OSHA: Proposed Standard For Indoor Air Quality: ETS Hearings, January 18, 1995

OSHA: Proposed Standard For Indoor Air Quality: ETS Hearings, January 18, 1995


UNITED STATES DEPARTMENT OF LABOR

OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION

PUBLIC HEARING
PROPOSED STANDARD FOR INDOOR AIR QUALITY

Wednesday, January 18, 1995

Department of Labor

Washington, D.C.

The above-entitled matter came on for hearing, pursuant to notice, at 9:35 a.m.

BEFORE: HONORABLE JOHN VITTONE

Administrative Law Judge

AGENDA

PAGE

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.

Questions:

Ms. Sherman 11588
Dr. Samet 11629
Ms. Sherman 11659

EXHIBITS

EXHIBIT NO. IDENTIFIED RECEIVED

NONE

P R O C E E D I N G S
9:35 a.m.

JUDGE VITTONE: Good morning. We resume our hearings this morning on the Occupational Safety and Health Administration's proposed rule on indoor air quality.

We had the direct presentation yesterday by the panel from the R.J. Reynolds Tobacco Company. We began questioning in a limited area by Ms. Sherman and we resume with Ms. Sherman and the OSHA panel this morning.

Ms. Sherman?

MS. SHERMAN: Good morning. How do you accommodate non-smokers at RJR?

DR. COGGINS: Ms. Sherman, we realized last night -- just before we answer any of your questions --

JUDGE VITTONE: Excuse me.

(Pause)

JUDGE VITTONE: Ladies and gentlemen with the cameras, it's the same procedure as yesterday, okay? I'd like the cameras to remain where they are. At 11:30, if you need to move the cameras to take a side shot, that would be fine, on either side. I don't want you up on the stage, though, okay?

I guess these two pillars right here on either side will be the furthest point that I would like for you to come, okay? But otherwise, between now and 11:30 and after you take the side shots, I want the cameras to remain where they are.

Thank you.

All right. I'm sorry. Now we will begin.

MS. SHERMAN: As you were saying?

DR. COGGINS: We realized last night we hadn't answered one of your questions and that was concerning leased buildings.

MS. SHERMAN: Yes.

DR. COGGINS: And Mr. Bohanon now has the answer for that question.

MS. SHERMAN: Good.

MR. BOHANON: What we were talking about with regard to leased buildings, I still don't have the numbers, but the specific question had to with what one does in leased buildings or how one assures indoor air quality as a tenant or occupant in a leased building.

MS. SHERMAN: Yes.

MR. BOHANON: I wanted to share with you some of my personal experience in being the tenant's representative or the building manager accountable for our tenants and occupants in leased space where there were multiple tenants within the space and we did not own the building.

In that case, again, what our practices were, and still would be, is that before we enter into any lease agreements we inspect the building, assess the quality of the HVAC system to assure that the owner has good maintenance practices. We certainly make sure that we define comfort levels within the terms of the lease. And in one case that I can think of where there was a large building that seemed to in fact not have any humidification at all, as a part of signing the lease we required that the building manager as a part of leasing the space provide an HVAC upgrade so to speak to provide humidification in the space so that we could maintain comfort levels in the coldest part of the winter when it gets very dry.

So I think that by showing a proactive interest during the lease process in the operational aspects of the building, which includes the HVAC system but also goes beyond that on other tenant service issues such as deliveries of packages and mail and cleaning frequency of both the office space and common areas, all of those operational factors, we take that into account in the lease negotiation process, and that's really our practice in how we do that.

The other thing I would like to just clarify, you're asking me about policies which implies we have some huge book of policies and in fact 10 or 15 years ago we did. We had several books that were massive and it was hard to keep up with what all those written policies were.

In streamlining our internal bureaucracy, much of that is gone and really we rely on good practice because practice is more flexible than policy. As an example I gave you yesterday, if someone has found some sort of an insect infestation in their office, it really doesn't behoove the building manager or the company to go in and say, well, such and such policy prevents me from taking care of this problem.

So relying on good practices and good judgment of people who have the accountability to provide building services and supervise the maintenance services with regard to the HVAC systems are really, I think, the keys to providing good indoor air quality as far as things relate specifically to the air.

MS. SHERMAN: By the way, do you know whether R.J. Reynolds is participating in this building air quality alliance program that's being sponsored by the U.S. Environmental Protection Agency?

MR. BOHANON: I believe that at this point in time we are not participating in that project with the EPA. In fact, at this point in time our relationship with the EPA is not at its best. We are in litigation with them.

MS. SHERMAN: So that's why you're not?

MR. BOHANON: I would think -- basically, we have a disagreement. As I understand, some of the qualifiers in that program are things that we disagree with, specifically with relationship to environmental tobacco smoke.

MS. SHERMAN: How do you accommodate non-smokers at Reynolds?

DR. COGGINS: Hoy?

MR. BOHANON: Our policy is that smokers and non-smokers both need to be accommodated and smokers and non-smokers need to deal with each other's wishes. And that's really enforced on an individual-by-individual basis. It's up to individuals to work out what their practices are within various work areas.

Now, I would point out that with proper ventilation of our workspaces we have very low levels of any indoor contaminants, including anything that might come from environmental tobacco smoke, so there really doesn't exist that situation of the smoke filled office or smoke filled conference room.

MS. SHERMAN: Do you happen to know how many of your employees smoke and how many don't smoke?

MR. BOHANON: No, I don't happen to know that in total. We did report on a survey, in fact, the experiment that we ran on the one floor of the building and I can look up the number. I believe there was something around 30 percent smokers on that one floor of that building.

MS. SHERMAN: Well, do you have any reason to believe that that's representative of the company workforce?

MR. BOHANON: No, I don't. It's just a single sample of one occupational segment of our workforce and would not, I don't think, represent the whole workforce.

MS. SHERMAN: So you don't keep track of smokers versus non-smokers in terms of your health insurance or anything else?

MR. BOHANON: I don't know the answer to that. I don't know why we would but I don't know.

MS. SHERMAN: If you do have this data, I would like for you to submit it as a post-hearing comment.

Do you keep any data on employee absenteeism?

DR. COGGINS: I'm sure we do. That's probably out of our domain as scientists.

Does anybody know anything about absenteeism?

I don't think we do.

JUDGE VITTONE: Could we have maybe a little bit more specific question?

MS. SHERMAN: Okay. What I was going to ask them is if they keep data on employee absenteeism and if there is a difference in absenteeism between your smoking employees and your non-smoking employees.

If you have such information, I would like for it to be submitted as a post-hearing comment.

DR. COGGINS: There are a number of papers on the rates of absenteeism in smokers and non-smokers. I don't think we have any data on that but the paper I am particularly thinking of has examined this and, of course, smokers and non-smokers are different in many facets other than just the fact that they smoke. So just taking the rate of absenteeism in the two groups and saying, ah, there's a difference and it's due to smoking, was examined in the paper and I don't have it with me but I can certainly find it.

MS. SHERMAN: Well, if you wish to submit that paper also but I am asking more for the experience of your company.

DR. COGGINS: Okay.

MR. BOHANON: Again, I don't believe that we count smokers and non-smokers in our workforce. I think in general we believe that's an individual's business as to whether or not they're a smoker.

MS. SHERMAN: Do you make available your product to your employees at a discount?

DR. COGGINS: I've never seen any. I don't know if anybody else has. We certainly don't get free cigarettes.

MR. BOHANON: The answer is no, I don't believe that we do. I believe it's the retail price.

DR. COGGINS: Dr. Ogden?

DR. OGDEN: Well, first of all, to reiterate, cigarettes are not distributed to the employees. There is a souvenir store that I'm aware of that does sell cigarettes in addition to other souvenir items and I believe there is a very minimal discount on everything in that store and that does include cigarettes. But it's a minimal discount.

MS. SHERMAN: That's just at your headquarters building?

DR. OGDEN: I don't believe there is one at the headquarters building. I believe it's associated with the factory.

MS. SHERMAN: You do conduct your own research and you also contract out research?

DR. COGGINS: The work we've described today, yesterday, of course, is all of our own research and occasionally we do contract other research out. Yes. But the work that, for example, I described, it was all done in-house and I was the principal investigator. The other guys here, the work that they presented yesterday was their own work. Yes.

MS. SHERMAN: And you also contract out research?

DR. COGGINS: Yes. On occasion, we contract out research, too.

MS. SHERMAN: What types of research project would you contract out instead of doing in-house?

DR. COGGINS: I can only speak for my area so I will and then I'll ask the other guys if they have any comments. We've contracted out a number of toxicology studies to contract research laboratories, the main reason being for some confirmation of the results that we have performed. We may want to get a second lab's opinion.

Other reasons are sometimes that we have such a workload in our in-house facilities that we can't get it all done and so we use an external facility.

MR. GROSSMAN: Let me clarify the question, if I may, Ms. Sherman. You're referring to research dealing with ETS, certainly not research dealing with, say, new product development or anything else.

MS. SHERMAN: That's correct.

How do you select the contractor when you feel it's necessary to contract out a project, to replicate your results or to explore something you don't have time to?

DR. COGGINS: As far as I know, we haven't, and I didn't realize that Mr. Grossman was going to make the point, we haven't as far as I know contracted out any ETS work but I can answer it in a very generic sense of how I would select a laboratory. It would be on the basis of their expertise, their published record and knowledge of the individual scientists.

JUDGE VITTONE: Excuse me a second. I think the question was related to ETS. Is that correct?

MS. SHERMAN: Yes, it was.

JUDGE VITTONE: While I appreciate you're trying to be as complete as possible, I don't want to get into extended answers or extended questioning on subjects that really are not part of the proceeding.

MS. SHERMAN: You also make contributions or fund the CIAR, do you not?

DR. COGGINS: I don't know too much about the Center for Indoor Air Research. I understand that they are a grant-giving body and I understand that we donate funds to that body. Other than that, I don't know too much about them.

Can anybody else on the panel comment on that?

DR. OGDEN: No, I would just concur with that. I do believe Reynolds is a sponsor, which means they do contribute, but as to details of the amount, I couldn't speak to that.

MS. SHERMAN: Well, I guess -- and perhaps nobody on this panel can answer it, I am interested in how contributions are made to the CIAR. Are they made on the basis of a specific project that gets supported or is it a yearly grant? And who in the company has anything to do with that?

DR. COGGINS: I think my answer to both those questions is I don't know.

DR. OGDEN: Yes. I'm not sure that I know any details about that either.

MS. SHERMAN: Well, R.J. Reynolds has a very large research budget, judging from the number of laboratories and everything that you have. When -- I don't know if you would call it a grant or just money is given to another agency such as CIAR, I guess in a post-hearing comment I would like to know who makes these decisions and what criteria is used and the percent of the research budget that gets parcelled out in this manner.

MR. GROSSMAN: Is that going to affect the question of whether there is substantial evidence on the record that ETS presents a significant risk of material impairment of health?

MS. SHERMAN: Well, I think what it does, Mr. Grossman, is it suggests how research is carried out by your company and the relationship with the research projects. When the company does a research project, of course, they control it. If they ask a contractor to do it, they perhaps control it. If they give a grant, maybe they do and maybe they don't.

MR. GROSSMAN: The panel has testified that to their knowledge Reynolds has not contracted out ETS work.

MS. SHERMAN: And my next question was what about work done by the CIAR, do they fund it. And the answer, I believe, was that they know that some funds are given to CIAR and I'm trying to explore how this happens.

MR. GROSSMAN: I don't see the relevance of your request but we'll take it under advisement.

JUDGE VITTONE: Can you provide a statement of what your relationship with this organization is? I think that's essentially what she's asking for.

DR. COGGINS: I can give you my answer and that is that --

JUDGE VITTONE: Do you know?

DR. COGGINS: The answer is that R.J. Reynolds provides some funds to the Center for Indoor Air Research. I'm not sure if it's done on an annual basis, on a project basis. There are many other companies, I think, that are involved. That's all I know.

MS. SHERMAN: Do you know if R.J. Reynolds has representatives on the board of CIAR?

DR. COGGINS: Again, I don't know.

MS. SHERMAN: I believe Mr. Ogden helped participate in the Oak Ridge study, did you not?

DR. COGGINS: That's Dr. Ogden.

MS. SHERMAN: Dr. Ogden.

DR. OGDEN: I did. That's correct.

In answer to your previous question, which board are you talking about? The board of directors or the science advisory board?

MS. SHERMAN: The board of directors.

DR. OGDEN: Yes. I believe that there is at least one representative from R.J. Reynolds on the board of directors.

MS. SHERMAN: And who is that?

DR. OGDEN: I believe Dr. Green is on the board of directors.

MS. SHERMAN: And what is his position in the Reynolds company?

DR. OGDEN: I believe his job title is Principal Scientist.

MS. SHERMAN: Do you work for him?

DR. OGDEN: No.

MS. SHERMAN: Okay. What other people from Reynolds helped participate in the Oak Ridge study?

DR. COGGINS: Mike, I think you're the expert on this one.

Dr. Ogden?

DR. OGDEN: Are you asking me for a list of names?

MS. SHERMAN: Yes. And their positions. Are they all people who work for you?

DR. OGDEN: No. Gosh. There are many people because we had a multi-disciplinary team.

MR. GROSSMAN: Excuse me one moment.

(Pause)

MR. GROSSMAN: I don't see any reason for providing a list of employees. And, in fact, let me reiterate something that I said at the beginning of this.

On the first day of these hearings, I asked your panel, Ms. Sherman, who wrote the NPR, who wrote the sections of the NPR, which members of the OSHA staff wrote which sections of the NPR so they could be questioned, and you refused even to give that.

Now, we'll take under advisement your request for the employees of Reynolds who participated in some way or another in the Oak Ridge project. We won't be giving those names now but I would like to know from your agency who is responsible for which portion of the NPR so that we in any --

JUDGE VITTONE: Mr. Grossman, you can make that -- this is not the time to raise that.

MR. GROSSMAN: In any event, we'll take advisement that request.

JUDGE VITTONE: You've made your point.

DR. OGDEN: What I can do, Ms. Sherman, is I am familiar with all of our involvement and I believe I can adequately address any questions you have about any particular piece of that involvement as to what we did without getting into who did what. And I would be happy, to the extent of my knowledge, to represent the nature of the science, the quality of the science and to the extent I'm able answer your questions directly on those issues.

MS. SHERMAN: Okay. Did the marketing firm that was involved in the study, I don't remember their names, perhaps you do?

DR. OGDEN: Yes. Bellomy Research.

MS. SHERMAN: Did Reynolds suggest Bellomy Research as a participant in the study?

DR. COGGINS: Yes, please, Mike.

DR. OGDEN: Our history or my particular research history with Bellomy Research predates the study done by the Oak Ridge National Laboratory. When this particular project was conceived, we already had a relationship, a research relationship, with Bellomy Research in conducting exposure monitoring studies. In fact, since 1991, we've conducted studies. The studies that I've testified to here on the record, we have conducted with the assistance of Bellomy Research.

So when the Oak Ridge project came, we suggested Bellomy Research as one agency that we had worked with. We knew that they were competent. We knew that they had relevant experience and we knew that they could do a good job.

So to that extent, yes, we provided the name of Bellomy Research as somebody we could attest to could do the quality and the quantity of the job that was being asked.

MS. SHERMAN: And they were hired on your recommendation?

DR. COGGINS: Didn't we work that out with -- CIAR was the overall sponsor of the work, isn't that right, Dr. Ogden?

DR. OGDEN: Yes. The Center for Indoor Air Research sponsored the project. Oak Ridge National Laboratory principal investigators, as he testified some weeks ago, had final authority as to who participated and who did not participate and that included the participation of Bellomy Research.

DR. NELSON: If I could add to that --

DR. COGGINS: Dr. Nelson.

DR. NELSON: When Dr. Roger Jenkins testified, he made some statement to the extent that he also approved and agreed with the use of Bellomy Research.

DR. COGGINS: Thank you, Dr. Nelson.

MS. SHERMAN: Your lab, then, went out and assisted the principal investigator in taking the samples?

MR. GROSSMAN: I'm not sure I understand when you say "your lab". What are you referring to?

MS. SHERMAN: I believe that R.J. Reynolds did the analytical work in the Oak Ridge study and I believe it was Dr. Ogden's lab that did this analytical work. Am I incorrect?

DR. COGGINS: Is that right, Dr. Ogden?

DR. OGDEN: My lab and another lab. Yes.

MS. SHERMAN: Which other lab?

DR. OGDEN: Part of the analysis, the air quality monitoring, the exposure markers, were done in my laboratory. The cotinine determination in saliva is done in a biological chemistry area of research and development.

MS. SHERMAN: Within the Reynolds company?

DR. OGDEN: Yes. Within Reynolds Research & Development.

DR. COGGINS: So we measured nicotine and cotinine in saliva --

DR. OGDEN: Yes. Let me be specific. We measured only cotinine in saliva. That was done in a biological chemical research unit. Then in our particular group, my particular group, we measured all of the other airborne markers of environmental tobacco smoke.

MS. SHERMAN: How many laboratories do you have at Reynolds?

DR. COGGINS: A lab, is it four foot by four foot or a great long building? That would be a difficult question to answer.

MS. SHERMAN: Okay. Are your laboratories organized along the lines of who is in control of the laboratory or what the subject matter of the laboratory is?

DR. COGGINS: The labs are in a constant state of change. Facilities move, management changes. Within the Research & Development Department, which is, of course, the only --

MS. SHERMAN: The Research & Development Department is the only department that has laboratories, is that true?

MR. GROSSMAN: I don't even know what you mean by the term laboratories, Ms. Sherman. Are you referring to buildings in which scientists do work?

MS. SHERMAN: And experiments. Yes.

DR. COGGINS: For example, Mr. Bohanon here is not part of Research & Development and yet he has laboratories.

MS. SHERMAN: Okay. So you're part of the engineering department, Mr. Bohanon?

MR. BOHANON: I'm a part of the Environmental Department. We have a laboratory where we analyze water samples as a part of our environmental activities.

MS. SHERMAN: In the Research and Development Department, do most of the laboratories in the company come under the Research & Development Department?

MR. GROSSMAN: Once again, I don't understand how organizational structure at Reynolds is of any relevance to this proceeding, Your Honor.

MS. SHERMAN: I'm trying to understand how the research is done and what research and organization you have to do it so I can better direct my questions.

JUDGE VITTONE: Are your questions more related as opposed to laboratories in buildings as opposed to -- not laboratories in buildings but questions of laboratories on subject matter or subject line, particular areas of science?

MS. SHERMAN: Yes.

JUDGE VITTONE: Okay. Does that help answer your question?

DR. COGGINS: I wouldn't know how to count them. There are so many peripheral parts. For example, Dr. Ogden mentioned that one lab was doing some analyses of salivary cotinine. That may well have been a very small fraction of their overall work but as part of Dr. Ogden's study, it was a large part. There are many, many labs that could be participating in a major or minor way and for me to give you an answer of (a) how many labs there are and (b) how much of their work, if any, is related to environmental tobacco smoke, I really couldn't do it.

MS. SHERMAN: Well, could you submit to the record the organizational structure of R.J. Reynolds' Department of Research and Development?

MR. GROSSMAN: Once again, we'll take this under advisement but I really think it ill behooves this agency that refused to allow its own scientists to testify to the NPR that they wrote to ask for organizational structure of people who have come here to testify in this proceeding and give information as we did for a full day yesterday of a scientific nature that might be useful to the agency in deciding whether to proceed with the regulation.

MS. SHERMAN: What is the mission of the R.J. Reynolds deBethizy lab?

DR. COGGINS: Don't know what the R.J. Reynolds deBethizy lab is. I know a Dr. deBethizy.

MS. SHERMAN: What does he do in his laboratory?

MR. GROSSMAN: Once again, first of all, I don't know if this relates to proprietary research that Dr. deBethizy may do or to non-proprietary research. I would direct the witnesses not to answer any question that relates to the development of new product or other proprietary information. And I don't know what this has to do --

JUDGE VITTONE: If the question relates to product development or something of that nature, you can object to the question. But if he knows who --

What's his name?

MS. SHERMAN: deBethizy.

JUDGE VITTONE: If you know who Dr. deBethizy is, if you can answer the question, I'm going to ask that you do so, please, Dr. Coggins.

DR. COGGINS: I know Dr. deBethizy. He is in charge of a large group within R&D. When I say large, I think it's in excess of a hundred people. I have no idea what the vast majority of those people do. I know a couple of the individuals, even some of them are on this panel. To say what does his lab do is a very, very large question. I can't tell you the entirety of it.

MS. SHERMAN: Well, okay. We have some submissions from Dr. Doolittle.

DR. COGGINS: Right.

MS. SHERMAN: Does he work for Dr. deBethizy or does he have a separate area of expertise?

DR. COGGINS: As I said earlier, the management structure changes continually in R&D. I think Dr. Doolittle does report to Dr. deBethizy, yes.

MS. SHERMAN: Do you know the mission of Dr. Doolittle's laboratory? I assume he has one.

DR. COGGINS: In terms of a formal mission, like a formal policy that Mr. Bohanon was saying? I'm not sure if he does.

MS. SHERMAN: The type of research that he does in the laboratory.

MR. GROSSMAN: Dr. Doolittle had a submission that indicated the nature of the work he was doing.

MS. SHERMAN: Dr. Doolittle had a submission that was perhaps one aspect of the work he was doing. We have many papers in the docket.

MR. GROSSMAN: You want to know about things that an individual employee of Reynolds does other than relating to the ETS matter here?

MS. SHERMAN: No. Dr. Doolittle has submitted many papers to the docket on different areas.

Correct, Mr. Coggins?

DR. COGGINS: Yes, that's right. I have them in front of me. For example, his comments on the genotoxicity of environmental tobacco smoke.

MS. SHERMAN: Correct. Does he do research in this and other areas?

DR. COGGINS: Clearly, otherwise he wouldn't be able to written the comments and delineated the research results that I presented some of yesterday. For example, the DNA adduct data that I presented yesterday came directly from Dr. Doolittle's laboratory. We work together.

MS. SHERMAN: Does he work for you or do you work for him?

DR. COGGINS: Neither.

MS. SHERMAN: You are colleagues in the same department?

DR. COGGINS: He, like myself, are both board certified toxicologists so we tend to have informal communications, yes

MS. SHERMAN: When somebody, let's take you, Dr. Coggins, since you're here, when you have a research project, how do you go about getting the project approved?

DR. COGGINS: Certainly. I can give you a very good example of how we got our research approved on environmental tobacco smoke because we have the full papers that are in the docket. I can describe if you wish exactly how we got that project underway.

MS. SHERMAN: Did somebody ask you to do the research or did you decide that the research was useful and you went to somebody for approval?

MR. GROSSMAN: Ms. Sherman, I believe you cut off the witness when he was about to describe the process.

JUDGE VITTONE: Well, I think she was following up with the question. He made an offer, she's following up with the question.

DR. COGGINS: Okay. Let me give you, then, the example of how we initiated our biological research on ETS.

The work was originally initiated as a result of conversations between myself, Dr. Doolittle and Dr. Lee. Dr. Lee and I had reviewed published work on animal studies with environmental tobacco smoke and we felt that these studies were of very poor scientific quality for the reasons I gave yesterday. Many of the studies used the wrong test material, mainstream smoke, and most of them used the wrong concentrations. They used massive concentrations of the wrong material.

Dr. Lee and I decided to put forward a research protocol whereby we would develop a method for exposing animals to aged and diluted sidestream smoke such that we could perform toxicological evaluations.

Dr. Lee and I worked along with other colleagues in the inhalation department, Drs. Mosberg and Ayers and a large number of multi-disciplinary meetings were held between the scientists. We then came out with a plan of action of how we would want to build a facility and we then took that plan, the construction of the inhalation laboratory that I described yesterday in my slides, and said to management this is what we want to build.

MS. SHERMAN: And this would be the head of the research department that you would send this to or is there some funding board or how does this work?

DR. COGGINS: I can't recollect the exact detail. It wasn't anything like as high as the head of R&D. I believe it went to our then department head and we said, look, to build this will take us X dollars and Y days, can we go ahead. We were given that permission, built the facility and then tested it out, did a number of runs under different experimental conditions. And then went back and said, okay, we're now ready to do some animal work, having proven the facilities work.

MS. SHERMAN: And which Dr. Lee is this?

DR. COGGINS: Dr. Chin Lee, who is the co-author on the 90-day paper.

MS. SHERMAN: And --

DR. COGGINS: I hadn't quite finished.

MS. SHERMAN: I'm sorry. I didn't mean to interrupt you.

DR. COGGINS: So once we said that we could perform biological studies, we wrote a research protocol and said that we wanted to do the kind of studies that are described and that we have published and we decided to embark on the 14-day study that we performed originally.

We then looked at the results of that and said, well, yes, that's very interesting but we would really like to see a little bit longer term exposure and then we wanted to add on the extra endpoints that I described to you yesterday. Again we went to management and they just said go ahead.

MS. SHERMAN: Is this a formal process? Is this all done in writing in terms of proposals?

DR. COGGINS: We have a formal position for the definition of an experimental protocol. This is largely required in the area of animal use. We have a number of internal committees that we have to ensure that we do not break any of the principles of animal experimentation, so we have a formal protocol that is approved by, for example, pathologists, veterinarians and, indeed, we have a group called Institutional Animal Care and Use Committee and they reviewed the procedures that we scientists wanted to perform and evaluated whether or not they felt as an IACUC whether they thought that our procedures were justifiable scientifically. So just to complete that out, it was scientist driven, management approved. We drove very much that project ourselves.

MS. SHERMAN: Do you collaborate with other tobacco companies on your research?

DR. COGGINS: I personally do not collaborate with other tobacco companies. I don't think anybody in R&D does.

Can I ask my colleagues to comment?

MS. SHERMAN: Certainly.

DR. OGDEN: Presently, I have no collaborations with any other tobacco scientists. We have collaborated in the past, both in terms of -- for instance, conducting the collaborative studies that were used to validate the XAD-4 nicotine method. That's the official method by a number of agencies. There were other tobacco company laboratories that participated in those studies, as well as outside the tobacco industry.

I am aware that there are some ETS-related studies, perhaps six, seven, eight years ago, that I know there were at least representatives from Reynolds and representatives from another tobacco company that participated in those types of projects. The ones I'm thinking of particularly I know are published relating t indoor air quality investigations in restaurants and things of that nature. But those are the extent of the collaboration that I'm aware of.

DR. COGGINS: Thank you, Dr. Ogden.

Mr. Bohanon, do you have any --

MR. BOHANON: The research that I have been a part of and a party to regarding ventilation and indoor air quality and environmental tobacco smoke levels has been Reynolds work solely. We have not collaborated with other tobacco companies on that research.

DR. COGGINS: The other members of the panel confirm that they have no collaborative research with other tobacco companies.

MS. SHERMAN: Getting back for a moment to the Oak Ridge study, who approached R.J. Reynolds about the study?

DR. COGGINS: Dr. Ogden, can you answer this?

DR. OGDEN: I'm not sure I understand your question as to who approached R.J. Reynolds.

MS. SHERMAN: Well, did you initiate the study or did somebody come to you and ask you if you would work on the study?

DR. OGDEN: I believe that in his testimony Dr. Jenkins portrayed adequately and accurately the genesis of the project from his involvement, so what I'll do is give you my interpretation of the genesis prior to his involvement.

I do recall a presentation that I made to the Center for Indoor Air Research. It was an invited presentation to basically summarize the status of my research on ETS to that point. And that included the studies that I've reported here, the Columbus study, the New Jersey study and the nine-city misclassification study, these studies spanning since 1991.

At the conclusion of that presentation, I was asked for recommendations as to what further research was needed in the area of ETS and I do recall mentioning to them, those present, that I believed the studies that I had done although representative in a small sense needed to be conducted in a nationally representative sense for a much broader representation of the country.

And in my mind that's the genesis of what now is known as the Oak Ridge 16-city study.

MS. SHERMAN: And when was this? Do you remember when it was?

DR. OGDEN: I don't know an exact date. I would say middle of 1992.

MS. SHERMAN: In the preceding studies, was the same marketing firm used, Bellomy, was it?

DR. OGDEN: Yes. As I said in answer to one of your previous questions which was, I believe, an issue that you were trying to raise, that Bellomy Research had participated with us on various research projects and in terms of offering their expertise in marketing research, meshing that with our expertise in exposure measurement, we formed a very good working relationship in terms of being able, from our end point, to be able to do things we didn't know how to do and we certainly brought the exposure monitoring expertise to that junction. And, yes, Bellomy Research was our primary contact in all of those studies.

However, also in all of those studies, Bellomy Research acted as an agent that went out into the cities that were selected for study and actually recruited agencies in those cities. So in a word, Bellomy Research was the go-between because all of the marketing research agencies in the cities where we actually conducted the studies, and this was a firm requirement going into these studies, they absolutely did not know that R.J. Reynolds was participating in the study, they absolutely did not know that the issue being studied was tobacco or tobacco smoke. So that was the best way that we could conceive of to make sure that we got the work done in a way that was representative and was qualified and accurate and also keep out any of the vested interests that might sway the results based on their knowing who the sponsoring organization might be.

MS. SHERMAN: Well, would it be fair to say, then, that the idea for the Oak Ridge study originated with you?

DR. OGDEN: In it's final form, I'd like to say that but that's not true because the Oak Ridge study as I'm referring to it evolved into something much better than I had envisioned early on. The small genesis of an idea maybe could be attributed to me but through working with particularly the scientists at Oak Ridge, Dr. Jenkins, there was a lot of value added to that project. And I must say it turned into something much larger, I can certainly attest to, and much better than I had initially envisioned in terms of the quality of the laboratory measurements, the number of quality control checks that they imposed on us and also a number of suggestions made by the Oak Ridge team for ways of improving certain aspects of the study that I think bring it down to, and as it's been entered into the record, what certainly I believe is the largest and most representative study ever done to date on environmental tobacco smoke exposure in the workplace.

MS. SHERMAN: Do you happen to know how Oak Ridge was selected as the principal investigator?

DR. OGDEN: Exact details of that, no, I'm not familiar with. I recall very vaguely some discussion after I had made the suggestion that this type of study needed to be done on a much grander scale.

There was some discussion of who was qualified to conduct such a research project. I do recall that Oak Ridge's name was among others. I can't recall any others but certainly Oak Ridge's name was one of the first to come up as an organization that was both experienced in tobacco smoke chemistry, that was both experienced in the monitoring of environmental tobacco smoke and indoor air quality and certainly an organization that had a fine reputation in analytical chemistry and the statistical evaluation of the enormous amount of data that would come out of such a study.

DR. COGGINS: Just a second. Oak Ridge does, of course, have a very long experience with tobacco smoke. Dr. Jenkins and his boss, I believe, Dr. Guerin, go back a long way in terms of not only analytical chemistry but tobacco toxicology. They have done a great deal of work over the last 20, 25 years in that field.

MS. SHERMAN: So this was discussed with the sponsor of the study, CIAR?

DR. COGGINS: Is that right, Mike?

DR. OGDEN: Yes. There were -- I only recall one -- well, Dr. Eisenberg, who is, I believe, the executive director of CIAR, I know he was in attendance and it was at his invitation that I had made my scientific presentation. But, yes, that was basically -- I think the question may have even originated from him. He was seeking my scientific opinion as to who could conduct such a research project. So I do know that he was in attendance at that meeting. Or at that presentation.

MS. SHERMAN: When people from the company submit published work, does the company have an internal review process that it goes through before it's submitted?

MR. GROSSMAN: Does the company have a what process?

MS. SHERMAN: Internal review process

DR. COGGINS: You mean work we publish?

MS. SHERMAN: Yes.

DR. COGGINS: Yes. We have an internal publications review panel that review draft manuscripts that have been prepared by scientists. The panel has a large membership that includes scientists, management, legal advisors. Once the manuscript is sent to them, they have a very rigorous review procedure that takes a lot of getting through. I've published 25 papers through Reynolds and it's a lot of paperwork. They're very critical and I find them an extremely fair group of people. But we have an established policy, yes.

MS. SHERMAN: And if somebody from Reynolds writes a letter to the editor of one of these journals, does it go through the same internal review process as a paper that's to be submitted?

DR. COGGINS: Conceptually, the same basic process but a letter being somewhat shorter, many journals limit the length of letters to, for example, 500 words, and so the process is very much streamlined for something such as, say, a letter to the editor.

MR. GROSSMAN: Dr. Nelson?

DR. NELSON: I would just like to add a little something. It is basically a scientific review process. That is, other scientists review the work to make sure that the data do support the conclusions that are reached in the paper, that the conclusions in the paper don't overstate what is actually in the data. And the main process of it is essentially very similar to a peer review process when something actually enters into a journal.

MS. SHERMAN: I think you also said that lawyers were part of the review process?

DR. COGGINS: As I say, lawyers -- primarily scientists, lawyers, management, a number of different groups of people sit on the panel.

But just to reiterate something that Dr. Nelson was saying there, I personally have never had any substantive changes made to my manuscripts. The changes have tended to be along the lines of Dr. Nelson's comments, do the data match up to the statements that you have made, is it scientifically acceptable. Because the next stage in the publication process, of course, is that that manuscript would be examined by the journal's editors who then send it out for peer review and we don't want it to be rejected, so that we want our papers when they go out of R.J. Reynolds to be in absolutely impeccable form so that when they are sent to the journal's reviewers they cannot be rejected on technical grounds.

Would the panel like to comment on that? We've all published extensively.

DR. OGDEN: Just as an anecdotal reference, I do recall one change suggested by a lawyer and it was -- actually, it was a technical change because I remember I had caught myself in the same error that was published in the proposed rule and one comment came back when -- I had used the word exposure and the comment came back "Do you mean exposure or concentration?" So just as an example, that would be something. I think of lawyers as wordsmiths and hanging on the precise definition of every word and that was a comment that would come back as an example. Of course, I did mean concentration and I revised the manuscript accordingly.

DR. COGGINS: Could I just add one final point to this? Of course legal review is necessary in case we are giving away proprietary information that our competitors would love to find out what we've been doing, so a legal review is, of course, essential.

MS. SHERMAN: Does the company have a policy about publishing all research that they do that's not proprietary?

DR. COGGINS: All is one of those all-embracing words and I'm not sure about all. I can speak only for myself that a very large part of the work that I have done for R.J. Reynolds has been published. There have been studies that I have done that have had proprietary information in them. There have been studies that I've done that just haven't produced data that's worth publishing. Clearly we don't want to publish every piece of work. Clearly every piece of work we generate is not necessarily publishable. I've performed studies that just didn't turn out right. I've performed studies that have shown data that has been published 25 other times.

In general, we like to publish. We have published -- in the last three years, R.J. Reynolds has published over 200 manuscripts in the peer reviewed literature in the last three-year period. I think that's a very substantial piece of work.

And I would like to ask my colleagues if they have any additional comments.

Dr. Nelson?

DR. NELSON: I would just like to add a little bit in terms of that. Reynolds is really unusual in that most industries discourage publication or don't encourage publication. When it comes to the work that I've done, Reynolds has really been saying, yes, go ahead and publish it or try to publish it and it's really very unusual among industrial chemist companies, at least in talking with my peers in the field.

DR. COGGINS: Yes, 200 papers is quite a lot.

MS. SHERMAN: What do you mean by a study that --

DR. COGGINS: I'm sorry, Dr. Ogden wanted to add something there.

MS. SHERMAN: I'm sorry.

DR. OGDEN: I just had a comment. Any research that I initiate, it is initiated with the intent of publishing the results. Protocols are set up in that way, experiments are designed so that the results would meet the criteria of peer review and publication and that is the intent.

DR. COGGINS: And, of course, that's one reason why we have the protocol up front because if the experiments aren't designed properly, you'll never be able to get them published. So it's really a two-phase program: design the protocol such that it could be published, do the study, look at the data and see if it's publishable. It's really a two-stage or even a three-stage process.

MR. BOHANON: I would also like to add on that, since it's a general question to the panel, my experience is that for the specific tests of indoor air quality within buildings, the intention always is to publish those tests. And, in fact, in some forms such as the form we submitted to OSHA in response to the RFI, the documentation of that study was over 300 pages long. That's simply not a publishable form but it's not something that we minded sharing with OSHA in its totality, including all of the measurements, all the markers, all the details, all the references back to the protocol, were shared directly with agency. So, we have -- again, with my experience, have published information, summaries of information that is in a publishable form regarding the studies done relative to ventilation and indoor air quality and found essentially in all cases that that relationship does exist, that ventilation drives down the levels of compounds within the indoor air.

JUDGE VITTONE: Okay, Doctor. I think we're getting away from the immediate question.

MS. SHERMAN: Dr. Coggins, in answer to an earlier question, you said, well, sometimes research didn't turn out right. What do you mean by that?

DR. COGGINS: Clearly, you haven't performed research.

MS. SHERMAN: No, never.

DR. COGGINS: There are so many things that can go wrong. For example, we were once performing some studies with experimental animals and we got into the study and found that they had developed an infection. Clearly once animals are compromised to that extent, the study is useless and was immediately abandoned. That's just an example. There are many other ways that experiments go wrong. If only it was not the case but sadly it is.

MS. SHERMAN: Have you had any experience where you have had trouble getting a study with negative findings published?

DR. COGGINS: I'm not sure what you mean by negative findings.

MS. SHERMAN: Well, we've had a lot of discussion at these hearings about something that is, I think, called publication bias and so I was wondering from your own experience if you had experienced difficulty getting a study that didn't have a positive result published.

MR. GROSSMAN: If I may interject only on the question of your use of the term, I believe that the term publication bias as it has been used in these proceedings refers in large part to the desire of scientists to submit materials for publication, to the impetus of scientists to submit materials for publication and not just the decision of editorial staff to accept various materials for publication.

MS. SHERMAN: I believe that the terms has been used in many ways, Mr. Grossman.

JUDGE VITTONE: Again, I think we've been all over the board with respect to what the term means. At one time I thought it meant a bias by publications not to print anything that an effect would have been shown that tobacco smoke or environmental tobacco smoke had no effect on people and then there seemed to be branching over into whether there was a bias against publishing that showed only a negative result, didn't show anything -- I guess what some people might call a positive result. I think we've been kind of over -- so maybe we ought to try to define the term a little bit better.

MS. SHERMAN: Yes, Dr. Coggins?

DR. COGGINS: Well, I was thinking perhaps the study that I described yesterday was kind of negative. We didn't see any histopathology but that may be over-interpreting it. I can only answer your question in one way and that is that largely as the result of the wordsmithing that my colleagues have referred to and the quality of the protocol preparation, I've never had a manuscript rejected.

MS. SHERMAN: So it's your experience that good research is published.

DR. COGGINS: In general, as long as there are no proprietary aspects.

Dr. Nelson has a comment.

DR. NELSON: Let me kind of illustrate this point with perhaps some examples. First of all, in going through graduate school and the like we're told if you do something and it's in the literature already, generally that sort of thing won't be accepted in the literature, so if you repeat something that's been done often, you wouldn't necessarily at the outset even consider submitting it.

In the other case, there are things we do that, as Dr. Coggins said, don't turn out right. Once with a mass spectrometer study, I wanted to use a remote sampling line, draw air samples several hundred feet through some Teflon tubing to a space. It turned out the anilide I was interested in wouldn't go through the tubing, it absorbed into the tubing and wasn't detected. That sort of thing is not publishable. That's a negative result in the sense that it's an experiment that didn't work and people don't care about things that don't work.

And so just as a scientist, that's the sort of thing that, in my opinion and as I was taught, would clutter up the literature and obviously you wouldn't go ahead and publish that sort of thing.

MS. SHERMAN: Because it wouldn't be very interesting.

DR. NELSON: It wouldn't be very interesting.

DR. COGGINS: Thank you, Dr. Nelson.

MS. SHERMAN: I think I understand.

I believe Dr. Samet is here and he would like to ask some questions. I believe you remember him from earlier in the hearing.

MR. GROSSMAN: Are you done with your questions?

MS. SHERMAN: No, I am not.

MR. GROSSMAN: Your Honor, this is an unusual procedure.

JUDGE VITTONE: This whole proceeding is unusual, Mr. Grossman.

(Laughter)

MR. GROSSMAN: Well taken.

JUDGE VITTONE: Well intended.

MR. GROSSMAN: But I think that to the extent that the panel for OSHA is questioning R.J. Reynolds, certainly it can't be handled as a tag team where it goes from questioner to questioner in a circle. To the extent that we are not receiving questions from a single examiner, and I believe we should, but to the extent that we're not, certainly the examiner's examination should be complete before the next person asks a question.

JUDGE VITTONE: Well, okay. I understand your point but I'm not going to abide by those kinds of rigid guidelines. I think it's the OSHA panel as a total that is asking questions. We will probably -- I don't see that anybody is surprised or taken advantage of. I think Dr. Samet's questions are not very -- I don't know how long they're going to be but I think he's only here for a limited time. He is an advisor to the OSHA panel and has participated in this proceeding before and has asked some questions.

I understand your point but I'm going to overrule your objection.

Dr. Samet?

DR. SAMET: Thank you. I am John Samet. I would like to first direct some questions to Dr. Sears and Mr. Steichen. I didn't have the opportunity to see you yesterday but --

MR. GROSSMAN: Dr. Samet hasn't been here for a while, Your Honor, but all questions are to be directed to Dr. Coggins and he can decide whether to --

JUDGE VITTONE: Dr. Coggins will try to answer the question or designate the person on the panel or seek comments from additional members.

DR. SAMET: Okay. Well, in any case, these questions are in reference to the statements of Sears and Steichen.

I think it would be useful first in considering epidemiology to consider some terms and the framework. The first question I would like to direct at you is what is causality?

DR. COGGINS: Casualty is a very large word in terms of epidemiology. It's much bigger than just epidemiology. Books, treatises, philosophers have talked about causality. It's a very, very large word. I can tell you what it means to me and then I'll certainly pass it to Mr. Steichen and Dr. Sears.

To me, causality has many components. It is, if you like, a convergence of the data but the first necessary item in my mind is epidemiology where you would establish risk factors, and we can certainly give you our definitions of risk factors, but then that's purely an observation and observations as such cannot prove causality, they can only generate hypotheses and, in my opinion, those hypotheses can then be tested using the scientific method. In this case, I would suggest corroborating studies in experimental animals, different species.

I would then suggest that you need a third set of data before you could actually go in and use the word cause and that is the identification of a mechanism. But only when you have these three items, the epidemiology generating an hypothesis, the development of an assay using the scientific method and then hopefully identification of a mechanism can you then use the word case with the big C.

I'm going to ask my colleague Dr. Sears first to see if he entirely agrees with me.

DR. SEARS: In fact, Dr. Samet, I could hardly say it more eloquently. It's easier to describe what causality is not than it is to describe what it is. I think that Dr. Coggins has done a lovely job of emphasizing that it requires far more than epidemiology, far more than the evidence of an association to conclude causality.

Certainly as the word is sometimes used, in fact, I would say abused, in the medical and epidemiological literature, that is a far cry from what causality actually is. Statistical association, no matter how strong, can never conclude causality.

DR. SAMET: Let me ask you then within the context that you have just said, can you give me an example of an agent that causes a disease?

DR. COGGINS: Yes, I think I can give you an example. There may be others. I've thought this through in many different ways.

I think that one material that I could give you an example of that would provide all three links would be asbestos and lung cancer.

DR. SAMET: Can you tell me the mechanism by which asbestos causes lung cancer?

DR. COGGINS: Let me just give you that at the end of the answer. I think first of all the epidemiology has been identified, I think, the animal studies using the rather complicated inhalation procedures that are needed with the different types of asbestos. I think the current mechanism that's postulated, and different people will agree and disagree and, of course, we're getting way off the subject here, is that somehow or other the asbestos fibers interfere with the cellular nucleus during the state of mitoses and myosis but that's very much a hypothesis in some people's minds but it is at least the development of a mechanism that I kind of buy into.

DR. SAMET: Does asbestos cause mesothelioma?

DR. COGGINS: Again, getting way off our subject, but I think that the information on the epidemiology is strong but there are less stronger here in terms of the animal studies because it's difficult to perform these inhalation studies with the different asbestos types. And I don't think we've really identified how that mesothelioma mechanism is evaluated through the cellular processes. But may be it does.

DR. SAMET: So the evidence on asbestos and mesothelioma would partially meet your criteria.

DR. COGGINS: In my opinion as a scientist, I think yes.

DR. SAMET: Does active smoking cause lung cancer?

DR. COGGINS: I don't know because the evidence here is much less, weak. We certainly have the epidemiology but we do not have corroborating animal evidence. There are numbers of studies, dozens upon dozens of inhalation studies that have been performed with mainstream smoke, many different species, durations of many years, and uniformly these studies have not produced an increase in the background rate of lung cancer as a result of those exposures. So we have the epidemiology, we do not have the corroborating animal evidence and I do not believe that we have any estimate of mechanism. So my answer is no, I do not think so, we just don't know based on the evidence we have today.

DR. SAMET: Do we have less understanding for active smoking in terms of mechanisms with regard to lung cancer than we do for asbestos and lung cancer?

DR. COGGINS: Over the years, there have been a number of different theories as to basic mechanisms involving several different compounds. It's been almost a moving target as these compounds have been identified as being the quote active agent.

I could perhaps work through a chronology of these but several different compounds have been identified throughout the years. I don't think that we have a current hypothesis that's been valid but, of course, we still don't have the corroborating evidence of the animal studies with all of these dozens of studies that have been performed.

DR. SAMET: The 1964 Surgeon General's report provided criteria for weighing evidence and offered a framework for assessing causality. Do you agree with that framework?

DR. COGGINS: I haven't glanced at the '64 report recently. I have read it.

DR. SAMET: Well, perhaps I could direct the question to Dr. Sears and Mr. Steichen who mentioned standard criteria for causality and failure to use them.

MR. GROSSMAN: Before you do, Dr. Samet, could you identify for the record what the criteria that you are referring to?

DR. SAMET: I'm referring to the criteria for causality listed in the 1964 Surgeon General's report. They're included in the chapter in which the evidence is weighed.

MR. GROSSMAN: Could you identify for the record what those criteria are?

DR. SAMET: Well, I don't think my purpose now is to list the criteria but to obtain an answer.

MR. GROSSMAN: I understand you're not a lawyer but that's what normally is done.

JUDGE VITTONE: Dr. Sears is going to answer the question, if he knows what the criteria is or has an understanding of it, that's one thing. If he doesn't know, then that's his answer, he doesn't know what the criteria is.

Dr. Samet, I assume we're going to get to environmental tobacco smoke.

DR. COGGINS: I just have a comment on the 1964 Surgeon General's epidemiologic criteria for causality, a critique by Dr. Burch, Journal of Chronic Diseases, Volume 36, 1983, pages 821 to 836. And I'll just read you a quick quote here and then we'll talk about ETS, I hope.

JUDGE VITTONE: Just a second, Doctor. You've made a reference. I don't think we need to get into the report. If it's part of the record already, it's part of the record.

What's your question again, Dr. Samet? I think we've lost it.

DR. SAMET: The question, as I recall it at this point, was do you agree with the criteria for causality listed in the 1964 Surgeon General's report?

JUDGE VITTONE: Dr. Sears, if you are able to answer the question.

DR. SEARS: Dr. Samet, I believe that I know the criteria that you're referring to. I have read at least portions of that report. My understanding is, though, that those criteria are first of all a synopsis or a restatement at least of an earlier set of criteria developed by Bradford Hill, perhaps even predating the 1964 report, and it seems to me that there were eight or ten of them. Is that -- those are the ones you're referring to?

DR. SAMET: Correct.

DR. SEARS: In my earlier comments about causality, I believe that I stated to you and to the panel that in my opinion the word causality is sometimes abused in the medical and epidemiological literature. My reading of those eight to ten criteria lead me to believe that those criteria are important for establishing linkage between a disease end point and exposure of some kind. However, because of the critical component of causality mentioned by Dr. Coggins, that being the component of mechanism, and perhaps some other components that I am not able to recall right now, I would say that those criteria are certainly necessary but they are not sufficient to infer causality.

I would also add to that, Dr. Samet, that my recollection is that when those criteria are listed in the epi literature they are usually called criteria for epidemiological causality and I take that, my reading of the epi literature leads me to believe that that's something quite different from biological or real causality.

DR. SAMET: Just one more general question about epidemiology that is quite relevant to interpreting your comments about the ETS literature. That is the issue of confounding. Could you provide me with the definition of confounding that's been used as you've considered its relevance to the ETS literature?

DR. COGGINS: Confounding is a word that has been used a great deal in these hearings and it seems to mean different things to different people.

I think Mr. Steichen or is it Dr. Sears who is going to answer this one?

DR. SEARS: Perhaps I'll start and Tom can add something to it.

Certainly I agree with your proposition that confounding is an important concept in the area of ETS epidemiology and the reason for that is so many of the studies control so inadequately for important confounders. In fact, nearly every study has shortcomings in this respect. I would say every study has shortcomings.

But to answer your basic question, I believe that a confounder is a variable that has two characteristics. It's statistically correlated with both the exposure and the disease outcome and in order for a variable, a potentially important variable, to be a potential confounder it has to obey both of those criteria.

MR. STEICHEN: I think you've pretty well defined the essence of it. Again, it's a variable that's related to the disease or some would say a risk factor. It's also a variable that's not balanced between the two exposure groups and therefore generates a correlation to the exposure variable.

DR. SAMET: So a confounder is a risk factor for the disease of concern in its own right?

DR. COGGINS: Mr. Steichen, I think you could answer that best.

MR. STEICHEN: Right. When we say it's a risk factor, that presumes knowledge. Without the knowledge that we have previous evidence, it doesn't still mean that the particular variable isn't a risk factor, it just says we don't have knowledge. And so to say offhand that we know it's a risk factor and therefore that's a requirement for it to be a confounder isn't quite true. It may well be a risk factor that we don't know about yet. It also may be in a different sense a variable that's correlated to a risk factor and can stand as a proxy for it.

DR. SAMET: Could you name some of the risk factors that you would consider as confounders in studying lung cancer in never smokers?

DR. COGGINS: I think I can answer that if I can find it in my file. What I'm trying to refer to is a paper that was recently published that had a list of, I think, 20, 30, 40 different risk factors for lung cancer in non-smoking people. And if I could find the reference, I will indeed give it to you but I've forgotten the name that I put it under in my reference book.

We were looking at it this morning, Tom.

Katzenstein. That's a paper I believe in 1992. I'll find it and get it to you next morning.

DR. SAMET: And you would accept each of these factors in that paper as a risk factor for lung cancer in never smokers?

DR. COGGINS: Dr. Katzenstein has an entire table in this paper where he examines risk ratios for a number of different factors. For example, he has factors much higher than ones we've seen associated with lung cancer and ETS. For example, he had one in there, we were examining earlier this week dietary fat where we looked at the paper by Alavania where, for example, with dietary fat, Alavania, which of course is a subset of the Brownson study, in the Alavania study where he looked at five different rates of fat consumption. When he compared the highest with the lowest the odds ratio obtained for lung cancer, the fat consumption was about six. And if you restricted -- and, of course much, much higher than the 1.19 even that we don't even accept as being a risk factor, but about six for fat consumption. And that when you look at adenocarcinoma only, Alavania in this subset of Missouri women found that the risk ratio for adenocarcinoma for the highest versus the lowest quintile was almost 12.

DR. SAMET: Just to finish this up, then, you would consider --

DR. COGGINS: I'm sorry, Dr. Sears has an addition to that. I'm sorry.

DR. SEARS: Chris, I wsw jotting down some notes as you were talking so I may repeat a factor.

Certainly there are important dietary factors that are potential confounders in ETS epidemiology. I don't think I heard Dr. Coggins say a history of lung disease would be another factor and certainly there are a number of socio-economic variables that are potentially confounders.

I might draw your attention to a recent editorial in the New England Journal of Medicine by Marcia Angell, who I think is an editor if not the executive editor of that journal, who points out how important socio-economic confounders are, especially in the context of epidemiology where the risk is extremely low. And, in fact I believe that she even mentions ETS as an example case.

MR. STEICHEN: I think there's also the obvious demographic variables, age and certain racial characteristics also.

DR. SAMET: Okay. And just to finish the discussion on confounding, does confounding necessarily increase risk estimates? That is, is the bias in an upward direction uniformly or can it be in a positive or a negative direction?

DR. COGGINS: I think again Dr. Sears and Mr. Steichen will be more than happy to answer that.

MR. STEICHEN: I think I'd like to speak first on that. Confounders don't necessarily move it in either direction. There are some, of course, that would move it in one direction, some in the other direction.

The important issue when we're talking about ETS is that the variables that have been typically considered as potential confounders have been considered because when they are included they typically result in a reduction in risk.

There have not been very many put forth that when they are included would result in an elevation in risk after correction for confounders.

DR. SEARS: May I add something, Chris?

DR. COGGINS: Yes, please.

DR. SEARS: Certainly there are variables, I'm thinking primarily of dietary variables, that depending upon the definition of the variable in a particular study could go either way. One that comes to mind is consumption of fruit and vegetables. Depending upon whether you mean relatively low consumption or relatively high consumption, I could see that possibly that might be either a positive or a negative influence on the ETS relative risk.

DR. COGGINS: I found the paper, Dr. Samet, it's by Dr. Katzenstein, Environment International, Volume 18, 1992, "Environmental Tobacco Smoke and Lung Cancer Risk, Epidemiology in Relation to Confounding Factors."

DR. SAMET: Okay. Fine.

I'd like to turn to the question of the exposure to environmental tobacco smoke and I had the opportunity to review some materials from Dr. Ogden. I think one important issue is the consideration of the representativeness of these data.

I'd like to ask first, when the word representative is used, what does that mean?

DR. COGGINS: Mike, can you take this?

DR. OGDEN: The word representative can mean many things, of course. It depends on what you're wanting to represent. If you're wanting to represent typical workplaces then you would go out and recruit people at random from typical workplaces. If you're wanting to represent never smoking females married to smokers, you would go out and recruit never smoking females married to smokers. So out of context, representative means that it should be as representative as possible, or more representative than other studies, in particular. To whatever categorization you're trying to represent.

DR. SAMET: In your testimony you describe the findings of two recent representative population-based surveys of workplace RSP levels. In that context, what does representative mean?

DR. OGDEN: Actually, I think I have to say that representative may have to be interpreted as more representative than. So taking that particular word out of context. Representative in my mind means we're trying to represent a certain group of individuals. For instance, in Columbus, Ohio, we were interested in never smoking women who were either married to smokers or non-married to smokers. So in terms of workplace issues, I think representative again means they're drawn from the population at large, which is how I'm using the term population-based. They are somehow randomly selected. They're not all chosen from one small grouping of individuals like was done in many of the studies cited in the proposed rule.

DR. SAMET: So when I read your comments in regard to Slide 15, I should not construe representative as meaning nationally representative?

MR. BOHANON: I think, Mike, you used the phrase "more representative" then. Have you got Slide 15 there?

DR. SAMET: This is on page seven of comments provided to the hearing.

JUDGE VITTONE: Are you talking about the statement he made yesterday?

DR. SAMET: Yes.

DR. OGDEN: Let me find that. Page seven, you say?

DR. SAMET: It's in reference to Slide 15.

DR. OGDEN: Where would I best look first? Slide 15 or page seven?

DR. SAMET: It's your comments about this on pages seven.

DR. OGDEN: Okay.

(Pause)

DR. OGDEN: Could you direct me on the page?

DR. SAMET: At the top of the page, Slide 15 in brackets. The sentence begins, "In contrast..."

Let me read the sentence. It says, "In contrast to these area monitoring values cited in the NPR, I presented in my written submission the personal monitoring results from two recent representative population-based surveys of workplace RSP levels."

DR. OGDEN: By representative in those studies, and again, under the context of maybe a slightly narrower group than the entire U.S. population, in general we're looking for non-smokers in these studies, so we're recruiting non-smokers.

In representative, I basically mean that the target population, the entire target population in that demographic area has an equal opportunity of being contacted.

DR. SAMET: So I could not construe this word as nationally representative as written here?

DR. OGDEN: I believe that does not say nationally representative. As you just read the comment, "I presented in my written submission the personal monitoring results from two recent representative population-based surveys of workplace RSP levels."

DR. SAMET: So the bounds on that interpretation would be within the context you expressed, and national would not be included in that bound.

DR. OGDEN: I would not include national in that particular statement. The issue, though, really is representativeness of a given study versus another study. As I could point out many examples, and have in my submission, for instance when we compare that to the data of Cummings where all of the subjects were recruited from a cancer screening clinic; where all of the subjects were invited to participate in a study on ETS. In that context, I think the correct usage would be more representative.

DR. SAMET: Let me turn to the misclassification...

JUDGE VITTONE: Before you do, it's 11:00 o'clock. This is about the time we usually take a break. Would this be a good point for you to...

DR. SAMET: Fine.

JUDGE VITTONE: Five minutes.

JUDGE VITTONE: On the record.

Dr. Samet was asking some questions.

DR. SAMET: I wanted to move to the misclassification survey again and deal with the issue of representativeness for that survey.

The survey was accomplished by identifying subjects using the mall intercept technique. Would that technique lead to a representative sample of the communities in which the malls were cited?

DR. COGGINS: I'm not sure that all of our work was mall intercept.

Dr. Ogden, you're the man here.

DR. OGDEN: No, it wasn't. The study I believe you're referring to is the one I've identified as the nine city study, and that one was mall intercept. Assuming I'm correct.

DR. SAMET: I'm referring to the study labeled smoker misclassification survey.

DR. OGDEN: Yes, I believe that is the... Well, that is the only study we have conducted by mall intercept, so I assume by default that's the one we're talking about.

I'm sorry. The question again, Dr. Samet?

DR. SAMET: The question is, will that technique achieve a representative sample of the community in which the mall is located?

DR. COGGINS: Dr. Ogden, can you answer that?

DR. OGDEN: Certainly, I'll try.

The mall intercept technique can certainly skew the demographics slightly, particularly if you were to go to all up-scale malls or all rural type strip malls. There was concern for that in the design of the study, and there was an effort made to make sure that, for instance, all
up-scale, as I'm defining it here just basically, all up-scale malls were not identified and used.

But the issue really comes back to more or less representative.

DR. SAMET: Can data obtained by the mall intercept technique be extended to epidemiological studies of lung cancer?

DR. COGGINS: Can you repeat that? I'm not sure I understand that.

DR. SAMET: Can data on misclassification, let me elaborate a bit. Can data obtained on misclassification rates using the mall intercept technique, be extended to epidemiological studies of lung cancer in never smokers?

DR. COGGINS: Can you answer that, Mike?

DR. OGDEN: I believe that they certainly can, because data of certainly poorer quality have been used. For instance, I cite the EPA risk assessment. The issue goes back to more or less representative. If you're asking me could a better study be designed and conducted, the answer would be certainly. The issue, though, is what does that study, in terms of its demographics, say about the target population of never smoking married females. Again, this is in context with the EPA report, and I realize this is not EPA we're testifying in front of, but the issue really boils down to spousal smoking etiology, which I believe the agency did rely heavily on the EPA risk assessment.

If you compare the recruiting and the subject based in the mall intercept study, you find a number of things. One, it is the target population. They were identified, the never smoking married to a smoker, or married to a non-smoker.

If you look at the other studies that were cited by EPA, in fact one of your studies was cited, Dr. Samet, in which all of the subjects were hispanic. I think you did a very eloquent job in the publication of stating that the limited generalizability of those particular subjects. But we're not arguing about the subjects themselves, we're arguing about how they're used.

We could go on and cite other studies. The Cummings study comes up again in the EPA misclassification. There is a study by Haddow in which all the subjects were caucasian and pregnant. So the issue now though, again, is more or less representative. I think it is certainly far more representative than the studies that have been used in the risk assessment.

DR. COGGINS: It's really more representative than, I think is the phrase that Dr. Ogden is wanting to use.

DR. SAMET: Let me just keep on with the issue of representativeness for a moment.

The typical age distribution of persons who develop lung cancer, whether smokers or never smokers, is highly skewed towards the older age groups. Lung cancer is a relatively rare disease below age 50, increasingly, rates increase after age 50, in a more or less logarithmic fashion. So in terms of interpreting the data on spouses, data from this age range are the relevant data to represent the potential for misclassification bias.

In the mall intercept study, can you describe the age distribution of the subjects included?

MR. GROSSMAN: I'm going to object to the question as containing testimony by the questioner. But with that objection, I'll let the witnesses answer.

JUDGE VITTONE: Do you understand the question, sir?

DR. OGDEN: Let me ask for one point of clarification. Your statement was that somehow the subjects should be restricted to those of age 50 and older?

DR. SAMET: I'm asking what the age distribution of the participants was in the mall intercept survey.

DR. OGDEN: I believe you predicated that with some statement about it should be age 50 or older. That's what I wasn't sure about.

(Pause)

DR. OGDEN: It may take me a minute to find it.

JUDGE VITTONE: If you don't know...

DR. OGDEN: I do know, I just don't know it off the top of my head. If he's asking me to recall it then I can't...

JUDGE VITTONE: All right.

I question the value of asking him what a printed report already shows, to repeat what we already have in the record.

DR. SAMET: Actually I asked the question because I could not find the information in the record.

JUDGE VITTONE: All right.

DR. OGDEN: As I stated in my testimony yesterday, that study has been described at several opportunities. It was described in more detail in my written submission, and I did enter into the record yesterday that a final report for that study would be entered into the record during the post-hearing comment period.

I have a draft of that paper with me. I'm looking for the age distribution.

(Pause)

DR. OGDEN: I don't have a distribution. I do have summary statistics, would that be helpful?

DR. SAMET: I think if you don't have the distribution it would be important to submit it for the record.

DR. OGDEN: I do have mean, median, minimum, maximum, standard deviation, that sort of...

DR. SAMET: Why don't you provide those statistics, but I think still the full age distribution would be relevant to interpreting the study.

DR. OGDEN: So you would rather wait for a full age distribution?

DR. SAMET: Why don't you go ahead and read...

DR. OGDEN: What would you like to know? Would you like...

DR. SAMET: Why don't you describe the summary statistics that you mentioned.

DR. OGDEN: For the never smokers?

DR. SAMET: That's correct.

DR. OGDEN: The mean age of the never smokers was 40.6 years; the minimum was 18 years which was a requirement of the study; the maximum was 77 years. Actually the mean and the median were very close to 40 years.

DR. SAMET: Thank you.

DR. OGDEN: You're welcome.

DR. SAMET: Just to turn for a moment, I have testimony, a written comment that you offered dated August 13, 1994 that includes on page five, this is entitled, "Comments on Smoking Status Misclassification"

DR. COGGINS: This is Dr. Ogden still?

DR. SAMET: Yes.

DR. OGDEN: This is my written submission to the record?

DR. SAMET: That's correct. This is a document with six pages entitled, "Comments on Smoking Status Misclassification."

DR. OGDEN: Okay.

DR. SAMET: I'll just read to you the conclusions. It says...

DR. OGDEN: Could you tell me what page you're on so I can follow you?

DR. SAMET: I'm on page five.

DR. OGDEN: Okay.

DR. SAMET: There's a conclusion listed that states, "A proper consideration of misclassification bias nullifies the observed risk in spousal smoking epidemiology."

Is that conclusion based to any extent on the findings of the mall intercept study?

DR. OGDEN: Yes, certainly the mall intercept study is used as a study to offer data relevant to that issue. And as I said just previously, if you compare that to the data that was cited in the EPA risk assessment, I think clearly these data are more representative of the target population.

DR. SAMET: I want to ask a question about the cut points for determining that someone was an active smoker rather than a never smoker with a particular level of cotinine. The choice of ten nanograms per ml was made. There are alternatives that have been used. I think probably what is most important is what was the distribution of values in the 10 to 30 range?

DR. COGGINS: I think Mike had data on two sets of...

DR. OGDEN: Actually, I believe you've misspoken, Dr. Samet. In this study, the cut point of 10 nanograms per mil was not used. In fact, as I've said many times, it was done in exact accordance with EPA recommended methodology in their misclassification adjustment model in Appendix B of the 1992 risk assessment. The cut point for regular smokers was 30 percent of the mean value determined in all self-reported current smokers for this data set, and that equated to 106 nanograms per milliliter.

DR. SAMET: And the cut point for discriminating, those who said they were never smokers, and separating them out into those who apparently misreported their smoking and those who were true never smokers?

DR. COGGINS: Do you have that, Mike?

DR. OGDEN: I thought that's the question I just answered. Could we try again?

DR. SAMET: Perhaps I am confused, then.

I'm looking now at page 13 of a document labeled "National Incidents of Smoking and Misclassification Among the U.S. Married Population, Interim Report No. 1."

DR. OGDEN: Okay. And the page again?

DR. SAMET: Page 13.

There's a figure on this page that describes a value of ten for separating out non-smokers. Does that apply only to the current smokers?

DR. OGDEN: You're talking about the sentences directly under Figure 1?

DR. SAMET: That's correct.

DR. OGDEN: What I'm saying there is that from an examination of that distribution, those would appear to be more reasonable cut points. That is not a statement of what was actually done in this study. Again, the study was done, as you look on the previous page, on page 12, we talk about the 10 nanograms per mil, the generally recognized concentration, quoting the paper by Edsal for Centers of Disease Control. The 35 nanograms per mil is the 10 percent of the mean. That is what was done in the EPA risk assessment. That would be the cut point for occasional smokers. Then the 30 percent of the mean found in self-reported current smokers, which is the delineation point for a regular smoker as defined by the Environmental Protection Agency in their '92 risk assessment.

DR. SAMET: Then just again, when you considered those who self reported as never smokers, whom did you consider as misclassified? Those above 10?

DR. OGDEN: For calculating the misclassification rates?

DR. SAMET: Yes.

DR. OGDEN: It's exactly as I just said. We took all the never smokers. We applied the cut points of 30 percent of the mean found in current smokers, which is the 106 nanograms per mil, so all self-reported never smokers with cotinine levels greater than 106 nanograms per milliliter were then determined, by EPA's definition, to be regular smokers. All reported never smokers who lied in the range of 10 percent to 30 percent of the mean, which for this study would mean that the cotinine values would lie between 35 and 106 nanograms per milliliter. Those reported never smokers are then reclassified as occasional smokers, and then all remaining self-reported never smokers with cotinine levels below that ten percent, which is now below the 35 nanograms per mil, remained, according to this EPA construct, correctly classified as, well non-smokers, but they were self-reported never smokers.

DR. SAMET: Okay. Thank you.

DR. COGGINS: Thank you, Mike.

DR. SAMET: Let me return to the question of the relevance of the studies of lung cancer risk in the home environment to the workplace or other environments. It's clearly stated in the testimony that only studies in the workplace environment with regard to lung cancer or other diseases should be considered relevant to that environment.

Would this concern extend to another agent where exposure might be experienced in an environment outside the workplace and in the workplace as well?

DR. COGGINS: It seems to me that that's part of the substantial evidence of a significant risk of materially impairment of health at the workplace, but I think maybe Dr. Sears, you might be able to add something to that?

DR. SEARS: Dr. Samet, I'm going to have to ask you to repeat the question. I think I missed your final qualifier.

DR. SAMET: The question was, in the testimony it's clearly stated that studies, workplace risks can be assessed only by epidemiological studies done in the workplace environment, that the studies done in the home environment are not applicable. My question was, would that concern extend to other agents where there might be exposure in the workplace and another environment.

DR. SEARS: If I understand your question correctly, I think that the answer is a qualified yes, but let me expound just for a moment.

Certainly the target population should be, the epidemiological study should be built around the target population that one is interested in. If one is interested in a particular nationality, then the epidemiology should focus on that country. If the epidemiology is built around a certain gender, then the target population should be of that gender. That's pretty much axiomatic, it seems to me, for any epidemiology study.

Here, OSHA is interested in risk in the workplace, potential risk of disease due to ETS in the workplace. For that reason, the target population should be the workplace.

Have I answered the question that...

DR. SAMET: I think so. Based on what you said, would it be necessary to even further stratify the workplace and do studies of men, women, those of different ethnic or racial backgrounds, regional backgrounds?

DR. SEARS: I think, Dr. Samet, if I may continue for a minute.

DR. COGGINS: Please.

DR. SEARS: You may have missed some testimony yesterday given by I believe my colleague Dr. Nelson, and perhaps Mr. Bohanon as well, stating that, for example, the exposure to environmental tobacco smoke is highly dependent on occupation. And therefore, I would advocate further epidemiological stratification to determine whatever epidemiology might apply to different strata in the workplace. However, I have to emphasize to you that the current epidemiology in the workplace, both by examining the individual studies and by looking at pooled estimates, gives a relative risk of identically one. So there is really very little suggestion that further epidemiology would reveal anything different.

Of course the single outlier, the single study that stands out from that body of data is the Fontham study, and I've discussed it in some detail in our written submission.

DR. COGGINS: So you can go on and do subsets and subsets and subsets, but the data that we have available to us today on workplace exposures, do not indicate substantial evidence of significant risk of material impairment of health.

DR. SAMET: Okay, thank you.

DR. COGGINS: Thank you.

(Pause)

JUDGE VITTONE: Just for planning purposes, I'd like to break for lunch at about 12:30.

(Pause)

MS. SHERMAN: For a moment, getting back to the Oak Ridge study, how was Reynolds selected to do the analytical work on that study, do you know?

DR. COGGINS: Dr. Ogden is the expert, just to keep the record straight.

MS. SHERMAN: You notice I didn't say a name, I just looked. I'm sorry.

DR. COGGINS: Mike, can you answer that question?

DR. OGDEN: I'll try.

As was stated previously in my testimony and as was stated also previously in the record by Dr. Jenkins of Oak Ridge, the concept of the study was presented to Oak Ridge, and as part of that initial concept there was, just as an idea that certainly Reynolds would be willing to participate -- having expertise in the area, having worked in the area for ten years.

That was, as again I want to make very clear, the initial concept. Dr. Jenkins and his co-principal investigator, Dr. Guerin, of Oak Ridge had, once they received, and I'm not sure of the right lingo, maybe a grant, as he characterized it, he had fully within his domain to select any laboratory he wanted. The fact on the record is, that he chose to go with us.

I think there are a number of reasons why that would be. I'd be happy to enumerate those, but that may not be exactly where you'd want to go. Just to summarize the essence of why that is, we have worked together in the past on a very limited effort. We have collaborated as scientists. He is very familiar with our published work. I think we share a mutual respect as scientists.

DR. COGGINS: If I could just sum it, I think Mike's being a little modest there. I think that Dr. Jenkins, who I've known for many years, would always pick the very best lab he could, and I think Mike's lab is the very best. That's maybe not a reason you'd heard Dr. Ogden say, but that's my opinion.

MR. BOHANON: I would also echo that. Why not use a laboratory that is run by the scientist who developed the methods.

DR. OGDEN: I am modest.

(Laughter)

MS. SHERMAN: We, of course, appreciate your modesty.

DR. OGDEN: Thank you.

MS. SHERMAN: However, I guess perhaps my question could have been a little bit clearer. What was the mechanism of the selection? Was there a solicitation of a proposal? Were there other facilities in the running to do the work? I take it that this was a fairly large job so it would perhaps bring profit to some other group, as well as...

DR. COGGINS: It seems to me that is more of a question for Dr. Jenkins, but I'm sure Mike can make some comment.

DR. OGDEN: You characterized it as very large. I might characterize it as enormous.

MS. SHERMAN: Modestly.

(Laughter)

DR. OGDEN: Yes, modestly.

As to any thoughts or other contacts that may have been made by the Oak Ridge principal investigators, I'm not aware of any, and I think that would have to be a question for them.

MS. SHERMAN: So you submitted a proposal to them?

DR. OGDEN: No, no. In fact, the initial idea, as I said, was basically, as Dr. Jenkins said, was an approach to Oak Ridge from Center for Indoor Air Research, basically along the lines of would you be interested and willing to conduct this type of project. Beyond that, the drafting of the grant proposal and what it would entail was entirely within the purview of Oak Ridge.

DR. COGGINS: The CIAR decided to fund the work. They said to Oak Ridge, would you do it? Then Oak Ridge, as I got it, said who is the best lab to do it, and then they came to Dr. Ogden. Is that right?

DR. OGDEN: That may be a fair characterization.

MS. SHERMAN: When one has a study with different groups participating, does the principal investigator get all the money and then he bundles it out as he sees fit, or how does this work?

MR. GROSSMAN: I'm going to object to that very vague question. It presumes that every scientific project undertaken is undertaken with the same funding mechanism. If I could just add, OSHA's own paid witness, own expert, Dr. Neil Benowitz in his testimony, testified that he uses R.J. Reynolds labs because he finds them to be of the highest possible quality.

MS. SHERMAN: That's not the point of the question.

JUDGE VITTONE: What is the point of the question?

MS. SHERMAN: First of all, the question involves the Oak Ridge study. What I am trying to ask is, was the Reynolds part of the study paid by Oak Ridge as the principal investigator having a pool of money to divvy out for the various parts of the study, or was it paid by the sponsor of the study, CIAR, directly?

JUDGE VITTONE: So your question is who paid R.J. Reynolds to do the laboratory work they did for the study?

MS. SHERMAN: Yes.

JUDGE VITTONE: If you know.

DR. COGGINS: I don't. Dr. Ogden does.

DR. OGDEN: There was partial remuneration for our analytical services for our exact expenses in terms of travel and supplies, those were paid directly.

MS. SHERMAN: By whom?

DR. OGDEN: I'm getting to that.

As I understand it, all three of the team, if you will, were paid directly from the Center for Indoor Air Research.

DR. COGGINS: So CIAR was the funding agent. They funded the three -- Oak Ridge, Reynolds, and Bellomy.

DR. OGDEN: Yes, but the overall concept I hope is not lost here. Oak Ridge was clearly in charge of deciding who would run the samples, and they remained with us as the laboratory.

DR. COGGINS: So the work is done by Oak Ridge, but some of it's subcontracted. We happened to be the subcontractee.

MS. SHERMAN: Did Reynolds submit a formal proposal to Oak Ridge to do the work? Was it a formal process, and were there other people formally competing to do this work on the Oak Ridge study?

DR. COGGINS: Again, it seems that that should be a question for Dr. Jenkins. Maybe Dr. Ogden knows the answer.

MS. SHERMAN: The reason I'm asking you is that you would have been the ones who would have submitted it or not submitted it, as the case may be.

DR. COGGINS: Well we would only have submitted it as Reynolds. If there were other companies bidding, we couldn't have any knowledge of that.

MS. SHERMAN: You may or may not know what other companies were doing, but you do know what you were doing in relation to this work.

DR. OGDEN: It's been some time ago. I will give you to the best of my recollection how that process worked.

There was not a formal proposal as I would identify it or define it. I prefer doing work rather than writing proposals, but...

MS. SHERMAN: I think we all do.

DR. OGDEN: Some of my management maybe doesn't, but that's another...

I do recall submitting to the Center for Indoor Air Research an estimate of the cost in terms of both development work, in terms of materials, in terms of analytical services, and in terms of at-cost expenses such as travel to the various cities and that sort of thing, shipping, and that.

I do also recall submitting to Oak Ridge not any formal proposal, but the published manuscripts describing the methods that we would employ to analyze the samples, which I would imagine they were already familiar with, but I do recall sending that as a package. We will analyze nicotine by this published method, we will analyze solanesol by this published method, et cetera.

I think the essence of your question is, though, what may Oak Ridge have done in soliciting that from someone else. I can't answer that, I don't know.

DR. COGGINS: We're involved in the science aspects of the work. The panel certainly were involved in the scientific aspects.

MS. SHERMAN: What do you mean by that?

DR. COGGINS: Non-contractual. We're scientists, not financial people. We can tell you about the science of the Oak Ridge study, but I don't think we know very much about the way the money flowed.

MS. SHERMAN: I believe you were talking about travel expenses in the various cities. Speaking of the other cities, did you assist Bellomy in selecting the cities to be studied?

DR. OGDEN: Yes, I did. As did Dr. Jenkins of Oak Ridge.

MS. SHERMAN: What was your criteria for suggesting the cities?

DR. OGDEN: The initial criteria was as Dr. Jenkins stated in his testimony, that it be a fairly large, I forget his exact acronym, but metropolitan statistical area or some categorization as used by the census.

That was deemed necessary to be able to first of all, find a reliable field service in such an area, but also as a population base for being able to find enough potential subjects to adequately find the participants that met the criterion that had been established for subject participation in the study. So it was a much involved process in terms of there were different people involved.

I had no pre-conceived notion as to city. Bellomy Research was asked, in fact in all of our studies, they have a list of other agencies that they either know by reputation or they know because they've worked with them in the past, and they limited as much as possible that list to those people that they knew could do such an extensive project and perform in a quality fashion. There were some agencies that they'd worked with in the past that they refused to work with again, for example.

I also solicited information about what the official regulations against smoking might be in a number of cities. As I recall it, I asked Bellomy for a list of cities. They broke it down by census region. As I recall, we broke it down, in the initial phase of the study it was broken down into, I believe it's nine regions. The four major regions and then there are some sub-regions. They offered up a choice of cities, two or three cities within each of those regions, which brought us a list of maybe 30 or 40 potential cities.

I then sought information from a public firm that tracks that type of smoking regulation as to what the regulations may be against public smoking in those cities. The reason for doing that was we did not want to go into a city and attempt to measure smoking in indoor places when there was no smoking in indoor places. For example, that excluded Los Angeles as a city from consideration. That was an initial city. We, in fact, had been to Los Angeles in a prior study when they did not have a city-wide ordnance against smoking. So that type of information was then obtained solely for the purpose of estimating where are we likely to find enough non-smokers who are likely to be exposed in the workplace, because that was a prime consideration of the study.

From that, as I recall, we eliminated some cities, Los Angeles as an example. There were others, I can't recall them right off. There was then a volley back to Bellomy to say our recommendations would be based on the smoking restrictions in these potential cities. We narrowed the risk down, basically.

Then at that point, Bellomy would, if there was only one city left, they would obviously contact them. If there were two or more cities left, then they would offer an opinion as to whether one of those agencies would likely be better or worse than another one. In some of the demographic areas, some of the census regions, after we looked at the restrictive smoking policies that we thought would preclude us from getting subjects exposed at work, there were no cities left so they would go back to the drawing board and we would start the process again and they would pick other cities.

Once we had, as I recall it, a tentative list, and it may have been one city in each region, and there may have been one or two in some regions, the list then went to Oak Ridge for their suggestions as to did they have any preference on if there's a choice of cities, any preference on the geographic location -- far north, far south, far east, far west, that type of thing, and also the scheduling.

Part of that initial process also, of course, included the criterion that the local agency in a potential city was available during the study time frame. Many of them were not. In other words, they had a job already booked, that type of thing.

For instance, as we tried to coordinate the cities in terms of weather and travel considerations, we had, in one or two cases there would be a fairly narrow window of say three weeks when we could be in one city, and the agency that had initially indicated they were available would then call back and say we can't do it during those three weeks, so we'd start the process over again in that census region.

It was a fairly complicated process, generally following the guidelines that I just portrayed to you.

Does that help in giving clarity of how it...

DR. COGGINS: I think he's being modest again. It isn't fairly complicated, it sounds extremely complicated.

JUDGE VITTONE: Thank you, doctor, for that comment, but let's get back to the questions.

MS. SHERMAN: So it would be fair to say that you did play a role in the selection of the cities, an active role?

DR. OGDEN: The role that I played, as I recall and as I just stated, was to basically seek out from a public firm what the smoking restrictions may be in that city, which narrowed the list down. It was very much a joint effort among all of us, but yes, I did play a role.

MS. SHERMAN: You also went to some of the cities as part of your work on the study?

DR. OGDEN: That's correct. The number of scientists and technical people required to handle the number of pumps and the calibrations and the shipment of samples, storage of samples, generally required that we have between two and four scientists in each city at any one time. As part of that effort, there was a bit of a rotation, as you can imagine. I think in 1993 one of our principal investigators spent 180 nights in a hotel. So you can imagine the magnitude of this. So there was some rotation out, and I was one of the principals from Reynolds, if you will, that did in fact go to some of the cities.

MS. SHERMAN: Did you happen to go to San Antonio?

DR. OGDEN: No, I did not.

MS. SHERMAN: Do you have any insight into the difficulty they encountered in getting an adequate number of respondents?

DR. OGDEN: No. All of the information regarding difficulty in recruitment, how the recruiting was going, as I recall, that was all communications between Bellomy and Oak Ridge. There may have been some interaction with the Center for Indoor Air Research, I'm not sure, but I don't have access to any of those records.

Somebody may have called up and said, "We're having trouble in San Antonio," but in terms of any detail of what that might entail and how it would compare to other cities, I can't comment.

MS. SHERMAN: Thank you.

DR. OGDEN: You're welcome.

(Pause)

MS. SHERMAN: Aside from the inhalation studies, I believe it was a 14 and a 90 day inhalation study that was described yesterday, have you carried out any animal carcinogenicity study involving environmental tobacco smoke?

DR. COGGINS: The simple answer is no. The studies that we have performed were clearly not carcinogenicity studies. They were comparative toxicology studies. Of course with 90 day duration, carcinogenesis would not be expected.

We did perform another study which we have not yet published, which was only five days duration.

MS. SHERMAN: On carcinogenicity or on toxicity?

DR. COGGINS: I'll describe it to you, if you wish.

MS. SHERMAN: Okay.

DR. COGGINS: The five day study? Fine.

MS. SHERMAN: You haven't described it to us so far, correct?

DR. COGGINS: No.

The five day study was performed in conjunction with M.D. otolaryngologists. That's middle ear people from the Bowman Gray School of Medicine in Winston Salem. They approached us, the professor of the School of Otolaryngology and said could we expose some rats for him to environmental tobacco smoke. We said sure, what had you in mind, could we do a collaborative study?

We then entered into a long and fruitful relationship with the Bowman Gray School of Medicine to develop an animal model for middle ear effusion. This is linked epidemiologically in children with exposure to ETS. But as my colleagues, Dr. Sears and Mr. Steichen have pointed out, it's only one, it's an epidemiological link. There are many others, so we wanted to examine one other risk factor for middle ear effusion, which is low relative humidity.

So we performed a five day inhalation study with very much the same experimental design as I described yesterday, with three groups of animals. One was a group of animals that was simply exposed to environmental tobacco smoke, as I described yesterday, to see if that exposure would result in middle ear effusion.

The second group had pre-existing middle ear effusions induced in them, and there's a well known procedure for so doing this, to see if the exposure to environmental tobacco smoke would exacerbate or regard the clearance of those middle ear effusions.

The third group was not exposed to ETS at all, but was kept in chambers with a very low relative humidity, I believe around five to ten percent -- very dry air.

We performed this study over the five days, as I just described. At the end of the experiment, the otolaryngologist from the Bowman Gray School of Medicine examined the ears of these animals, in a blind manner so that he couldn't be affected by knowledge of the treatment. Basically he found that exposure to ETS did not produce middle ear effusions; that exposure of animals with pre-existing effusions were not affected, in other words, there was no change in the rate of clearance of those effusions; and in the third group of animals where the animals were exposed to low relative humidity, there was a much higher than normal incidence of middle ear effusions.

Some of this has been written up by the Bowman Gray School of Medicine. I'm not sure if that has been entered into the record or not. The second part I am still writing up, the tobacco part. Tobacco smoke part. But the humidity part has been written up.

MS. SHERMAN: The study was done with some type of rodent?

DR. COGGINS: This was all done in [sprague dolly] rats, in exactly the same conditions as I described.

MS. SHERMAN: Why did you choose five days as your protocol for the study?

DR. COGGINS: That was the decision of the resident at the Bowman Gray School of Medicine, Dr. Lovejoy, whose paper I have with me, that he had a number of other commitments. He only had a short period of time to commit himself to examining animals. It was he that decided on the five days. We said we can to longer if you wish.

But what we did do, and it's included in the paper that I am writing out, is that he did have time to come and look at the animals in the 90 day study. He came and looked at those animals, although clearly we didn't have the low relative humidity and we didn't have the pre-existing effusions, he did look at those animals before we killed them, and there was no middle ear effusion in those animals, in any of the concentrations used.

So it was Dr. Lovejoy who just didn't have time for anything longer than a five day exposure.

MS. SHERMAN: Are two year bioassays important in animal studies in assessing cancer risk from exposure to toxic chemicals?

MR. GROSSMAN: That's a vague question.

Can you answer it, Dr. Coggins?

DR. COGGINS: Yes.

The two year bioassay is the central part of the national toxicology program to evaluate carcinogenesis.

MS. SHERMAN: So you would agree with it?

DR. COGGINS: No, I was just about to continue.

MS. SHERMAN: Okay.

DR. COGGINS: It's under increasing siege from toxicologists, and I have some quotations I can read to you here. For example, Dr. Bruce Ames and a number of other scientists that are saying that these studies using massive doses of materials are not representative of the real world, and that they are, to a certain extent, creating false positives.

There's also a great deal of current research on the concept of DNA repair. Indeed, there was a recent issue of the Journal of Science, which is the American Association for the Advancement of Science, that had a molecule of the year, and the molecule of the year was the DNA repair molecule. The statement made by the researchers is that, and I quote from Science, Volume 266, and it's just a one line quote, Your Honor.

"Moreover, the new understanding of repair mechanisms may bring about the reexamination of the postulated linear extrapolation for pesticides and radiation, and allow more realistic assessments of environmental risk."

So what's going on is that scientists are looking at these two year bioassays and saying how do we get a better understanding of what's going on? How do we understand more as I described earlier, of the mechanism of what is going on? And can we do this in a shorter mode? That's one of the reasons why we added the extra end points into our 90 day study, such as the cell proliferation.

MS. SHERMAN: If I might, my question involved the amount of time for the bioassay. I believe your answer dealt with dosing patterns or dosing amounts.

DR. COGGINS: Right.

MS. SHERMAN: Let's get back to the amount of time.

DR. COGGINS: Sure.

MS. SHERMAN: Are two year bioassays important in animal studies in assessing cancer risks?

MR. GROSSMAN: I want to see if I can get this clarified. As I said when you first asked the question, I wasn't clear.

Are you saying is a period of two years necessary or appropriate for a bioassay of carcinogenesis?

MS. SHERMAN: Correct.

DR. COGGINS: Yes, I think the answer is yes, that there are studies, for example, with diesel exhaust that have shown tumors with 24 months. It's also clear that with new techniques in animal husbandry that there are some researchers now that are suggesting for rodents that this could be extended, in certain cases, to 30 months -- if you can get a high enough survival rate.

MS. SHERMAN: The two year period was originally chosen, was it, to approximate a general life span expected of the rodent, or an adult life span of the rodent or whatever?

DR. COGGINS: Yes, it's a constantly evolving figure. For example, one of the studies I included my CV, which was a chronic inhalation study with mainstream smoke was restricted to 18 months because at the time, that was as long as you could expect some of these animals to live. But with improved animal husbandry techniques, improved understanding of nutrition, it turns out we're probably over-feeding these rats all the years, that 24 months is probably the standard today. If under circumstances one wanted to extend it, 30 months is, in rats, considered probably the norm today.

I think mice would not be expected to live as long as 30 months.

MS. SHERMAN: So one would try to extend it because this would be considered a more representative length of time to represent the full useful life of the rat?

DR. COGGINS: Yes, I think the national toxicology program states that their idea is to expose animals over a representative period of the life time of the animal. But as I say, the entire assay is under a great deal of critique in toxicology circles at the moment -- the bioassay program.

MS. SHERMAN: Do you believe that the two year length of time or the 30 month length of time is a reasonable and good length of time to look at these animals?

DR. COGGINS: You mean reasonable and good in terms of producing carcinogenesis?

MS. SHERMAN: Yes.

DR. COGGINS: Yes, I have no reason to think not. For example, inhalation studies with diesel exhaust in rats and hamsters has shown lung tumor responses after 24 months, something like that.

MS. SHERMAN: Have you carried out any genotoxicity studies of environmental tobacco smoke?

DR. COGGINS: I personally did not. My colleague, Dr. Doolittle did. I have in front of me his submission. He performed a number of genotoxicity assays in experimental animals and in vitro techniques, too.

MS. SHERMAN: He studied the genotoxicity in mainstream smoke or sidestream smoke?

MR. GROSSMAN: Or ETS?

MS. SHERMAN: I asked for mainstream smoke and I asked for sidestream smoke right now.

MR. GROSSMAN: Those are the only two classifications you're referring to?

MS. SHERMAN: For this question, Mr. Grossman.

JUDGE VITTONE: Mr. Grossman, could you hold it down a little bit?

MR. GROSSMAN: I just want the record to be clear.

JUDGE VITTONE: Unless you have an objection, sir. If he needs clarification he can ask for it.

MR. GROSSMAN: That was an objection to form.

JUDGE VITTONE: All right.

DR. COGGINS: I have in front of me Dr. Doolittle's comments on the genotoxicity of environmental tobacco smoke. Dr. Nelson was involved in some of this work, if you have questions on the exposure conditions. Was that the way you were leading?

MS. SHERMAN: No, I just wanted to know the substances studied in the genotoxicity studies. In other words, okay, they were done with mainstream smoke, yes.

DR. COGGINS: We have done studies with mainstream smoke, yes.

MS. SHERMAN: And with sidestream smoke.

DR. COGGINS: I believe yes, but I'm not as sure. But we have done studies with environmental tobacco smoke, yes.

MS. SHERMAN: Have you done it with aged and diluted sidestream smoke?

DR. COGGINS: That was really how I was going to introduce Dr. Nelson. He was the one...

MS. SHERMAN: Introduce.

DR. NELSON: I'm not sure that I was involved in everything that Dr. Doolittle has done, but there is one series of experiments that were carried out in the environmental chamber that I worked with in which we generated environmental tobacco smoke, and I am fairly certain that it is environmental tobacco smoke that we generated as opposed to aged and diluted sidestream smoke. I'd have to go back and check to be certain on that. That was an experiment done with an apparatus called a cellular smoke exposure technique or C-set technique, where environmental tobacco smoke at what was really a very high concentration, was drawn through and across flasks containing various types of cell cultures, and the results from those studies were all negative. They did, I believe, and I would have to go back to check some other things, but I believe they did an Ames assay in that, SCE, and a neutral red cytotoxicity test.

MS. SHERMAN: When one talks about an Ames test, one is talking about an in vitro test?

DR. NELSON: Yes. All these tests that I'm referring to are in vitro tests.

DR. COGGINS: There's a slight error there. They didn't do cystochromous exchange. I have Dr. Doolittle's submission in front of me. He says we have developed this filtration method to collect real ETS and use the method to evaluate the biological activity of ETS.

The biological end points utilized in the study included neutral red cytotoxicity, which is a simple... Neutral red cytotoxicity, how toxic are materials to the cells, do they die.

The second assay was the Ames bacterial mutagenesis, which is as we've just described.

Then I'm correcting myself. It was Chinese hamster over cystochromatic exchange assays. I have the results in front of me. There was no cytotoxicity observed in cells using even using grossly exaggerated ETS environments. Exposure of, exposures to an exaggerated concentration of 1.5 milligrams a cubic meter did not increase the Ames activity above controls.

Thirdly, none of the ETS exposed CHO cell cultures exhibited a statistically significant increase in cystochromatic exchanges.

MS. SHERMAN: Can you submit those studies to the record?

DR. COGGINS: I'm reading from Dr. Doolittle's submission. October the 6th.

MS. SHERMAN: My toxicologist indicates to me that those are his comments on the study, but not the study itself. Is that true?

DR. COGGINS: So you're wanting...

MS. SHERMAN: The study. Did he write up the study? Is it published? Or available.

DR. NELSON: I believe the study was presented, or the results were presented at a meeting of the Environmental Mutagenesis Society.

MS. SHERMAN: So a paper about it would exist.

DR. COGGINS: I have the reference. It's Environmental and Molecular Mutagenesis, Volume 17, 1991, page 11.

MS. SHERMAN: Okay.

MR. GROSSMAN: It's a public record. We'd be happy to give you a reprint.

MS. SHERMAN: That is, I believe, an abstract of the study. Has the full study been published?

DR. COGGINS: No, just the abstract that was presented.

The way scientists sometimes do, present their data to their colleagues, is not necessarily in the form of a full manuscript. What Dr. Doolittle and his colleagues decided to do in this particular case was to present the information in the form of a poster. Posters are these large panels where scientists walk by and interact directly with their colleagues. Dr. Doolittle decided to do that with this. He then submitted a manuscript, which is what we have here.

I do have the poster. It's going to be very difficult to submit that.

MR. GROSSMAN: We'll take your request for any further writing under advisement.

MS. SHERMAN: Why does one do genotoxicity studies? What do we hope to learn from them?

DR. COGGINS: The idea of doing a genotoxicity test is to see whether the test material affects the DNA structure. What relevancy it has in terms of any eventual carcinogenesis, we don't know. There are a number of genotoxicity tests that are being used. Some people have a bent towards one battery, other people have a bent towards another.

The beauty of these tests is they're very short term. A test on genotoxicity can be formed in several hours in some cases, as opposed to the carcinogenesis testing we were just discussing of perhaps 24 months.

MS. SHERMAN: If one gets positive results in a genotoxicity test, would you then feel that the results should be investigated further in additional studies?

DR. COGGINS: It would depend. I think that a single positive in a single assay may mean something. If it was a compound that, for example, was uniformly strongly positive in all the test, you'd take a different point of view. But I don't think we know scientifically what, for example, mutagenesis in the Ames test really means, if anything, in terms of human carcinogenesis. It's a screening test that's used, it's usually used as part of a battery of other tests. Toxicologically, I'm not sure that we really know what mutagenesis really means because of the DNA repair I was just telling you about earlier.

MS. SHERMAN: Have you conducted animal or human studies on the effects of any form of tobacco smoke and cardiovascular disease?

MR. GROSSMAN: As to all of these questions, I'm going to register an objection to the extent that the question seeks proprietary information about particular...

MS. SHERMAN: That is understood.

Now, you said as to any particular brand, is that what you...

MR. GROSSMAN: Any particular brands or new styles that are under development. Any proprietary information at all.

MS. SHERMAN: That was not the thrust of my question.

DR. COGGINS: So the question is how do we perform studies on animals or humans on cardiovascular systems.

MS. SHERMAN: On the effects of any form of tobacco smoke on cardiovascular systems.

DR. COGGINS: Any form?

MS. SHERMAN: Cardiovascular disease, excuse me.

DR. COGGINS: Any form is kind of a...

MS. SHERMAN: Well, you can...

DR. COGGINS: I think that all of the inhalation studies that we performed that I described to you yesterday on ETS, although they were not specifically designed to examine cardiovascular effects, we did examine the cardiovascular system. We did a number of assays that would provide information on cardiovascular toxicology. We examined, for example, the heart in detail in a number of different sections, and basically didn't find any responses, histopathological responses.

We have also performed studies, for example, with carbon monoxide which is a component of cigarette smoke. So if you exaggerate very massively the CO concentration, and we've submitted this to you, too, then you can show under certain circumstances, increased weight of the heart tissues. But those were absolutely massive concentrations almost approaching death in the animals.

Those are the only two specific areas I think I can say that in inhalation studies we've always examined heart and to a certain extent other tissues, and we had one specific study where we looked at heart as the end point.

MS. SHERMAN: Your answer involved RJR in general, not just you, Dr. Coggins, is that correct?

DR. COGGINS: I was talking just me, but I don't think we've done any other inhalation studies that I'm aware of. The only one that I'm really aware of is the offers of a component, which I think was really your question, was published in Inhalation Toxicology, Volume 1, 1989, page 349. That was the component.

MS. SHERMAN: Has Reynolds conducted any studies of tobacco smoke and cardiovascular disease using any other route of exposure besides inhalation?

DR. COGGINS: I don't know of any route other than inhalation where you could possibly have cardiotoxic effects. We're interested in the inhalation of ETS. There, we didn't see any results with the animal studies, nor did the epidemiologists show any results in the cardiovascular effects, as pointed out by Dr. Sears.

MS. SHERMAN: Have you conducted any epidemiological studies on cardiovascular effects of environmental tobacco smoke?

DR. COGGINS: We haven't. All we've done is looked at the information in the literature. That was described yesterday by Dr. Sears and Mr. Steichen.

MS. SHERMAN: You have not yourself conducted epidemiological studies.

DR. COGGINS: No.

MS. SHERMAN: And by yourself, I mean Reynolds.

DR. COGGINS: Is that right?

(Pause)

JUDGE VITTONE: For the record, the other members of the panel indicated agreement with Dr. Coggins.

Go ahead, Ms. Sherman.

MS. SHERMAN: Are there any acute health effects associated with exposure to environmental tobacco smoke?

DR. COGGINS: There are a lot of things in there. Any acute health effects. In animals, in humans? What do you mean by an acute health effect? I'm not sure at all what you mean here.

MS. SHERMAN: Why don't we start with animals, and then we can go to humans. I guess I would allow you the flexibility to define a health effect in any way you see fit.

MR. GROSSMAN: You're asking the question. I really don't think this is an appropriate form of questioning. Why don't you just ask your question and we can answer it.

MS. SHERMAN: An acute health effect is something that happens quickly. We can start with the eyes and go down through the system if you wish. We're dealing with animals in the first part of the question, okay?

DR. COGGINS: Okay.

So you're asking me to define any health effects that I've seen in animals with acute exposures to ETS.

MS. SHERMAN: Yes.

MR. GROSSMAN: Is that the question?

MS. SHERMAN: Yes.

DR. COGGINS: The simple answer is that by an acute exposure you would presumably mean something on the order of minutes or hours. We haven't done those studies. What we've done is the four day study that I've described, and the 14 and 20. But what I can tell you is the results that we observed in those animals at the end of the six hour exposures. That is very simply, we didn't see anything.

In our four day and 14 and 90 day studies, in fact after every day of exposure of every study, we performed clinical observations, as defined in our manuscript, on the animals as they came out of the tubes in which they're exposed during the exposures. As they came out, trained animal care attendants were there to observe to any effects those animals may have, any abnormal traits. These were recorded into the computer.

Basically we saw a couple of animals that had got twisted around in the tubes that had somehow got over-heated in the tubes, that had got somehow upside down for four or five hours, but we didn't see anything major in terms of a clinical observation in any of the animals in any of the studies, even at the highest exposure group. These were taken out every day, at the end of every day of exposure, examined, and records put into the computer. And remember, those records were submitted to the AFIP along with the tissue.

So a long winded answer. We didn't see anything in animals.

MS. SHERMAN: You were just referring to the animals in the tubes. Were those those pictures you showed us yesterday that they looked like plexiglas cones?

DR. COGGINS: Yes.

MS. SHERMAN: Where I guess you had a cone for each animal.

DR. COGGINS: That's right.

MS. SHERMAN: The purpose of putting the animal in the cone was so that all the exposure was directed toward the nose, is that...

DR. COGGINS: That's partially the case. When you expose animals in a whole body chamber, and we have to use whole body chambers to get the amount of dilution we needed to ensure we were using aged and diluted sidestream smoke. When you expose animals in a so-called whole body mode, large amounts of material will be deposited on the skin. Some material will, of course, be inhaled. That material that is deposited on the skin could be absorbed through the skin, and indeed, at the end of the exposures would be licked off by the animals and swallowed. So those two routes of administration are clearly very different from the routes of administration of ETS in the real world.

So we put the animals inside the tubes during their exposures to minimize the non-inhalation routes of administration. That is to say the skin route and the dermal route. So the animals lived in the cages all their life. In the mornings they were taken out of the chamber, put in the tube, the tube was sealed, so the only real way animals could be exposed was with their nose, then the sealed tube was put back in the chamber, the doors closed, and animals exposed.

MS. SHERMAN: I'm sure they loved that.

DR. COGGINS: But as I say, actually, when they came out again at the end of the six hours, as part of our protocol by the laboratory veterinarian, those animals were examined every day for signs, clinical signs, which I think was the reason for your question, and the answer was, we did not see any clinical signs at the end of those six hours of exposure.

MS. SHERMAN: What types of effects, was it an animal handler or a vet? I'm not sure what you said.

DR. COGGINS: We have three grades, really here. We have simple animal attendants that put the food in, take the food out, clean the feces and urine out, that sort of thing.

In addition, we have trained animal attendants who have been trained by a laboratory veterinarian. It's these people that do the clinical observations and enter them into the computer. At the same time, we do have a laboratory veterinarian who is experienced in experimental animals. In fact we're required to have one by the regulations, and he came through at times to check that the observations being made by the trained assistants were what he thought was the case.

MS. SHERMAN: So what parameters was he looking for in these observations?

DR. COGGINS: The system that we have is driven by a software program resident on our large computer, and it basically comes up with, "Did you see X, did you see Y, did you see Z?" The computer list is commercially available, and is sold to us by this toxicology vendor.

Basically the list has a very large number of possible things ranging from "dead" to "twisted toe nail." The animal attendants were trained to examine the animals, and they would dictate to an operator whether or not they had seen any of the changes that were listed by the computers as possibles.

MS. SHERMAN: Do you remember the name of the program that you're using?

DR. COGGINS: Yes, I do. It's called Xybion, and it's a commercially available toxicology program from a firm in Cedar Knolls, New Jersey.

MS. SHERMAN: It seems to me that all of these things look like science fiction movies, the names they choose to give them.

DR. COGGINS: Certainly the logistics of loading and unloading almost 600 animals in the morning and in the evening, performing clinical observations on them, weighing them, were very substantial.

MS. SHERMAN: How long did these examinations last per animal to get through this checklist?

DR. COGGINS: On the first day of the experiment and the second day and the third, a long time, because we're not sure whether anything is there. On the 90th day when we haven't seen anything previously, it takes a lot less time, because if it wasn't there on day 89, it's unlikely to be there on day 90. But on the order of, you would, a skilled animal technician could probably do, they did one chamber of 90 animals in about an hour. Ninety-six rats per hour. That was two teams of two.

MS. SHERMAN: We've had some testimony at this proceeding about the adequacy of nicotine as a marker for tobacco smoke. We've also had some testimony about the fact that nicotine and RSPs deposit on furnishings, people's clothes, what have you, and perhaps later get readmitted.

In view of this information, might not the animals in your little plexiglass cones that prevented anything from being deposited on their coats, have been perhaps in a purer environment than people exposed to environmental tobacco smoke?

DR. COGGINS: Certainly the animals were exposed to these massive amounts of smoke. They were only really exposed by the nose-only route. I'm not sure what you mean by purer. But remember, the controls were also put in these tubes, too. So the comparison is apples with apples. Was that your question?

MS. SHERMAN: No. Well, my point was that when people are exposed in smoky areas, they perhaps get deposits on their coats and they're not in plexiglass tubes.

DR. COGGINS: I understand. Dr. Nelson has an answer to that.

DR. NELSON: Well, the first point, I'm not sure I'm aware of anybody that then goes home and licks their jacket or their fur...

(Laughter)

MS. SHERMAN: One can hope not.

DR. NELSON: There's just one issue I wanted to clear up, and I'm not sure I'm familiar with the testimony that may have talked about the readmission of the particulates, absorption or deposition, the re-emission in the particulate phase of environmental tobacco smoke. But it's something, since you brought it up I thought it was important at least to clarify on the basis of my testimony.

It is true that some particles may stick or drop out onto various surfaces, but the rate at which that happens appears to be very different than nicotine. Particles appear to behave, at least so far as in my experience, and particularly in the chamber, very much, I would almost say in an ideal fashion. In an environmental chamber, particles behave very much like gases. That is, most of them are removed by ventilation, not by deposition on surfaces.

The opposite is the case for nicotine. Nicotine tends to be removed both by ventilation and by deposition on surfaces. The relative fraction which is removed by ventilation and deposition on surfaces is really dependent on a number of factors including surface characteristics, and how much air is coming into the room, how rapidly you're ventilating the room has an effect on the relative elimination of nicotine by those two methods. The particles in nicotine behave very differently. They don't deposit on surfaces, and I certainly would not expect an ETS particle which is essentially a little sticky viscous liquid droplet to suddenly pop off a surface again some time down the line. Whereas nicotine, which is a chemical absorption or a weak chemical bond to the surface, could re-emit much more easily.

MS. SHERMAN: Do you have a citation to support your discussion just now?

DR. NELSON: The work that I did in... Some of the various pieces of information which are built into that argument are included in my Environmental Science and Technology paper that has been submitted for the record. Also various other documents which I have submitted for the record would also verify that. Some of it is, I guess, more or less basic chemistry. It's not something you can say oh, this chemist says this is what absorption is. But a chemist who has had some experience knows what absorption processes are, what essentially is going no in absorption on surfaces. My own experience with looking at nicotine's desorption which is in the record and is in the literature, is probably not worth repeating at this moment,

MS. SHERMAN: In the 14 and the 90 day experiment that was discussed, you created the aged and diluted sidestream smoke for the purposes of your experiment, correct?

DR. COGGINS: Yes, that's right.

MS. SHERMAN: How long did you age the sidestream smoke in order to get the substance that I believe you refer to as ADSS?

DR. COGGINS: It's difficult to measure an actual age because you can't measure an individual smoke particle leaving the tip of the cigarette right to the rat nose. There's no way we can do that. But by doing approximate flow rates and calculations of distances, we calculate that the age for the animals at the lower part of each chamber, and we circulated the animals in the chambers, was about 30 minutes. We have described this in our manuscript in the American Industrial Hygiene Association journal, Volume 55, 1994, page 806.

MS. SHERMAN: Did you design it to be 30 minute old smoke, or is that just the way it happened?

DR. COGGINS: We designed it to be old, as per Dr. Ogden.

(Laughter)

MS. SHERMAN: That was unfortunate.

DR. OGDEN: May I object?

(Laughter)

JUDGE VITTONE: Yes, you may.

DR. COGGINS: As per his recommendations on how long we should go. We did some approximate calculations with the size of the chamber available to us, the size of the room, the size of the tubing we decided to use. It worked out very well at 30 minutes. Wouldn't you agree it was a reasonable surrogate?

DR. OGDEN: The age of smoke, of course, is a continuous variable. We've known for years, in fact we pioneered that research. We were the first to observe the fact that in fresh or very concentrated ETS or sidestream, somewhere in that continuum, that nicotine was in the particulate phase, but as you allow it to age and dilute, nicotine shifts almost quantitatively to the vapor phase.

So this is the history I think that Dr. Coggins is referring to. So there's both a time and a concentration variable there. No one's able to say at what point in time and space sidestream smoke, for instance, becomes ETS. But based on some of the physical transformations that we've seen, 30 minutes seems like a reasonable estimate of allowing things like nicotine to transfer from the particulate to the vapor phase, as an example.

DR. NELSON: I would go a step further and say that based on the work that we've done, being able to look at nicotine in real time with a particular instrument we have, that transfer is really much more rapid than that. The transfer for nicotine from the particulate to the vapor phases is almost instantaneous. For it to get most of it into the vapor phase. There may be a little bit of nicotine and there are reports of small amounts, very small amounts of nicotine remaining with the particulate phase. But the vast majority of the nicotine transfer very rapidly to the vapor phase.

Excuse me. A small amount of nicotine remains with the particulate phase, but the vast majority of it transfers very rapidly to the vapor phase.

MS. SHERMAN: I think I understand the concept that ADSS is a dynamic concept. However, is the 30 minute mark somehow thought to be characteristic of real life situations?

DR. NELSON: I think when you're dealing with a real life situation you may very well be dealing with a situation where some of the smoke, if somebody is smoking in the space currently, may be seconds or I suppose microseconds old if you imagine it at its formation right down there at the very end of the cigarette.

But also in that same environment you could potentially have smoke, based on the effects of dilution, that were several hours old as well.

For example, in a home with an air exchange rate which is typically below one, and often in the area of one-half an air change per hour, it takes a long time for all the smoke constituents to be removed from that space by ventilation. You may have smoke in the house that may be hours old. In other cases in workplaces where the air exchange rate is considerably higher and the smoke is removed more rapidly by ventilation, the smoke would be considerably less old than it may be in house.

So as you've stated, there is really a broad continuum. Many changes occur very rapidly, but that isn't to say that every possible change in the tobacco smoke going between sidestream smoke and ETS happens within 30 seconds or 50 seconds or a minute or an hour. Many changes happen very rapidly, but that aging process does continue, continually, I suspect, for as long as that smoke is present in the space.

MR. BOHANON: Let me add from an engineering standpoint, if one says that in a room or in a space or in a building, one assumes that the average air change is one air change per hour, which is not an unusual number, then you can relatively straight forwardly calculate that the average age of that air would be 30 minutes. In other words, a particle that's generated is changed out at the rate of one per hour, the average would be 30 minutes. That's not an unreasonable estimate.

MS. SHERMAN: When you performed the 14 day inhalation study in the rats with the ADSS, what were the objectives? What were your objectives in the study?

DR. COGGINS: The objectives of the 14 day study?

MS. SHERMAN: Yes.

DR. COGGINS: I quote from our manuscript, Fundamental and Applied Toxicology, Volume 19, 1992, page 133. "The aims were to determine whether biological responses could be observed after exposure to ADSS at different concentrations, what these observed responses were, and the no observed effect level for the study."

MS. SHERMAN: Excuse me. I didn't hear the last thing you said.

DR. COGGINS: I'm sorry. "And the no observed effect level for the study."

MS. SHERMAN: What is the relevance of your 14 day study to our rulemaking here?

DR. COGGINS: I think the...

MS. SHERMAN: Could you give me your opinion?

DR. COGGINS: Sure. The direct relevance of rodent inhalation studies to humans is clearly...

JUDGE VITTONE: Excuse me. I don't want anybody sitting in that front row.

MS. SHERMAN: Could you start again?

DR. COGGINS: I don't think we can make any direct extrapolation from the results in rats to the results in humans, and clearly OSHA is involved in humans. But I think what we're obtaining here is very significant data in these two experiments, and the work from Germany, with two separate species, that the toxicological activity of aged and diluted sidestream smoke, even at massive exaggerations of the real world concentrations that we've heard of, is effectively very, very minimal.

MS. SHERMAN: I guess I'm trying to focus on your choice of 14 days for this study.

DR. COGGINS: This is following standard toxicological principles, a 14 day and a 90 day, and indeed, even a five day are the standards used by scientists throughout the world.

JUDGE VITTONE: Excuse me, Ms. Sherman. It's about 12:37 or so. I don't want to cut you off in the middle of a topic, but if there is a point when...

MS. SHERMAN: Would you like me to stop now?

JUDGE VITTONE: If it's convenient for you and you're at that point. Okay?

MS. SHERMAN: Yes, we can pick up with this after lunch.

JUDGE VITTONE: Before we run out of here, though, let me raise a matter that came up yesterday.

This morning I placed a call to Dr. Bayard at the Environmental Protection Agency. I left a message on his answering machine and generally informed him what I was calling about.

I called him during the morning break at around 11:00 o'clock, and he and I had a conversation about his testimony before this panel.

As you know, Dr. Bayard is scheduled to testify next Monday, January 23rd. Dr. Bayard told me that he is reluctant to extend his testimony beyond Monday. That he would be certainly available as long as necessary on Monday, to make himself available. That his schedule afterwards was quite full, and that he was scheduled to be out of town on a number of different occasions.

In addition, he said to me that he, as I understand it from what he told me and I guess what he told me this morning, is that there is a lawsuit between one or more of the tobacco companies and the Environmental Protection Agency. That he has answered numerous questions with respect to the EPA study in the course of the discovery of that particular matter, and that he had responded to numerous questions posed by various congressmen, I guess, or congressional committees with respect to the EPA study.

He told me that none of that information, as far as he knows, is in this record, and that he would certainly be willing to make that information and his responses to any of those questions available in this record.

In addition he said that he is willing to stay late on Monday and answer any questions as much as possible, and that he would certainly take any questions in writing and respond to them in writing by any party to this proceeding.

That is his position, and I think it is also the position of the Environmental Protection Agency which he represents, and he also mentioned to me he had consulted with some agency attorneys.

That is his position, and the agency's. We will do our darndest to make sure that he is available here as long as possible. We have two witnesses. As I said, I'm willing to start early on Monday and stay late to make sure that there is as much examination available as possible.

As I said yesterday, nobody has been able to ask as many questions as they would like during this procedure to certainly the important witnesses, and I've had to limit examination as much as possible. I think that's the situation, and that's what we're going to have to deal with on Monday.

MR. GROSSMAN: Your Honor, may I suggest one additional alternative?

There are two witnesses who are scheduled on Monday, and I appreciate the call that you made to Dr. Bayard.

As Jeff Furr stated in his argument to the Court yesterday, the testimony of Dr. Ford, who is a paid consultant of this agency, is critical to the proceeding, and the questions that we intend to ask are necessarily extensive because they cover the full range of his testimony which covers at least 12 fields, beginning with general principles of epidemiology. He is the only epidemiologist who has been identified by the agency to cover both heart disease and lung cancer, and to cover the general principles of epidemiology applicable to this proceeding.

Inasmuch as both he and Dr. Bayard have been scheduled by the agency for Monday, I'd request that we move Dr. Ford, if Dr. Bayard cannot be moved at that time. We have three or four weeks that remain available. Dr. Ford is a professor at Johns Hopkins which is only 50 miles from here, and there must be some day when he can be available.

JUDGE VITTONE: I think Ms. Sherman spoke to that point yesterday. My understanding is that they do not want to move Dr. Ford.

MR. GROSSMAN: Why would that be? Why...

JUDGE VITTONE: Let's not...

MR. GROSSMAN: If I can just make one further statement.

We are here for three days, and I would just want the two hours to which I am entitled for the cross examination of Dr. Ford. I am sure there are many others who will want time to which they are entitled under the procedures that have been established for the cross examination of Drs. Ford and Bayard.

The agency has not begun to explain why it is that they decided, after many times of rescheduling Drs. Ford and Bayard, to reschedule them now after Reynolds testifies, as though they were rebuttal witnesses, and to schedule them in such a way as to limit the time for cross examination.

Could the agency respond to that, please, Ms. Sherman?

JUDGE VITTONE: Well, I'll tell you what. We're going to give the agency a chance to respond.

I suggest that if possible at some point after the completion of the examination here, that this might be a matter that you might be able to negotiate on off the record.

Mr. Furr, quickly, please.

MR. FURR: There's one other point that I'd like to clarify so that Your Honor is not operating under some misconception as he considers this issue.

I'm not sure what questions Dr. Bayard was referring to with respect to his responding to the lawyers in the litigation between a number of parties and the Environmental Protection Agency.

In that litigation there have been no depositions taken, there have been no interrogatories answered. The Environmental Protection Agency has resisted discovery at every turn, and there is currently a stay on discovery in that litigation.

The only proposed discovery that has been had is that the Environmental Protection Agency proposed a number of stipulations in response to requests to admit that were issued by the plaintiffs in that case. So there has been no response by Dr. Bayard in any way personally to any discovery in that litigation. So I'm not sure what it is he's offering to add to the record. We'd like to look at it, but I don't believe there is going to be anything to add to the record.

JUDGE VITTONE: I'm merely informing you what he told me this morning on the phone.

Let's come back in one hour, at 1:45.

A F T E R N O O N S E S S I O N

1:55 p.m.

JUDGE VITTONE: On the record.

Mr. McNeely?

MR. McNEELY: I would like, if we could, to get some indication from R.J. Reynolds how late they would be willing to stay tonight in an attempt to try to get through as much of the OSHA questions as possible.

As an observer in the audience the format of the mediated panel, and, of course, Mr. Grossman's participation, seems awfully inefficient where we're losing a lot of good time. So I'm just asking how late are they willing to stay tonight? Or is that an option with the Court?

JUDGE VITTONE: Well, it's always an option for us to stay late. I would to see how much progress we make this afternoon. They are going to be here tomorrow and, as I understand it, are willing to stay the whole day.

MR. GROSSMAN: There are other witnesses who are scheduled for tomorrow but it was our intention that a good part of tomorrow was reserved for Reynolds. That was our understanding.

JUDGE VITTONE: I'm not sure where you got that understanding from.

MR. GROSSMAN: Yesterday Your Honor asked whether Reynolds would be here today and tomorrow and we said yes. Your Honor also said that there were two other witnesses scheduled for tomorrow.

JUDGE VITTONE: Right. Okay. But my understanding is that you would be available for examination not only by the OSHA panel but every other participant in this proceeding, whoever appears. And quite truthfully I think that is going to take us through substantially most of tomorrow, I would guess. I don't know how much longer Ms. Sherman has. One of the questions I was going to bring up before we got into the questioning was to talk about the rest of the afternoon and how far we're going to be.

Certainly as I said yesterday, and maybe that's what you're looking at, that we would give you an opportunity to respond or to clarify anything you want to but I did not view that as a substantial amount of time, Mr. Grossman.

MR. GROSSMAN: You're referring to when the questioning is done?

JUDGE VITTONE: The questioning is done by the OSHA panel and the participants, other participants.

MR. GROSSMAN: I didn't expect that that would be a good deal of time, Your Honor, for Reynolds to respond when it was all done.

The only thing I can say in response to Mr. McNeely's request is that we are the only group or individual that has testified before OSHA that has taken this much time or anything like this much time, including OSHA's own panel and the NIOSH panel and the one thing that I certainly will not allow is to tire out these witnesses.

They'll be here for the full day today and they'll be here tomorrow but we're not going late into the night.

JUDGE VITTONE: Well, we may go past five o'clock. We may not go very far past five o'clock but I can see where we would go past five o'clock.

And, Mr. Grossman, I'll decide when --

MR. GROSSMAN: Oh, no. I didn't mean to usurp the Court's authority and I apologize if you thought so. But it would be a tremendous inconvenience to these witnesses in a multi-day process of testimony to be going for extended hours. Now, when we get to five o'clock, we'll see where we are. I understand that's your intention but extended hours would be very difficult on this panel.

JUDGE VITTONE: Well, certainly I don't anticipate being here until eight o'clock tonight. I don't anticipate being here until seven o'clock tonight. But if we stayed some time past five o'clock, I don't think that should inconvenience anybody, particularly if we're close to completing the examination of the OSHA panel.

They are going to be here tomorrow.

MR. McNEELY: And their testimony will be prioritized over any potential other witnesses?

JUDGE VITTONE: They're here. I'm going to get through them and then I'll take up the question -- if we have to stay late tomorrow night to take care of whoever they are, we'll stay late to take care of them.

MR. McNEELY: Thank you, Judge Vittone.

JUDGE VITTONE: Let me talk about this afternoon because I wanted to bring it up.

I am somewhat concerned that we have not made as much progress as I was hoping we would make today. I have several suggestions in order to maybe move things along a little better and would like the parties to take them into consideration and to abide by them.

I appreciate the very complete answers that you all have provided and I think that that is very important but I would ask that you try to keep the answers more directly related to the question and respond to them as directly as possible.

On the other side, I would like to see the questions be more direct and specific in nature.

As part of that, I would like the other members of the OSHA panel who are not asking questions to remain quiet. I think it would be much better if Ms. Sherman is going to be the questioner that she ask her questions. If there are other things that some of the other members of the panel want to ask as follow-ups or want to tell her to ask, I suggest you take notes. There will be breaks at appropriate times. You can inform her at that time of any follow-up that you think might be needed. And then if she thinks it's necessary, she can ask those questions. But I think it would be much more conducive if there was a little less back and forth.

I think Ms. Sherman has a very large burden on her and it is difficult for her to ask a question, listen to the answer and then get prepared to ask the next question.

I am asking the other members of the OSHA panel to let her conduct the examination and then at some point you all can consult and ask any clarifying questions. Take good notes and consult later.

All right. There is something else and I can't remember what it was but it will come back to me.

I think if we follow that pattern we'll get along a lot further here and maybe come to the point where you all can go back to North Carolina or go home or whatever and we can go home and all relax, okay?

Ms. Sherman, I'm going to go back to you.

MS. SHERMAN: I think at the time that we broke for lunch we were discussing your 14-day and 90-day inhalation study.

Had you exposed the rats for a longer period of time, say, two years, would you have been more or less likely to have seen an effect of ETS?

DR. COGGINS: Of course, I have no idea what the results would be if we had continued for a further period of time. The study was designed to be a 90-day study. I'm not sure that we would have seen any further responses.

The work that I had performed prior to joining Reynolds showed that with mainstream smoke the responses at 90 days were the same as at almost two years. In other words, that there's no progression of the changes in the rat exposed to mainstream smoke for extended periods of time.

Of course, we can never know unless we did the experiment but I would say that based on the evidence from mainstream smoke that that would not have -- the change would not necessarily have progressed any further than it did.

MS. SHERMAN: Did you determine the LD-50 of ADSS?

DR. COGGINS: The LD-50 is an abbreviation for the percentage of animals which are killed, what smoke concentration kills half of the animals, and as such it is a complicated procedure in a complex mixture such as ETS. We did not determine it, is the simple answer. I'm not quite sure how I would determine it because I could change the smoke exposure concentrations and times such that the concept of an LD-50 is difficult to translate to an inhalation study, especially an inhalation study with a complex mixture.

MS. SHERMAN: What are the effects of ADSS after dermal or oral exposures to the animals?

DR. COGGINS: I don't think we know the answer to that. Certainly we haven't done that experiment. Those are the very things we tried not to do in our study. But I think that in experiments, whole body experiments, with materials such as smoke you would expect the ingestion of large amounts of the deposited particulates on the skin and, indeed, some of those materials could easily transfer across the skin and, indeed, if they did not transfer that way they could be eaten. For example, very large amounts of nicotine that could be ingested as opposed to being inhaled. The simple answer to the question is we tried deliberately to avoid exactly the position you are describing.

MS. SHERMAN: Would you have expected these effects of ingested particulates or nicotine to have been adverse if you had allowed them to be ingested?

DR. COGGINS: Again, I'm not sure what you mean by adverse. We have no idea what those effects were because we tried to avoid that very circumstance because we wanted to have inhalation and only inhalation. So I really couldn't speculate on what those changes might or might not have been.

MS. SHERMAN: So you basically didn't have any idea, you just wanted to guard against having to deal with that issue? Is that your position?

DR. COGGINS: Yes. The position we had is that we wanted to do as good an inhalation study as we could and that we wanted to prevent dermal and oral routes of administration because they wouldn't reflect, apart from Dr. Nelson's comment, they wouldn't really reflect human exposures. And so we wanted to restrict the route of administration to inhalation and only to inhalation.

MS. SHERMAN: Thank you. At the bottom of page three and in business paper number seven, I believe you said that the cost of a smoking lounge could be as high as $21,253.

DR. COGGINS: I thought you meant me for a moment. You meant Mr. Bohanon.

MS. SHERMAN: Well, I was directing it to you.

MR. BOHANON: At the bottom of page three?

MS. SHERMAN: Yes.

MR. BOHANON: As high as $21,253. That is correct.

MS. SHERMAN: Does this estimate appear in any of the material that R.J. Reynolds distributes to the business community when attempting to convince businesses to build smoking lounges?

MR. BOHANON: The answer to that question is no because it really doesn't apply. It applies directly to the OSHA proposal but does not apply to smoking lounges as described in our guide to building a smoking lounge.

MS. SHERMAN: And why is that?

MR. BOHANON: Well, the reason for that is really in two areas. One is that our brochure on a guide to developing a smoking lounge was intended for business owners in office type situations. Those business owners in office type situations face a choice on what sort of smoking policy to have within their buildings and so we provided for them guidance of what it might cost in a typical office location to provide the additional ventilation that would be required to adequately ventilate a smoking lounge.

Now, in contrast, OSHA has proposed not only for small business office locations but indeed for every business location and business type, including restaurants, bars, and many others, that rooms would have to be built.

Now, there are many restaurants that don't have separate rooms, that would have to build a separate room, have that room built to the decor, have to contain the room with negative pressurization as per the OSHA standard. So those additional costs that would apply in, say, a restaurant environment are really irrelevant to the suggestion that in the office environment one of the ways of accommodating smokers and non-smokers, one of many ways, is to have a designated smoking lounge.

DR. COGGINS: So that wasn't in the overall price list that you had.

MR. BOHANON: Yes. It's apples and oranges. Our guide on developing a smoking lounge really had a focused distribution. We did not distribute that to restaurant owners suggesting that restaurants should build smoking lounges. In fact, we have different information that we offer and make available to restaurants. So that the focus of the smoking lounge guide was to provide information to essentially small business owners that wanted to know what it would take to install a smoking lounge and we feel that the numbers in there are representative within that context but they're not representative within the context of painting a confined smoking room broadly across all the building stock in the United States and all the different building types and business types.

MS. SHERMAN: Do you know how many copies of the brochure you've distributed?

DR. COGGINS: Which brochure is that?

MS. SHERMAN: The brochure we were just discussing.

DR. COGGINS: I'm sorry. Because we have several brochures.

MR. BOHANON: The brochure, developing a smoking lounge? No, I do not have an exact count on the amount that we have distributed.

MS. SHERMAN: And you haven't distributed these brochures to inhabitants of high rise office buildings?

DR. COGGINS: Which brochures again?

MS. SHERMAN: The same one.

MR. BOHANON: I certainly can't say if we have or haven't. Let me get the brochure.

(Pause)

MR. BOHANON: Okay. The statement that's in the brochure, now, I don't know -- anybody that asks for one, we'll give them one so I don't know what the distribution is or really who has that but what we said was a variety of factors within this brochure, a variety of factors, may impact the cost. These include type of building, high rise, low rise, type of HVAC system, distance from the lounge to the outside, local codes, urban and suburban, and local construction cost factors.

And I think those are fair statements, that the range or the distribution of the most likely cost is within that $1500 to $4000 range for the cost of the ventilating only, not including the cost of constructing a room because we didn't really pose it that way.

The OSHA proposition is that if you don't have a room you would have to build one and that's really a different proposition and therefore a different basis from which to make an engineering estimate.

DR. COGGINS: So the figure of $20,000 is to build a new room.

MR. BOHANON: The figure of $20,000 is not only the ventilation costs but also some room construction costs. That was developed by Raytheon Engineers & Constructors and it is itemized in detail as far as the various different component costs that can go into making up the cost of both building and also ventilating the room as Raytheon Engineers understood the OSHA specifications.

MS. SHERMAN: So you did say in this brochure that building type is a parameter to be taken into account.

MR. BOHANON: Yes, indeed. And this is guidance on what to do. And I think that the important part of the guidance is right up there on the first page of the print, which says, "This publication is not intended to take the place of qualified professional assistance. Your best assurance that a smoking lounge will function properly is to enlist the help of a professional who is properly qualified in HVAC systems."

So the intent is to familiarize a building owner with the concept and some of the principals but that specific information such as how to comply with local building codes and so forth as well as specific costs should be provided on an individual basis because one just can't generalize a number that would fit every possible situation.

MS. SHERMAN: And did you alert the people reading your brochure that there would be different costs for different geographic regions?

DR. COGGINS: That's fairly understood, that you can't have a one size fits all -- this brochure has been distributed very widely.

MR. BOHANON: Yes. I don't think we called that out specifically. We just said for example a probable range would be $1500 to $4000. And as we were talking about cost consideration on page nine of this guide, which you do have in the docket --

MS. SHERMAN: Yes.

MR. BOHANON: -- is local construction cost factors. Yes, that's a geographic factor, a local construction cost factor. In different geographic regions, construction costs are different.

MS. SHERMAN: Okay. The different construction costs would account for the difference perhaps between $1500 and $4000. It would not account for the difference in cost between $1500 and $20,000, is that true?

MR. BOHANON: Generally, I believe that is true. If you're asking me to characterize the difference in the costs, the difference has to do with the cost of room construction and some of the other factors that one may get involved with in a setting that's not like a small suburban, typical office facility. We're talking about a typical, probable, likely facility and we generalize that there is a range of costs.

Now, if you go beyond that distribution of locations, I mean, there could be locations like a room in a warehouse where you just punch a hole in the wall and stick in a fan, that would be less than $1500. If you're talking about something smack in the middle of the Empire State Building, that's going to be much higher than $4000. But if you look at the central distribution of types of buildings and places that people would install smoking lounges, we just felt that was a representative cost and didn't really try to imply that that would be the actual cost and, in fact, directed business owners to consult with professionals for their specific situation.

DR. COGGINS: So it's a common sense range.

MR. BOHANON: It's a range that applies in a lot of places within the constructs of buildings that are office buildings and doesn't apply to restaurants and a lot of other situations.

MS. SHERMAN: On page four of Ms. Chang's submission, OSHA was criticized for its estimate of the cleaning cost per year per smoker.

DR. COGGINS: Of the what cost? I'm sorry?

MS. SHERMAN: Cleaning cost per year per smoker.

MR. BOHANON: Page four of what?

MS. SHERMAN: Of Guo-Mei Chang's submission to the record.

DR. NELSON: Dr. Chang's submission to the record dealt with the use of -- or dealt with pharmacokinetic modeling of environmental tobacco smoke exposure.

MS. SHERMAN: I take that back. It's Mr. Bohanon's. I'm sorry.

MR. BOHANON: Yes. I've found that.

MS. SHERMAN: Is there any difference at all in the cleaning costs associated with smokers compared with non-smokers?

MR. BOHANON: That's an interesting question and I don't know that there is a specific answer to that. I don't know that a cleaning contractor is going to quote a different rate of cleaning for a smoking building or a non-smoking building nor that if a building manager declares that he's not going to have smoking in his building that he's ever received a reduction in the charges for cleaning. So I really can't answer that. I think it's something that needs to be investigated more in those terms, are there examples of where people have actually changed their contractual costs based on a change in smoking policies. I don't know of any such case.

The point we were trying to make was that the estimate of $500 cleaning cost per smoker is certainly not aligned with the national average cleaning cost of office buildings, which is 84 cents a square foot a year, which would give you a number of about $250 a year total cost of cleaning per person in the office building.

MS. SHERMAN: On page 10 of your submission, you indicated that people employed in different occupations have different rates of smoking, correct?

DR. COGGINS: Again, this is Mr. Bohanon's --

MS. SHERMAN: Yes.

DR. COGGINS: On page 10?

MS. SHERMAN: Yes.

MR. BOHANON: Yes, that is correct.

MS. SHERMAN: Does this create a concordance effect by occupation for smoking rates?

DR. COGGINS: What do you mean by concordance effect?

MS. SHERMAN: Well, if you remember we had testimony earlier about the concordance between spouses smoking habits. Is this the same thing?

DR. COGGINS: Do you understand the question?

MR. BOHANON: No. Actually, I think -- if you're talking about an epidemiological type of concordance? Is that what you're asking?

MS. SHERMAN: Yes.

MR. BOHANON: That's beyond my field. The point I was trying to make in that citation is that there are differences in different work environments in the percentage of the smokers that one would expect to be there and that those differences can best be accommodated by the business owner who knows how many smokers are there, how many non-smokers are there, his type of building and the other factors that he can then take into account to establish what his smoking policy should be.

DR. COGGINS: Dr. Sears has something, I believe.

Go ahead.

DR. SEARS: I think that there may be a misunderstanding of what epidemiologically a concordance factor is.

I am unaware of any evidence that would indicate that a smoker is more likely to work with a smoker as opposed to the typical definition of a concordance factor in the epi literature which is that smokers tend to marry smokers at a higher rate, which is the typical epidemiological definition.

If there is a concordance factor of the type you are talking about, Ms. Sherman, I am unaware of it.

MS. SHERMAN: So then I shouldn't take the statement on page 10 as referring to that type of an issue.

DR. NELSON: What statement on page 10?

DR. COGGINS: This is Mr. Bohanon's submission. Could you read it to us perhaps?

MR. BOHANON: Well, it's a citation to a study that was published in 1994 about cigarette smoking prevalence by occupation which just points out that there is a wide range of percentages of smokers in many different occupations and I think that the authors had in excess of 100, I do have a copy of the paper, if we need to refer to that, different occupations that had a wide range of different smoking behaviors that were observed along with some calculations of the confidence intervals, is what was in the paper.

The point being that in the private sector and free market that those types of differences can be accommodated on a case-by-case, location-by-location basis without some overall restrictive rule.

MS. SHERMAN: In Mr. Bohanon's submission, I believe, on page 36 you stated that OSHA does not present any evidence that general dilution ventilation would not be effective in substantially reducing exposure, correct?

MR. BOHANON: Okay. Page 36 of which submission? I'm sorry.

MS. SHERMAN: In your initial summary comments.

MR. GROSSMAN: Are those dated in August or are those dated in January?

MS. SHERMAN: In August.

MR. BOHANON: In August. Okay. Page six?

MS. SHERMAN: Thirty-six.

MR. BOHANON: I believe I only have six pages in my initial summary comments, so I'm not --

MS. SHERMAN: It's the summary statement from R.J. Reynolds.

MR. BOHANON: Oh, the R.J. Reynolds summary statement. Okay. That is -- okay. Page 36 of the R.J. Reynolds summary.

(Pause)

DR. COGGINS: Okay. We've got it.

MS. SHERMAN: Okay.

MR. BOHANON: Okay. Yes. That is what that says, that OSHA does not present any evidence that general dilution ventilation would not be effective in substantially reducing exposures.

MS. SHERMAN: Are you familiar with any other studies that have been well designed and peer reviewed that demonstrate a strong statistical association between various rates of general dilution ventilation and ETS exposure?

DR. COGGINS: Again, I think that's for you, Mr. Bohanon.

(Pause)

MR. BOHANON: I will answer. I'm trying to think here. Actually, there have not been a lot of studies outside of laboratory settings looking at the effects of dilution ventilation on concentrations of environmental tobacco smoke. In fact, as I pointed out in my summary, that's one of the factors, what is the ventilation rate, when one is trying to measure that.

Now, in response to not being able to find strong citations from well designed studies, I believe as you characterized it, we did run the one study which was the third study I believe I talked about where we took a 5500 square foot office space and varied the ventilation rates to try and demonstrate very clearly what the relationships would be between ventilation and also added the factor of separation to the study so we had a two factorial statistical experiment that was designed to study exactly that, what are the effects of ventilation and what are the effects of separation on environmental tobacco smoke exposure. And so I must say that if there was a large body of literature, we certainly would have cited that as opposed to running a test to try and make a clear demonstration as to the effects of ventilation and separation.

DR. COGGINS: Dr. Nelson has a point, too.

DR. NELSON: To add a little bit to that, as Mr. Bohanon has pointed out, in buildings and building studies, there is not a lot of data to that effect.

However, there is environmental chamber data to that effect. In fact, in the various studies that we've performed, those that Dr. Walker submitted to the docket and some of that work which has been presented in peer reviewed literature, what we do is to achieve various levels of environmental tobacco smoke concentrations in the chamber or constituent concentrations in the chamber, what we do is systematically vary the ventilation rate. If you double the ventilation rate, you have the concentration of most components of environmental tobacco smoke in the environmental chamber. And the reverse, if you halve the ventilation rate, you double the concentration. It's kind of a general principle sort of thing.

A similar way of looking at it would be to look at the industrial hygiene literature where they suggest that you have an emission rate and you're trying to achieve some target concentration, then what you need to do is add a specific amount of air or rate of air into a space in order to dilute that emitting source down to appropriate levels.

MS. SHERMAN: Thank you.

Do you read the ASHRAE journal, Mr. Bohanon?

MR. GROSSMAN: Direct your questions, please, to Dr. Coggins.

JUDGE VITTONE: Well, Mr. Bohanon is a member of the panel. He has testified. The question is in his area of expertise, Mr. Grossman.

MR. GROSSMAN: Your Honor, we've been through these proceedings for many months and --

JUDGE VITTONE: Yes, Mr. Grossman, and I've been here for many months and I have watched you direct specific questions to individual panel members when they were up here.

MR. GROSSMAN: I was forbidden from doing so when the AMA testified, Your Honor.

JUDGE VITTONE: No. There was some restriction, yes, I cut your questions off after a point.

MR. GROSSMAN: And you refused to allow me to direct towards members of the NIOSH committee either.

JUDGE VITTONE: All right. Look. If we've got to keep running a very specific question which we all know that Mr. Bohanon is going to respond to through you and then through Dr. Coggins, we're going to be here forever.

Now, the question was specifically directed at him. I would like for him to answer the question. Or we will be here until eight o'clock tonight.

Now, come on. Let's move it.

MR. BOHANON: I'm sorry. The question was?

MS. SHERMAN: Do you read the ASHRAE journal?

MR. BOHANON: Yes, I receive the ASHRAE journal and I do read the articles. I may not read all articles in every journal but I do receive that. Yes.

MS. SHERMAN: Are you familiar with an article by Mr. Janssen in the ASHRAE journal which indicated that ventilation alone cannot effectively control the risk of environmental tobacco smoke? Do you remember reading it?

MR. BOHANON: No, I don't.

DR. OGDEN: Excuse me. But we were talking about -- I believe the previous question was about the effect of ventilation on concentration levels and now you've changed the question.

MS. SHERMAN: It's a new question.

JUDGE VITTONE: It's a different question, sir, okay?

Your next question, Ms. Sherman.

MS. SHERMAN: In Appendix A and B to Dr. Ogden's paper on environmental tobacco smoke exposure, there are determinations of RSPs, TVOCs and many independent VOCs for the purpose of apportioning these contaminants to ETS and other sources and correlating these contaminants to lifestyle activities, like having a husband who smokes.

Why wasn't ventilation with outside air one of the parameters measured and correlated in these two studies?

JUDGE VITTONE: Who is the best person to answer this?

DR. COGGINS: I think this is Dr. Ogden's question.

DR. OGDEN: Allow me to find the study, please. This is the written submission, the August submission?

MS. SHERMAN: Yes.

DR. OGDEN: Appendices A and B, I believe you said?

MS. SHERMAN: Yes.

(Pause)

DR. OGDEN: Okay. I'm sorry. Could I ask you -- I have them now. Would you repeat the question?

MS. SHERMAN: Okay. In Appendix A and B, there are determinations of RSPs, TVOCs and many independent VOCs for the purpose of apportioning these contaminants to ETS and other sources.

DR. OGDEN: Correct.

MS. SHERMAN: And correlating these contaminants to lifestyle activities, correct?

DR. OGDEN: Correct.

MS. SHERMAN: Okay. Why wasn't the ventilation with outside air one of the parameters measured and correlated in these studies?

DR. OGDEN: The answer to your question is that it was not one of the design criteria of the study and there's a specific reason for that.

From Mr. Bohanon's perspective and some of the previous testimony and questions is the effect of ventilation on concentrations. My research and the results of these two papers are not so much interested in the effect of ventilation per se as is measuring what exposures really are.

So while I certain concur that ventilation can be an effective tool for reducing concentrations, that wasn't one of the design criteria of the study. We wanted to go into a representative number of homes and workplaces in Appendix A and Appendix B is just in homes and determine what typical levels are. And, as I think those documents show, those typical levels are very low.

Now, if we added another variable in terms of ventilation, it would have obviously been a much more complex study and that just simply was not the design criteria or the interest for those particular studies.

MS. SHERMAN: In the paper entitled "Engineering Alternatives for ETS Control," on page one, I believe that you reminded OSHA that OSHA employs general dilution ventilation for the control of benzene, formaldehyde and styrene associated with emissions from building materials.

DR. COGGINS: This is again for Mr. Bohanon, obviously.

MR. BOHANON: Yes. That is correct. That's what that says.

MS. SHERMAN: Are carpeting and ceiling tiles and cabinetry sources of these chemicals in the non-industrial environment?

MR. BOHANON: Well, I shall have to refer to your publication because that was the source of all of that information.

(Pause)

MR. BOHANON: The answer to that is, yes, it is listed in OSHA's Table III-1 as emissions from building materials or interior furnishings.

MS. SHERMAN: Is it physically or economically feasible to put a local source capture device like an exhaust hood over any of these emission sources?

MR. BOHANON: It's not even necessary if you ventilate your building.

MS. SHERMAN: Well, my question is it physically or economically feasible to put a local source capture device like an exhaust hood over any of these emission sources?

MR. BOHANON: In general, I don't think it would be.

MS. SHERMAN: These sources wouldn't be considered point sources, would they?

MR. BOHANON: I suppose that depends upon how you define a point source. A chair could be a point source. A laser printer could be a point source. I suppose there are lots of things one could call a point source or an extremely localized source of an emission. The point is that if spaces are properly ventilated all the levels that you find will be low.

MS. SHERMAN: So that what you're saying is that you don't consider -- well, okay. You would consider or you would not consider carpeting to be a point source?

MR. BOHANON: In general, carpeting would be broadly applied and would be an area source. If carpeting were only in one room within a building, then you might consider that room a point within the building. It just depends on your perspective.

MS. SHERMAN: It depends on how broad a perspective one takes, perhaps?

MR. BOHANON: Sure. In how you define point.

MS. SHERMAN: Well, wouldn't you consider cigarettes to be a point source and to be distinctly different than a diffuse source like carpeting?

MR. BOHANON: Cigarettes are, I think, a point source that can be related to the location of the smoker but there are other point type sources that are listed here within your table that will move around within buildings.

MS. SHERMAN: Well, is it physically possible to move carpeting to a designated area under negative pressure and exhausted to the outside?

MR. BOHANON: Well, for carpeting that may not apply but it may apply to appliances, copy paper, computer display terminals, duplicating machines, there are lots of things that move around within the building. But is it -- that's not a practical thing to do.

MS. SHERMAN: Is it physically possible to move a burning cigarette emission source to a designated area under negative pressure and exhausted to the outside?

MR. BOHANON: Yes, that is a physically possible thing to do.

MS. SHERMAN: You submitted a paper called "Engineering Paper No. 2, Effects of Ventilation and Distance from Smokers on Levels of ETS in a Large Modern Office Building."

MR. BOHANON: That is correct. Yes.

MS. SHERMAN: Has this paper ever been peer reviewed and published?

MR. BOHANON: No, this paper has not been published. It was completed in time to submit it to OSHA. The publication cycle takes longer than it does to submit --

MS. SHERMAN: Do you have plans to publish it?

MR. BOHANON: The paper in its current form probably is not publishable because it's 70 pages long. I do have plans to try and make some of the conclusions known in publications.

MS. SHERMAN: In this paper, the overall building occupancy was 1180 people and the total floor area was 630,000 square feet. That's correct, isn't it?

MR. BOHANON: Okay. Yes. That's what's reported on page two.

MS. SHERMAN: This yields an overall building occupant density of 534 square feet per person and I believe that you stated that the arithmetic mean occupant density was 794 square feet per person?

MR. BOHANON: I'm sorry. Where do you see those numbers? Seven ninety-four sounds high.

MS. SHERMAN: I think you reported 73.8 meters squared per person and I think we just sort of recalculated it. On page three.

(Pause)

MR. BOHANON: Okay. I would have to go back and check the numbers but, yes, that's what is reported in the paper.

MS. SHERMAN: Isn't this an extremely low density when compared to the ASHRAE recommendations?

MR. BOHANON: Yes, it is lower than the typical ASHRAE assumptions. One of the issues with square footage has to do with the difference in gross net occupiable, net rentable, there are many, many different definitions. On a gross square footage basis, this building has a lot of additional spaces that are not fully occupied and used as office spaces. But, yes, that is a high number relative to the ASHRAE design number for occupied spaces.

MS. SHERMAN: In the description of the HVAC system on page four, you indicated that the air conditioning unit serving the tenth floor is designed to use outside air.

MR. BOHANON: I can't find the words -- yes, it is.

MS. SHERMAN: Do you mean for ventilation purposes or to cool the building with an economizer cycle?

MR. BOHANON: For both.

MS. SHERMAN: I think you indicated that the air handlers are equipped with a three-stage filtration system which included an electrostatic precipitator sandwiched between two roll filters. Is that true?

MR. BOHANON: Yes. That's an accurate description of what's in place within that building.

MS. SHERMAN: Do you know how prevalent the application of this type of filtration system is in conventional centralized HVAC systems?

MR. BOHANON: No, I don't think I can offer an estimate as to nationwide. Filtration manufacturers could probably provide you with their market penetration from various types of filters. This is a good filter system.

MS. SHERMAN: You have some knowledge at least within North Carolina of existing inventories of office buildings, don't you?

MR. BOHANON: I have some knowledge. I would say that. Not extensive.

MS. SHERMAN: Isn't it more conventional to have a 30 percent efficient pleated media filter installed at the central air handler?

MR. BOHANON: That's probably more typical. Yes.

MS. SHERMAN: Were the electrostatic filters operational when the air sampling was performed in your study?

MR. BOHANON: Yes, they were.

MS. SHERMAN: I believe on page eight of your discussion you decided to use the design occupant density rather than the actual occupant density. I think both figures were available.

MR. BOHANON: I'm sorry, where are you now?

MS. SHERMAN: On page eight.

MR. BOHANON: I'm not sure where you're reading that. Is that -- let me tell you what we did because I don't what you're interpreting.

What we did was the planning record we're referring to is actually the number of offices or work stations or seats within the building. What we did was we counted that up. It's very hard in a dynamic test situation to run around and count how many people are in a building of this size so we decided to not try and do that and maintain 20 cfm per actual person that happened to be in there as they were going in and out and being on vacation or having meetings and that sort of thing.

So we took the actual number of working locations where people would sit and said that's probably a good number for design type purposes or for actual type purposes to represent how many people would be in the building because you know there are people that come over and have meetings and then you've people leaving, in and out. And so that's what we did, we took the actual built-out condition to represent the amount of occupants on the floor and by using that to generate your 20 cfm per person.

As you pointed out, that will -- it's a little different than the ASHRAE number, it actually results in a lower air volume coming into the building than the ASHRAE design number which would be designed for a higher density.

MS. SHERMAN: So in conducting your study, I think I understand why you took the number you took but did you make any effort to compare the design occupant density with who was actually in there while you were doing the study?

MR. BOHANON: On the floors eight through 15, no, we did not. We only studied the one floor. We might be able to shed some light on it if we go and look back into the data and compare the actual occupancy of the tenth floor that we did measure from day to day and the capacity of the floor.

MS. SHERMAN: I see. Well, that would be interesting. And if you would like to submit that as a post-hearing comment, we would be interested in looking at it.

On page 10, I think you describe your tracer gas procedure, which is based on a protocol for tracer testing outlined in ASTM E741-83.

MR. BOHANON: Okay. Yes, we do describe that procedure.

MS. SHERMAN: And I believe that the ASTM standard requires a test for homogeneity in tracer gas concentrations by sampling from a number of different building spaces?

MR. BOHANON: I am not familiar with the contents of that ASTM method. The expert on that was one of the co-authors of the paper, Dr. Cole, who is a physicist who really is the expert on the SF-6 tracer. If you have a specific question about what we did or how we did it, I can't answer that.

MS. SHERMAN: Well, I believe the ASTM recommends that monitoring begin only after the average concentration measured within the structure differs by less than 5 percent between measurements. And I believe you only reported your tracer measurements on the tenth floor. Isn't that true?

MR. BOHANON: Yes. We can only measure -- in a certain time period, you can only take so many measurements with any kind of equipment so there is a constraint there. The procedure that we used is fully described here in the text and that is that we used a decay rate procedure which means that one never has steady state so using a decay rate, actually the building is dosed so that we have a mixture of sulfur hexaflouride gas distributed throughout the building. We did have a point that we measured on another floor to examine whether we got good mixing and distribution of the gas within the building. That was a concern, did we get good mixing, did the gas mix throughout the building.

We concluded that the gas mixed fairly well and fairly rapidly because we introduced it at the supply air fans which delivered air to all the floors in the building.

We found during the test that we had to dose both the upper half of the building and the lower half of the building because of some air interactions that occurred there. We learned that actually in some prior monitoring, some testing we did on a couple of Saturdays before we even started this test.

So the process was to establish a level of sulfur hexaflouride tracer gas within the building and then to watch the decay of the gas which represented the amount of gas displaced by infiltration or through the mechanical system introduction of outside air which is essentially free of sulfur hexaflouride gas.

MS. SHERMAN: So then you did not do the ASTM test for homogeneity.

MR. BOHANON: Well, without knowing exactly what that is, and I know you've described it but I still don't understand exactly what it is, I don't know that we did nor that it's even a feasible thing to do. There's an ASHRAE standard right now, a 129 standard, to try and develop a method for ventilation effectiveness that deals with some of these same issues. And the issues in large buildings are really very different than the issues in environmental test chambers. So processes or procedures that work in a test chamber really don't apply, especially when one gets into these very large buildings and try and make tests.

MS. SHERMAN: I think you testified that the building could be cooled by an economizer. This doesn't seem to concur with Table 10, which indicates that the maximum outside air ventilation rate was about one air change per hour.

Shouldn't the ventilation rate have been four to five air changes per hour?

MR. BOHANON: Let me find Table 10 and see what that's describing.

MS. SHERMAN: Page 29, I believe.

MR. BOHANON: All right. Now, could you please restate the question?

MS. SHERMAN: Okay. We were talking about the ventilation system and I believe you stated that the building could be cooled by an economizer.

MR. BOHANON: Yes.

MS. SHERMAN: Okay. And this doesn't seem to agree with Table 10 which indicates that the maximum outside air ventilation rate was about one air change per hour. Shouldn't the ventilation rate be four to five air changes per hour?

MR. BOHANON: No. Not for this building. And in fact, the building, if you look at the temperature diagrams, the building was under control when we were on maximum outside air and the way an economizer works is that it changes the amount of air coming in in proportion to the desired output temperature of the supply air. So under those temperature conditions during those two days, which appear to be October 12th and 13th, this was the amount of air exchange sufficient to provide comfortable conditions within the building. So I don't think that in an economizer situation there's any one pre-set number that one would expect it to be. It's the number that is sufficient to provide comfort conditions with outside air.

MS. SHERMAN: Well, doesn't the maximum flow on Table 10 represent the outside air damper being 100 percent open?

MR. BOHANON: I'm not sure whether it does or not. It just indicates that it's the maximum outside air brought in under that condition.

MS. SHERMAN: Does the maximum flow on Table 10 represent the outside air damper being 100 percent open?

MR. BOHANON: I'm not sure whether it does or not. It just indicates that it's the maximum outside air brought in under that condition. In effect it means we did not artificially constrain it to a lower rate. The other rates were the ASHRAE minimum rate and the absolute minimum rate that we could get by totally sealing off the damper.

So we had an absolute minimum rate, we had an ASHRAE minimum rate, and then the maximum rate is the rate that the building operated with under control, as best I recall.

MS. SHERMAN: I think you mentioned on page 12 that you used a questionnaire to identify the smokers and non-smokers.

MR. BOHANON: I can't find it on page 12, but yes, we did.

MS. SHERMAN: What was in the questionnaire?

(Pause)

MR. BOHANON: What was in the questionnaire?

MS. SHERMAN: Yes.

MR. BOHANON: We had a number of questions in the questionnaire. One of the questions was the smoker/non-smoker question.

MS. SHERMAN: Could you submit the questionnaire to the record?

MR. GROSSMAN: Once again, I'll take it under advisement, counsel.

MR. BOHANON: We have published some information based on this test and the questionnaire.

MS. SHERMAN: Were you delivering 55 degree air to the 10th floor during this study?

MR. BOHANON: Did I say that somewhere in here, or is that just a general question?

MS. SHERMAN: I think it's a general question.

MR. BOHANON: Okay, because I wouldn't want to argue with some data points that we had...

MS. SHERMAN: I'm not trying to trap you.

MR. BOHANON: In general, yes. The building is designed to operate at about a 55 degree discharge air off the fan system. That's the way it's intended to operate. As we all know, in operations things don't always occur the way they were intended. But the control output setting is normally about 55 degrees.

MS. SHERMAN: What is the actual floor-to-ceiling height?

MR. BOHANON: I don't see a description. It's nominally nine feet.

MS. SHERMAN: Not 11 feet?

MR. BOHANON: From the floor to the suspended ceiling is nominally nine feet.

MS. SHERMAN: Okay. What was the actual floor to deck, or floor-to-floor height?

MR. BOHANON: The slab-to-slab height? I don't believe we described that in the article. I can go back and pull the drawings and measure it.

What we assumed is that above the suspended ceiling was a part of the return air plenum, which indeed it is, and therefore, is not part of the occupied space.

MS. SHERMAN: I see.

MR. BOHANON: If it's relevant, and again I don't know why it would be, we could go pull a drawing and figure out a typical slab-to-slab.

MS. SHERMAN: Would that be possible? We'd appreciate it.

Table 9 lists the total flow to the 10th floor as 18,756 cfm. I believe this equates to 4.43 air changes per hour of circulating air applied to the 10th floor, based on your 254,000 cubic foot volume figure that you gave.

MR. BOHANON: I'll take your word that the mathematics are correct.

MS. SHERMAN: The circulating air change rate of 4.43 air changes per hour seems somewhat low if the supply air temperature is 55 degrees. This is based on an article by McNall and Persily entitled, "Ventilation Concepts for Office Building," which reports values of up to eight air changes per hour during cooling season.

From your experience, does the value of 4.43 air changes per hour seem low to you?

MR. BOHANON: Not for this building, no. The flow rates per floor, I think that's a fairly typical rate. I think we'll observe that in mid October it's not in the full of heating season, and there are a lot of other factors.

That calculation makes a lot of assumptions. The critical factors in trying to make that calculation are what is the internal heat load, what is the external heat load to the building, whether or not there's any infiltration, what are all the loads, and then it's a question of making the calculations both on the sensible and latent loads as to the amount of heat that would be removed by the volumes of air.

There can be some typical values, but I can assure you that this number worked to provide comfort conditions on the floor when we were testing it.

MS. SHERMAN: I believe that these measurements were done on September 21st?

MR. BOHANON: We actually measured every day. I have in Table 9, there's a listing for every test day. The representative total flow number.

MS. SHERMAN: They were in September, though?

MR. BOHANON: It runs from September 21st through October 13th.

MS. SHERMAN: Is September 21st still considered part of the cooling season in Winston-Salem?

MR. BOHANON: Actually, that's part of the difficult season in Winston-Salem because you're in the transition from heating to cooling so it's a difficult time. The weather conditions vary, and I don't recall exactly, I'm sure somewhere in our data we have the average outside temperature, or we can go find that from the weather bureau, but it varies. I do recall during the timing of this test there were some cold fronts which caused us some concern due to just stack effects in how we were able to control the ventilation within the building. The weather is a confounder, or certainly a factor in trying to run these tests.

MS. SHERMAN: In Table 13, was the outside air ventilation rate measured by tracer gas test, or by a pressure drop across an orifice which was described earlier in the paper?

(Pause)

MR. BOHANON: I'm not sure that we indicated in Table 13 what the source of the ventilation air changes per hour calculation was. Let me just tell you that at the minimum air flow rates, that the air changes were measured by SF-6 because in that case we had completely sealed off the orifice. Therefore, there was zero outside air coming in mechanically, and at those low air flow rates what you're measuring is just infiltration. So that number has to be the SF-6 number.

At the very highest rate, because of the amount of air exchange in the building, we could never get an amount of SF-6 to build up in the building so that we could measure it that way, so at the highest range, the measures were certainly the measures across the orifice measured through the system from the total volume of the system.

At the mid range, the thing that's represented is the ASHRAE minimum 20 cfm.

The numbers were in pretty good agreement, and I've presented that in a different paper. I can't find in here a reference to exactly which one we used, but it really doesn't make much difference. Both of them give you right at 20 cfm per person.

MS. SHERMAN: In Table 13, was there a particular reason why you didn't measure the outside carbon dioxide?

MR. BOHANON: Indeed, we did. That's what's represented here in the table, is Delta CO, which is the difference in the inside and the outside carbon monoxide, which is how one can arrive at these peculiar looking negative numbers.

MS. SHERMAN: But I asked for carbon dioxide, not carbon monoxide.

MR. BOHANON: Oh, okay.

Is there a reason we didn't put that in there, in the table. It's a relatively constant kind of number. I believe we made some readings on that. Let me see if I can get the...

(Pause)

MR. BOHANON: I can't find right here in the paper what we've said, but typically it's about 350 ppm in Winston-Salem.

MS. SHERMAN: On page 49 you reported that neither nicotine nor RSP showed trends of decreasing concentrations as ventilation increased. Why was that?

MR. BOHANON: On page...

MR. GROSSMAN: What was the result or why it wa the finding? Just to clarify your question.

MS. SHERMAN: I'm quoting from the paper. The report was that "neither nicotine nor RSP showed trends of decreasing concentration as the ventilation increased." I wanted to know why.

MR. BOHANON: That's a good question. I want to know why, too.

(Laughter)

MR. BOHANON: That can be the result of further study. I think we did make a couple of speculations within the paper as to possible reasons why.

One of the reasons is that nicotine, as Dr. Nelson has testified, has some peculiar characteristics and behavior of absorption and desorption.

It also appears within this data set to have some relationship to distance between the smokers and the sampling.

Exactly why it didn't in this data set show an effect from ventilation, but yet in my other data set it did, I can't really explain that. It's just what we measured and what happened.

As far as RSP, RSP is a non-specific indicator for environmental tobacco smoke. The levels, I believe, that we measured, are similar to the levels that were outdoors, so therefore... Let me just look up the number.

Let me explain it, and let me check a number first. If, indeed, the level inside is something like 30 or 35 micrograms per cubic meter RSP and you're bringing in outside air that has a number of 30 to 35, then you're not really exchanging anything, it's just all going to be 30 or 35 everywhere you measure. That's really a reason that you don't see, one of the reasons you don't see much difference in this test in outside level and the levels inside, why ventilation would not be a factor, because there's not a big differentiation between the RSP level outside and the RSP level inside. You're not going to be able to ease out statistically some effect.

Let me just check what the numbers actually were, to make sure that's accurate.

(Pause)

MR. BOHANON: The RSP numbers were about 41 micrograms per cubic meter, so that's really not too far removed from what one can measure in the outside air. That can be an explanation for why we did not observe that change, because the substance you're bringing in to dilute it with has approximately the same concentration.

MS. SHERMAN: I think you said you thought this finding might be the subject of further study. Have you planned another inquiry into this?

MR. BOHANON: In fact we did do the 5500 square foot office building study which showed a little different result. We had a little better control in that situation because we weren't working with one of these massive office buildings where it's so hard to tell what's going on and there were so many variables.

MS. SHERMAN: The 5500 foot office building was after this?

MR. BOHANON: Yes.

MS. SHERMAN: In your engineering paper number three entitled "The Effects of Ventilation and Separation on Environmental Tobacco Smoke"...

MR. BOHANON: That's the 5500 square foot study yes.

MS. SHERMAN: Right. In Figure 13 on page 12, does the nicotine levels for the designated area represent sampling station number three? Which I think was the only sampling station in the designated smoking area.

MR. BOHANON: Okay, Figure 13 on page 12. I have that, now. Now the question?

MS. SHERMAN: Do the nicotine levels for the designated area represent sampling at station number three, which I believe was the only sampling station in the designated smoking area?

MR. BOHANON: Yes, that's what that would represent.

MS. SHERMAN: Excuse me?

MR. BOHANON: Yes. The answer is yes. That number three is the sampling location in the designated smoking area, in the tables, the title indicates. These are the levels in the designated smoking area.

MS. SHERMAN: Now the nicotine levels for the integrated area, that represents levels from which sampling stations?

MR. BOHANON: Well, once again that would be station number three.

MS. SHERMAN: This is the integrated area? I'm not talking about the designated smoking area.

MR. BOHANON: This does get confusing. The title of the table is the levels in the designated smoking area. So regardless of where we had the smokers, it does represent the level that we measured there at station number three.

MS. SHERMAN: Okay, I think I understand.

In engineering paper number four, which was entitled, "Practical Techniques for Improving Indoor Air Quality in Restaurants."

How were the two restaurants chosen for the study?

MR. BOHANON: We worked with restaurants that participate in our peaceful coexistence program for restaurants, to encourage accommodation of both smokers and non-smokers alike, within the restaurant.

The director of that program and I visited some of the restaurants with whom we had had a relationship on developing that program, and selected restaurants that had really two criteria. One is that they had a high degree of smokers, had a lot of smoking patrons in the bar area or smoking section.

The other criteria was that they needed some improvement in their air handling system. So I guess to really simplify it or maybe over-simplify it, we were looking for a smoky bar.

MS. SHERMAN: So this was not done on the basis of measurements, it was just done by gut reaction on your part and the Director's part?

MR. BOHANON: It was done by observation, yes. We visited and we chose, from a small group of potential participants in the study, some restaurants and we reported on two of them in here.

The object of this study was to determine what some practical techniques would be for reducing the amount of smoke in the restaurant. So obviously if it's a restaurant that doesn't have a smoke buildup, I don't know what the technique is for reduction. We wanted to be able to see what we felt would be a nominal investment of capital, the kind of reductions that we could find in a place that we knew had a high patronage of smoking customers and that needed some help with their ventilation systems.

MS. SHERMAN: For the D.C. restaurant, what was the condition of the HVAC system?

MR. BOHANON: The condition of the HVAC system in the D.C. restaurant was that it was in operating order. Air conditioning systems and restaurants, or ventilation in restaurants gets a little complicated by the way the kitchen exhaust systems work. So let me remember that as I try and describe to you what happens. There are times when there's an imbalance in the kitchen exhaust and you get a lot of drafts that are coming through the patrons' area of the restaurant.

For the restaurant in Washington, D.C. the HVAC systems that were installed for comfort cooling and heating within the patron's area -- the bar and dining areas. Had no outside air supplied to those systems. Zero.

So there was no mechanically delivered ventilation air to those systems. The filtration type, I believe, was just an inexpensive filter which is not going to be very effective in the case of a lot of smokers and environmental tobacco smoke. The systems were operable.

MR. GROSSMAN: Your Honor, I've received a fairly urgent request from a panel member for a break, if we could have one.

JUDGE VITTONE: Okay. We've been going about an hour and a half.

Just one quick question, I just can't pass it up. Peaceful coexistence program?

MR. BOHANON: Yes, sir. That's what it's known as.

JUDGE VITTONE: Is this where Cold War years...

(Laughter)

JUDGE VITTONE: Ten minutes.

JUDGE VITTONE: For the record, I've been informed that Mr. Gene Davidson who is scheduled to be here tomorrow will not be here, but probably wants to be rescheduled for some time later in the hearing.

Dr. Allen Hedge from Cornell is still scheduled to return tomorrow.

MS. SHERMAN: After Reynolds.

JUDGE VITTONE: He'll probably come in tomorrow and complaint about that, but that's the way it will be.

Let's resume again with Ms. Sherman.

MS. SHERMAN: I think when we took the break we were discussing engineering paper number four, which was the "Practical Techniques for Improving Indoor Air Quality in Restaurants."

MR. BOHANON: Yes.

MS. SHERMAN: In the D.C. restaurant, how much did the modifications cost for labor, materials, and various recurring costs? Can you submit that to the record?

MR. BOHANON: Yes, we can. The target value for making the changes in restaurants is between $3,000 and $5,000 per restaurant.

MS. SHERMAN: Is this one time or recurring costs?

MR. BOHANON: No, no. It's one time. A one time modification.

MS. SHERMAN: Do you have any data on whether the modifications carried with them recurring costs? Such as higher energy costs or whatever.

MR. BOHANON: Yes, I believe I do. Let me just go through, I guess, both of the restaurants.

There is an energy calculation contained within this paper that deals really with the other restaurant, the Denver restaurant. Let me focus just on the D.C. restaurant right now.

MS. SHERMAN: Yes.

MR. BOHANON: We did not do an energy calculation for the D.C. restaurant. What we did do, in effect, was add some air that could be used for economizer, but some air that also is going to have some additional energy burden at other times of the year. So the answer for that piece of the actual heating and cooling cost in itself, I have not gone through the calculations. I would expect that there would be some positive cost associated with that, but that the perception of the restauranteur and the people tending bar would be that that would be a cost that would be minimal, because the situation of having no economizer on a direct expansion type air conditioning unit, you have no way to really get the heat out of that space in the winter. So it got extremely hot inside during the winter. So there's probably a cost, but I think there would be a definite perceived benefit in that case.

As far as the maintenance modifications we made, we put an in-line fan into the system. That should be a very low maintenance item. But we also did install an electrostatic filter which is an additional maintenance item that should be maintained at least quarterly and cleaned. I don't foresee that there would be a very high cost with that.

MS. SHERMAN: As to the Denver restaurant, how much did those modifications cost, and how long will it take for the savings in energy, et cetera, to pay for the modifications?

MR. BOHANON: Well, as to how much that costs, frankly in the Denver restaurant, and let me flip over to the diagram so I can remember all the parts, we did exceed our budget. The reason we exceeded our budget is because unlike the restaurant in Washington, D.C., there were components of that system in the Denver restaurant that were non-functional. Therefore...

MS. SHERMAN: You started out not doing too well.

MR. BOHANON: Right, we started out with some things that were broken and did not work, which was part of the cause of having such an air quality problem in the restaurant. The equipment wasn't working. So we incurred not only the cost of improvement, but also the cost of repairs. The major cost that we expended in that restaurant really did have to do with repairing the system. We found in that case that the toilet exhaust fans were non-functional. They had a little exhaust fan that whizzed and made noise but it didn't move any air, so we totally replaced those. We found the makeup air system was non-functional. The motor was broken and the gas control was broken. We had to completely repair that, rebalance the wheel, buy a new motor.

So in the course of doing all those repair-type things, the real improvements within the restaurant, the additional costs of that were not quite as much.

If I recall, we spent maybe $7,000 or $8,000 fixing and improving that restaurant.

MS. SHERMAN: Did the operators of the restaurant know that certain things in their ventilation system were broken, or they weren't even aware of this fact?

MR. BOHANON: In this case, I think operators are aware when things are broken. They knew that it wasn't working... Maybe the toilet exhaust they didn't. They just kept putting more deodorizers in there.

(Laughter)

MR. BOHANON: But for the makeup air fan, they were aware that it didn't work, and they were aware there was a cost to fix it, and they had made an incorrect judgment that by not fixing it they would both save money and save energy. In fact, they save energy by fixing the makeup air unit.

The other piece, doing a cost/benefit calculation, it would be along payoff time. I don't believe I've done that. I certainly didn't do it in the paper. But the big difference that was observed there is that the temperatures in that restaurant were just in terrible control. It was, in fact, 80 degrees in one part of the restaurant, and 60 degrees in the other. Those just aren't at all within the comfort range. By rebalancing the air in the restaurant and getting all the equipment properly and providing a new air balance to the equipment that was working, fixing the operating schedule on that, what they had was a situation where they could really, more fully utilize all their restaurant space. They wouldn't have if you're over by this door you're going to be cold, and if you're over here you're too hot. It really made the restaurant more useable. They felt that the patrons would stay longer if they're more comfortable, stay longer and order after dinner coffee or a drink, rather than say I'm so cold I've got to get out of here, or I'm not comfortable at all.

So I think the payoff there at least in the minds of the restaurant owners, was gee, I didn't know things were as bad as they were, and I didn't know they could work this well. It just never had been demonstrated.

The reasons some of those equipment items were in there in the first place and the real negative ramifications of those items not working.

MS. SHERMAN: You said you went a little bit over budget on the Denver restaurant, but were the costs for design and construction included in your cost figures, or was this just the cost of the equipment?

MR. BOHANON: That's essentially the cost for design and construction. For the Denver restaurant we really didn't do any construction. I would say the improvement that we made were more improvements... We changed out some diffusers to get better air distribution and we rebalanced the system. Those things aren't thought of as really being construction things. They're just kind of advanced maintenance activities or kind of tweaking the way the existing equipment worked. We didn't buy a whole new air handler or a big filter bank or anything like that in that restaurant. So it was really more of a maintenance and repair and kind of an incremental improvement activity, and those numbers do include...

MS. SHERMAN: Did you do the work yourself or did you have a contractor do it?

MR. BOHANON: No, I didn't...

MS. SHERMAN: No, I mean...

MR. BOHANON: No, Reynolds, no, we didn't do it. We hired a local contractor and a local test and balance firm to...

MS. SHERMAN: Did they submit reports on both of these restaurants?

MR. BOHANON: Yes. We had a local contractor in the D.C. area for the D.C. restaurant, and a local contractor in the Denver area for the Denver restaurant. They're different contractors. But we do have, yes, test and balance reports for those systems.

MS. SHERMAN: That's the only thing the contractor submitted to you, or to the restaurant as the case may be?

MR. BOHANON: The test and balance contractor submitted a test and balance report. The mechanical contractor made changes that were warranted in the restaurant and then submitted a bill.

MS. SHERMAN: I see.

I believe yesterday Dr. Ogden on Slide 10 mentioned the Columbus, Ohio study. Is the Columbus study typical of all workplaces?

DR. COGGINS: This is for Dr. Ogden now. You've finished with...

MS. SHERMAN: For the moment.

DR. OGDEN: Slide 10 does present some summary results from the Columbus, Ohio study. Your question was, is that typical of all workplaces? Was that your question?

MS. SHERMAN: Yes.

DR. OGDEN: To be honest with you, I don't know whether it is or it isn't. The subjects were selected randomly in a population-based survey. We put no requirements or restrictions on the participants, as far as their workplace, other than they could not work in a place where smoking was banned. Again, by doing this we're ensuring at least the possibility of being exposed at work in this particular study.

So as far as demonstrating representativeness exactly with the population we can't do. To the extent that a random draw from the population would be more or less representative, then I think that would be the case, yes.

MS. SHERMAN: I think you stated that the study was published. Was it peer reviewed?

DR. OGDEN: The Columbus study is published in the Indoor Air '93 which is a conference proceedings. There was some review for acceptance of that. I would not call that peer review in terms of, as it's used in typical journal publications.

MS. SHERMAN: I think on the same slide you stated that air monitoring in the homes revealed higher concentrations of nicotine in the homes of working subjects which, in your opinion, explained your findings about cotinine level in those who were exposed at home and potentially at work.

DR. OGDEN: Yes.

MS. SHERMAN: How do you explain this finding regarding your air monitoring data?

DR. OGDEN: When we first observed a difference in the concentrations in the homes, the first place we looked was the, what to me was the logical place, to test and see if the smoking behavior in those two groups of homes were different. That would have been a logical explanation. We made that type of analysis and test, and the smoking behaviors in those two groups of homes were not different.

We then, to be frankly honest, were a little puzzled, so we began looking at other variables. We only found one statistically significant difference, and it could explain that difference, and that is the home size.

In the homes where the husband and wife both worked outside the home and the husband smoked, the homes were, in general, on average, one room smaller. So again, just to summarize that, we did not see a difference in the number of tobacco products reportedly smoked in the homes, but we did see a statistically significant smaller house size.

The same number of products, smaller house, we would have expected, then, based on that, a higher concentration. That's the only variable that we saw that could explain it.

MS. SHERMAN: Could you submit your data on the study including the study design and the data collection process and the data analysis from this study?

DR. OGDEN: You're asking me to submit the raw data?

MS. SHERMAN: If you would.

DR. OGDEN: Certainly there are some potential problems with that. One is the confidential nature of the study...

MS. SHERMAN: Yes, minus the identifiers.

MR. GROSSMAN: We'll take that under advisement.

I don't know if that's possible to submit.

MS. SHERMAN: In any case where I ask for raw data, I'd like it understood that we don't have any interest in any personal identifiers that might be on your raw data.

DR. OGDEN: I understand.

MR. GROSSMAN: While we have this brief opportunity, from the very first day of the hearings, OSHA promised to provide us with material. We still haven't received it. That includes such simples things as the size of the work force in the United States that would be subject to this regulation, and a confirmation that you rounded upward every time you made a calculation in the NPR. Is there any time when we'll be receiving that?

MS. SHERMAN: I believe that at the time you asked for it we said we would provide it in the post-hearing comment period, Mr. Grossman.

MR. GROSSMAN: You didn't present the time. Is that when you say you're going to now provide it?

MS. SHERMAN: That generally is when material that is requested at the hearing, not only of us, but of other parties, is expected to be submitted.

JUDGE VITTONE: What is the question pending? Do we have a question pending?

MS. SHERMAN: I don't think so. I think we had finished.

JUDGE VITTONE: All right. You're going to take a look at the data, and yo understand that she doesn't want any of the identifying data, or indicators attached to any of the data that she's requesting.

DR. OGDEN: Yes, I understand that.

MS. SHERMAN: And by the way, that's not just for this study. That's for any study. We don't care about people's names.

DR. OGDEN: I wouldn't provide that information.

MS. SHERMAN: And we would have no interest in it, other than distinguishing Site A from Site B, which of course you would need to be able to make any sense of any data.

On Slide 16 in your summary of workplace RSP, and I believe also on Slide 31, you refer to "truly nationally representative studies of ETS exposures."

To which studies are you referring?

(Pause)

DR. OGDEN: Our Slide 16?

MS. SHERMAN: Sixteen and also on 31.

(Pause)

MS. SHERMAN: I believe it's not on the slide, it's in your discussion of those slides.

DR. OGDEN: Oh, without replaying the entire chronology of the presentation...

MS. SHERMAN: Excuse me, I didn't hear you.

DR. OGDEN: I'm sorry. Without replaying the entire chronology of the presentation, I'm referring specifically to the Jenkins et al Oak Ridge study. We've also summarized some of our studies. The New Jersey study particularly, on Slide 15, which precedes...

MS. SHERMAN: Is that the Mount Laurel study?

DR. OGDEN: Yes, sorry. Mount Laurel, New Jersey.

MS. SHERMAN: What sample characteristics made the Mount Laurel study representative?

DR. OGDEN: Again, the primary requirement in my mind is that the subject selection criterion is not restricted to an extremely narrow set of individuals like they are in many of the other studies cited in the proposed rule.

The Mount Laurel, New Jersey study, the subjects were contacted randomly from a population-based survey. In other words, other than minimal restrictions on age, and in that case sex or gender. They were all females in that study.

The general recruiting requirement that they be available from the population at large.

MS. SHERMAN: What about the Oak Ridge study? Would your answer be the same as to what characteristics would make it representative?

DR. OGDEN: Yes, I think that would be very much my answer in terms of placing it into context with more or less representative than the other studies, and I've already offered testimony on some of the limitations of those other studies -- the Cummings study, the Emmons study, and the like.

MS. SHERMAN: In the context of the Oak Ridge study, I believe that a preliminary presentation of the study was made at an earlier point before this hearing, and it was suggested that RJR should conduct split sample measurements with Dr. Pirkle's lab in Atlanta as a way to validate the cotinine measurements. Do you remember that?

DR. OGDEN: I'm not sure I understand what document you're referring to.

MS. SHERMAN: I believe there was an earlier summary of the Oak Ridge study.

DR. OGDEN: Not made by me.

MS. SHERMAN: Made by Dr. Jenkins.

DR. OGDEN: I have no knowledge or that statement, no.

MS. SHERMAN: I believe it was a representative of CIAR and Dr. Jenkins. There was a discussion about split sample measurements taken. I assumed you would know about it since it would have involved your laboratory.

DR. OGDEN: It would have. The conversation you're referring to I was not present at, I'm sure. Any considerations that Dr. Jenkins would have had for how he chose to perform quality control, et cetera, were his entirely. That may or may not be something he considered. I was not consulted about that particular suggestion.

MS. SHERMAN: Basically the discussion involved the validation of cotinine measurements because there was some discussion of the instability of the experimental technique used to measure cotinine at very low levels. The staff was assured that there was going to be an effort to do these split sample measurements.

I assume from what you're telling me, you don't have any knowledge of this conversation and you haven't been involved in any conversations with anybody about doing split sample measurements. Is that so? With Dr. Pirkle's lab.

DR. OGDEN: That is so. I'm not sure what you mean by the instability of the measurement.

We have done internally quality control...

MS. SHERMAN: Excuse me?

DR. OGDEN: We have internally performed quality control type of measurements where we put a known amount of cotinine on the cotton dental dam that is used to obtain the saliva sample. That has been done in the past, and we find very good recovery and very good accuracy.

If you're speaking of limited detection, that's another issue.

MS. SHERMAN: Did you ever approach the Center for Disease Control with a view to having Dr. Pirkle's lab do some analysis along these lines?

DR. OGDEN: No, I've never talked to Dr. Pirkle, nor was I requested to.

MS. SHERMAN: Do you have the raw data on the cotinine measurements from the Oak Ridge study?

DR. OGDEN: Yes, I do. As does Dr. Jenkins.

MS. SHERMAN: Is it your data or his data or both of your data?

DR. OGDEN: In the grand scheme of things, I would say it's the Center for Indoor Air Research's data. I released all of that data to Dr. Jenkins, and he has copies of the individual instrument reports. He also has copies of spreadsheet summaries of those reports. And for all the analytes, by the way.

MS. SHERMAN: Would you be willing to provide the raw data on the cotinine measurements, and also the diary data from the Oak Ridge study that maybe in your possession?

MR. GROSSMAN: Once again, we'll take that under advisement.

DR. OGDEN: May I clarify? I have never seen the diaries, the completed diaries from any of the subjects. They have never been in my possession nor has anybody at R.J. Reynolds ever seen those diaries. They are totally in the possession of Dr. Jenkins at Oak Ridge.

MS. SHERMAN: Okay. You can't provide what you don't have.

DR. OGDEN: Absolutely.

MS. SHERMAN: What about the air monitoring data? Do you have that from the Oak Ridge study?

DR. OGDEN: Of course.

MS. SHERMAN: Would you provide that to us?

MR. GROSSMAN: Again, we'll take it under advisement.

MS. SHERMAN: In looking at Slide 26 from your presentation...

DR. OGDEN: I have it.

MS. SHERMAN: I believe you mentioned that Dr. Cummings' explanation about the low levels of reported cotinine values for those with work exposure was not plausible.

DR. OGDEN: From the data that I have seen in the published accounts of that study, from the private communications between Dr. Cummings and OSHA that were submitted in the docket, I cannot find any plausibility for that explanation, no.

MS. SHERMAN: Are you aware that Dr. Cummings too samples from his subjects on Mondays, and therefore, most of the subjects had been away from work for two days at the time the samples were taken?

DR. OGDEN: No, I don't believe that's in with the published accounts, is it?

MS. SHERMAN: I don't believe it is, either.

Could this information cause you to change your remarks about Cummings' explanation?

DR. OGDEN: If I could, let me find the Cummings papers.

(Pause)

DR. OGDEN: Did you say most of or all of the data were obtained on Monday?

MS. SHERMAN: Most of it.

DR. OGDEN: The reason I'm searching is because I thought I read something in one of the papers that didn't sound like that was exactly what he described.

DR. COGGINS: While Dr. Ogden is checking that, Dr. Nelson has a point to make.

MS. SHERMAN: Certainly.

DR. NELSON: There is some relevant information, I believe, that may be contained in Dr. Chang's submission to the docket, and it relates to the study which I had up on one of my latter slides, I believe Slide 20, where there was controlled exposure during the course of a week to environmental tobacco smoke.

This is a case, also, where the two days prior to the exposure, no exposure had taken place. I'm quoting from page six of her submission. It says, "Among the 20 subjects, nine had statistically significant increases in urinary cotinine after ETS exposure. However, there was no significant difference in 11 subjects before and after they were exposed to ETS. This is a very large exposure to 59 micrograms per cubic meter, ETS nicotine. It is a bit of data that shows that cotinine, even in a case where you have a large exposure, it's very hard to tell, on the basis of at least urinary cotinine, that there are changes, or what sort of changes have taken place in exposure over a time period.

DR. COGGINS: Thanks.

DR. OGDEN: I know there's a relevant quote here and I won't waste too much more time looking for it.

The question you've asked me makes many other assumptions, and that is the assumption that nobody worked on the weekends.

MS. SHERMAN: That's true.

DR. OGDEN: That's true?

MS. SHERMAN: I agree with you.

DR. OGDEN: Oh, okay. That's certainly something that would have to be taken into consideration, to see what the potential bias may be for people who were not at work prior to going to the site, and also people that may not have been at home prior to going to the site.

MS. SHERMAN: I believe you discussed the Emmons study on a couple of slides, Slides 29 and 30 and 31. Would it surprise you to know that Emmons said that for those who did not live with a smoker, that the workplace contributes the highest ETS exposure?

DR. OGDEN: If you have a specific quote, I'd like to find it, but my recollection of those reports indicates that she's analyzing the questionnaire data when that statement was made. Am I mistaken? I believe when she describes, I'm not even sure it is a she. When Emmons describes the cotinine data, the description is very different. Those are the quotes that I provided in my testimony.

MS. SHERMAN: In Slide 35, you were discussing the pros and cons of the NHIS study, and I think you mentioned that RJR has information on the prevalence of exposure from two studies that you conducted in 1992?

DR. OGDEN: That's correct.

MS. SHERMAN: Which ones were they?

DR. OGDEN: They were actually two parts of what I'm calling the nine city smoker misclassification study which a preliminary report was submitted to the docket. In that report it's described how that study was conducted in two phases. Phase one of that study was a national random digit dialing telephone survey which I, at least at a superficial glance, would be very similar to the NHIS study. That incorporated 1200 respondents.

The second phase of that study was the actual field measurements where we went out into the nine cities in the mall intercept study, actually intercepting subjects, administering questionnaire, and collecting saliva samples. So really it should be properly characterized, I suppose, now as two phases of a much larger, or two phases of that study.

The second part of that study incorporated 900 respondents. So in total we're talking over 2,000 women.

MS. SHERMAN: We would be interested in looking at your raw data from that study, the nine city smoker misclassification study also.

Would agree that the CAP study is a large, representative and recent study?

DR. OGDEN: Representative of what? California, maybe. The U.S., I doubt.

MS. SHERMAN: Would you say representative of California?

DR. OGDEN: It's been some time since I've read that study. Of course CAP stands for California Activity Pattern.

Beyond that, I don't recall any particular demographics that would allow me to judge it. Of course the main qualifier there is it is restricted to California.

MS. SHERMAN: The sample size was over 1500, I believe.

DR. OGDEN: I don't have that study with me. I'm sorry.

MS. SHERMAN: Do you remember the CAP study?

DR. OGDEN: Yes, I remember reading various documents on it. I haven't re-read those recently. As I said, I don't have them with me.

MS. SHERMAN: Would you agree that a correct interpretation of the CAP study is that the longest ETS exposure is in the workplace?

DR. OGDEN: Longest in terms of duration of time, reported duration of time?

MS. SHERMAN: Yes.

DR. OGDEN: Again, without reviewing those tables, I wouldn't be able to comment as to whether...

MR. STEICHEN: Can I comment, please? I don't think we would agree with that at all. They never measured duration of exposure. They measured duration of potential exposure, which is exactly what the authors, I think, in a different paper say.

MS. SHERMAN: I believe I said the longest. I didn't say the greatest.

MR. STEICHEN: Regardless. Longest or greatest, they didn't measure exposure. They just measured potential exposure. That is documented in some of their own publications.

MS. SHERMAN: I believe in your submission you stated that the Emmons study concluded that "among all working non-smokers, 50 percent of the reported daily duration of exposure was in the workplace, compared to ten percent at home."

DR. OGDEN: Could you point me to that citation?

MS. SHERMAN: Just a minute. I'll find it for you.

(Pause)

MS. SHERMAN: We'll have to come back to this.

(Pause)

MS. SHERMAN: Well, the next question has to deal with this also.

(Pause)

MS. SHERMAN: I believe in your submitted comments, it starts on the bottom of page 18, and I believe it goes to page 20 --

DR. OGDEN: Referring to Emmons?

MS. SHERMAN: Excuse me?

DR. OGDEN: Referring to Emmons?

MS. SHERMAN: Yes.

DR. OGDEN: Okay.

MS. SHERMAN: I believe on the bottom of page 19 it says that among all working non-smokers 50 percent of the reported daily duration of exposure was in the workplace compared to 10 percent at home.

Do you agree that one can conclude from the Emmons study that half of the time that the subjects were exposed to ETS was during work and only 10 percent of their exposure time was at home?

DR. OGDEN: Well, let's make sure we're discussing the right piece here. We're discussing what Emmons says about it or what the proposed rule says about it?

MS. SHERMAN: What Emmons says about it.

DR. OGDEN: Oh. Okay. That's different.

As many of the other studies have shown, I think what the data show in this study would be a reported potential duration of daily exposure. Within that context, yes, that appears to be what the statement says.

MS. SHERMAN: So would you agree that in both the CAP study which is on the West Coast and the Emmons study which is on the East Coast that they both found that the workplace was the location of the longest potential ETS exposure?

DR. OGDEN: I think there is a more detailed analysis of that data necessary. As I understand the summary of data that you're asking about, and as I'll explain in a minute, it is very different from the approach that I was taking in the analysis here, where I was comparing home exposures for people who lived with smokers versus work exposure for people who work with smokers.

I think this 10 and 50 percent, of course, the 10 percent at home is, I imagine, most likely restricted for people who live with smokers, so there's another layer there that I'm not sure that we're capturing in this particular question.

The comparison I was making was the exposure at home, true exposure, not reported duration of exposure, at home for living with smokers versus at work, working with smokers, as the slide that I presented -- and let me find it -- I think it demonstrates it quite clearly, the concept or the conceptual problem is that basically in the Emmons study although as they've said and as I've reported, three times the number of people reported exposure at work but the reported intensity of the exposure was greater in the home.

And, as I concluded there, I would not speculate as to how those would weigh out in terms of true exposure. I think as you look at Emmons' data, and they did include one analytical estimator of exposure and that was cotinine, if you look at the Cummings data, you get the same result, if you look at the Oak Ridge data you get the same result.

When people are asked to guess how much smoke they're exposed to, they over-guess. So we're reporting potential for exposure. Somebody may -- I forget which study this came from but basically they're saying were you exposed to any smoke in the last week, they say yes. If you live with a smoker, I think you're likely to be exposed every day. So there are many differences and the real issue is not potential duration of exposure, the real issue is actual exposure.

And the best data you can get on actual exposure from the Emmons study is the cotinine data. There are problems with that but that's the best available, the same as with the Cummings. And as you go to the Oak Ridge study, of course, there are now nearly 10 different markers of ETS that all lead you to the conclusion that true exposures at work for working with smokers are many times lower than true exposures at home living with smokers.

DR. SEARS: Chris, may I add something to that?

DR. COGGINS: Dr. Sears has a comment here.

DR. SEARS: On the subject of reevaluation of the Cummings data, I think it's important to point out to OSHA that according to his reevaluation he found that cotinine levels were higher for those subjects exposed neither at home nor at work than for those exposed at work only.

In addition to that, as I recall reading Dr. Ogden's further criticism of that, it certainly remains valid that on the basis of physical arguments, that is half-life of cotinine arguments, it is incredibly unrealistic on the basis of that argument to explain those findings

MS. SHERMAN: Turning to the Mt. Laurel and to the Jenkins study, could you describe the work locations in the Mt. Laurel study where the samples were taken?

DR. COGGINS: Dr. Ogden?

DR. OGDEN: If you will allow me to -- let me refer to my notes.

(Pause)

DR. OGDEN: I don't recall right off if there were any exclusion criterion in that study regarding type of workplace. I think that there were not. I believe that there was a requirement that those that reported they worked would have to work basically a full shift, 35 hours a week.

MS. SHERMAN: What I was really asking, I asked for the work locations.

DR. OGDEN: Oh, I'm sorry.

MS. SHERMAN: And what I'm interested in is private offices, open offices, production areas, printing areas, et cetera. I would like a range of the workplace type and a breakdown of your sample by type of workplace.

DR. OGDEN: Okay. Let me make a note of that. A breakdown of the sample -- in terms of the results, you mean?

MS. SHERMAN: Yes.

DR. OGDEN: Certainly we have the information on type of occupation. I thought you were asking were there any rejection criteria that would have limited the possibilities.

MS. SHERMAN: Is there any difference between the smoking and non-smoking workplaces in the Mt. Laurel study other than the smoking policy?

DR. OGDEN: I'm sorry, I don't understand the question.

MS. SHERMAN: You sampled a number of workplaces, correct?

DR. OGDEN: Correct.

MS. SHERMAN: Okay. Is there any difference between --

DR. OGDEN: Oh, I'm sorry. When you said policy -- you mean the fact that smoking is allowed in one and --

MS. SHERMAN: Yes.

DR. OGDEN: I thought we were now talking about smoking policies. Pardon my confusion. I'm not aware of any. Of course, again, we're dealing with a random draw. I don't know that we've formally analyzed that data to see if there may be more office workers in one versus more something else in the other. We certainly can do that.

MS. SHERMAN: Can you provide that information to us?

DR. OGDEN: We can certainly see what type of data analysis we can perform. Certainly.

MS. SHERMAN: Now, in the Oak Ridge study, was there any difference between the smoking and non-smoking workplaces other than the smoking policy?

DR. OGDEN: Well, as Dr. Jenkins stated in his testimony, I don't have any idea what the data from that study look like. I have never seen any of the filled-in questionnaires, I've never seen the completed diaries. Other than his tabulations that are in the docket, I have absolutely no knowledge of that.

MS. SHERMAN: Okay. So you really can't answer that question.

DR. OGDEN: I can't answer that.

MS. SHERMAN: Okay.

Could you look at Table 2 on page 23 of your docket submission? It's a table entitled "RSP and ETS RSP Concentrations in Smoking and Non-Smoking Workplaces."

DR. OGDEN: This is the August submission?

MS. SHERMAN: Yes, I believe so.

DR. OGDEN: Page 23?

MS. SHERMAN: I believe so. The bottom of the page.

DR. OGDEN: Okay.

MS. SHERMAN: Let's look at the median concentrations measured in the workplace in both the Mt. Laurel and the Jenkins study. In the Mt. Laurel study you found a difference in respirable particle concentrations between smoking and non-smoking workplaces of 23.5 micrograms per cubic meter, is that correct? What I'm doing is subtracting --

DR. OGDEN: 52.5 minus 29?

MS. SHERMAN: Yes.

DR. OGDEN: Okay.

MS. SHERMAN: Just so I understand -- now, this difference is attributable only to ETS?

DR. OGDEN: Oh, I wouldn't make that assumption at all. You're assuming the only difference in those workplaces is ETS.

MS. SHERMAN: Excuse me?

DR. OGDEN: You're assuming that the only difference in those workplaces is the presence of ETS and that's not a fair assumption.

MS. SHERMAN: Okay. Well, then, what might it be attributable to?

DR. OGDEN: Well, we're almost equating this to a discussion of confounders in epidemiology. There could be many potential differences in terms of different point sources, et cetera. I'm not saying that I know that there's a difference but I'm saying I don't believe it's safe to assume that the only difference is the presence of smoke.

MR. BOHANON: I might add that in our studies of ventilation the ventilation rates in different spaces as well as outside air, RSP levels, as well as just other kinds of general dust that can be stirred up in an area can add to the particle mass that's collected in the samples.

MS. SHERMAN: I think you also reported an estimate of the respirable particle level from ETS based on the solanesol concentrations.

DR. OGDEN: Yes, I did.

MS. SHERMAN: I think you reported a difference of approximately 12.5 and what I'm doing is I'm subtracting the non-smoking quantity of less than 2 from 12.6. So therefore the difference in smoking and non-smoking workplaces was 23.5 micrograms per cubic meter respirable particles but when the respirable particle level is calculated from solanesol then the difference is 12.5 micrograms per cubic meter between the smoking and the non-smoking areas. To what would you attribute the difference?

DR. OGDEN: I would attribute that to the ubiquitous nature of RSP in indoor spaces.

MS. SHERMAN: Which of these two numbers, the 23.5 or the 12.5, would you consider to be more accurate of respirable particulates?

DR. OGDEN: Of respirable particulates or ETS particulates?

MS. SHERMAN: Of ETS particulates.

DR. OGDEN: Well, as we've documented fairly well in our submissions and also in the peer reviewed literature, the best marker for the particulate phase of tobacco smoke in our opinion, and that's shared by at least some other researchers that have published an opinion, is that it is solanesol. Based on the available information, based on my experience and our studies, I would say that a direct indication of the ETS particulate matter fraction of RSP is obtained by solanesol and not simply by a difference of two categories. The solanesol method allows us to apportion RSP directly in every location in which we sample.

(Pause)

DR. OGDEN: As I was saying, the utility of the solanesol method or a direct apportioning method is that it allows you to make an apportionment estimation on every sample that you take. The only other way you can gain that type of information is to group people into cells and take a difference, as you can do on two rows of this table. I believe the more accurate way of doing that is solanesol. Yes.

MS. SHERMAN: At what concentrations of nicotine can the average person detect the presence of cigarette smoke? Do you know?

Dr. Coggins, I'll let you direct it where you will.

DR. COGGINS: Dr. Nelson?

DR. NELSON: I'm not going to be able to give an especially good answer. The answer is in short I don't know but in part it's because nicotine is not necessarily what you smell about environmental tobacco smoke and so as nicotine varies with other ETS constituents and also the level which you would smell tobacco smoke would vary, nicotine would also vary with the level at which you could smell smoke.

Why smoke smells the way it does is something that is not really known. Dr. Walker's submission, I think, addresses odor strength of environmental tobacco smoke in terms of RSP concentrations or in terms of CO concentrations.

MS. SHERMAN: Well, would 5 to 10 micrograms per cubic meter seem reasonable?

DR. NELSON: I am not aware of any work that has been done in that area. That is getting more to the edge. I have had some involvement in sensory studies and environmental tobacco smoke. I am not infinitely familiar with that literature. Based on what I have seen and my knowledge of what Dr. Walker has told me, there are basically no studies that have been done at low levels of environmental tobacco smoke in terms of sensory impact.

Now, he did see an elevation of odor strength, I believe, at the 50 microgram per cubic meter level so there is some detection of tobacco smoke odor at that level but where the actual threshold of detection is, I am not qualified to answer.

MR. BOHANON: That is an RSP level that Dr. Nelson was talking about.

MS. SHERMAN: Does RJR have any information on the odor threshold to submit?

DR. COGGINS: I'm sorry, on the odor threshold of?

MS. SHERMAN: On ETS.

DR. COGGINS: Again, I think most of that has been documented in Dr. Walker's submission, which I am not at all familiar with.

Is anybody else?

DR. NELSON: Not that I'm aware of. Because nobody knows exactly what it is in environmental tobacco smoke that gives it its characteristic odor, it's not really possible to say at what threshold that compound is detected. To my knowledge.

MS. SHERMAN: Thank you.

(Pause)

DR. NELSON: Although as I'm sitting here thinking again, there may be a paper by Moschandreas that might begin to address that issue but I'm not entirely certain.

MS. SHERMAN: Let me show you an overhead of Dr. Nelson's slide that I think you showed us yesterday.

DR. NELSON: Could you identify the slide for us?

MS. SHERMAN: I'll pass it over.

DR. NELSON: I have it here, I'm sure.

MS. SHERMAN: I think this was in your written submission.

DR. NELSON: Yes. All right.

MS. SHERMAN: We have it marked as slide 8 and I can put it on the screen if perhaps that would be easier.

DR. NELSON: That's fine with me.

MR. GROSSMAN: That's number 9.

DR. NELSON: That's number 9 and it's also number 7.

MR. GROSSMAN: Yes. It's not number 8. It's number 7 or 9, both of which are the same, but 8 is different. Eight is not a graphic chart.

MS. SHERMAN: Excuse me?

MR. GROSSMAN: Eight is not a graphic chart.

DR. NELSON: That is slide 7 and slide 9 from my testimony. In fact, that looks like that is actually from a previous presentation that I gave to OSHA, not from yesterday's testimony. What you're looking at here.

MS. SHERMAN: It's your slide.

DR. NELSON: It is my slide. I presented those to OSHA. This particular slide was not presented yesterday. It was reproduced yesterday but it is in a submission that I made back in January of 1994.

MS. SHERMAN: So it is in our docket.

DR. NELSON: Yes, it should be.

MS. SHERMAN: And I guess it should be labelled RSP versus nicotine for 51 cigarettes. Would that be a fair identification?

DR. NELSON: That would be a fair identification.

MS. SHERMAN: Okay. Now, I think that the yield of nicotine and ETS RSP was determined for 51 cigarettes.

DR. NELSON: That is correct.

MS. SHERMAN: The top 50 U.S. brands plus the one R4F.

DR. NELSON: Reference cigarette.

MS. SHERMAN: Which is the standard reference cigarette?

DR. NELSON: That is correct.

MS. SHERMAN: How does the one R4F cigarette differ in ETS RSP and nicotine from the top 50 brands?

DR. NELSON: One thing that I should perhaps point out before we go on, you probably see more than 50 dot up there.

MS. SHERMAN: Well, that was going to be my next question.

DR. NELSON: Let me address that. In this case, we're looking at all the data that we collected so that's the top 50 brands, all of them duplicated at least twice, some of them are triplicate measurements. This is just kind of giving the field of yields.

Now, the one R4F, as I recall, I don't have the data tally here in front of me, but as I recall it was fairly close to the sales weighted average RSP yield and it was one side or the other of it but I'm not sure exactly which side without the tally here. And the nicotine yield was also fairly close to the center of the nicotine yield. I could determine that information but I can't cite it off the top of my head.

MS. SHERMAN: Can you submit it to the record?

There are 111 data points here, I think.

DR. NELSON: That would not surprise me.

MS. SHERMAN: Does that sound ballpark?

DR. NELSON: Yes.

MS. SHERMAN: Okay. Can you submit your raw data and you can take off the identifiers as to which brand is which?

MR. GROSSMAN: Once again, we'll take that under advisement.

MS. SHERMAN: Is this the same slide as slide 7 and 9 from your yesterday submission?

DR. NELSON: I believe that it is, yes.

MS. SHERMAN: Okay. Would the plot look different if you only had 51 data points and you didn't have some duplication in here?

DR. NELSON: It would look essentially the same. Obviously there wouldn't --

MS. SHERMAN: There wouldn't be so many data points.

DR. NELSON: There wouldn't be so many data points and so the more random -- but it would look essentially the same.

DR. OGDEN: Could I clarify something? Your slide 7 and 9, I believe you deleted the Kentucky reference cigarette, didn't you?

DR. NELSON: That may be the case.

DR. OGDEN: It's for only the 50 market brands in his testimony yesterday.

(Pause)

MS. SHERMAN: In this figure, were the cigarettes smoked by smokers?

DR. NELSON: That is correct. The way the data was gathered for this figure, it was done in our old environmental chamber, an 18 cubic meter stainless steel environmental chamber, and two smokers entered the chamber and each smoked one cigarette apiece. And I believe they took cued puffs on the cigarette.

MS. SHERMAN: How many?

DR. NELSON: Cued puffs. They took one puff a minute until they reached a line three millimeters from the overwrap.

MS. SHERMAN: Is this the experiment that you describe beginning on page 15 of Appendix A of your docket submission?

DR. NELSON: It may be but...

(Pause)

DR. NELSON: I'm getting very close.

MS. SHERMAN: That's fine.

DR. NELSON: I'm not sure that I have an Appendix A.

MS. SHERMAN: Let me try to find it for you.

DR. NELSON: I have several supplements. A Supplement 1, a Supplement 2 and Supplement 3.

MS. SHERMAN: Just a moment.

DR. NELSON: And, again, this is my written submission on August 13th that we're referring to.

(Brief pause)

MS. SHERMAN: Okay. I believe we're going to have to come back to this.

I stand corrected. I think it's Dr. Ogden's submission. Comments.

DR. OGDEN: Shall I start looking, then?

(Laughter)

DR. OGDEN: The written submission? The August submission?

MS. SHERMAN: Yes. I can show it to you.

DR. OGDEN: Well, I've got it right here. You say it's Appendix A?

MS. SHERMAN: Why don't we just show you since there's a lot of paper floating around.

(Judge Vittone hands document to Dr. Ogden)

DR. OGDEN: Okay. There are questions?

MS. SHERMAN: Yes. I asked you if this experiment was described in part beginning on page 15.

DR. OGDEN: Yes. That's the same experiment.

MS. SHERMAN: Yes. Okay. Thank you.

Is there a technical report or publication in the scientific literature which describes in detail the experiments which generated this data?

JUDGE VITTONE: Excuse me a second. Do we still need to have this up?

MS. SHERMAN: I think not. I'm corrected.

JUDGE VITTONE: You need to have it up?

MS. SHERMAN: Yes.

DR. OGDEN: Oh, I'm sorry.

MS. SHERMAN: Should I repeat my question?

DR. OGDEN: Please, yes. Maybe Dr. Coggins needs to address that one. I'm not sure where it should go but let's try it again.

MS. SHERMAN: Is there an RJR technical report or publication in the scientific literature which describes in detail the experiments which generated this data?

DR. COGGINS: These data?

MS. SHERMAN: Yes.

DR. COGGINS: I have no idea.

DR. NELSON: I believe there are two presentations that have been made. A publication has not yet been submitted to the literature on this, on this data. That I'm aware of.

MS. SHERMAN: I guess we can take this overhead off, but I think there's another one that I'd like to put up.

In your presentation yesterday... In Dr. Nelson's presentation yesterday, I believe on page 9 he said "it would be an error for OSHA to assume that nicotine is a good quantitative marker for ETS RSP."

MR. GROSSMAN: There appear to be two slides here. It's an interesting effort to speed up the tempo, here.

MS. SHERMAN: Just say yes.

MS. SHERMAN: Okay. I believe that we now have slide #7 on the overhead screen, which is entitled "RJR Vapor Phase Data."

Okay. And you said that it would be an error for OSHA to assume that nicotine is a good quantitative marker for ETS RSP. Correct?

DR. NELSON: That is, I believe that is correct. I'll take your word for it, though.

MS. SHERMAN: Isn't your comment contradicted by Dr. Ogden's slides 7 and 8, which when overlaid appear to show that nicotine tracks ETS RSP quite well?

DR. NELSON: There's... When taken, in a sense, out of context, that may be true. But that is not entirely true. And I'll explain why.

MS. SHERMAN: Please.

DR. NELSON: As I stated elsewhere in my testimony, in our environmental chambers at a single ventilation rate at a single, essentially single way of running the chamber, we get very reproducible results. And very often in fact we can get the same regardless -- in some cases, not all cases. You smoke the same number of cigarettes under exactly the same environmental conditions in the chamber, you can get reproducible results.

Now the problem happens, it's when you try to extrapolate that out to the real world, we have very different environmental conditions. From my paper on environmental science and technology this would be essentially, would be a slice through a plane, essentially, through one of the 3-dimensional drawings I made.

As you go to different ventilation rates, different ventilation conditions and different surface conditions the ratio that may be fixed at one condition will be different at other conditions. That is to say, yes, under this one specific circumstance nicotine might be a good marker for ETS RSP. But as a general rule, if you try to extrapolate that or apply that in the real world in the field, or even in an environmental chamber at different ventilation conditions, you'll get very different results.

DR. OGDEN: Well, there are other considerations as well. If I may, Dr. Coggins?

DR. COGGINS: Please.

DR. OGDEN: Realize this is a very controlled experiment. It was done to replicate and to address a criticism made by Dr. Hammond.

Everything in this experiment was controlled. The size of the room, the same room -- in other words, the same surface area of this chamber -- the same cigarette, and the smoking behavior. So to add that to what Dr. Nelson was saying in the published paper where he looked at the effect of ventilation and sampling time, again, in that experiment, everything was kept the same except two parameters: the ventilation rate and the sampling time. And as he was referring to, that paper shows quite clearly that nicotine and RSP don't track each other, even in the same chamber using the same cigarette smoked under identical conditions.

MR. BOHANON: And if one extrapolates that on to the real world test, the slide that Nr. Nelson showed showing the five different locations in the office buildings, which is the test that I presented, one finds that there is no relationship and no correlation if you go beyond just the one building to all buildings that have been reported you end up with that thing that I hope you remember from yesterday that was just an absolute scatter-shot of numbers all over the map. They were not at all straight clean lines.

MS. SHERMAN: Thank you.

Who on the panel is familiar with the issue of dietary nicotine?

DR. COGGINS: Dr. Nelson.

MS. SHERMAN: What happens to the nicotine when the food is cooked?

DR. NELSON: That, depending on the food, would depend on the type of food. And I can relate that to various published papers. I believe Dominos's said that, for example, if you cooked the food in water you would expect some of that nicotine to end up out of the food and into the water. That would make sense.

If I were making tomato sauce I would take tomatoes and a little bit of wine, mix them together, and just cook them and boil them down. And in that case, we're not going to extract nicotine into the water. We're probably going to end up concentrating it in that puree.

In the case of Dr. Davis' work. Or, excuse me, Mr. Davis' work, I guess, on nicotine in foods, he was looking at, in the case of raw tomatoes, what you would get from a raw tomato, eating a raw tomato, and also tea prepared as you would prepare tea. So if you would consider tea a cooked food, then what you would find in the tea is actually what he found in his samples.

MS. SHERMAN: What about eggplant? Do you know anything about what happens to the nicotine in cooked eggplant

DR. NELSON: I don't cook much eggplant, and so I don't have any feel for what sort of or typical preparation methods there would be to be able to predict what might happen.

MS. SHERMAN: But you would agree that eggplant is not eaten raw in this country.

DR. NELSON: As far as I know.

MR. GROSSMAN: Not for long.

DR. OGDEN: My wife had a party tray at Christmas. I swore it had eggplant on it and it was raw, but I don't...

MS. SHERMAN: Did anybody eat it?

MR. GROSSMAN: Well, I'll have to check my files on that.

JUDGE VITTONE: I'll take that under advisement.

(Laughter)

MS. SHERMAN: In, I believe it was Dr. Coggins submission concerning the 1980 paper of Repace and Lowrey, it was stated that the authors estimated an average population to RSP of 250 micrograms per cubic meter.

Do you remember where in this manuscript the authors made any estimate of the average population exposure?

DR. COGGINS: I'm sorry. You're asking me where in my submission on Repace and Lowrey of '93...?

MS. SHERMAN: Where in Repace's submission they make any estimation of average population exposure.

DR. COGGINS: Population exposure to...?

MS. SHERMAN: I believe that you say that the authors estimated an average population exposure to RSP of 250 micrograms per cubic meter.

DR. COGGINS: No. That was in the 1985 paper. The 1985 Repace and Lowrey arrived at an average exposure of 250 micrograms per cubic meter for ETS RSP. I'm sorry. 1980. Excuse me.

MS. SHERMAN: Okay. Where in that paper? Do you have it?

DR. COGGINS: I have the '93 paper. And I have the '855 paper. I don't have the 1980 paper.

(Judge Vittone hands document to Dr. Coggins)

JUDGE VITTONE: Is that it?

MS. SHERMAN: I believe that this is a reprint of it. Thank you.

JUDGE VITTONE: After this question I want to take a break. Okay?

MS. SHERMAN: Yes.

DR. COGGINS: So, your question for me is where in this 1980 paper does Repace and Lowrey arrive at the average exposure of 250 micrograms for ETS.

MS. SHERMAN: Yeah. Of average population exposure. Yes.

MR. GROSSMAN: Do you want Dr. Coggins to spend this time reading the paper?

MS. SHERMAN: No. He can submit it to the record, or you could do it during the break that the Judge wants to take. If, in fact, Dr. Coggins doesn't mind doing it during the break.

DR. COGGINS: Well, I think it will take me a while to go through it to find the actual reference.

JUDGE VITTONE: Okay. I'd like to take a break. It's five minutes until 5:00.

Ms. Sherman, I would not like to go... I assume you have more questions. Many more questions.

MS. SHERMAN: Yes.

JUDGE VITTONE: I would like to go until 6:00 tonight and break and resume tomorrow morning at 9:30. Will you be done tonight, or will you have more...

MS. SHERMAN: I think not. Is it possible to start a little bit earlier tomorrow morning? Like 9:00?

JUDGE VITTONE: Well, yes.

MS. SHERMAN: Or 8:30?

JUDGE VITTONE: We'll resume... Does anybody have any objection to starting at 9:00 tomorrow morning? It's only 30 minutes earlier.

MR. GROSSMAN: 9:00?

JUDGE VITTONE: 9:00.

MR. GROSSMAN: 9:00.

JUDGE VITTONE: All right. Let's take a ten minute recess, and we'll break at exactly 6:00.

Off the record.

JUDGE VITTONE: On the record.

Ms. Sherman?

MS. SHERMAN: Yes.

Dr. Coggins, I believe you also asserted that in a 1985 paper Repace and Lowrey's estimate of an average daily population exposure of 1,430 micrograms of ETS RSP was based on a questionable estimate of lung retention. And I'll ask you to submit this to the record so we don't waste hearing time. But I would like for you to point out what paragraph in this 1985 manuscript did the authors make any estimate whatsoever of lung retention of RSP.

Do you need a copy of that paper?

DR. COGGINS: No. I have that paper.

What I'm proposing to do is that... The Repace and Lowrey papers, first of all, there are lots of them.

MS. SHERMAN: Yes.

DR. COGGINS: They're very highly technical. I haven't read them recently. What I could do is read them, either tonight and give you answers tomorrow, or in the post-hearing comment which I would.

MS. SHERMAN: Either one would be okay, Dr. Coggins.

DR. COGGINS: Thank you.

MS. SHERMAN: At your convenience.

DR. COGGINS: Thank you.

MS. SHERMAN: I mean, these are fairly straightforward questions. I would just like to have an answer on the record, and there's no trick in these questions that I know of.

DR. COGGINS: Okay.

MS. SHERMAN: Okay. Similarly, I believe you stated that in the Repace and Lowrey 1993 paper a key basis for their model is based on assumptions based on lung cancer in active smokers. Could you point out in what paragraph in this 1993 manuscript the authors made any assumptions whatsoever based on lung cancer in active smokers?

DR. COGGINS: So that's the third question you'd like me to address. The exact place in the Repace and Lowrey '93 paper where the...

MS. SHERMAN: Authors made any assumptions based on lung cancer in active smokers.

DR. COGGINS: Right.

MS. SHERMAN: Also in the 1993 paper you asserted that Repace and Lowrey did not consider the possibility of different retention factors for ETS and mainstream smoke. And could you explain what assumption in the 1993 Repace and Lowrey paper would have required the use of retention factors?

DR. COGGINS: That's kind of related to the second point...

MS. SHERMAN: Yes, it is.

DR. COGGINS: ...on the lung retention factor. Yes. I'll address those.

MS. SHERMAN: Part A and B.

DR. COGGINS: Part A and B.

MS. SHERMAN: In Appendix B to RJR's docket submission there was a paper entitled "Determination of VOC's and ETS Apportionment in 49 Homes in Ohio," by Heavner, et. al. Twenty-eight VOC's were reported on, and other indicators of smoking activity were measured. I think that included nicotine and salivary cotinine.

Nicotine and cotinine data do not appear to be reported.

DR. COGGINS: I think this is Dr. Ogden?

MS. SHERMAN: I think so.

DR. OGDEN: Yes, it is.

MS. SHERMAN: Could you supply this missing data?

DR. OGDEN: Let me make sure I'm... This is... Let me find it. And I think there may be an inherent assumption.

At Appendix B?

MS. SHERMAN: Yes. It may be page 5. I'm not positive of that.

DR. OGDEN: Yes. Determination of volatile organic compounds and ETS apportionment in 49 homes?

MS. SHERMAN: Yes.

DR. OGDEN: On page 5?

MS. SHERMAN: Don't hold me to page 5, but try there.

DR. OGDEN: I may have to hold you to it. I see there's a sketch of the VOC's but I don't see nicotine.

MS. SHERMAN: Okay. Can you supply this?

DR. OGDEN: No. Nicotine wasn't measured in that study.

MS. SHERMAN: You didn't measure any nicotine?

DR. OGDEN: No. What we... Well. I'd ask you to rephrase your question.

MS. SHERMAN: Okay.

DR. OGDEN: Did we attempt to measure nicotine or did we not attempt it.

MS. SHERMAN: I thought that you measured nicotine and salivary cotinine and five day average nicotine concentration. Perhaps I was wrong.

DR. OGDEN: Oh, wait a minute. You're right. I was thinking of Appendix A.

The nicotine data for this study are also in the docket. They are in the study... Well, it's... Should I find it so the record is clear?

MS. SHERMAN: If you could direct me to... Maybe I don't understand that it relates to this study.

DR. OGDEN: Okay. Okay. Let me do that. Let me find it here.

Yes. The Appendix B that you're describing is the study conducted in Columbus, Ohio in 1991. The nicotine and cotinine data are described. The title is "Multiple Measures of Personal ETS Exposure in a Population Based Survey of Non-Smoking Women in Columbus Ohio," Proceedings of Indoor Air '93, Volume I, page 523.

MS. SHERMAN: Okay. And that's where I'm going to find not only nicotine but cotinine.

DR. OGDEN: That's correct.

MS. SHERMAN: Okay. Thank you.

DR. OGDEN: You're welcome.

MS. SHERMAN: In Appendix A of your docket submission there is a paper called, "Determination of RSP and VOC's in 104 New Jersey and Pennsylvania Homes and Workplaces." Again, by Heavner, et. al. Thirty-three VOC's were reported on and salivary cotinine, I think, as an indicator of smoking activity was measured.

Was nicotine measured in this study?

DR. OGDEN: That's the question I was answering a minute ago. No, it was not.

MS. SHERMAN: Okay. Why not?

DR. OGDEN: The technique used for personal monitoring in that study consisted of... Well, actually there were two sampling systems that each participant was given.

MS. SHERMAN: Excuse me?

DR. OGDEN: I'm sorry. There were... I misspoke. There were actually four sampling systems that each participant was given. Two to be worn at home and two to be worn at work.

Now, the two sampling systems that they wore at a single time consisted of a VOC measurement sampler, if you will, a pump, and a 10X based thermal desorbtion type of endpoint, but in essence to collect the VOC's. And then they were also given a pump that was connected to a filter and a clycline separator for collecting RSP.

The volatile organic chemical determination based on thermal desorbtion in our hands has never proved a reliable method for measuring nicotine. So while we did report 3-thenylpyridine, which we believe is a better vapor phase marker, the nicotine data... There are no nicotine data from that study.

We don't believe... Well, in our hands, we cannot determine nicotine based on thermal desorbtion from that type of a trap. Even though I know others in the literature have reported that, we have not been successful at that.

MS. SHERMAN: I think salivary cotinine was reported for homes but not for workplaces. Is that true?

DR. OGDEN: The salivary cotinine would be reported for the subject. It wouldn't be differentiated between home and work. Maybe we need to clarify that. I'm not sure I understand that question.

JUDGE VITTONE: Do you have follow-ups?

MS. SHERMAN: Oh. Well, I was going to go to Table 12 of that study next.

(Brief pause)

MS. SHERMAN: My question was... I thought I understood the salivary cotinine was reported for the homes but not for the workplaces.

DR. OGDEN: Oh. Okay.

MS. SHERMAN: And I thought you said that there was no differentiation and we were checking on that.

DR. OGDEN: Okay. Well, I thought you were asking a question as to whether cotinine was somehow sampled separately in the home and the workplace.

MS. SHERMAN: No, no.

DR. OGDEN: I realize that now.

Yes. Table 12 show the population broken down by whether there was a smoker in the home or not. And as stated in the title to Table 12, the reason for breaking it down that way is to enable calculation of the so-called background correction factor that is used as an adjustment in the risk assessment. For instance, as performed by the EPA.

Now, you're asking if we have a similar breakdown for smoking work and non-smoking work?

MS. SHERMAN: Well, if you notice the title to Table 12, it says, "Summary Statistics for the Background Correction Factor in Smoking Homes and Smoking Workplaces" and I just don't see anything for smoking workplaces, or at least I don't see anything that I understand to be smoking workplaces.

DR. OGDEN: Well. Oddly enough, it is correct as listed. This is the summary data.

Okay. Let me back up and describe what was done.

As I outline, we had basically four sampling systems. Two at home and two at work. With the background correction factor this is basically pooled to give a 24 hour exposure measurement. So what this has done is, the at-work sample is combined with the at-home sample to give a total estimate of exposure, if you will, for a 24 hour period. That's done for every subject in the study.

And now, for data analysis, they are broken apart as to whether or not they live with a smoker or not.

So the cotinine, of course, you can't split out that way, because there's not a cotinine sample at work and a cotinine sample...

MS. SHERMAN: Yes.

DR. OGDEN: ...at home. But for instance the next entry in the table, 3-ethenylpyridine, there's roughly an 8 hour sample at work and a 16 hour sample at home. So those two are weighted back together to, basically to calculate a 24 hour exposure. The concentration at work times the time at work, plus concentration at home times the time at home, divided by the total time, home plus work.

So this is actually a measure of daily exposure, if you will, which we had to, we had to pool that data from home and workplace monitoring to give a one day estimate of exposure. Then the data were separated by smoking home and non-smoking home to make this calculation.

MS. SHERMAN: Can we calculate it along the lines you said, or would you have to give it to us for us to see how you derived it?

DR. OGDEN: How the numbers in this table were derived?

MS. SHERMAN: Well, I guess we're interested in the workplace data separately.

DR. OGDEN: Well, could I direct you to Table 3 in that report and see if that's not what you're asking for?

MS. SHERMAN: Yes. Let me try to find it.

Is Table 3 entitled "Salivary Cotinine Results for All Participants by Cell Assignment"?

DR. OGDEN: Yes, it is.

MS. SHERMAN: Okay. Now, Table 3 is cotinine.

DR. OGDEN: That's what you're asking about. Right?

MS. SHERMAN: Yeah. Okay. So I can find the... Well, I still can't find the smoking workplaces separately. Correct? Because in all cases it's combined with another category.

DR. OGDEN: Right. The cotinine determination, though, will not allow us to... I mean, we can't differentiate it. What we could do would be to pool the first row in Table 3 with the third row in Table 3 and give you all smoking work without regard to whether there was a smoker in the home, and then pool rows 2 and 4 to give you non-smoking work.

But the confusion, as I'm hearing it, is hanging on the fact that in Table 12 all the analytes except cotinine -- these are air monitoring results -- they were all monitored separately at work and at home. And of course cotinine, it would make no sense to monitor in that fashion.

MS. SHERMAN: Because of the half-life, et cetera?

DR. OGDEN: Sure. Right. I mean, it's not a discrete sample for at-work versus at-home.

MS. SHERMAN: Well, what about the RSP levels? You didn't report the RSP levels for smoking workplaces. Is there any way we can derive that data?

(Brief pause)

DR. OGDEN: It's in Table 7.

MS. SHERMAN: Table 7?

DR. OGDEN: Yes.

(Brief pause)

MS. SHERMAN: Thank you for explaining that.

DR. OGDEN: You're welcome.

MS. SHERMAN: Sometimes it's a little confusing with different tables from the same study.

DR. OGDEN: That one took me a minute, too.

MS. SHERMAN: In the RJR comments on page 39, they mentioned that a majority of workplaces in the United States have formal working policies.

(Brief pause)

MS. SHERMAN: Let me rephrase. You mention that a majority of workplaces in the United States have formal smoking policies. What is the basis and the year that that statement was aimed at?

DR. COGGINS: I think Hoy will have to answer that. Mr. Bohanon?

MR. BOHANON: What is the date?

MS. SHERMAN: This is August 13, 1994. And it's in the second paragraph. You say, "OSHA must recognize that the majority of workplaces in the United States have formal smoking policies." Would you...

If you're having trouble finding it you can look at this.

MR. BOHANON: I believe the basis was the same basis as the statements on smoking policy in the proposed Rule.

MS. SHERMAN: Oh, okay. So you were merely referencing us. You didn't have any independent source. Is that correct?

MR. BOHANON: I can't really recall right now. I'm really looking in the Rule to see exactly what it said in the Rule. I believe there were a couple of references in the Rule that...

MS. SHERMAN: I'm asking if you had any independent information that you're basing your statement on page 39 of your August 13th submission on.

You don't have it attributed at all, Mr. Bohanon, okay?

MR. BOHANON: Right.

MS. SHERMAN: And if you're just referencing us, that's fine. If you have independent information I'd like to know what it is.

MR. BOHANON: It appeared we were in agreement. There are two or three studies on that. I believe you have all of them cited, although I'm not sure. I'll need to check on it.

MS. SHERMAN: Okay. Perhaps in a post-hearing submission.

Do you know the percentage of workplaces in the United States that have smoking lounges presently?

MR. BOHANON: The answer is no. I do not.

DR. COGGINS: Nor does anybody else on the panel. I don't...

MS. SHERMAN: Yes. It's mentioned that RJR's lost workplace incidence rate, I think in Business Paper No. 1 is 1.4, compared with the national average of 2.8. What types of injuries and illnesses are represented in this rate?

MR. BOHANON: The rate represents reported illnesses and injuries, and I'm sure that it's comparable to the National Safety Council numbers. As far as more specific questions, this was provided by our safety group. I can't answer specifically if you're asking about OSHA 200 logs or that sort of thing. And I can't answer that accurately.

MS. SHERMAN: Okay. Well. Perhaps I could ask you, are all of your employees included in the injury and illness lost workday rate, or are these just hourly employees?

MR. BOHANON: I don't know the answer to that. I can find out.

MS. SHERMAN: If you can find out...

MR. BOHANON: But they are comparable numbers to the other reported numbers.

MS. SHERMAN: Okay. I'd like to know if they are hourly or salaried or both.

MR. BOHANON: Okay.

MS. SHERMAN: I'd like to know the criteria. In other words, is it the OSHA 200, is it a workers' comp formula? What gets included in there? And does it include any fatalities. I guess that's the ultimate injury, but...

MR. BOHANON: Does it include... I would assume that it would. I will get that clarified on what, whether it's hourly or salaried workforce and what types?

MS. SHERMAN: Yes.

MR. BOHANON: Whether it's OSHA 200 as opposed to workers' comp.

MS. SHERMAN: It may be OSHA 200, it may be workers' comp. You mentioned the National Safety Council criteria. There may be other criteria out there also that this may be under.

MR. BOHANON: Okay. Yeah. I will try and clarify that. It does say the incidence rate for lost work day cases is specifically...

MS. SHERMAN: Right. But as I said, what injuries, what illnesses, are included in that?

MR. BOHANON: Okay.

MS. SHERMAN: Does RJR follow good recommended practices to protect workers from exposure to chemical and physical agents associated with renovation and remodeling activity?

MR. BOHANON: The answer to that would be yes, we do have some specific practices and I guess general guidelines that we follow on renovation and remodeling. They are really very dependent upon the location, the proximity of the people who are working in the site of the remodeling effort. And in cases of remodeling a significant portion of a floor, like, say, 5,000 square feet where we're moving walls and redoing electrical wiring, and perhaps even painting walls. In that case we do generally cordon off that area, separate the area with very temporary kind of barriers like black plastic, just to keep dust levels and other things out of the area.

In general, if there were other people working in there the painting would be done after hours in a large area like that. And small things like touch-up painting, that's just kind of done during the day. Whenever.

MS. SHERMAN: Do you have any formal guidelines or criteria that you could share with us for when you do things at night away from workers and when you do it during the day?

MR. BOHANON: We don't have any formal policies. You know, there are some guidelines and in fact when I was working in the building management, a guy who was an architect and myself wrote an article advising facility managers of what our practices were, and I'd be glad to provide that article where we described how we did that.

For instance, if we're working on a floor of a building that can be isolated, you know, then you do things like open the windows on that floor. Those are kind of good practices. So it's very dependent upon the specific environment and in different types of environments you really do different things.

MS. SHERMAN: Do you still have windows that open?

MR. BOHANON: Why, yes. Yes, we do. In our 1927 building. And in fact in our building that was built in '77 those are operable windows. Not so much...

MS. SHERMAN: I think that's wonderful.

MR. BOHANON: ...operable by the tenants, but they are openable for these kinds of cases.

MS. SHERMAN: I think that RJR estimated the total cost of compliance with the OSHA IAQ proposal would be almost $7 million with an annual cost thereafter of $1.5 million. I have a couple of questions concerning the first year estimated cost.

Is this cost with tobacco and related products, or is it for your food enterprises as well?

MR. BOHANON: Okay. I can answer that without finding it.

MS. SHERMAN: I think it's in Business Paper No. 6.

MR. BOHANON: It is for tobacco and related products. It applies to R.J. Reynolds Tobacco Company specifically.

MS. SHERMAN: Are all your indoor air quality cost estimates confined to your non-industrial workplaces?

MR. BOHANON: Yeah. I would like to look at the spreadsheet, but the answer is yes, the indoor air quality is applied to the non-industrial, non-factory workplaces.

MS. SHERMAN: Of the 9,000 employees working for RJR, how many are production workers?

MR. BOHANON: I don't know that number.

MS. SHERMAN: Could you submit it to us?

MR. BOHANON: How many of the 9,000 are production workers?

MR. GROSSMAN: We'll again take that under advisement.

MS. SHERMAN: Okay. We talked about it a little bit yesterday. We're sort of revisiting this.

MR. GROSSMAN: Right. Right.

MS. SHERMAN: Do you have any estimate as to the percentage of your workforce that's full-time?

MR. GROSSMAN: As to these kinds of statistics, of the Reynolds workforce, some of the material may be of a proprietary nature. If you let us know what kind of breakdown you'd like of the Reynolds employees we'll...

MS. SHERMAN: I'm telling your right now.

MR. GROSSMAN: We'll consider your request and we'll respond in the post-hearing submission.

MS. SHERMAN: Yes. Excuse me, Mr. Bohanon?

MR. BOHANON: So you want full-time...?

MS. SHERMAN: I'd like to know what percentage are full-time.

MR. BOHANON: Percentage that are full-time. Okay.

MS. SHERMAN: In some industries they use contract workers almost as an adjunct to the regular workforce. I don't know if this is true of Reynolds or not. Where a contract worker will report daily to the worksite, et cetera.

Do you have a component of these types of people?

MR. BOHANON: I can answer for when I was in charge of office buildings. Let me just limit it to my experience and not make some general answer for the whole company. I really don't know.

Yes, there were contractors that were present in the building for, or in the facilities, for extended periods of time doing various different things. And a case in point, the security force, as far as the people that check ID's at the door, were contracted workers.

The cleaning crew that came at night, that was a contracted workforce that came in every night. The workers who performed delivery service from the dock delivering boxes up to various people in the offices were a contracted workforce.

So, yes, we had both.

MS. SHERMAN: Now, the figure that was given of 9,000 persons employed by RJR. That excludes contract workers, I assume?

MR. BOHANON: Yes. Yes it would.

MS. SHERMAN: Does RJR's smoking policy differ by the type of facility that you operate? By that I mean a manufacturing facility versus an office facility versus the warehouse facility?

MR. BOHANON: There are two components to the smoking policy. One is, there are areas in various facilities where smoking is prohibited due to considerations regarding the product and considerations regarding safety. The overall general policy of accommodating employees, both smokers and non-smokers, should apply throughout the work, employee base, regardless of their specific building location.

MS. SHERMAN: In Business Paper No. 6, again, you had a table that was entitled "Proposed Rule on Indoor Air Quality - Financial Impact." And I believe that under compliance costs you show a program manager at an annual cost of $100,000.

Now, is the program manager that you're talking about in this estimate, is this a person who OSHA would say is the designated person within the meaning of their proposal, or is this some other type of person?

MR. BOHANON: I am sorry. I cannot find Business Paper 6, but I know I had it the other day.

MS. SHERMAN: May I make it available to you?

MR. BOHANON: Yes, please. If I could just refer to it, in just a second I believe I can answer your question.

(Judge Vittone hands document to Mr. Bohanon)

MR. BOHANON: Yes. Indeed, it's indicated. The OSHA contact/program manager. So this would really be the designated person for the company.

The costs, I believe, are generated on the basis of both salary and benefits, all that overhead as well as the additional overhead of office space and the other true costs of employing a person in that capacity.

MS. SHERMAN: So then the person's wage rate is not $100,000 per year.

MR. BOHANON: No. No, no.

MS. SHERMAN: Okay. So you say that this $100,000 is overhead?

MR. BOHANON: It includes the wages, benefits, you know, all the overhead that goes with it. Like the employer social security paid tax and the individual costs associated with having an individual doing that such as travel cost, office space, furniture, supplies, you know, a pro rated amount of computer cost, all the telephones, the whole...

You know, you can't just pay a person a salary. You have to provide them a place to work and a lot of other things.

MS. SHERMAN: So this is for one person, though. It's not some sort of a combination of persons.

MR. BOHANON: No. This would be... The assumption here in generating this table is that for our company with the number of buildings we have and the number of non-industrial spaces and the paperwork and detail that would be required to comply with the rule, that we would have in essence one person...

We couldn't look around and find one, so we said well, we'll just add one person to the payroll to do this.

MS. SHERMAN: Are you... I've heard figures that between fringe benefits and overhead, et cetera, that one adds about 30 percent to a wage rate. Can I assume that in this case, that the wage rate would be about $70,000, or am I way off.

MR. BOHANON: Well...

MR. GROSSMAN: Don't guess. If you don't know, don't guess.

MR. BOHANON: No. The other costs. You've got to first subtract out the other costs. The phones, the office, all those other sorts of cost that go with it. The computer, the communications costs. And then I would venture that our overhead is a little higher than 30 percent, so that would underestimate what our rate is. I'm not sure exactly what it is, but I believe it's...

MS. SHERMAN: Well, I notice that you have a category here for clerical and I'd think that you'd have a category for computers. So, does that get subtracted out, or don't I understand. You also have a centralized phone system costed out here.

MR. BOHANON: Oh, okay. The centralized phone line has to do with the concept of being able to record all the complaints. And there's some additional costs with having a centralized answering machine system that's going to be separate. That was the concept there, and that was a, just throw in a $1,000 for that because it's either a one or a zero in the way this is put together.

The new computer system and maintenance compliance had to do... See, this both is software and data input. It doesn't really contain the types of hardware costs of just word processing and the other things that I was talking about previously.

Again, because of the amount of data that it appeared would be required to be generated to show full compliance with the Rule as written, this was our estimate of how to best manage that, and that was to establish a new computer system similar, perhaps, to what we do to track MSDS sheets. Which is a whole system to try and track all that information.

MS. SHERMAN: Okay. Well, to clarify this number. Could you supply the base wage rate for this person that we have in the table.

MR. GROSSMAN: I'm concerned about some competitive considerations as you get into these personnel matters. We'll look into these numbers, see the extent to which they're competitive, and to the extent that they are no we'll provide them to you.

MS. SHERMAN: The extent that you're not competitive, you'll...

MR. GROSSMAN: To the extent of the numbers do not have competitive considerations. That is, to the extent that our competitors could not glean information from these numbers that would be helpful to them in competition, we'll provide you with these employment statistics.

MS. SHERMAN: What are you assuming the qualifications of the person would be. This OSHA contact/program manager?

MR. BOHANON: I think the assumption is that this is a person that, a trained professional, maybe or maybe not a certified industrial hygienist, maybe almost to that level, as far as being able to show good judgement and be competent to assure that all the records are properly...

MS. SHERMAN: Might it be an engineer?

MR. BOHANON: Possibly.

MS. SHERMAN: I think you also included an estimate of $50,000 per year for clerical support. Now, again, this is not the wage rate. It's the total package?

MR. BOHANON: Yes.

MS. SHERMAN: And are you assuming that this would be a full-time or a part-time person?

MR. BOHANON: I believe the basis of this was full-time.

MS. SHERMAN: And any particular qualification?

MR. BOHANON: I haven't dealt with that for a while. Probably word processing skills. Good phone answering skills. Ability to deal with these computer systems and databases and manage those, manage files, keep records, compile reports.

MS. SHERMAN: Well, assuming that it wouldn't compromise RJR to its competitors, I would appreciate it if you could supply the wage rate for this person also.

I'd also like to know the wage rates that you are assuming for the facility, staff, data gathering, the consulting engineer, legal interpretation and the technologist/engineer system documentation set up. Are all of these people considered to be full-time under your scenario, or are these just portions of their time designated to this project.

MR. BOHANON: Those people would be... I can go through those one at a time. The facility staff data gathering is that this is overtime at each site, envision that there are certain things that only the facility staff are going to know, or it's most economical to get them to try and compile that information.

As to the consulting engineer, it was an estimate based on hiring an outside consultant. And again, all these costs are in year one. I'm sorry if I took your table. But these are all in Year 1, so they're one-time costs, not recurring costs.

Consulting engineer. This would be to develop a clean schematic of the operating systems in all the buildings as prescribed by the proposed Rule.

Legal interpretation would be just assistance in figuring out whether the program we were putting together was going to be in compliance with proposed Rule and interpretation. And, again, that's a one-time cost and a number that's put in just to cover that potential cost.

The technologist/engineer system documentation and Set Up, again, is just a matter of organizing all that information, specifically the schematics and the operating plans and the maintenance schedules so that it would be accessible on an ongoing basis for the contract and program manager that may or may not be familiar, but certainly would be familiar after he got in the job, with all those details.

MS. SHERMAN: Now, is this for each facility that you operate? Or is this person thought, or are you expecting them to go from facility to facility and do this for each one?

MR. BOHANON: This person would be in charge of all facilities. This would be a one-stop shopping site for OSHA to come visit. If you want to visit on our IAQ program we'd have one person. The way we envisioned this is we'd have one person that would be accountable for the whole thing and could answer all questions.

MS. SHERMAN: Were there any other significant assumptions that you made in terms of these labor categories, et cetera?

MR. BOHANON: I can't think of anything that would significantly affect this, no. I think we've covered most of it.

MS. SHERMAN: Under the implementation section you included a cost item for a new computer system, and included hardware and software. What were your assumptions for this estimate?

MR. BOHANON: The two items are software and data input. It's just development of a database and the inputting to the database whatever relevant factors need to be input.

Even though information is available and it's out in somebody's drawer somewhere, as you've heard in the proceedings and the testimony, it's not always easy to get to, nor is it easy to retrieve until somebody finds out that somebody else happens to have that information. So this is a one shot effort at trying to get the whole program organized one time, indexed, tabulated, so that the ongoing maintenance activity, we would be in full compliance at day one and the ongoing program would just be administration and maintenance of the program. We wouldn't be playing catch-up to get ahead and get established and be in compliance.

MS. SHERMAN: Wouldn't that be an ongoing cost if you have to keep on inputting data into the system?

MR. BOHANON: At the point you get over the hump and get the thing started, then the contract manager and the clerical person can do that. But trying to compile all that the first time and do all that work, we just viewed that that could be an additional effort.

MS. SHERMAN: Under the implementation, you costed $250,000 for HVAC system operation during cleaning and off hours. What were your assumptions for developing this estimate?

MR. BOHANON: The assumptions basically had to do with the utility costs which I don't have the backup spreadsheet on where we came up with that. But the assumptions were really the utility cost and running the system during the full time that the cleaning crew is present in all of the buildings.

Now our current practice is to run it during part of the time, but because of the size of the buildings and the small numbers of people that are in the buildings, and in fact what we found out when we tested the buildings, the infiltration rate of the air that just leaks in through the windows, whether the system is running or not, we don't make it a practice to run the systems the full time people are in there. In fact it's kind of a seasonal thing. When it's hot in the summer, we run it because the building heats up pretty quickly. In mild conditions, we feel comfortable in turning the system off earlier. In the winter we have a reset program that will restart the system to keep the heat level up in the building so the building doesn't get too cold.

So our current practice is not to fully run all systems during these off hours type activity, specifically like cleaning activities or even there are some other off hour construction type activities that do tend to go on in buildings from time to time.

MS. SHERMAN: But your main underlying assumption is cleaning activities in this estimate here?

MR. BOHANON: I would say the bulk of it has to do with extending the hours of operation of the full system to the full hours of cleaning.

MS. SHERMAN: Are you assuming a 24 hour operation in this number?

MR. BOHANON: I'm sorry, there's two things. You mean a 24 hour operation within the building, or... We have some buildings...

MS. SHERMAN: Running the system for 24 hours.

MR. BOHANON: I don't believe so. I think we're just incrementally doing it during the cleaning hours. I need to point out that we do have some operations that do go on on a 24 hour basis. We do provide the systems are on when people are in there on full work shifts. Those run 24 hours a day. Some of them are 24 hours a day, seven days a week, so no, none of that is confounded in here. This is just an incremental cost to providing additional ventilation in all of our buildings during these additional cleaning hours as projected throughout a year.

MS. SHERMAN: Could you submit to us how you calculated this cost?

MR. BOHANON: Okay, we'll give it a try.

MS. SHERMAN: Does RJR keep relative humidity at or below 60 percent in buildings with HVAC systems?

MR. BOHANON: Let me make a note of the last thing you asked for which is the basis of the energy calculations.

MS. SHERMAN: Yes.

(Pause)

MR. BOHANON: Now I would like to answer the question about the 60 percent relative humidity.

MS. SHERMAN: Yes.

MR. BOHANON: I read that in the proposed rule, and I'm just not sure I really understand what that means. Knowing what I do know about relative humidity, there are... you're going to get different readings in different places depending upon surface temperatures, certainly in the supply air ducts just downstream from the cooling coils, it's above 60 percent in the air conditioned environment. If you're talking about go out in the middle of the room and take a reading, then I can probably say that yeah, most of the time it's well below 60 percent. But if you're talking about surfaces, and I guess that's really the thing that one should be concerned about, there are a lot of factors involved there. The real issue is one of keeping moisture off of surfaces, and that has to do then with insulation, it has to do with outside temperatures, surface temperatures, if you're ducts aren't well lined you can have cold ducts, and the ducts will sweat, and you'll have all kinds of problems there.

I understand the intent, but I really have concern about just a blanket 60 percent statement like that because I'm sure that I can go find some place that's going to be out of compliance with that sort of a directive, that really shouldn't be of concern.

JUDGE VITTONE: It's a little after six right now. Would this be okay? Do you have one thing to finish up?

MS. SHERMAN: Ms. El-MeKawi would like me to ask one more question. May I?

JUDGE VITTONE: All right. One more.

MS. SHERMAN: Your assumptions on smoking lounges, I think that you gave a cost estimate of $4 million for smoking lounges? Is that correct?

MR. BOHANON: Yes. Yes, we did.

MS. SHERMAN: Okay. I would like to know the number of rooms and the size and the number of smokers served per room. I'm asking for your assumptions. And the cost of the space and the cost of the ventilation changes or the new construction. Also, does this estimate include furnishings?

MR. BOHANON: Okay. I can't answer all of that right here. I can try and provide you with some more information. We made assumptions based on a couple of things. One, we have employees spread out. We have concentrated areas of employees like in office buildings, other places we have employees that are spread throughout buildings so proximity was one of the concerns of how to come up with the number of smoking lounges, proximity to employees by their geographic location either within buildings or within facilities.

I don't believe that we added any costs for furnishings in the smoking lounges, which was one of your other questions. As far as the HVAC basis, I'll need to go back and look at the backup data that we used to generate this but there are differing costs depending upon the different kinds of buildings, and I think we did take that into account.

MS. SHERMAN: So that you might have taken into account high rises versus non-high rises?

MR. BOHANON: We did. Yes.

MS. SHERMAN: Now, I believe yesterday we had a discussion and I think you said you had some 370 buildings that you owned.

MR. BOHANON: Yes. I believe that was the number we had.

MS. SHERMAN: This $4 million cost figure, does this involve just those 370-odd buildings you own or does it involve all the buildings where you have facilities and where you might be providing smoking lounges for your employees?

MR. BOHANON: No, it doesn't. I think it just is the 370. We had narrowed our focus to our little world right there in North Carolina and hadn't really thought about the impact or the cost on all our other facilities.

MS. SHERMAN: Okay. So in your post-hearing submission, I think the record will reflect that we would like the number of rooms and the size, et cetera. And did you consider any recurring costs in the smoking lounge figure such as maintenance or cleaning or energy costs?

MR. BOHANON: No, I don't see any recurring costs on our spreadsheet. We only have, what, six categories of recurring costs and the items you mentioned would not fall into any of those.

MR. GROSSMAN: Ms. Sherman, when you refer to recurring costs, you're also referring to the fair rental value of the space, correct? That is if there is --

MS. SHERMAN: Yes.

MR. GROSSMAN: All right. If there is any post-hearing submission you would like to know that as well.

MS. SHERMAN: Yes.

MR. BOHANON: We did not include any in our cost estimate.

MS. SHERMAN: Thank you.

I think the judge is getting out the hook.

JUDGE VITTONE: Okay.

JUDGE VITTONE: That completes -- well, that doesn't complete anything, does it?

(Laughter)

MS. SHERMAN: If that would be useful to you, you can keep that overnight.

MR. BOHANON: I have one somewhere. It may be in my bag or somewhere. It just wasn't where it was supposed to.

MS. SHERMAN: Okay. We'll take it back, then.

MR. BOHANON: Yes. Please take it back. And if I can't find it, I'll check with you tomorrow.

MS. SHERMAN: Okay.

JUDGE VITTONE: Let me try to get a little idea before we run out of here what tomorrow may be like, then.

If we start at 9:00 tomorrow morning, do you have any idea?

MS. SHERMAN: Well, I have spent a lot of time paring down the questions for this panel and we have gotten rid of a lot but we still have quite a few. I'd say we have a good few hours of questions.

JUDGE VITTONE: Two hours, maybe a little bit more, a little less?

MS. SHERMAN: I'd say we're much more in the ballpark of three hours. Maybe. At least three hours. And that's assuming we can proceed apace.

JUDGE VITTONE: Okay. So if we start at 9:00 tomorrow, by lunchtime you should be probably completed.

MS. SHERMAN: Optimistically speaking.

JUDGE VITTONE: I'm talking to Ms. Sherman.

Ms. Sherman, so by 12 or so we ought to be through. I mean, quite truthfully, I've just been doing some rough calculations -- not rough, exact calculations. Counting yesterday and today, and yesterday that was just a short time but we've gone a little over seven hours so far, total time.

MS. SHERMAN: Of questions?

JUDGE VITTONE: Of questions. I know it seems longer, it's kind of like people seeing an accident and everybody having a different idea of what happened. So I'm just trying to get an idea because there are other people.

MS. SHERMAN: I understand. And I don't want to hog other people's chance.

JUDGE VITTONE: Well, I know that. And also if we can give everybody an idea of how long we're going to be tomorrow.

The only person -- well, not the only person but Mr. Dinegar indicated to me, and he has not been back since yesterday but he indicated to me that he may have 10, maybe 15 minutes worth of questions tomorrow. He's with BOMA.

Let me ask who else has questions tomorrow so I can get an idea here.

Mr. Myers, Mr. McNeely, can you give me an idea of how long you might be?

MR. MYERS: It's ballpark, outside, three hours.

MR. GROSSMAN: Your Honor, we've never --

JUDGE VITTONE: Wait a minute.

MR. MYERS: Total time.

JUDGE VITTONE: Wait a minute. Total?

MR. MYERS: I'm talking for both of us.

JUDGE VITTONE: Both of you. You two gentlemen will be doing the examination for --

MR. MYERS: Actually, not. It will be me and Mr. Herman.

JUDGE VITTONE: Mr. who? Herman?

MR. MYERS: Mr. Herman.

JUDGE VITTONE: Okay. But somewhere between two to three hours, you're estimating at this time.

MR. MYERS: And we will try to keep it as pared down as possible.

JUDGE VITTONE: All right.

Is there anyone else so that I can figure out if there's anybody else here?

(No audible response)

JUDGE VITTONE: Okay.

Did you want to say something? I'm sorry.

So even if Dr. Hedge is here tomorrow, okay. So we may go a little late with him tomorrow but basically we should be through with this panel certainly by four or five o'clock tomorrow. Somewhere in that range. All right. So that we all know.

MR. MYERS: Your Honor, I just want to make certain, Ms. Sherman's questions are obviously important and shouldn't be cut off, so we're prepared to go, to start however late we need to start, after Ms. Sherman finishes, whether it's noon or two or three. We can go as late as necessary. I don't know if everybody else is willing to do that. We won't expand beyond the time I've mentioned to you but we don't mind starting mid-afternoon if that's what's necessary for OSHA to finish.

JUDGE VITTONE: Okay. I'm going to ask, though, that everybody pare their questions down to the important things tomorrow. I know that's in the eye of the beholder but if we start at nine and we go the whole day, I cannot understand why we would need to go late with this panel if we concentrate and try to pare it down to the important things. Now, maybe we'll order pizza and have it brought in and we'll keep moving.

Okay. I'm sorry, Ms. Ward?

MS. WARD: I just stood up so I could see, Your Honor.

JUDGE VITTONE: Good night.

Nine o'clock tomorrow.

This document's URL is: http://www.tobacco.org/Documents/osha/950118osha.html


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