OSHA: Proposed Standard For Indoor Air Quality: ETS Hearings, January 17, 1995
OSHA: Proposed Standard For Indoor Air Quality: ETS Hearings, January 17, 1995
UNITED STATES DEPARTMENT OF LABOR
OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION
PUBLIC HEARING
PROPOSED STANDARD FOR INDOOR AIR QUALITY
Tuesday,
January 17, 1995
Department of Labor
Washington, D.C.
The above-entitled matter came on for hearing, pursuant to notice, at 9:45 a.m.
BEFORE: HONORABLE JOHN VITTONE
Administrative Law Judge
AGENDA
PAGE
R.J. Reynolds
Christopher R. E. Coggins 11378
Michael W. Ogden 11381
Paul R. Nelson 11420
Stephen B. Sears 11445
Michael W. Ogden 11471
Christopher R. E. Coggins 11486
Hoy R. Bohanon, Jr. 11512
Questions:
Ms. Sherman 11543
EXHIBITS
EXHIBIT NO. IDENTIFIED RECEIVED
228 11419 11419
229 11419 11419
230 11444 11444
231 11444 11444
232 11468 11468
233 11468 11468
234 11486 11486
235 11486 11486
236 11511 11511
237 11542 11542
238 11542 11542
P R O C E E D I N G S
9:45 a.m.
JUDGE VITTONE: Good morning, ladies and gentlemen. We resume our hearings into the proposed rule by the Occupational Safety and Health Administration on indoor air quality.
For the record, this is day 51 of these hearings.
We have on this morning a panel from the R.J. Reynolds Tobacco Company that will be testifying today and will be also here for the next several days, Tuesday, Wednesday and Thursday of this week.
I would like to begin by introducing the chairman of the RJR panel, Dr. Coggins.
DR. COGGINS: Thank you, Judge Vittone.
Good morning, ladies and gentlemen. I am Chris Coggins. I hold a Ph.D. from the University of Edinburgh, Scotland, and I am a board certified toxicologist.
JUDGE VITTONE: Excuse me a second. I'm sorry. I forgot something here. I have a preliminary matter that somebody wanted to raise with me.
Mr. McNeely, would you come forward, please?
MR. McNEELY: Actually, Mr. Herman will be making --
JUDGE VITTONE: Okay. Mr. Herman.
Why don't you come on around here, Mr. Herman?
MR. HERMAN: Judge Vittone, I am not at all certain of the procedure that will be followed this morning.
JUDGE VITTONE: I will be glad to explain it to you, then. What we plan to do here today, and I guess I should advise everyone here, sometimes I tend to forget that not everybody understands how we operate, what we will be doing over the next several days is simply this: the R.J. Reynolds panel will be making a presentation today, individuals members of the panel will be called at various times and make a presentation on various subject matter, on topics, I'm not sure exactly what each person will be talking about.
We will be taking them in seriatim. Dr. Coggins is the chairman, as I understand, of the panel and then he will call upon individual members of this panel to speak on various topics.
That will probably consume all of this morning and at least a portion of this afternoon's proceeding. After they have completed their direct testimony, using the slides and everything, then they will be made available for examination by the participants in the proceeding.
I will then turn to Ms. Sherman, who heads up the OSHA staff. Ms. Sherman and her staff will be able to examine the panel about their testimony. I do not know how long that will be but I am sure it it's gong to be lengthy examination.
After she has completed her direct examination, then I will make the panel available for examination by other participants in this proceeding who have complied with the rules with respect to becoming actual parties or participants to the proceeding and that will probably take us through some time on Thursday.
Then at that point after all of the participants have completed their examination, if there is any brief clarification that the panel members want to make, I will give them an opportunity to make a statement at that point and then we will end with them.
It is the same pattern we have pretty much followed in this proceeding for every other witness or panel of witnesses that have testified in this proceeding so far, including the NIOSH panel, the American Medical Association, the unions that have testified, anybody else.
So that's basically our regular process, so that's it.
MR. HERMAN: May I ask if any of these gentlemen have engagements that will cause them to leave at any time before we have an opportunity to fully speak with them about the issues they have raised?
JUDGE VITTONE: Well, I think we've gone over this but I'll give Mr. Grossman an opportunity to respond to that.
Mr. Grossman, since you haven't been back for a while, why don't you tell everybody who you are?
MR. GROSSMAN: I will. Your Honor, my name is Ted Grossman. I am here on behalf of R.J. Reynolds.
The panel, all of the members of the panel, have reserved today and tomorrow and Thursday for these hearings as the schedule calls for. Obviously they haven't scheduled an indefinite appearance and neither has any other organization.
JUDGE VITTONE: So they will be here.
Now, just so we are clear, the OSHA panel has also scheduled for Thursday two other individuals which we will bring on at the completion of the RJR panel, Mr. Allan Hedge and Mr. Gene Davidson. I don't know anything about those gentlemen but they will be here on Thursday but they will be here after the RJR panel is completed.
MR. GROSSMAN: Yes, Your Honor. We scheduled them in accordance with the schedule, has OSHA has.
JUDGE VITTONE: Okay.
Mr. Herman, does that answer your question, sir?
MR. HERMAN: Yes, it does. And I understand that thankfully we will have a full opportunity because the entire panel will be here for the duration.
MR. GROSSMAN: For the duration of Reynolds' testimony. Yes.
MR. HERMAN: And cross.
MR. GROSSMAN: Yes.
MR. HERMAN: Your Honor, I have only one comment.
JUDGE VITTONE: Okay.
MR. HERMAN: And I appreciate your allowing me to take this time just to clarify what the procedure was.
We have an objection in principal to allowing RJR to appear en masse like this. It really thwarts the ability, our ability, to examine each of the gentlemen individually and it allows RJR to take the stage for a very long period of time without breaking the continuity and allows them in effect to have a continuing commercial for the benefit of the cigarette industry.
We understand your ruling and we appreciate it and our concern is that while unintentional certainly the way that this process is being allowed falls square into the concerns that those of us who represent the other side of this case are most concerned about and that is a full and complete airing of the issues without the opportunity, though we respect your ruling, I want to state it for the record, without the opportunity of being able to question each of these gentlemen after their testimony is concluded. It's going to adversely affect our ability to get a full and complete airing of our side of the issue.
And having said that, I appreciate the time you have allowed me.
JUDGE VITTONE: You are welcome, sir.
Mr. Grossman?
MR. GROSSMAN: Thank you, Your Honor. If I may respond briefly, we've been across this bridge many times before, both as to Reynolds and as to others, and, as Your Honor has already said, every other panel, the AMA, OSHA, NIOSH, has testified in precisely this way. The only difference, I might add, is that Reynolds has identified the authors of the submissions that it has before you.
Mr. McNeely raised exactly this point on December 7th and at page 8686 of the transcript --
JUDGE VITTONE: Mr. Grossman, I don't want to cut you off, I'll give you an opportunity to respond but I do not intend to change my ruling in this matter.
MR. GROSSMAN: I was just going to say at that page you said that there would be no revision and no reconsideration of your ruling.
JUDGE VITTONE: My ruling stands. I will permit the RJR panel to proceed, present its entire direct testimony and then be made available for examination.
Thank you, Mr. Herman, for your comments. I understand your position and it's the same position that the OSHA staff took but it's a position I decided not to adopt and decided to proceed in this manner and this is the way we will go forward.
Thank you, Mr. Herman.
Thank you, Mr. Grossman.
Anything else before we begin?
(No audible response)
JUDGE VITTONE: Seeing no other hands raised, Dr. Coggins, you can resume what you were saying before.
DR. COGGINS: Thank you, Judge Vittone.
Good morning, ladies and gentlemen. I am Chris Coggins. I hold a Ph.D. from the University of Edinburgh in Scotland and I am a board certified toxicologist. I am a Principal Scientist in the Research and Development Department of the R.J. Reynolds Tobacco Company. I have performed and published toxicological evaluations with tobacco smoke since I received my doctorate in 1976.
My colleagues and I are here today to present data that will illustrate a number of serious shortcomings in OSHA's proposed rule as it relates to environmental tobacco smoke, ETS.
We hope that our information will help OSHA develop a better, more appropriate approach to ETS in the workplace.
As you will hear, Reynolds Tobacco believes that the proposed rule requires substantial modification. In particular, we do not believe there is any justification for treating ETS in a different manner from other indoor air components.
When we have completed our presentations, we will answer questions concerning them. I will be the moderator for the panel and I will direct the questions to the most appropriate panel member.
Now, let me introduce our panel.
Michael Ogden, who received his Ph.D. in analytical chemistry from Virginia Tech in 1985, will speak first. Dr. Ogden will present data on the actual amounts of ETS that are found in a number of different environments, including workplaces and homes. Dr. Ogden will show that non-smoker exposures to ETS are typically very much smaller than those cited in the proposed rule.
Next, Paul Nelson, who obtained his Ph.D. in analytical chemistry from Georgia Tech in 1987, will talk about the severe limitations in the use of nicotine and cotinine to precisely predict ETS exposure.
Then, Stephen Sears, on my left, who obtained his Ph.D. in theoretical chemistry from UNC at Chapel Hill in 1980, will review some of the problems in the OSHA risk assessments, problems that in the main have not yet been raised at these hearings.
Dr. Sears' presentation was co-written by Mr. Thomas Steichen, who obtained his Master's degree in statistics from the University of Kentucky in 1978. Mr. Steichen will also be on our panel to answer questions.
After that, Dr. Ogden will return to present data showing that misclassification affects the results in epidemiologic studies concerning ETS.
I will then analyze some animal inhalation studies. I will show that the studies used in the proposed rule are inappropriate and that more relevant studies were not given the attention they deserve.
Finally, Mr. Hoy Bohanon, who obtained his Bachelor's degree in mechanical engineering from Georgia Tech in 1974, will discuss engineering solutions as alternatives to a national smoking ban. Mr. Bohanon is a professional engineer.
Our presentations will demonstrate why from a scientific and technical point of view there is no justification for attempting to impose a zero exposure standard for ETS in the workplace and why proper ventilation under the general IAQ standard is the least costly, least intrusive and best way to deal with workplace ETS issues.
Now, Dr. Ogden will present data on the actual amounts of ETS that are found in a number of different environments, including workplaces and homes.
Dr. Ogden will be using the slide projector.
JUDGE VITTONE: Okay. Each of you has slides, as I understand it, which you will be using.
DR. COGGINS: That's correct.
JUDGE VITTONE: I have been provided with copies of your presentation as well as copies of the slides.
With the completion of each witness I will identify by exhibit number his presentation and slides for the record.
It is also my understanding that there are copies of your statements and slides available in the back, outside the hall here?
DR. COGGINS: That's correct.
JUDGE VITTONE: Okay. So they are on the table back there for anybody who may want to see them.
DR. COGGINS: Correct.
JUDGE VITTONE: Thank you very much.
We will proceed with Dr. Ogden if you are ready, sir.
Are you going to be using the slides right away, Doctor?
DR. OGDEN: Yes.
JUDGE VITTONE: Let me move out of your way.
(Pause)
DR. OGDEN: Thank you, Dr. Coggins, Your Honor.
Good morning. I am Dr. Michael Ogden. I hold a Bachelor of Science degrees in both chemistry and applied mathematics and a Ph.D. in analytical chemistry.
Since 1985, I have been employed by R.J. Reynolds Tobacco Company in the Research and Development Department. For the past nine years, my research has been almost exclusively focused on studying environmental tobacco smoke by developing and applying methods for assessing ETS exposure.
My testimony will address the treatment of exposure to ETS in the Notice of Proposed Rulemaking and comments made by OSHA consultants.
In slide 1, I pose five questions. They are:
(1) How should we measure exposure to ETS?
(2) What is the correct definition of exposure?
(3) How much ETS is actually in the workplace?
(4) How does ETS exposure compare for living with smokers and working with smokers?
(5) How many workers are actually exposed in their workplace?
Significant new data relevant to each of these questions and, more specifically, to OSHA's assertions are also summarized and introduced at the appropriate places.
Before OSHA can regulate any workplace exposure, including ETS, it must demonstrate with substantial evidence that a significant risk of material impairment to health is present in the workplace.
In addition, OSHA has to know the answer to two very basic questions and these are how much ETS is in the air and how many workers are exposed. The NPR does not adequately answer either of these questions. As a result, the proposed workplace ETS rule is based on inadequate information.
In my testimony here today, I will demonstrate the following points as outlined in slide 2.
(1) Methodology for measuring exposure. OSHA has not measured ETS exposure in the workplace and has not considered the most up-to-date and relevant information on how to go about measuring the exposure.
(2) The definition of exposure. In much of the NPR, OSHA is apparently using an incorrect definition of exposure.
(3) The concentration of ETS in the workplace. OSHA doesn't know how much ETS is in the typical workplace. As I will demonstrate, typical exposure levels are up to 250 times lower than assumed by OSHA.
(4) Equating home and workplace exposures. In lieu of actually measuring exposure, OSHA attempts to equate workplace exposure for people who work with smokers with home exposure for people who live with smokers. Research shows that instead of these exposures being equal, the workplace exposures are actually five to 10 times lower than home exposures.
(5) The number of workers exposed. OSHA doesn't know how many workers are actually exposed to ETS at work. They have significantly overestimated the number of workers exposed.
The important point is this: Without the best available answers to any of these questions, there is only one logical outcome: OSHA's conclusions regarding ETS in the NPR are not meaningful.
I'll now turn to the first question I posed: How do we actually measure exposure to ETS? Quite simply, we can measure people's exposure to chemicals in the air that are attributable to ETS. These compounds are called markers. This is slide 3.
In May 1993, I presented to OSHA a summary of the commonly used ETS exposure markers. In that presentation, I concluded that two markers, 3-ethenylpyridine and solanesol, were the best available markers for the vapor phase and the particulate phase, respectively, of ETS.
Nicotine is a commonly used marker for ETS; however, it is inferior to both 3-ethenylpyridine and solanesol, particularly at low concentrations.
Recently, these conclusions regarding nicotine and 3-ethenylpyridine have been questioned by Dr. Katherine Hammond at these hearings. I would like to address her criticisms here but before I do I would like to present some additional background information that is relevant to support my qualifications to make these conclusions.
I developed and published the method for measuring nicotine in ETS that is referred to as the XAD-4 nicotine method. As outlined here in slide 4, this method is currently the most thoroughly tested, the most rigorously validated, and the most widely used method in the world.
I currently serve as Association of Official Analytical Chemists Associate Referee for studying nicotine in environmental tobacco smoke. This title is used to designate a technical expert charged with supervising method validation and providing statistical analysis of the results and writing the technical protocol.
This XAD-4 nicotine method has undergone two successful international collaborative studies. As shown in slide 5, it is an approved or official method of the following organizations: The Association of Official Analytical Chemists, the U.S. Environmental Protection Agency, and the American Society for Testing and Materials. Also, this method is currently a draft international standard within ISO, the International Standards Organization.
It is currently in use by researchers in at least eight countries. The analysis is also available in at least four commercial laboratories in the U.S. and one in Canada. This same method is also used for the determination of 3-ethenylpyridine in ETS.
Testifying on behalf of OSHA, Dr. Hammond correctly concluded that one of the most important attributes of a marker is that its concentration should increase with the source strength and reflect the concentration of the complex mixture, here, ETS. However, she incorrectly concluded that 3-ethenylpyridine fails this most fundamental test for a marker.
In her Figure 1, which I have reproduced here in slide 6, Dr. Hammond shows results from one experiment done by another researcher in which both nicotine and RSP increase more or less linearly with the number of cigarettes smoked. However, the data for 3-ethenylpyridine do not appear to increase in the same fashion. Not only is this result for 3-ethenylpyridine implausible, it is incorrect.
Shown here in slide 7 are the ETS vapor phase marker results from a similar experiment conducted at R.J. Reynolds. These data demonstrate two points.
First, 3-ethenylpyridine increases linearly with the number of cigarettes smoked. Second, 3-ethenylpyridine also tracks exactly the vapor phase of ETS, as measured by carbon monoxide and flame ionization detector response, which is an indication of the total volatile organic compounds present in ETS.
As you can see, although nicotine increases in a similar fashion, it actually overestimates the vapor phase of ETS. This overestimation becomes more predominant with increasing levels of smoke.
Myosmine also exhibits the same trend as nicotine, although to a lesser extent.
Dr. Hammond levies an additional criticism against 3-ethenylpyridine. She claims that 3-ethenylpyridine is not as sensitive a marker as nicotine in detecting ETS. This also is not true.
In 1992, we published limits of detection for both nicotine and 3-ethenylpyridine showing that the that 3-ethenylpyridine is actually twice as easy to detect as nicotine.
Slide 8 shows the ETS particulate phase marker results from the same experiment at RJR. As for the vapor phase components, all markers increase linearly with increasing concentration. However, all particulate phase markers track each other very well. This is to be expected in this controlled experiment where all RSP comes from ETS.
In addressing how to go about measuring ETS exposure, the NPR concludes that the use of an internal measure of individual exposure such as body fluid cotinine is preferable to actually measuring external exposure. I disagree with this statement.
While an internal measure may be well suited to some experiments in the workplace, it is certainly not true with regard to ETS.
First of all, of the potential biomarkers currently available for estimating exposure to ETS, cotinine is the only one that is even marginally useful.
Of all biomarkers that have been proposed, cotinine is the most tobacco-specific. Also, cotinine has a half-life of approximately 17 hours, although it certainly can vary over a much wider range. This was discussed in more detail previously by Dr. Neil Benowitz.
This half-life is the amount of time it takes for half of any nicotine inhaled to be eliminated from the body as cotinine. This means that at best cotinine provides an integrated estimate of exposure over the preceding one to three days.
However, in the context of measuring workplace ETS exposure, cotinine is not to be preferred over air monitoring. There are several reasons for this, however, I will explain only one of them here in slide 9.
A significant problem with the use of cotinine for workplace exposure assessment is this same relatively long half-life that I just mentioned. By relatively long half-life, I now mean relative to the continuous amount of time spent at work.
The continuous amount of time spent in the workplace for most workers is only about eight hours. This continuous amount of time would even be less for workers who may leave their workspace to run errands, go out to eat, et cetera.
In order to use cotinine or any other biomarker with a similar half-life to infer anything about exposure at work requires the implicit assumption that all out-of-workplace exposures are the same for everyone.
This is, of course, an illogical assumption. An individual's body fluid levels of cotinine cannot distinguish between nicotine inhaled at work, at lunch, at home or anywhere else.
I would like to cite one specific example from my own research that illustrates how relying solely on cotinine levels would have resulted in a serious error concerning potential workplace exposures.
This study, outlined in slide 10, was conducted in Columbus, Ohio in 1991. The results were presented to OSHA in May 1993, and were published later that year.
Among all non-smoking subjects who were exposed to ETS at home, a statistically significant difference in cotinine levels was found between those who worked outside the home and those who did not work outside the home. In short, the subjects who were spousal-exposed to ETS at home and who also worked outside the home had higher cotinine levels than subjects who were spousally exposed at home and who did not work outside the home.
If I had relied solely on cotinine data, I would have attributed this increased cotinine to ETS exposure at work. However, I would have been wrong.
Air monitoring in the homes revealed higher concentrations of nicotine and 3-ethenylpyridine in the home of the working subject. Thus, the difference in cotinine was truly attributable to a difference in home exposure and was not due to a workplace effect.
Personal monitoring of workers going about their daily activities in their workplace is a much better way to determine actual exposure.
I would like to offer this specific advice to OSHA: If you want to know what exposure is in the workplace, measure it.
With readily available materials and methods, a number of informative constituents of ETS can be measured, including 3-ethenylpyridine, solanesol and even nicotine.
From the quote in slide 11, you can see that Meridian Research reached the same conclusion regarding ETS exposure in the workplace. This was in a 1988 report which was commissioned by OSHA.
Moving to my next point in slide 12, now let's examine the proper definition of exposure and contrast that to what was actually used in the NPR.
Since it is critical in evaluating the merits of this entire section of the NPR, the correct definition of exposure must first be given.
Exposure can correctly be defined simply as being equal to concentration times time. This equation defining exposure is explicit in that exposure in any given environment is equally dependent upon both the time spent in that environment and the concentration level of the contaminant in that environment. Without assessment of both variables, exposure cannot be determined.
Let me illustrate with a simple analogy. Remember that exposure is equally dependent on two variables, time and concentration. Similarly, the distance you drive in your car is dependent on two variables, the amount of time you spend in your car and the average speed of the car.
Imagine if you will trying to estimate how far I drove yesterday if all I tell you is that I spent an hour and a half in my car.
If I were at home in North Carolina yesterday in the middle of the afternoon, I could have driven all the way from Winston-Salem to Durham, a distance of about 75 miles. If I were here in Washington yesterday during rush hour, I might not have made it the four miles or so to the Key Bridge.
The treatment of ETS exposure among the non-smoking, working U.S. population in the NPR is superficial and extremely problematic. In fact, OSHA consistently uses an incorrect definition of exposure in the NPR in sections which focus only on duration.
OSHA employs comparisons of reported durations of ETS exposure between homes and workplaces where smoking occurs.
The data sources on which OSHA relies, such as the CAP survey, only yield estimates of potential exposure. The vast majority of information cited in this section of the NPR contains no measurements of workplace exposure whatsoever, an omission that most seriously limits the development of a workplace risk assessment.
Compounding the problem of using an incorrect definition, OSHA also has improperly analyzed many of the studies on which it does rely.
For example, in the NPR's treatment of the California Activity Pattern, or CAP, survey, this contains a number of errors and misinterpretations. I'll cite just one example from the CAP survey.
The NPR claims the CAP study shows that 51 percent of male and 38 percent of female non-smokers reported ETS exposure at work and further claims that this verifies the high percentage of non-smokers who are exposed to ETS while at work.
These figures actually represent the percentages of exposure time reported to occur at work for non-smokers who reported exposure to ETS at any location. These are not the percentages of the working populations exposed, as stated in the NPR.
Additional shortcomings of the CAP survey and OSHA's interpretation of it in the NPR are detailed in my written submission.
Similar problems occur in two other studies cited predominantly in the NPR, the studies of Cummings et al. and Emmons et al. In these two studies, the authors actually incorporated an analytical measure of ETS exposure in addition to subjective responses regarding potential exposure duration.
The NPR failed to cite the analytical data from either study and chose instead to rely entirely on potential exposure duration as an inappropriate surrogate for exposure. Additional details on these two studies will be provided later.
As I stated earlier, OSHA is obligated to determine how much smoke is actually in the workplace air before they can move to regulate it.
Moving now to my third point, let's see how OSHA went about determining this critical information.
In an attempt to establish the concentration of ETS in the workplace, OSHA has relied on a limited number of outdated, non-representative and extreme data sets. Proper consideration of recent, representative personal monitoring studies demonstrates that the NPR has overestimated typical worker exposures at least 10 to 100 times.
In the NPR, four studies are cited to support the conclusion that the average RSP level during smoking in smoking buildings was 262 micrograms per cubic meter while in non-smoking buildings the RSP levels averaged 36 micrograms per cubic meter. This is slide 13.
Of the four citations given in support, one is obviously an incorrect citation and cannot be verified. The other three include a report by First and two from Repace and Lowery. These three studies describe RSP measurements made with a portable piezobalance over a decade ago.
There are four reasons why this is important. These are outlined in slide 14.
First, without getting into too much technical detail about this measurement device, suffice it to say that the portable piezobalance is most often used for short-term measurements. This is because it requires substantial maintenance between measurements to keep it operating adequately.
Accordingly, the levels reported are in general short-term, peak concentrations, not long-term, time averaged concentrations, the latter of which is needed to truly characterize exposure. For example, Repace and Lower report most sampling times are only 10 to 20 minutes.
Second, the suitability of this type of measurement device has been questioned by First, one of the authors cited for the measurements. In his opinion, First says, and I quote, "This apparatus was not designed for this type of service and lacks the sensitivity and precision needed to sense the small incremental concentrations attributable to tobacco smoking in public places."
Third, the portable piezobalance is meant to measure area concentrations, not personal exposures of people going about their normal activities.
And, fourth, it is readily apparent that typical smoking behavior in public in the 1990s is much different from smoking behavior when these measurements were taken in the late 1970s and early 1980s.
While measurements of the magnitude reported in these studies are possible, they are far from being typical, at least in the 1990s. These extreme values need to be viewed in the context in which they were generated and also compared to modern day, realistic RSP concentrations in workplaces with and without smokers.
In contrast to these area monitoring values cited in the NPR, I presented in my written submission the personal monitoring results from two r