the kind suggested by counsel.

JUDGE VITTONE: Mr. Herman, do you have a specific reference?


MR. GROSSMAN: If I can...

MR. HERMAN: You made reference to an RJR guidelines for smoking, some booklet or something that I recall reading?

DR. COGGINS: I think this is obviously a question for Mr. Bohanon. I would like to try to field them. But clearly this is a question for Mr. Bohanon. Hoy.

MR. BOHANON: Yes. R.J. Reynolds has published a guidance entitled "Developing a Smoking Lounge." That published documentation is available to anyone who calls. It was submitted to the docket in August. That is only one of many forms of accommodating both smokers and non-smokers in the workplace.

As I've pointed out in my presentation to OSHA, which did not focus on that document, the presentation focused on the fact that properly ventilated work spaces have low levels of contaminants. And indeed there is no reason to single out environmental tobacco smoke from all the other contaminants that OSHA has found to be in the workplace.

JUDGE VITTONE: All right, Dr. Bohanon, let's wait for...

MR. HERMAN: I'm sorry.

JUDGE VITTONE: That's okay. Go ahead. I'm waiting for a question.

MR. HERMAN: And as I recall that paper that you submitted, you spoke about accommodation between smokers and non-smokers in the workplace. Is that correct?

MR. BOHANON: Yes. That... The general company policy is to promote accommodation of smokers and non-smokers in the workplace.

MR. HERMAN: And in fact the company policy is repeated and has been repeated in numerous advertisements appearing in The Wall Street Journal and others, other papers, talking about smoking being an annoyance, speaking about the issue of let's get together and have peaceful coexistence. And when I read your paper I thought that it pretty much followed the company line in that regard.

DR. COGGINS: It's true. We've had a long campaign...

MR. HERMAN: You're Dr. Coggins.

DR. COGGINS: That's correct.

It's true that we've had a long campaign, since the middle of last year, using the concept of accommodation. Using the concept of peaceful coexistence, which we discussed yesterday. And you're now questioning Mr. Bohanon about his use of the word "accommodation."

MR. HERMAN: That's correct.

MR. BOHANON: I'm not sure I understand the question. Is there a question?

MR. HERMAN: I was generally trying to set -- get in my head, frankly, and on this record -- what it is that RJR is suggesting, and when I look at the advertisements and I read your paper and some of the others, it seemed to me that you're looking for some accommodation somewhere, some middle ground, because you talk in terms of accommodation, and you speak in terms of peaceful coexistence.

MR. BOHANON: Well, I think if you want to know exactly what we are suggesting, you should examine our submission to the docket. That covers in detail exactly what we're suggesting. We're suggesting many things, in fact. And basically that there's no evidence for OSHA, no substantial evidence, for which OSHA to make a rule.

MR. HERMAN: But you do propose, and you have proposed an accommodation, and in that line you gave testimony here today, and you did some engineering analyses of costs, which indicate what the costs are going to be in order to comply with OSHA, which you say are going to be exorbitant costs. You also in your writing did an analysis which shows what RJR's costs would be.

And I believe, it appeared to me, that you had some analysis of what the workplace could be with proper ventilation, at a less expense in order to accommodate smokers and non-smokers.

MR. GROSSMAN: Is there a question there, counsel?

MR. HERMAN: I'm asking them if my analysis of his writing is correct.

MR. BOHANON: That's a summary that may not take into account all of the presentation. What I would say is that yes, as a company we do encourage a policy of accommodation. We did offer some specific suggestions to OSHA regarding some of the things we view as more costly aspects of their indoor air quality policy for their beneficial use, and that indeed we do find that there are many ways to accommodate both smokers and nonsmokers. Indeed, that when workplaces are properly ventilated that concentrations are very low.

MR. HERMAN: I'm looking at this document which was submitted by you in this record.

JUDGE VITTONE: What is it?

MR. HERMAN: It's entitled, "Business Impact of Proposed Rule," and it's in the nature of a summary of what you're suggesting, as I take it. It's dated August 12, 1994. It consists of 12 pages and attaches eight other documents to it.

MR. BOHANON: Yes. That looks like...

MR. HERMAN: You refer to the publication, the brochure, entitled "Developing A Smoking Lounge" on page 3 of that document.


MR. HERMAN: Do you have that brochure with you?

MR. BOHANON: Yes, I do.

MR. HERMAN: Did you write it?

MR. BOHANON: No, I did not write this brochure. This was written by a team of individuals.

MR. HERMAN: Why was it written?

MR. BOHANON: Why was this document written?

MR. HERMAN: Yes. For what purpose?

MR. BOHANON: It was our observation that many times when smokers were asked to go smoke in rooms, that those rooms were not properly ventilated. So as an engineer I thought it would be important to try and help the R.J. Reynolds team in producing a document that could communicate proper means of ventilation to business owners that shows, to allow their employees to utilize smoking lounges.

MR. HERMAN: I wasn't clear if the brochure was for internal purposes for RJR only or for RJR and the public. And I understand from what you've said it's for public use as well as internal use.

MR. BOHANON: Yes. This is distributed to the public on request.

MR. HERMAN: And also in this document...

Let me ask this question. Why did RJR feel compelled to produce a booklet for the benefit of the public which sets up a smoking lounge within a business area.

MR. GROSSMAN: I object.

MR. HERMAN: Which... Excuse me. Let me finish. Which, it appears to me, segregates smokers from non-smokers. Why did RJR feel compelled to publish such a book?

MR. GROSSMAN: Let me object to the use of the word "compelled" in that question. There's no evidence of that kind on the record.

Mr. Bohanon, if you can answer the question.

MR. BOHANON: Well, at R.J. Reynolds Tobacco Company, we work for smokers. We had observed, as I told you before, that smokers were put in rooms that were improperly ventilated in some cases. Therefore we thought it was important to have information available demonstrating the proper ventilation techniques for a business owner that already had a smoking lounge or if a business owner was considering establishing a smoking lounge as their own decision, ways to make that a productive workplace and a productive part of their business activity.

MR. HERMAN: So you as the manufacturer of the product which produces the smoke which... You have proposed that in order to alleviate the irritation and annoyance, as your advertising describes ETS, you propose that the businessman set up special ventilation in a separate room located in the businessman's place of business.

MR. GROSSMAN: I object to that question.

MR. HERMAN: Isn't that correct.

MR. GROSSMAN: I object again. That's a mischaracterization of the testimony and an attempt by counsel to inject into the record his own characterization of the effect of smoke on others and attribute it to Reynolds.

MR. HERMAN: Your gentlemen, here, Mr. Grossman, have been very, very well trained for this process. I don't intend to mislead anyone. That question is a very clear and direct question, Your Honor. It's based upon Mr. Bohanon's publication to this committee, to OSHA, referencing an RJR work which he admits is distributed into the workplace for the public.

MR. GROSSMAN: Your Honor.

JUDGE VITTONE: He testified about that yesterday, and quite extensively.

MR. HERMAN: Who did?

JUDGE VITTONE: He testified about it yesterday quite extensively, about the number, about the amount of distribution and all that other stuff.

MR. HERMAN: I'm not asking those questions.


MR. HERMAN: I have a different question. My question is completely different than that.

I want to know what compels a manufacturer who claims ETS does no, is not a health hazard, to publish a book for the use of businessmen to spend their money providing a separate smoking lounge with special ventilation.

MR. GROSSMAN: Once again, Your Honor, there are two obvious points that are a problem here. The first is that Mr. Bohanon did indeed testify at great length about this yesterday and explained that where other companies want a smoking policy with a smoking lounge, Reynolds helps to provide engineering for such lounges. And secondly, Mr. Bohanon has not suggested that there is the kind of irritation or annoyance that is specifically referenced in Mr. Herman's question.

JUDGE VITTONE: Okay. Without, except for Mr. Herman's characterization, I think essentially the question is, why are you, what's your reasons for distributing the brochure.

MR. BOHANON: His characterization is most unfair, and I would recommend that he actually read the document to which he's referring.

MR. HERMAN: I've read it, Mr. Bohanon. I want you to educate me.

MR. BOHANON: All right. Let me read to you from the document. It says, "While a lot of attention has been given to places where smoking has been banned entirely, a majority of large private employers have found it possible and preferable to accommodate the wishes of both smokers and non-smokers. In some cases conflict can be avoided by..."

MR. HERMAN: Where is this?

MR. BOHANON: I'm reading on the first page. The very...

MR. GROSSMAN: Please don't interrupt him.

MR. HERMAN: Well, I want to be able to find it.

JUDGE VITTONE: He said he's reading from the brochure.

MR. BOHANON: I'm reading from the brochure. I'm reading from page 3, which is the first page of the written documentation, the brochure you're asking about, about what is the brochure for, what's its purpose. It's stated right in the front.

JUDGE VITTONE: Wait, wait. Wait one second.

MR. HERMAN: Is that brochure in this record?

MR. BOHANON: Yes it is.


MR. HERMAN: Okay. I'm not reading from that brochure. I'm reading from your...

MR. BOHANON: Well, you're asking me questions about it, okay?

JUDGE VITTONE: Wait, wait. Wait a minute.


JUDGE VITTONE: Mr. Herman. Just a second. Now, you asked him a question about the brochure, sir.

MR. HERMAN: Correct.

JUDGE VITTONE: And that's what he was responding from.

MR. HERMAN: I just... I didn't realize that. And that's why I interjected. I thought that he was reading from this document, which is the one in which the brochure is referred to.

JUDGE VITTONE: Well. Okay. I thought it was clear that he said he was reading from the brochure.

MR. HERMAN: No. I missed that. I'm sorry.

JUDGE VITTONE: And now you understand what he's reading from.



MR. BOHANON: May I begin reading again from the brochure? Because I think it explains within itself the purpose of this document.

Again. From the second paragraph. "While a lot of attention has been given to places where smoking has been banned entirely, a majority of large private employers have found it possible and preferable to accommodate the wishes of both smokers and non-smokers. In some cases conflict can be avoided by simply letting employees work out differences among themselves. In others, smoking is restricted to private offices and designated areas of cafeterias, lobbies, or other common areas. In still other instances, managers may decide to restrict smoking to designated smoking lounges. This guide has been developed to offer practical assistance for those who choose to accommodate the needs of smokers and non-smokers through the use of smoking lounges."

MR. HERMAN: When a businessman requests that information, do you tell him that your research shows that ETS is not harmful to health?

DR. COGGINS: Quite often the request for these brochures...

MR. HERMAN: It's just a yes or a no.

DR. COGGINS: I don't think it is. Quite often when these brochures are requested it is not necessarily from the business owner. Sometimes it's from individual smokers.

Now, the second part of your question was, do we inform them, I believe. Could you repeat?

MR. HERMAN: Do you inform them that ETS is not injurious to health?

DR. COGGINS: I'm not sure if we even could make that statement. I think that statement that we'd make today is, based on the evidence available to us, we have not established that environmental tobacco smoke is a risk factor for disease. Because of the work that Dr. Sears described earlier we have not concluded that it is a risk factor. But we do not inform requesters of the brochure of that information, I don't think.

Is that right?

MR. BOHANON: Yeah. I actually don't know. I believe when people call in and request a piece of information they are just sent the piece of information they requested.

MR. HERMAN: Do you believe that smoking -- and this can go to anybody -- is a necessary part of a person's job?

DR. COGGINS: I'm sorry. I don't understand.

MR. HERMAN: Do you think that smoking is a necessary part of an individual's job?

MR. GROSSMAN: I... That's a rhetorical question. It has nothing to do with the question before OSHA or the legal standard before OSHA of whether there is substantial evidence on the record of the significant risk. Is counsel suggesting that if carpeting were not a necessary part of the manufacturing process, the fact that carpeting emits formaldehyde should lead to the ban of carpeting in the workplace?

JUDGE VITTONE: Let's leave formaldehyde and carpeting out of here. We're having a tough enough time with ETS.

You really want an answer to that question?


Are you aware of any occupation which requires smoking as a necessary part of that person doing his job?

DR. COGGINS: I think Mr. Bohanon has an answer for you.

MR. BOHANON: Well, the concept of what a person's job is and what their employment location is, for the terms of this standard, is very broad. Indeed, it includes places such as hospitality locations where if one is to be hospitable to smokers as customers and smokers want to smoke, then that's a necessary part of performing that hospitality service. The standard may apply to hotels, it may apply to a lot of other places where in terms of being hospitable or in terms of not wishing to control employees' behaviors and choices, the decision may be that it's a part of that business activity.

MR. HERMAN: Well, I was curious, because it seemed to me that the thrust of RJR's position is, is that, that we must accommodate smokers in the workplace because it's a necessary part of the occupation of smokers. This is the Dictionary of Occupational Titles.

MR. GROSSMAN: Your Honor, could we move on?

MR. HERMAN: Well, just a second.

JUDGE VITTONE: Mr. Grossman.

MR. HERMAN: It's a... Not all of it. I went through all of it. Thousands of occupations. And I'd like this to be part of the record, Your Honor, it's...

JUDGE VITTONE: It's a public document and we can take official notice of it.

MR. HERMAN: All right. It's the Dictionary of Occupational Titles, Volume 2, 4th Edition, revised 1991. Thousands and thousands of occupational definitions. And not one says that smoking is a part of a job.

Do you have any kind of an employee profile or job definition that requires smoking?

MR. GROSSMAN: I object as I stated before, Your Honor.


Mr. Herman, I don't think we're getting anywhere with this. Would you please move on?

MR. HERMAN: Well, Your Honor. The reason I ask is because in this document which Mr. Bohanon put in this record, on page 5, he says that "OSHA has ignored potential and likely adverse affects on the productivity of smokers."

One would think that if productivity was important, it would certainly be included in the thousands and thousands of definitions provided by the Labor Department and any other standard that it was a necessary part of a person's work and there is no such standard anywhere to be found. Except maybe inside RJR.

JUDGE VITTONE: Okay. Well, you can make that argument in your post-hearing brief, sir.

MR. HERMAN: Do you believe, any of you, that ETS presents any kind of a health risk?

DR. COGGINS: "Any" is one of those...

MR. HERMAN: Any kind of health risk.

DR. COGGINS: "Any" is one of those all-embracing words that all-embraces. All we are prepared to say today is that as scientists we've examined the scientific literature and we've performed scientific studies and we have come to the conclusion that exposure to ETS in the workplace does not provide substantial evidence of a significant risk of material impairment of health. That's what we're here to tell OSHA about from a science point of view.

MR. HERMAN: Do you believe that smoking is an annoyance?

DR. COGGINS: If you mention smoking, it may under certain circumstances be annoying to certain people, I believe.

MR. HERMAN: So you agree with the RJR advertisement that begins, "The smell of cigarette smoke annoys me," and then goes on, to be fair for the record, "but not nearly as much as the government telling me what to do." You do agree that smoking is an annoyance, because here is your advertisement that says it.

MR. GROSSMAN: Your Honor, it's unclear whether this is for the camera or OSHA, but it certainly has nothing to do with...

MR. HERMAN: You know, Mr. Grossman, I'm blind to that camera. Forget about the camera.

MR. GROSSMAN: I am suggesting that it has nothing to do with the OSHA proceeding. Nothing to do with the question of material impairment of health.

JUDGE VITTONE: Just a second.

MR. HERMAN: Sure it does.

JUDGE VITTONE: Are you quoting... You're quoting from an RJR advertisement?

MR. HERMAN: Yes. It's an RJR advertisement.

JUDGE VITTONE: Dr. Coggins, you can state your agreement or disagreement. If you even have an opinion, I don't know.

DR. COGGINS: I think the ad -- and I haven't got it in front of me -- reflects the opinions of an individual. And clearly, if that individual, he or she thinks that smoke is annoying, that's their opinion.

MR. HERMAN: Do you deny that this was an ad that was put in The Wall Street Journal by RJR? Have you seen it before?

DR. COGGINS: I can't see it now.


(Mr. Herman hands the document to Dr. Ogden.)

MR. HERMAN: If you haven't seen it before, then, it's okay.

DR. COGGINS: Yes. I believe this is one of a series of ads. We ran a lot. I think this is one of them. "The smell of cigarette smoke annoys me..."

MR. HERMAN: Right.

DR. COGGINS: "...but not nearly as much as the government telling me what to do." And this is from New York Times of August the 2nd, a lady called Martha Kramer, who's a non-smoker.

MR. HERMAN: Do you believe that, that ETS...

Are you still looking at that?


MR. GROSSMAN: Are these your notes from here, counsel?

MR. HERMAN: Um-hmm.

JUDGE VITTONE: Let's not... Come on.


JUDGE VITTONE: I didn't hear you.

MR. HERMAN: Okay. Let me get on here a little bit.

Dr. Ogden. Or anyone. I want to ask one of you... And I think it's Dr. Ogden. You're the air quality...

DR. COGGINS: Well, again, this is burdensome. This is where it would be a lot easier if you did address your questions to me because...

MR. HERMAN: Who is it that supervised...

DR. COGGINS: Just a second. I was going to give answer. That if you did direct your questions to me I would have a pretty good idea of who to direct the question to, because I think the air quality person, and I'm not quite sure of your question, is of course Mr. Bohanon.

MR. HERMAN: In various of these submissions, you gentlemen have relied on some studies by Healthy Buildings International. Is that correct?

DR. COGGINS: I don't think we have. Have we, gentlemen?

MR. BOHANON: I have not.

MR. HERMAN: Well, you've cited...

MR. GROSSMAN: Let the panel complete its answer.

DR. COGGINS: Has anyone here? Dr. Nelson? I think your turn now.

DR. NELSON: I don't recall specifically whether or not I have.

DR. COGGINS: Mr. Bohanon, have you?

MR. BOHANON: I don't recall. I've just been looking at citations now and I don't see any. It might be.

MR. HERMAN: I can give you a specific reference. Dr. Coggins cites a 1992 report, "Measurement of ETS in 585 Office Environments" and that was by Simon Turner of HBI.

DR. COGGINS: That was a scientific citation. I have not worked with Simon Turner of HBI. I've read the literature, read his paper, and included it in one of my papers. That's not to say I worked with HBI.

MR. HERMAN: I didn't say you worked with HBI.

Did anyone else use Turner or HBI studies in connection with any of the testimony you gave here?

DR. OGDEN: I don't recall that I have.

MR. GROSSMAN: Counsel, if you have citations in the footnotes that you'd like to direct the panel to, that would be most appropriate.

MR. BOHANON: I've found a citation in Engineering Paper #3, but I don't know the location of it in the paper, okay? There's probably about 30 citations.

MR. HERMAN: HBI was under contract to RJA to perform, and The Tobacco Institute, to perform air quality studies in various buildings. Isn't that correct, Dr. Ogden?

DR. COGGINS: I'll just take it the first pass. I'm not sure what HBI did and who they did it with and whether Thierre is involved or not. We're not -- I'm not -- aware of any such contact.

Anybody else?

DR. OGDEN: By your question, I couldn't answer it. I don't know.

MR. HERMAN: Well, Dr. Ogden, did you supervise any studies performed by HBI on air quality?

MR. GROSSMAN: This is another area that we covered at length with the questions, I believe, by the good doctor across the aisle this morning. The beginning of this morning.


MR. HERMAN: I am informed that not one question was asked of this panel along those lines.

JUDGE VITTONE: I'm not... And quite truthfully, I can't recall. I thought maybe something had come up about HBI. But anyway, what's your question. What's your question with respect to any of the reports that they may have relied upon.

MR. HERMAN: Did Dr. Ogden supervise any HBI air quality studies?

DR. COGGINS: Please, Dr. Ogden.

DR. OGDEN: To my recollection, no I have not.

MR. HERMAN: You did not supervise the HBI PASS study?

DR. OGDEN: No, sir.

MR. HERMAN: Did you participate in that study?

DR. OGDEN: I can't recall.

MR. HERMAN: Do you know what the PASS study was?

DR. OGDEN: Not by that definition. I know PASS stands for. That's an acronym that we coined for a portable air sampling system that was basically a briefcase device that was used, that has been used by many, for indoor air quality investigations.

MR. HERMAN: Did you devise that briefcase device?

DR. OGDEN: No, sir, I did not.

MR. HERMAN: Who did?

DR. OGDEN: That was a joint effort in the Research and Development Department of R.J. Reynolds.


DR. OGDEN: And the PASS, the PASS, as we call it, has been patented by R.J. Reynolds.

MR. HERMAN: Did you participate...

DR. NELSON: Excuse me. I do believe that device is patented and that description may probably be found in the patent literature.

MR. HERMAN: Did you participate in the New York PASS study with HBI?

DR. COGGINS: I didn't. I don't know what the New York PASS study was. Does anybody else?

MR. HERMAN: Well, I didn't ask you.

MR. GROSSMAN: Well, you asked the panel.

DR. COGGINS: Yes, you did.


MR. HERMAN: I asked Dr. Ogden.

JUDGE VITTONE: I assume you want anybody on the panel who may have to answer. Dr. Coggins says no. All right. Anybody else?

DR. COGGINS: I said no.

DR. OGDEN: I can't recall, again by that description. I did not go to New York as part of that study. I did not collect any air samples as part of that study. So without your being able to refresh my memory I'd have to say, no, I don't believe I was.

DR. COGGINS: Anybody else on the panel?

MR. HERMAN: Excuse me.

DR. COGGINS: Well, I just want to check the panel for you.

MR. HERMAN: Go ahead.

(Chorus of no's)

DR. COGGINS: None of us have any involvement with that.

MR. HERMAN: Dr. Ogden, previous to this appearance here, have you on other occasions utilized HBI air quality studies in connection with your work and research?

DR. OGDEN: Are you asking me if I've ever cited any result from an HBI...

MR. HERMAN: Used. Used results of HBI studies in connection with your work at RJR.

MR. GROSSMAN: Dr. Ogden asked you for a clarification. What do you mean by used if it's not cited to?

MR. HERMAN: Air quality studies.

MR. GROSSMAN: What do you mean by used? If it means something other than cited to?

MR. HERMAN: Well he can, he can answer that question. Has he taken the HBI data and used that data in connection with any of his work, Dr. Ogden's work, at RJR.

DR. OGDEN: Let me clarify. You're asking me if I've taken any raw data from any HBI study and incorporated that into any study that I've conducted?


DR. OGDEN: The answer to that is no.

MR. HERMAN: Have you analyzed any HBI air quality studies that were presented to you by HBI management prior to publication by HBI?

DR. OGDEN: To my knowledge... I don't even know what HBI management is. I have not met with any HBI management. I don't recall even a telephone conversation, and certainly no data from HBI has ever been presented to me to my recollection.

MR. HERMAN: Do you know Guy Oldaker, O-L-D-A-K-E-R, Ph.D.?

JUDGE VITTONE: You're referring that to the panel, right?

MR. HERMAN: Yeah. Mr. Ogden, or anybody.

DR. COGGINS: I know Dr. Oldaker. He is an ex-employee of R.J. Reynolds.

Dr. Ogden?

DR. OGDEN: I also know Dr. Oldaker.

MR. GROSSMAN: I don't think, I don't think which members of the panel know him now that he's been identified is a reasonable area of inquiry.

MR. HERMAN: Well, I'm just trying to refresh his memory.

MR. GROSSMAN: Well, I...

MR. HERMAN: Just let me ask the next question.

DR. OGDEN: I also know Dr. Oldaker.

MR. BOHANON: I think we all do.


MR. HERMAN: Did you participate in a study with Dr. Oldaker in New York, a study which was performed by HBI technicians studying air quality in over 240 -- 240 studies of restaurants and offices in New York in 1988 using the briefcase that you referred to?

DR. OGDEN: And again, I'll reiterate my answer and maybe elaborate in some area.

I did not go to New York City, nor did I use the PASS briefcase in New York City to make any measurements. I have on many occasions participated or assisted Dr. Oldaker's research efforts in analyzing samples.

It is possible that some samples were analyzed, either by me or someone working with me, that resulted from that study. I suspect at that time, if you're saying 1988, I suspect that is not true. There was a qualified analyst who worked directly for Dr. Oldaker, and if those analyses were done at RJR they may have, I suspect they were done by him. Without more information, I can't, I can't answer.

I did not participate in that study in a direct way, which I would say would be to go to New York City and collect samples. He may have consulted me regarding protocol. I simply can't recall.

JUDGE VITTONE: Can I ask a question? Who is Dr. Oldaker? I mean, it's a new name.

MR. HERMAN: Well, we just found out he's a former employee of RJR. He was a Ph.D. scientist in the R&D Department.

DR. OGDEN: Yes. He has published in the field, affiliating himself with RJR. There are a number of publications.


DR. OGDEN: And I think they are in the docket. Most of them, if not all of them.

MR. HERMAN: Did you set up the HBI study that I just described of 240 restaurants and offices in New York with the PASS briefcase?


MR. HERMAN: I didn't ask if you went there. I said, did you set up that study?

DR. OGDEN: No, sir, I did not.

MR. HERMAN: Did you review, or do you recall if you reviewed, and in that review changed any of the information gathered in that study of air quality.

DR. OGDEN: What do you mean reviewed? You mean raw data?


DR. OGDEN: If I reviewed any raw data, and I don't recall whether I did or did not, I would not as a matter of principle have changed any data. That is not something that I would do, and I certainly resent an implication if there's one there.

MR. GROSSMAN: If I may say, Your Honor, I don't see what this inquisitorial process of questioning has to do with the question before OSHA. And I don't see where it's going.

We have limited time here and we have an important issue.

MR. HERMAN: I'm not going to spend much more time on it. It has relevance because they cited the HBI studies in their reports.

JUDGE VITTONE: Okay. It may have relevance, but I don't see where it's a crucial to the Rule. And that is one of the things the Department's rules require. Is it crucial?

(Brief pause)

MR. HERMAN: One of you gentlemen relied on and cited in your reports the Center for Disease Control, some information from the CDC. I think it was either Mr. Coggins... I'm sorry. Dr. Nelson.

DR. NELSON: That is correct.

MR. HERMAN: Isn't that correct?

DR. NELSON: That is correct.

DR. COGGINS: Could I just make a clarification here?

A scientist, when he uses a citation, doesn't consider that use. It's just, he looks around and then... It's been very difficult for me -- I don't know about the rest of you guys -- to remember every single cite you've ever used in any of your papers.

MR. HERMAN: Lawyers have the same problem.

For what purpose did you cite the CDC study, Dr. Nelson?

DR. NELSON: In the NPR, or the proposed Rule, I guess I should call it, OSHA made a statement based on some results from a CDC study -- and I'm not sure exactly which cite you're referring to, but I can respond generally. OSHA responded to some work that was done by the Centers for Disease Control where they had detected cotinine in all of the subset of samples that they had analyzed as part of the NHANES-III Project. And on the basis of that citation in the OSHA document, OSHA made the statement that, I believe made a statement, that that pointed to the ubiquity of environmental tobacco smoke from smoking.

On the basis of that statement, which I believe to be an incorrect statement, I made reference to a number of things, including some discussions I've had with scientists from the Centers for Disease Control, some scientific discussions that I've had over the years. I've also discussed the potential in some individuals to exposure to nicotine in the absence of environmental tobacco smoke, either from nicotine desorbing from surfaces or nicotine that is ingested through the diet.

DR. OGDEN: I also cited the CDC study in my testimony.

MR. HERMAN: Do you... Did you agree with that study that you cited?

DR. OGDEN: The citation...

MR. HERMAN: As I recall...

DR. OGDEN: The citation in my written response, and it also was presented in my oral response, was simply to correct a number of errors in interpretation that had found their way into the proposed Rule. And that study was the NHIS study which OSHA did rely on in trying to set the number of workers that may be potentially exposed in the workplace. So the limit of my use of that study was to correct the errors that OSHA had incorporated in the proposed Rule.

MR. HERMAN: But I think you confirmed that in your report. You didn't dispute the findings of that NIH study. What you were doing was disputing how OSHA used it?

DR. OGDEN: I believe there was some dispute over some of the statements made in some of the reports of that study. But the primary purpose was to clarify the, as what I see as the improper use of some of those data in the proposed Rule.

DR. COGGINS: Dr. Nelson has a comment to make.

DR. NELSON: Additionally, without the specific cite, knowing specifically to which citation you're referring, it's hard to respond.

I don't disagree or dispute the Center for Disease Control's ability to detect nicotine or that they have very good, essentially detection limits, because they can see very small amounts of nicotine. And so I'm not disputing that. My dispute is with the conclusions of that on the basis of the possibility for exposure to nicotine either incidentally or through the diet in the absence of environmental tobacco smoke. And the potential for, then, cotinine in body fluids following that to be misattributed to environmental tobacco smoke exposure.

Dr. Sears might also say the CDC one time, in reference to a particular study that's not appropriate as an ETS study, and we used some of the logic that CDC used for that purpose.

MR. HERMAN: I'm sorry. Were you critical of the CDC study?

MR. STEICHEN: No. We just cited them as one source who had said that this particular ETS study, or potential ETS study was in fact not an ETS that...

MR. HERMAN: Are you gentlemen aware of...

MR. GROSSMAN: One moment. Dr. Nelson has another point.

DR. NELSON: Something that just listening here is seeming very confusing to me. I'm not sure which citation, again, that you are referring to, or I am, or whether or not we're all referring to specifically the same thing.

MR. HERMAN: Okay. What I was trying to recall was the studies that I heard cited here that were based on, where you cited CDC, you were not disputing the CDC studies. You were citing them for reference in your report.

MR. GROSSMAN: Counsel, I object. It appears that you are suggesting that a reference in a paper's footnote...

MR. HERMAN: I'm not suggesting.

MR. GROSSMAN: Well, let me complete this. It appears that you are suggesting that a reference in a paper's footnote to a study by the CDC for a particular piece of information suggests that the scientists on this panel either approve of everything in the study cited or approve by everything published by the CDC.

Now, I'm sure you don't intend that. But the implication of your question, it leads in that direction. Could you confirm that you don't mean that at all, counsel?

MR. HERMAN: Could I do what?

MR. GROSSMAN: Confirm that you don't mean that at all, by...

MR. HERMAN: Mean what at all?

MR. GROSSMAN: Mean that the scientists in any way are suggesting that by their reference in a footnote to a CDC study that they agree with everything either in the study or everything that the CDC publishes?

MR. HERMAN: Well, I'm sure they would dispute that if I implied that.

MR. GROSSMAN: All right.

MR. HERMAN: RJR uses rats in some of its analysis of ETS. Is that correct?

DR. COGGINS: I described two days ago, now...

MR. HERMAN: Dr. Coggins.

DR. COGGINS: That's right. Or was it yesterday. I described a series of toxicology studies that we did using ????? smoke as a surrogate for eight years.

MR. HERMAN: And you used rats, some kind of rat, in your studies.

DR. COGGINS: Yes. Yes.

MR. HERMAN: And you have used rats, Dr. Coggins, in your studies for many, many years.

MR. COHEN: That's correct.

MR. HERMAN: And you still use rats.

DR. COGGINS: No longer. No. I'm no longer associated with the laboratory.

MR. HERMAN: You're no longer a rat man?

DR. COGGINS: No longer a rat man.

MR. HERMAN: You don't do any laboratory work any more?

DR. COGGINS: They kicked me out.

MR. HERMAN: When did you discontinue doing your laboratory work?

DR. COGGINS: The exact date? I can't remember. It would be about two and a half years ago.

MR. HERMAN: Are you familiar with... For what purpose do you use rats? Can you tell me in just lay language? In connection with ETS.

MR. GROSSMAN: Are you asking him to give you every purpose for which rats...

MR. HERMAN: No. Just generally, why do you use rats?

MR. GROSSMAN: Let me say, Your Honor, that we went over at length the question of the use of rats, the question of the use of mice and the determination of when you use rats versus mice at length this morning and yesterday.

JUDGE VITTONE: Yes. I know. We really have had an extensive examination on these tests.

MR. HERMAN: I'm not going to be long on this.


MR. HERMAN: I think I'm going to cover some ground that hasn't been covered.


DR. COGGINS: There are a number of animal species that could be used in a study such as the one I described. As I said in my testimony, or questions and answers this morning, in my opinion, the default position is the rat.

MR. HERMAN: The what?

DR. COGGINS: Default.


DR. COGGINS: And that other species are available, but that it seemed to me that, the reasons I described this morning, the rat was the most appropriate model to use for the reasons I presented this morning.

MR. HERMAN: Which was to study environmental tobacco smoke? The effects. Or lack thereof.

DR. COGGINS: No. You're describing the results of the experiment. What I was describing is why -- and I think this was your question -- why we used rats. Which was your question.

MR. HERMAN: Yes. Why you used rats.

DR. COGGINS: Okay. My first answer still stands, and I think they're the default animal to be used. One of the additional reasons we went along with the use of the rat was that we wanted to prove that animals had actually inhaled smoke. And so to do that you would need biomarkers, and to obtain biomarkers you need blood.

I mean, it's very difficult to obtain repeated samples of blood from animals as small as a mouse. Whereas it is relatively easy from relatively large animals such as rats, particularly male rats. It's relatively easy to obtain repeated blood samples without any stretch to the animal.

MR. HERMAN: Do you know, or are you familiar with Dr. Idle's testimony here before OSHA?

DR. COGGINS: Again, I was asked that this morning. And the answer is no.

MR. HERMAN: Did... Were you asked, or was it pointed out to you that Dr. Idle testified that animal modeling for human ETS exposure is primitive and would not fulfill FDA requirements?

DR. COGGINS: Yes, it was.



MR. HERMAN: I don't want to cover all this ground again.

JUDGE VITTONE: Thank you. We had a discussion on that.



MR. HERMAN: But your preference, and I think most agree with you, that rats are a better, do the job for the studies that you regularly performed when you were in the lab. You just have a divergence of opinion with Dr. Idle.

DR. COGGINS: I haven't seen his written testimony, and I'm not quite sure...

JUDGE VITTONE: If I understood his prior testimony, yes, he said he disagreed with Dr. Idle. Okay? And the record will clarify that, I'm sure.

MR. HERMAN: You performed some mouse/rat studies which were written up in Toxicology Journal. You may have been asked a couple of questions about this article.

DR. COGGINS: We haven't yet been asked that. Which article are you talking about?

MR. HERMAN: It's toxicology. "The Tumorogenicity of Smoke Condensates from Cigarettes Containing Different Amounts of Citrell as Assessed by Mouse Skin Painting."

MR. GROSSMAN: Is that an ETS article, counsel?


DR. COGGINS: No. This is an article entitled, "The Tumorogenicity of Smoke Condensates from Cigarettes Containing Differing Amounts Citrell as Assessed by Mouse Skin Painting." It has nothing to do with ETS.

MR. HERMAN: I believe the reason I brought this article up is because you cited it in an exchange of correspondence criticizing Drs. Penn and Snyder in this journal, the American Heart Association Journal of Circulation. And you cited your article on toxicology, and they cited your article, and you criticized Drs. Penn and Snyder, whose work was on ETS.

JUDGE VITTONE: Okay. So, the question, Mr. Herman?

DR. COGGINS: No. That's not true.

MR. HERMAN: Well, sir.

JUDGE VITTONE: Does he agree or disagree with that question?

DR. COGGINS: No. I have the letter that I wrote criticizing Penn and Snyder. And it does not refer to my article on skin painting.

MR. HERMAN: There is a footnote, or its mentioned in the body of the article, as I recall.

In any event, let me...

MR. GROSSMAN: Could you direct us to the citation that you're referring to?

MR. HERMAN: Sure. It's the journal Circulation, Volume 89, No. 6, June 1994.

MR. GROSSMAN: Could you direct us to the particular quote that you are referring to, since you are so adamant that...

MR. HERMAN: I'm not so adamant. I believe it's quoted, and I'll look at it in just a second.

Let me ask you a couple of questions, and then I'll come back to that.


MR. HERMAN: And I'll try to find the footnote.

DR. COGGINS: Okay. Maybe I could ask it for you, because the other reference that there is in there, where I'm the first author, was an inhalation study. Not a mouse skin painting study.

MR. HERMAN: Your mouse skin painting study. The first one I referred to. Is it your testimony it has no bearing whatsoever on ETS?

DR. COGGINS: I think that mouse skin painting studies using cigarette smoke condensate on mouse skin provide information on cigarette smoke condensate on mouse skin. Nothing more, and nothing less.

MR. HERMAN: The cigarette smoke condensate consists, or is it derived from sidestream smoke?

DR. COGGINS: The way that cigarette smoke condensate is usually referred to, and the methods are described in the paper that we're talking about, specifically refer to mainstream smoke.

MR. HERMAN: Can it be... Can the condensate be also derived from sidestream smoke?

DR. COGGINS: I believe there is a paper -- there may be more -- where people have attempted to trap the sidestream. However, it's much more difficult to do, and I don't believe there's a standard method. Whereas for mainstream smoke there is a standard method of how you will trap smoke particulates using a number of different methods to condense the smoke.

MR. HERMAN: In Drs. Penn and Snyder's response to you, their reply?


MR. HERMAN: They state, "We have now shown unequivocally that inhalation of sidestream cigarette smoke alone, without additional experimental manipulations such as enhanced cholesterol intake, markedly accelerates arteriosclerotic plaque development."

Do you agree or disagree with that statement?

DR. COGGINS: We discussed that extensively this morning with Dr. Glantz. I'd disagree with that statement.

MR. HERMAN: Do you have scientific studies which specifically show a different conclusion?

MR. GROSSMAN: Your Honor, once again, this has been asked and answered at length.

MR. HERMAN: I don't, I don't recall that.

JUDGE VITTONE: Dr. Coggins, do you recall?

DR. COGGINS: Well, it's true that Dr. Penn and Dr. Snyder used an experimental animal that's very rare. Really, in fact, they are one of the few groups that are using these species.

However, it's true also that in our studies with rats, that we have not examined the site of likely arteriosclerotic plaque development. There is one caveat to that, that I have discussed that with the pathologist who examined the rats in our study and said, "Look," because at the time the Penn papers had no appeared.

I said, "Is there any way we could go back and look at the issues from our 90 day rat study to see if we could have seen arteriosclerotic plaque development?" Of course the problem with that is that we've given the tissues away. We no longer have the tissues. We gave them to the Armed Forces Institute of Pathology.

So I then discussed at length with the pathologist whether or not we may have seen traces of arteriosclerotic plaques in the heart sections that we examined. He was of the opinion that we would probably have seen such a plaque development if there had been one. He checked his files, and we have not seen one.

However, of course, the tissues are available with the AFIP if we wanted to go back in and look at them.

Sorry it's a long answer.

MR. GROSSMAN: Your Honor, may we request a five minute break?

JUDGE VITTONE: Sure. We've been going for an hour and half. Five minutes

Off the record.

JUDGE VITTONE: On the record.

Mr. Herman.

MR. HERMAN: Mr. Bohanon, I was asking you earlier about safety in the, the article, the submission that you gave to OSHA, in particular this one. Page 7.

JUDGE VITTONE: Is that the brochure, sir?

MR. HERMAN: No, it's not, Your Honor. Apparently the brochure was submitted with this.


MR. BOHANON: Yes, it was.

JUDGE VITTONE: Yes, it was.

MR. HERMAN: On page 7 you recite the number one tenet of RJR's operations division. Do you see that? In the very first paragraph?

MR. BOHANON: Yes. I do.

MR. HERMAN: It says, "We will have a safe and healthy workplace"?


MR. HERMAN: And it also says, "You'll operate in compliance with all safety, health and environmental regulation."

MR. BOHANON: Yeah. That's correct.

MR. HERMAN: And that is RJR's policy.

MR. BOHANON: Within the Operations Division.

MR. HERMAN: So, does that mean that if ETS is proven to be hazardous to health, your company would institute a policy which would require that smoking be off-premises entirely? Do you know?

DR. COGGINS: Again, that's a hypothetical question. We'd have to find there is substantial evidence of a significant risk of material impairment of health. Isn't that right?

MR. BOHANON: I believe that is right. It depends. We say we will be in compliance with all safety, health and environmental regulations.

MR. HERMAN: So that if ETS is found to be injurious to health -- a health hazard -- you would assume that RJR would require that there be no smoking on premises, wouldn't you?

MR. BOHANON: No. I would not assume that. Because that's not the same as being in compliance with regulations. Obviously you may have some opinion on health, but the statement is that we are going to comply with the regulations. So if OSHA promulgates a regulation, we certainly will comply with it.

MR. HERMAN: Well, sir, the statements...

MR. GROSSMAN: Your Honor, these hypotheticals are going nowhere. Whether would Reynolds would comply with an OSHA regulation if something were demonstrated or if a regulation were promulgated has nothing to do with the question of whether OSHA should be in the process of promulgating a regulation.

MR. HERMAN: No, no. That statement, with all due respect, is two parts. Separated by the word and. The first phrase says, "We will have a safe and healthy workplace."

My question is very simple. If it is determined that ETS is injurious to health, in compliance with RJR's stated policy to have a safe and healthy workplace, is it your opinion that RJR would ban smoking from the premises?

JUDGE VITTONE: Do you mean if the OSHA regulation is enacted as presently stated, or whatever?


MR. BOHANON: Would they... If the OSHA regulation is put into effect as presently written, we would comply with the OSHA regulation. Yes, we would. We will be in compliance with regulations. There's no question about that.

MR. HERMAN: And if it's determined by your own science, RJR's own science, that ETS is injurious to health, in light of this policy statement, is it your feeling that RJR would ban smoking on its premises?

That is a different question than just the regulation itself.

MR. GROSSMAN: And an equally irrelevant one, Your Honor.

MR. HERMAN: It seems like an easy question that could be answered.

MR. BOHANON: No, I think it's a very confusing question as to setting company policy. I am not in a position to set company policies, so I can't... I can interpret the policy that says that we will comply. That's pretty straightforward and clear.


MR. GROSSMAN: It's a hypothetical question, contrary to the evidence submitted in this hearing by Reynolds...

MR. HERMAN: The point is made. I'm going to move on.


MR. HERMAN: I'm going to move on.

JUDGE VITTONE: Okay, Mr. Grossman. Thank you.

MR. HERMAN: Does RJR export its products to Canada?

MR. GROSSMAN: Objection, Your Honor. This has nothing to do with the proceeding.

MR. HERMAN: Oh, sure it does.

JUDGE VITTONE: OSHA regulations stop at the border, Mr. Herman.

MR. HERMAN: Well, Your Honor, the Canadian Camel pack says "Tobacco smoke causes fatal lung disease in non-smokers." Here it is. And my questions relate to ETS in the United States, specifically.

Is there any difference between ETS in the United States and the ETS in Canada.

MR. GROSSMAN: That was for the benefit of the camera, not for this proceeding, Your Honor.

MR. HERMAN: Ah, come on.

JUDGE VITTONE: Okay. You've shown it. Now. All right.

Your question is, is there any difference between the ETS in the United States and ETS in Canada? Is that right?

MR. HERMAN: Yeah. Sure.

JUDGE VITTONE: Do you have an answer, Dr. Coggins?

DR. COGGINS: Yes. I think that the statement... First of all, let me answer your question.

Clearly, ETS is ETS, and I don't think there are any differences between Canadian ETS and American ETS. But the more important point, I think, is the statement on the pack there is the culmination of the Canadians' policy on ETS.

When you look at the overall set of data, just as Dr. Sears did in terms of epidemiology. When you look at the data from my work, when you look at the work from Dr. Ogden on the amounts that people are exposed to, and Mr. Bohanon has presented in ventilation, I think you come to a very different decision. And when you have policies based on poor science, I don't think those policies are worth a great deal.

MR. HERMAN: In that regard, the Canadian pack of Camels also has a warning. It says, "Smoking can kill you." And there's another warning...

JUDGE VITTONE: Mr. Herman, Canada can do what Canada wants to do. Let's stick to the United States.

MR. HERMAN: These questions strictly relate to smoke in the United States.


MR. HERMAN: And my question is, very simply...

JUDGE VITTONE: All right, stop using whatever those things are.

MR. HERMAN: Is the smoke in Canada from a Camel cigarette, different from the smoke in the United States from a Camel cigarette?

MR. GROSSMAN: That's already been answered, Your Honor. The Canadian government restrictions or the Thailand government restrictions are not before this tribunal.

MR. HERMAN: Dr. Coggins, are you familiar with the mouse house experiments that were performed some years ago?

DR. COGGINS: The mouse house experiments that were performed some years ago? I think you'll have to give me a little bit more detail on that.

MR. HERMAN: Well, RJR had what has come to be known, a mouse house experiment which was destroyed in 1970, involving rabbits and mice and meeses and rats and all those animals.

MR. GROSSMAN: Your Honor, I'm going to object to this question which is obviously geared for the litigation in which Mr. Herman is engaged for profit...

MR. HERMAN: Mr. Grossman...

MR. GROSSMAN: It has nothing to do with the question of ETS before this tribunal.

MR. HERMAN: First of all...

JUDGE VITTONE: How is it related to ETS?

MR. HERMAN: Of course it's related because I want to find out if those experiments had any relationship to ETS and sidestream smoke. If they did, I want to probe on that as those experiments may or may not relate to this current data.

JUDGE VITTONE: First off, we don't even know if anybody here knows anything about them.

DR. COGGINS: I don't know anything about any R.J. Reynolds work prior to my joining the company in 1985. Let's go through the panel?

Dr. Sears?

DR. SEARS: I have absolutely no knowledge of that.

MR. STEICHEN: I don't know what you're talking about, mouse house studies.

DR. NELSON: I was in second or third grade at the time. I certainly wouldn't have known then, and I haven't heard anything since.

DR. OGDEN: Nor do I know anything about the experiment that you're referring to.

MR. BOHANON: I know nothing of a mouse house.

MR. HERMAN: Have any of you all ever read any of Dr. Frank Colby's manuscripts on the RJR mouse house experiments which supposedly was destroyed by the company in December of '70?

MR. GROSSMAN: I object both to the question and to the characterization contained within the question.

MR. HERMAN: It's all related to ETS. I just want to know.


JUDGE VITTONE: I don't know how it is. How is it related to ETS?

MR. HERMAN: Because if there is a body of work out there...

JUDGE VITTONE: If you're accurate that this stuff has been destroyed, it's certainly not part of this record.

MR. HERMAN: Well, that's true.

JUDGE VITTONE: If it's not part of this record, it's going to be extremely difficult for anybody here to make any use of it.

MR. HERMAN: Only if manuscripts or diaries from those experiments still exist in the company archives which are used by these scientists as a basis for the studies which they're presented to OSHA here on ETS. If they haven't been, they all just need to say no.

MR. GROSSMAN: Your Honor, they cannot exist and be destroyed at the same time.

MR. HERMAN: What I said was the diaries and manuscripts and some of the work product based on those experiments. If they don't exist, they don't exist. Just tell me, no, you haven't used anything...

MR. GROSSMAN: These are irrelevant questions for rhetorical purposes.

JUDGE VITTONE: I'm going to sustain the objection.

Let's move on, Mr. Herman.

MR. HERMAN: There's an ad in the June 8, 1994 New York Times in which Chairman Johnston of RJR said, "We're committed to bringing the best quality products that we can make to our customers." Everybody agrees with that statement on this panel, correct?

JUDGE VITTONE: I think we can take it that they all agree with the chairman.


DR. COGGINS: Yeah, if I want to go home tonight.

MR. HERMAN: RJR is currently investigating and researching a different type of a cigarette called Eclipse, is that correct?

MR. GROSSMAN: Before Dr. Coggins responds, there have been published reports in the New York Times and elsewhere about a product under development referred to in the New York Times as Eclipse. Obviously, any product under development by Reynolds would be of great interest to Reynolds' competitors, and I direct the panel not to testify as to any proprietary information of the company about products in development.

JUDGE VITTONE: What's your question now?

MR. HERMAN: I want to ask one question on the Eclipse, that isn't based on the New York Times article of November 27.


MR. HERMAN: Is it true, gentlemen, that the Eclipse is being developed to substantially, among other things, cut down on second-hand smoke or ETS or sidestream smoke?

DR. COGGINS: First of all let me state that my knowledge of the Eclipse prototype is limited to that newspaper article. In fact I can't even remember exactly what was said in that article except there was a reduction in second-hand smoke. I have not been involved in the development of that project. I don't know anything about it. I'd like to ask my colleagues if they have any involvement in that project?

DR. OGDEN: No, I've not had any involvement in that project.

MR. BOHANON: I know nothing beyond what I read in the New York Times article, so I can neither confirm anything that's in it other than that I read it.

DR. NELSON: I've had some involvement in that project, but I cannot really speak as to what the development aims of that product are.

MR. HERMAN: What was your involvement in...

DR. COGGINS: Let's finish the panel and then we'll come back.

MR. STEICHEN: I have not been involved in that project.

DR. SEARS: I also have not been involved.

MR. HERMAN: Dr. Nelson...

MR. GROSSMAN: And I direct Dr. Nelson, as I directed the rest of the panel, not to provide any information of a proprietary nature about the development of a new product.

JUDGE VITTONE: Let's hear the question and if you have an objection you can object to the specific question.

MR. HERMAN: What was your involvement in this Eclipse project?

DR. NELSON: I would have to answer that it's part of the development, it essentially is part of a development effort, and as such, that information would be proprietary.

MR. HERMAN: What is your expertise, Dr. Nelson?

DR. NELSON: I'm an analytical chemist.

MR. HERMAN: Is it true, panelists, that the Eclipse is being developed to cut the cancer-causing tars of other cigarettes by 90 percent, when compared with other cigarettes by 90 percent?

MR. GROSSMAN: Your Honor, I object. First of all, as to the characterization in the question. The panel has already testified, Dr. Coggins the toxicologist, has testified at length as to what his definition of "cause" is, and the characterization misappropriates the testimony that the panel has already given.

Secondly, this is a product under development, and the purposes of the product and the design parameters of the product are clearly, clearly proprietary. We have Philip Morris here. We don't want them to know.

JUDGE VITTONE: But I think the point is, clearly, five of the panel members say they know nothing about the product other than what they've read in the New York Times. We have one gentleman who has said he has something to do with product development with respect to that product. If these five others have not been involved in it, I question how they can respond to your question.

Do you know anything...

DR. COGGINS: I do object to the statement that Mr. Grossman mentioned. The cancer causing tars, I've already discussed the concept of causation. I repeat, I have no involvement in the development program of Eclipse.

MR. HERMAN: Dr. Coggins, if you don't know about it, you just don't know about it. Dr. Nelson said he knows something about it.

My questions are framed precisely from this article. I just want to know what you all know. I want to know whether you confirm or deny what's written here in this print in the article. If you can't confirm or deny, just don't.

These questions are based on the statements attributed to Reynolds' executives in this New York Times article. That's the nature of the inquiry.

MR. GROSSMAN: The very phrase, "can you confirm or deny," is a newspaperman's phrase. This is not testimony being elicited for purposes of helping OSHA, but for other purposes.

JUDGE VITTONE: Just a second. It seems to me what you are asking questions about is a product that does not exist at least in the marketplace.

MR. HERMAN: Your Honor, the problem is that RJR spends a whole lot of time on this roving commercial for cigarettes denying that ETS is hazardous to health, and yet is developing, according to this article, a product, the objective of which, as I understand it, based on this article is, number one, to reduce second-hand smoke. Therefore, if there isn't a problem with second-hand smoke, why develop a product that reduces it? Number two, the other stated objective of this product, cut the cancer-causing tars by 90 percent, company executives say.

The purpose of this cigarette, when contrasted with their testimony, is absolutely relevant to this record, and we have a right to make that inquiry.

JUDGE VITTONE: But we have five people who say they know nothing about the product, as I understand it.

MR. HERMAN: Dr. Nelson, I don't understand what's so difficult about this.

MR. GROSSMAN: What's so difficult about it is that first of all, you're asking questions that relate to a product in development. Secondly, you're asking a panel that's not involved in the project except for one chemist who is not involved in the toxicology of the product.

MR. HERMAN: Are you testifying or do you want to let Dr. Nelson testify?

MR. GROSSMAN: No, that is a fair statement of the testimony....

MR. HERMAN: I didn't hear that. I heard that from you, not from him.


DR. NELSON: I am a chemist, not a toxicologist. Obviously, I would not be involved in any sort of toxicological characterizations.

MR. HERMAN: Does that mean...

DR. NELSON: And furthermore, I've not seen that particular article, so I'm not really sure exactly some of these attributions that you're making about.

MR. HERMAN: Does that mean you don't know if the cigarette is being developed to cut the cancer-causing tars in other kinds of cigarettes by...

MR. GROSSMAN: I object to the characterization of the question.

This panel has already testified as to their definition of the meaning of "cause" and you are trying to mischaracterize that testimony.

MR. HERMAN: I'm not trying to mischaracterize anything. I'm just trying to get to the truth.

MR. GROSSMAN: No. If you were interested in the truth, you'd simply ask questions.

MR. HERMAN: Mr. Grossman, this article is attributed to RJR executives who are quoted in this article. It directly relates to the purpose of this hearing which has to do with ETS, and if these gentlemen can't answer questions about it because they don't know, that's all they have to say, they don't know, and I'll move on. But I don't want to hear that from you.

JUDGE VITTONE: All right...

MR. HERMAN: You're not testifying.

JUDGE VITTONE: Okay. That's it, gentlemen.

Now your question can only be directed, as I see it, to Dr. Nelson. Dr. Nelson has given you a response about what his involvement is.

Is there anything else that you can add to that, Dr. Nelson?

DR. NELSON: Nothing else that I can think of that I could add.

MR. HERMAN: May I ask a couple more questions and find out?


MR. HERMAN: Otherwise I'll have to ask him to tell me everything he knows about it.

Do you know whether or not this cigarette delivers as much nicotine as traditional kinds of cigarettes, regular products?

MR. GROSSMAN: The parameters of a cigarette in development will not be discussed by this panel.

JUDGE VITTONE: You're telling me that's proprietary information?

MR. GROSSMAN: Yes. The nicotine content, tar content, taste, or any other parameters of a product in development are not subject to disclosure in this or any proceeding.

JUDGE VITTONE: I think that's a legitimate ground at that point. If it's proprietary information, I can appreciate their position on that point.

MR. HERMAN: Who is Mr. Griscom, G-R-I-S-C-O-M, of R.J. Reynolds?

DR. COGGINS: I'm familiar with Mr. Griscom. I believe he's, and I can't remember the exact title, Executive Vice President of something and something.


DR. COGGINS: I honestly can't remember.

MR. HERMAN: Do any of you, Dr. Nelson, do you know whether or not this cigarette is being developed so that it will produce fewer active compounds?

MR. GROSSMAN: Your Honor, you've already ruled on this. This is just a back door attempt around.

JUDGE VITTONE: I think we should move on, Mr. Herman, to another topic.

MR. HERMAN: Dr. Nelson, do you know if this product is less hazardous and has very little noticeable smoke?

MR. GROSSMAN: Your Honor, not only is this another attempt to subvert the Court's ruling, but it's obviously a rhetorical attempt, knowing that the question cannot be answered.

JUDGE VITTONE: Mr. Herman, you're asking questions about a product that is in development that may or may not be what that newspaper article attributes it to be, and which may never see the light of day for a variety of reasons. I think you should move on to another area, sir.

MR. HERMAN: Your Honor, I respect your ruling...

JUDGE VITTONE: Fine. Thank you.

MR. HERMAN: I also respectfully disagree, but I will move on.

Have any of you gentlemen reviewed a monograph produced by RJR entitled, "New cigarette prototypes that heat instead of burn," which was produced in connection with the development of the Premier cigarette many years ago?

DR. COGGINS: I can speak only for myself on this. I was involved in the preparation of that monograph.

MR. HERMAN: You were? Is that what you said?


MR. HERMAN: Is it true that that product resulted in a reduction of 90 percent to 99 percent of most of the harmful chemicals when compared with regular tobacco, when compared with the reference, as it's called in the study?

MR. HERMAN: I'm not sure how you interjected the word "harmful" in there.

I think that the simple act of only heating the tobacco rather than burning it reduced in a substantial simplification in the tobacco chemistry, but I'm not a chemist.

Do we have a chemist here that worked on the Premier project?

DR. OGDEN: Not in any substantive way.

DR. NELSON: It sounds like you're asking questions about mainstream smoke, and I've never done any research in that area.

MR. HERMAN: Dr. Coggins, who participated in the writing of this, this study addresses ETS and sidestream smoke as you recall, is that correct? My questions are related to ETS and sidestream smoke.

DR. COGGINS: So when you're asking about a reduction in compounds now, you're asking about the reduction in compounds in ETS as opposed to the mainstream smoke of the Premier?

MR. HERMAN: Mainstream smoke and in sidestream smoke.

DR. COGGINS: I think you have to break them down separately.

MR. HERMAN: I think you're correct.

DR. COGGINS: I don't think I can answer them, anyway, because I was only involved in Chapters, I believe it was Chapter 7, which was the inhalation studies. As I say, I'm not a chemist. I can't comment on the chemistry of that product.

MR. HERMAN: In the inhalation studies you used rats, is that correct?


DR. COGGINS: I was involved in several projects, most of which used rats. One of them used mice.

MR. HERMAN: This study was subject to peer review, is that correct?

DR. COGGINS: Which study is that?

MR. HERMAN: The RJR study that I identified as being entitled "New cigarette prototypes that heat instead of burn."

DR. COGGINS: It went through a very rigorous peer review that's rather different from the one we usually use in terms of peer review of published literature.

If you look in the front forward of that, there's a review of the science contained in the document by 12, 14 distinguished scientists...

MR. HERMAN: From Emory University? Or Emory coordinated it.

DR. COGGINS: I'm not sure about that. But there were a number of scientists, and a different panel there. I think there was a panel of three and then another group of 14. It went through, as I recall, it's been some time, a fairly substantial peer review. Then, of course, the manuscripts that came from it, certainly the manuscripts that I was involved in, did indeed go through peer review in their own scientific process.

MR. HERMAN: Just reading from the peer review committee statement, it says it was convened by Emory University School of Medicine at the request of R.J. Reynolds. That's where I referred to Emory.

The committee stated this on page XIII. I'm going to quote this to see how it jives with your recollection.

"The committee agreed with the conclusion," referring to the RJR study, "that assessed by non-smokers, as assessed objectively by non-smokers, there was substantial reduction in the irritant properties of environmental tobacco smoke produced by the new cigarette," meaning the Premiere brand cigarette, "compared to that of the reference cigarettes."

This study, at least in part on the Premier brand, related to ETS. Is that correct?

DR. COGGINS: As I said, the involvement I had in the Premier project was limited to the inhalation studies that I described in I think Chapter 7.

If that was the statement made by the Blue Ribbon Panel, then I'm sure it was their opinion. I cannot comment on their opinion. All I can tell you bout is my work in Chapter 7.

MR. HERMAN: Did your work in Chapter 7 indicate a reduction of the irritant properties of ETS?

DR. COGGINS: To rats or mice?


DR. COGGINS: No, the studies we performed were all on mainstream smoke. That's why I'm not sure why we're talking about it today. All I did was mainstream smoke.

MR. HERMAN: Do you know on what facts in the monograph the peer review committee based that conclusion?

DR. COGGINS: No, I don't.

JUDGE VITTONE: Mr. Herman, can I get an idea how much longer you might be?

MR. HERMAN: Fifteen minutes.


MR. HERMAN: At page IX of the peer review committee statement --

MR. GROSSMAN: Are you still referring to the Premier monograph?


MR. GROSSMAN: To a section that Dr. Coggins didn't write?

MR. HERMAN: I'm going to ask him if he recalls these conclusions coming from that section. Let me ask the question.

JUDGE VITTONE: Let's hear the question.

MR. HERMAN: "The stated objectives of the development of this product were to simplify the chemical composition of mainstream and sidestream smoke emitted by the new cigarette." Do you recall that as being one of the objectives of the studies that you performed in connection with the development of this cigarette?

DR. COGGINS: The studies that I performed weren't really in the development of the cigarette. It was a comparative set of work in inhalation studies with experimental animals.

MR. HERMAN: Another stated objective of the development of this product, the Premier cigarette, was, according to this monograph, "to minimize the biological activity of the mainstream and sidestream smoke emitted by the new cigarette." Do you recall that as being one of the objectives?

DR. COGGINS: Yes. One of my jobs was to evaluate that.

MR. HERMAN: And did the Premier cigarette simplify the chemical composition of mainstream and sidestream smoke, if you know?

DR. COGGINS: I've already answered that. I don't know about the chemistry.

MR. HERMAN: Did it minimize the biological activity of the mainstream and sidestream smoke?

MR. GROSSMAN: Could you break that down into two questions?

MR. HERMAN: Did it minimize the biological activity of mainstream smoke?

DR. COGGINS: I'm not sure about minimize. There was a reduction in the overall biological activity and that's what I published along with several colleagues in a number of different papers.

MR. HERMAN: Did it --

DR. COGGINS: Let me just finish. That was mainstream.

MR. HERMAN: Did it minimize the biological activity of sidestream smoke?

DR. COGGINS: As I recall at the time we did not perform studies on sidestream smoke on the Premier project.

MR. HERMAN: So based on your recollection today, if the peer review committee concluded that the Premier cigarette minimized the biological activity of sidestream smoke, you would say that's not correct, based on your recollection today?

DR. COGGINS: I'm not sure if the peer review committee said that.

MR. HERMAN: Well, I'm reading directly from it. I'll be happy to make it part of the record.

MR. GROSSMAN: We have no problem with having the Premier monograph or portions of it placed in the record but it would be more productive to move on, I think, Your Honor.

JUDGE VITTONE: What's the question?

MR. HERMAN: It's all about ETS. And the development. And RJR's history of trying to develop a product to cut down substantially on ETS which they have come before this body and said doesn't need to be cut down at all.

JUDGE VITTONE: Okay. I think we've lost the question, though, for Dr. Coggins.

Do you recall it, Dr. Coggins?

DR. COGGINS: No, I can't remember what you were saying.

MR. HERMAN: I'm going to start over. Do you recall whether or not the product, this Premier cigarette, minimized the biological activity of sidestream smoke?

DR. COGGINS: As I recall, we did not do any biological studies with sidestream smoke.

MR. HERMAN: Do you recall if the Premier cigarette achieved a significant reduction in environmental tobacco smoke? Again, reading from the report itself.

DR. COGGINS: Significant, I'm not sure of that. I believe in some of the chemistry chapters which clearly I wasn't involved in there were some very substantial reductions in ETS yields but I'm not a chemist and none of the other members of the panel are, I don't think.

Dr. Nelson has a comment. Excuse me.

DR. NELSON: I can't speak directly to what's in the monograph or what's been represented in the monograph. However, I have published some work in conjunction with other people from R.J. Reynolds showing that where -- it's appeared in the literature that on a per cigarette basis the amount of various constituents of environmental tobacco smoke generated by the Premier cigarette were substantially reduced relative to the reference cigarettes.

DR. COGGINS: Thank you, Dr. Nelson.

MR. HERMAN: Thank you.

Dr. Nelson, do you know what the irritant properties of ETS were that are mentioned in this monograph?

DR. NELSON: I can't speak specifically to what's in the monograph. One of the other scientists who made a submission to the OSHA hearings did in his submission point out a great deal of problem with the use of the term irritation. It's a term with many different meanings. Irritation can mean simple sensory stimulation or irritation could refer to tissue, some sort of tissue irritation and that's a very unclear term as you're using it and --


DR. NELSON: Excuse me. From one standpoint and on the other hand, I'm not really a sensory scientist or a toxicologist so I really can't directly address those questions.

MR. HERMAN: I want to make it clear that those are not my terms. I'm reading from the monograph itself which, of course, we will make part of this record.

JUDGE VITTONE: Okay. But if we're going to make the monograph part of the record, then doesn't it speak for itself?

MR. HERMAN: Well, yes. But it doesn't speak for the differences or the contrasts in the testimony these gentlemen have given here over the past couple of days versus the obvious attempt to develop a cigarette which cuts down substantially on ETS. It doesn't make sense to me, common sense, on the one hand to have these gentlemen come here and in effect say, hey, hey, nothing wrong with ETS and on the other hand develop products and spend millions of dollars trying to cut down on ETS.

MR. GROSSMAN: I have to object to counsel's characterization. Reynolds' attempt to meet the market as it has been characterized by these witnesses is very different from the characterization that's been employed by counsel.

JUDGE VITTONE: Okay. But his characterization is not evidence and the only thing that is evidence is the answers that these gentlemen and the other witnesses give to the record.

What's your next question, Mr. Herman?

MR. HERMAN: At page 10 of the monograph, there is a definition of environmental tobacco smoke and I'd just like to know whether you agree or disagree with this definition. "ETS is the combination of aged and diluted sidestream and exhaled smoke present in closed environments where people smoke."

DR. COGGINS: I think that's pretty well what we'd say today.

Dr. Ogden?

DR. OGDEN: That's a reasonably acceptable definition. Yes. I would, I think modify the trailing end of that, not where people smoke but as a result of smoking. But substantially, that's acceptable.

MR. HERMAN: Under that definition of ETS, it would include the workplace.


MR. HERMAN: Even in the workplace.

DR. OGDEN: Sure.

MR. HERMAN: And isn't ETS in the workplace, ETS, isn't it a combination of aged and diluted sidestream and exhaled smoke in the work environment which these OSHA regulations are designed to eliminate?

MR. GROSSMAN: I don't understand how this question can help in the regulatory process. We all understand that there is ETS in the workplace where people smoke. We all understand that the regulation is addressed to ETS in the workplace. This question appears to be based only upon rhetorical considerations and not on any other whatsoever.

MR. HERMAN: Well, do you want me to tell you in advance what the next question is? Why don't you let him answer this one and let me get on with it?

JUDGE VITTONE: I think we've been over this but, Dr. Coggins, for the panel, can you respond?

DR. COGGINS: Could you repeat the question?

MR. HERMAN: Sure. Isn't it true that OSHA by virtue of these regulations is trying to eliminate ETS in the workplace? Simple question.

DR. COGGINS: I think what OSHA is trying to do is develop whether or not there is substantial evidence of significant risk of material impairment of health as a result of exposure to ETS in the workplace.

Do any of my colleagues have anything to add to that?

DR. OGDEN: Yes, and whether it's ETS in the workplace or not, what we boil down to the essence is that based on the studies cited in the proposed rule leads me to the conclusion that OSHA doesn't know how much ETS is in the typical workplace and that's what I'm here to testify, to tell them how much ETS is there.

MR. HERMAN: You agree that ETS is the result of smokers puffing on cigarettes. You agree with that. I mean, it's easy. You could say yes. Do you agree with that statement?


MR. HERMAN: And OSHA has proposed regulations to try to reduce the amount of ETS in the workplace. Isn't that correct?

MR. GROSSMAN: I think that's a question of legal rather than scientific significance. OSHA has attempted to ban the use of cigarettes in the workplace except under certain circumstances through its NPR.

JUDGE VITTONE: The proposed rule is what it is. I don't think we're making any progress by trying to --

MR. HERMAN: Well --

JUDGE VITTONE: The rule says what it says.

MR. HERMAN: Let me say this --

JUDGE VITTONE: The purpose of the rule is stated in the rule, okay?

MR. HERMAN: As a non-scientist, I believe this rule is being proposed to reduce ETS in the workplace.

JUDGE VITTONE: And you and I and probably a lot of the people in this audience and even some people over here but --

MR. HERMAN: My question to you is --

JUDGE VITTONE: What's the question?

MR. HERMAN: If the Premium monograph is correct when it says ETS was reduced by 65 to 99 percent by that cigarette, wouldn't that kind of a product in and of itself substantially go a long way, substantially eliminate ETS in the workplace without any regulation?

MR. GROSSMAN: Your Honor --

MR. HERMAN: That's my question.

MR. GROSSMAN: OSHA is neither claiming nor assuming jurisdiction over the manufacture of cigarettes. This man standing here as counsel is engaged in litigation against R.J. Reynolds on --

MR. HERMAN: You --

MR. GROSSMAN: Let me finish. Let me finish. On a number of grounds, one of which is design defect claims. There is no basis upon which OSHA would have jurisdiction over the manufacture of cigarettes in the United States to determine design parameters of cigarettes and OSHA doesn't claim that.

The only person in this proceeding in the months that we've gone through who has even touched upon it is counsel in design defect litigation. I object to the question.

JUDGE VITTONE: If you're trying to say that by his question he's trying to assert that OSHA has jurisdiction over the manufacture of cigarettes --

MR. GROSSMAN: No, what I'm trying to say, Your Honor, is that by his question he is seeking through this hearing, the purpose of which is to develop regulations, to obtain statements that he can use in litigation against R.J. Reynolds. He's using it for an ulterior purpose. And where Reynolds has been here for three days, which is far longer than anyone else testifying on scientific issues, presenting a panel of scientists, it's inappropriate and wrong for this procedure to be used in that way.


Mr. Herman, the monograph is going to be in there. You and then the other party can make any argument you want with respect to whatever the comments are in the monograph, okay? I'm going to ask you to move on so that we can wrap this up because I have two more people and I've got one more witness to go.

MR. HERMAN: I'm going to go.


MR. HERMAN: While I'm still here, I've got to respond to this stuff about lawyers doing discovery for their other cases.

This whole auditorium is full of lawyers who represent the tobacco industry, okay? They're all getting paid, God bless them. They're all involved in litigation nationally and internationally, God bless them and they'll continue to make their money, okay?

I am here in order to try to extract the truth about what the industry knows about ETS and nothing more. Nothing more.

JUDGE VITTONE: That has been the goal of everyone who has participated in this proceeding, from Ms. Sherman to everybody else in this proceeding.

Now, I understand that you don't agree with his comments and I understand you strongly disagree.

MR. HERMAN: They're a diversion. You know, it's got nothing to do with this. It's a diversion.

JUDGE VITTONE: All right. Well, I'm trying to avoid the diversion so we can get back to finishing up here.

MR. HERMAN: I appreciate that.


MR. HERMAN: Dr. Nelson, you had one slide, slide number 9, which frankly I didn't understand a whole lot of what the slides are about, there's a lot of science in there, I'm not a good scientist of any sort. I'm not a scientist, obviously.

I want to ask you about slide number 9.

DR. NELSON: Okay. If you would give me just a moment --



DR. NELSON: I now have that slide in front of me.

MR. HERMAN: You don't?

DR. NELSON: Yes, sir.

MR. HERMAN: You do?


MR. HERMAN: Would you explain it to me? Briefly. Just tell me what it's supposed to represent.

MR. GROSSMAN: That's the same slide that we went over this morning.

MR. HERMAN: It is. I just want to know what it is meant to represent because I did not understand the explanation and I'm out of here after this question.

JUDGE VITTONE: Briefly, okay?

DR. NELSON: In it's proposed rule, OSHA makes a statement that nicotine is a valid quantitative marker for environmental tobacco smoke. What that means is then necessarily nicotine must be quantitatively or numerically related to other environmental tobacco smoke constituents.

As part of the rule, I believe, or as part of other testimony that has been given before this body, it has been stated that all cigarettes have essentially similar yields of -- excuse me, sir, if I might please finish. I'm trying to explain.

MR. HERMAN: You said something that helped me finally to understand.

DR. NELSON: Well, may I finish my answer, please?


DR. NELSON: In this slide we are looking at the environmental tobacco smoke yield, how much nicotine is given off in an environmental chamber when these cigarettes are smoked and how much respirable suspended particles is given off to the air as environmental tobacco smoke when cigarettes are burned. And what the data illustrated on this slide show are two things. First, that there is not a fixed quantitative relationship between ETS nicotine yields and nicotine RSP yields and second, as Dr. Glantz brought out again today, there is not a good -- the ratio between them or the relationship between these two species in environmental tobacco smoke cannot be expressed as a simple ratio.

MR. HERMAN: Well, I appreciate that. I understand a little bit better. When I listened to you first describe this slide the other day, I connected the dots.

JUDGE VITTONE: Don't put that drawing in as an exhibit. Please.


MR. HERMAN: It will be off the record, Your Honor.

JUDGE VITTONE: Okay. Thank you, Mr. Herman.

I'm going to switch to Mr. Dinegar, okay?

Mr. Dinegar, would you come on forward? I'll take you on now. I guess that's not an appropriate term. I'll permit you to come forward.

Mr. Dinegar, I have reconsidered. I have reconsidered.

MR. DINEGAR: What did you reconsider?

JUDGE VITTONE: If you can do it without the demonstration -- okay.

Mr. Dinegar, identify yourself, please. I don't think these gentlemen know you.

MR. DINEGAR: I'm Jim Dinegar, Vice President, Government Affairs with an organization called Building Owners and Managers Association. We're number 1 on the hearing docket and we represent a large part of the commercial real estate industry, the office building industry.

It has gotten a little out of hand on this hearing for quite some time, actually for the several months we've been participating, all of us have been participating in this, and I kind of wanted to remind everybody, remind panel members specifically, a little bit more about what the entire intent of OSHA's proposal is to do. It is not to single out tobacco smoke. You may feel that it's singling out tobacco smoke. We in the office building industry may feel that it's singling out the office building industry, but it is designed to work towards improving indoor air quality, identifying how widespread the problem is, watt the sources of indoor air quality contaminants are and then how to best remove indoor air quality contaminants at the source from the workplace so that the American public, the American workforce, increases in their productivity and they're not subject to adverse health effects.

MR. GROSSMAN: As Your Honor ruled when the woman from Virginia GASP was here, speeches from the podium are inappropriate. This is the time for questions.

JUDGE VITTONE: Okay, Mr. Dinegar. Come on.

MR. DINEGAR: R.J. Reynolds states four points in their thousand pages plus of testimony worth close consideration.

Point one, OSHA's proposed restrictions on smoking would impose enormous costs with few demonstrable benefits.

Point two, OSHA's proposed restrictions on smoking would reduce the productivity of the American workforce in comparison with the workforces of other nations.

Point three, OSHa's proposed restrictions on smoking would infringe upon the personal rights of smokers and the rights of businesses to accommodate their employees and customers.

Point four, there is no reason to single out ETS from all other indoor air quality constituents.

RJR further states that the key shortcomings of OSHA's ETS proposal is that the epidemiologic evidence relied on is (1) inappropriate for the workplace, (2) methodologically flawed, (3) insufficient to conclude increased risk.

Let me ask you, exactly how should the Federal Government design a research program to determine to your satisfaction whether or not secondhand smoke causes avoidable adverse health effects?

DR. COGGINS: I don't think you were here earlier today or was it yesterday when we described cause and the problems with cause and what we would need to do before we could actually use the word cause but I think one of the studies that my epidemiology colleagues would require before we could obtain -- this note now is getting a little crumpled -- substantial evidence of significant risk of material impairment of health.

They told me that they would require a certain kind of epidemiology study and I'm going to ask them to describe that and then I would be more happy to tell you what kind of biological study we would require to go along with that and then the identification of the kind of mechanism because we feel that you need all three of those in a kind of convergence of data scenario before you could use the word cause.

MR. DINEGAR: Dr. Coggins, is it your assertion that those studies have not yet been undertaken?

DR. COGGINS: No. I think that the studies that have been undertaken -- I'm going to ask Dr. Sears to quickly review them, the studies that have been performed to date have not shown that there is an increased risk of disease as a result of being exposed to ETS in the workplace.

MR. DINEGAR: No, I don't want to stray. I'm not asking if the studies have shown that or not shown that, I'm trying to determine exactly how should the Federal Government design a research program to determine to your satisfaction at R.J. Reynolds whether or not secondhand smoke causes avoidable adverse health effects.

MR. GROSSMAN: Let me just interject for a moment.

There has been no suggestion in these proceedings that the Federal Government designs its own independent research programs of this kind. I think you're injecting into these proceedings something new. OSHA may feel differently but they don't undertake independent research and they haven't suggested that they do.

MR. DINEGAR: Actually, I didn't mention OSHA. I said the Federal Government. And they undertake a great deal of research.

JUDGE VITTONE: Yes, but we're dealing with OSHA here.

MR. DINEGAR: I know we are and I'm trying to find out whether or not there is going to be a study that R.J. Reynolds would approve be done to determine once and for all whether or not environmental tobacco smoke causes avoidable adverse health effects. And the reason I ask, Your Honor, is because each of the studies that are outlined, and this is part of Mr. Sears' slide presentation, is that he points out the shortcomings, he says that learning from U.S. workplace studies, and here's slide number 12, six studies are not statistically significant, two studies provide limited evidence of risk. There are only two studies, one is of marginal significance but contains serious design and execution flaws.

Each of the studies that have been laid out on environmental tobacco smoke to at least my knowledge have been shot down either in the testimony that's been provided over the past three days or in prior testimony provided for the hearing record. What I'm trying to find out is is there some study that needs to be designed and what should that study incorporate so that you're satisfied that once and for all we come up with the answer.

MR. STEICHEN: I just wanted to comment. We don't have to be satisfied with it. It has to meet the requirements that are set out for OSHA. That's the requirement that we have to deal with. The studies before us don't do that.

MR. DINEGAR: None of the studies before you do that.

MR. STEICHEN: As a body of evidence, they don't do that.

DR. COGGINS: Plus any new study that you would do, you would have to combine with the previous studies to have all of this massive data, so you'd have to be a very, very large study to counter the current negative studies. You'd have to be very, very large indeed.

Is that logic correct?

DR. SEARS: Yes. Absolutely. In our written testimony, Mr. Dinegar, and as you pointed out in our slide presentation, I think we've clearly identified the problems in the current epidemiology. Of course, epidemiology is only one component of the scientific data that's needed to come to any sort of scientific conclusion which, of course, would have to come before any sort of possible regulatory conclusion as well. And, in fact, the current workplace data show, as I've said before, identically a relative risk of 1.0 in the pooled estimate across all the studies examining workplace data.

MR. DINEGAR: We're going to get to some of the specifics of the studies in a minute.

On the issue of RJR's statement that OSHA's proposed restriction would impose enormous costs with few demonstrable benefits, could you briefly explain to me the enormous costs involved in restricting persons who smoke to refrain from doing so indoors?

DR. COGGINS: I think Mr. Bohanon will attempt to answer that for you.

MR. BOHANON: Well, there are many different kinds of costs involved. The ones directly addressed by OSHA that we responded to, one of them had to do with the cost of constructing smoking rooms per the OSHA specification.

Another of the costs that are imposed by the proposed rule had to do with smokers having to move from the location where they normally perform work activities to the smoking rooms.

Another cost imposed by the proposed rule is that while smokers are in the smoking room they must refrain from doing any work and therefore that time is removed from their available time to be productive.

There are many other costs that would be classified as costs of choice or social costs by economists that weren't really brought into the proposed rule and that we didn't deal with directly but there are many costs. It's really a very broad economic question and I can highlight some of those issues but I'm not an economist and did not go into a detailed economic analysis.

MR. DINEGAR: Thank you. On the third point that you raised, is it your understanding that no working in smoking rooms is allowed to be undertaken?

MR. GROSSMAN: I'm sorry. Are you referring to
the regulation? OSHA itself has testified in response to my question on the first day of these proceedings, Dr. Silverstein testified, that under the regulation no smoking would be allowed in smoking rooms, rooms designated for -- I'm sorry, it's getting late. Dr. Silverstein testified that smoking would be allowed in rooms designated for smoking and no work could be conducted.

MR. BOHANON: Let me refer you to page 16,029 of the Federal Register where it says "It is OSHA's intent that no work of any kind shall be performed in a designated smoking area when smoking is taking place." So we thought that was pretty clear to interpret.

MR. DINEGAR: And it still is then your understanding that if a person goes in there, the room is empty and he decides or she decides to smoke in that room they are prohibited under the law from doing work in that room.

MR. BOHANON: Well, I don't know how else to interpret that without further clarification from the department. It says their intent, no work of any kind. That's fairly specific to me.

MR. GROSSMAN: Mr. Dinegar, your question is ambiguous. That's not the current law, that's the proposed regulation.

MR. DINEGAR: Thank you. I'm trying to determine whether or not I need to take up smoking.


MR. DINEGAR: ...that OSHA's proposed restrictions could reduce the productivity of the American work force in comparison with the work force of other nations, what worker productivity gains do you see would result from OSHA's restrictions?

MR. BOHANON: Is there a specific place where we were talking about that where I can refer?

MR. DINEGAR: It's one of your statements, that OSHA's proposed restrictions would reduce the productivity of the American work force in comparison with the work force of other nations.

I'm asking what worker productivity gains do you see would result from OSHA's restrictions?

MR. GROSSMAN: You're asking the inverse of the statement in Reynolds' submission?


MR. BOHANON: I don't know of any.

MR. DINEGAR: You can't identify any worker productivity gains by eliminating environmental tobacco smoke from the workplace?

MR. BOHANON: We have not identified any in our submittal to OSHA.

MR. DINEGAR: Please explain then how the American work force's productivity would increase in comparison with the work forces of other nations if more or all Americans took up smoking.

MR. GROSSMAN: That's not the implication of Reynolds' submission, and that's a terrible mischaracterization for no reason that could suit a regulatory purpose.

JUDGE VITTONE: If they didn't say it, Mr. Dinegar...

MR. DINEGAR: I'll rephrase this.

Regarding worker productivity of smokers forced to trudge down flights of stairs or press several elevator buttons in an effort to reach outdoors, why wouldn't it be fair to equalize worker productivity by requiring smokers who take such breaks to make it up beyond the hours of 9:00 to 5:00?

MR. GROSSMAN: Let me see if I understand your question. Are you saying that it would increase worker productivity to reserve all the breaks for outside the hours of 9:00 to 5:00?

MR. DINEGAR: Are you saying that worker productivity is reduced because people are forced to take smoking breaks? See that's what I read into your statement. And I'd like to make it very clear, that's what I understand from your statement.

MR. BOHANON: Can you give me a specific citation for that statement so I can find within our text where we made that statement? Maybe the surrounding paragraphs can clarify.

MR. DINEGAR: It's the press release or the statement that's left out on the table out front, on page two, and it's point three. "If adopted, the smoking restrictions in the proposed rule would have a severe adverse effect on American business and the rights of American workers. for example, the restrictions would," and I jump to point three, "reduce the productivity of the American work force in comparison with the work forces of other nations."

MR. BOHANON: You're asking me now to comment on a press release. That wasn't a part of my submission.

MR. DINEGAR: Well, I'm not...

MR. GROSSMAN: Mr. Dinegar, if you would like a submission by Reynolds on this that goes into greater detail we'd be happy to provide it. But if the panelists haven't testified on this, haven't provided statements on it, then this isn't the best use of our time.

JUDGE VITTONE: Mr. Dinegar, have you seen this press release or read it or anything like that, gentlemen?

MR. DINEGAR: None of you saw this? This sheet right here. The one that was out on the table and I picked it up two days ago? I believe it's still out there.

JUDGE VITTONE: It could be out there, and if they haven't seen it...

DR. NELSON: We have lots of paper, but...


(Panel looks at press release)

MR. DINEGAR: I didn't mean to throw you a curve.


MR. BOHANON: I think the references to productivity just have to do with the points that we made previously of the issue of smokers having to transport themselves from one place to the other, the issue of not being able to work within the designated smoking room, and the issue of time to go out of doors, which is another eventuality in the event that this proposed rule were imposed.

MR. DINEGAR: Good. Then I ask again. Regarding worker productivity of smokers forced to trudge down flights of stairs or press several elevator buttons in an effort to reach outdoors, why wouldn't it be fair to equalize worker productivity by requiring smokers who take such breaks to make it up beyond the hours of 9:00 to 5:00.

JUDGE VITTONE: You mean you want them to work later, if that's what they do.

MR. DINEGAR: If the worker productivity is reduced because they're taking smoking breaks, then balance the worker productivity by having the people who choose so smoke, because it's a choice, not an addiction, and make it up beyond the hours of 9?:00 to 5:00 or their regular work day.

MR. GROSSMAN: Let me see if I understand the question. You're suggesting that the Department of Labor promulgate regulations that require employers who provide the opportunity for their workers to smoke, to require their work force to stay later, to account for any times they took for breaks, when the smoked? Is that the question. You want the Department of Labor to promulgate such a regulation?

MR. DINEGAR: Is it Mr. Gross?

MR. GROSSMAN: Grossman.

MR. DINEGAR: No, actually, that's not mine. Actually, what I was asking was, are the breaks that smokers take to go outside or to use the separately ventilated rooms free time or on the company dime? If you're telling me that it's free time, then I'm trying to figure out how worker productivity goes down when the companies would charge the employees. I didn't say anything about Department of Labor requiring that. I read this twice and I didn't say OSHA or the Department of Labor or the federal government.

JUDGE VITTONE: With that clarification, Dr. Coggins, or any member of the panel.

DR. COGGINS: I certainly can't answer it. Anybody else?

MR. BOHANON: I think it's just one of those workplace situations that's going to come up in workplace by workplace. The situation is now that in some places smokers can smoke at their desk, at their workplace, uninterrupted, and do a continuous amount of work. What you're proposing of clocking in and clocking out, I suppose is a constrict that could be imposed in some workplaces, obviously wouldn't be imposed in others. One doesn't know what the outcome is going to be with any certainty. I think that would be an economic analysis of what those many, many decisions and outcomes might be.

The point is that if some of the outcomes are negative, that is that they're on the clock, then in total the result would be negative.

MR. DINEGAR: Actually, the assumption that you've just made is that people do not clock out for their smoke breaks, when there are a large number of companies that do, in fact, have people clock in and clock out and maintain the same level of worker productivity for all of the work force -- smokers or non-smokers.

MR. GROSSMAN: Your Honor, I just wanted to object to the testimony by Mr. Dinegar about what some companies do and some don't. He has many members of his association, and if he has information about which association members clock in and clock out, he can put it in the record.

MR. DINEGAR: Mr. Grossman, I guess the way I was laying it out is, what proof do you have that worker productivity is going to be adversely affected when you haven't gone through the policies including the different companies that do require people to check in and check out? You're making an assumption and then passing that information over to OSHA in testimony that worker productivity, I'll read again from the tremendous statement left out front, "will reduce the productivity of the American work force in comparison with the work forces of other nations."

If you think there's anybody in this room that wants to be held down according to other nations in terms of our worker productivity, you're wrong. So what you're coming up with are facts that are just getting spewed off to OSHA to claim that there's a reduction in...


MR. DINEGAR: ... the worker productivity.

JUDGE VITTONE: All right. Without hearing any more objections, can anybody respond to what his question is? Anybody on this panel?

MR. BOHANON: Let me give it a shot again.

There is a distribution of different smoking policies, working policies, pay policies, through out the country today. This rule would impose a change upon some, but not all, of those policies. When you change some of those policies, some of those situations in workplaces, there will be a distribution of different reactions. Some may be, as you have suggested, some may be as we have suggested, but in the end, there's not going to be a net improvement. There would be a net deficit if you look at the range of possibilities. To predict a numerical number for that possibility would then require an in-depth economic analysis of all those distribution probabilities and computation of some result.

We are anticipating that if one did that, since everything is skewed to one side of changing things the way people are doing things today, that the net would be a decrease.

MR. DINEGAR: Thank you.

Mr. Bohanon, in one of your statements, and I don't recall which page, I could look through and find it, you also mentioned that there's a feeling that a lot of the smoking rooms wouldn't be built. That it would be cost prohibitive to build out these smoking rooms. On the economic analysis that's been done, on the worker productivity side of things, has any information been provided by R.J. Reynolds regarding worker productivity on an increase, if you assumed again that it would just decrease.

I'm asking now, if worker productivity would increase because less people would be smoking, and therefore be healthier.

MR. BOHANON: The first assumption is that smoking, there's some inherent productivity difference between smokers and non-smokers, and I...

MR. DINEGAR: Absenteeism, yes.

MR. BOHANON: I don't believe that's the case when one takes into account all the various confounding factors. I believe Dr. Coggins can more fully address that.

When you're talking about the questions of increased productivity, if you're referring to the indoor air quality portion of the rule, Reynolds did not provide to OSHA evidence or testimony regarding increased productivity from implementation of the indoor air quality portion of the rule because our spaces in essence meet the requirements that OSHA has imposed. We ventilate our spaces to the American national standard, we maintain our equipment, we check our cooling towers, we prevent microbiological growth, we field complaints, we respond to them promptly. We do all the things that we can do to assure, in fact, the things recommended by OSHA. In general, maintain humidity under 60 percent, all of those things we already do. Therefore, we didn't really project any incremental cost of trying to comply with the essence of the indoor air quality rule, and therefore, making no changes to our operations, we would not be able to project any additional productivity increase for our specific operation.

MR. DINEGAR: It's been a very long day and I apologize if I misstated the question.

In the statement from R.J. Reynolds, it says that "OSHA has dramatically underestimated the cost for providing separate smoking areas. Given the exorbitant potential cost to comply with the rule, and to continue to allow smoking, it is likely that most, if not all businesses, would simply ban smoking at their facilities."

I'm then making the assumption that less people in the United States would smoke. You would have more people try to quit smoking. I'm asking if productivity because of less absenteeism has been factored into your worker productivity model.

MR. GROSSMAN: I'm going to object to that.

JUDGE VITTONE: Are you reading from the press release again?


JUDGE VITTONE: The press release is not part of the evidence of this hearing.

MR. DINEGAR: Well, a thousand pages was a bit to wade through. I thought we'd kind of cut it down to two pages.

MR. GROSSMAN: It doesn't add anything for the questioner to say that he hasn't read the submission, but he's read something that's not part of the record; then to ask questions about the document that is not part of the record and where those questions do not add to the body of knowledge that's before OSHA.

MR. DINEGAR: It's R.J. Reynolds' assertion that worker productivity would decrease. Is that nowhere in the thousand pages?

MR. GROSSMAN: Your Honor, furthermore, Mr. Dinegar's question is based on a presumption that if smoking were banned in the workplace, fewer people would smoke. OSHA has taken the position, again during the first two days of this hearing, that it has no intention of attempting to get people to stop smoking out of the workplace; and it presumes that people would continue to smoke at the same rates as before.

So unless Mr. Dinegar has evidence to the contrary of that which OSHA has suggested, I don't think the question has any relevance.

MR. DINEGAR: Mr. Grossman, with all due respect, until you switch sides and start working for OSHA, I'm not concerned with what OSHA's assumption was on worker productivity. I'm concerned with the statement that you provided to OSHA regarding a decrease in worker productivity.

JUDGE VITTONE: We've asked this question several different ways at least already. I don't know that this panel is any more able to give you any further information than the information they've already given you.

MR. DINEGAR: We'll move on to the next question.

JUDGE VITTONE: You keep getting Mr. Bohanon repeating some of the same stuff that we've already heard prior.

MR. DINEGAR: That's fine. I am reading through the statement, just for sake of discussion. I plan to finish some day.

Let's turn to the issue of infringing upon the personal rights of smokers, and then we'll get to the rights of businesses.

What are the personal rights of smokers?

MR. GROSSMAN: Your Honor, that, again, has nothing to do with the question of whether there's substantial evidence on the record of significant health risk from ETS in the workplace.

MR. DINEGAR: Mr. Grossman, I represent the office building industry, filled with thousands and thousands of work force employees. I'm trying to find out what the personal rights are of smokers, what the personal rights are of non-smokers so that when we infringe upon these different rights we understand where we're going exactly.

MR. GROSSMAN: Mr. Dinegar, my client is a member of your organization and it believes it's not well represented.


MR. DINEGAR: Trust me when I tell you the reverse is true.

JUDGE VITTONE: Can anybody answer that question? Do you have any thoughts on it?

MR. DINEGAR: Nobody from R.J. Reynolds can tell me what the personal rights of smokers are that would be infringed upon by OSHA's proposed rule?

MR. GROSSMAN: That is not a scientific question for a scientific panel, Your Honor. That is a rhetorical question.

MR. DINEGAR: No, it's actually not. I'm actually very interested to find out what are the personal rights of smokers. This is almost a tag line from your testimonies.

MR. GROSSMAN: Your Honor, could we move on to something else?

MR. DINEGAR: What are the personal rights of non-smokers?

MR. GROSSMAN: Once again, Your Honor, can we move on to something else?

JUDGE VITTONE: I think what we're talking about here is it varies from place to place and what people have negotiated and not negotiated, and what's required.

I really don't see that we're making any headway here, Mr. Dinegar.

MR. DINEGAR: RJR states that "OSHA's proposed restrictions infringes upon the rights of businesses to accommodate their employees and clients. Office building owners support OSHA's proposed environmental tobacco smoke restrictions, yet competitive markets prevent us from effectively removing an EPA-classified Group A carcinogen from the workplace."

What absolutely proof can you provide us that environmental tobacco smoke is not a contaminant which adversely affects high quality indoor air?

MR. GROSSMAN: Let me first object to the question. It began, "Reynolds says," and then it included such things as "EPA declared Class A carcinogen." Reynolds has never said...

MR. DINEGAR: No, no.

MR. GROSSMAN: ...anything of the kind.

MR. DINEGAR: The quote for R.J. Reynolds states that, "OSHA's proposed restriction infringes upon the rights of businesses to accommodate their employees and clients. B, Office building owners support OSHA's proposed ETS restrictions, yet competitive markets prevent us from effectively removing an EPA classified Group A carcinogen from the workplace."

JUDGE VITTONE: Okay, you've mixed two things there. You've missed what they said and what the position that you've taken in this proceeding is. Isn't that right? Isn't that what you just said?


The question is...

JUDGE VITTONE: What's the question?

MR. DINEGAR: ...what absolutely proof can you provide us that environmental tobacco smoke is not a contaminant which adversely affects high quality indoor air.

MR. GROSSMAN: Absolute proof? I believe there's been a great deal of testimony, Your Honor, on the question of who has the burden here and who has the burden under scientific investigation, and I think we're wasting time.

MR. DINEGAR: Does proof exist that second hand smoke is good for you?

JUDGE VITTONE: Mr. Dinegar, we have had extensive examination over this entire proceeding...

MR. DINEGAR: Your Honor, with all due respect, in representing the office building industry we've been told on one hand by EPA that it's a Group A carcinogen. Then we hear the defense from the tobacco companies, no, no. It's not a Group A carcinogen because their proof is lousy. They've done a poor job of doing the science. They continue to try to shoot down a Group A carcinogen label from EPA, which is really the reason that OSHA took this mantle up on environmental tobacco smoke. In that nature what I'm trying to do in terms of representing my members' interests is to find out which one is the truth so that we can go and follow that one, because otherwise we're caught in a very delicate position in the middle that's driving us nuts.

JUDGE VITTONE: What's your bottom line question on it?

MR. DINEGAR: Does proof exist that second hand smoke causes indoor air quality problems?

JUDGE VITTONE: I think we've gone over that, but I'm going to ask them to respond to it.

DR. COGGINS: Dr. Sears?

DR. SEARS: Mr. Dinegar, our written testimony and my oral testimony earlier, have addressed the issue of the epidemiology of lung cancer and heart disease. In my opinion, the epidemiology of both of those decisions does not show a significant increase in risk by exposure to environmental tobacco smoke.

MR. DINEGAR: So in your estimation there is absolutely no reason to single out environmental tobacco smoke from all other indoor air constituents?

MR. BOHANON: Yes, that is correct.

MR. DINEGAR: Can you briefly explain what other indoor air quality constituents you're talking about that you are singled out from?

MR. BOHANON: Well, it should be clear from reading the proposed rule that the section dealing with environmental tobacco smoke is singled out within the rule. It does, the scope of that section that singles out environmental tobacco smoke is much broader than the rest of the indoor spaces covered under the rule.

And if you look at the indoor air contaminants in constituents, if you'll look in my both written and oral testimony, will direct you to the table that OSHA has put together within this proposed rule. And if you look at the chemicals that are present in building materials, in office equipment, in supplies, in furnishings, and in there things that are normally in indoor spaces, you will find that there's a great similarity. The chemicals in many cases are identical.

Therefore if ventilation, through the ventilation based approach that OSHA proposes, that we agree with, if you use ventilation to reduce these chemicals from these sources, there's no reason why ventilation cannot be used effectively to reduce levels of identical chemicals that come from environmental tobacco smoke.

We find that when we make measurements in office buildings specifically, that when spaces are ventilated only to the minimum ASHRAE standard, that we measure very low levels of all indoor air contaminants, regardless of source.

MR. DINEGAR: Is it your assertion that the most effective way to attack indoor air quality problems is at the source? Or by increased ventilation and increased filtration?

MR. BOHANON: The most effective way to deal with indoor air quality issues is a multi-factorial approach.

MR. DINEGAR: Mr. Bohanon, I wasn't talking about issues. I'm talking about specific contaminants.

MR. GROSSMAN: Let the witness finish his answer, please.

JUDGE VITTONE: Let him finish the answer and then you can ask him another question.

MR. BOHANON: Is a multiple approach, if one looks at the compounds and the equipment and the items and even smokers that are within spaces, one finds that ventilation can drive all the levels down to very low levels.

In addition to that, that's not the one and only thing. We agree that proper maintenance of HVAC equipment is essential because there can be hidden biological growth and other unchecked growth that goes on in wet spaces and spaces that are not properly treated, in cooling towers that are untreated, can be breeding ground for Legionella. There are many, many aspects of indoor air quality, so I would hate to generalize and say that there's only one thing that you can do.

In the case of things like painting significant areas of the building, if you'll recall when I testified as to what our practices were, we made efforts to try and contain those areas, both by putting up temporary sheathing and by trying to ventilate the paint fumes out of the area. So our practices indicate that there are many things that one can do to assure that there's good indoor air quality. The point being that if spaces are properly ventilated for the common things that are in office spaces, including cigarette smoke, that the levels of contaminants will be very, very low.

MR. DINEGAR: Mr. Grossman, the reason I stopped Mr. Bohanon is because he wasn't answering the question that I asked, and rather than waste his time and his words, and your time, as you continue to look at your watch, it would have been more prudent to answer the question in the first place.

JUDGE VITTONE: Mr. Dinegar, restate your question.

MR. DINEGAR: Mr. Bohanon, I didn't ask you about the specific issues. I asked you one specific question. Is it more effective to attack problems of indoor air quality at the source of the problem, for contamination at the source, or to ventilate or filtrate? The example I'm going to give is, is it more effective if you've got a pile of horse manure sitting in the middle of your living room to open up all of the doors, to turn on the different fans, or to remove the pile of horse manure from the middle of your living room?

MR. GROSSMAN: Your Honor, I believe that Mr. Dinegar has received an answer to his question.

JUDGE VITTONE: Mr. Grossman, hold it.

Mr. Dinegar, I'm sure you're going to disagree with me, but we're not dealing with horse manure.


MR. DINEGAR: All right, then I will...

JUDGE VITTONE: Wait a minute. Let me ask you a question.

I have one more person behind you who has some questions. Do you still have some questions, Mr. Myers?

MR. MYERS: I do have a few, Your Honor.

JUDGE VITTONE: Five minutes, ten minutes?

MR. MYERS: Ten minutes.

MR. GROSSMAN: Your Honor, our panel needs a break. I've been informed....

JUDGE VITTONE: As I understand it, what time d you have to leave here?

MR. GROSSMAN: Six o'clock at the absolute latest to meet their flights.

JUDGE VITTONE: At my request they have rescheduled the flight. Based on the estimate we were talking about yesterday they scheduled it, and at my request they rescheduled it to a later time. Okay, your flight is leaving at 6:30 or something like that?

MR. GROSSMAN: Yes, before 7:00.

JUDGE VITTONE: How much longer are you going to be?

MR. DINEGAR: One last question. Same question, different words.


MR. DINEGAR: Page one, Mr. Bohanon of your statement -- not from the press release, not from anything on horse manure. Page one of your statement.

About halfway down, "There is no reason to single out environmental tobacco smoke from all other indoor air constituents"

The concept is very simple. If you burn your breakfast toast, you open the window and turn on the fan. There are engineering methods to do the same thing with modern HVAC systems.

My question, one last time, I hope, is wouldn't it be more effective not to burn the toast, rather than to have to open up the windows and turn on the fans?

MR. GROSSMAN: Asked and answered without the rhetorical flourish.

MR. BOHANON: I'll answer it.

JUDGE VITTONE: Go ahead, Mr. Bohanon.

MR. BOHANON: Very clearly studies have shown, in the studies that are extensively documented within the docket, have shown that if one ventilates through the ASHRAE minimum rate, then the incidental burning of cigarettes that goes on within the space is not of concern as far as the chemical levels. If you ventilate for all the other compounds that are in the air that are omitted from other sources, that ventilation rate will take care of the levels that are generated by cigarettes.

The converse is, if you allow things to build up, then not only should you not smoke in that space, but you shouldn't be in that space if it's a non-ventilated space.

MR. DINEGAR: I'm not going to ask it again. That's the end of my questions.


Let's take a very short, five minute break. I'm not leaving the room and I'm going to pound it down. In five minutes we're going to go to Mr. Myers and if we have time left, Mr. Furr, I'll give it to you, but I'm going to give him at least ten minutes.

Off the record.

JUDGE VITTONE: Back on the record.

Mr. Myers.

MR. MYERS: I will try to be very brief and to the point, and I have sat through the two days of questions and answers, so it's certainly not my goal at this late hour to duplicate anything.

There are a couple of times where questions were asked that answers didn't happen, and I may do that.

Let me start back, and Mr. Coggins you probably want to refer this to Mr. Bohanon, from what I understand.

In the material you did provide for the record concerning productivity, in which you projected a decline in worker productivity, I'm trying to understand, if I can, what it is you based the projection that there would be a decline in worker productivity. Was it because you believed or had data that workers would take more breaks or longer breaks?

DR. COGGINS: Yes, I think that is a question for Mr. Bohannon. Can you help us with that?

MR. BOHANON: No, it was not based on data. It was based on if you look at places where smokers currently are allowed to smoke in their workplace, and one says "setaris paribus" for economic analysis. Now you're not allowed to smoke there, you have to go to this other place, and when you're in this other place smoking, you are not allowed to work.

It appears that there is less productivity because even in a smoking lounge... let's take a simpler case. A case where there's currently a smoking lounge where people are allowed to work. Now this rule goes in place and people are not allowed to work. In whatever the conditions are, it would seem from an economic aspect, all other things being equal, that there would be a decrease in those people's productivity, because currently they can work in their smoking lounge. Under the rule they could not, to get to a simple case.

MR. MYERS: Mr. Bohanon, I'm not going to cut you off on anything because I want you to answer fully, but we have a real short time, so to the extent that you can get directly to the issue, it's important.

Let me understand a couple of times. You said you don't have data. You haven't done a study in a workplace that produced data, is that accurate?

MR. BOHANON: That is correct. There is no data, it's...

MR. MYERS: Have you done a study of any place that has gone smoke-free to measure relative worker productivity?


MR. MYERS: Have you evaluated in places that have gone smoke-free, whether individuals who smoke leave their work station more frequently for the purpose of smoking? Have you done a study of that?

MR. BOHANON: No, I have done no study.

MR. MYERS: Let me understand...

MR. GROSSMAN: Let the witness finish his answer before...

MR. BOHANON: No, I have done no studies of productivity.

MR. MYERS: Your projection then is based upon a belief that individuals who smoke will want to continue to smoke a certain number of times during the day, and therefore, will leave their workplace to go to this other place, is that correct?

MR. BOHANON: Let's go to the example I framed. There's a current smoking lounge. All other things being equal, if people are prohibited from working, then clearly, they will not be as productive.

MR. MYERS: Why couldn't the individual just not smoke during his or her normal work hours then?

MR. BOHANON: Because that's not a "setaris paribus" assumption.

MR. MYERS: Tell me what you mean by that.

MR. BOHANON: All things being equal. The economic question is, given a current situation imposing a change, what is the effect of that change and that change only.

MR. MYERS: There's a least one possibility that would alter the conclusion, and that is if individuals who smoke simply don't smoke during their working hours.

MR. GROSSMAN: Let me make an objection, Mr. Myers, and this may shorten your line of inquiry.

During the first day of testimony by OSHA I asked them to acknowledge that in their finding that there would be no loss of worker productivity in the workplace, they agreed with the position of R.J. Reynolds that those individuals who smoke have no dependency of any kind upon smoking, and if that was, in fact, their position, they should state it. There was also a questioning of...

MR. MYERS: I'm getting...

MR. GROSSMAN: Let me just say this for the record. It may shorten it.

We have no one on the panel who is a pharmacologist or who is a psychologist, psychiatrist, or other mental health professional.

If your questions are addressed to the question of dependency, we'd be happy to submit post-hearing comments on that, but this is not the correct forum.

MR. MYERS: First of all, in the limited time this isn't shortening things.

Second, I'm not sure why you're quite so paranoid about the dependency issue. I was asking about data that you possessed in assumptions that you were using. I may or may not get to a dependency question.

MR. GROSSMAN: I'm not paranoid about it, I...

JUDGE VITTONE: Mr. Grossman, you made your statement for the record.

MR. MYERS: The question I asked you, Mr. Bohanon, then was a pretty straight forward one. That was I was changing one of the parameters, and that is individuals amount of free time away from their work station isn't changed when the rules goes into place, and individuals who previously smoked while working stop smoking.

Now would that alter the projection, then, that worker productivity would go down?

MR. BOHANON: But that's not a valid basis for an economic analysis.

MR. MYERS: But would it alter it if that was the case?

MR. BOHANON: That's not the way one looks at a proposal economically. You're changing multiple variables. You can change variables and get any answer you want. In an analysis, the question is what's the impact of the rule? To do that, all other things being equal, you impose this rule on a population, in this case the U.S. work force.

MR. MYERS: So your assumption is that individuals who currently smoke ten cigarettes a day will continue to smoke ten cigarettes a day, but they will have to leave their workplace to do it. That's the assumption underlying your statement to OSHA that there will be a decrease in worker productivity.

MR. BOHANON: That's a basic economic assumption from an economic point of view that nothing changes.

MR. MYERS: That's RJR's presumption.

MR. GROSSMAN: That was OSHA's presumption on the first day of hearing.

MR. BOHANON: That's not my presumption. What I'm saying is in a smoking lounge people smoke. Now they can't work. Nothing else changes except that now they can't work by this rule. Therefore, there's a clear and obvious productivity decrease. Nothing else changes. That's the assumption one makes when making an economic analysis.

If you vary 100 different things, then you've got a very confusing answer where you have no idea what the economic impact is of a regulation. That's what we're trying to address.


MR. MYERS: Assuming that they have workplace rules that say you can take a break however often, every 15 minutes, an hour every 15 minutes, two hours, whatever that is, and they don't vary those rules. As you said, we're not varying things. So we don't change number of times you get a break in your place of employment. If that rules doesn't change, and therefore, obviously, a smoker will not be able to smoke during that period of time, then there's no evidence that workplace productivity will go down, is that right?

MR. BOHANON: In the case where there is a fixed rule in break time, then there would be no effect on productivity.

MR. MYERS: Is there any evidence that current smokers would have trouble obeying that rule? Do you have any evidence...

MR. GROSSMAN: Your Honor, I object to the question on the grounds that I already stated. We don't have any pharmacologist or...

JUDGE VITTONE: Thank you. The objection is overruled.

MR. MYERS: Do you have any evidence that workers who have difficulty obeying that rule?

MR. BOHANON: Difficulty obeying...

MR. MYERS: The rule that you get a certain number of breaks. No different after the rules goes into effect than before.

MR. BOHANON: Presumably if they're obeying the rule before, they would obey the rule after. Again, that's a specific assumption. People don't change. You only look at the effect of the rule.

MR. MYERS: Therefore, unless there was some drug-like effect to the product that would make a worker less productive, in fact as long as the employer doesn't change the number of breaks they give their workers, there should be no reduced productivity, isn't that right?

MR. BOHANON: In that small subset...

MR. GROSSMAN: I'm sorry. I didn't hear the question fully. Could you repeat the question?

MR. MYERS: Unless there is some drug-like effect to tobacco smoke that affects an individual's behavior, then if an employer keeps in place their current rules about when you can take a break and how long your breaks are, then the imposition of the proposed OSHA rule with regard to tobacco smoke, should not result in a decrease in worker productivity. Is that right?

MR. GROSSMAN: Are you including in the question, Mr. Myers, the question of employee satisfaction and happiness?

MR. MYERS: My question is very straight forward, and...

JUDGE VITTONE: I think the question is straight forward, Mr. Grossman.

Do you understand the question, sir?

MR. BOHANON: The question is unless there is some drug-like, you're asking me to predict people's behavior?

MR. MYERS: No, I'm asking you an economic assumption. That is, unless there is some drug-like effect to tobacco smoke that affects the workers' behavior, then as long as employers keep in place their current rules about when you can take breaks and how long those breaks are, the imposition of this rule should not affect worker productivity. Isn't that correct?

MR. BOHANON: No, that is not correct. That is not correct because you've got a whole bunch of broad statements here.

First of all, the assumption is that things don't change. So the blanket that there was no effect on productivity, would apply to a very narrow case where break times do not changes.

As far as a drug-like effect, I can't, I don't have any opinion or comment on that. Or as far as projecting why people may or may not behave the way they do. The assumption is that you only change one thing. If the situation is that the time of break is set by rule in the company, and then this rule would have no impact on that. I would agree that's a logical conclusion. Therefore, in companies that have that sort of rule, the regulation would not affect productivity in that subset of the whole population, but not as a broad statement for the whole population.

MR. MYERS: That was my question.

Dr. Coggins, I believe this is addressed most properly to you, with regard to the inhalation studies.

You've testified that you have also done research with mainstream smoke, is that right?

MR. BOHANON: Yes, I've performed inhalation studies with mainstream smoke, that's true.

MR. MYERS: Mainstream smoke as well.

Did you use the same species of rats used in your studies for environmental tobacco smoke.

MR. BOHANON: I'd say a rat is a species. They use the same strain. In general, as we were discussing earlier, there's a sort of a default position to the rat, and then within the rat there's really two choices that you could go. You could us an inbred strain called a Fisher, or you could use an outbred strain called a Sprague-Dawley. All of my work has used the outbred Sprague-Dawley rat.

MR. MYERS: For both mainstream and for environmental tobacco smoke?

DR. COGGINS: For both mainstream and the studies with our surrogate for ETS.

MR. GROSSMAN: Your Honor, Mr. Myers had asked for 10 minutes. It's now 15. We need 10 to 15 for minutes for --

JUDGE VITTONE: I am perfectly capable of keeping track of the time.

MR. MYERS: I don't have long, Your Honor, and I haven't wandered.


MR. MYERS: In your studies with this particular strain of rat of mainstream smoke, did your inhalation study produce an adverse toxicological effect?

DR. COGGINS: Which particular study are you referring to?

MR. MYERS: Any of the studies that you've done with mainstream. Inhalation studies you've done with mainstream smoke with the same strain of rat.

DR. COGGINS: Okay. So you're wanting to know if any of my studies with mainstream smoke have produced an adverse -- what was the other word you used?

MR. MYERS: Well, I was using the toxicological effect. The same factors you were looking at in your ETS studies, your surrogate for ETS.

DR. COGGINS: I'm sorry, you changed it again. Did my studies with mainstream smoke produce the same effects as I produced with ETS?

MR. MYERS: Did they produce any effects in mainstream smoke?

DR. COGGINS: A number of different changes were produced in the respiratory tract of the animals exposed to smoke. These were largely of a hyperplastic nature, we discussed hyperplasia, an increase in cell numbers, but the additional changes were produced in these animals exposed to mainstream smoke. Largely these were restricted to metaplastic changes in the conducting airways where we had a conversion of differentiated cell type from one to another. For example, in the larynx, which we discussed a couple of days earlier, we would produce a metaplastic change. We also saw -- in the longer term studies with mainstream smoke, you see some accumulations of free cells in the lungs, the so-called macrophages. So briefly --

MR. MYERS: How long were those studies?

DR. COGGINS: I believe for macrophage accumulations we needed about eight weeks, 13 weeks, something like that. But just to recap, the main changes were throughout the respiratory tract hyperplasia, metaplasia in certain of the conducting airways, accumulations of macrophages. One other change that was noted was an increase in certain areas of the lung depending on the exposure period, an increase in the number of goblet cells, mucus releasing cells. This has all been published.

MR. MYERS: Now, I don't want to mis-summarize it so I may use the wrong terms and feel free to correct me. My understanding is your conclusion from your inhalation studies with these rats is that the toxicological data you learned from those studies indicated to you that the toxicological data did not give reason to believe that the surrogate for environmental tobacco smoke was the cause of disease.

DR. COGGINS: We're talking now of my ETS studies? We've moved?

MR. MYERS: ETS studies I'm talking about.

DR. COGGINS: In the ETS studies, my conclusions were --

MR. MYERS: That the toxicological data in toto that you received did not lead you to believe that the toxicological evidence lent weight to the assertion that the surrogate for environmental tobacco smoke causes serious disease.

DR. COGGINS: My conclusion was given in one of my slides. Let me quickly flip through it. Which was that the conclusions -- the conclusion made by OSHA in their NPR, that the results are supported ... by animal studies ... is simply not supported by the data from those studies. That's the studies that are included in the NPR and then the data from my study, our study, which was only evaluated in a very cursory way. That's my conclusion.

MR. MYERS: And would your conclusion be the same for mainstream smoke? And that is, the results of your study do not support a conclusion that mainstream smoke is a cause of lung cancer or other serious disease as well?

MR. GROSSMAN: That's based both upon the published literature and Dr. Coggins' research?

MR. FURR: I'm asking about Dr. Coggins' research right now.

DR. COGGINS: You're asking does my work with long-term inhalation of mainstream smoke indicate --

MR. MYERS: Using the same phraseology you used earlier for ETS.


MR. MYERS: I want to know, would you insert mainstream smoke there, take out OSHA rule and just put lung cancer in? Would you say the results of your study reach the same conclusion with regard to mainstream smoke?

DR. COGGINS: Yes, I think that OSHA conclusion here, we're talking about epidemiological reports are supported by animal studies, is simply not supported. I think that I could make the same statement, in fact, did make the same statement earlier on in the day that there's epidemiological studies with mainstream smoke that have indicated a risk factor. Well, not risk factor, a hypothesis of a risk factor. When that risk factor was examined using the scientific method, by animals exposed, different species, different durations of time, to mainstream smoke, the results are uniformly negative in terms of producing lung cancers in those animals.

MR. MYERS: And that's part of the reason you conclude -- I have two more brief sets and then I'll be done.

JUDGE VITTONE: All right. Very brief.

MR. MYERS: That's one of the reasons you've concluded that there is no -- one can't say that mainstream smoke is a biological cause of lung cancer and other serious disease, it's because your animal studies don't support any epidemiological data, is that right?

MR. GROSSMAN: One of the reasons, counsel?

MR. FURR: Is it the reason? I also understood the lack of understanding of mechanism, too. That's the reason I was trying to put that aside for the moment, okay?

DR. COGGINS: I think the epidemiological studies with mainstream, as I say, indicate existence of a risk factor. Testing the hypothesis does not provide corroborative data. No.

MR. MYERS: Your tests don't provide corroborative evidence.

MR. GROSSMAN: I think you're mischaracterizing the testimony. The witness has testified not only as to his --

MR. MYERS: His --

MR. GROSSMAN: -- but to tests in the literature and I think you are attempting to draw an inappropriate reference from this witness.

DR. COGGINS: Yes. That's a good point. And that it's not just my study. When you examine the literature on mainstream smoke inhalation studies with experimental animals, and there are dozens of such studies, they also have come to the same conclusion as I. In other words, there is no increase in the background rate of lung cancer as a result of exposure to mainstream smoke.

MR. MYERS: Two brief sets of questions. And I will try to be done.

JUDGE VITTONE: All right. Quickly because --

MR. MYERS: It's to the panel but I assume that you'll answer it, Dr. Coggins.

Is it your overall position that environmental tobacco smoke is also not a cause nor does it exacerbate the condition of individuals with asthma? Do me a favor, say yes or no and then explain.

DR. COGGINS: No, I can't say yes or no. That's a complicated question and I'm not sure if it's within the -- but let me tell you that I have reviewed some of the papers on asthma. Asthma is indeed a multi-causative, multi-etiology agent. There is no single cause that has been identified. There are a number of different factors that are linked epidemiologically with asthma.

Some of those studies have indicated that environmental tobacco smoke may be involved, others have not. The evidence is not conclusive. I have some quotations in here but in the limits of time I may not be able to find them.

MR. MYERS: You can put them in the record later on. But to make sure I understand, what you are saying to us here, as you have said with regard to ETS and other diseases, you don't feel that based on your evaluation of the overall evidence that the evidence is adequate to conclude that ETS is either a cause or that it exacerbates the condition of asthma.

DR. COGGINS: Now you've changed it. You said exacerbate. I was talking purely of cause. In fact, even the EPA came to that conclusion, too, in their report. That they could not --

MR. MYERS: Okay. What exacerbate individuals?

DR. COGGINS: That's a whole separate set of arguments and I'm not sure of that literature as well. I do think that there are studies showing that in some cases ETS may be involved, other studies showing that ETS is not involved.

JUDGE VITTONE: All right, Mr. Myers --

MR. MYERS: Does R.J. Reynolds provide day care centers for its employees' children?

MR. GROSSMAN: Your Honor, it's past six o'clock.

MR. MYERS: Two questions. Do they provide --

MR. GROSSMAN: We have not had an opportunity for our questions and the plane is leaving.

JUDGE VITTONE: Okay. I'm going to call it quits, okay?

MR. MYERS: Could I ask that R.J. Reynolds provide that for the record?

JUDGE VITTONE: You can ask them to provide it for the record in writing, okay? As a post-hearing submission.

MR. MYERS: Thank you.

JUDGE VITTONE: Mr. Furr? It's six o'clock.

MR. FURR: Well, Your Honor, by my watch it's almost five past six. In the interests of everyone catching their plane, I'm not going to ask any questions today. I do want to state for the record that we will be clarifying in our post-hearing comments some points that we would otherwise have clarified here today.

JUDGE VITTONE: I was going to say that if that's what you wanted to do, you could submit a clarifying comment.

MR. FURR: I also wanted to ask that once we could get these witnesses moving I have an objection I want to place on the record.

JUDGE VITTONE: All right. Fine.

JUDGE VITTONE: Let's go back on the record. We have back on the stand Dr. Hedge.

Thank you for returning. I should have said thank you to the panel from the R.J. Reynolds Tobacco Company. I appreciate their time for the past three days and their cooperation. We've have three extensive days, two days a very extensive amount of questioning and I appreciate that very much and I'm sure the OSHA panel does, too.

Thank you, gentlemen.

Now we have Dr. Hedge back on the stand who has graciously returned and I thank you for your patience in waiting, sir, and I'm going to turn it immediately over to Ms. Sherman.

MS. SHERMAN: Welcome back, Dr. Hedge.

DR. HEDGE: Thank you very much.

MS. SHERMAN: Thank you for waiting.

Dr. Hedge, we were having a very interesting discussion the last time you were here and I hope I do not re-ask any questions I've already asked. I've tried to review the transcript to make sure that doesn't happen but you'll bear with me. And if you remember answering something, let me know and we'll go on to the next thing.

On page four of your docket submission, you stated that there was little difference among the five different smoking policies. I think that was including smoking prohibited, smoking restricted to a separately ventilated room and recirculated from the smoking room, with and without air cleaning and the restricted to the cubicle, work stations or offices.

In Figure 1 of your submission, though, it seems to me that you show that all the options except the smoking prohibited expose smokers to ETS. Doesn't the exposed versus the non-exposed show a significant difference?

DR. HEDGE: Are you referring here to the effects of policies on indoor air pollutants or the effects on symptom reports?

MS. SHERMAN: I believe I'm referring to page four of your submission where you're referring to policy reports.

DR. HEDGE: Right. There I'm talking about effects on indoor air quality among the different policies and not to any symptom reports by people.

MS. SHERMAN: Oh, okay. So I don't have the same -- so this is --

DR. HEDGE: Well, it says little difference in the effects of alternative policies on indoor air quality and what I mean by that is that when we look -- rather than looking at variability among the buildings or between buildings, when we look at the five policies, then in fact there are few significant policy effects there.

If you look at the paper I published in the Annals of Occupational Hygiene, the tables there give the policy means for each of the environmental conditions that we measured.

MS. SHERMAN: Well, if you look at Figure 1, I don't know if it has a page, I guess it would be page 12. It's an unnumbered page. Perhaps I can just pass this over to you.

DR. HEDGE: Right. Thank you. That's right. It's nicotine concentrations. Yes.

MS. SHERMAN: Okay. Are the buildings in Figure 1 the buildings that you're referring to on page four?

DR. HEDGE: Let me clarify.


DR. HEDGE: There are two different things happening here. This figure represents the concentrations of the whole office buildings. That is, when we look in the center here these buildings labeled RF, which are buildings with restrictions in air filtration, that means those are the averages for the office areas which are non-smoking and for the smoking rooms, these are building means.

When I talked here about the different smoking policies, I was talking about the exposure of office workers in the offices. In other words, this includes the smoking areas. If you look at the tables here were I break down what you would get if you were in a building and didn't go into those smoking areas --

MS. SHERMAN: I see. Okay.

DR. HEDGE: So that's where the confusion comes in here.

MS. SHERMAN: Okay. I understand. Thank you.

Can I have the table back?

DR. HEDGE: Certainly.

MS. SHERMAN: Thank you.

I think also on page four you expressed non-smokers' exposure in terms of cigarette equivalents. Is that correct?

DR. HEDGE: Yes. That's making an estimate and that's a crude estimate that I talked about the last time in my oral testimony.

MS. SHERMAN: Yes. Are you aware that in the 1986 Surgeon General's report they concluded that the use of cigarette equivalents is essentially a meaningless method of assessing non-smokers' risk and a confusing method of expressing exposure?

DR. HEDGE: I was not here trying to characterize risk as such but to try and relate the information that we had on air contaminants back to something that people might be able to relate to. I don't know of any other way of doing that other than this kind of method and that's why it's fully described there. But I can't comment on the validity of the method. I suspect it must be fairly crude since we are taking area measures here anyway, as we talked about last time.

MS. SHERMAN: I think that on page five you stated that ultraviolet particulate matter is a measure of the tar aerosol or RSP in ETS? Is that correct?

DR. HEDGE: Yes, I would have stated that. At the time that this work was done, I think that was the only measure that generally was available and since then I believe there's something called fluorescing or fluorescent particulate matter, which is supposed to be a more sensitive measure.

MS. SHERMAN: Do you have information that there is a one-to-one correspondence between ETS RSP and UVPM?

DR. HEDGE: No, I don't. In fact, in the paper that we published on the physical data here, we looked at the correlation between nicotine, RSP, UVPM and the correlations, although there are some significant correlations, the correlations are in the .3, .4 range which suggested there's considerable variability.

MS. SHERMAN: So then the UVPM is only a fraction of the ETS RSP?

DR. HEDGE: No, no. Let me clarify that. RSP in our measures was gravimetric RSP and UVPM is derived from that RSP, from the paper on which the respirable particulate is being collected. And so those two measures are correlated. There's a correlation because one is derived from the other. I don't know what the total particulate fraction from cigarettes would be because we don't know what's in that RSP. In other words, we're just measuring everything at two and a half microns. We don't know how much of that may be coming from cigarette smoke.

MS. SHERMAN: Well, we're asking about ETS RSP. Does that change your answer at all?

DR. HEDGE: The RSP I'm talking about here is simply RSP measured at two and a half microns and also at three and a half microns. I can't say that that's ETS RSP. We use UVPM as a way of trying to estimate what the ETS RSP would be.

MS. SHERMAN: So the UVPM does not necessarily track the ETS RSP in a growth and decay curve?

DR. HEDGE: Again, I can't comment on that because we aren't measuring or we didn't measure ETS RSP. What we measured was RSP. Gravimetrically, we measured respirable particulates at two and a half microns and below and we don't know how much of that in the air in buildings is coming from cigarettes and how much was coming from other sources. Then from that sample we take a fraction which gives us our UVPM value and so there is a correlation between that measured RSP and UVPM but we don't knew whether the UVPM is in fact indicating that all of the RSP we measured was environmental tobacco smoke or 50 percent or 10 percent. I can't say. And then we also measured RSP at three and a half microns and needless to say that correlates to RSP at two and a half microns but it's not a perfect relationship because we don't knew where the largest samples are coming from.

It was not the intent of this study to look at how constituents might correlate with each other. We were just trying to find some field markers of potential environmental tobacco smoke.

MS. SHERMAN: On page seven of your docket submission, you implied that apart from nicotine and RSP, non-smoking workers in office areas with less restrictive smoking policies are not exposed to significantly greater indoor air pollution than non-smoking workers working in areas where smoking is prohibited. Is that correct?

DR. HEDGE: From the data that we have. Yes.

MS. SHERMAN: Isn't it true that ETS tracers other than nicotine and RSP, for example maybe carbon monoxide, are either non-specific for ETS or are not emitted in sufficient quantities to be good ETS tracers?

DR. HEDGE: Yes, that's certainly true. And in fact, I think in the paper we've placed some caveats on this and we say categorically that this situation would not apply if you were a non-smoker, for example, who was standing adjacent to a smoker who lit a cigarette because what we were looking at here to collect the nicotine samples and the RSP and the UVPM samples, we're looking at a time weighted average and so we can't generalize beyond that.

MS. SHERMAN: In your paper on the effects of smoking policy on indoor air and sick building syndrome I think in 18 air conditioned offices --

DR. HEDGE: Right. Yes.

MS. SHERMAN: Is that the correct title?


MS. SHERMAN: You state that you adjusted the results for BSS, I think that's what you called it?

DR. HEDGE: Building sickness score. That was a term that we coined back in the '80s.

MS. SHERMAN: So many acronyms.

DR. HEDGE: I know.

MS. SHERMAN: And so you adjusted the results for the building sickness score for sample size. Could you explain how the adjustment was made?

DR. HEDGE: That's what we mean by adjustment, is just the statistical adjustment that I'm talking about there, that we're looking at the least square's means.


DR. HEDGE: I believe in that 18-building study that's what we were talking about there.

MS. SHERMAN: I don't know if I asked for the questionnaire that you used on the 18 air conditioned offices.

DR. HEDGE: I have a pile of information, if that's the correct terminology, that you requested.


DR. HEDGE: And I would like to very quickly take you through that, if I may.

MS. SHERMAN: Certainly.

DR. HEDGE: Your Honor, if I may submit all of that and take you quickly through there and explain what is here.

There were a number of things that you asked that I wasn't able to give information at the last hearing and not all of it is here, there's just a little bit of information here.

You asked about where our analyses were done and I told you they were done by International Technologies. For the nicotine and the UVPM and the gravimetric RSP, those samples were analyzed in the lab facility in Knoxville, Tennessee and for formaldehyde, they were analyzed in an IT lab facility in Cincinnati, Ohio. So that's where they were done.

In the information that I've just passed you, the first sheet is in fact a correction of the Figure 4 that you had in which we inadvertently put a line between policies in the wrong place. It's not that the data were wrong, it's just that our post-data graphics were slightly wrong.

I also enclosed a copy of a letter that I sent to all organizations asking whether they would grant permission for their name to be given to you and also whether they would grant permission for floor plans to be given to you.

There's a spreadsheet here that gives you all of the buildings that we looked at by policy and gives the type of company that we looked at, the city where the building was, the state. The month and the year that the buildings were surveyed, whether it was single or multiple tenant. And then just whether or not we've received any reply on this release form that we mailed out before Christmas.

And since we've only had a sort of handful of replies from that, I haven't yet prepared the list of organizations. Some have said no, some have said yes.

In addition, you expressed an interest though not a specific request to see the original data for all 27 buildings.


DR. HEDGE: So what we've done is to give you the mean -- these are the data on which this paper is based and the testimony on the 27 buildings is based, the physical environment data. These are the means for each of the eight sites in the buildings that we surveyed.

Where we have things like carbon monoxide, carbon dioxide, temperature, relative humidity and illumination that were measured with portable meters, the value for a site represents the mean sampled over a morning or afternoon period. Where you see the values for nicotine, UVPM, formaldehyde, those are the time weighted averages. So I just wanted to clarify that. Some of these points are means of a series of points but they all correspond in time, so those correspond.

And on each of these, we've separated out or we've tried to highlight what the smoking areas were and what the non-smoking areas were and where those smoking areas are. So you have there all of the original physical data that we were working with.

MS. SHERMAN: Thank you. And I was going through the transcript last night and I did see that I asked you for a bunch of stuff and you are going to have considerable time to submit but thank you for doing this now.

DR. HEDGE: Also, I submit something here which shows you the percentage of smokers and non-smokers in each of the 27 buildings so that you know how many people are smoking. And then you had asked questions about estimated work exposure and you'll see from the questionnaires, there are three questionnaires: the questionnaire we used in the smoking prohibited buildings, the one that we used in the spatially restricted buildings and the one that we used in buildings where smoking was allowed at individual work stations. Based on results from those questionnaires, we also compiled this figure which is non-smokers' reports or estimates of how many hours a day they are exposed to other people's cigarette smoke in their building. And so you can see by policy, these are just for the policies where smoking is allowed, you can see the pattern of estimated exposures. There are two things to point out here. One is this building was surveyed early on before we had all of the smoke exposure questions in the questionnaire, because as we did surveys we improved the --

MS. SHERMAN: Dr. Hedge, we are sitting across the stage from each other and of course I haven't had a chance to examine these but just could I interject since you have that waved in the air right now? How were the estimates made of the amount of exposure? Was that from the questionnaire?

DR. HEDGE: From the questionnaire. We asked whether people were never exposed, less than one hour, one to two, two to three, three to four.

MS. SHERMAN: So this is the person's own estimate.

DR. HEDGE: The person's own estimate. And we asked for their estimated exposure at work, at home and in other places. And then we used those estimates to have an estimate of workplace exposure and an estimate of total exposure. And then you asked for the three regression analyses that we did and I've given you copies of the printouts here which look at the relationship between estimated total exposure and reports of symptoms between estimates of work exposure and reports of work-related symptoms, i.e., symptoms that people say get better when they leave the workplace. And then that same analysis excluding the workplace exposure. Although workplace exposure was just barely significant, below the 05 level, it actually only added .0008 to the R squared value for our regression model and that was the reason that we concluded that it wasn't a major factor in reports of the sick building syndrome.

MS. SHERMAN: Dr. Hedge, refresh my memory. Was it you who were making the conclusion that the thing was workplace related or was it the complainant?

DR. HEDGE: It's both. We asked whether, as you'll see from the questionnaire, whether a person experiences a symptom and if they experience it whether the symptom is alleviated, stays the same or gets worse when they're away from the workplace. And when we look at the total exposure, we just simply look at the symptoms people are reporting, because they could be reporting symptoms that are caused by things outside, exposures outside the workplace. When we look at the workplace exposure, we're looking at only those symptoms that people say improve they're away from the workplace. And typically the prevalence for those is something like 10 percent below the general level of symptom reporting.

MS. SHERMAN: Was there a cutoff point as to how long after they left the workplace that they would improve?

DR. HEDGE: No, there isn't. I don't think any questionnaires have that in them. I think in fact we say some days away from the workplace in the same way that --

MS. SHERMAN: Excuse me?

DR. HEDGE: I believe in the questionnaire we may -- and here I get confused with the British questionnaires where we phrased it as days away.

The question we asked is "During the past month, how often have you experienced each of the following symptoms while working in this building?"

And then "During the past month, what happened to these symptoms at times you were away from work, for example, evenings or weekends?" And they can say it got worse, it stayed the same or it got better. And the symptom is scaled, I never experience it, experienced it one to three times in the past month, one to three times a week and almost or every day.

MS. SHERMAN: So you made the decision based on the self-reporting -- I'm sure I'll understand better when I look at the questionnaire itself but I guess what my question is, did you factor in the fact that some sick building symptoms take longer to mitigate after leaving buildings than others?

DR. HEDGE: Well, no, we didn't. I don't actually know of any good evidence that that indeed is the case. What we have here is a questionnaire which essentially asks about symptoms in pretty well what is the standard way now that research groups ask about those. And we analyzed the data in two ways, either by not making the symptom reports conditional or by making them conditional, that a symptom has to improve when you're away from the workplace for it to potentially be related to something that is in the workplace. But, no, we didn't ask about the length of time it took for a symptom to resolve itself after leaving work.

In addition to that information, since the analyses are based on a count of the number of symptoms that people are reporting, what we also have done is to go through our data and there are a series of figures that you'll have here and to do a symptom-by-symptom analysis for non-smokers looking at their estimated exposure to environmental tobacco smoke and looking at their symptom reports and what I'm giving you here are the figures that come out just for those symptoms where there is a statistically significant difference in the distributions but then I've plotted those distributions so you can see that because we have a very large N size, over 2000 workers here, the Ti-square values are actually being driven by relatively small differences in percentages but this shows you the patterns for those symptoms.

MS. SHERMAN: So that describes what you've been able to bring here today.


MS. SHERMAN: I'll look forward to reading through it. In your survey of the occupants in the 18 air conditioned offices, you presented the results of sick building syndrome symptoms and you lumped smokers and non-smokers together, I believe?

DR. HEDGE: That's correct. We found no significant difference between smokers and non-smokers in their symptom reports.

MS. SHERMAN: So you didn't find that smokers and non-smokers had different irritation or odor thresholds to ETS?

DR. HEDGE: That's not what I can say from what we collected. I can say that there is no -- the symptoms that we're asking about are symptoms that have come to be known as those of sick building syndrome and although some of them are irritation symptoms, they're not necessarily specific to environmental tobacco smoke.

What we find is that the symptom reports are comparable for smokers and non-smokers for those symptoms. Now, that's not to say that there aren't irritation symptoms linked to environmental tobacco smoke exposure. I think that's a different statement and we haven't measured that specifically.

That may well be addressed by the analyses that I've just provided which give you the non-smokers estimated exposure to environmental tobacco smoke for specific symptoms, so you can see how as exposure time changes there's a difference between smokers and non-smokers. But the difference is a relatively small difference.

MS. SHERMAN: Have you looked at how the differences -- what the differences are between ETS exposure and sick building syndrome complaints? Aren't they the same types of complaints?

DR. HEDGE: The problem with sick building syndrome complaints is that the symptoms are non-specific and therefore they could be related to a whole variety of exposures.

MS. SHERMAN: So one just doesn't know.

DR. HEDGE: One just doesn't know. Right. Except that smoking status doesn't figure in any of the multi-variate regression analyses that we do as being an important variable, compared to the really powerful variables which are the level of stress the worker is under, their perception of air quality and the agenda of the literature.

MS. SHERMAN: I think that on page six of your submitted comments under paragraph 3.10, you indicated there was little variation in thermal conditions amongst the buildings and that the temperature was not significantly associated with the sick building syndrome.

DR. HEDGE: That's correct. Yes.

MS. SHERMAN: Then in paragraph 3.11, you indicate "An analysis of an individual perceived indoor air quality questions showed that air temperature was the dominant influence on perception of IAQ."

DR. HEDGE: This is the perception that conditions may be too warm. The perception of whether the environment is too warm or not unfortunately is not simply predicted by air temperature. The sensation of thermal discomfort relates to a variety of factors such as air temperature, relative humidity, air velocity. It relates to activity level. It relates to the clothing insulation value. And to radiant temperature. And we only measured air temperature and relative humidity, so we weren't able to characterize the full spectrum of the thermal conditions.

So what I'm talking about here is the scale. The perception of indoor air quality scale has a question in it which is do you rate the environment as being too warm, as you'll see from the questionnaire. What I'm saying is that is a very powerful question and it does relate to air temperature but it's not a one-to-one correspondence.

And one of the problems we have, of course, is remember we are measuring air temperature at the sample. We are measuring air temperature at the sample sites and around those sample sites you have individual employees who are completing the questionnaire. So it's quite possible that an employee, for example, could be sitting by a window and be getting radiant heat gain from the winter sun and report that the environment is too warm when that isn't reflected in the air temperature that we measure in the building.

MS. SHERMAN: I think on page seven in paragraph 3.15 you mentioned that the results show that constant or variable air volume systems can both provide sufficient ventilation to satisfactorily dilute the air pollutants produced by the levels of smoking activity which were observed among several alternative restrictive smoking policies. That's true?

DR. HEDGE: Yes. We only looked at those two types of systems in buildings.

MS. SHERMAN: What is your basis for concluding that the CAV or the VAV can provide the sufficient ventilation to satisfactorily dilute the air pollutants?

DR. HEDGE: Well, first of all, we were looking at the carbon dioxide levels which give us kind of a surrogate of ventilation adequacy and the levels that we saw in the buildings invariably as you'll see were well below the 1000 parts per million that ASHRAM 62-89 cites as a comfort level. Secondly, the fact that we actually found very little variability between the different policies in the contaminants that we were measuring. And thirdly that we didn't find sick building syndrome symptoms actually co-varied by either policy or by the contaminants that we were measuring.

MS. SHERMAN: Did you say you measured for carbon dioxide or carbon monoxide?

DR. HEDGE: Both.

MS. SHERMAN: And how did you decide what to measure for?

DR. HEDGE: When we started the study, we looked at carbon dioxide as an indirect indicator of ventilation rates and occupancy, although we weren't calculating ventilation rate. We looked at nicotine, UVPM as being constituents of environmental tobacco smoke, carbon monoxide as being a potential constituent of the smoke as well as being a constituent from car exhaust which may cause problems in buildings. Formaldehyde as being something that may be produced by smoke or may come from other sources such as laminate and presswood products in buildings. And contrary to Mr. Grossman's statement, it does not come from the carpet in buildings. So we really just selected the kinds of contaminants that when this was being planned in 1989 were generally being measured in buildings, temperature, humidity, lighting levels.

MS. SHERMAN: Outside of temperature and humidity, you measured carbon monoxide, carbon dioxide, formaldehyde --

DR. HEDGE: Nicotine.

MS. SHERMAN: Nicotine --

DR. HEDGE: Respirable particulates and ultraviolet particulate mass.

MS. SHERMAN: And that's about it?

DR. HEDGE: That was the repertoire.

MS. SHERMAN: You didn't look at solanesol?

DR. HEDGE: No. No.

MS. SHERMAN: Do you have any experience measuring solanesol?

DR. HEDGE: No. In fact, I believe in '89 --

MS. SHERMAN: Perhaps nobody did it.

DR. HEDGE: Yes, that's right. We did at one stage think of looking at cotinine and we were thinking of possibly salivary cotinine as well. But we were primarily interested -- remember, the motivation behind the study was not necessarily to find out what the exposure of an individual is as to what the ambient conditions are in buildings that are operating in different policies. So our unit of analysis was really the building.

MS. SHERMAN: Now, I think that you said in relation to this that you didn't calculate the ventilation rates but they somehow -- you figured it in?

DR. HEDGE: We were using carbon dioxide here as an indirect indicator to ensure that -- on the assumption that if we are seeing carbon dioxide levels around the five, six, seven hundred parts per million then the space is likely to be adequately ventilated for the occupancy of the space. But we didn't set out to calculate a ventilation rate as such which would necessitate doing simultaneous indoor and outdoor measures. And, in fact, there is some debate as to whether carbon dioxide is even a good indicator of ventilation rates. And some people argue that one should use tracer gas like sulfur hexaflouride and then it becomes very complex to characterize a large variable air volume ventilation system. We simply didn't have the resources to do that.

MS. SHERMAN: How many occupants were in these sites that we're talking about? In other words, were there enough to generate a carbon dioxide trace?

DR. HEDGE: Oh, yes. I mean, as you'll see from the paper, these are large buildings and we're looking at samples of a couple hundred people in each building. A typical floor in a building would have -- if it's a tower block, would have 100 to 150 per floor.

MS. SHERMAN: Just as a reference point, I believe that you wrote in your comments that the CAV or the VAV can provide sufficient ventilation to satisfactorily dilute the air pollutant. So what was the level that you considered satisfactory?

DR. HEDGE: That's based on ASHRAE -- well, ASHRAE has a definition of acceptable indoor air quality and we were simply taking what we measured and relating it to the figures that are published in ASHRAE 62-89 and saying that the carbon dioxide levels are below the published level, the carbon monoxide levels are below that, the formaldehyde level was below the published levels and so forth. So that was the basis for that statement.


DR. HEDGE: That's not to say people were happy with the air quality in the buildings.

MS. SHERMAN: If I remember the ASHRAE 62-89 correctly, they're talking about achieving an 80 percent satisfaction rate?

DR. HEDGE: That's right. One of the problems with their definition is it doesn't actually specify how to measure what is construed as acceptable indoor air quality.


DR. HEDGE: In fact, we make the statement, I think, in one or other of the papers that although in terms of what we objectively measured these buildings all would appear to meet ASHRAE 62-89 in terms of subjective measures or satisfaction with air quality, none of the buildings, I believe, met that 80 percent satisfied standard. And so I think that essentially the subjective and objective variables are actually decouple in buildings.

MS. SHERMAN: If I can understand what you just said, ASHRAE feels that if you achieve an 80 percent happiness ratio --

DR. HEDGE: Right.

MS. SHERMAN: -- you're okay and they think that those numbers will achieve it. What you found in your study is that you met ASHRAE's numbers but you're not sure that you had 80 percent being happy.

DR. HEDGE: Oh, we're absolutely, categorically sure that we don't have 80 percent satisfaction.

MS. SHERMAN: So perhaps ASHRAE has to revisit their --

DR. HEDGE: Absolutely. I mean, the problem with the ASHRAE standard is the 80-20 division actually is, I think, a carryover from their thermal comfort standard which was 80 percent of people satisfied with thermal conditions. And as far as I know there's no empirical evidence to support that view other than one study published that is a Danish study that looks at carbon dioxide levels and I think at a 1000 parts per million you start to get more than 20 percent of people reporting discomfort.

What we -- the problem we have with the ASHRAE definition is it doesn't tell us who the 80 percent of the people are. It doesn't say whether those are people sampled at one point in time or how often it's 80 percent or it could be the same person time and time again. Or what would happen if you had a floor -- say you had 10 floors in a building with 200 workers on a floor and all 200 workers on one floor complained and nobody else in the building did, you would meet the ASHRAE standard for acceptable air quality. There are lots of quirks and nonsensical aspects to that definition. It doesn't tell us how to measure satisfaction or anything.

MS. SHERMAN: Well, now, in your case, did you take lots of measurements and put them all together to get your 80 percent or was this within a congruent sample area?

DR. HEDGE: Well, we had two ways of doing that. When you see the questionnaires, there are a series of questions, do you believe that there is sufficient ventilation, do you believe that you've got enough fresh air, these kinds of questions. So in part I'm basing my statement on responses to individual items and then in part I'm kind of responding to people's overall -- when you aggregate across a series of things, what does the figure look like for the perception of air quality.

MS. SHERMAN: But the ASHRAE numbers, if I've learned anything at this hearing, are comfort base and they're not necessarily health based?

DR. HEDGE: Well, that's very confusing because ASHRAE sidesteps that issue. A thousand parts per million for carbon dioxide, my understanding is that really is a comfort level. I don't know of any health data on that. Yet ASHRAE then in the appendices presents tables from World Health Organization and from the American Conference of Governmental and Industrial Hygienists which really are giving health-based figures. And so the standard has a mix of comfort and health figures in there.

MS. SHERMAN: Are those appendices part of the standard or how does one read the standard? Are these considered guidelines?

DR. HEDGE: Well, in the definition of acceptable indoor air quality, they state that there will be an absence of contaminants at levels judged to be hazardous, I'm paraphrasing, hazardous to individuals as determined by cognizant authorities and then they present a series of appendices. And I don't think they specifically say, you know, to find out whether formaldehyde is a problem, look at appendix 113. I think they give both federal and state levels where they have those and so it's confusing.

The other problem with the ASHRAE standard is it's a design standard really and it's not a mandatory national standard and it's not intended as an operational standard as such.

MS. SHERMAN: Doesn't the forward to the ASHRAE standard say that with respect to tobacco smoke and other contaminants the standard does not and cannot ensure avoidance of all possible adverse health effects?


MS. SHERMAN: So this is just something else for us to consider?

DR. HEDGE: Yes. The standard is written in very confusing language because it starts essentially by saying that we're not a health standard, we're a technical design standard. And then in the definition of acceptable indoor air quality, they introduce the health dimension, and then to add confusion to that, in the appendices, they cite some standards from organizations like World Health Organization. So there's a good deal of confusion as to just what the status of that standard is.

MS. SHERMAN: I don't know about your experience but I've found that a lot of consensus organizations produce confusing documents.

DR. HEDGE: I think they did the best job they had with the limited information available at the time and I believe that the next revision of the standard will see a substantial improvement in the precision of what's contained in there.

MS. SHERMAN: On page eight when you discussed breathing zone filtration systems which could be used to contain indoor air pollutants released by cigarette smoking at the work station, what markers of ETS did you use to determine what the level of worker exposure was before and after the installation of the breathing zone filtration systems?

DR. HEDGE: The fact is that I haven't and didn't. That statement is made simply as a you can also use this system. It was originally designed -- the commercially available systems were originally designed to capture contaminants, environmental tobacco smoke contaminants. That was the idea behind them, that workers would breathe into these filtration systems. I personally haven't collected any data on that. The data that I collected was what came out of our study was one of the areas of interest was looking at manmade mineral fibers in the dust in buildings and we found that those fibers were coming predominantly from the ceiling systems in buildings and therefore filtration within the ventilation system wouldn't actually affect the levels of fiber shedding within a space. So the studies that I have been involved in with the filtration system have looked at other contaminants within the space, particularly particulates and fibers. And so that was a carryover from the original design intent of this kind of system.

MS. SHERMAN: Are these systems widely utilized?

DR. HEDGE: Well, that's a difficult question to answer because in part it depends on how one characterizes the system. Because what's grown up in the last five years are a whole series of small portable personal air cleaning systems and some employees can have them on their desks. The system I was talking about I would say is not widely utilized but within the sales of the type of furniture, it's probably utilized in about 50 percent of the sales there. But the major furniture manufacturers haven't yet taken this system on board but there are a whole variety of variants on this kind of filtration system.

MS. SHERMAN: And you didn't mean these little individual air cleaners.

DR. HEDGE: No. No. These are large HEPA filter based systems that can move sizeable volumes of air through the system.

MS. SHERMAN: I believe that your studies appear to indicate that the majority of the buildings had carbon dioxide levels below 800 parts per million?

DR. HEDGE: That's correct.

MS. SHERMAN: So would you agree that ventilation rates to keep carbon dioxide levels below 800 parts per million could be easily attained?

DR. HEDGE: In the buildings that we looked at, they could be easily attained. It becomes questionable quite why one would want to attain them, since we find no clear relationship between the carbon dioxide levels and the symptoms people report in the buildings. But, yes, I'm sure they could be attained.

MS. SHERMAN: In one of your articles, you indicated that many companies have chosen to implement spatially restrictive smoking policies rather than prohibit smoking. Were you referring to the specific companies that you studied or where is that coming from?

DR. HEDGE: I was referring to information from the IFMA surveys. I believe I mentioned the IFMA surveys the last time around.

MS. SHERMAN: Yes. Okay.

DR. HEDGE: IFMA does a survey either every year or every couple of years where they poll their members and ask what kind of smoking policy they are operating. I suspect what you'll find is that buildings that are in the more inclement parts of the USA in wintertime will actually operate some form of indoor spatial restrictions so that workers aren't freezing outdoors and it may well be quite different when you get into the warmer climates. But I don't have any data on that. That's what I was referring to, the IFMA survey.

MS. SHERMAN: I think that you had an article on -- let me see if I can get the right title to the article. It's Table 1 and I believe it's page 265 or 66. It's --


MS. SHERMAN: In your article that you submitted called "The Effects of Alternative Smoking Policies on Indoor Air Quality in 27 Office Buildings" --


MS. SHERMAN: I'm turning to Table 1.

DR. HEDGE: Right. Yes.

MS. SHERMAN: Do the air change rates in Table 1 reflect circulating air or outside air?

DR. HEDGE: No. Those are the design air change rates, not the measured air change rates. In other words, this is what the facilities people were able to tell us the building was designed to operate as and was operating as but we didn't have any way of actually verifying that because we weren't looking at ventilation rates.

MS. SHERMAN: So you're saying that these do not reflect what you actually observed, these were just what the building was designed for? In other words, do we know if this reflects outside air?

DR. HEDGE: No, we don't know. Because we weren't measuring ventilation rates as such. These were simply the design rates. The only indication that we have are the carbon dioxide levels and I believe in the last set of information I gave you we give you those for all 27 buildings so you can see what the levels are.

MS. SHERMAN: Were they design circulating air rates or design outside air rates?

DR. HEDGE: Oh, I see. These would be -- I would have to go and check exactly what we were given by the facilities people because I'm not sure what proportion of the air change there would be recirculated air and what proportion would be outdoor air.

MS. SHERMAN: But you can try to supply this?


MS. SHERMAN: On page 266 of this article, I don't think that you described how the generation or emission rate of ETS was generated.

DR. HEDGE: Pardon? I'm sorry.

MS. SHERMAN: Let's try to find 266.

DR. HEDGE: 266 didn't describe how -- I'm sorry, I didn't understand the question. How --

MS. SHERMAN: Let me try to find the reference.

DR. HEDGE: And also in the interests of time I will have to very soon be going. I have a 7:25 flight.


JUDGE VITTONE: It's ten minutes 'til.

MS. SHERMAN: We don't want you to miss your flight.

DR. HEDGE: Thank you very much.

MS. SHERMAN: However --

DR. HEDGE: But I will provide whatever information you require.

The ETS generation rates were not anything that were controlled, this is simply we're just going into a building and observing what the level of activity was in that building. We were not going in -- the people in the building were not aware that we were going in specifically to look at ETS. You'll see from our questionnaires that we talk about an office environmental quality survey. The focus of our measures and everything else was not -- we tried not to focus on ETS. So these are the day-to-day types of levels that one would see in the buildings that we looked at.

MS. SHERMAN: In terms of estimating the number of cigarettes smoked, I think you wrote that you used a survey plus you employed the average percentage of current smokers plus an employee survey to estimate the number of cigarettes smoked. Did you try to validate your estimate in any way by counting the cigarette butts or something?

DR. HEDGE: In fact, we have that information for nine buildings that we've looked at this past year but I don't have the data analyzed yet.

MS. SHERMAN: But you'll supply it, I'm sure.

DR. HEDGE: We have that information, only for smoking rooms. I believe these were all separately ventilated smoking rooms in which what we have are the pollutant levels and then twice a day we counted the cigarette butts before the cleaners came in. But that doesn't necessarily tell us the nature of the cigarette. It will hopefully give us a slightly better understanding of what's happening.

MS. SHERMAN: Now, am I correct that Table 4 represents means?

DR. HEDGE: Yes. These are least squares means. That is, when we analyzed the data using multi-variate analysis of variants, these means represent the best estimates for the policy effects. So they're slightly different than calculating just a straight arithmetic average over the data that we've got.

MS. SHERMAN: Is the 44.2 micrograms per meter cubed of nicotine high or low in the range established by your experience?

DR. HEDGE: Well, that was one of the puzzles there. We found that buildings with -- I don't want to use a commercial word but with charcoal and electrostatic filter systems in them, the smoking rooms in those buildings actually had more nicotine present than in other kinds of smoking rooms. Now, we're not sure whether that means that there was more smoking activity occurring in those rooms or whether it means that the systems, things like the charcoal, was acting as a reservoir, a sink, for nicotine and that was subsequently being re-released into the environment or quite what the reason is there.

If you look at the individual building figures, you will see that those numbers are being driven by a couple of buildings in that particular category.

JUDGE VITTONE: Ms. Sherman, it's five minutes 'til.

MS. SHERMAN: Yes, I am mindful of it.

I am mindful of that but do you consider that on the high side or on the low side? Or don't you have an opinion?

DR. HEDGE: Relative to everything else that we've measured, it clearly is higher than anything else and that was a significant difference in our data. So relative to what we have, it's higher. I'm not sure quite what it means.

MS. SHERMAN: Dr. Hedge, I want to thank you for your time. I have other questions that I would like to ask you but I understand that you have the last plane to Ithica or something.

DR. HEDGE: Yes. That's correct. Can I say that if you do have other questions, then please just direct them to me at Cornell. We will provide whatever information will be useful to you and we will keep you posted of research results that we have as soon as we get them analyzed.

MS. SHERMAN: Thank you. That's very kind of you.

DR. HEDGE: And if you would like some of our data as well, please just let us know.

MS. SHERMAN: Thank you.

JUDGE VITTONE: Dr. Hedge, thank you. I understand nobody else has any questions for you, so why don't you rush and go catch your airplane.

DR. HEDGE: Thank you very much.

JUDGE VITTONE: That completes Thursday.

Tomorrow we have the Steel Workers --

MS. SHERMAN: We don't have the Steel Workers tomorrow, Your Honor.

JUDGE VITTONE: We don't have the Steel Workers tomorrow. We have the AFL-CIO. We have that group called NAIOP. And that's it. NAIOP.

MS. SHERMAN: AIHA, I believe, will be on the 24th.

JUDGE VITTONE: Yes, that's right. They have been moved to the 24th. They've been moved off.

Benda is not coming, right?

MS. SHERMAN: Mr. Benda has said that he cannot come and he has asked us to cancel his appearance. Which I think we announced that -- yesterday, was it? If we didn't, we should have.

MS. WARD: So we're looking at two groups, AFL and NAIOP?

MS. SHERMAN: I believe you're correct. At least that's all I'm going to prepare for.

JUDGE VITTONE: All right. So we have those two groups tomorrow and then that's it.

Thank you. Good night.

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