OSHA: Proposed Standard For Indoor Air Quality: ETS Hearings, January 5, 1995

OSHA: Proposed Standard For Indoor Air Quality: ETS Hearings, January 5, 1995


UNITED STATES DEPARTMENT OF LABOR

OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION

PUBLIC HEARING
PROPOSED STANDARD FOR INDOOR AIR QUALITY

Thursday, January 5, 1995

Department of Labor

Washington, D.C.

The above-entitled matter came on for hearing, pursuant to notice, at 8:30 a.m.

BEFORE: HONORABLE JOHN VITTONE

Administrative Law Judge

AGENDA

PAGE

Oak Ridge National Laboratory
Roger A. Jenkins 9689

Questions:

Dr. Samet 9733
Ms. Sherman 9762
Dr. Hammond 9844
Mr. Hopper 9867
Mr. Myers 9904
Mr. Rupp 9935
Ms. Sherman 9957

Dr. James Bridges 9959

Questions:

Ms. Sherman 9983
Mr. Myers 10022
Mr. Weinberg 10039
Mr. O'Neill 10041

EXHIBITS

EXHIBIT NO. IDENTIFIED RECEIVED

195 9761 9761

196 9761 9761

197 9762 9762

198 9762 9762

199 9983 9983

P R O C E E D I N G S
8:42 a.m.

JUDGE VITTONE: We resume our hearings into the proposed rule on indoor air quality.

A couple of minor housekeeping matters before we begin. Mr. Paul Kamenar of the Washington Legal Foundation was scheduled to testify. He was here on December 16th and we asked him to come back today. I had a conversation with him yesterday. He has requested that his testimony that he had previously submitted be received into the record in this proceeding and he said that he would be most willing to respond to any questions that people wanted to submit to him in writing and submit his answers for the record in writing. As7 I understand it yesterday, there were probably very few people, if any, who had any real questions for Mr. Kamenar. I think basically his statement is a policy as opposed to a scientific argument with respect to the rule. So if there is no objection, I will permit Mr. Kamenar, his statement will be received into the record of the proceeding, it already is in the record of the proceeding but if any of the parties have any questions they should share them in writing, submit them to Mr. Kamenar by the close of what I call the first phase of the proceeding where we have the scheduled witnesses as opposed to the people who will be coming at a later date, after January 20th, on an unscheduled basis. So if anybody have any questions for Mr. Kamenar they should prepare those questions by January 20th or the day whenever we close this first phase of the proceeding.

A change also in tomorrow's schedule. Mr. Collett, I received a fax yesterday from Mr. Sterling of Thomas D. Sterling and Associates stating that Mr. Collett, because of an illness in his family, would not be able to testify. And I will just briefly read the letter. It says, "Due to the same family matters that have restricted his travel, my associate, Chris Collett has made the difficult decision to take an extended leave of absence. He will not be available to testify as scheduled January 6th. Because it is essential that our testimony material be integrated, I, too, with withdraw from testifying. I sincerely apologize for any inconvenience our change of plans may cause the hearing proceedings." They were supposed to testify tomorrow so they will not be testifying.

Our first witness this morning is Mr. Jenkins.

First off, let me ask, is there anything else? Any preliminary matters anybody needs to raise?

(No audible response)

JUDGE VITTONE: Mr. Jenkins, would you state your full name, please, and the organization that you're affiliated with, please?

DR. JENKINS: I'm Roger Alan Jenkins. My affiliation is Oak Ridge National Laboratory.

JUDGE VITTONE: I understand you have a presentation with a number of slides. You're going to use that machine there.

DR. JENKINS: That's correct.

JUDGE VITTONE: Okay. Let me get out of your way and you can proceed. You're going to be approximately one hour?

DR. JENKINS: About an hour and five minutes or so, something like that. Unless I get really going fast and then we'll get it done faster.

Is there any water available some place?

Okay. Why don't the slide projector and then I can get going?

Good morning. As I said, my name is Roger Jenkins. I hold a Ph.D. from the University of Wisconsin-Madison in analytical chemistry. I am employed Oak Ridge National Laboratory.

ORNL is a multi-program basic and applied research facility in eastern Tennessee. It's staffed by more than 4500 scientists and supporting staff. The facility itself is owned by the U.S. Department of Energy. My current position is that of Group Leader for Environmental Monitoring in the Chemical and Analytical Sciences Division of ORNL.

In the more than 19 years since I've earned my doctorate, I've been principal investigator for a number of projects for the Departments of Energy, Defense, National Institutes of Health and private and educational concerns.

My professional interests include the chemical characterization of airborne mixtures. That includes process effluents, fugitive emissions, military obscurance and tobacco smoke. I've worked in the general area of characterization of tobacco smoke and methodology for the definition of animal inhalation exposures and the definition of them since 1976.

The studies regarding tobacco smoke with which I've been involved have been supported by the Center for Indoor Air Research, the Council for Tobacco Research, the University of California at Davis, the National Institute on Drug Abuse and the National Cancer Institute.

I am the co-author of a monograph entitled "The Chemistry of Environmental Tobacco Smoke, Composition and Measurement" and I have published both in the general area of symposium proceedings and peer reviewed literature concerning ETS levels in public places.

I am not here today as an advocate for or against this rulemaking but as a scientist that's been conducting a study and gathering some information I think is going to be useful to OSHA.

Along with Dr. Michael R. Guerin I am the co-principal investigator for what is to my knowledge the largest study ever conducted in the United States of personal exposure to environmental tobacco smoke. On the 16th of March last year, I privately briefed OSHA and EPA representatives on the initial status of this study and since that time, the field and laboratory analyses of the samples have been completed. The data interpretation is still ongoing but I think that some of the initial conclusions ought be interesting and sort of bear on some of the findings and some of the thinking that's going into this proposed rulemaking.

Now, it's important to bear in mind as I go through this discussion that much of the data has been assembled over the last six weeks or so because we didn't get all of the laboratory data until relatively recently, about early November, so you may see some minor modifications when you see the final published reports or peer reviewed literature on these things and also because I did these slides myself, there's a couple of errors through them and I'll try to point those out as we go along.

This is slide number two for those of you that are following along. There were copies anyway of the slides outside and also my testimony.

This study has been sponsored by the Center for Indoor Air Research and is a joint effort of the Chemical and Analytical Sciences Division and the Computing Application Division of Oakridge National Laboratory.

Now, what we were trying to do in this study was to determine personal exposure to ETS. We recruited subjects from 16 cities around the United States, about 100 subjects in each of those 16 cities. We asked the participants to wear sampling pumps at their workplace and then at their away from work location and that includes anything that they did away from work, sleeping, eating, dining, shopping, whatever.

We collected both particle and gas phase constituents and we assessed the smoking status through the use of salivary cotinine. We began the field operations in the city of Knoxville, Tennessee in May of 1993 and we finished up 15 cities later in New Orleans, Louisiana in the middle of June of this past year.

The cities were chosen on the basis of a number of factors, the time of year, the likely ambient weather in the location. By the way, in this presentation, there's no difference between the red stars and the green stars, those are just the cities. You can see that they're scattered throughout the four major census regions of the country. We also picked them on the basis of logistics and marketing research support in the particular area where we were doing the study.

We determined a number of constituents. The particle phase ETS markers were collected on the membrane filter at flow rates of approximately 1.7 liters a minute and you can see a listing of the particle phase constituents.

The RSP is a 3.5 micron cutoff. The gas phase constituents were 3-ethenyl pyridine, myosmine and nicotine and we also measured salivary cotinine. The RSP was determined gravimetrically. UVPM and FPM were determined by high performance liquid chromatography. The gas phase constituents were analyzed by gas liquid chromatography and we used radio immune assay to do the analysis of the salivary cotinine.

Now, in any kind of a study design, you need to decide who you're going to include the study and who you're going to exclude in the study. How we did the recruiting and the inclusion of the individuals is that a marketing research firm was contracted in each of the 16 cities to randomly recruit the subjects. The recruiting began a minimum of three weeks before the testing was to take place. Telephone numbers in each metropolitan area were dialed at random.

The factors that we used for the inclusion or exclusion from the study was that the individuals had to be at least 18 years of age, no tobacco use within the last six months and this included prescription use of a nicotine patch or nicotine gum. They had to work at least 35 hours a week outside the home on a regular shift and we requested regular shifts just because of the logistics of conducting this. The pumps had to go out and then come back in on some kind of a schedule that we could orchestrate all this.

We didn't want people, no offense to the attorneys in the group, but we didn't want any attorneys in there because attorneys, my experience is that all are advocates in one form or another. We wanted to eliminate certain people in certain branches of government that might have a stake in the outcome of the study, such as EPA or OSHA people. And we also didn't want individuals that were in smoking-related advocacy groups whether it's the pro-tobacco people or the anti-tobacco people. So there were a number of questions in the screening questionnaire.

The screening questionnaire interview, if it went all the way to completion on the telephone, took about 20 minutes. Each person was either terminated or they were invited to participate based on their responses to the screening questionnaire.

Let me see if there's anything else I want to say about that.

We told the subjects that this was a study related to indoor air quality but no specific reference was made to environmental tobacco smoke. As soon as the survey forms were completed for individuals, they were rechecked to make sure that there in fact weren't any mistakes according to the categorization.

Now, I want to sort of take you through in a couple of slides what happens to the participants so that you get a better feel for what they're doing, what's going on and that sort of thing.

This is slide seven, if you're following along.

Okay. The first thing that happens is the person is contacted in a random telephone survey. They pass the screening questionnaire. Then on the evening of the first day, they arrive at the test coordination site and they are re-screened to make sure that they are giving us the same kind of answers that they did over the telephone. We eliminated several people from the study based on changes in their answers when they got there.

When they get to the coordination site and they all get together, they watch an instructional video that takes about 22 or 23 minutes. They answer sort of what we call a first visit survey concerning their lifestyle and other kind of habits and whatever that they have. They receive their sampling pump systems, they're trained on how to actually turn the sampling pump on and off and they provide a saliva sample.

They go home and on the morning of day two when they arrive at work they turn on their workplace sampling pump that they're wearing around them. They fill out a workplace diary on an hourly basis. At the end of their workday -- they're asked to remain at their desk during the lunch hour if possible.

At the end of the workday, they turn off their workplace sampling pump, they complete this workplace diary. They sort of fill everything out and finish the work part of the survey. Then they put on their away from work sampling pump which is outfitted with a larger battery pack.

They go home via whatever errands they've got to run wearing this sampling pump. And they continue to fill out an away-from-work diary on an hourly basis.

At bedtime, they take off the sampling pump and they put it alongside their bed and the pump continues to sample while they are sleeping. We also asked that they remove the pump while they take a shower or a bath. And also tell us what times that they may have removed the pump for those kinds of activities or other forms of personal activities which they may not want to describe in detail. However, some of them did describe in detail exactly what they were doing when they took the pump off.

Okay. On the morning of day three, after they get to work, they turn off the away-from-work pump, they complete their diary and then after work on day three they go back to the coordination center. They take all the test materials back, they complete another survey, they provide another saliva sample and receive their gratuity.

Clearly, for 1600 subjects this is a huge study and these are the people and the major role players in the study and what their responsibilities are.

This is slide nine, institutional responsibilities. The three organizations that were directly involved in the study were my organization, Oak Ridge National Laboratory. Our responsibility was overall study design and oversight. We provided independent surveillance of the field and laboratory analyses. We also assisted with some of the field operations. It was our responsibility to do all the data integration, interpretation and reporting and quality assurance.

Bellomy Research was the primary marketing research firm. They provided initial questionnaire design to us. They were also responsible through subcontractors with field recruitment of the subjects. They assisted with the field operations and they were responsible for coding all the subject demographic data.

R.J. Reynolds Tobacco Company essentially handled the field sampling operations and logistics, the sample management, and they performed all the laboratory analyses for both the ETS components and salivary cotinine.

Now, it's important to remember that while RJR and Bellomy research maintained the primary responsibility for the initial development of the recruiting and training questionnaires, ORNL had final approval on all of the materials, we reviewed the scripts for the training videos and stuff like that and we were responsible for the revisions in the questionnaires to meet some of our additional needs and concerns.

In order to assure that the data was reported to us objectively, neither Bellomy Research nor R.J. Reynolds had access to each other's data during the course of the study. They all had to feed the data directly to us and it wasn't fed back and forth. So essentially RJR did not know whether the subjects for the samples which they were analyzing in fact were from smoking homes, non-smoking homes or what have you.

Now, because of the sensitive nature of the data and we understood that a lot of critics may question the appropriateness of tobacco company scientists performing laboratory analyses of the collected samples, a number of controls and surveillance practices were instituted to ensure the quality and the integrity of the data. And I'm not going to go through all of these in detail but essentially we provided a number of ETS marker component solutions to them under terms of blind analyses, that they had to essentially get the right answers on those things. We provided them with spiked sampling traps. We also sent them XAD-4 traps which had been exposed to known concentration atmospheres of environmental tobacco smoke that were generated in our chambers back at Oak Ridge and we also sent them smoker/non-smoker saliva samples from ORNL staff members just to make sure that they were in fact getting the right kinds of numbers for those things.

We also provided some surveillance of the field operations. As I said, there was an ORNL staff member at each one of the cities in which the field operations were conducted. As I said, both Bellomy and R.J. Reynolds had to provide ORNL with certain key pieces of what we call raw data before they had had a chance to get out in the field and if there was any kind of monkeyshines going on with the data. Not that we didn't trust them but we had to act as thought we didn't trust them. And this included Xerox copies of the participant diaries and also electronic copies of all the pump flow data and what have you. And this, of course, was all checked after we received it to make sure that that was being handled accurately and appropriately.

We also selected at random some of the individual surveys and manually checked the data that had been coded by Bellomy to make sure that the coding was accurate.

Now, I don't have hard copies of the next slides but I just wanted to show you a few pictures just to kind of give you a feel for things. This is some of the field staff recalibrating the pumps after they came back from the individual operations at the participants' home or workplace or what have. The samples were removed, the pumps are recalibrated and then they're set back out again. These are the blue sports bags that contain both the away-from-work sampling pump and the workplace sampling pump and all the materials and what have you. That's being lined up.

Here's a photograph of -- this is actually what we referred to as the home sampling pump. You can't see it too well but there's an extra battery pack right here and this affords sampling for 18 hours. Here's the actual sampler itself. The filter sample, basically the device to use to cut off the particles at three and a half micros and here's the XAD-4 tube here which collected the gas phase components.

These are individuals filling out one of the many questionnaires. Somebody commented to me that they thought for all this work $100 wasn't enough of a gratuity to do all this because it involved two trips to the sampling site and all of this stuff.

And here's the individual couvets. They contain cotton dental dam that was used to take the saliva samples.

And this slide is the individuals providing us a saliva sample. And I think that was taken in Fresno, California.

This is a participant being shown how to turn the sampling system on and off.

Okay. We have a wealth of demographic information about the participants in this study and the data just includes, just to kind of give you a feel for some of the things that we have, data on age, sex, household income, smoking history, the lifestyles of these individuals, what their dietary habits are, what kinds of pets, heating and cooling systems. Some of the questions in the study were clearly red herring questions to make sure that they didn't catch onto the idea of the fact that this was an environmental tobacco smoke study.

We have a great deal of information on self-reported exposure information, that is, the number of cigarettes, cigars, pipes, whether or not they burn incense in the home, the kind of food cooking smells that they have, whether not there are woodburning fireplaces. And also we have data from the National Weather Service on essentially hour-by-hour climate information while the field operations were being conducted in the cities so we can tell whether or not there were any effects of reduced ventilation in the various private homes during particularly hot or cold weather.

Okay. Now, given this, what I want to go through now is just sort of what are the demographics of our subject data base.

This first slide compares the male/female ratio with that of the U.S. population. This data was taken from the 1993 statistical abstract. That information is from the 1990 census. What all the demographic information that you are about to see has all be age adjusted so those individuals under 18 years of age have been excluded from the demographic comparisons.

One thing you can see right away is that we have more females in our study than the U.S. population as a whole. I'm told by my marketing research colleagues that this is not surprising. First, in general, women are more likely to answer the telephone in homes than are men and also in this kind of a study that requires this much volunteerism, women are more likely to participate in a study that requires this much effort.

Now, it's also important to realize this, that all the comparisons that I'm going to show you now are with the U.S. population as a whole. Remember that in fact what we are looking for, we've asked for non-smokers in our study and we have not yet made the correction for the non-smoking fraction of the United States population over the age of 18. And we know that there are some important demographic differences between smokers and non-smokers and so you want to just keep that in mind when we're making these comparisons.

The next slide, slide 21, is the educational distribution in our study or the age distribution, rather. Because of the requirement that individuals work outside the home, many individuals that are older than 60 years were excluded from the study and so that's why you see some of these differences here, at least that's what I speculated as to why that's the case.

This is the educational level of individuals in our study versus the U.S. population as a whole. Again, this hasn't been corrected for just the non-smoker population in the United States.

Differences in household income, this doesn't show up too well in this brightened room here but essentially we have a slightly higher household income than what the U.S. average is. The U.S. median is about $30,000 a year and in our study the median income was about $40,000 a year and this is partially reflected in this higher educational distribution.

This is the racial distribution of the subjects in our study relative to the U.S. population as a whole. Slightly fewer blacks, slightly more whites, otherwise, relatively close.

This is the breakdown of occupational categories. This is slide 25. And you can see that we have a preponderance of sort of what we might refer to as white collar occupations, technical, sales, administrative, management, professionals and those sorts of things.

We don't have as many service occupations represented in this study and those kinds of individuals that work in factories and that could very well be because the latter kinds of individuals decided not to participate because of safety reasons. That is, they couldn't wear this kind of a sampling pump around their job that wasn't provided to them by their own industrial hygiene operation. We ran into that. Some people had volunteered to participate in the study and then they came to the study site telling us that basically they're sorry but their boss wouldn't let them participate because they would have to wear the sampling pump during the day.

And also the requirement that the subjects hold at least a 35-hour-a-week job outside the home and work on a regular shift also tends to produce a greater fraction of the white collar subjects and that probably also contributes to this general boost in overall income of the participants in our study.

Now, as I indicated previously, we did an awful lot of work associated with field and laboratory surveillance to ensure that the data was being provided to us in an accurate and appropriate manner.

I could show you charts of this but you're going to see enough charts already and I don't want to bore you with long numbers of 92 percent versus 93 percent and things like that. But essentially what the data shows from the quality assurance and surveillance activities, in general, the laboratories were doing a pretty darn accurate job of conducting the analyses.

But I wanted to share with you some of the results of one of the tests and tell you this because I've talked to other people and they seem to be interested in the idea and this is what we refer to as the surreptitious exchange or surreptitious switch.

What we did was as follows: In nine of the 16 cities in the study, an ORNL staff member on site would essentially abscond with one of the blue sports bags during the operations that evening. What they would do -- now, you understand that the field team that were comprised of R.J. Reynolds staff knew that this was going on but they didn't know which one of the bags were going to be essentially stolen that night and there was about 25 or 30 out at any one evening.

Now, when the ORNL staff member got back to his or her hotel room, what they would do is they would turn on the sampling pumps and let them run for an appropriate length of time and then after the sampling pumps had run, say, the workplace sampling pump running eight or nine hours, something like that, and the away-from-work running 16 or 17 hours, then what we would do is turn the pumps off and switch the traps that were in the units with traps that we had loaded either with environmental tobacco smoke atmospheres or known quantities of tobacco smoke markers in the traps.

R.J. Reynolds had provided us with copies essentially of the same kinds of labels that they were using in their study for the individual traps so we relabeled our own traps with their -- and they're the identical traps, they can't tell the difference between one trap and another, and then we put them back into the sample stream a couple of nights later as these individual pumps were coming back in.

So R.J. Reynolds thought in fact that these were real people in the study, in fact, they were just dummy samples that we had put into the sample stream. And here is the data from just those surreptitious switches.

These are the ETS loaded samples. You can see the mean recovery was about 95 percent or so and here for about 89 percent on the spiked samples. To us, this indicated that in general these kinds of analyses were going pretty well.

On the actual ETS loaded samples, when we analyzed duplicate samples of the atmospheres, we hit about the same 93 to 95 percent recovery, so we were getting essentially the same answers as they did.

Now, any study of this kind of magnitude which requires this kind of a voluntary participation, we know is not going to be exactly representative of the United States as a whole and so one potential criticism of any study is that it's going to exclude those individuals in lower socio-economic status groups.

Obviously, there's individuals in this study, we recruited mostly by telephone survey so we exclude all those individuals that don't have telephones in this country, which tends to be lower income groups. And so it would be easy to criticize and say, well, you know, but this is too many high socio-economic status individuals that are participating in this study and that's really going to affect the results by a huge amount.

What we tried to do here is just segregate some of our data using four of the smoke markers as a function looking at the concentration of those smoke markers. These are time averaged concentrations, sort of the average exposure that an individual received over the course of the study as a function of household income, whether or not they were present in smoking homes or non-smoking homes.

And what you see is that there is this general trend towards decreasing exposure with increasing household income. But it's important to see here that while this inverse correlation appears to exist that the range of variation of these things is certainly not a couple of orders of magnitude, that they're in fact about a factor of two to six changes in the average exposures.

Now, we haven't all this particular data for statistically significant differences between these two but the important point here is that if there are differences, these are the median values, if there are differences, the differences are not, say, more than order of magnitude, they're probably a factor of two, three, four, five, something like that those segments of the population which may be reflected in the higher income relative to lower income segments of the population.

Okay. Now I want to talk about some of the results of this study sort of as a whole that relate to the kinds of issues that OSHA is considering.

In this slide, I have presented the overall distribution of nicotine and 3-ethenyl pyridine 24-hour time averaged concentrations for all the subjects in our study which were not excluded because of potential misclassification. I'm going to talk later about misclassification of smokers. We, of course, wanted only non-smokers in the study. We found that a lot of people in the study, it would not have been appropriate to include them in the study. I think the euphemistic term is misclassification.

What we see here, essentially this is -- I want to explain to you because you're going to be seeing time averaged concentration a lot in some of the data that I'm showing. These values that you are seeing are equal to the sum of the concentration time products for the workplace and the away-from-work sampling systems divided by the total time of measurement of the two sampling systems. That's about 24 hours. Essentially this time averaged value is the average level of exposure an individual is exposed to both at work and away from work.

Okay. Now, the other thing I want you to note here in this is that the size -- this is a histogram but the size of the cells are different in the lower end because most of the data occurs in the lower end although there's a few, and you can't see it too well in this slide right here but there are a few at the higher exposure levels.

These are exposures to nicotine and 3-ethenyl pyridine, gas phase markers, and what you see is that most of the time weighted average exposures are considerably less than a microgram per cubic meter over the course of that 24-hour period.

So what you can draw from this slide is that while there are a few subjects that encounter higher levels, that the average levels are again in this range of a half to one microgram per cubic meter.

Now, before I describe the next slide, I want to talk briefly a little bit about the issue of what constitutes exposure. I talked about this in my original comments that I submitted back in August of 1994 but I think that it sort of bears repeating and I'm going to summarize rather than read through my written testimony because I get bored with myself reading when I'm speaking like this.

Essentially, I read through the justification for the proposed rulemaking about four or five times before it started to hit me and that is that one of the difficulties that I see with the justification is really a comparison of apples and oranges.

Throughout the justification, the use of the term exposure is used in the context of the amount of time around which an individual spends around smokers or the number of cigarettes that they may have observed, that sort of thing. For example, in the California activity pattern survey, and this is a quote from one of the exhibits, I guess, for this proposed rulemaking, it says, "The data from this study showed that the workplace is the location with the highest reported exposure to ETS in enclosed environment and such exposure is on the average three times more prevalent at work than at home."

But if you look at the actual document, the actual activity pattern survey itself, what they show you is that they're only talking about the duration of the exposure and not the intensity of the exposure. And the real scientific definition of exposure has in it both a concentration factor and a time factor and many people, and you're going to see the numbers here, also include how much do individuals breathe during that period of time.

And later on in the justification document, they mention very briefly, and this is a direct quote here from the bottom of page 15,990 of the justification, it says that "Measurements of nicotine and ETS RSP in indoor spaces do not constitute a direct measure of exposure. Concentrations measured in all micro environments have to be combined with human activity pattern studies to determine the time weighted sum of the various exposures."

And I heartily agree but then they go on to continue to use the term exposure to refer to just the amounts of time being spent around cigarettes.

Okay. Now, that said, what I want to do is present some exposure data from this particular study and this is to nicotine. Again, this is a histogram of the number of subjects in the study. This is slide 29. What you see here, these are all the subjects in our study which were not excluded because of high cotinine. This data here essentially was derived taking the average smoke marker concentration over the 24-hour period from both the sampling pumps, multiplying it by the time of exposure and the estimate breathing rate. And we used a breathing rate of 1.2 cubic meters per our which is what the National Research Council Report on Environmental Tobacco Smoke used. We can argue about whether it's 1 or 1.2 or .8 or whatever but all the numbers -- we're trying to do comparative studies here and so this is the number that we picked.

Now, in an earlier study that Mr. Repace did, he indicated in that, which was out of the Journal of Risk Analysis in 1993, that they estimated that a typical non-smoker is exposed to about 143 micrograms of nicotine per day and that's using an average breathing rate of a cubic meter per hour. We used a somewhat higher breathing rate and what we find here is that about half of the subjects in our study had an exposure of about 2 micrograms of nicotine rather than 140 micrograms of nicotine per day.

It's certainly difficult to conclude from this data set that the typical exposures are more than 100 micrograms per cubic meter a day. It clearly looks like -- I think about 80 percent of the individuals had exposures less than 10 micrograms per day.

The next data here is the 24-hour time weighted average concentrations of a couple of particulate phase markers, the three and a half micron RSP and the fluorescent particular matter which fluorescent particulate matter is an indicator of combustion-related particulates. And what we see here is that most of the data falls on the average certainly less than 50 micrograms per cubic meter. All this data, of course, has been field blank corrected.

Now, slide 31, I just want to talk briefly about the recruiting of the study and the cell populations. It was very difficult to recruit subjects for this study. For example, in San Antonio, we had to make 5000 telephone calls to recruit 100 subjects. In many cases, it was impossible to recruit all 100 volunteers from just random telephone surveys and so in those situations, we asked the marketing research firm to go back into their databases, do averse searches. Typically, marketing research firms in a city will have databases of up to 50,000 individuals in their database and we'd go back and ask them to look for people that might fit in some of these categories and then certainly again re-screen them, not just bring them into the study but actually re-screen them.

This describes sort of the overall cell assignment, according to the initial screening questionnaire.

In cell one are those individuals that live in smoking homes and work in smoking workplaces.

Cell two is smoking homes and non-smoking workplaces.

Cell three is non-smoking homes and smoking workplaces.

Cell four, the largest category, a little over 50 percent of the participants in the study, live and work in non-smoking homes.

Now, the next couple of slides present summaries of exposure. I've got more detail in the addendum to the comments that I submitted right before Christmas but you just can't put that degree of information on a slide and expect anybody to read it. And it's very hard in this room here to read these slides anyway but essentially the green values are the median levels for an individual cell and the red values are the most highly exposed individuals in that cell.

These are time averaged exposures in micrograms of constituent over the course of a 24-hour exposure and what you see here is a general trend towards decreasing, say, median exposures. Okay. Here's 3-ethenyl pyridine, nicotine is the same way, with decreasing time spent in smoking venues, okay?

And this sort of shows that whether the most highly exposed individuals, the 95th percentile cutoff points, or the median individuals the trend is the same way.

Again, we've excluded all individuals that have greater than 15 nanograms per milliliter of salivary cotinine.

This is the same data presented in terms not of the micrograms of constituent but in sort of the time averaged concentration because these are numbers that people are more used to seeing. This is sort of the average concentration which an individual would experience. The median levels for those individuals living and working in smoking homes and workplaces, say, for nicotine here, is about 1.5 micrograms per cubic meter. The 95th percentile is about 9 micrograms per cubic meter of nicotine.

Now, these are individuals that were segregated by use of the screening questionnaires only and I want you to keep that in mind because I'm going to present some additional data here in just a minute or two but I want to make this point, that those individuals that essentially live and work in non-smoking environments, you here some of them still have some -- at least measurable exposures.

Well, this is a real world study and we have real world blanks and when you correct the blanks, the blanks vary from city to city, and we think that many of these participants, not all of them but many of these lower levels here are in fact just due to the apparent presence of environmental tobacco smoke markers, may be due in fact just to variation in the blanks. We haven't checked that out thoroughly.

The most highly exposed individuals, that is, the 95th percentile of these, those are probably real exposures and may speak to whether or not individuals really accurately classify themselves as to whether or not they really work in a non-smoking workplace where there is no smoking going on around them.

The next two slides, slides 34 and 35, the subjects are segregated on the basis of the confirmation of their cell assignment from the screening questionnaire with the self-reported tobacco product observations in the various venues.

In other words, you couldn't include them in a smoking workplace cell if in fact they never observed any cigarettes being smoked around them in the workplace. That's not an appropriate thing to do.

And what we've done here is we've produced this data with this additional constraint.

Now, one thing that you'll notice is that the number of individuals in the cells decrease. I'm just going to go back up here. Look at cell one, for example. With the more stringent requirements, it's 122 subjects and with the less stringent requirements, it's 157 subjects. And also those individuals that claimed to be in non-smoking environments, they dropped from 808 subjects in that cell to 555. So consistency in reporting is a very important issue when you look at overall exposures.

Again, just to sort of point -- even the most highly exposed individuals in these cases, here this is about the 95th percentile, those individuals working and living with smokers, what you see is about 260-some micrograms of nicotine per day and about 32 micrograms of RSP per day. And these are the time averaged concentrations.

You see again that the numbers don't change all that much from the data that you saw in slide 33.

Now, I want to move from this to the general issue of perception of exposure and I start talking about that on slide 36.

Many epidemiologic studies and other studies rely on self-reported exposures to environmental tobacco smoke as their primary or sole assessment parameters. The data in our study permits us to speak essentially to this general issue of comparison of exposure perception with the reality of exposure.

For example, these are there responses to the questions that we asked the subjects at the end of the study, in which environment do you think you are exposed to the most tobacco smoke in the air? And they answered, by far and away the largest response was restaurant and bars.

Now, if their interpretation of this question was in what venues do you see the highest concentrations of ETS, this is probably accurate because bars typically have the highest concentrations of ETS.

The next slide is a summation of the responses from the last visit survey and it was in response to this question, "During the study period how many tobacco products did you think you were exposed to and the approximate number in each location?"

And we sort of added them all up and just kind of summed everybody's up together and they had already completed out these workplace pump surveys and workplace diaries so they sort of remembered kind of totalling up how many cigarettes and tobacco products and what have you that they observed around them.

And what you see here is that from this as a whole, as a general compilation of the individuals in the study, you would see that the individuals respond that their greatest "exposure" is to that of smoking products in the workplace but only if the exposure is considered to be an observation that a tobacco product is being smoked around them.

Now, the next slide, we also asked them, okay, we also looked at their away-from-work diaries and actually counted up where they observed tobacco products being used outside the workplace and by far away the largest venue where they saw tobacco products being used around them was the home.

Okay. Now, this might appear to be in contradiction with the data that's in that perception slide that you saw a couple of slides ago that said -- it depends on how you interpret these questions. It speaks an awful lot to this general issue of the accuracy of self-reported exposures in epidemiologic studies.

Now, if you just sort of take the information on the last three slides, it might be easy to conclude that about 50 percent of all the tobacco product observations occur at work, about 25 percent of the observations are at home and about 25 percent are distributed among other locations.

That's the perception. Let's look at the reality.

The first thing I want to point out, that there is an error in this slide. This number right here should be 30.6. That's the 95th percentile for the workplace exposure for 3-ethenyl pyridine, 30.6 rather than 31.6.

This is a comparison, again, of the actual exposures, that's concentration multiplied by time of exposure and breathing rate, for three groups of subjects. The three groups of subjects have been segregated according to those that reported tobacco products being used in their workplace, those who reported tobacco products being used anywhere away from work, including home, or they could have not had anything in a home but hung out in a bar for a while and recorded cigarette observations there and then to be in this category you had to have for sure observed products only in the home, not only in the home but you had to have them in the home, they could also be other places as well.

Okay. What this shows is that if you look at the marker concentrations, I've reported the mean for these three, there's more data in the addendum that I sent, but essentially if you compare the media with this median, with this median or whatever category, the 80th percentile or the 95th percentile, what you see is that the absolute exposures in terms of micrograms of material, are larger in the home than they are in the workplace, okay? By a factor of at least four to six, depending on the individual component.

Now, if you look at the next slide, which is slide -- I'm losing track now, here -- that's 40, I believe. And on that slide, this number instead of being 56.1, it's supposed to be 58.6. That's also a little fuzzy, too, but that's okay. We'll live with that.

What are the reasons for the differences in the home versus workplace exposures?

Tthe reasons for the differences are as follows:

Number one, the concentrations of components are somewhat higher in the home than they are in the workplace and, secondly, you spend more time away from work, or at least most of us do, than you do at home, you spend more time away from work than you do in the workplace.

So just sort of if you look at these, to kind of summarized this last discussion here, judging from the number of cigarettes and the other tobacco products being smoked around them, one might conclude that individuals perceived their greatest exposure to be in the workplace, in fact, by a factor of about four to six, exposures are greater in smoking homes than they are in smoking workplaces.

Now, trying to conduct this study wasn't necessarily easy because there's an increasing amount of workplace restrictions and you might wonder, well, gee, how did they ever get enough individuals to study if they encountered something like 80 percent of the individuals actually having some kind of restrictions in the workplace?

Well, it's true that they did report some restrictions. A little over half of the individuals that reported some kind of restriction said that there was a total ban inside the building and others indicated that there were designated areas and then some of them said, well, there are designated areas but the visitors ignore them.

And if you then ask yourself how well were the restrictions enforced, this is slide 43. What you see here is that while we looked at the responses from those individuals that said, okay, well, there's a total ban inside the building and then how many of them actually observed smokers within 100 feet, and this is a small but significant number, there's well over 100 individuals that reported seeing cigarettes being smoked -- rather reported actual smokers within 100 feet of them and then there's a smaller fraction of them that actually observed tobacco products being smoked around them.

And the same way goes for the designated smoking areas and for those individuals that said designated smoking areas but visitors sometimes ignore those areas.

So essentially the bottom line to all this is while we did run into an awful lot of restrictions in the workplace, in fact there were still plenty, several hundred individuals, that actually observed smoking near them.

Now, clearly there is a significant effect with workplace smoking restrictions on ETS marker levels. And, again, this is one of those slides where I've used green to indicate the median exposures and red to indicate the higher exposures and this time I've just picked the 80th percentile. All the numbers are in the addendum to the comments.

What do you see here?

Well, essentially, there's a considerable decrease when you restrict smoking to designated areas only and there is a greater decrease if there's no smoking within the building.

But the interesting thing was that even in those workplaces where there was essentially no smoking restrictions that the average concentration levels were pretty low. I mean, here the median levels are about .6 micrograms per cubic meter of nicotine.

And this is low relative to what other people have reported in a number of studies and I want to speak to that now.

Slide 45 is a comparison of some data which was obtained from another study. Office levels here refers to a large study that was done essentially by the tobacco industry. There were a number of companies involved with this and this was reported in "The International Archives of Occupational and Environmental Health" back in 1990.

The green here is a distribution level of the nicotine values in smoking offices where there is obviously smoking going on in these offices. These were all one hour exposure measurements, okay? They weren't really personal exposures, they were area measurements made with stationary samplers inside these offices.

What we've done here is take the data from the ORNL study and segregated out just those office workers that actually reported smokers within 50 feet of them, okay? And what do their eight-hour exposures look like?

Well, it's clear here that while the levels that you would get from looking at one-hour exposures range from, say, 2 to maybe 10 micrograms per cubic meter, most of the actual personal exposures that occur over an eight-hour work day of these same types of office workers are much lower, on the order of 2, maybe 3 micrograms per cubic meter.

In other words, the short duration area measurements made in other studies in an earlier time tend to yield a higher distribution of nicotine levels when compared with these eight-hour personal exposure samples. So the levels in smoking offices that you measure over a short duration probably represent a worst case scenario that may be difficult to really define in the real world.

Now, if you look at the data over the last several slides, this is the picture that I'm trying to draw here. Individuals who work and live and operate around smokers receive substantially greater exposures to environmental tobacco smoke and that the environment outside the workplace tends to be the primary contributor to those exposures.

Now, it's important to note that in general the levels of ETS to which individuals are exposed are substantially lower than those which might be inferred from previous studies, including some of the studies that we've done ourselves, using area measurements over relatively short duration.

As I indicated earlier, we published a book back in 1992 on the chemistry of environmental tobacco smoke and we reviewed an awful lot -- virtually all of the field studies that had been done up to that date. And if you look at nicotine levels in offices, in general, those studies reported mean values anywhere from the order of 4 to 14 micrograms per cubic meter. This compares with mean levels, which I haven't reported here but which are in the addendum to the comments of about 2.8 micrograms per cubic meter and median levels about six-tenths of a microgram per cubic meter.

There are probably two reasons for these differences. One, some time has passed between this study and previous studies. There's been a general trend in the U.S. society for smokers to not consume smoking materials in the presence of non-smokers. But the obvious explanation to me is that non-smokers just don't spend their entire day in areas where ETS levels are high. Individuals may believe they're being exposed to the smoke of many cigarettes because they see cigarettes or pipes or cigars being smoked around them but because either due to the distance from the smoker or the time that they spend around the smoker, the actual exposure that they receive is very small.

In slide 46, I have looked at the RSP and nicotine in smoking workplaces --

Is my time up or is that just somebody's beeper? Okay. That's somebody's beeper.

One important parameter used in the risk assessment investigations that have been done is the ratio of RSP to nicotine. And, again, Jim Repace and his co-worker have reported a study in "Risk Analysis" in 1993 and they selected an RSP and nicotine ratio of 10 for the purposes of doing risk assessment and they cited a few studies which supported that.

We've looked at some other studies. Clearly, what ratio you get depends on what your cutoff point is for RSP. If you use a high particle diameter for RSP, you're going to end up with more respirable suspended particulates and so you're going to get a higher ratio.

We used a 3.5 micron cutoff, which is the same cutoff point that OSHA uses in its studies. In some of the other data that we've looked at, we saw ratios on the order of 19 to 1 or in offices on the order of about 32 to 1.

Now, clearly there are other sources which contribute to respirable suspended particulates other than just environmental tobacco smoke in the workplaces. We wanted to present to you -- this is sort of our data, again, for individuals that reported themselves being in smoking workplaces as confirmed through both the screening questionnaire and the diary observations and here's the histogram of the distribution of the subjects relative to the RSP/nicotine ratio.

And what we see here, again, I've expanded the cells to show this lower range, but essentially the data is really all over the map. Certainly a number of participants did experience RSP to nicotine ratios in their exposures on the order of 10 but almost as many experienced them at 20 and certainly more experience at 20 and 30 than they did at 10. Clearly, 10 is probably not the best number to use in these kinds of studies. Our median RSP to nicotine ratio for individuals, for this segregation of individuals, was about 30 to 1.

This is my first cut on slide 47 here of an attempt to get a handle on occupational differences to ETS workplace exposure. Of course, one of the problems you've got -- my wife said to me, I was showing her some of these slides and she said, "My, God, you guys are the Vegematic of data interpretation. You can slice and dice this information any way you want to." And it's true that we can slice and dice the data in a variety of ways but the problem is that when you start restricting those individuals and occupations to very limited occupations, like barbers and hairdressers or waiters and waitresses, we didn't have that many subjects in the study, you may only run into 10 or 20 subjects, and I haven't done a statistical analysis yet to determine whether or not any differences which you might see are statistically significant here.

Basically, anybody, any worker that fit within the general restriction of working in a smoking workplace and observing smoking within 50 feet of them, what you see here is that barbers and waiters tend to have higher exposures to ETS components. The more white collar levels are somewhat lower.

I want to sort of conclude my presentation by talking a little bit about salivary cotinine levels and nicotine exposures.

Many investigators propose the use of salivary cotinine as an indicator of environmental tobacco smoke exposure. It's interesting and we think that some of the data being generated in this study will provide independent assessment of the utility of this kind of an approach.

What I've done here is compare for the various cells, again, those individuals living and working in smoking environments, et cetera, et cetera, compare the median cotinine levels for those individuals versus the median nicotine levels for those individuals. And in this slide, they're just segregated -- the cell segregation is done only by the screening questionnaire and the next slide is done not only by the screening questionnaire but by diary observations. In other words, you had to have recorded appropriate kinds of tobacco exposures to be included in those cells. In other words, you couldn't be in a non-smoking workplace cell and report cigarettes being smoked around you at work.

The trends are the same. There's really not much difference. In general, what you see is this decreasing trend in median cotinine levels for the entire group of hundreds of participants with decreasing median nicotine exposure.

However, and I haven't presented this data formally here but if you look at individual salivary cotinine levels versus individual nicotine exposures, the correlation is pretty poor. We're seeing an R-squared of about .22. If you lot cotinine versus nicotine exposure, it looks like somebody fired a shotgun in the lower corner of the page.

I want to talk briefly about misclassification rates from salivary cotinine. We understand that misclassification rates are very important in epidemiologic studies. I'm not an epidemiologist. What we have done in the next slide is compute the misclassification rate -- of course, our study included all non-smokers and so we had to sort of estimate how many smokers we would have run into had we been surveying a full population and not just the non-smoking population and you can make some pretty good estimates of this based on the general population, how many individuals smoke in the overall population, et cetera, et cetera.

All the individuals, again, in our study were classified or reported themselves to be current non-smokers. Some of them were previous smokers. And here we've segregated and looked at only those individuals that are reporting themselves as lifetime never smokers, and this is the misclassification rate.

Now, you can fight over what's an appropriate level to use for salivary cotinine to draw your line and rather than get into that fight, I'm just going to present -- here's all the data and you guys can decide which is a more appropriate level.

We used 15 to excluded individuals from our study because we really didn't want people that were occasionally smoking around the sampling pumps. If you look at our cotinine, all of our cotinine data, you can see why we sort of picked 15. It's in the range that Edsel reports as being an appropriate level to segregate smokers and non-smokers. It's a little lower than some would use, a little higher than others would use. But, anyway, the misclassification rate for males and females as a whole range from about 2.5 percent up to here and this is about as high as I would go, about 4.6 percent.

When we look at the rates for males, we see that -- if we segregate out just the males in the study, they tend to report themselves as lifetime never smokers -- they tend to lie to you more, basically. Their misclassification rates are higher. I get tired of using the euphemism sometimes.

Here is the female misclassification rate, since many of the epidemiologic studies have been related only to females I thought this might be of interest to you. Actually, I had sent -- Judson Wells called me up right after Christmas, he indicated you had provided him with a copy of our addendum and wanted a breakdown of the males and females rate and I faxed that information to him, and so he has this information, he has reviewed how we have done the calculations, et cetera.

But essentially here you see this range from about 2 percent up to 3.7 percent, depending on want cutoff point you use.

Okay. Finally. I don't know how long I've been running. These are the conclusions and observations from the study. Our population tends to be younger, more highly educated and have a higher household income. I do want to make the point that observation of tobacco products being consumed is not equivalent to actual ETS exposures. Across the study cells, the median exposure to ETS constituents tend to decrease with decreasing time spent around smokers. This is kind of a trivial observation, of course this should be the case, when in fact here we've got the data to show that that's the case.

Exposures calculated from short duration area measurements are going to likely to overestimate the actual ETS exposure. If you really want to measure exposure, you've got to measure exposure.

In general, most RSP to nicotine ratios are greater than 10 and exposures to environmental tobacco smoke, at least these markers that we've used, in the home or away from work areas in the presence of smokers tend to be greater than those received in the smoking workplaces typically by a factor of four to six.

About 80 percent of our study subjects received exposure to less than 20 micrograms of nicotine per day. The median salivary cotinine levels tracked the median nicotine exposures but on an individual basis, there was very poor correlation. And if you use a cutoff of about 15 nanograms per mil of salivary cotinine to exclude those individuals that are misclassified as lifetime never smokers, what you end up with is a misclassification rate of about 3.8 percent and the rate of males is higher than the rate of females.

That concludes my formal presentation. Now you can start grilling me, I guess.

JUDGE VITTONE: Thank you, Doctor. Why don't we give you a five-minute break?

DR. JENKINS: Sounds like a great idea.

JUDGE VITTONE: Dr. Jenkins is back in place. And the OSHA staff, I understand Dr. Samet would like to go first?

MS. SHERMAN: Yes, Your Honor.

JUDGE VITTONE: Okay. All right.

Dr. Samet.

DR. SAMET: Dr. Jenkins, hi.

DR. JENKINS: Good morning.

DR. SAMET: John Samet. I'm going to ask you some questions both about your August submission and then the study that you described today.

I want to start with just the definitional framework. In your testimony today and in your August submission, you emphasize the importance of proper definitions of exposure.

DR. JENKINS: Correct.

DR. SAMET: And I'd like t make sure that we have a common framework for conceptualizing exposure and dose. You're familiar with the EPA exposure assessment guidelines that were published in the Federal Register in 1992?

DR. JENKINS: I've probably seen them but I can't quote them to you.

DR. SAMET: And are you familiar with the National Academy of Sciences National Research Council report entitled "Human Exposure Assessment for Airborne Pollutants" in 1991?

DR. JENKINS: Not particularly.

DR. SAMET: Let me give you pages from these documents that provide definitions, just so we can work on establishing a common framework. We will be passing those over to you but let me just begin by reading the definition from the National Research Council report, page 19.

It says, "An exposure to a contaminant is defined as an event that occurs when there is contact at a boundary between a human and the environment with a contaminant of a specific concentration for an interval of time." This is on page 19, in the second paragraph, and I think I have brackets on it. Can you see that?

DR. JENKINS: Yes, I see that.

DR. SAMET: So that is the definition of exposure developed by this particular National Research Council committee convened to provide a framework and address principles of exposure assessment. Is that a definition that you would accept?

DR. JENKINS: Yes, I think that's a good guideline. Yes.

DR. SAMET: So you would accept the definition?

DR. JENKINS: Yes, I would accept that.

DR. SAMET: And then if you would turn to the next page, which is page 20, again, second paragraph, it says that "Dose is the amount of a contaminant that is absorbed or deposited in the body of an exposed organism for an increment of time." Is that an acceptable definition?

DR. JENKINS: Yes.

DR. SAMET: And then, finally, if you turn to the last page from the National Research Council report, page 39, there is a simple expression of exposure as the interval of concentration with time, again, an equation of 2.2. Is that again a formulation of exposure that you would accept?

DR. JENKINS: Sure.

DR. SAMET: Okay. And then if we could just turn to the EPA exposure assessment guidelines and, again, just some very similar materials but I think on the third page which is, I guess, page 22,892 from the Federal Register, the mid column, the first paragraph begins, "Potential dose is simply the amount of the chemical ingested, inhaled, or in material applied to the skin." So the EPA exposure assessment guidelines offers that definition of potential dose. Is that a definition you would --

DR. JENKINS: Sure. I can live with that.

DR. SAMET: Okay. So, first, I would just like to turn to your -- I think we could either consider your tables where you discuss exposure in your presentation today or in your December 22nd addendum, if you would turn, for example, to Table 2, you describe these measures in the table as exposure. And what I would like to do is address whether these tables are in fact supplying a measure of exposure as defined by the National Research Council or the U.S. Environmental Protection Agency or are a measure of potential dose.

DR. JENKINS: Okay. Do you want me to comment on that or do you want to ask me a question?

DR. SAMET: Well, I'm asking the question, are these a measure of exposure or --

DR. JENKINS: I guess really under that terminology that you would consider these to be sort of potential dose, okay? Because they involve the use of an indicator of the breathing rate, okay? And the reason why we do that is how much material is going to be potentially breathed in.

DR. SAMET: That's right. So just at least -- then you would agree that by the frameworks established by the National Research Council and the EPA the measures that you have labelled as exposure are in fact potential dose levels.

DR. JENKINS: I could live with that. Yes. Yes.

DR. SAMET: Okay. I just wanted to clarify that.

DR. JENKINS: Sure.

DR. SAMET: Now, let's just adjust for a moment the issue of potential dose and the use of a particular breathing rate. Are you familiar with, for example, the reference man breathing rates that have been published by ICRP?

DR. JENKINS: I can't quote those exactly to you. I'm sure that I've seen them but -- I think that we can talk about for a long time what kind of breathing rates that we want to use here. We can calculate this with whatever breathing rate you want to use.

DR. SAMET: Right. But I just want to again return to the breathing rate that you use in your presentation.

DR. JENKINS: Okay.

DR. SAMET: Do breathing rates vary with level of activity?

DR. JENKINS: Oh, absolutely.

DR. SAMET: Would breathing rates, for example, during sleep, be lower than during sedentary activity, light activity or moderate activity?

DR. JENKINS: Obviously, they'd be lower during sleep and I'm not even a physiologist.

DR. SAMET: Okay. So they are lower during sleep. I'll suggest that the average breathing rate during sleep is approximately five liters per minute. You use a value here of 20 liters per minute throughout the 24 hours, so would this provide an overestimate of potential dose during times of sleep?

DR. JENKINS: For sure. For sure. I mean, if anything, these calculations -- and we deliberately did that. We picked a number that tended to be on the high side, 20 liters a minute, as an overall average number, as a conservative approach to essentially to quote overestimate exposure or to use the terminology that you have asked us to use here, potential dose.

DR. SAMET: Okay. So as we look then at your estimates of potential dose as presented in the December 22nd addendum or in the graphic materials, the breathing rates during times of sleep, for example, you would agree, would be higher than those that people actually experience while asleep.

DR. JENKINS: Oh, yes.

DR. SAMET: They would be. So at least if my suggestion that the average breathing rate during sleep is five and you've used a value of 20, you would be overestimating potential dose during sleep by a factor of four.

DR. JENKINS: That's correct. That's correct.

DR. SAMET: So as we compare the potential doses received in the home and in the workplace or in the workplace and away from the workplace, we would need to consider the weightings that you used for breathing rate as they might be some value other than 20, is that correct?

DR. JENKINS: You might want to do that. Yes.

DR. SAMET: And I think we did agree that the breathing rate during sleep would be lower than 20.

DR. JENKINS: Sure.

DR. SAMET: Okay. I just wanted to clarify these definitional points.

I wanted to go back again just to your August testimony and address for the moment the issue of personal versus area sampling. In your statements here --

DR. JENKINS: Will you direct me to which page you're --

DR. SAMET: Well, I think -- we can look at page nine or other pages.

DR. JENKINS: Okay.

DR. SAMET: Where you suggest that it's important to make personal measurements and that the area measurements made with short-term sampling may overestimate personal sampling. I just want to return to the issue of personal sampling versus area sampling when ETS is actually present and ask if under those circumstances personal and area sampling would give comparable or non-comparable results.

DR. JENKINS: Well, ETS is -- I think it's important that we think about what ETS is and when you ask the question about whether or not ETS is really present, ETS is present in a room long after any smokers have been in the room. As we know from nicotine, some of the components of ETS, at least nicotine, may be present for days in a room, long after smokers have left the room.

I can recall in one of the studies that we published back in -- I think it was 1989 looking at short duration exposures, these were personal exposures, in restaurants in the Knoxville area, I can remember doing the field study myself and there were no individuals in the room whatsoever smoking in this restaurant and yet we were able to detect nicotine concentrations present.

So the issue of what is ETS and how long is still ETS is something that's very, very complicated and may require studies beyond that which have already been conducted.

I am not quite sure what you were trying to get out of that question from me but I'll be --

DR. SAMET: In your submission, the August submission, you provided a copy of a paper presented at a meeting of the Air and Waste Management Association that would appear to involve a comparison of personal and area sampling on a relatively short timeframe. Is that correct?

DR. JENKINS: That's correct. Yes. We did provide that. I don't have a copy with me with but I remember the study.

DR. SAMET: Right. And one of the conclusions of that paper is, it says, "Results from this investigation indicate that the sampling and analytic procedures used for both the area and personal monitoring can provide comparable results over a wide range of ambient nicotine concentrations under conditions of maximally homogeneous ETS."

And, again, in -- I'm sorry, I'm looking for the -- yes. "The purpose of this study was determine the extent to which a stationary area sampler could estimate actual personal exposure to ambient nicotine when the exposed individuals are moving in and through a field environment." That's out of the introduction to the paper. And then I read to you the conclusion again, "Results from this investigation indicate that the sampling and analytic procedures used for both the area and personal monitoring can provide comparable results over a wide range of ambient nicotine concentrations under conditions of maximally homogeneous ETS."

DR. JENKINS: Right. And I still agree with that conclusion. Now, you must understand, though, that both -- if you read that paper very carefully, both of those measurements that were made of personal exposure which involved a breathing zone air sample using a 10 AX base methodology and an area sampler which used a briefcase, stationary briefcase near the individual and there were two samples being taken on that briefcase using XAD-4 cartridges to collect nicotine, both of those measurements were made with short duration interim measurements and in general the individuals were relatively stationary or moved only within that particular environment when that study was being conducted. And within the constraints of those kinds of parameters, yes, I believe that conclusion to be an accurate one still today.

DR. SAMET: So what you're stating, then, is there could be circumstances under which personal and area sampling for an appropriate time duration could provide comparable results.

DR. JENKINS: Oh, yes. Absolutely.

DR. SAMET: Okay. Good.

I'd like to move on to some questions about the survey that was reported. You, I think, carefully described the protocol and I just wanted to check on some additional details.

The 16 marketing organizations, I assume they're 16 different ones?

DR. JENKINS: I think in some cases there were branches of the same companies in different cities. I have that information, I don't have it with me so I can't go through and tell you which company was subcontracted by Bellomy Research in each of the 16 cities. I just don't have that information in front of me.

DR. SAMET: Do you know, was the same telephone screening protocol used by each firm?

DR. JENKINS: Yes.

DR. SAMET: And are you familiar with the details of the random digit dialing or other method that was used to identify the telephone numbers?

DR. JENKINS: I'm generally familiar. I am not specifically familiar with the random digit dialing. I mean, I've never seen somebody conduct that before. Depends on what you mean by familiar.

DR. SAMET: Do you know if the technique that was used was random digit dialing in the study?

DR. JENKINS: In most of the cities, in all of the cities, random digit dialing was the preferred way of recruiting of the subjects, okay? After about city seven or so, it became clear to us that random digit dialing was not providing adequate numbers of subjects in the most highly exposed cell categories, smoking homes and smoking workplaces. It was just getting increasingly hard to find those. Because it was not only the random digit dialing but then these individuals have to make it through the screening questionnaire and the overall process was not getting us to where we really wanted to be.

DR. SAMET: But the process that was used initially was random digit dialing.

DR. JENKINS: That's correct.

DR. SAMET: Do you know what the response rate was to the initial screening calls?

DR. JENKINS: It varied markedly from city to city. In Portland, Maine, the response was phenomenal. I think they made a couple of hundred telephone calls to get a hundred subjects. In the city of San Antonio, as I indicated earlier, they made 5000 telephone calls to recruit their subjects. It really varied from city to city. The data exists, I don't have it in front of me. I mean, I've looked at it before but I just don't recall the particulars.

DR. SAMET: I think because the issue of representativeness would be very important, I think it would be important to provide that information, perhaps in a post-hearing comment.

DR. JENKINS: Sure. Sure.

DR. SAMET: Because of the potential for bias if the response rate was not high. The response to the initial random digit dialing screen was variable among the cities.

DR. JENKINS: Oh, absolutely.

DR. SAMET: And what proportion of the subjects across the 16 cities was selected by random digit dialing as opposed to other sampling methods?

DR. JENKINS: Well, as I indicated in my testimony, in the written testimony, I don't know if I mentioned this in what I said orally, there was a breakdown in communication and in one city, St. Louis, we had about a third of the subjects were recruited by mall intercept which was absolutely not -- we thought was not appropriate. We retained them for the study because they represent a relatively small fraction, 5 percent of the total subjects.

My gut just sort of an estimate, I would say that it was something on the order of about 70 to 75 percent of the individuals were recruited through random digit dialing, with initiation of random digit dialing, okay? And then perhaps 20 to 25 percent were recruited through databases and that sort of thing.

DR. SAMET: Again, because of the issue of representativeness, I think it would be useful to provide that information as well.

DR. JENKINS: Sure. I'd be happy to provide that. I think it's also important to remember, I think in any study that requests this degree of voluntary cooperation, I mean, you can't possibly have a perfectly representative population because -- I mean, if you start listening to what these people have to go through, I mean, I'm not sure that I would agree to do the study. I mean, there's an awful lot of stuff that you've got to do.

DR. SAMET: Nevertheless, the issue of representativeness would be very important for interpreting the data so the information will be needed.

DR. JENKINS: Oh, yes. Sure.

DR. SAMET: Turn now just to Table 3 in your December submission, and I think you provided some similar information. I just wanted to make certain that we agree on what concentration, the term concentration here now represents. And you've provided a footnote. As I interpret these concentrations, these are average concentrations based on time during which pumps were running.

DR. JENKINS: That is correct.

DR. SAMET: So -- go ahead, I'm sorry.

DR. JENKINS: Let me just explain so we make sure that we're working on the same wavelength here.

What we did is we had this workplace sampling pump that the individuals wore for approximately eight to nine hours. We'd take a sample from that. We also then take a sample from their away-from-work pump which I'll sometimes refer to as a home pump, because that's how it was colloquially referred to, but it really covers everything away from work. We get a sample from that, and that sample is approximately 15, 16, 17 hours.

We take the average concentration over say the eight hour work sample and multiply it times the actual time that that sample was taken. Add it to the concentration time product of the away-from-work sample and the duration of the sampling pump, and divide that by the total time of sampling of the two pumps to give a time average, a 24 hour time average concentration.

DR. SAMET: We talked before about the fact that, as you pointed out, that it might be difficult to say what is an actual time of exposure and what is an interval of non-exposure. These time average concentrations could not be interpreted as actual concentrations in either the workplace or the home. They're an average concentration of costs, either the interval during which pump was on at work or pump was on at home, is that correct?

DR. JENKINS: That's correct. It is the average concentration over the time of the sampling to which the individual is exposed.

DR. SAMET: Again, thinking back to our definition of exposures, interval of concentration, and time. If there were intervals during which C was actually zero, those have been simply integrated in.

DR. JENKINS: Absolutely.

DR. SAMET: So we would need to be cautious in saying that these were the actual levels over particular short intervals of duration or under particular circumstances.

DR. JENKINS: I would never claim that these are exactly equal to the concentrations of environmental tobacco smoke at any one location at any given time, and that's the reason why OSHA in the workplace does eight hour workplace sampling, is because they want to get an integral of what is the average concentration to which an individual is exposed over that time period.

DR. SAMET: Turning now to page nine of the same December submission, I just want to address the effect of workplace smoking restrictions. In this, you have Table 6 that describes the differences across the different environments by type of restriction. You make a sentence that says, "The data indicate that smoking restrictions have a substantial effect on the workplace exposures to ETS." This is in the mid-sentence of the third paragraph on page nine.

DR. JENKINS: Okay.

DR. SAMET: I just want to ask you, have you made comparisons of the various workplaces in which these measurements were made? Are they, in fact, comparable in characteristics that would determine levels of ETS or other air pollutants?

DR. JENKINS: When you say they're comparable in characteristics, what do you mean by that?

DR. SAMET: You're drawing an inference from Table 6 by looking across, down these columns, and I'm asking you now, have you looked at the comparability of the environments so that you know that other factors are not contributing to these differences that you have attributed to restriction?

DR. JENKINS: Do you mean the physical environment such as the size of the workplace and the kind of ventilation system...

DR. SAMET: I think these are among the factors that could be important.

DR. JENKINS: We have all that data. In the interest of trying to get as much of this to Ms. Sherman as possible in the time that we had, I have not looked specifically at the physical characteristics of the workplace. We certainly will do that as part of our final assessment for this study, but we just haven't done that yet.

DR. SAMET: So right now when you say the data indicate that smoking restrictions have a substantial effect on the workplace exposures to ETS, there could also be other factors that could explain these differences that have not been explored?

DR. JENKINS: Yes, there could be. But I think that for this, and I don't know this, and that's one of the reasons why we want to look very carefully at all this data, but that one of the advantages of having a study of this size is that many of these kinds of differences tend to average themselves out over this population of individuals.

DR. SAMET: But from what you just said, to this time you have not yet examined...

DR. JENKINS: That's correct. I have not examined that data carefully.

DR. SAMET: And these data are simply cross-sectional, so you, in these individual buildings, would not have access to levels, exposures pre- and post-restriction, for example?

DR. JENKINS: No.

DR. SAMET: Any inference that would be drawn from the dataset you have would be based on this cross-sectional comparison.

DR. JENKINS: That's correct.

DR. SAMET: I just made a few additional notes as I was listening to your testimony and looking at the slides. First, looking at number 25, this is the occupational category.

DR. JENKINS: Correct.

DR. SAMET: Again, I think there's an important issue of representativeness and interpretation of lack of representativeness. This slide at least compared to U.S. data would show an over-representation of persons holding technical sales or administrative positions.

DR. JENKINS: That's correct, relative to the U.S. population as a whole. Again, we have not done the comparisons with the U.S. non-smoker population. We also... I would agree with you that we're over-represented, but the purpose of this study was to get volunteers to participate in these kinds of things, and it's very, very difficult to get people to volunteer when they're in jobs like waiters and waitresses and barbers, because they work with their hands.

DR. SAMET: So when you say the purpose of the study was to obtain volunteers, was the purpose then, the purpose did not include attempting to obtain a nationally representative sample?

DR. JENKINS: As soon as you put constraints of non-smokers on this... Excuse me, that's incorrect.

We attempted to get as representative as possible a sample of the population with the understanding that conducing a study with the logistics that were necessary, we were going to, by necessity, exclude parts of the population that you just can't conduct a study of this magnitude and not have these kinds of exclusions. It was an attempt to get it as representative as humanly possible within these constraints of getting those individuals that work essentially a 40 hour work week, and then, given those constraints, this is what we ended up with.

DR. SAMET: Looking at this slide, for example, you certainly did not succeed in obtaining a nationally representative population. The issue of how your population actually relates to the population of non-smokers remains to be assessed?

DR. JENKINS: That's correct. We still are going to have to assess what these profiles are of non-smokers, because we understand the demographics of the smoking population is different.

DR. SAMET: Let's look at Slide 27 together. This slide showed the average airborne concentrations, these again being the 24 hour averages, which would be the away-from-work pump and the work pump.

DR. JENKINS: That's correct.

DR. SAMET: By household income.

DR. JENKINS: That's correct.

DR. SAMET: You commented that you thought these differences were relatively minor, perhaps up to an order of magnitude across the spectrum of income. Is that correct?

DR. JENKINS: Well, relatively minor to...

Well, let's call a spade a spade here. I'm a great believer in being open.

Back in May I testified at a Maryland OSHA hearing. After I left for the afternoon, Jim Repace was there and commented something to the effect that because we had so many subjects in our study which were basically high socioeconomic status females... We have a lot of higher socioeconomic status females in our study, and we're aware of that. I've got a copy of his testimony somewhere, and please forgive me if I don't get this quite right, but essentially what you said was gee, there's a lot of high socioeconomic status females, and this data under-estimates the exposures by what I would estimate the exposure to be... It underestimates it by about two orders of magnitude, so the population clearly can't be representative. That's sort of what you said, I guess. I've got the testimony here and I'll be happy to go through it some place if you have it.

DR. SAMET: I'm not particularly concerned about the exchange in Maryland...

DR. JENKINS: No, no, no. But this slide speaks to that issue. That is, clearly household income seems to be a factor in this. It may be as much as a factor of two or five or six. It's clearly not two orders of magnitude. That's what this slide specifically addresses, whether or not... In other words, if you make certain socioeconomic slices of our population, what kind of differences would you see if you only looked at very rich people or very poor people.

DR. SAMET: I think, again, just going back to the interpretation of Slide 27, it does show a gradient by household income and a number of concentrations. Again, it would imply that if these data are used without proper weighting to represent the national average, because of the over-representation, perhaps, of higher income individuals, there would not be an appropriate representation of the best you could do no the national estimate.

DR. JENKINS: I'm not sure I would phrase it quite that way. I guess I would say that this study is about as representative as you can make a study like this requiring voluntary cooperation and given a non-infinite budget and non-infinite time to do the work, and I know it's a lot more representative than any other studies that have been done.

I would agree that the study design and the representativeness relative to the population as a whole is not perfect.

DR. SAMET: Why don't we look at number 34, and this is simply a slide that compares the exposures among cells, or reviews both the screening questionnaire and now the diary observations.

DR. JENKINS: The diary observations, correct.

DR. SAMET: The diary observations involved a checkmark on whether people considered themselves exposed or witnessed smoking activity, I guess.

DR. JENKINS: What happens, and I'll explain this carefully so I make sure that we're working on the same screen here. The diary is essentially a card that the individual has with them throughout the day, and every hour they are to mark down if they ever observe a cigarette or they smell coffee or they smell white-out, or the xerox machine goes nuts and sprays stuff all around. They mark down the different kinds of observations to which they're exposed. We look at the smoking category.

For example, if they had been put in a category which had them in a non-smoking workplace, but in fact they observed cigarettes being smoked around them in the workplace, then this particular way of looking at the data used the diary observations to screen out those individuals that would be inappropriate classified according to the screening questionnaire.

DR. SAMET: Could the diary observations be used to note at least how many hours people identified smoking activity?

DR. JENKINS: Yes, approximately.

DR. SAMET: Have you made those analyses yet?

DR. JENKINS: We have not performed those analyses yet. As I said, we received all the information together about the 7th or 8th of November.

DR. SAMET: Again, I understand the time constraints but I think for interpretation, particularly of the concentration data and perhaps better understanding the patterns of exposure in the workplace, I would think that again, having as a post-hearing comment the reports from the diaries at least on the number of hours in which smoking activity was reported in the various environments, would be a valuable adjunct to interpreting the information you provided.

DR. JENKINS: Yes.

DR. SAMET: On Slide 36, and the subsequent series, you address the issue of the validity of perception of exposure, and suggested that these data might be useful in interpreting epidemiological exposure measures. Most of the epidemiological studies that I'm aware of on health have used source descriptors. Parents smoking, spouse smoking, number of smokers in the home. Some perhaps, number of smokers at work, or whether smoking activity is present.

Do you think that questions on perception provide us with guidance concerning the validity of source description?

DR. JENKINS: I'm not an epidemiologist.

DR. SAMET: But you did make the inference...

DR. JENKINS: Yes, I did. And maybe that's an analytical chemist looking at the issue of epidemiology.

I think that in general if you ask people what their perception is, I think that gives you a clue and gives you some additional information with which to put the source descriptors, as you referred to them as, into some kind of a context in an epidemiologic study.

These are not the only questions that we have asked these individuals. There are a lot more questions in the study. I think that overall, this kind of data will permit us... We have information like the number of workers that smoke around them, whether it's their spouse that smokes, it's their grandmother that smokes in the home and that kind of thing.

DR. SAMET: Again, just to ask the question, do you think that assessing the validity of perception of exposure tells us something about the validity of source description as used in most of the epidemiological studies?

DR. JENKINS: Not specifically related to source description, but again, I think it provides a context.

DR. SAMET: Let me just ask, on some of your tables, I think perhaps any of the tables where you've used both a combination of the screening questionnaire and diary observation, you point out that there's a change in the sample size.

DR. JENKINS: That's correct.

DR. SAMET: And that there have been losses. You probably haven't had the opportunity yet to compare the characteristics and exposures of those who drop out of these analyses versus those who stay in?

DR. JENKINS: In some cases we have, but I haven't looked at them in a careful enough way to provide you with any kind of conclusions yet.

DR. SAMET: Again, I think that would be...

DR. JENKINS: Yeah, you're giving me all kinds of great ideas to continue to work up this data.

DR. SAMET: Finally, just a last question on Slide 50, you address the issue of misclassification, and offered these misclassification rates. Again, there has been concern in the epidemiological literature about misclassification.

The circumstances under which this study were obtained involved a telephone contact, an interview, an offer to participate in the study, and presumably an offer for remuneration as part of the enrollment procedure.

DR. JENKINS: But only after the participants agreed to partake in the study. The questions about their smoking status were asked very early on in the screening question, in the telephone screening questionnaire, so they had no idea essentially what they were getting into when they answered the questions concerning their smoking status.

DR. SAMET: Again, my concern is the extent to which these results may or may not be generalizable to other contexts. In this case they were obtained under the circumstances that I think you carefully described for us, in terms of assessment. Do you feel that these rates could be applied to studies in other contexts?

DR. JENKINS: Whoa... I do not know the answer to that question. I don't know if it's appropriate. I am not an epidemiologist, and I don't want to make any statement other than these are the rates that we found for this particular study population. I've noted that they're not grossly different from some other studies that have been done. I think there is a ten city IARC study that was done and we saw similar kinds of rates of misclassification. But to whether or not they're generally extractable to all parts of the population is just difficult for me... I just don't have the expertise to be able to make that professional assessment at this point.

DR. SAMET: Thank you for the answers to my questions. That's all the questions I have.

JUDGE VITTONE: I'm going to ask everybody to take a five minute break here. I have to make a phone call.

JUDGE VITTONE: On the record.

Mr. Tyson, do you want...

MR. TYSON: I noted that Dr. Samet had asked questions earlier; I note Dr. Hammond is apparently prepared to. I wonder if we could just get you to clarify on the record the status that they hold in the proceeding. Are they, as Dr. Glantz did earlier, representing the Agency in this process?

MS. SHERMAN: As I said earlier, both of these people have testified for OSHA and I have invited them to assist us in asking questions.

MR. TYSON: Thank you, Your Honor.

JUDGE VITTONE: Thank you.

A real quick housekeeping matter here. The slides that Dr. Jenkins used will be identified as Exhibit No. 195.

(The document referred to was marked for identification as Exhibit No. 195, and was received in evidence.)

JUDGE VITTONE: His prepared testimony which is dated January 5, 1995, will be Exhibit No. 196.

(The document referred to was marked for identification as Exhibit No. 196, and was received in evidence.)

JUDGE VITTONE: Ms. Sherman, Dr. Samet used a couple of documents?

MS. SHERMAN: Yes, Your Honor. Why don't we identify this document called "Human Exposure Assessment for Airborne Pollutants, Advances and Opportunities," maybe that should be the next Exhibit, No. 197.

JUDGE VITTONE: No. 197. Is there a date on that?

MS. SHERMAN: No there isn't. The words I read you were from the cover page of the book, and the exhibit consists of the cover page and page 19, 20, and 39 from that volume.

JUDGE VITTONE: Okay.

(The document referred to was marked for identification as Exhibit No. 197, and was received in evidence.)

MS. SHERMAN: The next thing I wanted to identify was Exhibit No. 198, which will be a Federal Register document from the Environmental Protection Agency entitled "Guidelines for Exposure Assessment."

JUDGE VITTONE: Okay.

(The document referred to was marked for identification as Exhibit No. 198, and was received in evidence.)

JUDGE VITTONE: Okay, Ms. Sherman.

MS. SHERMAN: I want to thank you for your amended submission, Dr. Jenkins.

DR. JENKINS: I hope you found it useful and enlightening.

MS. SHERMAN: I found it very informative.

DR. JENKINS: Okay.

MS. SHERMAN: I'd sort of like to explore with you a little bit how you got involved in the study. Have you always been the principal investigator?

DR. JENKINS: I am the co-principal investigator of the study. Dr. Michael R. Guerin and myself are co-principal investigators for this study. It's been mostly my responsibility but we usually assign work based on time and effort and what other things are going on and that kind of thing. So I've not been just the sole principal investigator. I'm the co-principal investigator with Mike Guerin.

MS. SHERMAN: When did you start planning this study?

DR. JENKINS: I tried to think about this last night because I thought you might ask me that question. But I've slept a few times since the study started. Somewhere in the fall of 1992 the Center for Indoor Air Research approached us. We'd done work under contract with them previously. They said we want to conduct an exposure of workplace, workplace exposure to ETS, and also away from work exposure to environmental tobacco smoke. We would like you to have primary responsibility for that study. What do you think?

We said, well, we're going to have to think about that. How are we going to structure this? We talked about structure, and we ended up having some meetings with both R.J. Reynolds, CIAR, and Bellomy Research, and we eventually concluded that this was something that we wanted to do, we being the team at Oak Ridge. So we subsequently put the mechanisms in place to start conducting that study.

MS. SHERMAN: When you said you've done work for CIAR previously, did you mean you in the institutional sense, or you Roger Jenkins?

DR. JENKINS: Both in the institutional and the personal sense. I think as I indicated previously, I'm the co-author along with Mike Guerin and Bruce Thompkins... Pardon me, Dr. Guerin and Dr. Thompkins. When you work with a thousand other PhDs, you hardly ever use the term doctor. Anyway, we're co-authors on this book. This book was essentially done under a contract between Martin Marietta Energy Systems which is our prime contractor, and the Center for Indoor Air Research. I spent, as you might imagine, lots of hours writing that book, so that was done under contract with the Center.

Also, we did some work under contract with the Center looking at this issue that Dr. Samet raised earlier, and the work that was presented at that EPA or Waste Management Association meeting concerning area versus personal exposure that we did that he quoted there earlier. That also was done under contract with the Center for Indoor Air Research.

MS. SHERMAN: So there was about a two year period between the time that the study was first thought about and the time you actually started executing it?

DR. JENKINS: No. We'd been thinking about doing a study like this, we'd have loved to do a study like this for a long time. In fact I think I wrote in this book that one of the real holes in the data, I thought, was the absence of home-type exposures. It's easy to get into public places, but it's very difficult to get into people's homes. So I thought of this study back in the 1980s.

But the Center first approached us in the fall of 1992, and after we agreed to do it, I think it was January or February of 1993, we then had to get the paperwork in place at Oak Ridge National Lab to be able to do this. We do work for private agencies as well as public agencies all the time, and it typically takes a few months from the time you start working on that with all the paperwork, to the time the money actually starts flowing and we can get started on a study.

The period was, I would say, something about six to seven months, and I might be a little bit off on this, but about six or seven months from the time that CIAR first approached us until the time that the first field studies started to be conducted in the middle of May of '93.

JUDGE VITTONE: Excuse me a second, I'm not sure the record is clear when you keep saying "this book."

DR. JENKINS: I'm sorry. When I refer to "this book," I'm referring to this monograph, "The Chemistry of Environmental Tobacco Smoke, Composition and Measurement" of which I am a co-author with Drs. Guerin and Thompkins.

MS. SHERMAN: Judge, they have also submitted that book to the record, but I would be very hard pressed to tell you what exhibit number it is.

JUDGE VITTONE: As long as we have it identified.

DR. JENKINS: I'm sorry. Excuse me.

MS. SHERMAN: I lost my train of thought.

DR. JENKINS: We were talking about the length of time...

MS. SHERMAN: Okay.

Was the protocol for this study sort of a product of a group consensus? Whose product is it?

DR. JENKINS: Originally R.J. Reynolds had some idea about how this thing would be conducted, and we also had some ideas about how it would be conducted, and when you talk about protocol, that's a tremendous number of things that you're covering in the study. Everything from how the subject recruiting goes, what kinds of questions in the questionnaires, and all that sort of stuff.

But essentially it was the Center that had... Just like any kind of contract research, they had a general idea of what they would like to have, and it's then up to us to kind of hammer out how you conduct that work specifically.

R.J. Reynolds had the ideas, we discussed this with them. We thought that there needed to be some changes, some introductions of pretty tight laboratory and field surveillance activities, and basically that we sort of laid our cards on the table and said this is what we could... The study design was fairly close, it had to be fine tuned. Then we kind of laid the cards on the table and said if we're going to do this, these are the kinds of things that we need to be able to put in place for us to be comfortable with doing this study in this way.

MS. SHERMAN: So would it be fair to characterize then, the evolution of the study as being a process of committee?

DR. JENKINS: Yeah, I'd say so.

MS. SHERMAN: And...

DR. JENKINS: Bellomy Research, and this is important. I haven't mentioned them very much yet, but Bellomy Research was also at these meetings, and they tried to bring this analytical chemist here, into the real world in terms of what you could do from... I wanted certain things done certain ways, and they said there's just no way in hell you're going to be able to do that. Because of their experience in the marketing research firm, we sort of had to come to some kind of agreement as to what could and couldn't be done.

I guess it would be fair to characterize this as a kind of committee effort, if you will.

MS. SHERMAN: Who from the CIAR were you interfacing with, if I can use the term?

DR. JENKINS: Our interface was Dr. Max Eisenberg, who is the Executive Director of the CIAR.

MS. SHERMAN: I think we have some articles by him in our docket also.

DR. JENKINS: That could very well be the case. If you say so.

MS. SHERMAN: Who from R.J. Reynolds were you interfacing with?

DR. JENKINS: Our primary, I guess what I call scientific collaborators in the original development were Dr. Mike Ogden and Dr. Charlie Green at R.J. Reynolds. They were the primary interface. There were many representatives from R.J. Reynolds in the meetings that were held, but they were the primary actors.

Let me state, I guess if you were going to look at this as kind of a core committee activity, which is, I think, where you're...

MS. SHERMAN: A steering committee?

DR. JENKINS: Yes, a steering or a development committee. The primary actors in this were from Oak Ridge, myself, Dr. Mike Guerin and Dr. Charles Baine of the Computing Applications Division of Oak Ridge; Dr. Mike Ogden and Dr. Charlie Green from R.J. Reynolds; and Lacey Bellomy of Bellomy Research.

MS. SHERMAN: I'd like to ask you some questions about Bellomy Research, because I must confess that I really hadn't heard of them before.

DR. JENKINS: They're a marketing research firm that's based in Winston Salem, North Carolina. They do an awful lot of work under contract for R.J. Reynolds. They were responsible, as I indicated in my testimony, for the development of some of the initial screening questionnaire data. I'm told they have a great deal of experience. I'm not an expert in marketing research.

They were willing to do the work for the Center for Indoor Air Research under the budget that the CIAR had to provide them with to do this activity. They seemed to be relatively level headed. I can't judge beyond that how good of a company or how bad of a company they are.

Again, they provided us with original questionnaire data. We made several modifications to those questionnaires to include essentially information that we wanted that may not have occurred to them in the development of the questionnaire, and those were integrated into the questionnaires. But that's Bellomy Research is a marketing research survey firm based in Winston Salem, North Carolina.

MS. SHERMAN: Had you worked with them before?

DR. JENKINS: No, we had never done a study like this before, because of the size of the study.

MS. SHERMAN: I remember in one of your submissions you had sort of a breakdown of duties during the...

DR. JENKINS: That was in one of my slides. I don't know which slide it is.

MS. SHERMAN: But one of their prime duties was to formulate the questionnaire?

DR. JENKINS: Yes. Initial formulation of the questionnaire. The Oak Ridge staff that was involved with this at the time had final approval on all of the questionnaire development for the study.

MS. SHERMAN: Other than them being a market research firm, do you have any knowledge of what their background and experience was and the ability to formulate the questionnaire?

DR. JENKINS: I have no particular experience with their abilities to formulate the particular questionnaires. Ultimately it ended up to us to pass final judgment on those questionnaires. They looked pretty thorough. I know they had done some questionnaire development work for R.J. Reynolds. I have a really good working relationship with sort of the fellow at R.J. Reynolds, Mike Ogden, who had done work with them previously, felt very comfortable with them, but it was really up to us to have the final say-so on the questionnaires.

I didn't have any specific first-hand knowledge of their particular abilities to develop questionnaires.

MS. SHERMAN: Did they have experience in recruiting of subjects, or just in the formulation of questionnaires?

DR. JENKINS: My understanding is that they have experience with recruiting these kinds of subjects. We deferred to some of their judgment in picking particular cities. The choice of cities we would go into, we had certain parameters that we wanted to have in place, but we many times deferred to their judgment as to whether or not they could get adequate subjects recruited in a particular city based on their knowledge of particular marketing research survey firms in that particular city.

MS. SHERMAN: I was going to ask you about the selection of cities. You said something about that one of your considerations was the temperature?

DR. JENKINS: Yes.

MS. SHERMAN: Did that have something to do with your sampling and analytical method? Or why was temperature a consideration?

DR. JENKINS: There were essentially two field periods during this study, and we wanted to have the data scattered. We haven't examined all the results. As I said, you got the first cut on the 23rd or whatever it was, of December.

We wanted to have the ability to have this be as representative of a variety of weather conditions as possible, because clearly, weather can affect household ventilation in a particular area. That's why we deliberately picked some cities to go into when we thought that the weather was going to be relatively cold, and then some cities sort of in the spring time of the year when the windows would be open and that kind of stuff.

MS. SHERMAN: Didn't you start the actual study in May?

DR. JENKINS: We started the study in May. We completed the first phase of the field investigation in about the middle of December of '93, and then we added four additional studies... I think it was about in April, and we finished up in June of '94. In other words, there were two field periods -- one mid-May through mid-December of '93, and then April through mid-June of '94.

MS. SHERMAN: So even though you were using different marketing firms in different cities, you didn't do your field work all at the same time.

DR. JENKINS: That's correct.

MS. SHERMAN: You did it in seriatim?

DR. JENKINS: In serial? Yeah. Those legal terms are hard for me.

We did them sequentially, yes.

MS. SHERMAN: Why did you decide to do them sequentially rather than take say a one month window and do it every place?

DR. JENKINS: The capital investment to conduct such a study is monumental. The sampling pumps which were used for this... I can't quote you the exact number, but it was something like 65 sampling pumps that were used. We had to do them in sequence, because to field the field teams all at the same time would have required resources that just weren't available to do this study.

To do them all simultaneously would have meant that we would have had to have 16 cities times 60-some sampling pumps. I don't know what the cost of one of those sampling pumps is, but a rough estimate is several hundred to $1,000 per unit. Especially by the time you get around to sound insulating them. So you may have an investment on the order of $40,000 to $60,000 just on the sampling pumps and chargers for an individual city. If you had to duplicate that in every city simultaneously, 16 times say $50,000, that's an awful lot of money. That's number one issue.

Number two, is the load on the analytical laboratories. You cannot get, you just can't physically analyze... I'm sorry, Kathy Hammond is laughing, because she knows these kinds of issues. You just can't dump this number of thousands of samples on a given laboratory and expect them to keep them all straight and to do it right all at one period of time. The logistics of trying to do it... This was a very expensive study, as you might be able to gather. I don't know what the exact cost of it was.

MS. SHERMAN: I was just going to ask you that.

DR. JENKINS: I really don't know the exact cost. I can tell you what our part of it was worth, but it was a very expensive study to do it. The other way, you would have had to have arranged for many laboratories around the country to do this, and there just aren't that many labs that are that competent in doing these kinds of analyses.

MS. SHERMAN: So even within a city, you didn't do all the sampling at once.

DR. JENKINS: No, these were conducted basically on each city, this is what happened in terms of sampling. The first group came in on Sunday night, the first group of approximately 25 participants. Twenty-five pumps go out on Sunday night. Another group comes in on Monday evening, and their pumps go out. On Tuesday...

MS. SHERMAN: That's 50 pumps so far.

DR. JENKINS: Okay, I've used 50 pumps. Is that right?

VOICE: (Inaudible)

DR. JENKINS: You're right. Twenty-five sets each time. You have two pumps. So I got my pump numbers off, and I apologize for that.

But basically 25 sets of pumps, which are 50 pumps, go out on Sunday night; another 25 sets go out on Monday night.

MS. SHERMAN: When you said you had 65 pumps, you mean 65 sets of pumps.

DR. JENKINS: That's correct. I was mistaken.1

MS. SHERMAN: Then Tuesday afternoon, the group that went out Sunday night, they start to come in on Tuesday afternoon. We then pull the samples from those pumps, recalibrate all the pumps, before we pull the samples, to make sure that the flow rates on the pumps are close to what they were when they went out, so there hasn't been a gross change in the sampling that occurred during the system. We also had a chance to physically inspect the pumps. We found that some participants like to take these things apart, even though they're told they're not supposed to be doing those kinds of things.

Then you essentially get the pump recalibrated with a new set of samples and the set that went out on Sunday night goes out again on Tuesday night. So Tuesday is a very busy day from about 3:00 o'clock in the afternoon until about 10:00 o'clock at night, because you are working to get all these things changed out and recalibrated and reintroduced and get the people trained and what have you.

On Wednesday, the group that came in on Monday afternoon, they come back in on Wednesday afternoon. They deliver their 25 sets of pumps. They're all redone. And they go out Wednesday night.

Then Thursday afternoon the pumps come back in, we pull the samples, and those pumps are sort of put to bed.

On Friday afternoon the group that went out Wednesday night comes back in and the samples are dropped off and the pumps are put to bed, you put everything back in the van and you get ready to drive to the next city.

MS. SHERMAN: Where was it that the people were asked to report for their training? Was it at the market research firm...

DR. JENKINS: No. Typically the marketing research firm in each city subcontracted out a place. It could be a suite of offices. There was a church that essentially rented out its facilities to do this stuff. We did some of the stuff in motels. I just can't, at this point I don't have the location of each one of the places. I can tell you the kind of places in a particular city. One was a country club. I think in Indianapolis we used one of the country clubs that were in the southern part of town.

Essentially you need to have a room where you can get these people on tables, and you also have to have a room or some space where you can be doing all this recalibrating of pumps, plus storing the freezers, putting a freezer in at each place for the salivary cotinine samples that are going in. So the logistics are considerable. You need to have a considerable amount of room in each place.

MS. SHERMAN: Was Bellomy Research your contractor or CIAR's contractor?

DR. JENKINS: No. My understanding of the contractual arrangement is that they had a contract with the sponsor. The sponsor essentially, effectively contracted out the three aspects of this. The overall study design, the QA, data interpretation, reporting, which was us; R.J. Reynolds' participation in the field stuff and what have you; then Bellomy Research was individually contracted through the Center for Indoor Air Research.

MS. SHERMAN: The Center for Indoor Air Research is the sponsor?

DR. JENKINS: That's correct.

MS. SHERMAN: You've used both terms.

DR. JENKINS: I'm sorry. The Center for Indoor Air Research is the sponsor for the study. When I say sponsor, what I'm referring to is the Center for Indoor Air Research.

MS. SHERMAN: Then you were all sort of subcontractors or contractors of the Center in the study?

DR. JENKINS: That's correct.

MS. SHERMAN: So you didn't choose or not choose each other to work with.

DR. JENKINS: Well, I'm not sure that's quite accurate. I think that if we had felt uncomfortable about the arrangement, we could have... One of the things that Dr. Eisenberg had asked me... He asked me, it must have been 30 times, are you specifically comfortable with this particular arrangement? Do you have any problems? Do you want any changes?

There were certain aspects, and I don't want to go into all the details, but the way certain aspects were being held in certain cities, I can remember a telephone call from the Atlanta Airport where he said, "If you are uncomfortable with the way that this is being handled, it will be changed and it will be changed now."

MS. SHERMAN: So you were sort of the...

DR. JENKINS: Yeah, that's right. Because it's our study. It's an ORNL study. The only way we would accept this, to basically agree to do this study, is if that was our position. We had to be the principal investigators for the study.

MS. SHERMAN: Is that just the way ORNL does business, or was it just in this case?

DR. JENKINS: ORNL does business in many, many, many different ways, but that was the way it was handled in this case. Dr. Guerin and I would not have agreed to do the study except under the terms which I've just stated.

MS. SHERMAN: I think you said your doctorate is in analytical chemistry?

DR. JENKINS: That is correct.

MS. SHERMAN: You've published articles on method development for the sampling and analysis of various ETS markers?

DR. JENKINS: That's correct.

MS. SHERMAN: You also said that the project was a joint effort of the Chemical and Analytical Science Division and the Computing Applications Division of ORNL?

DR. JENKINS: That's correct.

MS. SHERMAN: Then why didn't your laboratory with all its expertise in this area not perform the...

DR. JENKINS: The chemical analyses?

MS. SHERMAN: Yes.

DR. JENKINS: I thought you'd ask me that question, so I actually gave a little...

MS. SHERMAN: I didn't want to disappoint you.

DR. JENKINS: Good. I gave a little thought to it.

I think there is really, there are several reasons. Number one is that while we have done these kinds of, we've done analyses, with the exception of radio immune assay, we've performed all of these specific kinds of analyses in the past, in our laboratory, as part of collaborative studies, as part of method development, what have you. We know how to analyze nicotine XAD-4 cartridges for myosmine, and 3-ethenylpyridine. We've done RSP measurements of the kind that were used in this study.

However, to put in place that to handle it on kind of a mega scale, which is what we're talking about, would have required a great deal of time. So the time was... We knew that the potential workplace regulations were a driver force. The sponsor wanted to have this information ready for these kinds of deliberations that were here today.

So time was a consideration. For us to set that up to do that would have taken, on the kind of sample load that was being projected for this study, would have taken a great deal more time to get things in place. That's number one.

Number two, is a cost consideration. Because I work at a national laboratory, our costs are almost as bad as some attorneys. Not quite that high, but almost as high...

MS. SHERMAN: Cheap shot.

(Laughter)

DR. JENKINS: What can I say? It just slipped out!

Our man-year costs for our division run approximately $200,000 a man year. For us to do those number of analyses would have cost an extraordinary amount of money, and frankly, they could be done cheaper elsewhere. That's another consideration.

A third consideration is that you have to look at how DOE and its prime contractors do business by law. By law, we are not allowed, permitted by the Department of Energy, to do work which otherwise could be done in the private sector. Otherwise that brings us into violation with the sort of the terms of agreement that you have a national laboratory. We can't do things that the private sector can do as well.

That may not be the constraints under which some people operate, but if you're at a Department of Energy laboratory, that's the constraints under which you have to operate. You can't be in competition with the private sector. If there's somebody else that can do the work, then you can't do it.

It's the sponsor's decision as to whether or not anyone else, you might look at what we're doing and say gee, maybe Harvard School of Public Health could have done the same study, too. That's up to the sponsor's discretion. But in the case of analyzing thousands of samples, it was clearly not within the scope of the things we're permitted to do at ORNL, so that would have been very difficult to justify that to DOE.

MS. SHERMAN: In other words, the sponsor makes the decision as to whether anybody else is capable of doing, whether it's the study or the analytical chemistry?

DR. JENKINS: The sponsor makes the original call, and they will request that of either Martin Marietta Energy Systems, which is the primary contractor... That's who's name is on my paycheck this month. We have different contractors at different national laboratories.

MS. SHERMAN: Right.

DR. JENKINS: But the contractor and the Department of Energy have the say-so, the final say-so. They are welcome to hear from the potential sponsor, but unless they agree to that, you're not going to be allowed to do the work.

MS. SHERMAN: Are you saying implicitly that a decision was made that Oak Ridge National Laboratory was the only one who could perform such a study?

DR. JENKINS: By the sponsor, that's who, the sponsor wanted us to do the study and they essentially wrote a letter to DOE and said we believe that these are the best... Not the only people, but the best people to do the study. They have a great deal of experience in looking at these kinds of data, we want them to do the study, here are the reasons why, et cetera, et cetera, et cetera. If the contractor, Martin Marietta Energy Systems and Department of Energy accepts that, then that's fine.

DOE won't permit you as a principal investigator to do the work unless they've examined essentially the content of the study. We had to make it very clear in the descriptors -- you're talking now about the internal paperwork -- to get permission to do the study. That we would not be analyzing the thousands of samples, because I'm sure that would have raised a red flag.

MS. SHERMAN: Even if the sponsor had wanted you to, you don't think...

DR. JENKINS: I guess the sponsor would have... He would have had to have made a very, very strong argument that Oak Ridge National Laboratory was the only person that could do that. I can't speak for the people in DOE that regulate these things at the Oak Ridge Operations office, but I would imagine that they would maybe start to smell a rat.

MS. SHERMAN: So...

DR. JENKINS: Also, let me say this. I wanted to say this at some point in the discussion because I knew we would get to this.

I've known Dr. Ogden who was going to be the person that was primarily responsible for the R.J. Reynolds part of things for several years now. He and his group have published in peer review literature on many or all of these marker analyses. I know that they do very good work. We've had a good working relationship in the past when we've collaborated with them in round robin studies. And frankly, I trusted that he would do a good job and would be committed to this, because I knew that without a humongous personal commitment to this study, that it could never be done in a way that we would be satisfied with.

MS. SHERMAN: Bellomy then subcontracted with other people in each of the 16 cities.

DR. JENKINS: That's correct.

MS. SHERMAN: Did you approve the people that they subcontracted with?

DR. JENKINS: No, I did not personally approve those individuals. I basically said look, you pick who you want, but I'm deferring to your judgment.

MS. SHERMAN: You said in your Slide 9, I believe, that Bellomy designed the initial questionnaire; through subcontractors they recruited field subjects; they assisted with field operations; and they coded subject demographic data. Were there other things that they did?

DR. JENKINS: That's the bulk of what they did. If you ask me that question a month from now I might be able to remember something else, but that essentially is what they were responsible for in the study.

MS. SHERMAN: In the category of assisting field operations, what did that entail?

DR. JENKINS: They had an individual at each one of the cities that was responsible for doing sort of the instruction to the participants in the study. In other words, that individual will get up, introduce the videotape. She would oversee the other marketing research survey people from the other company in there, and she would handle some of the participant questions and what have you.

MS. SHERMAN: However, was it the R.J. Reynolds people who actually taught the people how to use the pumps?

DR. JENKINS: The R.J. Reynolds people were the ones that showed them how to turn on and turn off the pumps, or if one of the ORNL participants happened to be over there and they were asking one of the ORNL participants, we showed them how to turn on and off the pumps. It was sort of whoever was available when somebody asked a question.

MS. SHERMAN: So representatives from all three organizations would be in a city at the same time for the kickoff?

DR. JENKINS: That's correct. Not necessarily all at the same... Not the same participants all at the same time in each city or anything like that, but there was not an ORNL participant there through the entire duration of the... Essentially from Sunday night to Friday night. Typically we show up in the middle of the week. They also could use our assistance in terms of hands, in terms of just changing out batteries on the pumps and answering... We also spent time trying to answer questions.

MS. SHERMAN: Did you personally go to all of these cities?

DR. JENKINS: No. I did not personally go to all of the cities, but one of the, I think there were a total of six people from Oak Ridge that were at one of the cities during the course of the study.

MS. SHERMAN: I believe you said Bellomy chose the cities?

DR. JENKINS: Bellomy was responsible for picking the cities. We talked to R.J. Reynolds about that, and it always came up were you comfortable with this, based on what the regulatory climate looks like in those cities. I guess if we would have strongly objected to a particular city, they would have found some place else, but there were no cities that I can recall, anyway, that I objected to.

MS. SHERMAN: You said one of the things you looked at was temperature, and I think you sort of, the map that you showed in slide four showed that you do have a geographic distribution.

DR. JENKINS: Right. We tried to pick cities at least -- I think it was at least three cities from each of the four major U.S. census region districts in the country.

MS. SHERMAN: However, I noticed that you don't have the three largest cities. You did not pick -- I think the three largest cities are New York, Chicago and Los Angeles.

DR. JENKINS: Yes, that's correct.

MS. SHERMAN: Was there any particular reason for that?

DR. JENKINS: I would have to review the notes that we made from those individual studies, individual cities, to see whether or not -- why they may have been excluded. It may have just had to do with the size of the -- the kind of marketing research survey capability. Clearly there's competent market survey research firms in each one of those cities. The question was whether or not Bellomy Research had a good working relationship with a customer that they knew in those cities.

MS. SHERMAN: Well, was there any population cutoff? Like were cities of fewer than 200,000 people not considered?

DR. JENKINS: Well, I think cities less than, say, something like -- with an SMSA less than about 50,000 weren't considered just because of the difficulty of getting recruits. However, you see that Portland, Maine was one of the cities and that's certainly not --

MS. SHERMAN: Would you identify for the record what SMSA stands for?

DR. JENKINS: Oh, I'm sorry. Standard metropolitan statistical area. It's a term used in the literature just to describe sort of the -- you know, like I live in the Knoxville SMSA which includes not only Knox County but also Blount and Anderson Counties which surround it. It's just sort of, you know, the general area around a city. That's how the Census Bureau looks at these kinds of things.

MS. SHERMAN: Do you know, for instance, if, say, all of the cities of over, say, 200,000 were considered and then systematically rejected?

DR. JENKINS: No. I don't know that all cities were considered, it was more specifically in terms of when we could get to them, what kind of marketing research support that they had in those various cities and what the smoking climate was. If you have -- I mean, we did not conduct -- we conducted the study in Fresno, California. We didn't go to Davis, California because Davis has an extremely restrictive smoking policy.

MS. SHERMAN: But you did not design the study to go to places that were very restrictive or very wide open. Or did you?

DR. JENKINS: We wanted to avoid the very restrictive and you saw the results.

MS. SHERMAN: Because you didn't think you'd show much or what?

DR. JENKINS: It's very difficult to get individuals who work in four cells which include smoking workplaces if you have a total ban on smoking in public buildings in the town.

MS. SHERMAN: Well, now, in terms of your four cells, were you always trying to get the people with their workplaces within the city limits or that was not important?

DR. JENKINS: That wasn't important. In fact, we never actually -- for reasons of confidentiality, we didn't even ask the individuals, we don't have this data specifically, whom they worked for in a given town. So there's no way that their employer could be identified. Now, I mean, you probably could go through and make some educated guesses about who their employers were in a given town but we did not specifically require them to be inside or outside the city limits of a particular area. When I used the term Seattle, Washington, I believe that the test site was in Everette, Washington and the marketing research survey firm was in Bellevue and I would imagine that if you were to look, I don't think that there were any participants from Tacoma, Washington there because they would have had to drive a long way to the site to participate.

MS. SHERMAN: And were there any notes kept as to your decision to include or exclude any of these cities?

DR. JENKINS: Oh, I'm sure that we've got notes. I mean, I have -- my individual notes go to a couple of file cabinets of stuff on this study. For me to produce them would be very difficult. I'm sure that the other individuals, the other participants, in the study also made notes but I do not know that for a fact.

MS. SHERMAN: What about the questionnaire that was developed? Did you actually make suggestions to modify the initial draft of the questionnaire?

DR. JENKINS: Absolutely.

MS. SHERMAN: And can you make a copy of that questionnaire available to us?

DR. JENKINS: I can make a copy -- I can make a copy. I believe I can do this. I don't think that there's any proprietary issues associated with that at the present time, although I would clearly want to clear that with both Bellomy, R.J. Reynolds and the CIR. But if there's no problem -- I mean, our intent is to include that as part of the final report and ultimately we think the final report will receive very wide distribution. And so I don't see any problems with doing that but I would want to clear that first. I will not provide copies of the draft questionnaires just because I'm not sure that we've got them any more but I would be happy to provide you with copies of the final questionnaires.

MS. SHERMAN: So that there were many drafts of the questionnaire before you finally hit on what you thought was a good one?

DR. JENKINS: I think many is probably an overstatement. In some cases, there were two. In some cases, we went to three or four drafts of the questionnaires to get it. I mean, it had to do with things like -- clearly we want to get some idea of combustion related particulates in environments. I mean, that's my own professional interest. And I recall on the original diaries there were no questions about incense burning that occurred and so I wanted to make sure that they incense.

MS. SHERMAN: Now, okay. I'm getting a little confused. Are we talking about the initial questionnaire or are we talking about diaries?

DR. JENKINS: In this case, I was referring specifically to the diary but I think that that kind of thing is generally indicative of both the questionnaires and the diaries themselves. Changes were made by sort of consensus and what have you, the steering committee as you characterized it following the original drafts of the questionnaires that were developed by Bellomy.

MS. SHERMAN: Now, these diaries, as you say, these weren't just blank pieces of paper?

DR. JENKINS: No.

MS. SHERMAN: They were sort of pre-printed to sort of prompt people to make certain checkmarks or whatever?

DR. JENKINS: That's correct.

MS. SHERMAN: And were the same diaries distributed in each city or did it evolve as the study evolved?

DR. JENKINS: No. The same diaries were distributed in each city. To the best of my recollection, we used identical questionnaires in all the cities. All the material -- that's one reason why we used a videotape for the training rather than an individual just getting up there and talking, so that we could make sure that all participants saw exactly the same basic set of materials.

MS. SHERMAN: And can you make a copy of the diary available to us? How long was the diary, by the way?

DR. JENKINS: The diary essentially consisted of a card that was eight and a half by 11 printed on both sides of it with kind of a matrix drawn and kinds of questions that you could fill in at the bottom like when did you take off the sampling pump to take a shower or were there other things that you did when you took the sampling pump off. And that was essentially printed on two sides on an eight and a half by 11 card. It was heavier paper. And they had one of those for the workplace sampling and then one of those for the away-from-work sampling.

MS. SHERMAN: The same questions were not asked on both cards, were they?

DR. JENKINS: The same kinds of questions were asked but we may not have put -- and without looking at them again, we may not have put things like "Do you smell copying machine smells" on the home diary. That kind of stuff. They may not be exactly identical. And clearly there were also -- you know, there's some differences according to the times. I mean, we have like from eight to nine a.m. and nine to ten a.m. And we expected like the 10 to 11 a.m. time that we don't have those times specified on the away-from-work diaries because expected them all to be at work at the time from 10 a.m. to 11 a.m. So there's a little different look to each diary but it's basically the same. The same kinds of materials, coffee and cooking smells and that kind of stuff, correcting fluid.

MS. SHERMAN: So you can provide both of those diaries to us?

DR. JENKINS: Yes.

MS. SHERMAN: Now, were the diaries set up in such a way, I suppose I'll know as soon as I see it, that the person actually had to fill in their own ideas in writing or was it set up in such a way that they could make a little hash mark and then it could be graded by machine or something?

DR. JENKINS: They made a checkmark. I mean, most of the stuff was either -- it was predominantly checkmarks. In some cases, they actually had to fill in the blank with a specific piece of information like -- it was mostly time. The big thing was that they were sort of -- we wanted them to wear the pumps at all times except when they were taking a shower and they weren't sleeping, okay? So we wanted to know what times that they were taking a shower, for how long that was. And that required them to write down a specific amount of duration of time and when the start and stop time was.

MS. SHERMAN: How long did this random digit dialing take? I assume it would have taken much longer in San Antonio than it did in Portland, Maine because more people were called.

DR. JENKINS: Right. Right.

MS. SHERMAN: But did you allot a certain amount of time or a number of weeks?

DR. JENKINS: We started no later than three weeks, as I testified earlier today, no later than three weeks prior to the onset of field operations in the city. In other words, if we were going to start the field operations on the 22nd of July, the we were starting to call people by the first of July.

MS. SHERMAN: And do you have records of the time of day that the people were called?

DR. JENKINS: I don't know. I don't know if that data exists. Now, it was a time of day that the individuals -- I suspect that there is someplace that we could find that data but -- I mean, in many cases, people were called -- I'm sure that we were calling them during -- we tried to do most of the calling towards -- I mean, if you want people that work a 40-hour-a-week shift, you tend to call them in the evening. You're not going to call them at home, which is where we called them, at some time like at 2:00 in the afternoon because they ain't going to be there at 2:00 in the afternoon. So we tried to call those individuals during the evening hours but I don't know that we have records of what particular time that the first initial contact was made of a particular individual that eventually ended up passing the screening questionnaire and was included in the study.

MS. SHERMAN: If you had that, that would be very interesting. However, if you don't have that, it would be interesting to know perhaps in a particular city calls started at 6:00 and ended at 7:30 or the calls were only initiated on Saturday afternoons, et cetera. And it may be different for different cities because this may not have been rigidly controlled. It may have had something to do with the proclivities of the subcontractors.

DR. JENKINS: That's right.

MS. SHERMAN: Were they all instructed to do exactly the same thing at the same time or was a little bit left to their imagination?

DR. JENKINS: I think some things were left to their imagination but they had some general instructions. I don't think that Bellomy specified the specific -- they did specify the script of the questionnaire that they had to read. I don't know that the times at which the individual calls were specified, although I think that they were all told that they had to call them pretty much in the evenings, I guess, or on weekends.

MS. SHERMAN: Well, any information that you have on that I think will help us understand how this thing was gone about. Did they keep track of how many people hung up on them?

DR. JENKINS: I don't think so. I mean, I think there were some crude estimates that were made but we -- in fact, originally, I had wanted copies of every single screening questionnaire that was used as opposed to just like erasing things on the questionnaires, the script. And I can remember a conversation I had with Lacey Bellomy and he tried to be as polite as he possibly could be but he told me essentially that you're nuts if you think that you're going to get -- you know, you want records of each one of the screening questionnaires that's used because the stack -- I mean, like San Antonio where they started and essentially they would have had 5000 individual screening questionnaires that were kept, most of which were unused. So they erased the questionnaires and started over. So I don't think -- there's not -- there may not be the specific information that you're trying to look for but we can provide some general guidelines.

MS. SHERMAN: Well, I guess that if you don't have the specific questionnaires it's very difficult --

DR. JENKINS: We have -- now, wait. Let me rephrase this. We do not have the specific questionnaires from those individuals that hung up on us. We do have the specific questionnaires, we have every piece of paper that's associated with every single subject in the study.

MS. SHERMAN: Yes. But I guess there's a middle ground between the guy who hangs up on you after they know what --

DR. JENKINS: Initially. Like I do on most people right away when they call.

MS. SHERMAN: Exactly. So that there is a middle ground between the people who hang up on you within the first two minutes and the people who, if you will, flunk the questionnaire and who don't get to go further.

DR. JENKINS: My understanding of how the scripting was done is that there were several termination points during the screening. And how the script was written was that if a person essentially -- as soon as they flunk the question, well, thank you very much for your time, we appreciate your effort in answering these questions, have a good evening, thank you. They were terminated at that point. We did not take them all the way through the questionnaire.

MS. SHERMAN: I understand that. But my point is --

DR. JENKINS: That would have been nice to have. I don't know that we've got that data.

MS. SHERMAN: Okay. If you have it, I think we would like to see it.

DR. JENKINS: Okay. But I'm telling you know, I don't think that we have that information. Yes, in an ideal world, I'd like to have it, too.

MS. SHERMAN: Well, okay. Do you have data on the percent that flunked at each stage?

DR. JENKINS: I don't believe so.

MS. SHERMAN: Do you have data on -- how many stages were there for one to flunk in the questionnaire? Do you remember?

DR. JENKINS: Without looking at the questionnaire, I couldn't remember. I'm sure it's like six or seven places in the questionnaire.

MS. SHERMAN: Do you have data on how many people flunked stage in Indianapolis --

DR. JENKINS: I doubt it.

MS. SHERMAN: -- as opposed to -- Orlando, I think you have -- Daytona Beach.

DR. JENKINS: Daytona Beach. No, I doubt it. I don't think we have that data. I mean, the individual marketing companies may be able to provide some kind of ballpark estimates but I do not have that data personally.

MS. SHERMAN: And you don't know how many people refused to answer the questionnaires. Did you keep that data or you didn't?

DR. JENKINS: No, I don't believe that we kept that data.

MS. SHERMAN: So you don't know how it would compare with other people's experience?

DR. JENKINS: Not right off hand, no, I don't. If that data does exist. No. We do not have that kind of information.

MS. SHERMAN: Who did they say they were when they called up each person? Did they identify themselves as the public relations firm, as Oak Ridge, as Bellomy?

DR. JENKINS: They did not -- I believe that this is right, that they identified themselves just as a local marketing research firm in whatever city that they were in and I want to ask you a few questions. No identification was given of Bellomy Research, R.J. Reynolds or Oak Ridge National Laboratory to anybody during the course of the study. The participants never knew who was involved in the study.

MS. SHERMAN: When they got their check, who signed the check? Or was it cash?

DR. JENKINS: They did not get a check. They got cash.

MS. SHERMAN: And so they never knew for whom they were working.

DR. JENKINS: That's correct. For whom they volunteered. And from whom they were paid a $100 gratuity. Correct.

MS. SHERMAN: Did you get any inquiries from their employers as to what all this was?

DR. JENKINS: Oh, absolutely. And we actually had provided ahead of time to them a sheet with information, information to your employer to take along with you and it was sort of a description of the study, this is an indoor air quality study, if you have any questions, there was a number, a local number that they could call and also a toll-free number that they could call.

MS. SHERMAN: Did you identify who you were on that sheet?

DR. JENKINS: No.

MS. SHERMAN: Did you keep track of the percentage of people by city where you had people who were willing to participate and their employer said no?

DR. JENKINS: We may have that data for at least some of the cities. We have not looked at it yet. I think that we would have that data because we kept the original -- if they were terminated from the study for that reason, the marketing research firm has kept the information but has not sent us the data because they were never allowed to go on and we didn't get air marker samples from them and things like that. They still may have those questionnaires and we may have that information as to how many employers told them no, they couldn't participate.

MS. SHERMAN: Did you insist that they get permission from the employer or was this left up to the subject?

DR. JENKINS: It was left up to the subject. I mean, the subject knows their work environment better than certainly we do and that in some cases, I can remember in Indianapolis, there was one participant who their employer was the U.S. Army or something, they worked at an Army base, and the person's supervisor said I will not permit you to participate in this study unless you tell me why -- you say it's indoor air quality, I want to know more. And we told them basically we will not tell you any more other than this is an indoor air quality -- which is a true statement. And so that individual was not allowed to participate in the study and they were very upset because they wanted -- I mean, a lot of people think this is a fun thing to do because it is kind of interesting, you know. But they were not allowed to participate.

MS. SHERMAN: Did you ever at any point in the whole process with these people apprise them of who you were or what the study was about?

DR. JENKINS: No. We said that we were from -- that this was an indoor air quality study. I think that some of them may have gleaned that there was a sort of a hierarchy of authority within -- if they're at the field site and there's a question, I mean, a questionnaire this detailed, you're always going to have interpretations and so the rule was that if there was an ORNL employee at the site that they would have the final say so on any kind of an interpretation of a question or a response to a question. When you're filling out these long sheets of paper, what exactly does it mean by this or we're not sure if they should put this answer or that answer and the Bellomy Research person would come and talk and R.J. Reynolds might be brought into it but ultimately -- I mean, sometimes there were some cases in some cities where I was there and I would just say I'm the principal investigator for the study, I make the judgement call, I say this and that's the way it is. So they had some sense that there may have been a hierarchy of authority at the place but they did not know where I was from or anybody was from.

MS. SHERMAN: Did you introduce yourself to them by name?

DR. JENKINS: I may have said -- I don't recall ever introducing myself by name. I may have said that but I don't recall that.

MS. SHERMAN: You started, you said, three weeks beforehand with these telephone surveys.

DR. JENKINS: Typically, yes. I mean, it might have been plus or minus a few days on that but typically three weeks ahead of time.

MS. SHERMAN: So that some people would have been contacted on, say, the first day and so they would have had to wait three weeks before coming in to report.

DR. JENKINS: And they were typically -- there were follow-up telephone calls made by the local marketing research survey firm to sort of kind of keep them interested, you know, we have you down for such and such a night, are you still planning on attending? And sometimes, oh, well, I can't do that any more. Oh, my God, well, this is a cell one participant and those are tough to get so we've got to go out and make some more telephone calls. So we'd have people quit on us because they made their plans three weeks ahead of time and something came up and they decided not to participate.

MS. SHERMAN: So do you think that that was one of the reasons why you had to make so many phone calls, because there was this hiatus between the recruitment and the actual action item?

DR. JENKINS: That may have been a contributor by my sense is that that was -- and this is all I think you can really ask me is is there a sense here and my sense was that that was small but not particular important. I think it was the main thing -- again, I can't get into in the minds of even the 1600 subjects that participated in the study, let alone the thousands and thousands of people that declined to participate in the study.

I think some of it was distance. I mean, you get in a city like Baltimore, you know, and the test site's on the north side of town and they live on the south side of town, hey, I don't want to drive that far, you know, even if they are going to pay me a hundred bucks.

MS. SHERMAN: So they would agree to do it and then they would --

DR. JENKINS: Some of them would back out. Yes.

MS. SHERMAN: Okay. So what percentage agreed to do it and then didn't show or backed out?

DR. JENKINS: My gut feel is that that might be between 5 and 10 percent.

MS. SHERMAN: And did it vary between cities?

DR. JENKINS: Yes, but not like up to 50 percent or anything like that.

MS. SHERMAN: Excuse me?

DR. JENKINS: I'm sure there was variation among cities. I did not go to all the cities and I didn't have that personal, firsthand sense about that. My idea is that there was some variations in this no shows from city to city but I don't think it -- it may have varied around 5 or 10 percent, some cities, it might have been 15, it might have been 4 or 2 in some other cities, but it was in that general range.

MS. SHERMAN: Did you do any analysis of these no shows by city?

DR. JENKINS: No.

MS. SHERMAN: Do you have that data available?

DR. JENKINS: I believe that that data exists. If that data exists, it's at Bellomy Research because, again, these were not subjects that were ultimately included in the subject data base and so I don't have them in our locked files.

MS. SHERMAN: Would it be possible for you to try to obtain that for us?

DR. JENKINS: I can try. If we've got it. I mean, we may not have it.

Let me make sure that I understand specifically what you're looking for now, okay?

MS. SHERMAN: Yes.

DR. JENKINS: You're looking for the subjects that agreed and then were basically no shows.

MS. SHERMAN: Right. And how about the subjects who agreed and showed up and once they were there got less enthusiastic about the project?

DR. JENKINS: That didn't happen -- my understanding is that that didn't happen very frequently. We did run into some situations, I remember one case where -- I'm not going to make any jokes about lawyers but a young attorney showed up and he had somehow basically had not -- he either had misunderstood the question or whatever but we didn't want any attorneys in the study and he showed up and then he threatened to sue us because he had driven all the way over. I mean, there's all kinds of stories we can tell you about the individual participants without revealing any confidentialities but essentially we ended up paying this guy -- I think he was paid off some amount of money with a written agreement that he wouldn't sue us, you know? But, I mean, he wanted to sue us because we had administered the questionnaire inappropriately over the telephone or something.

See, I didn't make any jokes about lawyers there.

MS. SHERMAN: You came close.

VOICE: You just made us look stupid.

DR. JENKINS: No, no, no, no. There were many, many good, smart attorneys that were very forthright in their original responses to the answers and therefore didn't --

MS. SHERMAN: Why did you decide to exclude attorneys?

DR. JENKINS: Without making any lawyer jokes, I don't know if I want to say that in this kind of a room, we just -- we decided basically that they're overly inquisitive and perhaps antagonistic --

MS. SHERMAN: I can't imagine why you would say that.

DR. JENKINS: We just didn't feel like it would be appropriate. It was interesting, we also didn't want any laboratory scientists, too, and that means that I would have been excluded from the study.

MS. SHERMAN: Who else did you exclude?

DR. JENKINS: Well, I think I listed the kinds of people. We didn't --

MS. SHERMAN: Well, I know you said something about you didn't want members of the lung association or employees of tobacco companies.

DR. JENKINS: Or Action on Smoking and Health, or the Tobacco Workers Support Group. I mean, Sierra Club and National Rifle Association were okay but we didn't want Action on Smoking and Health and we didn't want the pro-tobacco people and that kind of thing.

MS. SHERMAN: Well, how did you -- did you actually say in your questionnaire, "Are you a member of Action on Smoking in Health?"

DR. JENKINS: In some cases, I think that Action on Smoking and Health, I don't know if we identified them particularly but we may have had a part of the script, again, I can't visualize -- without having the questionnaire right in front of me, I can't recall the specifics but we may have asked them, "Are you a member of any tobacco-related public interest groups and, if so, could you tell us which one?" And, you know, that's just a part of the screening questionnaire. So we might ask them a few more questions and then say thank you very much and exclude them from the study, terminate their involvement.

MS. SHERMAN: Did you have any law enforcement personnel in your study?

DR. JENKINS: I don't know the answer to that question. I don't think that they were excluded but without looking at the detailed questionnaires, I can't tell you. If they would fit the rest of our guidelines, I don't think we would have had any reason to exclude them. If it was sort of a policeman on the beat that he spent all of his time driving around in a car or something like that, then he probably would have been excluded because we wanted individuals that essentially worked in the same workplace for at least 75 percent of their day, we wanted them to spend 75 percent of their day in one location in a given workplace.

MS. SHERMAN: Did you exclude any health care personnel?

DR. JENKINS: It depended on what kind of health care personnel that they were. If they were an individual worked in a particular given location over the course of a day, then, yes, they would be included. This tended to exclude, and I forget again the individual specific criteria, but if you had, for example, say, a physician who made rounds all day or something like that, they would be excluded because they weren't working in the same general area over the course of a day.

MS. SHERMAN: Well, I'm a little bit curious about that. Why was it important to you or to your sponsor to have the people be so stationary when you were using personal monitoring pumps?

DR. JENKINS: Because we wanted some idea and to be able to relate this to other data that's been taken. Most of the previous studies that have been published have been published with those -- they were taken from one location. And wanted individuals that this would sort of be representative of their general workplace and their exposures within a general workplace.

MS. SHERMAN: So in other words, they're not necessarily representative of the general population.

DR. JENKINS: We never made any claim that these are necessarily representative of the general population. That's why I went through all of this --

MS. SHERMAN: But you don't -- you're not necessarily making a claim that these workplaces are representative even of the community in which they are in, are you?

DR. JENKINS: We can't make any claim -- no. I'm not making any of those kinds of claims. We realize that there are so many -- as I've said previously but I just want to make sure that it's clear, there are a lot of logistical constraints to this study. There is a lot of self-exclusion. You're going to exclude people on both the high and the low end of the scale. We can't make any kind of claims relative to the -- if we tried to make too many claims about the representativeness, you could always ask questions about, well, gee, why didn't you include this person or that person. Rather than do that, what we've tried to do is say, look, these are the kinds of people, these are the constraints under which they were included in the study and then this is what the demographics are of our population and say to this extent we are either representative or non-representative and let the reader of this study decide how it relates to the particular issue, the question you want to answer.

MS. SHERMAN: Why did you ask them to stay at their desks at lunchtime?

DR. JENKINS: So that it wouldn't be confused with going out for lunch and what have you and essentially that would bring in the issue of, my God, well, they went over to the bar at lunchtime and they got this huge exposure or they went and had their lunch outside and that's not indicative then of what's really the atmosphere in their workplace, so we could relate it to some of these other studies.

MS. SHERMAN: Well, did you ask any questions about whether the place where they worked had a cafeteria?

DR. JENKINS: I can't recall. It will show up certainly in --

MS. SHERMAN: It will show whatever it shows.

DR. JENKINS: I cannot recall that.

MS. SHERMAN: Well, do you recall if the workplace provided a lounge for employees to eat their lunch in or a cafeteria, if you told them not to eat their lunch there that day?

DR. JENKINS: I think the general statement was that we asked if you can to try to have your lunch at your desk. Now, they may have gone to some place and picked up stuff to go and then come back to their work station.

MS. SHERMAN: Do you have any idea of how many of them obeyed your request?

DR. JENKINS: Well, I think like in any kind of a study like this, you're always going to have questions to whether or not the people accurately self-reported anything, whether it's the number of cigarettes around them or whatever. At some point, you have to trust them. We did have a point -- I believe that we had a point on the questionnaire where if they did leave their workstation, for how long were they gone or something like that and we would hope that they were truthful. But, no, we have no way of checking the authenticity of essentially any of their responses with the exception of the salivary cotinine data. Of course, we also -- and how long the pump was sampling. We asked them to write down how long they sampled for, in fact, we had an internal timer inside the pump that we could read and see whether or not there was good agreement between how long they claimed that they sampled and how long they really sampled.

MS. SHERMAN: And was there?

DR. JENKINS: In general, the agreement was very good. Yes.

MS. SHERMAN: Did you have to pitch anybody out of the study because of disagreement?

DR. JENKINS: Oh, yes. There were a couple of folks that claimed that they did exactly everything that they were supposed to and then you'd come back and you'd find the pump taken apart or you'd find -- I mean, the clearly the thing was -- or it failed. You know, sometimes in the case of pump failure, the battery went dead, we noted that and depending on how long the pump sampled, we may have included them in the study or we may have excluded them from the study or we may have just thrown out their workplace or their away-from-work sample.

MS. SHERMAN: So in other words, you didn't insist that both samples be acceptable to keep the person in the study? Well, you would have had to insist that both samples be acceptable or else it would be very difficult to compare.

DR. JENKINS: Oh, no. No. There are a few individuals in the study for which we don't have a home or we don't have a workplace sample. Now, they've been excluded from those kinds of compilations where we say we have a 24-hour time weighted average sample. Of course you can't include them in that because we don't have a 24-hour sample from those individuals. But, for example, suppose the batteries failed on their away-from-work sampling pump. If we got a workplace sample from them that we deemed to be of sufficiently high quality, we have included them in the workplace smoke characterization but have not included them in, say, those compilations of data which require an overall sample.

MS. SHERMAN: What was your rate of pump failure?

DR. JENKINS: Very, very low.

MS. SHERMAN: Did you keep track of it?

DR. JENKINS: Oh, yes. I mean, all of this stuff was noted. I mean, I would say it was way, way less than 1 percent. I mean, it happened a few times. I must say, that it was really -- as somebody who has done similar kinds of studies although not to this extent, I mean, I was amazed at how things worked so well. I mean, the field staff that was working were so committed to this thing. I mean, they just jumped through hoops to make sure that everything worked. All the batteries were checked for charges before they went out at night. One night I remember in Grand Rapids we had a failure, the power clicked on and off and that sent the pump chargers into kind of disarray and we came up that night and, oh, my God, what are we going to do, we essentially don't have enough batteries to run all the pumps that we've got people. And I can't recall this but I think we may have actually excluded one or two individuals who showed up and we paid them, you know, thank you very much for coming out here but, gee, all of a sudden there's a problem and we don't have a pump for you because we had battery failure. We wouldn't send them out with stuff that we thought was defective.

MS. SHERMAN: Did you have problems with absentee rates? The person would come in for their preparation and then for some reason they couldn't go to work the next day or something like that?

DR. JENKINS: That was a problem in some cases and what we had them do, for example, if they came back in, they would call and say, oh, my God, I'm getting ready to go to work and my shift superintendent called me and said they want me in tomorrow versus the next day and we explained to them how we wanted them to do the pump, the sampling, so that the workplace sampling would occur on, say, the morning and afternoon of day three rather than the morning and afternoon of day two. But they had numbers to call on their sheets if there were any problems, if there was anything that they didn't understand. And the numbers were a beeper that was one of the field staff that could basically rectify -- could come and change out a pump if that needed to happen but I don't think that happened in the study.

I must say that I've been drinking a lot of water.

MS. SHERMAN: So have I.

JUDGE VITTONE: It's 10 minutes after 12. I'll take the hint.

DR. JENKINS: I would really appreciate a break. I mean, if you want to keep going, as far as I'm concerned --

JUDGE VITTONE: No. It's 10 minutes after 12.

You've got more questions, right?

MS. SHERMAN: Yes, I do.

JUDGE VITTONE: Okay.

If you can hold on for 30 seconds.

DR. JENKINS: Not much longer.

MS. SHERMAN: He's drinking more water, Your Honor.

JUDGE VITTONE: We have the Robens Institute people this afternoon.

How long is their initial presentation? Thirty minutes? Okay.

We have the Robens Institute people this afternoon and, as you well know, we've got to get out of here at 3:00.

How much longer do you think you might be?

MS. SHERMAN: Perhaps an hour.

JUDGE VITTONE: An hour.

Who has questions for Dr. Jenkins?

(Show of hands.)

JUDGE VITTONE: One, two, three, Mr. Rupp.

Mr. Gross, give me an estimate.

MR. GROSS: Five minutes.

JUDGE VITTONE: Five minutes.

The gentleman in the white shirt. I'm sorry?

DR. HAMMOND: I also have some questions.

JUDGE VITTONE: How long?

DR. HAMMOND: Twenty minutes.

JUDGE VITTONE: All right. Twenty minutes.

The gentleman in the white shirt.

VOICE: A half hour, 45 minutes.

JUDGE VITTONE: Okay.

Mr. Myers?

MR. MYERS: No more than half an hour.

JUDGE VITTONE: Okay.

And Mr. Rupp?

MR. RUPP: About a half hour.

JUDGE VITTONE: A half hour.

DR. JENKINS: I have a seven p.m. flight but, as I said, I don't have to go home first.

MS. SHERMAN: I think that we are committed to having Professor Bridges testify even if we're here later than we would like to be.

JUDGE VITTONE: Okay. All right.

Should I cut it down to 45 minutes?

Let's make it 1:00 we'll return.

AFTERNOON SESSION

1:10 p.m.

JUDGE VITTONE: Let's go back on the record.

We resume with Ms. Sherman.

MS. SHERMAN: I was wondering if I could ask the Court Reporter to refresh my memory with the last question.

THE REPORTER: My courier has already picked up that tape.

DR. JENKINS: ...whether or not we had data on the no-shows, but that's about what I remember. I had a lot of questions asked so far. I'm sure I've got a lot to go, so...

MS. SHERMAN: So you don't want to help, right?

DR. JENKINS: No, if I could remember, believe you me, I would help.

You can start a new line of questioning. If it occurs to you where we were, you can come back, certainly.

MS. SHERMAN: I believe you indicated in some of your written submissions that potential participants were asked questions about the type of building where they were employed. Did you try to obtain information about the type of ventilation system in the building?

DR. JENKINS: Yes. To the extent that the participants knew what that ventilation system was.

MS. SHERMAN: If you asked them about it and they didn't know, did this result in them being excluded from your sample?

DR. JENKINS: No.

MS. SHERMAN: Do you remember what percentage of people had information about the ventilation systems?

DR. JENKINS: I don't remember because I haven't specifically looked at that information yet. We have the information, I just haven't looked at that set of information.

MS. SHERMAN: But you can make that available to us?

DR. JENKINS: Oh, yeah.

MS. SHERMAN: Okay.

Did you ask people what type of ventilation system their home had?

DR. JENKINS: Yes.

MS. SHERMAN: Do you remember what percentage knew?

DR. JENKINS: No, I don't recall that. Again, we have that information and we can provide that to you.

MS. SHERMAN: Were they generally more familiar with it than they were with their workplaces, or you can't make a generalization?

DR. JENKINS: It would be difficult to make a generalization. It's difficult for me to make a judgment relative to the population as a whole. I'm always aghast at people that don't know the size of their own homes, for example.

MS. SHERMAN: I was just going to ask you that. Did you try to come up with any figures as to square footage?

DR. JENKINS: Yeah. We certainly did. We asked them the size of their home, the square footage, and we also provided them with some guidance.

In the rooms that they were sitting, to try to get sort of... In other words, we would step off and say okay, this is about 650 square feet, this room, it's one big room and most people don't have large rooms like that in their homes, but just to try to give them some kind of an idea as to how bit their homes were and that sort of thing.

MS. SHERMAN: Did you try to find out square footage of workplaces?

DR. JENKINS: Yes, when they had that information, yes. We didn't exclude them if they didn't know what that information was.

MS. SHERMAN: Did you make any attempt to find out how many people were within a certain number of feet of them at the workplace?

DR. JENKINS: Yes.

MS. SHERMAN: So you have...

DR. JENKINS: Also how many smokers...

MS. SHERMAN: ...diary?

DR. JENKINS: Oh yeah. In fact some of the information I have right on my computer with me right now, but given the time, we won't probably want to spend the time taking breaks so I can track it down for you.

MS. SHERMAN: However, you can provide that to us?

DR. JENKINS: You want to know home or work ventilation, and how many subjects close to them, how many people. Okay.

MS. SHERMAN: Do you have any breakdown as to what the cost of the sampling was?

DR. JENKINS: I can make some estimates. I know about the times, but without doing some careful calculations I couldn't tell you what the cost was. It involved maybe four to five or six people over the course of a week in any one city, plus set-up time of a typical couple of days for a couple of people. You're talking probably 30 to 40 or 50 man days per city.

MS. SHERMAN: Do you have any information as to the analytical costs?

DR. JENKINS: No, I don't. Again, I could make some estimates of that but I don't have... I'm sure that I could get some estimates if that was really important to you, but I'd have to ask R.J. Reynolds what their estimated costs were. I shudder to think what they are, but... I know exactly what our costs were, but I don't...

MS. SHERMAN: You absorbed analytical costs?

DR. JENKINS: No, no, no, no. The Center for Indoor Air Research pays for the work that we've done on the study, and to date, despite what the article in USA Today said, we will have been paid, when the time is over with, about $450,000 for our participation in the study. That is equivalent to about two and a quarter man years worth of work.

MS. SHERMAN: I believe that in the work and home pump surveys you asked the participants if anything happened during the sample collection that might exaggerate the reading in the IAR?

DR. JENKINS: I don't think we used the term exaggerate. What would contribute to the amounts of material present in the air, but we didn't use the term exaggerate. That's a very value-laden term, and it's not particularly appropriate for this.

MS. SHERMAN: Did you ask if anything happened that would minimize the readings?

DR. JENKINS: We asked them about, I believe, things like were windows open, much of their work day did they spend outside, that kind of stuff. Yeah, we have that kind of information.

MS. SHERMAN: You say the diary entries indicate how close the participant was to those observed using tobacco products?

DR. JENKINS: No, the diaries don't, but they're asked to self-report that information on the last visit survey. I believe what I'm saying to you is correct. Again, without all that information in front of me...

MS. SHERMAN: But you're going to make that last visit survey available to us.

DR. JENKINS: My plans are with the permission of the Center for Indoor Air Research, to make this information available to you, yes.

MS. SHERMAN: Do you have the raw data on the demographics of each subject who you accepted into the survey?

DR. JENKINS: Yes.

MS. SHERMAN: Can you make that available to us?

DR. JENKINS: Absolutely not.

MS. SHERMAN: Without personal identification?

DR. JENKINS: I just really don't think that would be appropriate, to be honest with you. Every one of the subjects in the study signed a confidentiality agreement, and we said in that... We also had to do this in terms of a human studies project, are you aware of human studies considerations? We were acquiring saliva samples from these individuals, and because that's a biological fluid we had to get DOE essentially to agree for us to do the study on human studies considerations. Because of that, we basically provided them with a statement saying this data will not be generally shared so that it can identify individual responses, other, obviously, than the principal investigators in the study. But I don't think that would be appropriate to make that kind of personal information available.

MS. SHERMAN: Well, I don't want to quibble with you about it. We have no interest in knowing the person's name, certainly.

DR. JENKINS: No, I understand that. Let me say this. Our plans, in addition to the final report, are also ultimately, although it may not come out with the final report, to provide much of this data in the format of a Microsoft access database that you can cut and slice and dice and whatever you want to do with your heart's content with it. That information is going to be made available... We've talked to the CIAR about that, they don't seem to have any particular problems with it. Originally we're not going to provide every single last piece of information, but there's going to be a wealth of information there.

But to provide you with copies... We had to devote a whole room. We've had to put locks on a storage room so that we can limit access to the room where we're storing all this data. It takes an entire office, basically, to store all the information just for the subjects.

MS. SHERMAN: Well, I'm not computer literate, but I understand there are things called datatapes that...

DR. JENKINS: Oh, yeah. Those are...

MS. SHERMAN: ...smaller...

DR. JENKINS: That's correct. We have all the information coded on datatapes. Again, I would have to discuss whether or not the... These are the properties of the Center for Indoor Air Research, really, and I would have to discuss that on them whether or not they want to make this detailed kind of data generally accessible to everybody. But you're right, they do exist on datatapes.

MS. SHERMAN: If you see fit to do that, you could pass it...

DR. JENKINS: I'll certainly discuss this with Dr. Eisenberg.

MS. SHERMAN: So then you have data in your datatapes as to how many of the participants by city were waitresses or school teachers or...

DR. JENKINS: Oh absolutely. In fact we have all... Yeah. You saw some of that data this morning.

MS. SHERMAN: Right, and I guess I'm asking to see more of it.

DR. JENKINS: Again, we're planning to have it in the final report, and ultimately we expect to publish this stuff. But I know you need to have that information sooner rather than later, right?

MS. SHERMAN: Yes. I was going to say, when are we talking about?

DR. JENKINS: Theoretically, the final report is supposed to be done by the end of this month. I would like to hope that we're going to be able to finish it by that time, although I think that's a pretty optimistic projection, given that we only received the last laboratory data at the beginning of November. But when the final report does become available, certainly it would be some time the end of January, beginning of February some time when that data would be made available. We would provide that to the sponsor, and if the Center was willing to provide you with a copy, which I think they probably would be, then I'm sure you can have it.

MS. SHERMAN: Well, I don't have the Center here, I have you here.

DR. JENKINS: I understand that. But I can't make promises for the Center.

MS. SHERMAN: I understand you can't promise, however, the...

DR. JENKINS: I will certainly convey your desires and wishes to the Center, and we'll...

MS. SHERMAN: The easiest conduit of it would be through you in a post-hearing comment.

DR. JENKINS: That's fine.

MS. SHERMAN: I believe that in part of your written submissions you were talking about buildings where smoking was banned entirely versus buildings that had designated smoking areas, et cetera. What was the definition that you used for a designated smoking area?

DR. JENKINS: I don't think there was a specific definition that we provided the individuals with that in the study. We just said what kind of restrictions? Total ban, designated areas only? It's impossible in this kind of a survey to define every single term that's used in the survey.

MS. SHERMAN: In other words, you would have no way of knowing if somebody checked "designated smoking area" if it's the type of an area that perhaps is contemplated in our proposal?

DR. JENKINS: With a separate ventilation system, you mean?

MS. SHERMAN: Yes.

DR. JENKINS: I do not believe that we specified separately ventilated designated smoking area, so no, we would not have that information.

MS. SHERMAN: So it might be or it might not be.

DR. JENKINS: That's correct. It might or it might not be.

MS. SHERMAN: In your December 22nd addendum, you have a Figure 3 on page 17.

DR. JENKINS: Let me look at that.

(Pause)

DR. JENKINS: Okay.

MS. SHERMAN: Is this data based on diary information, or is it based on the last visit survey?

DR. JENKINS: That data on Figure 3, which is the same as one of the slides I presented this morning, is based on the last visit survey.

(Pause)

MS. SHERMAN: I believe that in your study report you indicate that the levels of the ETS markers people are actually exposed to are lower than that which may be inferred from previous studies of ETS markers. I think this was covered in your book on the chemistry of tobacco smoke...

DR. JENKINS: The previous studies referred to were the studies reported in that book that was published in 1992.

MS. SHERMAN: Right. Do you believe that improved sampling and analytical techniques might be an explanation for this?

DR. JENKINS: As I recall, in some of the cases that we looked at in the studies that were described in the monograph, it's true that the detection limits there were higher than they would be today. That may contribute, but in general most of the levels that were reported previously were above the detection limits that were being reported at the time. Therefore, the improvement in detection limits only tells you about, gives you an accurate measurement at the very, very lowest possible end of the scale. The improvements in the detection limits shouldn't affect the high end. It may have a small contribution, but I don't think it's an important one.

I think, for example, in one of the studies that we looked at, I think the detection limit was something like 1.4 micrograms per cubic meter. We had to count all that data as essentially say half of the detection limit or one microgram per cubic meter for nicotine. Nowadays with the methodology that's being used and the detection limits that we have, you can get down considerably below that. So the numbers at the lower end of the scale, below one microgram per cubic meter, are much more accurately represented by the new data. But the overall distribution shouldn't change. How much stuff is queued kind of at the lowest end of the scale.

MS. SHERMAN: I think you said that in one of the cities there was a failure of communication and people did some sort of a mall intercept.

DR. JENKINS: Yeah.

MS. SHERMAN: This is different from using a market research database.

DR. JENKINS: That's correct.

MS. SHERMAN: The market research database, they got the numbers from the database and then they called them, so it was no longer random digit dialing.

DR. JENKINS: That's correct, absolutely.

MS. SHERMAN: But it was over the telephone?

DR. JENKINS: It was over the telephone, correct, yeah.

MS. SHERMAN: Do you have the cities in which you had to use market research data...

DR. JENKINS: Oh, yes.

MS. SHERMAN: How many of the cities were there, do you remember?

DR. JENKINS: I know for all the last four cities we did, and for about the final, maybe about half of the cities, the last half of the cities, say nine through 16. I might be wrong on this because I haven't looked at that data in awhile. I could have told you better last June.

I would say between six and eight of the cities that we used, that we surveyed, we had to use at least some marketing research databases to augment those participants that were in smoking homes or workplaces.

MS. SHERMAN: Can you provide me with those cities and the percentages?

DR. JENKINS: I think I can.

MS. SHERMAN: When you were using this market research database to fill in your cells or whatever, was there any way of sort of correcting your universe of subjects?

DR. JENKINS: I'm sure that there is. I don't think we attempted to do that at this point. We haven't made those kinds of corrections in the data.

MS. SHERMAN: But there are acceptable ways of doing this that you're...

DR. JENKINS: I'm not a marketing research expert and I'm out of my area of expertise here. We can talk about detection limits and all that kind of stuff, but we get into market research, that's not my strong point. I'm not sure that we can do those kinds of corrections. We certainly can draw demographic profiles, and that's something that we asked Bellomy Research, was that if we went to these databases, how representative would they be of the population in that city? Lacey, Mr. Bellomy, was very emphatic that the reason why they had those particular databases in those particular towns is because they were representative of the city as a whole. That's why they developed those kinds of databases.

MS. SHERMAN: So is it your impression that these databases have been, I'm not sure if I'm using the term correctly, but validated?

DR. JENKINS: My impression of it is I think any time you use a term like validated, different people have different means, but I think generally, I guess I'd say yes, that's my impression.

MS. SHERMAN: Was the mall intercept only used in St. Louis?

DR. JENKINS: Yes.

MS. SHERMAN: And then you did not redo it, you just decided it was less than five percent so you...

DR. JENKINS: We just went ahead and included the people.

MS. SHERMAN: What is the reason that you believe there was so much difficulty in recruiting people in San Antonio?

DR. JENKINS: I have no idea. I really don't. I just can't tell you. It would be sheer speculation on my part.

MS. SHERMAN: Do you know whether Bellomy looked into the skill of their subcontractor? I believe you said in some cases you would have the same subcontractor for more than one city.

DR. JENKINS: Yes, and I don't remember which subcontractor it was in San Antonio. My recollection is that it was a San Antonio only sort of a place. Bellomy had done work with, may have done previously and had a great deal of confidence in this group. I don't know why they had such a difficult time recruiting those subjects.

(Pause)

MS. SHERMAN: In Table 8 of your December 22nd addendum, results seem to yield ETS nicotine concentrations in the workplace which averaged 1.7 micrograms per cubic meter, and away from work, 1.76, is that correct?

DR. JENKINS: That's correct. In the home where they had to have reported exposure in the home, it went to 2.16.

MS. SHERMAN: Right. Yet in Tables 9 and 10 you concluded, apparently you concluded that non-workplace or residential exposures were four to six times larger than the workplace exposures.

DR. JENKINS: That's because I was really discussing the data on Table 7 which is what I referred to as overall exposures which incorporate both the average concentrations to which the individuals are exposed and the time of the exposure. And of course because you're away from work longer than you are at work.

MS. SHERMAN: So that was really dose?

DR. JENKINS: Yeah. That's what Dr. Samet referred to as dose this morning.

MS. SHERMAN: And you agreed that...

DR. JENKINS: I agreed that's a good way of describing that.

MS. SHERMAN: When you reported your subjects with the salivary cotinine of about two nannograms, .2 nannograms per milliliter, I believe?

DR. JENKINS: Yes.

MS. SHERMAN: Using a radio immune assay. What was the limit of detection there, do you remember?

DR. JENKINS: No, I don't remember, but I have it with me, I think. Well, wrong. I don't have it with me. That certainly is very near the detection limit if not the detection limit. I thought I had brought that, too. This is my detection limit sheet, and I don't have that. I'm sorry. I can certainly provide that to you, and it sounds like you'd like to have that information.

MS. SHERMAN: Yeah. In your docket submission from August, your interim report number three.

DR. JENKINS: That was actually submitted by the Center for Indoor Air Research.

MS. SHERMAN: But I assume that...

DR. JENKINS: Well, I provided them... They needed something to send in to the hearings, so they asked me to put together an interim report, and I certainly suspected it was going to go into the docket.

MS. SHERMAN: It does have Dr. Eisenberg's name on it, but it also has yours.

DR. JENKINS: Oh, that's right. Because I submitted it to him. Anyway, what about that? If I can find it I'll...

Here we are.

MS. SHERMAN: I believe Table 10.

DR. JENKINS: Okay. Those are the comparison of the salivary cotinine levels and the median nicotine exposures?

MS. SHERMAN: Right.

DR. JENKINS: Or median nicotine dose, depending on... I guess we're going to call it dose.

MS. SHERMAN: You presented data on median cotinine units of nannograms per milliliter and the corresponding median nicotine exposure, but in the footnote you refer to the cotinine values as mean values. As opposed to median.

DR. JENKINS: That's correct. That is the median of the mean values. As I think I may have indicated in my testimony this morning, we took a salivary cotinine sample on day one, the evening of day one, and then we took another salivary cotinine on the afternoon of day three. Two measurements were made on each one of those samples. We typically took a mean of those, and we had like a mean start and a mean stop. Start on day one, stop on day three. Then we averaged those two together to give an overall average mean concentration for salivary cotinine for the participants that were measured during the study.

We then took all those mean values and statistically analyzed them, and we're reporting here the median of those mean cotinines. It's just one way of handling the data, without trying to overwhelm anybody that's trying to read this with all the fine print. I can understand why that might be a little confusing.

MS. SHERMAN: Yes.

You stated in Tables 9 and 10 of that document that salivary cotinine doesn't appear to be proportional to nicotine exposure.

DR. JENKINS: In Table 10 of interim report number three, we're discussing the salivary cotinine. And in Table... I just want to make sure, again. Nine and ten of the interim submission dated the 22nd of December, I think that's the tables you're referring to now?

MS. SHERMAN: No, I'm referring to the...

DR. JENKINS: There's only one table in the interim report that refers... Well, there's two tables. There's Table 10 and Table 11 that have salivary cotinine discussed, in interim report number three.

Whatever your wish is, I'll go to that table and we'll talk about it. I just want to make sure we're talking about the same thing.

MS. SHERMAN: You are correct about Table 9 in the their interim report. It does not appear...

DR. JENKINS: Table 9 does not appear?

MS. SHERMAN: ...to be reporting cotinine levels.

DR. JENKINS: Right, that's correct.

MS. SHERMAN: You said in your January report, is that it?

DR. JENKINS: December 22nd. The one I just sent you right before Christmas. What's referred to as the addendum to the comments on the proposed rulemaking. It's dated the 22nd of December. I think what you're referring to is Tables 9 and 10.

MS. SHERMAN: Yes, I stand corrected.

Wouldn't you expect the relationship to be proportional?

DR. JENKINS: I've learned as a scientist never to anticipate too many results. I am not surprised that the medium cotinine levels track the median nicotine levels as a group, but also from some other studies that we've looked at, I'm also not surprised to see that for an individual basis there's very, very poor correlation between the nicotine dose or exposure and the salivary cotinine.

MS. SHERMAN: What was the cutoff point on your initial screening above which you decided that somebody couldn't participate in the study because they hadn't been quite candid about their smoking status?

DR. JENKINS: The misclassification level? All this data that you saw in the addendum that is dated the 22nd of December, had the subjects excluded from it whose mean cotinine level, that is the average of their start and their finish cotinine level, was greater than 15 nannograms per milliliter.

MS. SHERMAN: That's an impossible number to get just from exposure to environmental tobacco smoke?

DR. JENKINS: Basically we've relied on the data that was sort of compiled and summarized in a paper by Edsal, I believe, in was it Preventive Medicine 1990? I have it somewhere here in my stacks, and I've quoted it. But basically, they allude to the fact that it might be possible to... It depends on if you're trying to avoid false positive or false negative results. If you go to a very, very low level, yeah, you might be excluding those individuals who may get very, very high ETS exposures, but you are for sure excluding those who are smokers, and you don't want those smokers smoking around your sampling pumps.

I've had several discussions with the various members of the team on this study and where to set the cutoff point, and we've just gone around and around about this. We ended up saying if we looked at our salivary cotinine data and you plot this out on a histogram, and I don't have one of them here with me. But essentially what happens is that about somewhere on the order of 15 or so there is no body right there, there's this group, there's a few between 15 and 30, and then there's more people above that level.

It seemed to us that, sure, a better number, we could argue 12 or we could argue 20, but somewhere in that range is a range where we wanted to make a cut. We looked at our data and said 15's a great place to cut because there's nobody sitting at 15.10. So that's a good place to make the cut.

I think all these things, we could talk with a number of investigators here, and I'm sure they'd come up with different numbers to argue about where is the best place to make that cut. It was my judgment that we made it at 15.

MS. SHERMAN: And you don't have any information to make you believe you were wrong?

DR. JENKINS: There are reports in the literature which suggests that there may be some individuals who are in fact just exposed to ETS which have very, very high salivary cotinine levels. But it was the judgment, again, of Edsal who was writing this paper that that seemed to be a low-risk possibility and you've got to pick it some place.

It's very easy, and one of the things we're planning on doing is reexamining the data. For here, I've done it at 15 nannograms per milliliter. We're going to do it at 30 and 100. Frankly, with this number of subjects in the study versus the relatively low number of subjects that were misclassified, I think there was only a total of 15, using a cutoff of 15, we excluded something like 60-some people from the study, out of the 1500 or 1600 that we have.

Don't forget now, I know that Katherine's starting to look at one of the other tables in there. Those numbers in there are only those individuals that claim to be lifetime never smokers.

As I testified this morning, those individuals in the study could either be never smokers or former smokers, but we didn't want any current, active smokers. It's hard to keep it all straight.

MS. SHERMAN: I believe you used a six month cutoff, that they couldn't have smoked for the last six months. Was that...

DR. JENKINS: Just convenience. Six months is easy for them to remember. Has it been six months since you smoked cigarettes. We didn't want to get arguments about well, was it three weeks ago or four weeks ago? We didn't want to get into arguments about okay, was there some residual cotinine, et cetera, et cetera. We just said six months.

MS. SHERMAN: But in fact, cotinine clears the system relatively rapidly, does it not?

DR. JENKINS: Yes, but I didn't want to get into the situation where we've got people say that they're former smokers, but then they've sort of, well, I was a former smoker as of yesterday, but today I had to have a cigarette or two. So you quit for six months, then we figured at least for the immediate... Although I realize that people do start up again after a year or two.

MS. SHERMAN: Were you at all concerned about any residual nicotine or other residues of smoke on the clothes of more recent smokers?

DR. JENKINS: I guess that's always a possibility, but I wasn't so much interested in that. I was just interested in making a clear distinction and make it easy... You've got to understand, you're dealing with people... This is the general public we're dealing with, and you have to make things very easy for them to discern a distinction between a former smoker and a current smoker.

MS. SHERMAN: Do you report any information on ETS emission factors in milligrams per cigarette for RSP and nicotine for commercial cigarettes?

DR. JENKINS: We haven't done that kind of work. That's not part of the study.

MS. SHERMAN: Have you ever measured it?

DR. JENKINS: Yes, we've measured emission factors for research cigarettes. In particular, the Kentucky reference 1R4F cigarette for certain constituents. We came up with a new sidestream smoke generator because some of the earlier sidestream smoke generators had humidities inside them of 100 percent, and we didn't think that was very relevant to ambient smoking conditions. I think we reported on that at a tobacco chemists' conference back in the mid 1980s.

MS. SHERMAN: I'd like to thank you for your time, Dr. Jenkins. I think that Professor Hammond has a few questions for you.

DR. JENKINS: No doubt. That's fine, this is fun. I'm cool.

MS. SHERMAN: If you're having a good time, we're happy.

(Laughter)

DR. JENKINS: There's probably some analogy to my recent hernia surgery, but we won't make that too strong, here.

(Laughter)

DR. HAMMOND: First, I'd like to ask a few questions about the core group of people who were participating in designing this study.

Who would you say in your core group were the exposure assessment experts? People who were expert at designing exposure assessments for occupational or environmental exposures?

DR. JENKINS: I think it depends on what you consider to be an expert. Everybody has a different idea of what's an expert.

DR. HAMMOND: I'm asking who you would consider an expert.

DR. JENKINS: I would consider Mike Ogden pretty darn good at that. And I have done some work in it as well. I don't know if I'd consider myself an expert in it, but then an expert's anybody that's more than 50 miles away from home maybe, so...

DR. HAMMOND: Would you say that Bellomy Research Institute has, prior to the study, had experience in designing questionnaires to assess exposure?

DR. JENKINS: It's my understanding that this was not the first study that they had conducted involving exposures of individuals to ETS. This was not their first study. Whether or not that makes them an expert is difficult for me to judge.

DR. HAMMOND: Are you aware of the fact that there are research firms, not marketing research firms, but actual research firms who specialize in developing questionnaires for exposure assessment and interacting with people in that manner?

DR. JENKINS: Yes.

DR. HAMMOND: That are not marketing oriented.

DR. JENKINS: That's right.

DR. HAMMOND: Is there some reason you didn't choose one of those type of firms?

DR. JENKINS: Bellomy Research was suggested to us by the Center. That's sort of who they had in mind based on what their experience had been, and what R.J. Reynolds' experience had been, and I felt as though as long as I was comfortable with their willingness to adopt certain guidelines and make sure there was a good pathway of communication, I felt comfortable with the data they were generating.

DR. HAMMOND: I think I've heard it two different times, two different characterizations on your part of the study protocol from the point of view of the subjects. One time I think you referred to it as extremely onerous and difficult, and you weren't sure you would want to participate in it yourself, and then another time you said it would be kind of fun.

DR. JENKINS: Well, I guess I would liken that to divorce. It can be awful onerous, but it can also be an interesting experience, too.

(Laughter)

DR. JENKINS: Maybe that's a poor analogy.

The protocol is very demanding. The very fact that they have to show up twice at a location and they have to record this information requires a great deal of participation on their part.

DR. HAMMOND: Have you participated in similar studies like this, doing this?

DR. JENKINS: No, I have never personally...

DR. HAMMOND: Had anyone else on the study team participated in any study like that?

DR. JENKINS: I don't know about personally them doing it...

DR. HAMMOND: That's what I mean, personally. Have any of them...

DR. JENKINS: To my knowledge, no.

DR. HAMMOND: I know we've gone back and forth about...

DR. JENKINS: Let me, though, make sure you understand. I have personally conducted, my own self, using me as the guinea pick, personal exposure studies previously out in the field. In other words, I would go...

DR. HAMMOND: You conducted field studies.

DR. JENKINS: Field studies of personal exposure to environmental tobacco smoke of which I was the subject.

DR. HAMMOND: There's a difference. Let me explain to you. There's a difference between measuring an exposure and doing exposure assessment. Be aware of that.

DR. JENKINS: Oh, yes.

DR. HAMMOND: I'm asking about exposure assessment.

The next question relates to the difficulty, the "extreme difficulty" you cited several times, of recruiting subjects to the study.

DR. JENKINS: Yes.

DR. HAMMOND: I know you've already told Ms. Sherman that you don't have information step by step by when people, so to speak, flunked the screener. But I was wondering if you might have an overall view of the people who recalled what percentage, for instance, refused to answer questions, what percentage flunked the screener at any point, and what percentage passed the screener but refused to participate?

DR. JENKINS: We may have that information, but I don't have that information yet.

DR. HAMMOND: Could you please submit that in your post-hearing comments?

DR. JENKINS: If we have it, I'll be happy to provide it.

DR. HAMMOND: Thank you.

You have implied in your testimony that you thought the reasons might be related to the onerousness of the sampling and stuff. Are you familiar with anyone else who has done large field studies like this and the degree to which they are able to solicit the general population and get them to participate?

DR. JENKINS: I'm not personally familiar, no.

DR. HAMMOND: Would you be surprised to find out, for instance, that when EPA does very similar kinds of studies, such as the particle team studies, and they approach people, they find that 75 to 85 percent of the people are quite willing to answer the screening questionnaire, and of those who pass the screening, approximately 70 percent are quite willing to wear the sampling device?

DR. JENKINS: I'm aware of the team study.

DR. HAMMOND: Are you aware of the fact that they did not have this difficulty getting participation?

DR. JENKINS: I wasn't aware that they had that degree of compliance. As I indicated, we did have some good responses in... Portland, Maine stands out as a real high point because it was...

DR. HAMMOND: To what...

DR. JENKINS: I don't want to speculate.

DR. HAMMOND: Okay.

Do you know what percentage of your subjects had private offices at work?

DR. JENKINS: I can't tell you right off hand. We have...

DR. HAMMOND: Could you...

DR. JENKINS: Absolutely, we have that information.

DR. HAMMOND: Could you provide that in the post-hearing comments, and specifically segregated by the type of the cells you have of the type of smoking restriction? In other words, what percentage of the subjects who worked at a workplace with no smoking restrictions had private offices; what percentage of the subjects who worked in areas that had smoking in designated areas only had private offices; and which had smoking bans?

DR. JENKINS: I'll try to provide that information for you. I hope somebody's taking really good notes. I have a page of them already for...

(Laughter)

MS. SHERMAN: The transcript tells all.

DR. JENKINS: Okay.

DR. HAMMOND: Similarly, just for your information, since you haven't had... I have had a lot of experience myself in conducting these studies.

DR. JENKINS: Yes, I know you have.

DR. HAMMOND: I'd like to turn to this question of the smoking policies. This is Table 6 in your addendum. If it's easier for you, it's Slide 44.

DR. JENKINS: That's fine, Table 6 I've got.

DR. HAMMOND: Which ever is easier. Can you tell me what percentage of your subjects worked in a workplace where smoking was banned entirely from the building?

DR. JENKINS: I can do a quick mental calculation of that. Approximately 80 percent of the people reported some kind of restriction. Of those 80 percent, it was something like 50 percent reported a total ban, so it could be as many as 40 percent of the subjects in the study.

DR. HAMMOND: Would it be correct to say it's 823 according to Table 6? Eight hundred twenty-three divided by the sum of 168, 365. and 823?

DR. JENKINS: Without being able to... We can make some ball park estimates, but without being able to go back and examine...

DR. HAMMOND: No, isn't this table, isn't this information right here in the table? Or am I misreading the table?

DR. JENKINS: Okay, 823 participants... Right. What did I say? Forty percent of the participants... So it's closer to 50 percent.

DR. HAMMOND: If you divide 823 by the sum of those three numbers, would you be willing to believe me if I told you a percentage, or do you want to use your own calculator to ...

DR. JENKINS: No, no, no, no, no, no. I believe you. Of the participants of which we got that information, I believe 823 out of the probably 1200 or 1300 people. But as you can see, this number does not add up to say the 1498 individuals for which we have say salivary cotinine data.

DR. HAMMOND: There does seem to be a problem throughout of people falling by the wayside, but as long as we look at the data that you have. You have the data. If you divided 823 by, I think if you do the sum, that's 1356?

DR. JENKINS: Okay.

DR. HAMMOND: Would you be willing to believe that's 61 percent?

DR. JENKINS: I could believe that.

DR. HAMMOND: You can check the numbers later.

DR. JENKINS: No, I trust you. You sound like a good mathematician.

DR. HAMMOND: No, I have a calculator.

(Laughter)

I'm not going to even ask that you do long division.

DR. HAMMOND: Do you have any idea what percentage of these subjects, according to your table here, worked in buildings where smoking was restricted to designated smoking areas?

DR. JENKINS: Well, using this same kind of approach, you would say there are 365 out of the 1300 and whatever.

DR. HAMMOND: Which is 27 percent.

DR. JENKINS: Ok.

DR. HAMMOND: What percentage worked where smoking...

DR. JENKINS: The remainder.

DR. HAMMOND: Twelve percent.

DR. JENKINS: Okay.

DR. HAMMOND: Does that surprise you at al, that only 12 percent of your subjects worked some place where smoking was allowed?

DR. JENKINS: Twelve percent of the subjects appearing in this table.

DR. HAMMOND: Yes. Which are the vast majority, over 90 percent of your total subjects, correct?

DR. JENKINS: That's correct. Would it surprise me if I said was the 12 percent worked in non-restricted? No, it wouldn't surprise me at all. That's what the data shows.

DR. HAMMOND: Do you think that's representative of the cities in which you performed your sampling?

DR. JENKINS: It's difficult for me to judge without having all of the information at my fingertips regarding what the smoking workplace policies were in the individual cities. However, it's important to keep in mind that while there were this large number of individuals, a large fraction of the population where there was smoking only in designated areas or no smoking at all inside the building, in fact many of those people reported smoking quite near them.

DR. HAMMOND: Was it really many? I was a little confused by that slide that you showed. It looked to me like if you said there were smokers nearby, I wasn't sure. Were those people who just happened to be smokers but not that they were smoking nearby, and you had to move to the third bar to say that they actually were smoking nearby.

DR. JENKINS: Uh huh, individuals smoking nearby. But if you...

DR. HAMMOND: That would be the thing that's of relevance that would lead to ETS exposure.

DR. JENKINS: That's right.

DR. HAMMOND: The middle bar, we all know there are smokers around there. It's not so relevant.

DR. JENKINS: But they were also asked whether or not there were smokers within, typically within 100 feet, even though they had a total smoking ban. And these...

DR. HAMMOND: These were smokers, though, and not people smoking.

DR. JENKINS: That's correct. But people who do smoke... Again, it's always difficult any time you ask a question in a study to try to get inside the mind of the individual and think what they were really, how they were really trying to respond. Hopefully you design your questions so that they;re very explicit.

DR. HAMMOND: That's exactly why you have experts who do that, yeah. Right.

DR. JENKINS: Yes.

DR. HAMMOND: I'd like to turn to looking at the relative exposures in the workplace and the home. Again, help me to understand. Is Table 6...

DR. JENKINS: Which...

DR. HAMMOND: This is the addendum. Is Table 6, the exposures, measured entirely from just the workplace sample?

DR. JENKINS: That's correct.

DR. HAMMOND: In Table 8, when you have for instance the home venue, it says 16 hours, that is measured entirely from the other sample that was collected away from work, is that correct?

DR. JENKINS: That is correct.

DR. HAMMOND: That just helps me to understand this data.

It seems to me that if one wants to understand what are the relative exposures in the workplace and in the home, one wants to look at where there are no restrictions on the smoking, we would look at this table of non, the individuals who were non. And for instance, if we look at this table and say we pick a particular thing, what would you say in the, actually going to Table 8 in the home exposures, which are the higher exposed people away from home, what was the median concentration of their exposures of nicotine?

DR. JENKINS: The median concentration of the exposures of those that were exposed in the home was .68 micrograms per cubic meter.

DR. HAMMOND: What's the 80th percentile of the exposure subjects who worked where smoking was allowed? That's from Table 6.

DR. JENKINS: Three point six micrograms per cubic meter.

DR. HAMMOND: Now that's a much higher number by about what factor, would you say?

DR. JENKINS: I don't know. We're talking about, about a factor of five.

DR. HAMMOND: Even if we adjust for the time spent in those two locations to get your measure, you still would have over double the exposure in this 80 percentile.

DR. JENKINS: But you're comparing here medians and...

DR. HAMMOND: I understand that. So the way to interpret this, these comparison groups now, are that 20 percent of people who work in a workplace that allows smoking, help me if I'm wrong on this, are exposed to more than half of the people, more tobacco smoke than half of the people who are exposed in the homes.

DR. JENKINS: In terms of the average concentration...

DR. HAMMOND: No, medians.

DR. JENKINS: No, no, no. We're comparing now... Remember that we're comparing the time weighted average concentrations...

DR. HAMMOND: Yes.

DR. JENKINS: So we're not talking about exposures or dose here. We're only talking about what is the overall average concentration. Yes, I would agree that 20 percent of the people in the workplace experience an overall average concentration of nicotine which is five times greater than half of the, that the people receive in the home. That's sort of a... Yeah.

DR. HAMMOND: If we think about from the epidemiologic studies that the home exposure, the median home exposure has been shown to present a health hazard, to increase the risk of lung cancer and heart disease, if you were to accept that. I'm not going to ask you to accept it or not. If you accepted that, then wouldn't you say that at least 20 percent of the people work in a workplace where there are no restrictions on smoking actually are definitely at a risk quite comparable to the home exposure?

DR. JENKINS: Wait a minute, now. I thought that we were only talking about, you brought in the subject of epidemiology. Again, I'm no epidemiologist here, but I thought we were talking about the excess, this concept of excess deaths due to smoking and lung cancer, right?

DR. HAMMOND: No, not excess deaths.

DR. JENKINS: Well, increased risk.

DR. HAMMOND: What I was saying was if we for a moment, if you would just grant me for a moment that we'll agree with IARC and EPA and the NRC and the Surgeon General and the EPA and say that passive smoking in the home does increase the risk of lung cancer and also, in many other studies, increase the risk of heart disease, so that is a hazardous...

DR. JENKINS: For the constraints on the studies which were done.

DR. HAMMOND: Right. But let's just accept that for now, not argue the epidemiology since neither of us...

DR. JENKINS: Good.

DR. HAMMOND: If you accept that that level of exposure in the home represents a hazard as many other models have agreed, then aren't you also saying that 20 percent of the workers who work in a place without smoking restrictions are exposed to higher levels than half of those people in homes?

DR. JENKINS: That's correct.

DR. HAMMOND: That's what your data is saying.

DR. JENKINS: That's correct. That's correct.

DR. HAMMOND: Okay. Thank you. Okay.

Maybe you can help me with something. I just loved a little thing you were able to do. Would you tell how you can take, as you did in your paper, the arithmetic mean, the arithmetic standard deviation and the geometric mean and from that tell whether distribution is log normal? I was intrigued with that.

DR. JENKINS: Oh, I didn't claim that the distribution -- where did I say that the distribution was log normal? I said it was skewed.

DR. HAMMOND: Page 439.

DR. JENKINS: Page --

DR. HAMMOND: The third paragraph. In your submission in August. This is from your paper from EPA -- it was -- I always get the initials wrong.

DR. JENKINS: Oh, the EPA MWA?

DR. HAMMOND: Yes.

DR. JENKINS: I don't have that with me.

DR. HAMMOND: I can read it to you, perhaps. Do you want to look at it? Yes.

MS. SHERMAN: Perhaps for purposes of the transcript, we should read the title of the paper into the record.

DR. HAMMOND: That's not the paper itself.

JUDGE VITTONE: This is the "Comments on Proposed Rulemaking"?

DR. JENKINS: No. That's not the title of the paper. Why don't you give it to me and I'll read the title.

DR. HAMMOND: You know what I'm referring to.

DR. JENKINS: I know what you're referring to. I was almost going to say I know what I was doing but --

(Pause)

DR. JENKINS: The title of the paper to which you were referring to is "Nicotine and Environmental Tobacco Smoke, Comparison of Mobile Personal and Stationary Area Sampling." The authors are Jenkins, Moody, Higgins and MoneYour Honoreim.

DR. HAMMOND: So page 439.

DR. JENKINS: Page 439.

DR. HAMMOND: Third paragraph.

DR. JENKINS: Third paragraph.

DR. HAMMOND: And it's near where the red arrow is and there's a circle with a question mark.

DR. JENKINS: It states arithmetic mean and standard deviation, geometric means, for the area samplers those parameters were such and such. "These values indicate a log normal distribution of the data."

DR. HAMMOND: I was wondering how you could come to that conclusion from those numbers.

DR. JENKINS: You probably can't come to it from those numbers and that was probably a misquote and probably what I had done is look at the date more thoroughly and performed a log normal analysis.

DR. HAMMOND: Okay. I thought maybe you found some new method to make our lives much easier.

DR. JENKINS: No.

DR. HAMMOND: Thank you.

Then I would like to turn to slide 46 in your presentation. And this is a distribution of the respirable particles to nicotine ratios in the workplace, is it not?

DR. JENKINS: That's correct.

DR. HAMMOND: Why did you prepare this figure?

DR. JENKINS: Why did I prepare the figure?

DR. HAMMOND: Yes.

DR. JENKINS: Okay. There was a -- as I went through the proposed justification, one of the things that struck me was the contention that RSP to nicotine ratios, I think, that Mr. Repace in his article had indicated that he had picked a 10 to 1 RSP to nicotine ratio.

DR. HAMMOND: Was that total RSP or RSP from environmental tobacco smoke?

DR. JENKINS: I believe that that was total RSP.

DR. HAMMOND: Do you think that any RSP that you would measure in a room is entirely from environmental tobacco smoke?

DR. JENKINS: Of course not.

DR. HAMMOND: What other sources of respirable particles are there in the workplace?

DR. JENKINS: How many days do we have here? There's plenty.

DR. HAMMOND: A lot.

DR. JENKINS: There's a lot.

DR. HAMMOND: Did you measure any marker in your series of ETS markers? Did you measure any marker that you might consider a better marker for the respirable particles that do come from environmental tobacco smoke?

DR. JENKINS: Sure. Sure. UV absorbing particulate matter.

DR. HAMMOND: Okay. Let's take that. Let's take that, UV absorbing particulate matter, okay?

DR. JENKINS: Okay.

DR. HAMMOND: Wouldn't you think that a comparison of the ratio of UV particulate matter to nicotine would be a much more appropriate ratio to examine? To look at the RSP from environmental tobacco smoke to nicotine?

DR. JENKINS: If that's what you wanted to do, yes.

DR. HAMMOND: Did you do such an analysis?

DR. JENKINS: I haven't done it yet. I'd be happy to do that, though. Thank you for the suggestion.

DR. HAMMOND: Yes. Sure. By the way, I didn't have access to your full data set, of course --

DR. JENKINS: I hardly have access to my full data source.

DR. HAMMOND: However, I did take some of your data from Table 8 and just looked at that data. Would you be surprised to hear that when I took those ratios that they came out to average 10.2?

DR. JENKINS: No, I wouldn't be surprised. The data from Table 8?

DR. HAMMOND: Yes.

DR. JENKINS: Using UVPM?

DR. HAMMOND: Yes. What I did is specifically I took the home and work median, mean, 80 percentile and 95 percentile just to give me several points, eight points. I took each of those ratios of the UVPM, this is your own data, to nicotine and found ratios that ranged from 8 to one of them was 16 but the average was 10.

DR. JENKINS: Great.

DR. HAMMOND: What is the more appropriate way, if you didn't have the UVPM, do you have any idea what might be a better, more appropriate way to try to understand RSP from ETS from particulate data and from nicotine data?

DR. JENKINS: If I didn't have UVPM or fluorescent particulate matter?

DR. HAMMOND: Right.

DR. JENKINS: Well, I guess one thing that you could do is you could look at something like solanosol and then relate to --

DR. HAMMOND: Let's say the only data you had was RSP and nicotine. Is there any way from that you could get to what the RSP from ETS is?

DR. JENKINS: Well, theoretically, you could -- I think you've really hit on one of the real problems and I know one of the issues that's important to you is the issue of markers and their utility and that sort of thing. The problems with relating RSP to nicotine directly in environments is that the nicotine, you know, plates out on stuff, it's just -- it's also affected by the ventilation.

DR. HAMMOND: No, I'm just asking, though, if we wanted to just determine what the ratio was.

DR. JENKINS: What you could do is you could start with some chamber measurements. The question is how relevant those chamber measurements are to the real world and try to get kind of a feel for what the RSP to nicotine ratio was then and then try to relate that to the real world but that's --

DR. HAMMOND: Has anyone done that?

DR. JENKINS: Oh, sure, people have done that. We've done that. We've published RSP, nicotine data. The problem is, you know, when you're generating stuff in a chamber, it's a very controlled kind of a situation, it is not particularly relevant to the conditions that exist out in the field.

DR. HAMMOND: Well, okay. I don't want to beat this into the ground. Let me make a suggestion to you of one way you can do it and that is if you were to make a plot of the respirable particles against the nicotine concentrations, the slope then gives you that ratio of the respirables for ETS --

DR. JENKINS: Oh, I know.

DR. HAMMOND: -- and the intercept gives you the background. If we take this data from Table 8 and I did such a plot, I got a slope of 12 and an intercept of 19, which is darn close to the 20 average that people talk about for background. So your data to the degree I can look at it, it looks very interesting that way. You might want to look at that, consider that.

DR. JENKINS: Well, we've done that. I think I have looked for individuals, you know, just looked at individual levels of RSP versus nicotine. And the problem is that they still look like -- I mean, yes, you can draw a line through it but they look like somebody fired a shotgun at the graph.

DR. HAMMOND: Have you ever done a correlation coefficient?

DR. JENKINS: Oh, yes. I don't know that I've done it for this particular data set but I've done those with other data sets. The correlation coefficients tend to be very low.

DR. HAMMOND: Have you seen the paper that was published by Leaderer and Hammond on the New York state study?

DR. JENKINS: When was that published?

DR. HAMMOND: '91.

DR. JENKINS: I believe I have seen it. And that was one of the few as I recall now, thank you. In fact, I think we mentioned that in the book.

DR. HAMMOND: You did.

DR. JENKINS: And that was one of the few cases where you did see the relatively good correlation.

DR. HAMMOND: By the way, for your own data since my computer does give me this number, the R-squared for your data in Table 8 that I just quoted to you, the R-squared was .99.

DR. JENKINS: That's great.

DR. HAMMOND: Yes. Yes. Okay. One final thing. Would you be willing to give us the limits of detection for all the ETS markers, as well as the cotinine?

DR. JENKINS: Sure. I mean, I have them right here.

DR. HAMMOND: Oh, if you have them now, sure.

DR. JENKINS: Of course, the limits of detection varied from city to city because of blank corrections.

DR. HAMMOND: Oh, actually, that's the other thing. Could you give us the limits of detection and also the average blank values? By city.

JUDGE VITTONE: Is that something --

DR. HAMMOND: In your post-hearing comments. In the post-hearing comments.

JUDGE VITTONE: Let's do that in the post-hearing.

DR. HAMMOND: Yes, I would like to see the blank values as well.

DR. JENKINS: Am I going to get -- does somebody send me a copy of this transcript so I know what I've promised here? How will we do that?

DR. HAMMOND: I'll turn you over but thank you very much.

DR. JENKINS: You're quite welcome.

JUDGE VITTONE: I'm sure Ms. Sherman will get you a copy of the transcript.

DR. JENKINS: I just want to make sure that I can provide everything that I've tried to promise here.

JUDGE VITTONE: Okay. Are you done, Ms. Sherman?

MS. SHERMAN: Yes, I am. Thank you for your time.

DR. JENKINS: You're welcome.

JUDGE VITTONE: It's 2:15. Where is Mr. Myers? He had 15 minutes worth of questions and I'd like to work him in, if I could.

Okay. And see if Mr. Gross is out there, too.

(Pause)

JUDGE VITTONE: Sir, would you identify yourself for the record?

MR. HOPPER: Good afternoon, Your Honor. I'm Randy Hopper. I am a partner with the law firm Zimmerman Reed in Minneapolis, Minnesota. That law firm also is a member of the Castano litigation team based in New Orleans.

Since numerous of other of my counsel as we went through yesterday related to Mr. Gori's testimony have already entered into the record our clients, if Your Honor has no significant need and it will expedite matters, I'll move right on, if that's okay.

JUDGE VITTONE: Okay. Go ahead.

MR. HOPPER: Good afternoon, Mr. Jenkins.

DR. JENKINS: Good afternoon.

MR. HOPPER: You already, I believe, entered into the record quite a bit of background about your education and your past and the work you've done. I want to just clarify a few things related to that as preliminary matters, if I may.

DR. JENKINS: Sure. Sure.

MR. HOPPER: Your prior work experience and associations, if my homework is correct, has also involved work with the National Cancer Institute, the National Institute on Drug Abuse, the Federal Trade Commission and Health and Welfare Canada. Is that true?

DR. JENKINS: That's correct.

MR. HOPPER: Are there other organizations or associations that you've been involved with?

DR. JENKINS: Oh, absolutely. Several branches of the military, program manager for Rocky Mountain Arsenal, the United States Army Biomedical Research and Development Laboratory. For me to -- I didn't bring a C.V. with me so I don't remember all the stuff I've done over the last 19 years but basically Departments of Defense, Energy, National Institutes of Health.

MR. HOPPER: And has that involvement all been as an analytical chemist?

DR. JENKINS: That is correct.

MR. HOPPER: And that's your principal occupation now with the ORNL?

DR. JENKINS: That's correct.

MR. HOPPER: And has your tenure -- how long have you been at Oak Ridge now?

DR. JENKINS: I've been at Oak Ridge since December 16, 1975.

MR. HOPPER: So you were there actually prior to the Martin Marietta takeover, correct?

DR. JENKINS: I am not sure that I would characterize it as a takeover but, yes.

MR. HOPPER: As the contractor --

DR. JENKINS: Yes. It used to be Union Carbide and then Martin took over. Right.

MR. HOPPER: Took over in that regard.

DR. JENKINS: Yes. In that broadest possible sense.

MR. HOPPER: Right. Took over that contract. And I understand you're not an epidemiologist and you're not drawing any conclusions as an epidemiologist.

DR. JENKINS: That's correct.

MR. HOPPER: Can you tell me, you also, I think, as an analytical chemist consider yourself to be a tobacco chemist. You've been on record in a number of instances where that's the case. You consider yourself an expert on tobacco?

DR. JENKINS: I would say that I have a pretty good background in the area of tobacco smoke chemistry in terms of making many of the measurements associated with it. Yes.

MR. HOPPER: Are you a smoker yourself?

DR. JENKINS: No.

MR. HOPPER: Does anyone in your family smoke?

JUDGE VITTONE: That question, maybe it's late in the season to be asking that but we've been asking that question since the day one. Why is that relevant, whether this gentleman or any witness is a smoker or his family has smokers?

MR. HOPPER: That's fair, Your Honor. It's relevant, I think, because if someone has professional experience with this substance that we're dealing with that's largely at the very core of a lot of this nicotine, I think it's a fair question to ask what one's personal experience may be with it. I think if we were dealing in a FDA situation or in a NIDA situation or any other judicial proceeding, rulemaking proceeding there, it would be fair to ask someone what their own personal experience would be with any given drug or substance like that. I'm not going to go any further with it. I was just curious to know.

JUDGE VITTONE: I question what value it has but go ahead.

MR. HOPPER: Well, and I'm curious to know what his own experience is in a passive smoking environment, whether that's at home or at work and I think that's a fair question, if he's dealing with this issue and purporting to be an expert in it.

DR. JENKINS: I smoked a few cigarettes when I was 11 years old. I didn't inhale.

(Laughter)

DR. JENKINS: It turns out that I am asthmatic and so it's probably not a good thing for me to do anyway.

MR. HOPPER: Why is that?

DR. JENKINS: Because it would probably make me cough and I don't need to cough any more than I have to. Also, I have tried smoking marijuana and I didn't inhale that and it was because of the same reason. That, by the way, is not new information, that's clearly a matter of public record on my security forms.

I have never lived with anybody who smoked cigarettes. I don't recall that I've dated anybody who has smoked cigarettes. Some of you in the audience who may know me personally may know that none of my wives have ever smoked cigarettes. That's multiple, yes.

MR. HOPPER: I assume that predicates your remark about divorce.

DR. JENKINS: With Martin, they passed an edict back in, I don't know when it was, maybe '90 or '91, making it a smoke-free workplace. There are individuals -- I don't think I've ever shared an office with anybody who smoked cigarettes. The co-principal investigator of this study, Dr. Michael Guerin, is a smoker and has been a smoker as long as I have known him, which has been 19 years.

MR. HOPPER: So currently ORNL is a smoke-free environment.

DR. JENKINS: That is correct.

MR. HOPPER: Everywhere?

DR. JENKINS: Yes. There are no designated areas inside the building.

MR. HOPPER: If someone has to smoke, they have to go outside.

DR. JENKINS: That's correct. Except for obviously experimental uses, and we smoke inside for that.

MR. HOPPER: I think you testified earlier that Martin Marietta is your employer, they write your paychecks?

DR. JENKINS: That's the name who's on my paycheck this month. That's correct. And the reason why I say it that way is that all of the DOE laboratories are GOCO, government-owned/contractor-operated organizations and the contractors frequently change. For example, just recently at Sandia National Laboratory it used to be AT&T and now a branch of Martin Marietta has taken over that operation.

MR. HOPPER: But they've been your employer since they took over Union Carbide and they've been on your check every month.

DR. JENKINS: That's correct.

MR. HOPPER: And they're a private corporation, right?

DR. JENKINS: That's correct.

MR. HOPPER: On a contract with the Federal Government?

DR. JENKINS: That's correct.

MR. HOPPER: I'm curious to know. You've made quite a strong point today in your testimony that you're not an advocate here for anybody and that you're here as a scientist and that you're trying to do your job and be objective as a scientist but I'm curious to know, did you meet with any of these lawyers here prior to your testimony today?

DR. JENKINS: Have I met with them?

MR. HOPPER: Yes. Did you hold any meetings with any of them?

JUDGE VITTONE: I think that question is a little indefinite.

DR. JENKINS: I was going to say the same thing. Thank you.

JUDGE VITTONE: There's a roomful of lawyers. Are you talking about the tobacco company attorneys?

MR. HOPPER: Yes, Your Honor.

DR. JENKINS: I mean, how many years back does this have to go?

MR. HOPPER: Say starting yesterday.

DR. JENKINS: Oh, no. I haven't met with anybody. I mean, I think I said hi to a couple of them.

MR. HOPPER: You know them?

DR. JENKINS: I don't know too many of them.

MR. HOPPER: Do you know Mr. Rupp, for example?

DR. JENKINS: As a matter of fact, I talked to Mr. Rupp on the telephone back in -- I believe it was 1989. We talked in 1989. That's the last time I can recall actually discussing something.

MR. HOPPER: Have any of these ladies or gentlemen here that you might know to be lawyers reviewed any of your testimony prior to testifying today?

DR. JENKINS: I don't know what the Center has done with -- I have not provided the Center with a copy of my written testimony.

MR. HOPPER: But --

DR. JENKINS: Just let me finish.

MR. HOPPER: Sure.

DR. JENKINS: I sent the Center a copy of the draft of my slides that I was going to show as a courtesy to them. They may have sent it on to representatives of -- I think Covington & Burling does some of the representation for CIAR.

MR. HOPPER: You wouldn't know, though, whether they have for sure?

DR. JENKINS: To the best of my -- I can't say for sure but they probably have but I don't know that for a fact.

MR. HOPPER: Okay. What about your December 22nd addendum submission, if that's the appropriate way to refer to it?

DR. JENKINS: I sent that as -- I sent a copy of that as a courtesy to one of my sort of co-workers on the study, Mike Ogden at R.J. Reynolds. Now, whether or not they circulated it, I don't know. I believe I sent a copy of the addendum to the Center, again, just of sort -- you know, like Holiday Inn, the best surprise is no surprise sort of thing, but that's all I can recall that I've done.

MR. HOPPER: But you've had no meetings -- have you had any meetings with any attorneys, whether they're in this room or not, related to your testimony or your submission of comments pertaining to this OSHA proceeding?

DR. JENKINS: Yes. Jim Gould, who is with Covington & Burling, I received a call from Max Eisenberg. This is back -- God, I can't remember when it was, back in the summer some time. And they -- Max said would it be okay if Jim Gould came down and talked to you about the testimony. I said, sure, that's fine.

MR. HOPPER: Was that before you went to Maryland and testified before Maryland OSHA?

DR. JENKINS: No, I don't believe so. I think it was actually after I did that.

MR. HOPPER: Under whose auspices did you appear before the Maryland OSHA?

DR. JENKINS: Maryland OSHA? Dr. Eisenberg, as our project officer, asked if I would testify at that hearing and I said sure.

MR. HOPPER: He invited you?

DR. JENKINS: Yes, he asked me. You know, it's sort of like when your boss asks you to do something, it's typically a good idea to do it.

MR. HOPPER: So he's your boss?

DR. JENKINS: Well, he is the project officer and you've got to understand, just like we have a number of project officers for whom we work all over the country, whether the Department of Defense or --

MR. HOPPER: I do understand. I was a senior program officer in a private foundation for some time so I know what those things are all about.

DR. JENKINS: Yes. You have to -- you want to be astutely concerned about the needs of your sponsor.

MR. HOPPER: I just find it interesting you referred to him as your boss.

DR. JENKINS: Oh, it's a colloquialism. I've got a lot of bosses in this world.

MR. HOPPER: By the way, did CIAR pay for your trip to Maryland?

DR. JENKINS: They didn't pay directly. I charged my time to their account that we work under and that's the same -- while I'm here today, I mean, I'm charging my time today to the Center's account with Martin Marietta.

MR. HOPPER: And then you get reimbursed for that, I assume? Or does Martin Marietta get reimbursed?

DR. JENKINS: Martin gets -- basically what happens is that charge is put against that account and then Martin then bills the Center and they pay the bills.

MR. HOPPER: I'm interested to know, my clients are interested to know and maybe the public is interested to know, when you set up a contract like you have with CIAR, now, first of all, is it a grant or is it a contract?

DR. JENKINS: It's a contract, it's not a grant.

MR. HOPPER: Who is the fiscal agent on that?

DR. JENKINS: Who is the fiscal agent?

MR. HOPPER: Who actually receives the grant? When Mr. Eisenberg or a board member or whomever from CIAR signs off on that and they send off, let's say, payments on that contract, who does it go to at ORNL?

DR. JENKINS: I have no earthly idea, to be honest with you. Well, I'm sure I could find out if that were really critical. But I really -- I mean, I can't tell you the individual that it goes to within Martin Marietta.

MR. HOPPER: Well, I don't care about --

DR. JENKINS: It goes to -- the money essentially goes to Martin Marietta or Martin bills the Center now, because the Center is a private organization just like universities are considered private, if we contract with a university, that they have to put some money up front essentially but then they bill, they continue to bill the contract against that.

MR. HOPPER: And you've worked on numerous grants and contracts through the contract research organization like Martin Marietta for quite some time now. Is that generally the way it's always done?

DR. JENKINS: The Center for Indoor Air Research, because it's a private organization, is different than other government agencies, okay? CIAR is considered to be a private organization. DOE considers it to be private.

MR. HOPPER: I understand.

DR. JENKINS: And the contract is different. With a private organization, the contract is between the Center for Indoor Air Research and Martin Marietta Energy Systems. If, for example, the Biomedical R&D Lab of the Army wanted to have us do some work, they would set up what's called an interagency agreement. Those are between two branches of the government, okay? But in this particular case, DOE still has to approve the work because it's being done at a government facility but it in fact there's no money that exchanges hands between the government, it's between Martin --

MR. HOPPER: I understand. It's a private contract.

DR. JENKINS: Yes.

MR. HOPPER: And since you're focusing on CIAR, as I understand it, if I've heard you clearly today, you've had two other contracts with CIAR? One to write the book --

DR. JENKINS: There's actually been there. There's another thing that we've been working on a little bit which is --

MR. HOPPER: You don't have to explain them all to me. Just --

DR. JENKINS: Just a little database, putting together a small database

MR. HOPPER: Just tell me what those three are.

DR. JENKINS: Okay. As I recall, to write the book, to conduct the study of area versus personal monitoring using the two different kinds of systems and that was the data we talked about with the EPA Air Waste Management Association. There is a little bit of money that we're supposed to be working on development of database looking at some of the current literature for them right now. And then this current agreement.

MR. HOPPER: The current agreement being --

DR. JENKINS: The study that we're talking about right now.

MR. HOPPER: Focusing on CIAR still, now, your co-investigator, Mr. Guerin. How long have you been working with him?

DR. JENKINS: I've worked with Dr. Mike Guerin basically since I joined the laboratory in 1975.

MR. HOPPER: Are you knowledgeable or familiar with the fact that he actually worked on the original safe cigarette team?

DR. JENKINS: Oh, yes. I know he was a member of the Tobacco Working Group. And I worked a lot on the less hazardous cigarette project when we were doing work for the National Cancer Institute in the general area of tobacco smoke.

MR. HOPPER: And he worked also with Dr. Gori, whom you know testified yesterday.

DR. JENKINS: Oh, yes. Yes. Oh, yes.

MR. HOPPER: Under CIAR, they have a board of directors, correct?

DR. JENKINS: That's correct.

MR. HOPPER: Isn't it true that that board of directors is made up entirely of tobacco companies?

DR. JENKINS: I can't really speak to that. I don't recall the makeup. I know that there's many members of tobacco companies on the board of directors. If you were to tell me that, I wouldn't be surprised, but I don't know that for a fact.

MR. HOPPER: Well, they were in fact formed in 1988 by Philip Morris and R.J. Reynolds and Lorelard and later --

JUDGE VITTONE: Mr. Hopper --

MR. HOPPER: Yes, Your Honor.

JUDGE VITTONE: If you want to have that information in the record, I'll take that as a late filed exhibit or something like that but let's ask him questions about something that he knows, okay?

DR. JENKINS: Thanks.

MR. HOPPER: Okay, Your Honor.

Do you know, for example, that Michael Guerin was on the Science Advisory Board of CIAR?

DR. JENKINS: Of course. Of course I do. I mean, I didn't fall out of a Christmas tree yesterday, you know what I mean. He and I do talk frequently, like once a day.

JUDGE VITTONE: Okay, Doctor. You've answered the question.

MR. HOPPER: You are aware, though, that tobacco companies form the Board of the CIAR? I mean, you didn't fall out of a Christmas tree, right?

DR. JENKINS: Right.

MR. HOPPER: Okay. Thanks.

(Brief pause)

MR. HOPPER: By the way, with respect to all the various post-hearing documents and data and all that you've been asked to provide, of which there seem to be numerous so far from all these hours of testifying, didn't you say to Mr. McNeely and me yesterday that you had your computer here and you had all your data on it? In fact, you used your cute little vegematic analogy and said you could slice it and dice it and present it any way you wanted to?

DR. JENKINS: I have much of the data. I don't have all of the data, but I have much of the data.

MR. HOPPER: Can't you just provide that right at the end of the hearing rather than having to go back and get it?

DR. JENKINS: It's in a computer. That doesn't mean that I am infinitely fast at doing that kind of stuff.

MR. HOPPER: Did somebody tell you not to present it out of your computer while you were here?

DR. JENKINS: No. I can do what I want, I think.

(Brief pause)

MR. HOPPER: It's true, isn't it, that when you were a part of the efforts to obtain the CIAR grant for this study that you've been discussing and testifying to today that you did not go through a peer review process to obtain that?

DR. JENKINS: Well, no, we didn't, because it's contract research.

MR. HOPPER: Okay. I understand.

DR. JENKINS: It's not a grant. You keep saying grant, but it's not a grant. It's a contract.

MR. HOPPER: I didn't. You said it was a contract, and I just asked you if you went through a peer review process.

DR. JENKINS: Okay. No.

MR. HOPPER: Okay. And you still haven't gone through a peer review process, have you?

DR. JENKINS: Concerning what?

MR. HOPPER: Before you published it. Concerning...

DR. JENKINS: Not yet. We haven't published the data yet. And we expect to go through a peer review process when we publish the data.

MR. HOPPER: Oh, after you publish the data.

DR. JENKINS: No. When we... You can't publish it unless it's peer reviewed.

MR. HOPPER: Okay. And then, do you have any idea who that peer review team will consist of?

DR. JENKINS: Whoever the journal that we decide to submit the publications to selects as their peer review.

MR. HOPPER: I mean, for example, would you be amenable to have Dr. Repace or Dr. Hammond or...

DR. JENKINS: Absolutely.

MR. HOPPER: ...anyone else sit on that peer review committee?

DR. JENKINS: Yeah. You know, I mean... Because I think I've reviewed some of her stuff under peer review. I mean, typically most peer reviewers are anonymous.

MR. HOPPER: Isn't it true that the Chairman of CIAR actually approved that contract?

DR. JENKINS: I have no idea.

MR. HOPPER: You don't know?

DR. JENKINS: I don't know.

MR. HOPPER: But the funding from CIAR comes from the tobacco companies through CIAR. And then, is the contract directly to Martin Marietta, then?

DR. JENKINS: The funding from the... I think that there's other supporters of the Center for Indoor Air Research other than the tobacco companies. I know that Carrier Air Conditioning is a supporter of the Center for Indoor Air Research.

MR. HOPPER: They don't sit on the Board.

DR. JENKINS: If you say so. I don't know that, but... You were asking me, in the funding -- yes.

MR. HOPPER: Well, just looking at their materials that the CIAR publishes and sent to me, they don't list them as Board members.

DR. JENKINS: Okay. Anyway, you were asking, does the money flow from CIAR to Martin Marietta, and the answer is yes.

MR. HOPPER: It wouldn't happen to go through the Center for Tobacco Research in any way?

DR. JENKINS: CTR USA, Inc., you mean?

MR. HOPPER: Yes.

DR. JENKINS: Not to my knowledge. But I don't know.

Again, I'm a principal investigator. I've spent a lot of time trying to worry about the science and I try to deliver as much of the funding stuff to the financial manager for our division and let her worry about it.

MR. HOPPER: Well, I understand that, and I know how we create subdivisions and we divide our labor up and things like that in our jobs. But you've been in this business for a long time and I understand...

DR. JENKINS: That's right.

MR. HOPPER: ...you're pretty familiar with the overall process, and you're a senior investigator...

DR. JENKINS: That's right.

MR. HOPPER: ...and I think you have certain responsibilities to manage related to the expenditure and disbursement of funds. And your partner, your co-investigator, Mr. Guerin does, too. Correct?

DR. JENKINS: That's correct.

MR. HOPPER: And so I would just wonder. I'm curious, and my clients are curious to know if you understand how the flow of funding works from the tobacco companies to CIAR. Does it go through the Center for Tobacco Research?

DR. JENKINS: I don't know that. I really don't.

MR. HOPPER: All right.

DR. JENKINS: My co-investigator may, but I don't.

MR. HOPPER: Is that something that you could ask him and provide as a post-hearing answer to us?

JUDGE VITTONE: Mr. Hopper, I think we're spending too much time on this.

MR. HOPPER: I'll move on, Your Honor. I understand. I'll move on.

JUDGE VITTONE: The subject is environmental tobacco smoke. The subject is his testimony. The politics beyond that is not relevant to this proceeding right now. Politics, I guess, is the wrong word. But whatever it is with that organization, we're concerned about how valid is the testimony he gave here today.

MR. HOPPER: Your Honor, I will move on. I'll honor that. But I think it's relevant.

Mr. Jenkins has submitted into the record that this is the most important and the largest study of its kind to date on environmental tobacco smoke, and I think that the scientific community, I think my clients, I think that the public is entitled to know from whence that study came. And I don't see anything wrong with revealing the genesis of it so that we can put it into context. But I'll move on.

JUDGE VITTONE: I think we've explored that in great detail and he's been, you know, he explained it right in the beginning. All right?

MR. HOPPER: I'll move on.

If the study is still preliminary, in the course of the way these processes work, and you've been in a number of them, should it, how can it weigh heavily in OSHA's final rule if it's still preliminary? You've been talking about it's preliminary, preliminary, preliminary for quite some time. If it hasn't been peer reviewed, how can they take it into consideration if it's still preliminary?

DR. JENKINS: That's up to OSHA.

MR. HOPPER: Okay.

Let's focus on the methodology again for a minute. You've talked a lot about that today. I'm curious to know if you know for a fact that all your participants, and I assume... I believe you've used the number of about 1,600, something like that. That's a lot of people.

DR. JENKINS: Yes.

MR. HOPPER: That you, nor anyone else for that matter, were with these people either at work or at home to be able to determine with veracity, to determine if in fact they wore these pumps around when they were supposed to.

DR. JENKINS: We run into the same problems that any study has, any investigator has, of trying to confirm that which goes on away from the test site. I mean, whether it's the Fontham study, trying to confirm that people really did live with smoking husbands their whole life, or whether it's our study, with whether or not they're wearing the sampling device.

MR. HOPPER: I take that to mean you don't know.

DR. JENKINS: Absolutely. There's no way we can...

MR. HOPPER: There's just no way.

DR. JENKINS: That's right.

MR. HOPPER: So it could affect the validity of the measurement?

DR. JENKINS: We try to ask them questions and instruct to them the importance of it, and we have kinds of check-off points that encourages them to continue to participate. But you're absolutely right. Without holding every one of those 1,600 participants' hands, that we could know.

But, you must also understand, that were we to be there, we would also affect the quality of measurement, too. You know, there's a principle in analytical chemistry which says that the manner of making the measurement affects the quantity that you determine. So you can't be there. If you were there, it would affect the study too and you'd be criticized, or somebody would criticize it by saying it's not realistic because you held their hand.

MR. HOPPER: Well, in fact, I'm glad you mentioned that because... How can you purport to get any kind of specificity or particularity in the validity of your measurements when you have the potential of getting this kind of a skew in a representative sample when you give up this kind of control over the selection sample? I mean, doesn't that in fact skew it pretty heavily? I mean, you even used the terms earlier today, a relative possibility of 75, 25 percent of affecting the population in the actual selection procedure. So how can you say that it is as valid as you want to claim it to be?

DR. JENKINS: I have claimed it only to be valid from the standpoint of, here is the data, here is what the demographics of the population are. You decide whether or not you think it's valid or invalid. I would ask you, though, how you would design a study to do it better.

MR. HOPPER: Well, you can't... You can ask me that all day. I'm a lawyer, not an analytical chemist.

DR. JENKINS: That's true.

MR. HOPPER: And you're the one testifying...

DR. JENKINS: That's right.

MR. HOPPER: ...and you're the one that owes an explanation to the scientific committee.

DR. JENKINS: I'm not asking him. Don't worry.

JUDGE VITTONE: I know.

MR. HOPPER: He proposed.

How many other duplicate samples did you have when you produced the samples with the pump? Did you do more than one sample when you took it from the participant?

DR. JENKINS: No. We only took one sample. One particle phase and one gas phase sample for the, essentially the away from work pump, and one particle phase and gas phase sample from the work place.

MR. HOPPER: And that's the only one you relied on.

DR. JENKINS: That's correct.

MR. HOPPER: Okay. How many other labs did you send the samples to for confirmation and analysis?

DR. JENKINS: We reanalyzed some of the samples the R.J. Reynolds had analyzed. Okay? Just as a spot-check. We sent them a random list of samples and we asked them to...

They sent us the samples after they had been analyzed. We reanalyzed them in our own lab. The data came up pretty close to what they had been. Some high, some low.

MR. HOPPER: Well, I thought you testified earlier today that you didn't set up for this contract to do those kinds of analysis.

DR. JENKINS: No. No. I'm sorry, you were... I did not, we did not set up to do the volume of analyses that were done. But clearly, with the data that I presented, with all of the surveillance activities we had to be able to analyze the 3-ethanol pyridine and the nicotine and some of the other constituents that were sent off just for our own test purposes to ensure that our ability to generate controlled atmospheres and environmental tobacco smoke was accurate.

All those... The analytical methods, with the exception of the radium in an assay, those analytical methods are in place and we can use them. We just hadn't set up to do them on an umpteen-thousand sample basis.

MR. HOPPER: Okay. But beyond R.J. Reynolds and what spot-checks you did at Oak Ridge, there were no others.

DR. JENKINS: Oh, of course not. No.

MR. HOPPER: Okay. So you had Bellomy, who did the market research end of this...

DR. JENKINS: Yes.

MR. HOPPER: ...whom you testified, who largely has represented and done work for R.J. Reynolds and the tobacco industry based in Winston-Salem. Correct?

DR. JENKINS: Yes.

MR. HOPPER: And you have R.J. Reynolds, who is doing the analysis on this. You have CIAR who is providing the grant, the contract, with a Board of tobacco companies, and Mr. Guerin on their Advisory Board.

I just have one question for you: Did it ever occur to you at any point that it might possibly affect the outcome of this study when it has that much involvement by the tobacco industry, who has a financial stake in the outcome of these proceedings? And that you are claiming to provide the best and the largest and the most important study? Did it ever occur to you?

DR. JENKINS: Our...

MR. HOPPER: That someone might question the integrity of that?

DR. JENKINS: Oh. Absolutely. Absolutely, we thought that people would question the integrity of it. But if you're implying that I would alter my testimony or alter my...

MR. HOPPER: I'm not implying anything.

JUDGE VITTONE: Mr. Hopper.

MR. HOPPER: I'm not implying anything.

DR. JENKINS: If you're... Well, but your question. It's very easy for anybody to infer that from that kind of a question. And I think my record speaks for itself.

If you've done your homework, and I'm sure that you have, you've probably read this book cover to cover, because you're very interested in the area of environmental tobacco smoke, and you'll see in there that I basically take the tobacco companies to task for using the terminology "cigarette equivalents." That book was written under CIAR funding. I know R.J. Reynolds is a big supporter of CIAR, and nobody ever said one thing to me about putting that in the book.

MR. HOPPER: Well, now, you're a tobacco chemist, and we're talking about ETS and you're very knowledgeable about nicotine. Do you believe nicotine's addictive?

DR. JENKINS: I do not have the... I don't have the professional expertise to comment.

MR. HOPPER: Okay. You don't have an opinion. As an analytical chemist of tobacco.

DR. JENKINS: As an analytical chemist I do not have an opinion on that.

MR. HOPPER: Have you ever conducted any other tests for the tobacco industry? Any direct smoking tests? In addition to this...

DR. JENKINS: If I could rephrase that question, maybe I'll answer it, and where I think you're going.

When the Council for Tobacco Research was enacted... We have done contract work for the Council for Tobacco Research.

MR. HOPPER: Have you ever done any studies or conducted any work under any contracts or grants on any smoking components or compounds?

DR. JENKINS: Yes.

MR. HOPPER: What were those?

DR. JENKINS: We did some of the methods development work which was done on the measurement of ambient nicotine with what we call a tenax-based methodology. That work was supported by the Council for Tobacco Research.

MR. HOPPER: And "we" being Martin Marietta, Oak Ridge National Lab?

DR. JENKINS: Yeah. We being my group. Yeah.

MR. HOPPER: Okay.

DR. JENKINS: We've all -- again, as you pointed out earlier, we've also done work for the National Institute on Drug Abuse and the National Cancer Institute as well on cigarette components.

JUDGE VITTONE: Mr. Hopper?

MR. HOPPER: Yes, Your Honor.

JUDGE VITTONE: Are you about done? I'm just looking at the time.

MR. HOPPER: I'm getting pretty close.

JUDGE VITTONE: Is Mr. Hall here? Okay.

MR. HOPPER: You testified earlier today, by the way, since we're on this issue and you're claiming such objectivity in this process on the study, and it was raised by Dr. Samet earlier, this issue of representativeness. You claim that you did surveillance. What kind of surveillance?

DR. JENKINS: Well, the surveillance is a term. If we were to say we were doing quality assurance and quality control checks on the laboratory, one of the problems with that is that it could be certainly misinterpreted by, say by the EPA, when EPA's contract laboratory program does QA/QC, about a third of the samples that are analyzed end up being control samples, or so. And for a study this large we just couldn't afford to have a third of the samples, and we didn't think that was necessary.

So the kinds of things we did are the kinds of things that I pointed out in my testimony. We submitted blind solutions of cigarette smoke components to the laboratory. We submitted adsorbent traps that were loaded with essentially samples of homogeneous atmosphere of ETS, and essentially we were looking for whether or not they could get the right answer. Now, clearly, they knew that those samples were quality control samples.

MR. HOPPER: But you didn't spend time actually int the RJR labs with those in this.

DR. JENKINS: We... Let me finish. Please.

MR. HOPPER: Okay.

DR. JENKINS: And actually, we would send the samples off to them to see actually what they ended up doing with those samples. As a matter of fact, we did send somebody to R.J. Reynolds, back to observe one of the particular procedures to make sure that they were doing them in a way that we felt was appropriate.

MR. HOPPER: Well, did RJR handle all the calibration of the pumps?

DR. JENKINS: They handled the calibration of the pumps. That was also done in many of the cities with a representative from ORNL watching them do the calibration of the pumps, and they also did it using methodology that ORNL suggested to R.J. Reynolds that they use for the pump calibration.

MR. HOPPER: But you don't know for a fact when the participants actually got the pumps how those calibrations were set at that particular time that they...

DR. JENKINS: I sure do.

MR. HOPPER: ...got them. You were there with them?

DR. JENKINS: Absolutely.

MR. HOPPER: You met with the participants?

DR. JENKINS: I wasn't in all of the cities, but I was in cities 1, 4, 7 and 11, and 14, I think.

MR. HOPPER: Well, what kind of safeguards are present on those pumps to ensure that you obtain reliable measures? How do you know?

DR. JENKINS: Well, what we do is, a mass flow meter is used which is calibrated against a primary standard. Okay? And that, the pumps...

The sampling flow rates through both the gas phase and the particle phase collection systems are measured when the pumps are outfitted with new sampling heads to make sure that they are within the constraints of the, as sort of the protocol for the sampling. Then when the samples come back to the lab, or come back to the test site, before those sampling systems are removed from the pumps, we re-check the pump sampling flow rates to make sure that they haven't changed. I think I specified that in my testimony.

MR. HOPPER: Did the pumps ever sit around? I'm curious to know. In the process, did the pumps ever sit around, say over a weekend, or for a couple of days, and, I mean, and if that occurred, wouldn't that cause some depletion or some degradation to the sample? Did you have that kind of situation?

DR. JENKINS: Typically, no.

MR. HOPPER: May I suggest...

DR. JENKINS: Just a second, now. As I stated earlier when we were trying to go through the subject itinerary, this all started on a Sunday night. Those pumps came back in and they were used for essentially 24 hours during the approximately 45 hour period from Sunday evening at 9:30 till Tuesday at 5:00 in the afternoon. They were in use for 24 hours during that period.

Now, it is true that some of the samples, the samples had to "sit around." There have been validation studies that have been done on these kinds of sampling systems to look at the degradation of the samples. I'm sure that you can conceive of a scenario, if somebody stuck it, you know, in their car on a hot summer day and left it inside the car, yeah, you could have degradation of the sample.

MR. HOPPER: Well, your study and your measurements are going to have artifact in them too. Correct?

DR. JENKINS: What do you mean by artifact?

MR. HOPPER: I mean that they're not going to always be true measurements because you get these various environmental effects. Some kind of artificial artifact effect into the process.

DR. JENKINS: I think you'd have to be more specific before I was able to say yes or no.

MR. HOPPER: I will let, I'll let your scientific colleagues get into that if they want to.

DR. JENKINS: Good.

MR. HOPPER: But, you'd say, though, that it is possible for depletion and degradation to occur. Based on what you just testified to.

DR. JENKINS: Anything is possible.

MR. HOPPER: But do you know in fact that that happened? You said it wasn't typical, but it did happen?

DR. JENKINS: I can recall in one or two cases where somebody commented, "Boy, these pumps are really warm, and they must have sat out in the car, you know, while they were, before they came back."

MR. HOPPER: Isn't it... Are you familiar with the 1988 PASS Study done by HBI?

DR. JENKINS: I'm... Yes, I'm familiar.

MR. HOPPER: Weren't those... You are.

DR. JENKINS: I'm familiar with the briefcase sampling system.

MR. HOPPER: Okay.

DR. JENKINS: And I think we wrote about it.

MR. HOPPER: It's not altogether dissimilar from this study, is it? I mean, I'm sure you can point out distinctions and characterize it differently.

DR. JENKINS: Well, those were area measurements done over short duration periods where this is a personal exposure study. The PASS Study was made with a briefcase in a stationary location, where this was... I mean, I think those are important considerations. And that's the whole point of this,...

MR. HOPPER: I understand.

DR. JENKINS: ...is the difference between personal exposure and area models.

MR. HOPPER: I understand. You are familiar with the PASS Study.

DR. JENKINS: Yeah.

MR. HOPPER: And I'm making no allegations. I just happen to know as a fact that that study is a part of a criminal investigation at this point, and are you aware of that?

DR. JENKINS: You know, I've heard about that. And when I heard Healthy Buildings International, that certainly did trigger something in my mind.

MR. HOPPER: And you're also familiar with the fact that the expert from RJR who served on your team also worked on that PASS Study? Do you know that?

DR. JENKINS: I wasn't aware that... If you're referring to Dr. Ogden, do you mean?

MR. HOPPER: Dr. Ogden.

DR. JENKINS: I wasn't aware that he worked on the PASS Study for the Healthy Buildings International.

MR. HOPPER: He did.

DR. JENKINS: If you say so.

MR. HOPPER: Your Honor, I'm pretty close. Allow me just to review my notes and...

(Brief pause)

On your slide No. 45, where you discuss levels versus exposures.

DR. JENKINS: Yes.

MR. HOPPER: Who did the measurement on that? Was it HBI?

DR. JENKINS: No. That data is taken from the study that was published by Gioldaker and co-workers, and I believe that the measurements were made by members of R.J. Reynolds, Philip Morris and Lorelard.

MR. HOPPER: Tell me that once more, please.

DR. JENKINS: R.J. Reynolds, Philip Morris and Lorelard were the individuals that made the measurements. There was also some contract work done through, I think IT Corporation in Knoxville, Tennessee. That's to the best of my recollection. There may be some error in that, but that's my understanding of it.

MR. HOPPER: When you were originally contacted in the fall of '92 to do this study, you had somewhat of a track record in this area. Correct?

DR. JENKINS: Well, we had...

MR. HOPPER: I don't mean to diminish. I just...

DR. JENKINS: Yeah. We had done work. We'd never done work quite like this, but yeah. Yeah.

MR. HOPPER: But you'd never done anything to this extent or this large...

DR. JENKINS: I don't think anybody's ever done anything this...

MR. HOPPER: ...or this important.

DR. JENKINS: Right.

MR. HOPPER: Did it ever to occur to you, that with you having the capacity as sophisticated -- and I happen to know from all the way back to my grandfather who worked at Oak Ridge what a fabulous laboratory that is -- that you guys could have done this study entirely on your own without the presence of the tobacco industry?

DR. JENKINS: Who would have paid for it?

MR. HOPPER: Well, we obviously know who paid for it now.

DR. JENKINS: No. But I want to know. Who would have paid for it?

MR. HOPPER: That's not an answer to my question. You had the capability and the confidence.

DR. JENKINS: But we -- having the capability and the confidence means nothing if you can't have somebody pay for it. We saw this as an opportunity.

MR. HOPPER: Oh, I think you did, Mr. Jenkins. And I think what it appears, unfortunately for you, is it's a classic case of the fox guarding the hen house, here.

JUDGE VITTONE: Okay. That's it, Mr. Hopper. We're breaking.

MR. HOPPER: Thank you, Your Honor.

JUDGE VITTONE: Back on the record.

Let's see. Mr. Myers.

Excuse me just a second. Mr. Repace, you're not going to eat, are you?

Mr. Myers.

MR. MYERS: Thank you, sir.

Mr. Jenkins, my name is Matthew Myers. I am here representing American Association of State and Territorial Health Officials, Occupational Nurses and a few others. I also represent the American Cancer Society, the American Heart Association and the American Lung Association.

And I'll be relatively brief.

DR. JENKINS: Great.

MR. MYERS: I'd like to make sure I understand a few things, if I can. And also, I was one of those people who did read your book. And I just have a few questions to ask you about some things that were said in that book as well that relates to this.

DR. JENKINS: I guess I need to get the book?

MR. MYERS: I think you will probably know it off the top of your head. If you don't, we'll stop.

DR. JENKINS: Okay. That's fine.

MR. MYERS: Nothing very tricky here.

DR. JENKINS: Good.

MR. MYERS: At least, I don't think so. If I'm wrong, you tell me about that.

One of the things I saw in your book that I thought was interesting and that's relevant to how you picked the different markers you were using here were comments about nicotine that you made in the book. Not long before you did, as you said, before you criticized the cigarette equivalent concept.

DR. JENKINS: Yes.

MR. MYERS: And in your book you said one of the reasons why people, including you, have used nicotine, as I understand it, is, the quote was, "because of its uniqueness to tobacco products at all but trace levels." Is that accurate?

DR. JENKINS: Yes. That's an accurate statement.

MR. MYERS: So the nicotine has traditionally been, in your professional opinion, a good marker because we don't see it in equivalent quantities anywhere else.

DR. JENKINS: That's one of the benefits. I'm not sure I would say it's a good marker. It is a marker. It does deposit on surfaces and so it has many downsides to its use.

But, frankly, it's been used so much that, if we were to conduct a study like we just did without using nicotine, somebody would have just probably thrown us out of the room. So nicotine was essential.

MR. MYERS: Okay. And the reason people have latched onto it -- latched is a terrible word.

DR. JENKINS: That's fine. That's fine.

MR. MYERS: Is because it really is unique in tobacco at all but trace levels.

DR. JENKINS: At all but trace levels. That's correct.

MR. MYERS: Now, another point you make in the book, and it's one that you were starting to say is one of the concerns about the use of nicotine, is that is so rapidly depleted in the air.

DR. JENKINS: That's correct.

MR. MYERS: So that if you're not using it as a direct biological marker using cotinine, there is a concern that once it moves through the air it's not itself necessarily a good marker because it creates the impression of underexposure. Is that right?

DR. JENKINS: Yes. Yes. That could very well be. Yes.

MR. MYERS: Another point you made in the book that I want to make sure that I understand that you agree with as well is that among the factors, of likely nicotine concentrations, when you're using it as a marker as again not with direct smoking is a cotinine measure...

DR. JENKINS: Yes.

MR. MYERS: ...but for an ETS related study, was... And I think the ones you listed in your book were the number of cigarettes smoked, the time required for smoking, the air volume in the room, the proximity of smokers to the sample location, the air exchange rate.

DR. JENKINS: That's correct. Yes.

MR. MYERS: So if you were really going to do a very careful case controlled study to try to evaluate, to use nicotine as a marker for environmental tobacco smoke, what you would try to do is control those factors as well.

DR. JENKINS: That's correct. You'd try. You'd try to do that. I imagine it would be very difficult to do.

MR. MYERS: Do you know of any study that succeeded in doing that?

DR. JENKINS: Not to my knowledge. That doesn't mean that one doesn't exist, but I'm not aware of one.

MR. MYERS: And if I read your study correctly in listening to you this morning, because of the practical problems of doing it you didn't even try to do that in your study.

DR. JENKINS: We recorded much of that kind of information, and I'm sure one of the ways that we're going to examine this data is through this issue of how many cigarettes, you know, were smoked around and is there really a relationship between things like nicotine concentrations and smoking density. But my... It's my opinion that those numbers are not likely to show a great deal of correlation because of all the problems that I have stated.

MR. MYERS: Now, when you say you've recorded it. You recorded it how?

DR. JENKINS: Well, we asked the individuals to provide estimates of the sizes of their work places, of the sizes of their homes, the rooms in which the smoking was occurring, the number of cigarettes that were smoked around them and that sort of thing. And to the extent that those numbers reflect some kind of an accurate measure -- and of course that's a big issue, as it's already been raised by several of the questioners here today -- to the extent that that's accurate, we could get some indicator as to the utility of that approach.

Whether or not we're going to end up with something that really says that there's a good indicator between, say, the number of cigarettes being smoked and the nicotine concentration, other than just sort of general, broad guidelines, I'm not too optimistic that that will occur.

MR. MYERS: Now, if I understand it correctly, then, the mechanism you're going to use to even try to evaluate that is self-reporting, what people told you.

DR. JENKINS: That's correct. Because you can't... We can't measure it independently.

MR. MYERS: And you didn't try to in this case.

DR. JENKINS: No. Absolutely not.

MR. MYERS: And, am I right you didn't even try to do it on a random basis? You just, whatever they told you, you took.

DR. JENKINS: That's right.

MR. MYERS: Do you have... Have you ever seen studies where people have tried to evaluate how people tend to be on some of these issues? I've seen studies where we talk about cigarettes. But you've talked about some things that I know, if you asked me how big are the rooms in the my house, what's the air flow in my house, as somebody who thinks about these issues I couldn't even ball park it.

DR. JENKINS: I don't... Yeah. And I don't know whether or not there have been studies done. I mean, I know that this is something that's important in terms of, you know, self-reported accuracy of information to a lot of epidemiologic studies. And I look at our data, frankly, as providing this to other investigators to make those kinds of assessments, you know. But I'm not aware of studies that have looked, you know, examined those kind of factors. They may exist, but I'm not aware of them.

MR. MYERS: I'm curious about something, under these circumstances. Because you're an analytical chemist.

DR. JENKINS: That's correct.

MR. MYERS: And you look at hard data as a general rule...

DR. JENKINS: That's correct.

MR. MYERS: ...and not the soft data as a general rule. But you obviously think there's some value to the self-reporting, otherwise you wouldn't be doing it, I'm assuming.

DR. JENKINS: That's correct. And it's a judgement call, and it's basically about the only thing that we have to verify some of the other... I mean, we only have self-reported information in the study.

We could just take -- if we were to take all the individuals and just sort of, this is the average exposure, people would be asking questions, like, "What are the exposures in smoking homes?" or "what happened when you excluded those, you know, individuals in a work place where smoking was truly banned?" And so we would end up just having a real mish-mash of the data, and the best that we can do in this particular case for this size of a study is to rely on the self-reported data.

And it's a gut feel that I've got, that much of the data, especially concerning things like the size of households and what have you, or offices, is going to be very, very poor. I talked about this with many of the participants that I saw in the study and I was not impressed with the accuracy of their, the confidence with which they stated, "My house is 2,754 square feet." You know. I didn't hear that.

MR. MYERS: A week after I bought the house, when I probably knew it, I couldn't tell you, I don't think.

DR. JENKINS: I see.

MR. MYERS: I mean, I'm struck by something you're saying now and you said this morning, and it's an issue that we face with a lot of the scientific studies that we run into here. And that is, we live in the real world and we can't design the perfect study. The perfect ETS study would mandate that we expose people to certain levels of things and it's unethical, or that we follow people around and, as you said, we'd alter behavior...

DR. JENKINS: That's right.

MR. MYERS: ...if we did those sorts of things. So that.. In this case, what you're doing is making a scientific judgement and making a lot of practical compromises.

DR. JENKINS: Absolutely.

MR. MYERS: I'm also trying to understand a couple things about exactly how your measurements were derived, if I can. Some of them you've explained and I think I understand, but if the record is confused like I was, it would be useful.

The pumps that people were given to wear for the not-at-work time.

DR. JENKINS: Yes.

MR. MYERS: Were they instructed that those pumps were to remain on all night, in the house?

DR. JENKINS: Yes. They were told to keep them on all night, and when they went to bed they were to take the pump off and set it by their bedstand. They saw a video. This was part of the videotaped instruction to them.

MR. MYERS: By the bedstand.

DR. JENKINS: Essentially right alongside of them. As close as you could put to where your head is.

MR. MYERS: Now, if I understand correctly, the rationale for keeping it on all night would be that even if no one was smoking at the moment, some of the items that you measure will remain in the air for a period of time thereafter.

DR. JENKINS: Yes. That's correct. That's been shown.

MR. MYERS: That's been shown.

DR. JENKINS: Yes.

MR. MYERS: Which of the items you were collecting in the pump stay in the air, and for how long, based on the studies that exist?

DR. JENKINS: Well, I think that all of them are going to stay in the air for some period of time. The particulate phase markers -- I mean, I can't recall exactly what the settling rate is for three and half micron RSP, but it's sure not fast. It's certainly going to be in the air for some period of time, whether or not it's an hour, or two hours, or six or seven hours. I just don't recall.

The 3-ethanol pyridine, it's a gas phase marker. It's not likely to be absorbed on surfaces. It's probably, the primary mechanism of its removal is just dilution, you know, from infiltration of air that does not contain ETS. There may be some absorption on surfaces.

As we've already alluded to, nicotine is very likely to absorb on surfaces, but it also means it's also going to be off-gassing from those surfaces as well. It will be diluted by the incoming air. It will be off-gassing from the surfaces that are present.

Myosmine, I don't think there's been as great a deal, and we haven't made a big deal of using that marker. That sort of was kind of, we didn't have to do anything extra to get that data for this study and so that's why we continued to report it.

MR. MYERS: I think it's more than my curiosity. I think for the ability of people to independently evaluate the data that you are going to be providing in the final study, it seems to me that it would be very useful if you could provide information to the record about what you know about how long the different substances remain in the air. And I guess the second part of it, because it's the second thing that I couldn't tell from the summary material that you provided today...

DR. JENKINS: Yes.

MR. MYERS: ...was, do you get different results, or did you measure results differently, not when you look at the amalgam of the different materials that are collected in the pump, but when you look at the individual ones?

Because I think we will all be able to assess the meaningfulness of some of your data if we know, for example, the correlations between the relative nicotine accumulation versus some of the others and were able to compare with what we would expect their duration to remain in the air. Do you see what I'm saying?

DR. JENKINS: Yeah, yeah. There is. In fact, I made a note to myself. There is some data that has been done, chamber studies and otherwise, looking at the retention of these materials in the air and we'd be happy to cite that data and provide some guiding bench marks for that in our final report. That's a good suggestion. Thank you.

MR. MYERS: The other question I was going to ask is, as I understand it, what you asked the people to do was put the pump by the bed or near where, in the bedroom somewhere. Is that right?

DR. JENKINS: That's correct.

MR. MYERS: Do you inquire of them whether they were actually smoking in their bedroom before they went to bed?

DR. JENKINS: Well, of course the individuals should not have been smoking at any time during the study. I mean...

MR. MYERS: Or their spouses.

DR. JENKINS: Or their spouses. Okay? We asked our participants where the individual smokes throughout the house and were they, if they were in bed they were to have recorded any cigarette smoke that they smell or observe, so we would have that data if they in fact properly recorded that.

Now, if, I guess if the individual was sleeping in the bed, their spouse got up and had a cigarette and, you know, went back to bed and they never woke up, or they forgot to write it down, then that would not, that would be a misrecording of that...

MR. MYERS: Have you parsed out those who say their spouse smokes in the bedroom versus those who say their spouses don't?

DR. JENKINS: I haven't done it. Well, let me say this. I have done that for some of the preliminary data that we had early on in the study. I have not done it for the entire body of this data.

MR. MYERS: The other piece that I've got a question to is, if you parsed out, based on the diary entries, circumstances where the individual says their spouse smoked that evening in the bedroom versus generally smokes in the bedroom.

DR. JENKINS: We haven't done that yet, but we certainly could to -- I mean, that's one, this is one of the many things that we'll be looking at. Again, we can look...

MR. MYERS: Let me come back so that you can see where I'm going, because I really am just looking at it in an objective way, to look at that data. And that is, as I understand how you do your measurements, it's not just the total accumulation of the substances. It takes into account the duration of the time that the pump was on...

DR. JENKINS: That's right.

MR. MYERS: ...and a variety of those other factors. So that if the pump was on for eight, nine hours in a room in a house where it's reported that people are exposed to cigarette smoke but in a house where no one smoked in the bedroom that night, depending on how the house is laid out, while there may be a lot of environmental tobacco smoke hanging around in the living room...

DR. JENKINS: Yes, yes.

MR. MYERS: ...there may be none sitting in the bedroom.

DR. JENKINS: Yes. Although our own experience has been that many of these constituents migrate throughout the house. We've done some studies that we haven't reported where we, somebody will smoke down in the basement of their own home and then we pick up the nicotine upstairs, you know. I mean, so this stuff does dissipate throughout the house.

But had we been able to do this study exactly the way I wanted to do it, with no consideration being for the participants in the study, I would like to have had them -- basically we would have had a device that they wore with them that measured in real time the concentrations of each one of these constituents. Okay? And that this device was the size of a cigarette pack that they could have worn in their belt, you know.

MR. MYERS: Yes.

DR. JENKINS: I mean, or that we could have sent them out with several different sampling pumps. That's a very difficult thing to do. And I wish I could have gotten more different sampling pumps on each one of those individuals. But believe you me, when you're dealing with the subjects, that's a great deal to ask.

MR. MYERS: I'm not being critical. I'm just trying...

DR. JENKINS: No. I understand.

MR. MYERS: ...to understand the limitations of the data.

DR. JENKINS: Yes. I understand that.

MR. MYERS: And that's what I'm trying to understand.

DR. JENKINS: Yes. I understand.

MR. MYERS: And what I'm hearing from you is because what we're really measuring is an average exposure...

DR. JENKINS: That's right.

MR. MYERS: ...that when we're looking at it for household exposure, whether or not there was someone smoking in the vicinity of the bedroom when you're going to leave this machine on for a very significant proportion of the time it may have a dramatic effect on the nature of the exposure.

DR. JENKINS: Yes. Yes.

MR. MYERS: Is that right?

DR. JENKINS: Oh, that's right.

MR. MYERS: It is simply something we don't know.

DR. JENKINS: That's right.

MR. MYERS: It's a limitation on the study.

DR. JENKINS: That's right.

MR. MYERS: Now, the other couple of questions I want to follow up on is -- and there are things that you mentioned, and I don't want to belabor them particularly -- but that the population you studied was somewhat skewed in terms of its educational level and in terms of its white collar level.

DR. JENKINS: Relative to the U.S. population as a whole.

MR. MYERS: Relative to the U.S. population.

DR. JENKINS: Yes.

MR. MYERS: And that there's a pretty strong correlation, if I understand it correctly, as well, and it seems to play out in the number of those people who are working in smoke-free work places, between higher education, more white collar, working in places where there's more restrictions on smoking to decreased or lesser exposure in the work place.

DR. JENKINS: Yes.

MR. MYERS: Would that be fair to say?

DR. JENKINS: Yes. Yes.

MR. MYERS: So, would it also be fair to say that, while I'm sure you would have liked to have had a representative sample in terms of what actual exposure in the work place is, you're not pretending to tell us here that your data is a reliable estimate on what we'll find in the assembly lines or in blue collar work places?

DR. JENKINS: Absolutely not. Because we are very underrepresented in those kinds of places. This was the best that we could do with the resources that we had.

MR. MYERS: And that, as I understand it as well, we don't have information about individuals, whether their day was a typical work day for them. Because we've got 24 hour glimpses. Is that right?

DR. JENKINS: Yes. But we did ask them those questions. Like, "Was this a typical work day for you? Did you do anything that was different? What was it that you did differently about your work day?" So that we would at least have the opportunity to go back and assess that at some time so that we could see, were there things that were atypical that may have skewed the results up or down. So we do have some information.

MR. MYERS: Some information. Enough for you to make concrete, scientific conclusions?

DR. JENKINS: I think we may. I think we may. I mean...

MR. MYERS: Again, this is going to be self-reporting that we're talking about.

DR. JENKINS: Oh, absolutely. It's all self-reporting.

MR. MYERS: And when you ask them this question about a typical work day, how much information do you get about what their work is?

DR. JENKINS: We have the kinds of, what they do for a living. I mean, there's 50-some, or 40-some occupational categories, and then just a general question, "Was this a typical work day?" and "If it was different," and then sort of fill in the blank, "what was different about it?" And all that data then was coded in separately, so we have that individually-coded data.

We do not have, you know, "Does you day consist of sitting at your desk for 25 percent of the time, 35 percent, et cetera, et cetera, et cetera.

MR. MYERS: So you don't have any real way to measure whether this population was at all representative in terms of their daily patterns in terms of exposure?

DR. JENKINS: Only from a self-reported standpoint. And to the extent that that's accurate, our analysis of it will be scientific.

MR. MYERS: Okay. Now. If I understand correctly as well your results, at least -- and I'm skipping the exact numbers for the moment -- is that you do find a correlation between nicotine exposure and the frequency with which the individual is exposed to environmental tobacco smoke, i.e., if I understand correctly, those people who report that there is both smoking in the work place and smoking at home had, I think -- if I remember, it was like 10 to 40 percent higher nicotine retention.

DR. JENKINS: Ten. Yeah. It was more than that. But I mean, you're right. If you look at generally broad groups, those that live and work in smoking homes and work places, I think... This is all starting to run together after a while here.

MR. MYERS: That's fair, though.

DR. JENKINS: But for those in, say in cell one, okay, which is the smoking home, smoking work place, they tended to have higher exposures than those individuals in cells two, three and four.

MR. MYERS: Now, when you gave these measurements in terms of nicotine exposures, which I found interesting because your book is pretty critical of the concept of nicotine exposure as opposed to -- and I'm not sure I'll pronounce it correctly. I'll be a lawyer as opposed to a scientist. Solanosol?

DR. JENKINS: Solanosol.

MR. MYERS: Solanosol. Which you seem to think...

DR. JENKINS: That's a pretty good marker.

MR. MYERS: ...is a better marker.

DR. JENKINS: Yeah. That's... And I only used nicotine because people are more familiar with the nicotine and that's what much of the literature has been.

MR. MYERS: But you're pretty critical of it, using it in ETS.

DR. JENKINS: Oh, absolutely. Absolutely. And that's one of the reasons why we were insistent in this study that other markers be used in addition to just nicotine and RSP.

MR. MYERS: Now, in terms of the type of nicotine you were using, as I understand, what you were measuring was the vapor phase nicotine.

DR. JENKINS: That's correct.

MR. MYERS: And if I understand correctly from your book as well, that's the type of nicotine exposure of which you are most critical. You think particulate phase nicotine is a better measure, even thought it too has flaws.

DR. JENKINS: Yeah, yeah. But, the problem is... Well, particulate phase nicotine is very hard to measure. Okay? And it's also, there's very tiny amounts of it. I mean, relative to the vapor phase nicotine it's a very tiny fraction, a few percent.

MR. MYERS: And what were the results when you looked at your data for solanosol?

DR. JENKINS: We saw the same general trends, okay? But one of the difficulties with the solanosol measurements is that we run into the detection of this. And we talked about that previously that in, as you get, because there's not a lot of solanosol in the particulate matter that's present in ETS. If there's not a lot of ETS present, which is in general what we found, it's very hard to find solanosol in the ambient environment, say, of smoke-free work places.

And that's why, although... I mean, the data is there. And I didn't mean to give it shorter shrift in the testimony. I mean, that's why I included in the addendum -- all of the constituents that were measured are present in the addendum, and you can look at those till the cows come home.

But the solanosol, as you can see with a smile, here, as I'm telling this to you. The solanosol is present in very low levels and it's very difficult to use it as a marker for some of these situations where there are very, very small amounts of tobacco smoke occurring. Tobacco smoking.

MR. MYERS: If I'm hearing you correctly, what you're telling us is that given the problems of getting an actual representative sample as opposed to a somewhat skewed sample, given the huge problems of measurements, given the compromises you have to make in order to do a study at all, given the problems with each of the markers that you've got...

DR. JENKINS: Yes.

MR. MYERS: ...which, as I understand based on reading your materials and others, are probably the best ones we can find for measuring the exposure levels in this sort of study, this is a good study for a general guidance. It doesn't give us final answers as to actual levels of exposure for individuals. It doesn't give us broad scale information about what a worker, you know, in an assembly line could expect, or any cumulative health impact information.

DR. JENKINS: Oh. Oh, no. But again I, it's... It is the largest of its kind and it gives a lot more information than most, than all of the studies that I'm aware of.

MR. MYERS: Exposure studies.

DR. JENKINS: The exposure studies that have been done. It makes no... We do not purport to look at anything related to health impact or anything like that.

I'm an analytical chemist. This is a study of making measurements in ambient environments under reasonable conditions and I'd like to think that while maybe 30 or 40 years from now when we do this study again and we have this device that will make these kinds of measurements in real time, we'll all look back at this study and look at it and laugh at it because it was such a crude effort. As we will look at all of the studies that we've been involved with here. And look at their crude efforts then. But it's the best that we've been able to do up until now.

MR. MYERS: And part of what you're saying is, as a scientist sometimes we just have to take the best that we can do and make decisions.

DR. JENKINS: That's exactly right.

MR. MYERS: As I looked at some of your other data as well, things like fireplaces in houses, what percentage of the population actually went out to a restaurant.

DR. JENKINS: Yes.

MR. MYERS: All of those pieces are somewhat confounding factors to the daily routine as to this exposure versus that exposure. Is that a fair thing to say?

DR. JENKINS: To the extent that don't represent, are not representative of that individual's behavior, yes, they would be considered confounders.

MR. MYERS: And it's hard for us to tell that in the limitations of this study. I mean, is that fair to say?

DR. JENKINS: Yes.

MR. MYERS: I mean, it's not something like, you've taken a step into the water to begin to give us a new path to look, but even you would say we've got to do a whole bunch more if we really want to draw any significant, solid...

DR. JENKINS: I think we can draw some significant and important conclusions from the study. I think that they are, certainly that this study is not the best study that ever could be done but it's a pretty darn good one given the resources that we had to conduct it. And I think it provides more information.

I mean, I can see, you know, some of the statisticians around here, you know, kind of drooling over the opportunity to perhaps get ahold of some of that data just to look at it in very great detail. And I understand that. It's a huge amount of information.

MR. MYERS: And I appreciate that. And I appreciate it because I think you're recognizing its limitations as well.

DR. JENKINS: Oh, absolutely. It's not perfect.

MR. MYERS: Now, one of the conclusions I heard you say today was that even though your population of non-white collar workers was much smaller than the national average here, the data was good enough to tell you that a number of those non-white collar work places, places like barber shops, beauticians, waiters, et cetera, that their exposure appears to be greater than the exposure in white collar work places.

DR. JENKINS: Yes. And I do want to say, I want to couch that in the terms "appears to be." And I just ran -- I mean, I ran those slides out, I think, what's, you know. Probably on last Friday or so. And that's why I said, "This is my initial attempt at." And I haven't even run those by our statisticians to see whether or not the difference is...

I mean, I can look at them myself and make some judgements about what is the statistical significance, but I'm not going to say that until I let Richard and Chuck look at those and say that they are statistically significant.

MR. MYERS: Richard and Chuck are?

DR. JENKINS: They are two of my co-workers. They are Dr. Charles K. Bain and Richard Counts, who are co-workers with me on this study. They were in the Computing Applications Division, Oak Ridge National Laboratory.

MR. MYERS: How much of your time is being spent on this study? What percent of your time?

DR. JENKINS: Well, in the last couple of weeks almost 100 percent of it.

Just to kind of give you a pattern, because I thought somebody might ask me this along the way, as I indicated, our funding has represented since about May of '93 until present the equivalent of two and a quarter man-years stretched over the period of time that, you know... So maybe about a man-year per year. And that represents about 10 percent of the funding in my group overall.

MR. MYERS: Earlier you said that both you and Mike Guerin had been working on the less hazardous cigarette.

DR. JENKINS: That's correct.

MR. MYERS: What were you doing with regard to that work?

DR. JENKINS: ORNL was, back in the 1970's, was responsible for basically two activities within that program. One was the analysis of whole cigarette smokes from the experimental cigarettes being used as part of the less hazardous cigarette program. We were also involved with the characterization of the cigarette smoke condensates which were used for the skin painting bioassays which were conducted as part of the less hazardous cigarette program.

And another aspect, although I don't know if it was part of the bioassay program, in 1975 NCI started as part of their bioassays a large effort to conduct inhalation bioassay exposures. They did rats and dogs. The pigeons were involved in this study. And we were also working with defining the airborne quantities of smoke in those inhalation biosassays that were being conducted by NCI. These were conducted under the sponsorship of NCI by private or government related laboratories.

MR. MYERS: And as part of that work, if, in my limited knowledge about your involvement in that, that involved as well just trying to get some measurements. As an analytical chemist you weren't doing it, but in terms of what the consumer was actually...

Measurements within the body of biomarkers, things like cotinine and others. Is that right?

DR. JENKINS: We have done some limited work with looking at biomarkers in animals. We did some work with relationship to dogs, urinary cotinine in dogs that had been exposed to cigarette smoke. I think that work was published in 1983 or '84.

MR. MYERS: Now, were you involved in choosing urinary cotinine as the biomarker?

DR. JENKINS: As a matter of fact, I was. Yes.

MR. MYERS: And why did you select that?

MR. MYERS: Well, because it's a metabolite of nicotine, and at the time...

You know, there's been a sort of a great revolution in our understanding of the use of cotinine as a marker, especially in urine over the past several years. I mean, we would...

And I was talking about this in some of my initial discussions with Neil Benowitz back in the early 1980's, about how we'd look for nicotine in the blood. You could hardly -- you couldn't account for the total exposure of nicotine in the blood. And while, you know, you looked for the cotinine you couldn't account for it with the cotinine. Obviously, it's not in the blood. And then we subsequently learned through a lot of investigations by a lot of scientists that in fact the nicotine is metabolized to a number of metabolites, including the trans-3 hydroxic cotinine and cotinine 1 and oxide, I think, and all the glucochronides of those materials. And to look at only the one small picture, that may not give a complete picture of the total metabolic process.

The reason why we selected cotinine in this study was that we know that there's a large study that's going on with the CDC. The CDC is supporting looking at just, you know, salivary cotinine, and so we wanted to see, okay, what is the, is there a relationship between salivary cotinine measured specifically as salivary cotinine and nicotine.

MR. MYERS: And were you involved in that choice to use salivary cotinine as one of, as the only biomarker.

DR. JENKINS: Yes. I was involved in that choice. Yes.

MR. MYERS: Because you obviously thought that there was some validity to it, even...

DR. JENKINS: No. I thought that it was interesting comparing it with the CDC. I mean, you know, sure. There's potential validity. It's relatively easy to measure. And that's I think why a lot of people are choosing it. And I...

MR. MYERS: And if I remember correctly, your colleague, Dr. Guerin, who I believe you mentioned had been involved in a study with the Federal Trade Commission involving Barclay cigarettes,...

DR. JENKINS: Yeah.

MR. MYERS: ...used a cotinine measure as a biomarker in his work in that circumstance as well.

DR. JENKINS: I don't think that we were responsible for making any of the specific measurements, but Dr. Guerin and I might have actually discussed the use of salivary cotinine as in regards to the Barclay cigarette measurements that were made.

MR. MYERS: Just one last thing. And if you don't know the answer, tell me that, because it does involve your colleague, Mr. Guerin.

It's my understanding that Mr. Guerin, either as an individual or as a representative of your laboratory, recently participated in a National Cancer Institute panel looking at the cigarette testing methodology. And I think that took place in early December of this past year.

DR. JENKINS: That's correct.

MR. MYERS: Is that right?

DR. JENKINS: Yes. I'm aware of that.

MR. MYERS: You weren't there. And one of the things they were looking at, they were looking at markers so that we could tell what was going on, and as I understand it that he was one of the individuals who supported the statement at the end of that meeting that indicated that as we look at low-tar, low-nicotine cigarettes, that there's no data to support the view that we have dramatically reduced the risk of cardiovascular disease.

Is that your understanding as well?

DR. JENKINS: If you say that he did that, I have no reason to doubt you. But I don't know. Frankly, we haven't discussed the results of that meeting very much because... I think that was in early December. Is that correct?

MR. MYERS: It was. It was.

DR. JENKINS: And by the time he came back from that I was on my way to give a talk in China. And then it was Christmas. And then I've had to get ready for this thing. So we really haven't discussed that meeting very much.

MR. MYERS: Have you ever discussed health related issues of the low-nicotine, low-tar cigarettes with him, either yourselves or with him?

DR. JENKINS: Oh, absolutely. But not from a, from a... I mean, this is an issue of professional curiosity and personal curiosity, but we certainly, neither one of us -- I wouldn't consider either one of us experts in health. I mean, both of our backgrounds are in analytical chemistry. I would like to think that we're pretty good at making measurements. And we've discussed issues of health related stuff.

MR. MYERS: One of the impressions -- more than an impression. The reduction of nicotine levels, the reduction of tar levels in the panel on which he participated indicated that it had not led to a significant reduction in cardiovascular risk. Is that consistent with your understanding?

DR. JENKINS: I really. I just...

MR. MYERS: It's beyond your area.

DR. JENKINS: That's really beyond what I can... As I say, he and I haven't discussed it. I haven't, frankly, haven't paid much attention to what the results were of that discussion just because I frankly haven't had the time. That's honest. That's from the heart.

MR. MYERS: I have no further questions. Thanks.

JUDGE VITTONE: Thank you, Mr. Myers.

Mr. Gross. Did your questions get asked?

MR. GROSS: Yes, Your Honor. They did. Thank you.

JUDGE VITTONE: Mr. Rupp. And then we're going to go directly to Dr. Bridges after this.

(Brief pause)

MR. RUPP: Dr. Jenkins, my name is John Rupp, and I represent in this proceeding a number of scientists who have filed notices...

JUDGE VITTONE: Excuse me, Mr. Rupp. The noise in the back carries forward a lot easier in this room than it does down in that other room. Okay?

Go ahead, Mr. Rupp.

MR. RUPP: I represent a number of independent scientists who have filed notices of intent to appear on behalf of The Tobacco Institute.

Dr. Samet asked you this morning whether there might not be times or circumstances in which personal and area monitoring studies would yield comparable results, and I think you answered that question in the affirmative. Now, in light of the results that you presented today, would you not expect such congruent results to be rare? That is, the exception rather than the rule.

DR. JENKINS: Of course, they'd be the exception rather than the rule.

MR. RUPP: Well, let me ask you this, to focus on the factors that might account for that. And let me list a few, and I'd like your reaction to them, and then I'd like you to help me in the areas where I simply wouldn't know what the reasons for that conclusion would be.

I take it one of the major reasons would be that, when you're talking about the personal sampling, and unlike area sampling, personal sampling takes activities into account. The movement of the person around the room or around the building, and indeed outside of the building.

DR. JENKINS: That is correct.

MR. RUPP: An area sample, by the very definition of the term and the methodology that's used, is tied to a particular place and the person's proximity to that particular place will vary over the course of the day.

DR. JENKINS: That is correct.

MR. RUPP: All right. Then I take it personal sampling, unlike area sampling, would not necessarily, or at least to the same extent, take factors such as air flow and air movement into account.

Let me give you an example of what I have in mind. If the air flow in this room is moving from the front of the room to the back of the room, where I am seated, insofar as the particular constituent source is concerned, is going to affect my personal exposures while the area sampling device may be located in some other place and be subject to different factors, depending upon the direction of the air flow.

DR. JENKINS: That's correct.

MR. RUPP: And then I would think that proximity considerations have to be taken into account.

DR. JENKINS: Absolutely.

MR. RUPP: How close I am to the particular source of the pollution.

DR. JENKINS: Absolutely.

MR. RUPP: What else? What are the kinds, what are other things I'm missing? Another one just popped into my mind, and that would be perhaps sinks that exist in a particular room. Carpeting. Drapes.

DR. JENKINS: I was getting ready to mention that.

MR. RUPP: Okay. And now I've pretty much exhausted my expertise.

DR. JENKINS: Well, I... You know. It's just time spent around the smoke, which you've sort of alluded to. The sinks that you mention. Air flow, ventilation. Those are the most important things, I would think.

MR. RUPP: Okay.

DR. JENKINS: I'm sure if it wasn't 4:00 in the afternoon after almost seven hours of this stuff, or six hours of this stuff, I might be able to think of some more. But we'll settle for that now.

MR. RUPP: Okay. Well, here's another one. Temperature. The buoyancy of the room, which might be expressed under the general rubric of air flow, but not necessarily. That is the heighth of the person in relation to the heighth of the pollution source and the buoyancy and temperature of the room.

DR. JENKINS: It could, theoretically, affect it. I mean, you know, that's hard to say.

MR. RUPP: Okay. You would probably say that perhaps too many questions have already been asked about the representativeness of the results you've presented today. And I think I've understood your responses. I nonetheless have a few remaining questions in that area.

As I understood Dr. Samet's questions, they seemed to be based on the premise that representativeness of the results you presented should be judged by, in terms of the characteristics of the population as a whole. I was wondering when those questions were being asked why the appropriate, whether the touchstone shouldn't be instead of the population as a whole, the working population of the United States, since this is a proceeding that focuses on the work place.

DR. JENKINS: That's a very good point. And it probably should focus on the non-smoking working population of the United States.

MR. RUPP: Right. That was my next question.

DR. JENKINS: I'm sorry to steal that from you.

MR. RUPP: Well, no. That's all right. In that connection, I take it that it one of the reasons you were not particularly concerned about the underrepresented representation, so far as general population is concerned, of people 60 and older. And, indeed, you established a cut-off at what, 65?

DR. JENKINS: There was no cut-off of age in our study.

MR. RUPP: It was just...

DR. JENKINS: There was not... Basically, you had to work. I don't recall what the oldest participant was in our study. But there was no specific cut-off of age, although they had to be able to work 35 hour a week regular jobs. So that sort of affected -- that was a de facto cut-off.

DR. JENKINS: Well, I take it that you weren't surprised when you found out that when you applied this screen of having to work a 35 hour week that you were getting fewer people 60 years of age and older than those people are as a percentage of the U.S. population.

DR. JENKINS: That is correct. That wasn't a surprise at all.

MR. RUPP: And I take it the same might be true of women? Might be true of various ethnic groups, and so on? The overall working population of the United States is not going to be a mirror of the general population. Is that correct?

DR. JENKINS: Yes. I mean, I'm not an expert at population dynamics, but you can look at the statistics, the statistical abstract, I think, and come to that conclusion.

MR. RUPP: In the monograph that you wrote with Dr. Guerin and others, and it's been referred to several times during the course of the day. As I understood it, what you attempted to do there was to collect, describe, analyze and synthesize all of the air quality monitoring data relating to ETS that had been published or that you otherwise could get your hands on as of the time the monograph was being put together?

DR. JENKINS: To the extent that I was aware that it was available. I had been made aware of the fact that I did exclude some critical studies from one of my questioners, today, Dr. Hammond. And I'm sure that I did not include everyone. But it was, it was certainly my best, good faith attempt to examine every single bit of data that I could get my hands on.

MR. RUPP: Do you know of any other analysis of the literature, either as of that time or subsequently, that was more comprehensive than the one you published?

DR. JENKINS: I'm not aware of any.

MR. RUPP: All right.

DR. JENKINS: I would question that than anybody.

MR. RUPP: On the question of representativeness, then, again. I take it the studies that are summarized in the monograph were done by a series of investigators, a number of different investigators, over a period of time in a number of different places.

DR. JENKINS: That's correct. Including countries, not only just the United States, but also other countries as well.

MR. RUPP: Now, if you apply the tests of representativeness that have been discussed today during the course of the examination, would any of the studies that you have reviewed and are summarized in the monograph, either singly or in combination when we're able to do a variety of different combinations, be thought, so far as the United States work place is concerned, to be more representative than the work you presented?

DR. JENKINS: I can't see how they could be.

MR. RUPP: In fact, they are very significantly less representative, are they not?

DR. JENKINS: Yes. That's correct. To my understanding of how those studies were conducted, yes.

MR. RUPP: And, indeed, would it not also be fair to say that there may be not more than one or two studies -- and those one or two studies don't immediately spring to my mind -- where an effort was made even to satisfy any criteria of representativeness? That the criteria were instead what buildings the investigators could get into, what the location of the university was or the other research institution. But no effort to construct a representative sample of any sort.

DR. JENKINS: From my analysis of that, that didn't certainly... If that was there, it didn't show through in the studies as they were written. No.

MR. RUPP: There was a quite brief discussion earlier today about breathing rates while sleeping. Which prompted me to wonder a bit about what we are to make of the home exposure information that you've presented. And let me tell you what was going through my mind and you tell me whether I'm right or wrong.

If one applies a lowered breathing rate for the period of sleeping, that's one adjustment one might make in the home exposures. But I take it that one also has to take into account in assessing the significance of those results the fact that the sleeping period is also a period of little or virtual no exposure to ETS. That is, people aren't smoking while they're sleeping and generally the lights are off in the house and nobody else is either.

DR. JENKINS: Yes. Although... But there still would be exposure to some of the ETS components. They would decrease with time.

Previously, I was questioned about that, and some of those components would last I think for several hours. They may not last the entire duration of that period. There is some data that exists upon that. But you're right. There certainly shouldn't be any new ETS being generated.

MR. RUPP: Well, would it be fair to say, Dr. Jenkins, that the period of maximum exposure insofar as the home is concerned is very likely to be the period when someone is up in the house?

DR. JENKINS: I would think that that would be the case.

MR. RUPP: All right. Now. I take it what you reported to us, at least today, insofar as the home exposure data is concerned, are integrated exposures over the full period that people were at home.

DR. JENKINS: That is correct. Plus whatever other activities that they...

MR. RUPP: Okay. So that we have what I will characterize roughly as a high exposure when people in the house are up and doing, carrying on their normal routine, and some may be smoking and some not, perhaps. And then a sleeping period, perhaps lasting as long as eight or nine hours when perhaps nobody in the house is smoking.

DR. JENKINS: That is correct.

MR. RUPP: So the exposures for the four or five hour period, let's say from 6:00 in the evening until 10:00 or 11:00 at night, is likely to be a period of substantially higher exposure to the constituents of ETS if there is smoking occurring in the home than a 16, 18 hour integrated measure would be. Would you agree with that?

DR. JENKINS: Yes. I would agree with that.

MR. RUPP: I think you indicated, and your data show, that one should anticipate encountering lower levels of ETS and the personal exposures would be lower to ETS in smoking restricted buildings than in buildings in which there are no smoking restrictions, but that the results of the personal monitoring that you have done reveal low levels overall regardless of the degree of smoking restriction. Would that be a fair general summary?

DR. JENKINS: That's a fair general summary. That's correct.

MR. RUPP: All right. Now. Again, if I go back to Dr. Samet. He asked a question that implied that that general situation -- which I think by the way was reported to us also by Dr. Hammond when she appeared here earlier -- that that might not be due to smoking restrictions but to other factors. And, again, I began to think what those other factors might be. And let me give you a few possibilities, which struck me as not very likely, but I'd like your reaction.

Is there any reason to believe, for example, that in buildings in which smoking has been restricted, ventilation rates can be expected to be higher than in buildings in which smoking has not been restricted?

DR. JENKINS: I don't have any information to say that they'd be higher or lower. I mean, I wouldn't expect them to be one way or the other.

MR. RUPP: That smoking restriction buildings are likely to have better filtration or use air cleaners to a larger extent than in buildings where there are no smoking restrictions, no data or intuitive reason to believe that's the case either, is there?

DR. JENKINS: No. I don't have any data to support that.

MR. RUPP: How about lower occupant density? Any reason to believe that in smoking restriction buildings there is a lower, a higher... Excuse me. A lower occupant density than in buildings where there are no smoking restrictions. Again, no data or intuitive reason to believe that's the case?

DR. JENKINS: I don't have any data. I mean, you know, I'm not an expert building engineer or anything like that. But there's nothing intuitive that pops out.

MR. RUPP: There has been some discussion about what I thought was an interesting chart on respondent perceptions of exposure to environmental tobacco smoke. And you'll be happy to know that this is the last question coming off a question that Dr. Samet asked that I'm going to put to you.

He suggested that however unreliable such perceptual information, self-reports of perception, might be as a general matter, they might be better if a source descriptor, such as one's spouse, were used. It's speculation, but he suggested that might be true. Do you have any reason to believe it is true?

DR. JENKINS: I don't have any reason to believe it is or is not true, really.

MR. RUPP: All right. Well. Let me ask a couple of follow-up questions on that point.

First, whether or not it's true, the point really doesn't apply at all, does it, to studies that have -- epidemiologic or other studies -- that have relied on self-reports of exposure to environmental tobacco smoke in the work place. There we have no source descriptor to rely on, such as a spouse.

DR. JENKINS: That is correct.

MR. RUPP: So to the extent that OSHA is prevailed upon to look at epidemiologic studies relating to ETS health effects so far as the work place is concerned, focusing on actual experience and disease incidence in the work place, the source descriptor speculation isn't going to help at all, is it?

DR. JENKINS: To me, that would seem to be the case. Yeah.

MR. RUPP: All right. Now. In a spousal smoking situation. And to the extent that you just don't know of any data or have no judgement about this, just feel free to let me know. But in the epidemiologic studies we have tended to discuss in this proceeding we have tended to look at exposures, of self-reports -- perception, if you will -- reports of exposure over a 30 to 40 year period of ETS components.

DR. JENKINS: Yes.

MR. RUPP: As an analytic chemist, is that the kind of information, exposure information, that you would tend to think is going to be all that good?

DR. JENKINS: I must say as an analytical chemist that my faith in self-reported information has not been... I wouldn't say it's been blown away, but it's certainly been shaken by much of the information that I've seen in this study. It is...

I'm really surprised at what I see as... There's much more uncertainty in it that I was aware of previously. People just don't know. They just don't know.

MR. RUPP: Okay. Well, I guess the question is, why is that so surprising? How many cigarettes have you been exposed to today? Do you know?

DR. JENKINS: Right off-hand, although... Yeah. Probably I do. But then, I'm used to thinking about those kinds of things. I can also remember what I had for dinner a few months ago, too. So I'm kind of strange.

MR. RUPP: That's the skill of the analytical chemist, is to focus.

DR. JENKINS: No. It's that.

MR. RUPP: I see. All right.

Back to the spousal smoking situation.

DR. JENKINS: Okay.

MR. RUPP: We exacerbate our situation. We just talked about the 30 to 40 year period, trying to judge exposure over that period of time and the uncertainties that are necessarily inherent in that kind of request for information. What if we have a situation where...

Let me put myself in the position of an investigator. I'm an epidemiologist. I go into you and say, "Look, Jenkins. I need exposure information. I'm going to do an epidemiologic study. We're going to conduct this over a 15 year period. I'm going to rely on self-reports of exposure and that is marriage to a smoking husband. But I'm not going to follow up during the 15 year period. That is, I'm not going to take into account divorces. I'm not going to take into account whether the spouse has ceased smoking at any point during that period. I'm not going to do any biological monitoring. I'm not going to do any air quality monitoring, whether area of personal. I'm not going to look at the ventilation system, I'm not going to ask where the smoking occurs, but this is what I'm going to do."

And what are you going to think about it when it's done?

DR. JENKINS: Well, I'm no epidemiologist, but that's going to be pretty minimalistic exposure information.

MR. RUPP: What if I told you that in addition to that I'm going to, not going to be too unhappy if I'm not going to be able to get to the spouse or the person that has the particular disease I'm interested in. I'm going to go to surrogates, and I'm going to ask next-of-kin, friends, other family members who may or may not have been present for any of the pertinent period, whether the spouse smoked and how much that spouse smoked. Are you going to be too happy about that kind of exposure information?

DR. JENKINS: Again, I'm not an epidemiologist. I'm an analytical chemist. But that seems to be very, very minimalistic information to me.

MR. RUPP: What if I failed to ask any questions whatsoever about proximity to source?

DR. JENKINS: That would certainly be a confounding factor in your exposure assessment.

MR. RUPP: I know that you've spent a good deal of your time since Thanksgiving or so working on your own data and I want to ask you a couple of questions, a few questions, about the OSHA preamble but if it's not something you've reviewed lately so you feel uncomfortable giving detailed information, just let me know and maybe I could ask you to think about these questions for purposes of rebuttal. But if you're able to give answers I would appreciate having them.

The part of the preamble that seems to me particularly to fall within your area of expertise is the discussion that begins around page 15,988 and it begins with a discussion of the CAP study, which you yourself have referred to, and a few others.

Let me read you a quote and ask you whether you agree with this quote. And this is a characterization of the OSHA preamble discussion of ETS exposure in the workplace.

"The drafters of the exposure assessment portion of the notice appear to have forgotten that exposure is a function of several factors operating in combination. That is, concentration, proximity and duration being the most important. The drafters have been content to focus most of their attention on only one factor, reported duration of exposure at various sites, which provides, of course, a wholly inadequate measure of total exposure, much less of actual dose."

Would you agree or disagree with that?

DR. JENKINS: I would agree with that statement. That's very similar to what I wrote in the comments that I filed.

MR. RUPP: All right. Let me give you the second of the third. "The drafters of the OSHA notice have failed completely to take into account the great bulk of the data that have been published documenting ETS exposure levels, particularly in the workplace." That is, of the studies reviewed, for example, in the monograph only a handful of studies were described in the preamble. And the comment that I am reading to you is that have failed to take into account the great bulk of the data that have been published focusing on the workplace.

DR. JENKINS: I'm not sure I'd use the term great bulk but I was surprised to see the limited number of studies that were cited. So I sort of agree.

MR. RUPP: All right. I'll take sort of. It's late in the day.

DR. JENKINS: I know. It really it is.

MR. RUPP: Finally, the third statement, "They have ignored the fact that personal monitoring studies, coupled when available with biomarker studies, are far superior to area studies in measuring non-smoker exposure to ETS because they, unlike the area studies, incorporate proximity and other time activity considerations."

DR. JENKINS: I have to agree with that.

MR. RUPP: All right. In your judgment --

JUDGE VITTONE: Mr. Rupp, can you just hold on for one second?

MR. RUPP: Yes.

(Pause)

MR. RUPP: In your judgment, Dr. Jenkins, what, if anything, does the CAP study tell us about actual worker exposure to ETS in the workplace as well as dose of exposure to ETS constituents in the workplace?

DR. JENKINS: I haven't thoroughly review the CAP, I've only looked at it briefly. My recollection is that it talks about this sort of thing of duration exposure, the amount of time around the individual. It does not talk about the specific quantities of ETS markers to which individuals are exposed.

MR. RUPP: That is, it has no quantity information at all, it's simply how long I perceive myself to have been exposed or somebody in the proximity.

DR. JENKINS: It is an activity pattern survey. And, again, I'm an analytical chemist but -- and it states its limitations in its title, it is only an activity pattern survey.

MR. RUPP: What I've just handed you, Dr. Jenkins, is a copy of the OSHA preamble and I've opened the preamble to a page that contains table that is marked 3-IX.

DR. JENKINS: Yes.

MR. RUPP: Do you see that?

DR. JENKINS: Yes, 3-IX, that's the table "Percentage of Employed Non-Smokers Exposed to ETS."

MR. RUPP: Right. Perhaps you could help me to read that table because as I read it, it doesn't make sense. As I read it, it indicates that 2 percent of the CAPs respondents were exposed to ETS at home, which seems to me awfully curious in light of the fact that over 20 percent of Californians smoke. Am I misreading that table?

DR. JENKINS: No, 2 percent. That's what the table says, 2 percent.

MR. RUPP: One percent of one sex and 3 percent of the other.

DR. JENKINS: Yes, 2 percent of the other but the overall quantity was 2 percent.

MR. RUPP: All right. If you look at Table 3-VIII, I read that one to suggest that -- no, let me ask you to stay on Table 3-IX for a moment.

DR. JENKINS: Okay. It indicates that of those respondents reporting exposure to ETS at work, only 80 percent were exposed to ETS at work. I know that sounds like nonsense but that's the way --

MR. RUPP: Yes, overall, there were fewer males than females but the average was 80 percent.

DR. JENKINS: And mathematically that cannot be. You can't report exposure to ETS --

MR. RUPP: I would certainly like to see how they slice and dice this data to get those numbers.

DR. JENKINS: All right. The study by Jenkins which is cited also in the preamble reported only the percentage of non-smokers who believed they had been exposed to ETS at any of several locations and the average number of minutes of reported exposure. Again, Jenkins reported no data on concentration or dose. I take it that that study, then, is going to be subject to precisely the same limitations and problems so far as the ultimate questions in this proceeding.

DR. JENKINS: The actual exposure. Yes. Yes. I mean, it's an activity pattern. Essentially, it's an activity pattern survey and, again, I'm an analytical chemist but it seems to me that this is a very indirect way -- I'm a simple minded analytical chemist from the hills of Tennessee. If you want to measure exposure, go out and measure exposure, don't use roundabout methods for doing it. I'm sorry. I just had to say that.

MR. RUPP: Kabat and Wynder is also a study cited in the preamble in the same set of paragraphs. Have you reviewed the Kabat and Wynder study?

DR. JENKINS: No.

MR. RUPP: How about Wald? The Wald study cited in the preamble, have you read that recently enough to --

DR. JENKINS: No, I sure haven't.

MR. RUPP: Okay. Emmons?

DR. JENKINS: No. I'll tell you this, I haven't read any of the studies that were cited -- I wouldn't say any of them but most of them that were cited, I haven't read them since back in August.

MR. RUPP: All right. Well, let's stop there because I don't want to take time. That's why I prefaced these questions by saying I understand you've been working on something else in the last few weeks.

DR. JENKINS: I want to be honest. Yes. Yes.

MR. RUPP: You were asked a series of questions about how many people flunked various screens when screening questions were asked. And for the life of me I couldn't figure out why anyone cared. Let me follow that up with you.

As I understand the screening process that you utilized in this study, you set a number of standards or criteria that people had to meet in order to pass through the screen into the next phase of the evaluation, whether they were going to be an appropriate subject.

And if you found someone who wasn't working, they didn't get to the next step.

DR. JENKINS: That's correct.

MR. RUPP: All right. If you found a lawyer, the lawyer didn't get to the next stage.

DR. JENKINS: That's correct. No offense.

MR. RUPP: Okay. No offense taken. Probably if you found Jim Repace or Sue Sherman, they would haven't made it through.

DR. JENKINS: They would have been eliminated, too.

MR. RUPP: The judge, if he had been wholly candid, he probably wouldn't have made it either.

DR. JENKINS: That's correct.

MR. RUPP: All right. Now, if we knew all of that, if we knew that all of us had been called and none of us had made it through, what would we know that we don't know now? What is the significance of that information? That unqualified people, some unqualified people received some initial calls?

DR. JENKINS: I don't know, other than perhaps the intellectual interest in trying to understand why we had a relatively difficult time recruiting subjects when other individuals have had relatively easy times recruiting subjects. And the questioners may have liked to have known exactly what it was we were doing that was so screwy that we were having a hard time getting people in the study. I don't know why they wanted that information but I can't possibly divine that out of their heads.

MR. RUPP: Okay.

(Pause)

JUDGE VITTONE: Mr. Rupp?

MR. RUPP: Yes?

JUDGE VITTONE: How much longer?

MR. RUPP: Your Honor, may I have just 30 seconds?

(Pause)

MR. RUPP: Your Honor, given the lateness of the hour, I think I will stop there.

Dr. Jenkins, thank you very much.

JUDGE VITTONE: Thank you, Mr. Rupp.

Dr. Jenkins, thank you, sir, for your extended time today.

MS. SHERMAN: I believe that in your conversation with Mr. Myers you mentioned a study involving biomarkers and dogs?

DR. JENKINS: That's correct.

MS. SHERMAN: Do you have a copy of that study to submit?

DR. JENKINS: No, I wasn't quite sure it was relative to these proceedings. It was published in "Toxicology and Applied Pharmacology" back in 1984, I think.

MS. SHERMAN: It's your study?

DR. JENKINS: I'm one of the co-authors of the study. I think Brassel is another co-author.

MS. SHERMAN: If you have an extra copy, perhaps you could send it along.

DR. JENKINS: Sure.

MS. SHERMAN: I have a request from our toxicologist for it.

JUDGE VITTONE: Is that it, Ms. Sherman?

MS. SHERMAN: Yes. Thank you.

JUDGE VITTONE: Thank you very much, Doctor. We appreciate your time today. You can go back to the hills of Tennessee now.

DR. JENKINS: I'll get these shoes off here.

JUDGE VITTONE: I thought it, you said it.

(Laughter)

JUDGE VITTONE: My daughter-in-law is from Knoxville and I introduced her to some friends of mine and this one wiseguy friend said at least she's wearing shoes.

JUDGE VITTONE: Okay. Dr. Bridges?

(Pause)

JUDGE VITTONE: Dr. Bridges, would you state your name for the record, please, and your organization?

DR. BRIDGES: Yes. I'm Professor James Bridges and I'm professor of toxicology at the University of Surrey in Guilford in the United Kingdom.

JUDGE VITTONE: All right. Thank you very much.

Ladies and gentlemen, the acoustics in this room are really bad. The voices and the papers being turned just bounce off this wall and I think they're all bounced forward. So please try to keep the conversations down, okay?

Doctor, would you go ahead, please?

DR. BRIDGES: Perhaps as we've just been playing role models, I should apologize for the fact that I have an English accent and I left my bowler hat back in England.

Let me first tell you a bit about myself and my institute that's relevant to today's hearing. My chair in toxicology was the first established in the United Kingdom at Guilford in Surrey and for those of you who don't know much about England, it's exactly halfway between Gatwick Airport and Heathrow Airport, which is probably what most people know about Great Britain.

I am Research Director of the Robens Institute of Industrial an Environmental Health and Safety, which is an academic department in the faculty of science of the university and, indeed, I founded the Robens Institute in 1978.

A little bit about the Robens Institute because you're probably not very familiar with it. We have around a hundred staff. We have a range of disciplines which include toxicology, occupational health, occupational hygiene, occupational safety, applied physiology, analytical chemistry, microbiology, public health and epidemiology, and psychology. And in our approach to industrial workplace problems, we try and use a multi-disciplinary approach.

In terms of size, we're the largest university-based institute in Europe concerned with workplace health and safety and because of that we get involved in a very wide variety of workplace problems.

In any one year we have something like 300 separately funded projects and these will range from funding, of course, from research councils to funding from industry, from the legal profession, from the United Kingdom and E.C. government departments, trade unions and lobby groups such as Friends of the Earth, Greenpeace and organizations of that kind.

As I've said, we have a major involvement in workplace health and safety. We provide, for example, the technical secretariat for the E.C. committee which is called DG-5 which sets workplace standards for Europe.

In terms of my own personal experience, perhaps I could just make a few pertinent points. My qualifications are rather long and I'll try and explain them. I have a BSC in physiology and chemistry, a Ph.D. in biochemistry with particular reference to drug metabolism, a DSC which is something I don't think you have over here. This is a particular research award, it's the highest research award that a university can give, and that's in toxicology. I am a chartered chemist and a fellow of the Royal Society of Chemistry. I'm a chartered biologist and a fellow of the Institute of Biology. I'm a fellow of the Institute of Occupational Safety and Health, a member of the Royal College of Pathology, a member of the Institute of Environmental Sciences and just for the sake of completeness a fellow of the Royal Society of Arts. So that just means I pay a lot of subscription fees every year.

I am a former chairman of the British Toxicology Society, which I helped to form. I was the first president of the European Federation of Toxicology Societies.

I've published over 300 research papers and reviews and I'm editor of some 16 books. I have supervised over 70 Ph.D. students and I've researched for various periods of time in several countries, including the United States, in North Carolina, at NIHS, at the University of Rochester in New York State and at the University of Texas.

I am also an honorary fellow of the Collegium Ramasini, which is an international organization concerned with improving occupational health, and I am an honorary member of the Society of Occupational Medicine and among the American societies I belong to is the U.S. Society of Toxicology.

Finally, because this is already sounding like a long obituary, I have served and continue to serve on a number of U.K. and E.C. committees and of special relevance to today's hearing I have been and continue to be a member of the Watch Committee of the Health and Safety Executive. The Health and Safety Executive in the U.K. is as near as we can get to the equivalent of OSHA and it's the committee in the U.K. that's responsible for setting workplace air quality standards.

I have been asked to appear at this hearing by Shook, Hardy & Bacon on behalf, I understand, of Philip Morris. However, the views expressed are entirely those of myself and my colleagues.

Now, going on to my presentation itself, I'll confine my remarks primarily to the office environment because this is an area in which my institute has developed particular experience over many years. Most of my staff at one time or another are out looking at office buildings or industrial workplace buildings, doing field studies of that kind. However, I will touch particularly towards the end of my presentation on some wider issues.

Firstly, I want to talk about sick buildings. There is no doubting that in a severe case of sick building syndrome there can be a substantial affect on office health and safety.

In identifying a strategy for dealing with a particular sick building, the first challenge is that as an adverse health condition it is ill defined and has many causes and contributing factors

On this first overhead, I've listed some of those. Some of you at the back may not be able to see them, but the overhead is divided into two columns. Firstly, the nature of the building and the second column, the quality of the job. Then the nature of the building, where it's modern or not, whether it has air conditioning, whether it uses spray humidifiers, whether it's in the public sector, whether it's speculatively built, whether it has an open plan interior, whether it high percentage exterior glazing, whether it has tinted glazing, whether its windows are able to open or not, the nature of the air quality and the lighting design.

These are just some of the building factors that are considered to be important factors in deciding whether or not you have a sick building.

And then in terms of the quality of job, these are also crucial issues that influence whether the building are sick or not. Low job satisfaction, non-challenging tasks, routine VDU work, under-use of skills, inadequate training, clerical work, undervalued by employer, lack of privacy, no control of work rate, no control of environment and poor management.

Now, all of these issues have been raised in relationship to sick buildings and when you investigate sick buildings a number of these factors are often found to be in existence and trying to remedy these factors does often seem to improve the condition of the building.

It's not possible to correct a building, of course, so that you don't have headaches, you don't have sore throats, you don't have sore eyes, so we're talking bate an improvement always, we're never talking about getting to a perfect situation because in a so-called non-sick building of course all these conditions are found as well.

Now, it is our experience in looking at sick buildings that no two buildings are ever alike. You can go to two buildings built by the same designer in different places, both of which seem to have conditions which would be described as sick building, and find that the causative factors or exacerbating factors or the risk factors tend to be somewhat different in the two environments.

And so what we have to deduce is that sick building syndrome generally is a multifactorial problem and it requires multifactorial changes, generally speaking, in order to remedy it.

The key feature of a sick building syndrome, of course, is a series of acute effects. Those acute effects that the staff experienced are generally irritant effects, particularly on the mucus membranes, affecting the eye, the nose, the throat, often coupled with a general malaise which I'm sure we're all feeling at this time of night so that tiredness is one of the key features and often headaches.

What you find is that as you go from sick building to sick building, the various prevalence rates of these different effects tends to be different. We've never found a consistent pattern of say, 80 percent headaches and 20 percent sore throats. It varies considerably from building to building.

Typically, a high proportion of the staff, however, are affected and that's a characteristic feature of a sick building.

In our previous report to OSHA, we dealt in some detail with many of the factors associated with sick building syndrome and related phenomena. My evidence today concentrates on the possible role of airborne chemicals which, among other things, includes ETS.

In considering the contribution of chemicals to sick building syndrome, a distinction must be made at the outset between sensory effects and true adverse effects on human health.

In terms of sick building syndrome, chemicals have tended to attract particular attention for various reasons, one of which is because their odor can often be detected; another is because often they can be readily measured analytically.

But you'll see looking at the overhead that chemicals are simply one aspect of the many factors involved in sick building syndrome.

The mere detection of the presence of a chemical, of course, does not imply that an adverse effect on human health will result. In this context, it's essential to appreciate that an airborne environment entirely free of chemicals is an impossibility because we're not only talking about synthetic chemicals, we're also talking about naturally occurring chemicals, including those produced by the body.

So the question in dealing with a chemical environment is not whether you can clean it up so there are no chemicals present but what level of improvement do you need to make so that you don't have a significant adverse effect on health?

On the next overhead, for the purposes of illustration, the levels of some 11 chemicals, with some of the literature values, found in office air are given.

And for those of you who can't read it from the back, I've listed as representative heptane, benzene, toluene, xylenes, all the isomers, in other words the ortho-meta impairers, ethylbenzene, tetrochlorethalene, 1,1,1-tricholorethane, trichlorethylene, 1,4-dichlorobenzene, naphthalene and carbon monoxide.

And then in the second column, I give a range of values expressed in micrograms per meter cubed and I'll just run down the list.

Heptane, 5 to 430.

Benzene, 10 to 52.

Toluene, 10 to 610.

Xylenes, 12 to 125.

Ethylbenzene, 5 to 40.

Tetrachloroethylene, 4 to 198.

1,1,1-trichloromethane, 15 to 290.

Trichloroethylene, 2 to 68.

1,4-dichlorobenzene, 7 to 99.

Naphthalene, 1 to 26.

Carbon monoxide, 1 to 60.

Now, alongside these chemicals and the values found in office air, and these are a selected group of chemicals and also a range of values found in the literature, I haven't attempted to cover all the literature but I've tried not to be selective in terms of favoring high levels or low levels.

Alongside these values, I've set out the U.K. workplace standards, both the short-term exposure standards, which are averaged over a 10-minute period, and the eight-hour standards, which were assumed on the basis of somebody working eight hours a day, five days a week.

The purpose of these standards is, I quote from the Health and Safety Executive document which lists the standards, which is reproduced on page 21 of my text, the purpose is as follows: "In setting a standard, the existence of a threshold must be shown above which there may be evidence of significant health effects but below which there are thought to be no adverse health effects."

So in setting these standards, and I've participated in setting most of them over the 10 years that I've been a member of the Watch Committee, dose-response relationships have always been crucial to setting an acceptable level.

I note that many of the standards set out on the overhead are actually identical with those currently used by OSHA. The exceptions, for those of you who may be interested in this area, are simply benzene, toluene, tetrachloroethylene and trichlorethylene, where the United Kingdom standard in numerical terms is six to 10 times stricter but the USA applies these standards differently so I'm not attempting to suggest that one is more rigorous than the other. They're simply applied in a different way. But most of the standards are comparable.

And just for those of you who can't read the standards, the eight-hour standard, which I'll concentrate on:

For heptane it is 1600 times 103.

For benzene, it's 16 times 103.

For toluene, it's 188 times 103.

For xylenes, all isomers, it's 435 time 103.

For ethylbenzene, it's again 435 times 103.

For tetrachloroethylene, it's 335 times 103.

For 1,1,1-trichloromethane, it's 1900 times 103.

For trichloroethylene, it's 535 times 103.

For 1,4-dichlorobenzene, it's 675 times 103.

For naphthalene, it's 75 times 103.

For carbon monoxide, it's 55 times 103.

I've listed the WHO values. Now, these are values set by WHO particularly in relationship to Europe because it's published by the European office but the WHO are hoping that member countries will seek to achieve.

This is for external air and it's of course therefore air that we expect to be breathed by the very young and the very old, the healthy and the sick. And you'll notice the values for toluene are 8000; for tetrachloroethylene, 5000; for 1,1,1-tricholorethane, 1000; and for carbon monoxide, it's 10,000.

Again, these standards are set on health-based criteria and again you'll notice the values for the air that we breathe outside are considerably higher than the values that are quoted here for office air.

I think the ambient air guideline values are pertinent because the intake for air conditioning that's going to supply our offices is after all ambient air which we may or may not be cleaning up. But what we find very interested in sick building syndrome is that we generally find even in crowded cities that if people can open windows they are less likely to show problems with sick building syndrome than if they have closed windows, when we assume they're exposed to sometimes quite heavy levels of chemicals in ambient air.

On the next table, overhead three, I've produced again a table from various sources, this time of nicotine and RSP values which are found in various offices. Unfortunately my secretary went home and I had to type it. I'm not as good as she is at producing overheads.

This on the first two columns gives RSP values and on the next two columns gives nicotine values. As we've heard rather a lot about nicotine values today, let me simply say that the levels are relatively low and that the greatest range or the top figure as far as I can see is 71.5 in this set of values for nicotine and for RSP it's 133 on this particular set of values.

Again, if we relate these to the current workplace standards, the U.K. value for nicotine for an eight-hour working day, five days a week, is 500 micrograms per meter cubed. That's exactly the same value that I believe that OSHA currently uses.

With RSP, which is respirable particles, it's rather more difficult to talk about a workplace standard because with particulate matter you really should have some understanding of the nature of the particle. But the nearest we can get to that is the workplace standard for RSP in general, is 5 milligrams per meter cubed or 5000 micrograms per meter cubed. So these values again are very, very much lower than the recommended workplace standards.

So if I could briefly summarize the position of chemicals in relationship to sick building syndrome, in favor of the hypothesis that chemicals are an important cause of sick building syndrome, I have several points.

Firstly, a number of chemicals are known to produce each of the symptoms specified as effects of sick building syndrome, namely, we know of chemicals that can produce sore eyes, sore nose, sore throat, headache and general malaise. But of course we know of many other things that can do that as well, including very long hearings.

We know that these chemicals that can produce these effects have been found in office air and we have a certain amount of confidence that the more detailed the analysis, the more chemicals we will find in office air, albeit the levels may be very low.

And, lastly, occasion, and let me emphasize on occasion, much higher levels of such chemicals have been found than I have referred to and alleviation of some of the symptoms have been claimed when these levels have been reduced.

In our experience, there are two situations where very high levels of chemicals tend to be found commonly. One is when you've got a recently refurbished building or somebody's moved into a new building and, secondly, where the air intake relates to the underground car park and we've come across three cases where sick building syndromes have been alleviated when the position of the air intake has been removed so that it isn't near the underground car park.

So those are the points in favor of chemicals causing sick building syndrome or having an important role in sick building syndrome.

If I could have the next overhead, which is overhead five --

With few exceptions, as I've tried to illustrate, the levels of chemicals identified are very low, typically approaching or below ambient air guidelines for health and certainly very well below workplace standards for health.

There appears to be a general commonality of chemicals in terms of composition between office and home exposure yet the characteristics of sick building syndrome is a development or worsening of the symptoms in the office environment and generally a lessening of such symptoms when people go home, have holidays and so on.

The third point, which I've already touched on, many other aspects of the office environment can provoke comparable symptoms and these include things like poor temperature control, low humidity, stress and other psychological factors. And we find in our experience that stress of various kinds is a very important feature of many sick buildings.

And, lastly, because VOCs or volatile organic chemicals have often been focused on, where such studies have been done, it's worth emphasizing that the levels of VOCs don't generally seem to correlate with symptom rates.

So our analysis of the situation is that although chemicals from time to time may have a significant role to play in sick building syndrome, and indeed we've experienced that ourselves on occasion, this is relatively rare and it's generally much more likely that other factors, usually in combination, usually are the major cause or exacerbating factor or risk factor for the sick building.

Next overhead, please, which is overhead six.

Now, this one I am afraid is impossible to read. All I'm attempting to do here is list the risk factors that have been identified for coronary disease.

The first point I want to make about air quality and coronary disease is that if we look at the risk factors for coronary disease, we find they're numerous. Various authors have attempted to list the entire number of risk factors which have been found to influence coronary disease. Estimates of the number vary between 200 and 300 but I'm sure somebody will find others.

Within this list, of course, some are clearly much more important than others and on the list there are some that are extremely obscure as to what their connection with coronary heart disease could be.

For example, for those of you who have very good eyesight, you will see that slow beard growth is a factor that seems to link with coronary heart disease. As I shave mine off each morning, I'm not quite sure whether I have this symptom or not.

There is very little specific toxicological data and experimental models to indicate that inhalation of chemicals is a cause or an exacerbating factor for chronic cardiovascular disease except for a few chemicals where high dose levels clearly have produced coronary heart disease in long-term feeding studies and perhaps the best example of that is a chemical called Brown FK which you probably are not familiar with but it's the chemical that was used in the United Kingdom until the '70s to color kippers, which is a fish that we have smoked and we like to have them nice and golden yellow. Now, that chemical produced profound coronary heart disease in experimental animal models and also caused considerable heart problems for the kipper industry.

There is not to my knowledge any direct data to indicate that office workers have any increased incidence of cardiovascular disease which could be attributed to airborne chemicals.

Evaluating the possible health risks from the relatively few studies on ETS and other chemicals which employ biochemical endpoints are fraught with potential problems which makes their interpretation somewhat difficult. I'll just list four of these.

Firstly, the great majority of the studies are examining acute phenomena. Their relationship to the chronic condition in man which we define as cardiovascular disease is very unclear.

Secondly, the magnitude of the changes observed are generally very small and their connection to the levels of chemicals, including ETS, found in the office environment is very questionable. This is a dose-response issue and one which I will return to in a minute because I think it's fundamental to this whole issue of air quality and the importance of chemicals in determining adverse effects.

Thirdly, the particular chemicals which produce cardiovascular changes which are present in ETS or other complex mixtures, has not been identified.

And, lastly, for animal work, the validity of the models to the human situation is generally not at all clear.

Overhead seven, please.

I just want to digress to a simple toxicology model of a dose-response relationship because I understand that it's come up several times. What I've got on this overhead is a rather generalized dose-response relationship to illustrate the various terminologies that tend to be used by toxicologists to refer to the effects of chemicals.

The first point to note is that for the great majority of chemicals, toxicologists believe and in many cases have data to support the fact that the dose-response relationship, the vertical axis equals the extent of a particular effect and the horizontal axis equals the exposure level to the chemicals.

And we generally find something of a sigmoid dose-response relationship, although the shape of the curve and the position of the curve along the horizontal axis will differ from chemical to chemical.

And so if we look at high doses, what we find is a substantial effect on health and it's a truism that every chemical will produce adverse effects on health. I always tell my toxicology students, my Master's students, that there are six recorded deaths in the U.K. literature from drinking too much water and that is why I go to the bar regularly each evening. And it's certainly true that given a high enough dose of anything you will get toxicity. So when we talk about chemicals being toxic, yes, I would agree, whatever you list is toxic providing the dose is high enough. What we need to know is how that chemical's toxicity changes as you change the exposure level and then we can talk about the significance of the values.

So we start with substantial effects on health and as we reduce the concentration, we go to what often is described as significant but minor effects and then we move down to a point where it's quite difficult to draw the arrow so I haven't put one in but it says biological changes of questionable relevance to health. And that includes a series of biochemical measurements which enthusiastic biochemists will always come up with additional measurements which could be made but often we have no idea how they relate to health.

And then we get to a point where however hard we try we can't detect an effect of the chemical. That's often called the no detectable effect level but over here I think you know it more commonly as the no observable effect level or the NOAEL value.

And then somewhere along that bottom line we draw the acceptable level. And generally where it's appropriate we vary the acceptable level according to the quality of the data in terms of the dose-response curve.

Now, I note that in the risk assessment models used by OSHA to identify the risk factors for cardiovascular disease which are based on, for example, the Helsing studies, there is no dose-response consideration formally included.

I am very concerned at the apparent absence of any attempt to make a thorough assessment of the dose-response relationship which is claimed between ETS and cardiovascular disease because to a toxicologist, as I've pointed out, a proper evaluation of the dose-response relationship is absolutely critical to any assessment of risk. Indeed, without this, any risk assessment is of very questionable value.

So to summarize very briefly our position, the case for giving priority to lowering the levels of airborne chemicals in the office, which includes ETS, in terms of improving human health, appears to be weak. I therefore question what the real benefits to the health of office workers could be from the proposed OSHA regulations as they currently stand.

Could I now go to overhead eight?

I am strongly committed to encouraging regulatory action which will result in a genuine sustained improvement in human health. Indeed, I have served for a number of years, as I mentioned earlier, on government scientific advisory committees, which unfortunately in the U.K. and within the E.C. are unpaid, to help facilitate this particular process.

With regard to the proposed regulations, I have a number of particular concerns in addition to those I've mentioned.

Firstly, as somebody who deals with the workplace situation regularly in the U.K., I am very uncomfortable with the underlying argument that in relationship to exposure to airborne chemicals in the working environment office workers should be considered in a very different way, apparently, from industrial workers who may even work for the same company.

Introduction of the regulations could serve to heighten the common perception which at least occurs in the United Kingdom and I presume over here to some extent as well that in terms of health protection white collar workers continue to be given priority over blue collar workers.

The second concern is that in our experience, companies and other organizations have a very limited budget for improving health and safety. And if priority is given to a particular set of measures by virtue of government regulations, this is commonly at the expense of other health protection measures which might have been developed.

We, for example, have experience in the U.K. that when the so-called COSHH regulations were introduced, which is a wonderful acronym for the control of substances hazardous to health, a lot of companies moved resources which would otherwise have been applied to things like slipping, tripping and falling accidents to comply with the new regulations.

The case for office indoor air quality being given priority within the general field of needed health and safety measures in industry its broadest sense we find somewhat difficult to justify.

Third, with regard to the proposed ban on ETS, in addition to the points mentioned earlier, we have a particular philosophical or perhaps it's a strategic concern. A ban is only really appropriate if there are strong reasons to believe that a major real health hazard is involved and that control cannot be achieved by applying workplace standards or workplace guidelines.

Based on the evidence of ETS in the office and what we know about health in offices, it does not appear to us that a ban on ETS actually meets this criterion. I have some difficulty in seeing if a proposed ETS ban is adopted how on philosophical grounds we can justify not banning a whole range of other activities involving the combustion of materials, in particular those of plant origin, such as wood, coke and coal, since it is evident that many of the chemicals which are presumed to be present in ETS are also present in the fumes and smoke from these sources, too.

And, lastly, wearing an environmentalist hat, I would like to see as part of the OSHA evaluation an assessment of the increased ambient air pollution which will result from the greater energy demand which is a consequence of the greater air conditioning demands.

May I have the last overhead, overhead nine, please?

In my last overhead, I provide for consideration, and let me emphasize I am not seeking funding, some studies which we feel need to be conducted in order to identify how progress based on science could be made.

I'll just list them because of the time. I think it's extremely important that an investigation of incidence of heart disease in office workers and the contributions to that are identified and that we can dissect in such a study the contribution of chemicals in the office environment which would, of course, include but not be solely concerned with ETS.

I would like a proper evaluation of the dose-response relationship of the various biological effects identified by OSHA but at the sort of levels of chemicals which are found in the office environment.

Then in terms of sick building syndrome specifically, I think there's a need for much more thought about strategies for investigating sick buildings. Far too often what tends to happen is that one particular specialist goes into a building and looks for the area in which they have a specialism as the cause of sick building syndrome. We have to accept that as a multifactorial problem and we need to develop internationally, I think, better strategies for looking at it.

And, lastly, talking about chemicals in air, concentration tends to be on organic chemicals but I think we're giving far too little attention to the contribution of materials of fungal, algal and insect origin in indoor air and establishment of methodology which could be again encouraged on an international basis to deal with these seems highly pertinent.

This ends my presentation, sir. Can I thank the OSHA panel for the opportunity to discuss with you my concerns and suggestions?

JUDGE VITTONE: Thank you.

JUDGE VITTONE: A copy of the slides provided by Dr. Bridges will be identified as Exhibit 199.

(The document referred to was marked for identification as Exhibit 199 and was received in evidence.)

JUDGE VITTONE: Ms. Sherman?

MS. SHERMAN: Yes. Thank you.

Dr. Bridges, I confess I didn't quite understand the relationship between the Robens Institute and the University of Surrey.

DR. BRIDGES: Well, let me simplify. The Robens Institute, R-O-B-E-N-S, just for information, it's called the Robens Institute because it was named after Lord Robens who was the gentleman who set up our health and safety work procedures. So it's an academic department within the faculty of science of the University of Surrey, so it's a full department of the university.

MS. SHERMAN: So it's not independent.

DR. BRIDGES: Well, it's part of the University of Surrey. I like to believe that all academic departments in my university are independent but my head of university and vice chancellor often tells me different. It's just like any department of the university.

MS. SHERMAN: And you provide not only -- okay. Your employees of the institute, are they also teachers and professors at the University of Surrey?

DR. BRIDGES: All the staff of the Robens Institute are staff of the university, so the academic staff will all be what you would call faculty members in terms of being professors or we have categories called reader, senior lecturer and lecturer. Or they'll be senior research fellows, which is the university system in the United Kingdom. So all my staff are members of the University of Surrey, just like any other department has members.

MS. SHERMAN: Well, if I were to enroll in a graduate program at the University of Surrey and I were to get a degree, in this country one gets a diploma to show for a degree, say, a Ph.D., would I be getting my Ph.D. degree from the Robens Institute or from the University of Surrey?

DR. BRIDGES: None of the departments in the universities in England award degrees. The only people who can award degrees are the university. So students at the institute get a degree or a Ph.D. from the University of Surrey and then it will simply specify the subject area, occupational health or toxicology or occupational safety. It doesn't say the Robens Institute on the certificate.

MS. SHERMAN: I see. And when was the Robens Institute established?

DR. BRIDGES: 1978.

MS. SHERMAN: What percentage of your time do you spend teaching and what percentage do you spend consulting?

DR. BRIDGES: Well, it varies, of course. Currently, my situation is slightly different from normal because I've been asked to set up a new faculty of health and medical sciences of which the Robens Institute will be part so it will leave the faculty of science and become part of a faculty of health and medical sciences. This is simply because a number of other local colleges will be joining us who are concerned with health care training and then also become part of the faculty. But if we take a typical year, as from last year, then of my time something like 20 percent is teaching. That's at the BSC final year level in toxicology. And much of the post-graduate program in toxicology I also teach so that's my main teaching area although I do teach on occasion in occupational health and particularly these days in public health. The rest of my time is spent, when it's not administration and supervising students, in being advisor to government committees and various other things, so the consultancy work is probably something like 15 percent of my time.

MS. SHERMAN: Five-oh or one-five?

DR. BRIDGES: One-five normally.

MS. SHERMAN: Now, are you typical of the other academics involved in the institute in terms of your allocation of time?

DR. BRIDGES: No, because some of my staff, for example, the environmental specialists, will spend very long periods of time abroad, for example, so we have two in Nicaragua at the moment and they will be full-time doing their work for two years. Other members of staff do more teaching than I do. Some are full time in consultancy. So it's a real mixture.

MS. SHERMAN: Well, then would it be possible to characterize the prime function of the Robens Institute as either being basic research or a policy think tank?

DR. BRIDGES: The main purpose of the Robens Institute is to try and produce an interface between research, teaching and what we refer to as the real world because when I set up the Robens Institute in 1978, I was very concerned that we didn't do what many other institutes have tended to do, which is to create theoretical workplace problems and then set about solving them, only to realize it wasn't a problem in the first place. So I insist that at least 50 percent of the institute's time as a whole is spent in dealing with real workplace or environmental problems and the rest is basic research and teaching.

MS. SHERMAN: Is the University of Surrey a private school, or...

DR. BRIDGES: No, state owned.

JUDGE VITTONE: I'm sorry, I didn't hear you.

MR. WEINBERG: State owned. We only have one private university in the UK. All the rest are state owned.

MS. SHERMAN: So clients will come to you and I believe you were here earlier when we had Dr. Jenkins describe Oak Ridge National Laboratory and how clients will come to the laboratory, and the laboratory will make a determination whether a project should be done or not. Is there a similar procedure at the Robens Institute?

DR. BRIDGES: The Robens Institute is divided into three divisions. We have a Division of Chemical Safety, we have a Division of Human Factors, and we have a division concerned with the environment. So the proposed project will come to one of those groups who will look at it and make comments, will then go on to the Research Director which is myself, and the administrative head which is Professor Stubbs, and also to our own finance person. But then it has to go through the center of the university for approval in terms of ethics, sometimes, but certainly for approval in terms of finance and various other things. So it's a multi-stage process.

MS. SHERMAN: Approval in terms of finance in terms of whether it will be lucrative enough, or in terms of the source of the funding? What do you mean by that?

DR. BRIDGES: All universities these days, and I'm sure it's not just the UK, they do look at whether it's going to at least pay for itself, and they're always looking for additional monies. So it's not possible for me to do what I used to do, which is to do a lot of work which is uncharged except where it's government or EC, where the university for some reason believed that to be sufficiently prestigious that they'll allow me the equivalent of one day a week to do government and EC work. But the rest we have to make sure that we produce a financial return.

MS. SHERMAN: I may have gotten mixed up on the dates. Have you been at the Institute since its establishment?

DR. BRIDGES: I founded it in '78. I was a part-time Secretary, yes.

MS. SHERMAN: Who have been the major clients of the Institute over the years? Besides the government.

DR. BRIDGES: We have something in any one year like 300 clients, so I won't get them all right. Starting with industry, I suppose the main supporters have been the chemical industry, the oil industry, and the foundry industry because we do a lot of ergonomics work. In more recent years, the brewing industry.

MS. SHERMAN: The what industry?

DR. BRIDGES: The brewing industry. Beer production. Not because of the toxicological connection, but because of the great problems of handling barrels and the problems of back injury and wrist injury.

MS. SHERMAN: Oh, I thought it was an excuse to go to your favorite pub.

DR. BRIDGES: I do have a consultancy with a scotch whiskey association which I sometimes draw on, but it's, unfortunately, extremely rare that it's that sort of a project.

MS. SHERMAN: It sounds like a good client.

DR. BRIDGES: So in terms of industry, a wide range of industries, but it's true to say those would be the most important. Then we have research councils. We have a number of research councils. And something like 20 percent of our money generally comes from the various research councils. They're grants, of course, not contracts.

Then government departments and EC departments, it varies considerably. But what's happening in the UK is that increasingly the UK government doesn't want to fund projects and refers us to Europe where they believe all the money is. After a bit of toing and froing where the Europeans tell us that actually all the money's with the UK, and backwards and forwards, we usually get funded by the EC. So that's a growing activity.

We have a significant amount of money from trade unions and from what we would call lobby groups like Green Peace, Friends of the Earth, groups of that sort. It's my job and my colleagues' job to try and produce that sort of balance. What we don't want is to rely on one particular financial source or to lose the opportunity to say no to a particular client because we don't want to do a particular piece of work.

MS. SHERMAN: So you have had projects in the past for the Tobacco Research Council?

DR. BRIDGES: Not for the Tobacco Research Council, it's not been in existence, as far as I'm aware, for a long time. But if you're asking me about the tobacco industry then, as an Institute, yes, from time to time we've done projects for the tobacco industry, but they've always been pretty small. I think the highest we've ever approached, because I thought I'd be asked this question, is something like one percent of our funding in a particular year.

MS. SHERMAN: Which year was that?

DR. BRIDGES: 1982. When we did quite a lot of in vitro testing, and developing in vitro methodology to see if we could reduce the amount of animals being used at the time.

MS. SHERMAN: Have you done any independent research in the field of tobacco smoke?

DR. BRIDGES: Not specifically in tobacco smoke. In terms of the individual components that are found in tobacco smoke, yes. But not in tobacco smoke, per se.

MS. SHERMAN: What have you done in the field of the components?

DR. BRIDGES: If we start with benzo(a)pyrene, and we're talking about my personal research, not the Robens Institute...

MS. SHERMAN: Yes.

DR. BRIDGES: Then metabolism of benzo(a)pyrene by various tissues, particularly lung tissue, looking at dose response relationships for that metabolism was a project that lasted some time. That was with Dr. Gerald Cohen who was a committed anti-smoker.

Work on phenyl, again, particularly looking at metabolism and its relationship to toxicity.

Work on catacols and quinols, again looking at the dose response relationship. Those have been some of the most important.

The other area would be looking at in vitro methods. We became a center for looking at alternative methods to using animal studies. We've, again, looked at a number of components which happened to be in tobacco smoke, things like formaldehyde and so on.

MS. SHERMAN: I don't believe you included a list of your publications. Were these studies published?

DR. BRIDGES: Many of them were published, yes. I can certainly provide you with a list...

MS. SHERMAN: Yes, if you would.

DR. BRIDGES: Yes, of course.

MS. SHERMAN: Have you done any research in the field of lung disease?

DR. BRIDGES: The only work I've done specifically on lung disease is using in vitro models. That involves carbon black.

MS. SHERMAN: What about cardiovascular disease?

DR. BRIDGES: Personally, no. Dr. Hawkins, my colleague, has, but I have not worked on cardiovascular disease.

MS. SHERMAN: Have you done any specific work on environmental tobacco smoke?

DR. BRIDGES: No.

MS. SHERMAN: Do you believe that tobacco smoke causes eye, skin, or mucous membrane irritation?

DR. BRIDGES: I think that it's inevitable that it will at a particular concentration because it contains a number of irritants.

MS. SHERMAN: In other words, you think that a rational approach is to look at the constituents and then you can predict the effect?

DR. BRIDGES: It's certainly one approach that one can use, and it's the most common approach to trying to identify irritants in a complex mixture.

MS. SHERMAN: Have you done any work on looking at low level synergisms between compounds?

DR. BRIDGES: Can I rephrase it? Have we looked at combinations of chemicals and how they'll produce adverse effects?

MS. SHERMAN: Yes.

DR. BRIDGES: Yes, quite a lot.

MS. SHERMAN: You said it better than I did.

DR. BRIDGES: My personal main project at the moment is to look at the additive or synergistic or antagonistic reactions between different groups of chemicals. I don't want to go into a long rigmarole as to why, but fundamentally we're testing what's called the body burden hypothesis, which is an assumption that some individuals if they're exposed to a complex chemical milia over a long period of time may, if you like, be tipped over the edge into expressing toxicity. What we want to do is evaluate that hypothesis, because it's widely used in environmental medicine in terms of treating patients by depriving them of food and chemicals and so on in order to improve them. So we're very actively involved in looking at that hypothesis. The obvious way to tackle that is to look at combinations of chemicals and how they interact with one another.

MS. SHERMAN: Are you looking at them in vitro or...

DR. BRIDGES: Oh, no, this is both in vivo and in vitro, but at this stage we're concentrating primarily on in vivo techniques.

MS. SHERMAN: Do you have any plans to do toxicological animal studies along these lines?

DR. BRIDGES: Sorry, it is in vivo. It is animal studies, yes.

MS. SHERMAN: What animals?

DR. BRIDGES: Mainly rats, but we've also used mice and guinea pigs.

MS. SHERMAN: Do you have any plans to use primates?

DR. BRIDGES: We don't have a decent primate facility in the university, so any study we do there will have to be in conjunction with somebody else. We probably will go on to primates once we've got something that we specifically want to test. I wouldn't want to use primates unless I've got a very specific question that I wanted to address.

MS. SHERMAN: Is this the type of work where you might eventually look at large population cohorts to test out various hypotheses?

DR. BRIDGES: Not personally, because I'm not an epidemiologist.

MS. SHERMAN: I meant your institute.

DR. BRIDGES: I think I'd want to, before I answered that question, know the results of our current studies. It's certainly possible that if we found something of interest we'd want to look at the human population, and then there'd be a question of how we went about that, human volunteer studies or whatever it happened to be. But at this stage it's a question of what we find with the animal studies.

Perhaps I could just say, although it's disappointing, that so far with the chemical combinations we've found additive effects and synergistic and antagonistic effects have been rather rare. It's been a great disappointment. But we found one or two that worked together.

MS. SHERMAN: Is there a particular industry that you're doing the study for?

DR. BRIDGES: No.

MS. SHERMAN: This is just primary research?

DR. BRIDGES: It's funded by a charitable body known as Environmental Medicine Foundation, and this is a UK body that's raised money for civil research students and for us just to provide us with chemicals and so on.

MS. SHERMAN: There's been a lot of talk at this hearing about safe thresholds, no effect levels, et cetera. Do you believe that there are safe levels for exposures to carcinogens?

DR. BRIDGES: Can we divide the question into two parts? The first question is do I believe that all carcinogens are alike. I think the evidence increasingly is that there are two types of carcinogens. There's what we call the genotoxic carcinogens, and then there's a class known as the non-genotoxic carcinogens. The distinction is that the genotoxic carcinogens give positive results in mutational tests, and genotoxicity tests, whereas the non-genotoxic carcinogens don't.

If we could give you an example of a non-genotoxic carcinogen which is quite well established, dyethynol hexalphalate and chlofiborate are good examples of non-genotoxic carcinogens. For the non-genotoxic carcinogens, I think there's pretty good evidence with the few that we've worked on that there probably is a threshold.

For the genotoxic carcinogens, on theoretical grounds, then there may not be a threshold, but I'd emphasize that's on theoretical grounds. On practical grounds there may well be.

MS. SHERMAN: Would formaldehyde fall into the non-genotoxic category in your opinion?

DR. BRIDGES: Formaldehyde is a slightly tricky one. Fortunately, I'm reviewing it for the EC at the moment. But my view is that it probably is a non-genotoxic carcinogen, although it is capable of producing mutations in some test systems.

MS. SHERMAN: Would benzene be, in your view, a genotoxic substance?

DR. BRIDGES: I think it probably is.

MS. SHERMAN: You're familiar with the numerous chemicals that make up tobacco smoke.

DR. BRIDGES: Yes.

MS. SHERMAN: Would you agree that some of them are genotoxic and some of them are non-genotoxic?

DR. BRIDGES: I don't think there's any question that in genotoxicity tests under particular sets of conditions, some of them have proved to be positive.

MS. SHERMAN: So then you would agree?

DR. BRIDGES: Yes, under those particular test conditions there's no question in my mind.

MS. SHERMAN: Taking cigarette smoke as a whole rather than in its constituent parts...

DR. BRIDGES: Are we talking about ETS or mainstream?

MS. SHERMAN: Well, we can do it both ways. In terms of mainstream smoke, do you believe that it's a promoter or an initiator, or both...

DR. BRIDGES: I don't think I know the answer. Let me explain. What I understand is that from statistical studies in the human population, epidemiology studies, in other words, it's clearly a risk factor to be exposed to, to be a heavy smoker.

From a toxicology point of view, we then have to go from the risk factor stage to is it an initiator, is it a promoter, or is a coincidental factor? And wearing my toxicologist hat and looking at the animal toxicity data, it's very unclear from that data how tobacco smoke could be involved in the carcinogenic process because the great majority of animal studies have failed to demonstrate it to be a carcinogen as well. So I don't think we've got to the mechanistic basis of why it's a risk factor, and that's why I use the terminology risk factor, and I don't know whether it's a promoter or an initiator or just an associated factor.

MS. SHERMAN: So because you can't explain the mechanism, you're unsure as to whether it's an initiator or a promoter?

DR. BRIDGES: That's right. Or simply a co-associated factor. It could be any of those three. I could speculate, but I won't because I am a scientist.

MS. SHERMAN: What is your definition of sick building syndrome?

DR. BRIDGES: Sick building syndrome is a building where you have a high prevalence of the symptoms that I described, which is irritation of the mucous membranes, headache, lethargy. It's a feature that tends to start on a Monday morning and develop during the week, and seems to be alleviated weekends and during vacations and so on. That's a very crude definition.

MS. SHERMAN: You used the term high prevalence. What sort of percentages would you say would qualify under your terms?

DR. BRIDGES: I think the definition there is according to different people, but we would expect 20 percent or more, and often we see 80 percent.

MS. SHERMAN: And have you done any sick building syndrome studies yourself?

DR. BRIDGES: Personally, yes.

MS. SHERMAN: Has the Robens Institute been involved in a lot of sick building syndrome studies also?

DR. BRIDGES: Yes. Dr. Hawkins, who is my co-author of the report, is the leader of the team that looks at sick building syndromes. So he will go in usually with one or two of our colleagues, depending on what we know about the building, and conduct a questionnaire so that we've got some feeling of the prevalence of the various symptoms, have a look around, do a proper audit of the facility, and then he'll bring in other colleagues, if appropriate, with particular specialisms.

MS. SHERMAN: About how many buildings have you looked at in this sense?

DR. BRIDGES: Ones that we've actually classified as classical sick building, whatever that is, probably about 45. But if we look at buildings we've gone into because there's clearly an incidence of health problems, then it would be running into hundreds. Because we do Legionella analysis and we do all sorts of other things. So people tend to call us in if they've got any type of a problem.

MS. SHERMAN: When you're called into a building it's generally in a reactive situation?

DR. BRIDGES: Generally speaking, yes. We have, on occasion, been involved in the design of buildings, though, because of our ergonomics interest. So far, we haven't been involved in enough buildings to have generated one with sick building syndrome.

(Laughter)

MS. SHERMAN: When you get called into a building, do you find that the... Are the buildings to which you're called usually commercial buildings of one sort or another?

DR. BRIDGES: Quite a mixture, but I would say that probably more state-owned buildings than anything else.

MS. SHERMAN: But not private residences?

DR. BRIDGES: No. We don't generally do private residences. Perhaps we're too expensive. So we don't generally do it. We had one pop singer who was worried about the color of his water going green, who's very well known, that we investigated, but that was hardly a sick building syndrome.

MS. SHERMAN: When you do these investigations, do you charge on a square foot basis, on a time and materials basis? How do you...

DR. BRIDGES: Time and materials.

MS. SHERMAN: And then you write up a report for your client?

DR. BRIDGES: Yes.

MS. SHERMAN: And do you sort of... Are these reports publicly available without the identifiers of the specific client?

DR. BRIDGES: Some of them are. Some of the clients are particularly sensitive for various reasons, particularly because of the threat of legal action. But a number of them we've been able to make available.

MS. SHERMAN: When you go into a building, do you look at the maintenance of the HVAC system?

DR. BRIDGES: Everything, if we believe it's appropriate.

MS. SHERMAN: Have you found that sometimes there's a correlation between the lack of maintenance and perhaps the problems that the building is having?

DR. BRIDGES: Yes, quite often... Well, quite often is an exaggeration. We've found a number of buildings where the air conditioning system has been heavily contaminated, and remedy in that does seem to make an improvement in the general health of the staff.

I suppose the most common situation is where psychosomatic factors tend to dominate.

MS. SHERMAN: I guess I didn't understand. The maintenance of the system and psychosomatic...

DR. BRIDGES: They're quite separate. The most common observation is of psychosomatic, in our experience.

MS. SHERMAN: When you find that poor maintenance is the problem, do you find it's because the landlord is cutting corners, or is it really just a matter of lack of understanding on the part of the building engineer?

DR. BRIDGES: I think the most common problem is one of ignorance. They just don't seem to realize that they should clean it out. We've had several examples where they seem to have realized that they shouldn't allow microorganisms to grow, and therefore they dump large amounts of biocide in the system and blow that round the building instead.

MS. SHERMAN: Then you have workers, perhaps, reacting to the biocide?

DR. BRIDGES: We haven't seen any workers reacting to the biocide, but it's something that we're very aware of as a possibility.

MS. SHERMAN: And have you investigated cases of Legionella?

DR. BRIDGES: We've dealt with some cases of Legionella, yes.

MS. SHERMAN: And again, you found a lack of attention to sources of water?

DR. BRIDGES: Yes. The difficulty with Legionella that we find is that you can often detect it in various systems, and there doesn't seem to be a terribly good correlation between ability to detect it and the incidence of Legionella disease.

MS. SHERMAN: Why do you think this is?

DR. BRIDGES: I haven't any idea. We speculate. My colleagues speculate, microbiologists, that it's because the level is not high enough. One of the interesting things they've found is that in hotels, the highest level of Legionella in the shower system was usually at the very end of a corridor, presumably because the water pressure is rather less there than in other parts, but it hasn't ever correlated with Legionella disease.

MS. SHERMAN: Do you believe that Legionella is capable of producing serious adverse health effects?

DR. BRIDGES: Oh, yes.

MS. SHERMAN: Do you believe that asthma is a severe health condition?

DR. BRIDGES: It depends on how you define asthma, of course. It can be a severe health condition.

MS. SHERMAN: Have you encountered cases of asthma in your sick building investigations?

DR. BRIDGES: Inevitably so, because there's a significant number of the population with asthma. But whether the asthma is due to the sick building syndrome or the sick building is usually unclear. All we can say is that for some individuals it appears to exacerbate their condition.

MS. SHERMAN: But you haven't been able to analyze the data further?

DR. BRIDGES: No.

MS. SHERMAN: Have you encountered cases of difficulty in breathing and chest tightness?

DR. BRIDGES: Yes.

MS. SHERMAN: Do you think these can be serious health effects?

DR. BRIDGES: Potentially they can be. It depends, again, on the severity, but potentially, yes.

MS. SHERMAN: What about severe headaches? Have you had occasion to investigate buildings where the headaches are severe enough to require medical attention?

DR. BRIDGES: We have occasionally been dealing with sick building syndromes where people have migraines, and therefore, yes, they've had to have some sort of medical attention.

MS. SHERMAN: Have you investigated buildings where the headaches are such that the people can't concentrate on a job that requires concentration, or do you just view these as sort of subjective reports?

DR. BRIDGES: In our experience, and it's just our experience, we rarely see a situation where you've just got headaches. You've usually got other symptoms, too.

MS. SHERMAN: It's linked with other things then.

DR. BRIDGES: Yes.

MS. SHERMAN: Do you believe that dry or irritated mucous membranes can lead to a higher incidence of infections?

DR. BRIDGES: That's not an area of my personal knowledge. I'm told that it does, but it isn't an area of my personal knowledge.

MS. SHERMAN: The reason I asked you this is because you stressed the multidisciplinary approach.

DR. BRIDGES: Certainly some of my colleagues believe that to be the case, and therefore humidity is a factor that they look at particularly.

MS. SHERMAN: When you go into and investigate a problem building, do you find that the building engineers generally have at their disposal the schematics that will allow them to properly operate the system?

DR. BRIDGES: It depends on the age of the building, usually, and it also depends on whether they're the owners of the building or whether they have leased it. But it isn't uncommon to find they don't know their own system terribly well.

MS. SHERMAN: What about maintenance of these systems? In the buildings that you've had to investigate, has the maintenance been contracted out, or is it generally done in-house?

DR. BRIDGES: Generally done in-house, although that's progressively changing now. I'd say over the last few years there's been rather more contracting out.

MS. SHERMAN: Do you find that frequently the problem is as simple as filters that are just never changed?

DR. BRIDGES: We, unfortunately, don't see too many situations where it's one factor. Certainly changing the filters sometimes helps, but generally speaking, we haven't been able to pin down a sick building to a single factor. It's one of the great disappointments because there's nothing convinces a client more than you wave a magic wand and change something and everything is better.

MS. SHERMAN: I believe during your presentation you were talking about significant but minor symptoms.

DR. BRIDGES: Yes.

MS. SHERMAN: What type of symptoms would those be? Can you give me some examples?

DR. BRIDGES: Sometimes we get people who feel a little bit sick and nauseous, would be a good example, or have a sort of skin itch. That type of thing.

MS. SHERMAN: I believe that you stated that promulgation of this proposed indoor air quality rule might set up more protective a work environment for office workers, as compared to blue collar workers.

DR. BRIDGES: I think it's a demonstration which would be perceived that the office worker is more important.

MS. SHERMAN: And you don't believe this is so?

DR. BRIDGES: That your regulation is intending to make it so, you mean?

MS. SHERMAN: No, that the office worker is more important than the blue collar worker?

DR. BRIDGES: Of course not, no.

MS. SHERMAN: Do you have data on health effects in blue collar settings involved in sick building syndrome?

DR. BRIDGES: We look at industrial workplaces. We've never been asked to look at an industrial workplace specifically because of sick building syndrome, because the common belief which is probably wrong, is that sick building syndrome is concerned with offices and environments like offices. But we've often been involved in situations where the workplace people are showing more and more days off work, because that's often a reaction to these sort of problems, and trying to get to the bottom of that. Particularly in things like garages.

MS. SHERMAN: Garages?

DR. BRIDGES: Yes.

MS. SHERMAN: I believe you stated that epidemiological data is not conclusive on the relationship between cardiovascular diseases and ETS levels, ETS levels normally found in offices.

DR. BRIDGES: From the studies that I've seen and from consulting my epidemiology colleague, Professor Balarogen, yes.

MS. SHERMAN: And which studies were you referring to when you made the statement?

DR. BRIDGES: Well, the Helsing study particularly, but I'm not an epidemiologist. I just notice the absence of a dose response relationship study as part of the work that you quote.

MS. SHERMAN: Does the interaction between chemicals affect the odor recognition threshold that you listed in, I think it's Table 1 on page 16?

(Pause)

DR. BRIDGES: It's not an area of my personal experience, but I'm told that some chemicals do have an additive effect in terms of sensory effects, but many do not.

MS. SHERMAN: I believe that in another place in your statement you doubted that there was a synergistic effect, but you're willing to say there may be an additive effect in some cases?

DR. BRIDGES: Are we talking about odor?

MS. SHERMAN: Yes.

DR. BRIDGES: I don't recall making that statement, but...

MS. SHERMAN: I think it was on page 22. I'm not sure.

(Pause)

MS. SHERMAN: At the top of the page, I believe.

(Pause)

DR. BRIDGES: This is not particularly concerned, now with sensory effects. This is concerned with toxic effects. Because if you look on page 20, we've now moved to a new heading which is air toxicity.

MS. SHERMAN: I see. Thank you for explaining that.

(Pause)

MS. SHERMAN: Do you have any information on how many lost work days accrue in the United Kingdom due to poor indoor air quality?

DR. BRIDGES: Not as a specific category. I don't believe that data is available. We have quite a lot of information, obviously, on lost work days from various causes, but we don't have a category called indoor air quality.

MS. SHERMAN: So you don't have a category called sick building syndrome?

DR. BRIDGES: We obviously know about sick building syndrome, but our Health and Safety Executive to date has not recorded its data with a heading of Sick Building Syndrome. What it does, of course, if have data for days that people have taken off in offices for various reasons, but not a specific category of sick building. I think they will introduce that, but they haven't done yet.

MS. SHERMAN: Do you have a category involving building-related illness?

DR. BRIDGES: Yes.

MS. SHERMAN: So you do keep data on building related illness?

DR. BRIDGES: The Health and Safety Executive does. I don't personally.

MS. SHERMAN: Would it be possible for you to submit this data for the record?

DR. BRIDGES: I'll certainly do my best to provide it, yes.

MS. SHERMAN: Do you have any, since you don't keep sick building syndrome data in England, I assume that you wouldn't be able to...

DR. BRIDGES: Well, we keep our own, of course, but not other people's.

MS. SHERMAN: In a more...

DR. BRIDGES: Nationally, you mean.

MS. SHERMAN: ...national form.

DR. BRIDGES: No.

MS. SHERMAN: Do you have any data on the impact of productivity of building related illness encountered in your country?

DR. BRIDGES: Probably not. The reason would be because that will vary very much from building to building. It's a local problem. It may not be extrapolated readily from one building to another, but I will certainly check and see whether that's there.

MS. SHERMAN: I believe on page 39 and 49 and Table 8, you give the most commonly occurring organic compounds in four buildings?

DR. BRIDGES: Yes.

MS. SHERMAN: What's the source of this information?

DR. BRIDGES: I think that's data by Sheldon et al, 1988, but I looked at it last night and I would need to check the reference to make absolutely certain.

MS. SHERMAN: If you could.

DR. BRIDGES: Yes.

MS. SHERMAN: In Table 9, I believe on page 41...

DR. BRIDGES: Yes.

MS. SHERMAN: It says that it's derived from the building performance database of TDS Ltd?

DR. BRIDGES: Yes.

MS. SHERMAN: What is TDS?

DR. BRIDGES: I couldn't tell you, to be honest. It's a report that Dr. Hawkins has. But I can give you the full reference quite easily.

MS. SHERMAN: If you would, I would like that.

You did not do this report at your institute?

DR. BRIDGES: The report was done at the Robens Institute. There are three authors of it. My colleagues collected, obviously, quite a lot of the data that's in the tables. I then wrote the report, and went to them for comments and so on before it got to its final stage.

MS. SHERMAN: So you have the raw data?

DR. BRIDGES: I'm sure we have the data, yes.

MS. SHERMAN: I think we would be interested in seeing that data if it was available to us.

DR. BRIDGES: Yes, I'm sure it's a report that can be made available.

MS. SHERMAN: What is the source of the data given in Table 10 on page 42?

DR. BRIDGES: It's various sources, and it's all vapor phase data, but if you would like reference to the individual parts, I'm sure we could provide it.

MS. SHERMAN: In terms of indoor parameters that can affect the occurrence of SBS symptoms, I believe you had a chart that showed that sometimes they're associated with lack of satisfaction, et cetera.

DR. BRIDGES: Yes. Would it help if I put that overhead back up?

MS. SHERMAN: No, I think I saw it.

What about ergonomic factors?

DR. BRIDGES: Those are important too, and in our first submission to OSHA we had a chapter dedicated to that, yes.

MS. SHERMAN: You just didn't touch on it in your presentation.

DR. BRIDGES: No, it's simply because I didn't want to put too much information on the overhead. But certainly my ergonomics colleagues, if they had heard the presentation, would have reminded me quite smartly about that.

MS. SHERMAN: What about relative humidity?

DR. BRIDGES: That's certainly a factor.

MS. SHERMAN: And lighting?

DR. BRIDGES: Lighting, too.

MS. SHERMAN: And noise?

DR. BRIDGES: Yes, certainly we would expect noise, particularly influenced by the quality of the noise just not the volume.

MS. SHERMAN: Stress?

DR. BRIDGES: Stress, undoubtedly.

MS. SHERMAN: Do you have any specific references, or is this just based on your experience?

DR. BRIDGES: It's a combination of our experience and specific references. I think in the original submission we produced a number of references. I'm sure my colleagues have others.

MS. SHERMAN: On page 29, I believe in Table 5, you list building and people-related factors contributing to SBS?

DR. BRIDGES: Yes.

MS. SHERMAN: What is your reference for this table and for the discussion that follows this table?

DR. BRIDGES: It's taken from a variety of sources, and I think all the sources were cited in our Volume 1, but I'll check that, and if there are some sources that aren't cited, we can provide it.

MS. SHERMAN: I was going to ask you if the sources are given in your comment and response to our request for information, which was Exhibit 3-507, or if you have other sources for this.

DR. BRIDGES: This big volume here. I wouldn't be able to tell you from a quick glance whether all the references are there, but I believe most of them are, if not all of them. I can get Dr. Hawkins to check them through and make sure each point is referenced.

MS. SHERMAN: So you believe that your references are...

DR. BRIDGES: I think so, yes.

MS. SHERMAN: ...in your earlier submission.

DR. BRIDGES: But it is several years ago since it was written, which is why I'm hedging my bets slightly.

MS. SHERMAN: I believe on page 59 you said that office hours tend to be shorter than those of blue collar workers...

DR. BRIDGES: Which document are we talking about?

MS. SHERMAN: I think we're talking about your submission here, not the earlier one, doctor.

DR. BRIDGES: Page 59?

MS. SHERMAN: Yes. I believe it's in the middle of the page.

DR. BRIDGES: I found it.

MS. SHERMAN: I think you said that office hours tend to be shorter than those of blue collar workers and involve less physical activities. Hence, there is less total inhalation of air in their place of work than in a physically active worker.

DR. BRIDGES: Yes.

MS. SHERMAN: What is your source for that statement?

DR. BRIDGES: Oh, many, but if you would like me to provide some example sources, I can do that.

MS. SHERMAN: This was a characterization in the UK, or do you feel it's universal?

DR. BRIDGES: It's a UK statement, as many of them are, because that's where my experience lies.

MS. SHERMAN: And what percentage of your work force now works in offices?

DR. BRIDGES: I would have to look at that figure. I wouldn't like to quote a figure off the top of my head. I think I know, but I'd prefer to give you a properly judged response.

MS. SHERMAN: If you could also give a source?

DR. BRIDGES: Yes.

MS. SHERMAN: I believe that you also recommended on page 57 banning carcinogens where possible?

DR. BRIDGES: Page 57...

(Pause)

DR. BRIDGES: These are strategies of action proposed by DeNoble in 1989, so all I'm doing is citing the strategy that he quoted there.

MS. SHERMAN: And endorsing it?

DR. BRIDGES: I think where it's appropriate, such as something like asbestos. Therefore it can be achievable and make sense. It may be a sensible strategy. But you first have to be very clear that you're dealing with a carcinogen.

MS. SHERMAN: I believe on page 63 of your statement you make statements about differences between exposure conditions in the home as opposed to the workplace.

DR. BRIDGES: Yes.

MS. SHERMAN: What are your references for these generalizations?

DR. BRIDGES: There are several sources that have been used for that in the UK. Again, you'd like a reference?

MS. SHERMAN: Yes, if you could.

DR. BRIDGES: Yes.

MS. SHERMAN: On page 65 you mentioned that there would be increased energy costs stemming from our proposal, and what references did you use in developing this conclusion?

DR. BRIDGES: I think it's inevitable if you're going to improve your air conditioning system, that you're going to have increased energy requirements.

MS. SHERMAN: Isn't it possible that the system could be made to run more efficiently?

DR. BRIDGES: I doubt whether you could trade that off entirely, because what will tend to happen I think, is that overall you'll have an increased energy demand. If you can achieve it, that's marvelous.

MS. SHERMAN: I think you also said that fewer opportunities to smoke might have the effect of reducing the work efficiency of regular smokers?

DR. BRIDGES: I've said that in the report, yes.

MS. SHERMAN: What is your reference for this?

DR. BRIDGES: That's from Professor Ian Hindmarch who works in our university in the Psychopharmacology unit, who's done quite a lot of work on this area. But it's not my own area. I will get him to provide you with the data.

MS. SHERMAN: I didn't catch the name.

DR. BRIDGES: Professor Ian Hindmarch. He's the head of our Psychopharmacology unit within the faculty of science, but he's not part of my institute.

MS. SHERMAN: Do you have any opinion as to whether the efficiency of non-smoking workers might be increased if the smoking were decreased around...

DR. BRIDGES: I'm not a specialist on work efficiency, so I'd leave that to others to comment. Whereas Professor Hindmarch has done specific research on smokers, I'm not aware of it. I can ask him whether he's done comparable reverse studies, as it were, on non-smokers, but I don't believe he has.

MS. SHERMAN: I believe on page 49 you stated that airborne contaminants of environmental tobacco smoke in a room are often critically dependent on the respective locations of the smoker and the measuring device and the air movements.

DR. BRIDGES: Can I just find where that is? I remember it, but I don't remember the exact statement.

(Pause)

DR. BRIDGES: Yes.

MS. SHERMAN: Are you inferring that there's not a good correlation between personal sampling and area sampling for environmental tobacco smoke?

DR. BRIDGES: I think our experience generally is that personal sampling and fixed point sampling often don't correlate terribly well. Not just tobacco smoke which we've done very little on at all, but in industrial chemicals generally.

If I can just quote our most recent example, because we're looking at the problems of landfill gas and the effects of the face workers who are developing a new face of domestic waste deposition. If you look at the fixed point monitors, they tend to be on the ground, of course. You can, on occasion, get levels that are approaching or above the workplace standard. But if they wear personal monitors, then you get a very different situation. That's the most extreme example, but certainly in buildings too, we've often found differences.

MS. SHERMAN: Have you had any experience in using Lydel's work? I believe he published a sampling strategy manual for NIOSH that dealt specifically with appropriate placement of area samplers.

DR. BRIDGES: It's not a piece of work that I'm familiar with, but then I'm not an occupational hygienist. I'll ask my hygienist whether he is knowledgeable about that. All I can say is that in our experience, personal monitoring and fixed point monitoring often don't correlate. That doesn't mean they couldn't be made to with more sensible strategies for placing the fixed point monitors.

MS. SHERMAN: Getting back for a moment to increased energy consumption, which parts of our proposals do you think would result in increased energy consumption?

DR. BRIDGES: Well, could I respond subsequently, because rather than go through your proposals and identify the specific phrase at this stage...

MS. SHERMAN: In view of the hour, I think that would be a fine suggestion.

I guess I would also like to know if you're going to do this in a post-hearing comment, what data you would be relying on to support your opinion along these lines.

DR. BRIDGES: Yes.

MS. SHERMAN: I believe in Table 12A, and I'm sorry I don't have a page for you....

DR. BRIDGES: I know where that is. It's on page 46.

MS. SHERMAN: Page 46. For these studies that were quoted in this table called Findings of RSP and Nicotine Levels at Various Office Locations Using Fixed Point Monitors, was the volumetric smoker density recorded?

DR. BRIDGES: There's such a variety of studies that I would need a considered opinion because they'll have to consider each.

MS. SHERMAN: Can you do that?

DR. BRIDGES: I'll certainly do it, yes.

MS. SHERMAN: Do you happen to know if any of these studies that are listed in Table 12A were funded by tobacco companies?

DR. BRIDGES: I haven't any idea.

MS. SHERMAN: Thank you. And thank you for your time.

JUDGE VITTONE: Okay, who has questions?

Mr. Myers, Mr. Weinberg, Mr. Rupp. Let me take Mr. Myers first. I think he's got the most questions, if I understood everybody correctly.

MR. MYERS: I think they've probably gotten shorter, during the hour.

(Pause)

MR. MYERS: I'm Matthew Myers. I represent a series of witnesses including the Association of State and Territorial Health Officials, and a variety of other health-related organizations.

Let me take you back a little bit in response to a couple of questions from Ms. Sherman. I want to make sure I understand your views.

Am I correct that I believe you said to her that you don't believe that the scientific evidence at the present time is adequate to conclude that direct smoking is a cause or catalyst or an initiator of lung cancer? All we know so far is that it's a risk factor. There's a statistical association. Is that correct?

DR. BRIDGES: That's correct.

MR. MYERS: So that it's your view that we don't yet have enough scientific evidence to say that direct smoking is a cause of lung cancer, is that correct?

DR. BRIDGES: Not from the studies that have been done.

MR. MYERS: I'm assuming then, you tell me if I'm wrong, that you would also say that if we don't have it for lung cancer, we certainly don't have enough scientific evidence to say that direct smoking is a cause or an initiator of cardiovascular disease. All we know is there is a statistical association.

DR. BRIDGES: At this stage, yes.

MR. MYERS: Have you read the study of the Royal College of Physicians or any of our Surgeon General studies that have concluded that there is enough evidence?

DR. BRIDGES: Of course, yes.

MR. MYERS: And you simply disagree with their conclusions.

DR. BRIDGES: I don't think they've looked at the mechanistic data sufficiently. I think they've used the word risk factor and then jumped to, well that means a cause. I'm just, as a toxicologist, rather more cautious because I rely on the direct experimental data.

MR. MYERS: So that it's your view that we simply don't have enough evidence about a substance like tobacco smoke to say that there's a causative relationship or an initiator relationship until we fully understand the mechanism by which the substance actually causes the health-related problem.

DR. BRIDGES: Let me take you to my position as a toxicologist. I have no ax to grind at all about...

MR. MYERS: I'm just trying to understand it.

DR. BRIDGES: In terms of the animal studies which have been done with tobacco smoke, it's generally been the case that cancer hasn't been shown. So for a toxicologist, if you can't show that tobacco smoke is causing an effect in animals, you've got a problem in identifying how the thing works. That's why I can only consider it at this stage a risk factor.

MR. MYERS: Would you also conclude then, that we simply don't yet have enough scientific evidence to conclude that direct tobacco smoke is a cause or an initiator, to use your word, I believe, of chronic obstructive lung disease? Would the same be true?

DR. BRIDGES: From the experimental animal data, that is certainly --

MR. MYERS: That's true. You're not prepared to reach that conclusion yet?

DR. BRIDGES: Not from a mechanistic point of view, no.

MR. MYERS: Well, but I'm asking your professional scientific point of view. That's what I'm getting, I'm hoping, your best professional scientific viewpoint is that you don't yet believe we have enough scientific evidence to conclude that direct smoking causes lung cancer, cardiovascular disease or chronic obstructive lung disease.

DR. BRIDGES: If you're asking me on the basis of the data, that's the case. I could speculate but I don't --

MR. MYERS: I'm not asking for speculation. I'm asking for your views.

That makes a couple of other questions I was going to ask difficult. If your conclusion is that there's no proven causal relationship, then it goes without saying that you also would say for direct smoking that we don't have any evidence about what the threshold is for a link between tobacco smoke and these diseases because we don't have any evidence that it actually causes them, is that fair to say?

DR. BRIDGES: Well, in terms of risk factors, you can look, of course, in human studies at a dose-response relationship for that risk factor. You don't need a mechanism.

MR. MYERS: Okay.

DR. BRIDGES: But in animal studies, then we can't get off first base because we haven't got a decent animal model that mirrors what appears to be happening in man.

MR. MYERS: Okay. Then looking at some threshold data for the purpose of risk factors, as you say, have we identified for direct tobacco smoke a threshold above which it's likely to cause harm and below which it's not?

DR. BRIDGES: I'm not a specialist in mainstream tobacco smoke and it's not part of my testimony so I would prefer not to get too --

MR. MYERS: Have you looked at the scientific data?

DR. BRIDGES: Some time ago but not recently on mainstream at all. No.

MR. MYERS: So you simply don't know, is what you're saying to us? As a scientist, you're not prepared to give us a professional opinion?

DR. BRIDGES: When I give a professional opinion, I like to take into account all the latest data and I haven't seen the latest data.

MR. MYERS: So in forming the opinions you've given us here today, you haven't gone back and looked at any of that data.

DR. BRIDGES: Not on mainstream. No.

MR. MYERS: Not on mainstream at all.

DR. BRIDGES: No.

MR. MYERS: And I asked that with regard to lung cancer but I'm assuming the same is going to be true for coronary heart disease and chronic obstructive lung disease.

DR. BRIDGES: I haven't gone back over that data recently for these hearings.

MR. MYERS: So you're not prepared to give us an opinion one way or the other as to whether or not there is data that would indicate that there is or there is not a threshold with regard to mainstream smoke?

DR. BRIDGES: I would need to look at the data again before I made that opinion. Yes.

MR. MYERS: And you didn't do that in preparation of this and you didn't do it in preparation for the formation of the opinions you've given here today.

DR. BRIDGES: Well, I've obviously read all of this data but if you're asking me specifically whether I used mainstream tobacco smoke data to make my analysis based on a recent reading on mainstream tobacco, the answer is I didn't.

MR. MYERS: Well, what I'm asking you is whether you reviewed the data on mainstream tobacco smoke and whether as a toxicologist who has been asked to give an opinion about environmental tobacco smoke whether you have reviewed the data at all on mainstream smoke.

MR. ANDRADE: Your Honor, may I be heard for a second?

It's been a long day. The professor has been here available since 8:30. He's answered this question about three times. We haven't yet heard one question on environmental tobacco smoke or the substance of Professor Bridges' testimony. I think that speaks for itself.

MR. MYERS: Your Honor, these questions couldn't be more relevant. I haven't gone off the issue one second. I'm trying to figure out what it is he's looked at to formulate the opinions he's given today about environmental tobacco smoke.

I don't intend to be long but it is hard to go on to the area without exploring this. All I need is a yes or no, I believe the answer is that he did say that he has not --

DR. BRIDGES: I have not looked at it recently, is what I said.

MR. MYERS: And have you taken it into consideration in the formation of the professional opinions you've given today?

DR. BRIDGES: Well, there's obviously information that's at the back of the mind that influences some of the things that you say later on but I haven't given a recent analysis on mainstream tobacco smoke and a dose-response on mainstream.

MR. MYERS: Did you factor it in at all in the formation of the opinions you've given today?

DR. BRIDGES: The opinions I've given today are based on much different exposures for ETS.

MR. MYERS: So the answer is no.

DR. BRIDGES: The answer is no.

MR. MYERS: Now, you've also raised a question about the impact of cumulative exposures over time --

DR. BRIDGES: The body burden hypothesis you mean?

MR. MYERS: That's right. Yes. That's right. And the question I have for you is either mainstream or environmental tobacco smoke is there scientific evidence to indicate that the long-term exposure is more harmful than short-term exposure?

DR. BRIDGES: With mainstream tobacco smoke, prolonged exposure from the data that I recollect but not from having read it recently would suggest that prolonged exposure increases the risk factor, yes.

MR. MYERS: And so that cumulative exposure over time does increase the risk factor.

DR. BRIDGES: Depends what you mean by cumulative exposure but longer periods of smoking seem to lead to an increased risk factor. But how that links to body burden hypothesis, I wish I knew at this stage. I don't think we know enough about it.

MR. MYERS: Okay. So that -- while you're willing to say that there seems to be an indication that this cumulative exposure increases the risk factor, you're not willing to say as a matter of science that long-term exposure is more harmful.

DR. BRIDGES: I don't know the answer to your question.

MR. MYERS: You don't know the answer to the question.

DR. BRIDGES: Right.

MR. MYERS: For either direct smoke or environmental tobacco smoke.

DR. BRIDGES: No. Not specifically. Again, I could speculate but I won't.

MR. MYERS: Now, it's my understanding, if I'm correct, that you yourself haven't done any studies of the type of exposures to environmental tobacco smoke of the sort that we heard from Dr. Jenkins earlier today.

DR. BRIDGES: That's correct.

MR. MYERS: Have you done exposure studies yourself with regard to specific components of environmental tobacco smoke?

DR. BRIDGES: We've done studies on those particular chemicals but not using inhalation techniques so the extrapolation is problematic.

MR. MYERS: So you wouldn't draw conclusions one way or the other.

DR. BRIDGES: We don't have decent inhalation facilities.

MR. MYERS: Okay. So you can't draw a conclusion one way or the other is what you're saying.

DR. BRIDGES: We haven't done specific studies.

MR. MYERS: Can you draw a conclusion?

DR. BRIDGES: I think it would be inappropriate at this point.

MR. MYERS: It's inappropriate? Okay.

In your professional opinion, is environmental tobacco smoke even a risk factor for lung cancer?

DR. BRIDGES: I think it's very difficult for a toxicologist to talk about something without talking about the level but I would not be surprised if high levels of ETS were a risk factor.

MR. MYERS: So it really isn't your intention today to tell us that high levels of ETS might not be a risk factor.

DR. BRIDGES: I haven't made that statement.

MR. MYERS: And as I understand it, you are also in the process of looking at whether or not multiple chemical exposure increases risk of disease, is that right?

DR. BRIDGES: That's our area of research, yes.

MR. MYERS: So that there is a possibility that even if exposure to environmental tobacco smoke alone was not a risk factor for disease that exposure to environmental tobacco smoke in combination with certain other chemicals might be. You simply don't know one way or the other.

DR. BRIDGES: We don't know.

MR. MYERS: And you're not here telling us that you have an answer to that one way or the other.

DR. BRIDGES: I don't think anybody has an answer to that, unfortunately.

MR. MYERS: Okay.

DR. BRIDGES: And it's a complex issue because it could be additive, it could be antagonistic or it could be no interaction at all.

MR. MYERS: You simply haven't studied it yet to give us an answer.

DR. BRIDGES: Nobody's studied it, to my knowledge.

MR. MYERS: In your -- I think it's the first submission, the thicker submission, I was unclear as to what you were telling us about what we know about the interrelationship between ETS and asthmatics as whether or not ETS is an initiator of an asthma problem or a catalyst for an asthma problem in an asthmatic.

DR. BRIDGES: Well, I don't think it's clear. The problem is wider than that of course that the increase in asthma incidents which is particularly among children in the U.K. and elsewhere, it's very unclear whether chemicals are an initiator generally or not. What we do believe is that in certain circumstances they can exacerbate the condition.

MR. MYERS: Is your institute smoke-free?

DR. BRIDGES: No.

MR. MYERS: No? What's your institute's policy on tobacco use?

DR. BRIDGES: We don't allow smoking in the laboratories and people can smoke in their rooms if they have the agreement of any colleague who's sharing the room, basically.

MR. MYERS: And absent an agreement of the colleague, what's the --

DR. BRIDGES: Sir?

MR. MYERS: Absent --

DR. BRIDGES: They share an office and obviously we expect them to have an understanding between one another.

MR. MYERS: In the Department of Labor's Federal Register notice on this issue, at page 15,987 and 15,988, there are three tables which contain -- do you have that?

DR. BRIDGES: I do.

MR. MYERS: Okay. Which contain a list of various constituents in sidestream smoke.

DR. BRIDGES: Yes.

MR. MYERS: Including a ratio of sidestream smoke to mainstream smoke.

DR. BRIDGES: It's stated as a ratio, that it's an amount in mainstream and then a ratio of sidestream to mainstream.

MR. MYERS: Right. And at least in that chart, the five constituents that are listed as known carcinogens and the nine that are listed as probable carcinogens, are all shown to have higher levels in sidestream smoke than in mainstream smoke. Do you disagree with that conclusion?

DR. BRIDGES: Well, this data reported under a particular set of circumstances and I assume under that particular set of circumstances it to be correct.

MR. MYERS: Do you know what those circumstances were?

DR. BRIDGES: I don't. I did look at them at the time but it was some time ago.

MR. MYERS: So you don't dispute in your testimony that at least these 14 known or probable human carcinogens are emitted in sidestream smoke.

DR. BRIDGES: I have no reason to dispute it. No.

MR. MYERS: May I just have a moment? And then I will be done.

(Pause)

MR. MYERS: Have you looked at the scientific studies about how nicotine interacts with the cardiovascular system?

DR. BRIDGES: I have. Yes.

MR. MYERS: You have.

DR. BRIDGES: Yes.

MR. MYERS: And how does it interact, if you could tell me?

DR. BRIDGES: Well, it interacts in a number of ways but if you're asking me for a specific judgment, I would wish to put that -- to reconsider the data and put it in writing rather than give you an instant opinion.

MR. MYERS: Well, does it show that nicotine does any damage to the endo -- and I can never pronounce these --

DR. BRIDGES: The endothelial cells.

MR. MYERS: Thank you for saving me.

DR. BRIDGES: Under particular sets of circumstances, it can damage the endothelial cells.

MR. MYERS: Is that based on the dose ratio, do you know?

DR. BRIDGES: There have been some crude dose-response relationships as far as I'm aware but that's why I would not put it in writing because I think I would need to consider the data fully. But certainly high levels, yes, endothelial cell damage can potentially occur.

MR. MYERS: And is there any data showing that nicotine can lower the oxygen carrying capacity of hemoglobin?

DR. BRIDGES: I've seen such data.

MR. MYERS: Have you seen any other data about how it affects the cardiovascular system?

DR. BRIDGES: There are all sorts of papers, which is why I wouldn't give you an instant summary now but there are a range of potential effects on the cardiovascular system.

MR. MYERS: Now, as I understand, you're appearing on behalf of Philip Morris, is that right?

DR. BRIDGES: Well, to be honest, I was only vaguely aware of Philip Morris. Shook, Hardy & Bacon are our clients.

MR. MYERS: Have you worked for Shook, Hardy & Bacon before?

DR. BRIDGES: Yes.

MR. MYERS: Were you aware, did you inquire as to whether or not Philip Morris has any data about the impact of nicotine on the cardiovascular system?

DR. BRIDGES: No, because it wasn't a specific question that we were trying to address.

MR. MYERS: Wouldn't it be relevant to your concern about mechanisms?

DR. BRIDGES: Given time, there's a lot of data I would like to review that's around but I haven't done a specific review on nicotine and cardiovascular --

MR. MYERS: But in this case at least one former Philip Morris scientist has testified under oath before a subcommittee of the United States Congress that Philip Morris has a good deal of information about how nicotine interacts on the cardiovascular system. In fact, he was tasked to find a nicotine substitute that wouldn't have that effect. And you've never inquired to Philip Morris?

DR. BRIDGES: Well, I'm not even aware of the testimony.

MR. MYERS: If there was evidence that your client in this case knew exactly how nicotine interacted on the cardiovascular system, wouldn't that be relevant to your conclusion about whether or not we know enough about mechanisms to draw a casual relationship?

DR. BRIDGES: Well, if any one research group knows exactly how something works, I'd be absolutely delighted to get the information but I assume that I would want to review their data along with others.

MR. MYERS: Well, before you file any subsequent comments, maybe you want to ask your client for their very own data on this issue.

DR. BRIDGES: Well, my client is Shook, Hardy & Bacon. They would have to deal with this, I think.

MR. MYERS: Well, if you're going to stake your professional reputation, maybe your client would like to share what it knows.

I have no further questions.

JUDGE VITTONE: Thank you, Mr. Myers.

Mr. Weinberg.

MR. WEINBERG: Could we have just five minutes? We might be able to shorten the questioning time completely, if that's satisfactory.

JUDGE VITTONE: Mr. Rupp, do you still have questions?

MR. RUPP: I'll have to see what they're going to ask. Maybe I won't.

JUDGE VITTONE: Five minutes.

JUDGE VITTONE: We're going to go with Mr. Weinberg first.

MR. WEINBERG: Thank you.

JUDGE VITTONE: Okay.

MR. WEINBERG: Dr. Bridges, my name is Myron Weinberg and I have previously indicated the number of representations we have. I may steal some thunder from a method that Mr. Rupp introduced me to so we can move very, very quickly.

I'd just like to get some summation since I wasn't reading your testimony as you went along and I'd just like to ask four or five questions quickly about what I think I heard you say.

I think, Dr. Bridges, that you held that it was necessary to have a dose-response relationship in order to really establish that something was a hazard. Is that correct?

DR. BRIDGES: Correct.

MR. WEINBERG: And you to date haven't seen dose response data that links environmental tobacco smoke with cardiovascular disease.

DR. BRIDGES: Not as yet.

MR. WEINBERG: So it would be your conclusion that there is no hazardous link which has been established between environmental tobacco smoke and cardiovascular disease.

DR. BRIDGES: My position is I don't know.

MR. WEINBERG: But to date that would be based on the fact, at least one fact, that no dose-response relationship has been established.

DR. BRIDGES: Correct.

MR. WEINBERG: Thank you. Further, I understand that one area of your significant interest right now is an area of mixtures.

DR. BRIDGES: Yes.

MR. WEINBERG: I think I heard you say that generally speaking one cannot look at the components of a mixture and make a determination without some biological study as to whether or not the mixture shows potentiation, synergism, antagonism; whether the mixture is more effective or less effective than any individual chemical in the mixture.

DR. BRIDGES: That unfortunately is correct.

MR. WEINBERG: That's correct. Thank you.

I further -- I think there was a lot of question about your position on mainstream smoke, et cetera. It seems to me from what I've heard you say that it's your belief that environmental tobacco smoke is a unique and different chemical than mainstream smoke.

DR. BRIDGES: Well, I haven't really talked about the chemical nature. I've talked about levels of exposure to particular chemicals. Certainly my reading of the literature is that mainstream smoke at ETS are not of identical chemical composition.

MR. WEINBERG: So that in looking at ETS, you look at it as a unique chemical and what it does.

DR. BRIDGES: You certainly have to do that. Yes.

MR. WEINBERG: Fine. And then the last thing I wanted to ask is I think I heard you say that irrespective of the mechanism by which something may cause carcinogenicity, practically, there is a threshold for all materials.

DR. BRIDGES: It's my understanding on the basis of what we know biologically that there's likely to be a threshold.

MR. WEINBERG: Thank you very much.

JUDGE VITTONE: Thank you, Mr. Weinberg.

Mr. O'Neil.

MR. O'NEIL: Thank you, Your Honor.

My name is Bernard O'Neil. I'm asking questions on docket number 51.

Dr. Bridges, you had a discussion with both Mr. Myers and Ms. Sherman on genotoxic substances. Isn't it true that a genotoxic carcinogen may under test conditions result in a mutagenic change in the test medium, that's your definition, is it not?

DR. BRIDGES: A genotoxic carcinogen is one that shows positive effects in genotoxicity tests of various kinds and obviously produces cancer in experimental animal models.

MR. O'NEIL: That doesn't mean, though, does it that a mixture containing several genotoxic carcinogens as established in animal tests would cause cancer in humans, does it?

DR. BRIDGES: It doesn't necessarily mean that at all, no. Because we have to take into account the various components of the mixture, presumably.

MR. O'NEIL: Mr. Myers asked you about some tables occurring in the preamble in the Federal Register and described the list of constituents as human carcinogens that have been found in environmental tobacco smoke. Am I correct in that?

DR. BRIDGES: Well, I didn't take the point they were necessarily human carcinogens, but they're carcinogens in animal models.

MR. O'NEIL: Carcinogens in animal models does not necessarily mean, does it, that they are inhalation carcinogens.

DR. BRIDGES: No. It can be influenced, of course, by the route of exposure.

MR. O'NEIL: That's correct. And furthermore, it doesn't establish that ETS is a carcinogenic substance because it contains some of these substances which have been shown to be animal carcinogens, does it?

DR. BRIDGES: You can't judge the toxicity of a complex mixture just by separate analysis of each of the components, so the answer is yes.

MR. O'NEIL: Another aspect of the table that Mr. Myers showed you was the ratio of sidestream to mainstream.

DR. BRIDGES: Correct.

MR. O'NEIL: Is sidestream tobacco smoke the same as environmental tobacco smoke?

DR. BRIDGES: Well, it may or may not be but generally, no, if we're talking about the office type situation.

MR. O'NEIL: Indeed, isn't it true that sidestream tobacco smoke is generally measured as coming off the burning end of a cigarette without any account of dilution or aging?

DR. BRIDGES: Or going through the smoker, of course, first.

MR. O'NEIL: Yes. That's right. So to talk about a ratio of sidestream to mainstream might have little relevance to environmental tobacco smoke as encountered in the office environment.

DR. BRIDGES: Well, that's what I meant about specific measurements. No doubt the data was correct but I didn't know how to use it.

MR. O'NEIL: During these hearings, there has been evidence that some of Mr. Myers' clients, the American Cancer Society, the American Heart Association, the American Lung Association, had in their possession data from studies they conducted which showed that environmental tobacco smoke was not statistically associated in a significant way with various disease end points. Would you then, of course, be interested in seeing what data those organizations would have in forming your scientific opinions?

DR. BRIDGES: Well, if I'm given the opportunity to do a thorough review and somebody is prepared to fund it who is not linked with a group that is immediately going to say, well, it's a prejudiced study before you start, I'd be very interested. But I think there's a much more fundamental problem for toxicologists and that is that negative studies usually are never published, whether it's to do with one particular group of chemicals or anything else.

MR. O'NEIL: So you definitely would be interested in results from studies which provide negative results on the issue.

DR. BRIDGES: Well, ideally, if you're going to do any evaluation you want all of the available data and then you need to make some judgments on how valuable the various components are.

MR. O'NEIL: You might recall that Ms. Sherman asked you whether ETS can cause irritation, do you, sir?

DR. BRIDGES: I do remember. Yes.

MR. O'NEIL: To your knowledge, have there been any studies which have shown clinically significant irritation based on exposure to environmental tobacco smoke levels commonly found in office environments?

DR. BRIDGES: I'm not specifically aware of such studies but I think I was asked whether ETS can cause irritation and that certainly is true.

MR. O'NEIL: Clinically significant irritation would be different from just --

DR. BRIDGES: I'm not aware of a study that actually demonstrates clinically significant irritation. That doesn't mean to say it does exist or it doesn't exist, I'm simply not aware of it.

MR. O'NEIL: I know it was late in the day and I believe the question was asked by Mr. Myers whether nicotine lowers the oxygen carrying capacity of the hemoglobin. It's not nicotine, he misspoke in that question, do you agree?

DR. BRIDGES: I can't recall the paper in sufficient detail but I do remember an association in something I read between nicotine and lowering oxygen.

MR. O'NEIL: Okay.

Those are all the questions I have, Your Honor.

JUDGE VITTONE: Thank you.

MR. McNEELY: I have a statement to make about one question for a clarification.

The gentleman who just asked these questions, and I didn't want to interrupt because there may have been a ruling that I was not aware of but he's testifying or at least questioning on behalf of witness 51, which is Philip Morris. Again, it's my understanding that they have withdrawn from these proceedings. They certainly withdrew their witnesses. Has there been a ruling that they can still participate in questioning?

JUDGE VITTONE: There has been no ruling that they may not participate in questioning. They have withdrawn their witnesses. My understanding is that they have not withdrawn as a participant in the proceeding.

Mr. Andrade and Mr. O'Neil, you can respond to that directly.

MR. ANDRADE: Yes. Allow me, Your Honor.

I'm not sure that there's been any motion that Philip Morris should not continue in this proceeding, that I'm aware of that's been discussed on the record.

I think it's very clear that the entire goal of this proceeding is to develop an extensive record. We have attorneys who are questioning on behalf of parties, many attorneys have provided nothing to the record, are simply representing their clients. We on the other hand, although we didn't testify orally, have submitted extensive written comments, extensive written testimony. We have invited many distinguished outside scientific experts to present their testimony and they have appeared. We have invited many people from the business community, economists and others, to appear and testify, and they have done so.

I am not aware of anything in the rules or procedure that would preclude us from continuing to participate on our own behalf and the record is replete from the very beginning with references to the fact that we are also representing a number of other individuals: scientists, businesspeople, and, indeed, I have an ample stack of letters in my briefcase if you wish, you haven't required this of anyone else, Your Honor, but letters authorizing us indeed to cross-examine witnesses on behalf of independent scientists, independent businesspeople, and so on.

But, again, I'm not sure that there's a meritorious argument to be made. So I respond but I don't think it's necessary.

MR. McNEELY: Judge Vittone?

JUDGE VITTONE: Yes.

MR. McNEELY: I'm aware of your preliminary statement on how these hearings were supposed to be conducted and I believe in order to engage in questioning of witnesses they had to participate in the proceedings and answer questions from the panel.

And if there hasn't been a motion been made as far as Philip Morris, I certainly do not disagree -- as long as they're in a representative capacity for somebody else besides Philip Morris, I don't see that there's a problem. But with regard to Philip Morris, I would certainly make the motion that they not participate on behalf of Philip Morris after having withdrawn their witnesses.

JUDGE VITTONE: Well, Mr. McNeely, my understanding and the way these proceedings have been conducted and Ms. Sherman can comment if she likes, even if Philip Morris had never submitted one witness statement or offered one witness, if they had identified themselves as a participant and somebody who was going to participate in the proceeding, they still would have been able to attend these hearings and to engage in examination.

The fact that you represent somebody who has submitted testimony is not dependent upon your ability to question a witness or to participate in the proceeding. I mean, John Q. Public, forget Philip Morris, if you as a private citizen had submit a notice of intention back in July that you wanted to participate in this proceeding and even if you hadn't submitted anything but you came to the proceeding, you would have just representing yourself at least ten minutes to question any witness who got up on this podium and testified.

So the fact that they have withdrawn their testimony does not prevent them from participating in the proceeding and I do not believe prevents them from engaging in examination of witnesses.

Now, I should add to this that the other day I received a motion from an organization called Action on Smoking and Health signed by Mr. John Banzaf objecting to Philip Morris' participation and questioning their right to cross-examine. Well, let me see. I'm trying to remember. Basically, they were requesting that in the interests of fairness that Philip Morris put their people back in the proceeding to be examined and that all records of cross-examination conducted by Philip Morris or other tobacco industry interests should be struck from the record unless such parties are themselves willing to submit to cross-examination.

ASH, as I understand it, is not a participant in this proceeding. They have not officially filed the way everybody else has a notice of intention to participate.

Is that true, Ms. Sherman?

MS. SHERMAN: That is true.

JUDGE VITTONE: Under the rules, as I understand the rules, there is a question about whether they have standing to file the motion.

MS. SHERMAN: I have that very question myself. It would seem to me that at most, ASH's motion could be construed to be a late comment. But as far as I understand it, ASH is not a participant at this hearing.

JUDGE VITTONE: I haven't taken it up because, one, I just got it the other day and I wanted to give everybody an opportunity.

But with respect to your motion, I'm not going to rule on this thing right now, but with respect to your motion, if you're asking me to strike them from questioning, I think the way -- not I think, I know the way these proceedings have always been conducted and the interest of the agency is to have maximum public participation and it's not dependent upon submitting testimony and then withdrawing.

My understanding is the fact that they withdrew their testimony, I do not believe, stops them from continuing to be an active participant in the proceeding.

I've been talking a long time. Do you understand what I'm saying?

MR. McNEELY: I understand what you're saying. I wanted to have that on the record so that the record would know. And I agree as a matter of fundamental fairness -- I do not understand that ruling but if that's the way it's going to go --

JUDGE VITTONE: Well, it's simply the fact that in these kinds of proceedings, the agency wishes to have as many people participate as possible at whatever -- almost at whatever level they want to. And we have people who have come here, submitted testimony, been on the stand for five minutes and then left. We have had people who have been here every day.

The participation is varied and it's not required that you actually have to submit testimony in order to be an active participant in this proceeding.

As I said, I think any individual, any citizen, could file a statement and come to these proceedings and just as a private citizen participate in cross-examining witnesses as they come to the podium.

MR. McNEELY: All right. But, like I said, I wanted to put our objection on the record and we have your holding. Thank you.

JUDGE VITTONE: Okay. Just to be clear, my holding is that they can participate. If they have examination, I am going to allow them as long as it's relevant and material to this proceeding.

MR. McNEELY: That's very clear. And I will not withdraw from the proceedings.

MR. ANDRADE: Your Honor, so we are clear, Philip Morris will fully participate with respect to its own docket number and also be continuing to represent a number of other entities, scientists, individual businesspeople, who have authorized Philip Morris and/or Philip Morris' designee to cross-examine on their behalf.

JUDGE VITTONE: Okay. Let me just -- since I brought up this thing, are you going to respond to this thing from Action on Smoking and Health?

MR. ANDRADE: Well, I think I can respond right now. I share Your Honor's view that there's a serious question of standing. Quite frankly, I find it incredible that this motion or this objection was filed by an entity that's filed no written comments in the whole process, no written testimony, no notice of intent to appear and testify. Indeed, Mr. Banzaf has never set foot in the hearing room for these several months, or perhaps one day, Ms. Sherman --

MS. SHERMAN: I saw him one day.

MR. ANDRADE: He certainly has not participated. Does not have a docket number for ASH or himself individually, and in the objection doesn't purport to be representing anyone who does have a legitimate docket number.

I think that, again, the prehearing guidelines, the way Your Honor has conducted the hearing makes it abundantly clear that those people who file legitimate notices of intent to testify and who have been participating, who have been making serious efforts to help OSHA develop an extensive record, as I believe we have, through witnesses, through our own extensive written comments and written testimony, that if anyone has a right to continue to participate, it would be Philip Morris. And, as I said, I just see no merit whatsoever in this motion.

JUDGE VITTONE: Ms. Sherman, do you have any comments that you want to add?

MR. TYSON: While she's gathering her thoughts, Your Honor, because the letter was addressed to me, may I also just second the objections and response made by Mr. Andrade and Philip Morris?

JUDGE VITTONE: Thank you, Mr. Tyson.

MS. SHERMAN: I guess that my personal position would be that as long as somebody is representing somebody at the hearing they have the right to go on and I don't think we have to reach the issue as to whether they would have the right to go on if they were not representing anybody else.

JUDGE VITTONE: Well, I'm talking about the ASH thing. Do you have anything further?

MS. SHERMAN: Oh, as to ASH?

JUDGE VITTONE: Yes.

MS. SHERMAN: I have not checked with my office but my position would be that they are not a participant at this hearing and that at most their motion should be considered as a late comment.

JUDGE VITTONE: Well, they have two things -- and I assume there's nobody from ASH here? I've asked if anybody has been here before and I've told no.

(No audible response.)

JUDGE VITTONE: Okay. They have two things. One, that the presiding officer, I guess me, request Philip Morris and other tobacco industry representatives to submit to cross-examination in respect to their testimony. I assume that they're only talking about Philip Morris since that's the only one who has withdrawn.

MR. TYSON: Well, I have withdrawn as well. It's a joint letter.

MR. ANDRADE: Let me make an important point, Your Honor. We did not withdraw our testimony. We certainly didn't appear to testify orally. We stood on our written testimony, which was extensive in and of itself.

JUDGE VITTONE: Well, as I stated earlier, and the second thing they ask is that all records of cross-examination conducted by Philip Morris or other industry interests should be struck from the record.

MS. SHERMAN: They said or other industry interests?

JUDGE VITTONE: Other tobacco industry interests should be struck from the record.

With respect to the second part of that, I am not going to do that. I think under the guidelines of the proceeding, I cannot do that. And so that will not be granted.

With respect to the first part, as I said earlier on, I regret that you pulled your witnesses. I wish they had been here for examination. I think that would have been helpful to the proceeding. But that decision has been made. So that is up to you, gentlemen, and your clients to decide that decision yourself.

But I guess the bottom line is we're going to continue as we have continued up to this point and Philip Morris will have the right to participate as any other party to this proceeding has participated up to this time.

MR. TYSON: Would you include me in that, Your Honor? We have a separate notice of appearance.

JUDGE VITTONE: Yes, Mr. Tyson.

MR. TYSON: Thank you very much, Your Honor. And also, because ASH specifically in that document requests that you order the testimony, you might want to address that specifically.

JUDGE VITTONE: No, they ask that I request Philip Morris and other tobacco industry representatives to submit to cross-examination.

MR. TYSON: You made a request.

JUDGE VITTONE: My request has been there from the very beginning.

MR. TYSON: Thank you, Your Honor.

MS. SHERMAN: Your Honor?

JUDGE VITTONE: Yes?

MS. SHERMAN: Are you going to formally rule on the Philip Morris -- excuse me. On the ASH motion?

JUDGE VITTONE: I'll put out a written order to them. They submitted in writing, I will respond in writing.

Tomorrow morning, we have three witnesses, I understand: the University of North Carolina at Charlotte, Arthur Greenberg; New Jersey Department of Community Affairs, William Connoly; and the University of Arizona, Mark Van Ert.

MS. SHERMAN: Your Honor, it's my understanding that the New Jersey Department of Community Affairs has canceled.

MR. RUPP: Is that certain?

MS. SHERMAN: Mr. Rupp, at this hour, this is what my memory serves me.

Your Honor, I thought you faxed me that notice.

JUDGE VITTONE: Yes. I've gotten so many I can't keep up with them.

Okay. All right. So we're going to have at least two or three tomorrow.

MR. WEINBERG: Your Honor, I can tell you that both Drs. Van Ert and Greenberg are and will be here.

JUDGE VITTONE: Will be here.

MR. WEINBERG: Will be here.

JUDGE VITTONE: Okay. Thank you.

Thank you, ladies and gentlemen. It's late.

Doctor, thank you very much. We appreciate your time today.

JUDGE VITTONE: We're going to be back in the auditorium tomorrow morning at 9:30.

This document's URL is: http://www.tobacco.org/Documents/osha/950105osha.html


***********************
Return To: OSHA Hearings page
***********************
Go To: Tobacco BBS HomePage / Resources Page / Health Page / Documents Page / Culture Page / Activism Page
***********************

END OF DOCUMENT