OSHA: Proposed Standard For Indoor Air Quality: ETS Hearings, January 24, 1995

OSHA: Proposed Standard For Indoor Air Quality: ETS Hearings, January 24, 1995


UNITED STATES DEPARTMENT OF LABOR

OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION

PUBLIC HEARING
PROPOSED STANDARD FOR INDOOR AIR QUALITY

Tuesday, January 24, 1995

Department of Labor

Washington, D.C.

The above-entitled matter came on for hearing, pursuant to notice, at 9:50 a.m.

BEFORE: HONORABLE JOHN VITTONE

Administrative Law Judge

AGENDA

PAGE

Systems Applications International
Stanley Greenfield 12667

Questions?

Ms. Sherman 12689
Mr. O'Neil 12727
Ms. Sherman 12729
Judge Vittone 12730

AIHA
John Tiffany 12736

Questions:

Ms. Kaplan 12745
Clausen Ely 12797
Ms. Janes 12814

EXHIBITS

EXHIBIT NO. IDENTIFIED RECEIVED

253 12727 12727

255 12815 12815

P R O C E E D I N G S
9:50 a.m.

JUDGE VITTONE: We resume our hearings into the proposed rule on indoor air quality by the Occupational Safety and Health Administration. We have two witnesses scheduled for today.

Our first witness is Dr. Stanley Greenfield.

Dr. Greenfield, welcome. I would like to ask you to state your complete name for the record and also the name of your organization.

DR. GREENFIELD: My name is Stanley Marshall Greenfield and I am Senior Vice President of Systems Applications International in San Rafael, California.

JUDGE VITTONE: Okay. And you can make your presentation now, sir.

DR. GREENFIELD: Thank you, Your Honor.

As I said, my name is Stanley Greenfield and I am Senior Vice President of Systems Applications International, San Rafael, California. This company, this group, is a division of ICF Kaiser Engineers, Inc.

I received my Ph.D. in meteorology and physics from the University of California at Los Angeles. Over the past 44 years, I have been an active worker in the fields of atmospheric and environmental sciences. The first 20 years of my career were spent at the Rand Corporation and, as you probably know, the Rand Corporation was the first think tank in the country and was instrumental in development of areas like systems analysis. The last seven of my years at Rand Corporation were as head of the Department of Environmental Sciences.

From 1970 to '74, I was Assistant Administrator of the Environmental Protection Agency and head of the Office of Research and Development. One of my primary responsibilities as head of ORD was to overview the technical credibility of the material used in the development of standards within the agency.

Over the last 14 years, I have been with Systems Applications, first as president of Systems Applications, Inc. and after the merger with ICF Kaiser, as Senior Vice President of the Division.

Areas in which I work and have an active interest include environmental modeling, exposure and risk assessment, analysis of regulatory requirements and indoor air pollution.

I am the author or co-author of some 48 peer reviewed papers and I am submitting my full resume for the record.

I appear here today on behalf Shook, Hardy & Bacon who represent Philip Morris Company. It should be noted that while I appear on their behalf, the testimony I am about to give was prepared and written entirely by me and members of my group at Systems Applications.

An ever-increasing awareness has developed over the last several years as to the fact that consideration must be given to the total exposure of the population to toxic pollutants. That is to say it is not sufficient to consider just the concentration of various substances in the ambient environment, that is, outdoors, but one must also take into account the exposure experienced by the population as they spend the majority of any 24-hour period in an indoor environment.

It is for this reason that we applaud the efforts of OSHA to attempt to limit the exposure of workers to the many toxic substances that can be found in a host of non-industrial settings that exist.

OSHA, recognizing the almost overwhelming combinations and permutations of indoor and outdoor sources, populations and site characterizations, both indoor and ambient, has wisely chosen to address the regulatory problem from the standpoint of a general set of requirements directed at the establishment and maintenance of an adequate ventilation system for the workplace.

In proposing these general rules, however, it is imperative that the analysis that OSHA has carried out to arrive at their position carries sufficient scientific credibility and certainty as to support their position.

In addition, a credible methodology must be available to allow the operators of a specific site to determine in a credible fashion whether their system meets the requirements for their set of conditions, that is, building type, ventilation system, distribution of external and internal sources, et cetera.

It is to the end of assisting in this credibility and hence the defensibility of OSHA's proposed rule that we direct our comments.

The nature of comments reflects the capabilities and experience of the interdisciplinary staff of SAI and the active professional involvement of the company for over 20 years in the very technical fields of air pollution.

During this period, we have been deeply involved in the development and application of many of the analytical tools used to address the complex questions that are raised when one attempts to establish a process designed to protect the population from the health impacts of airborne contaminants.

Starting in 1982, we extended our efforts to include the indoor environment, essentially addressing the question of total human exposure.

During the entire period of our involvement with complex ambient air pollution problems, we have been impressed by the requirement that we establish the credibility of our analyses and the defensibility of the derived strategies.

The need to evaluate our models determined their precision and the degree of uncertainty carried into the analysis and determined the statistical validity, accuracy and applicability of the database utilized are all factors in the development and acceptance of ambient air pollution control strategies.

Each region, each urban area or subarea represents a new challenge with its unique set of problems and characteristics and while general control options have been established, control strategies appropriate to the specific problem area must be designed and defended.

In contrast to the ambient air pollution problem, we find that to date attempts to address the mitigation of exposure to air pollution in the indoor environment is characterized by our frustrating lack of appropriate data, information and adequate analytical tools.

In part, this may be a result of the many years of inadequate regulatory attention being paid to the indoor environment other than that associated with the occupational setting.

Regardless of the reason, however, it is clear that:

(1) The number of potentially significantly different indoor environments is very large, where the differences are characterized by source and sink distributions in time and space, building characteristics, ventilation, population dynamics, et cetera.

(2) The data are not available that would allow us to better define these indoor environments to date and determine such factors as the correlation between sources, sinks, ventilation and concentration, chemical and physical interactions, secondary pollutants, re-suspension and remission, et cetera.

(3) The current databases and models are severely limited and normally have been collected or developed for very restrictive set of conditions that make them not generally useful; and

(4) Little or no attempt has yet been made to evaluate indoor models and databases, determine uncertainty and provide guidance to those who wish to use these analytical tools that result.

Indoor exposures result from the temporal and spatial variations of indoor sources and sinks, chemical transformation, population dynamics and a background concentration of various pollutants that have a direct or indirect relationship to the outdoor ambient air quality.

Indoor temporal and spatial variations are such that more than simple averages over these variables produced by the simpler models are needed in many situations. Thus, more complex models may be required to express indoor exposures effectively and hence assist in the design of cost effective and cost beneficial building control systems.

This need to portray the indoor environment more accurately will demand better databases and models, the ability to assess model capabilities and database accuracy will ultimately determine the effectiveness of the analytical tools we create.

A key to choosing the best model for an application is an understanding of how it addresses various parameters relevant to the application. It appears possible to construct a set of general parameters or attributes which would permit one to ask how any model that is planned to be used addresses the parameters relevant to any specific application.

An obvious but often overlooked first step in choosing the correct model for a given application is to identify whether the output is consistent with the application and, if not, whether it can be converted to the desired type without undue effort, increased uncertainty or loss of precision.

If the model output is to be linked with an exposure model, it should consist of a time series of concentrations with the time steps consistent with the averaging time of interest to the exposure model.

The way in which models address airflow and building parameters is also a crucial consideration when choosing an analytical tool or the less experienced users are often not aware of the sensitivity of indoor pollutant concentrations to these factors.

Airflow parameters such as the number of air changes per hour and building parameters which control airflow characteristics such as the numbers of doors and windows, the type of HVAC system and the simple size of the room are very significant.

For example, if a room or building were of infinite size, any emission rate would still result in essentially zero concentration.

Conversely, if a room had nearly zero air exchanges, even a very low emission rate would ultimately result in high concentrations.

It should be pointed out that even these seemingly intuitive non-controversial statements that depend on the widely accepted assumption that emitted material is immediately distributed throughout the room space must be modified and face the recent experimental data which indicates that a gradient of concentration exists as long as the source is operating.

In essence, then, the old assumption that once you emit something into a closed space it immediately fills that space is a wrong assumption.

Before choosing a model for an application, one must evaluate the manner in which these parameters are treated and their ability to represent the conditions being modeled. For example, buildings which are not equipped with air conditioners may have wide open windows and doors during the summer. The resulting air exchanges, generally greater than 10 per hour, is far higher than that experienced with closed windows and doors with an operating HVAC system which is putting out generally about one to three air exchanges per hour.

Under the condition of open windows, however, the occupants are subjected to greater exposure to whatever pollutants are present in the ambient environment. It is clear, then, that when modeling summer or annual average conditions a model which is not equipped to handle varying building conditions is not likely to be appropriate for the application.

When evaluating a model's treatment of airflow and building parameters, issues such as the degree of generalization to the building stock of the geographic area being studied can be very important.

This need to understand quantitatively the inherent accuracy of our analytical tool is particularly relevant when applied to the problem of determining the indoor control requirement designed to avoid the risk of health impacts.

Given a quantitative understanding of the uncertainty of the analytical results provided, in principal it is possible for a designer to specify the level of control in a manner which will probabilistically assure that the desired reduction in risk is achieved.

In actual fact, however, one cannot simply increase the degree of control to accommodate the uncertainty in the design approach utilized if its magnitude is such that it spans several levels of risk for which solutions of significantly different economic and/or social consequences are required.

It is imperative, then, that if the designers understand to the extent possible the nature and relative effectiveness of the tools available and the accuracy with which they can be applied to the specific problem. In this manner the designer would in principle be provided with the best analysis currently feasible in the supplementary information that could permit it to be most effectively utilized.

Current data for human exposures consist of several detailed data sets collected for purposes other than pollution exposure and specific population activities as collected by the California Air Resources Board for chemical exposures.

The CARB data set is based, as are the other sets which are less comprehensive, on daily dairy data. That is, individuals were asked to recall exactly where they were for each hour of the day, along with their activities during that period and any "exposures" that may have been present. Though far from perfect, it is the only large population specifically designed for exposure studies.

There are few population exposure models with indoor components available. Typical of these models are NEM, which is the National Exposure Model of EPA, SHAPE and REHEX, all of which suffer some limitation.

SAI is currently under contract to the U.S. EPA to improve the NEM risk model using a national database for all of the chemicals covered by the Clean Air Act.

Our group at SAI recently had a peer reviewed paper published in Environmental Science & Technology entitled "Modeling the Indoor Environment". In that paper, we addressed the question of model uncertainty, model attributes and applicability for a specific set of models, including those I've just mentioned, that are well known in the indoor air area.

This paper also briefly considers the characteristics and limitations of some of the recent attempts to develop population activity databases. A reprint of this paper is included with the submitted written comments.

Included as Appendix B of this set of comments is a second paper prepared by our group entitled "Indoor Air Quality Data Requirements, Availability and Utility". This paper was presented at the EPA AWMA international symposium entitled "Measurement of Toxic and Related Air Pollutants" which was held in Durham, North Carolina in May of 1991.

Both of these papers expand on the current difficulties attendant to analyzing effective approaches to indoor air quality.

In conclusion, then, for this section of my presentation, these few comments are not meant as a criticism of OSHA's attempt to regulate occupational exposure to indoor air constituents. Rather, it is intended to bring to OSHA's attention the current weaknesses in our ability to generalize in the indoor arena and to analyze quantitatively the effectiveness and appropriateness of specific protective strategies for specific sets of conditions.

Now, I would like to also read into the record, Your Honor, since we provided another set of comments somewhat earlier, I specifically pointed towards ETS but I would like to read a small summary of those comments before we proceed with the questions.

JUDGE VITTONE: Okay.

DR. GREENFIELD: The comments submitted on 12 August 1994 of which what I am reading now is a summary, are based on an examination of the OSHA proposed rulemaking for indoor air quality docket number H-122 as contained in the Federal Register Volume 59, No. 65.

Specifically, we have examined the rulemaking from the standpoint of the supportability of the manner in which OSHA proposes to treat environmental tobacco smoke as compared to other indoor air quality constituents of concern that appear regularly in a non-industrial work environment.

In attempting to cope with indoor pollution in the occupational setting, it must be recognized that one is faced with:

(a) Complex settings of normally multiple interconnected spaces,

(b) Complex sets of sources, many of which are not well understood or characterized,

(c) Unspecified pollutant sinks that are not the same for each setting,

(d) Complex distributions of concentrations due to emitting sources even when the room air is thought to be well mixed,

(e) Complex mixes of potential human receptors who move through their settings in a random manner; and

(f) A general uncertainty and sufficient lack of adequate supporting data such that it is inevitable that serious questions will be raised with regard to any attempt to establish a sense of the population exposure to any given pollutant and hence its health impact.

This lack of sufficient information to enable one to properly characterize indoor pollution and hence indoor air quality is no more clearly demonstrated than when one attempts to model the indoor environment in a manner that approaches reality.

Models are at best approximations to the real world but are useful analytical tools if one has a quantitative sense of how representative they are.

In a paper that I cited in the first part of my presentation, namely "Modeling Air Quality and Human Exposure in the Indoor Environment," I would like to quote a short piece from it because in it we pointed out, "However, despite the progress to date, model inputs, data, source emissions, sinks, distributions, population activity patterns, are shown to be limited and restricted. Collateral information that would permit a degree of generalization is lacking. Evaluation of models and input data with regard to uncertainty, limitations and other comparative attributes is not currently adequate and relationships between airflow, ventilation, filtration and streamlining, et cetera, sources and sinks, concentration and exposure have not been established."

It is precisely the degree of knowledge of these parameters, attributes and factors that ultimately determine the design, defensibility and potential effectiveness of regulations developed to protect the population in a complex indoor environment.

Faced with this relatively deplorable situation with regard to the availability of good data on indoor air pollutant sources, sinks and concentrations, it is very difficult to establish defensible protective regulations and procedures.

For example, what concentrations of what pollutants from what sources under what physical indoor conditions, i.e., climate, building design, distributed population, activity, et cetera, are we to use to develop and implement a regulation or rule designed to prevent people from receiving a stipulated harmful exposure?

In view of the dilemma outlined about, it is understandable as to why OSHA has chosen in the case of IAQ the proposed approach based on ventilation requirements for the indoor workspace and not be specific with regard to limiting the concentrations of various pollutants.

Our concern, however, is not with the approach proposed by OSHA but rather with the reasoning that results in a deviation from this sensible approach.

Of particular interest is the analytical basis for singling out a specific source or pollutant for treatment significantly different than that required of other pollutants that fall under the indoor air quality definition utilized by OSHA for this proposed rulemaking. Special treatment of a single pollutant or a single source unfortunately raises questions that must be answered as to whether it is so unique in terms of the risk it poses to the health of workers that it requires separate consideration or, conversely, does it represent an attempt to implement another agenda through the expediency of more strongly regulating a specific source or pollutant category.

In either case, it detracts from the benefits that accrue through a consistent, well-ordered implementable policy and process. In the former case, it forces the sponsoring agency to effectively defend its actions or have its credibility brought into question. In the latter case, it raises serious concerns as to whether this is the proper use of the regulatory process.

Our specific concern in this regard is the defensibility of that segment of the proposed rulemaking which would treat environmental tobacco smoke in a manner different than the other recognized components of the indoor workplace air environment.

Without attempting to pre-judge whether the decision treat ETS separately has supportable scientific merit or simply represents a response to some form of pressure, we have attempted in this paper to present the results of our examination of the technical supportability of the proposal.

To this end, we have examined the chemical makeup of ETS as reported by OSHA in the Federal Register document and looked at the overlap of these materials with IAQ constituents that appear in indoor environments from non-ETS sources. In considering the indoor work environments, we have looked both at sources of these chemical components within the sites that fall specifically under the OSHA definition of this proposed rule, as well as industrial sources that contribute these components to the ambient environment.

In the latter case, the reasoning is that due to the very nature of businesses and the makeup of many of urban settings, what would be defined as a non-industrial workplace, offices, et cetera, are frequently found to be co-located or located in the vicinity of industrial sources such as those listed in Table 2 of our full comments. In essence, then, the workplaces, unless they contain special filtering equipment for all of their intake air, can have their indoor environment contaminated with many of the chemicals considered by OSHA as hazardous components of ETS.

As might be expected, there is considerable overlap between chemical components of ETS and chemical substances that normally arise from the operation of a work environment. When one adds the similar chemical materials that enter the work environment from external sources, it is clear that it becomes exceedingly difficult to determine the contribution of each specific source to the total exposure of an individual.

In view of that fact, one is forced to ask how a decision is made that ETS which produces an intermittent small exposure should receive special treatment when many of the other sources emit throughout the workplace.

For example, studies of offices, restaurants, train compartments and public buildings suggest that ETS contributes to the indoor air burden of volatile organic compounds but that other sources predominate.

In a recent study of residential environments by Ozkaynak of Harvard School of Public Health and his colleagues, they found that smoking contributes 20 to 40 percent of the total concentrations of polycyclic aromatic hydrocarbons, implying that 60 to 80 percent of what was presumed to be ETS chemicals actually came from other unidentified sources.

A survey by Shelton and his colleagues of VOCs in 16 various indoor environments detected over 200 individual chemicals or groups of chemicals. Only a small number of chemicals were detected with high frequency, about 11. One of the indoor environments in the study was a residential home for the elderly with a smoking resident. Some VOCs that were found in the smoking resident were not detected in other environments surveyed but they tended to be constituents detected with low frequency and were not considered major constituents of cigarette smoke.

It appears clear that if OSHA desires to regulate ETS separately from other impactors on air quality, they must first develop methodologies for separating out and quantifying the ETS contribution to the exposure of workers to these chemicals of concern. Only in this manner can they arrive at a credible, supportable decision.

In a similar fashion, an examination was made of the ETS risk assessment carried out by OSHA and reported in the proposed rulemaking. No attempt was made to look in-depth at the supporting health data and I should mention that what we have submitted as comments is by a team in my group and that team consists primarily of physicists, chemists, biochemists, statisticians, computer scientists, meteorologists and what have you, not health people. What was examined was the question of uncertainty and the assumptions made by OSHA.

There was not adequate discussion of the epidemiological or statistical issues involved in the study selection process of OSHA or later in their section on risk assessment to support their conclusion that "The relative risk of lung cancer in non-smokers due to chronic exposure to ETS ranges between 1.2 and 1.5 and the relative risk of heart disease due to ETS exposure ranges between 1.24 and 3."

Once again, what I'm saying here is that not that we have looked at the epidemiological studies but rather that the data presented or the position presented by OSHA in their document was not adequate for us to conclude what OSHA concluded.

The relative risk values obtained from each of the 32 studies were not listed in OSHA's decision tables in Section 4. All risk assessments require that some assumptions and inferences be made because of lack of direct evidence. In the absence of clear scientific evidence, a public health agency must make many conservative assumptions that presumably would be least likely to underestimate human risk. That's what we did at EPA, that's what is still done at EPA and certainly OSHA must do the same.

Depending on the scope of the risk assessment, however, these uncertainties and assumptions should at least be addressed in a qualitative discussion of the professional judgments involved.

Additionally, uncertainty may be quantified to an appropriate degree by presenting risk as a range of estimates under varying conditions or by subjecting the estimates to analytical techniques such as sensitivity analysis.

In summary, OSHA's risk assessment, like all regulatory risk assessments, should be based on the data the agency has available. And we recognize some data may have to be inferred or extrapolated in order to develop the quantitative risk descriptors. But the risk assessment in OSHA's proposed rule appears to be based on sometimes unclear methodology and many unacknowledged assumptions. And once again all I can go on, all we can go on, is what was actually published in the rule.

The issues of uncertainty and risk estimate were not addressed in the final risk characterization, even in a qualitative sense. In the introduction to Section 4, the risk assessment, OSHA acknowledges there is uncertainty associated with the quantification of any kind of risk and states their intentions by describing many of the sources of uncertainty and to addressing their implications to OSHA's estimates of risk.

However, the only discussion of uncertainty appeared in the section on pharmacokinetics, the pharmacokinetics modeling of ETS exposure which appeared after the quantitative risk descriptors above were developed. The topic of pharmacokinetics modeling was presented as a request for future comment and had no apparent bearing on the qualitative risk assessment actually presented as a basis for the proposed rule.

ETS can be a major annoyance to the non-smoker and it has been associated in the literature with various health effects as well. A public agency charged with protecting some aspect of the public health must be conservative in its estimates of health risks. However, given the small magnitude of the relative risks involved, which I am not going to discuss here, and other uncertainties, the quantitative risk assessments of ETS such as EPA's 1992 document and the assessment contained in OSHA's proposed rule appear to be somewhat premature.

Both agencies are under considerable public pressure through Congress, through legal actions and other sources to make science policy decisions, prematurely regarding ETS, without enough regard for the uncertainties and assumptions which are inevitably part of the risk assessment in the interest of public health.

It is clear that better data are required to accomplish this. Based on our examination as summarized here of the OSHA proposed IAQ rule, we find that:

(a) ETS is not the only source of many of the constituents of concern found in the workplace;

(b) What information does exist indicates at best for some constituents ETS is a minor contributor to integrated exposure; and

(c) Considerable uncertainty exists in the attempts that have been made to date to conduct a risk assessment of ETS.

Based on our findings, it is our considered opinion that there is not credible support currently for treating ETS any differently than the entire mix of IAQ constituents that impact the quality of the non-industrial or industrial indoor air environment.

Thank you, Your Honor.

JUDGE VITTONE: Thank you, Dr. Greenfield.

Ms. Sherman?

MS. SHERMAN: Dr. Greenfield, how is Systems Applications International related to ICF Kaiser?

DR. GREENFIELD: We're a division of ICF Kaiser Engineers.

MS. SHERMAN: And ICF Kaiser Engineers somehow relates --

DR. GREENFIELD: Is a wholly-owned subsidiary of ICF Kaiser.

MS. SHERMAN: And how does that relate to the Kaiser we know that's involved in health care?

DR. GREENFIELD: Oh, that's Kaiser Permanente.

MS. SHERMAN: No relationship?

DR. GREENFIELD: No relationship. You've got to remember that Henry Kaiser back in the '40s created a whole set of companies, very few of which are related today.

JUDGE VITTONE: At one time they were, though.

DR. GREENFIELD: At one time they were, that's correct.

JUDGE VITTONE: They've all broken apart.

DR. GREENFIELD: Yes.

MS. SHERMAN: So at one time, you were cousins at least?

DR. GREENFIELD: Not we.

MS. SHERMAN: Okay. Have you ever published any original research on environmental tobacco smoke in the peer reviewed scientific literature?

DR. GREENFIELD: No.

MS. SHERMAN: Throughout these hearings we've heard a variety of comments about mixing, et cetera, and we've heard the term sinks used. It's been defined in different ways. How would you define it?

DR. GREENFIELD: I would define a sink in any environment, be it indoor or outdoor, as that which removes constituents or pollutants or material from the environment that you're dealing with. In other words, if I'm in an indoor environment and I'm concerned with concentrations in that indoor environment in the air, that which removes those constituents from the air constitutes a sink.

MS. SHERMAN: Well, what components of environmental tobacco smoke might go into the sink?

DR. GREENFIELD: Any of the components, for example, respirable particulate, because of their normal fall rate or their diffusion to walls or other areas in the indoor environment, can be picked up, can be adsorbed onto those surfaces and at least temporarily, sometimes permanently, removed from the air environment. Now, that also includes gaseous materials that can adsorb onto surfaces as well.

When you talk about sinks you have to also talk about sources because material that is picked up by a sink can also then turn around and be re-suspended or re-emitted and so that sink becomes a source.

MS. SHERMAN: Is there any way that you can predict whether it will become a source?

DR. GREENFIELD: Well, there's a paper that my group recently presented at an AWMA conference that tried to deal with that and looked at, for example, what the effect of changes in temperature might be which volatilizes material and puts it back into the environment, what is the transformation of material once it hits a sink and then may be re-released again. If I have material that lands on carpet, for example, a simple thing, and I scuff my feet over that carpet I can re-suspend the material in the air.

MS. SHERMAN: Now, you said you recently prepared a paper on this?

DR. GREENFIELD: There's a paper that we have, yes. Which I can make available to you, if you would like.

MS. SHERMAN: Would you be wiling to make it available to us?

DR. GREENFIELD: Of course.

MS. SHERMAN: Okay. Thank you. Now, was this a paper prepared for a seminar or symposium or was this --

DR. GREENFIELD: At one of the professional society meetings.

MS. SHERMAN: I see. I think in your submission you asserted that Repace and Lowery's 1993 paper on an enforceable IAQ standard for ETS claimed a validation of their ETS exposure assessment by three epidemiological studies. Could you point out the paragraph in this paper in which you feel this claim is made?

DR. GREENFIELD: Could you repeat that question?

MS. SHERMAN: Yes. In your submission, I believe it's on page A-4, you asserted that Repace and Lowery's 1993 paper on an enforceable IAQ standard for ETS claimed a validation of their ETS exposure assessment by three epidemiological studies.

DR. GREENFIELD: Can I tell you what page it's on? I don't have the paper with me so I can't do that. When I get back I'll be happy to let you know.

MS. SHERMAN: Certainly.

DR. GREENFIELD: Okay.

MS. SHERMAN: Or you could send me the page highlighted.

DR. GREENFIELD: Sure. I'd be happy to do that.

MS. SHERMAN: I think on page A-7 of your submission you criticize Repace and Lowery's assumption of an average 10-to-1 ratio between RSP and nicotine and that, I think, is in their 1993 paper. In your criticism you stated that a regression analysis relating RSP to nicotine is published by Leaderer and Hammond in 1991 and assumes that a background for RSP is the same for all the residences. Isn't it a fact that this is an inference of yours and that there is no place in this paper where such an assumption is made?

DR. GREENFIELD: No, it's not a question of whether or not the assumption is made in the paper, it's that to arrive at the conclusions that Repace and Lowery did of a single number which represents the ratio of RSP to nicotine, they have to assume a constant background. Otherwise, the argument begins to fall apart.

MS. SHERMAN: Well, isn't it a fact that the result of the regression analysis produces an average value for the background in all residences and does not assume that the background level in all residences is the same?

DR. GREENFIELD: If you came out, if you could that you indeed had a constant 10-to-1 value, I would agree with that. But we have enough data now, and I happened to be here last week when Coggins and the people from RJR were here and they presented a significant amount of information that showed that this is not a constant ratio by any stretch of the imagination and a lot of the problem associated with the assumption of a constant ratio is contained in what the background values are. The background varies considerably in terms of the non-ETS particulate material and it's not a question of averaging it over time. It's a question of going from site to site and set of conditions to set of conditions. You certainly don't have an average, constant background of RSP.

MS. SHERMAN: Are you familiar with the report prepared for the California Air Resources Board called "Toxic Volatile Organic Compounds in Environmental Tobacco Smoke, Emission Factors for Modeling Exposures of California Populations"? I believe it's October 31, 1994.

DR. GREENFIELD: I don't have it in front of me and I haven't seen it.

MS. SHERMAN: Would you like to look at a copy of it?

DR. GREENFIELD: I would be happy to look at it.

MS. SHERMAN: Judge?

(Pause)

DR. GREENFIELD: Thank you, Your Honor.

This is Joan Daisy's report. Yes. I have not read this report.

MS. SHERMAN: Would it surprise you to know that the Leaderer and Hammond study was explicitly reviewed by the Indoor Environment Program of the Lawrence Berkeley Laboratory in that report I gave you and was found to be useful together with other studies showing similar results for relating ETS RSP to ETS nicotine?

DR. GREENFIELD: Oh, I would not at all be surprised, if it were not reviewed and not found to be useful.

MS. SHERMAN: But you wouldn't agree with this.

DR. GREENFIELD: No. That's not the question. One of the points that we really -- and I should point out that this was done by my statistician was that when you look at the three outlyers in that report, if you remove those three outlyers, the largest values, then the correlation coefficient drops from .78 down to .3. And so it's not a question of whether these are useful data, it's a question of whether you can use them effectively to do what Repace and Lowery said.

MS. SHERMAN: Well, is your knowledge of ETS, RSP and nicotine from RJR's testimony? Or is it from a literature review?

DR. GREENFIELD: Well, the comments that we gave you were based on my team's literature review.

MS. SHERMAN: I see.

DR. GREENFIELD: We had no contact with RJR.

MS. SHERMAN: Well, except that their comments, of course, are a matter of public record.

DR. GREENFIELD: And the first time I saw them was this past week.

MS. SHERMAN: I believe that in your submission you stated that Leaderer and Hammond in their 1991 paper might have placed their RSP and nicotine monitors in such a matter that inhomogeneous distributions of RSP and nicotine might have resulted. Do you have any information that this was in fact the case?

DR. GREENFIELD: No.

MS. SHERMAN: So that it's just sort of speculation on your part?

DR. GREENFIELD: Yes. It's speculation. In a set of comments like this we're saying, look, why might have the data appeared the way it did and we certainly don't have information that says that's where they placed their monitors so we're just raising that as a possibility. Not that it has any bearing on it, really.

MS. SHERMAN: Well, also in your submission, I believe on page A-9, you stated that in Leaderer and Hammond's 1991 paper quadratic regression fits their RSP and nicotine data about 10 percent better than a linear regression.

DR. GREENFIELD: That's correct.

MS. SHERMAN: And that Repace and Lowery's assumption of linearity is therefore flawed.

DR. GREENFIELD: It is.

MS. SHERMAN: Isn't a 10 percent difference in such a fit relatively minor?

DR. GREENFIELD: Well, you can dismiss things like that very easily but we're talking about small numbers. We're talking about attempting to make decisions with small numbers where the question of uncertainty, the question of whether or not the chain of reasoning really applies, becomes an important question. And so that anything that goes to the question of how valid are the assumptions that are made, how valid is the analysis that has been done, is fair game for discussion, just like we're doing here. So if the statistical analysis done by my people says that a quadratic fit is better than linear, that's just another point in terms of asking the question as to whether or not this is a valid analysis.

MS. SHERMAN: Would it be possible for you to submit the statistical analysis that your staff did?

DR. GREENFIELD: Sure.

MS. SHERMAN: And also you said something about when the numbers are small. To which numbers were you referring?

DR. GREENFIELD: We're talking about small differences between -- in this case, correlations like .78 and .89 and you say that there's a 10 percent difference between those. It's a little more than a 10 percent difference but when I square this -- I'm sorry, the R squared is .78 and .89 and your question is what fraction of the variation am I explaining with the regression that has been suggested. I think there is a considerable difference when I'm talking about explaining 78 percent of the variation or I'm talking about explaining 89 percent of the variation because the question of am I leaving unexplained a larger amount of the potential variance and I think that's a legitimate question to ask at that point.

MS. SHERMAN: Well, do you know of any support in the peer reviewed scientific literature for your view that there is a non-linear relationship between ETS, RSP and ETS nicotine?

DR. GREENFIELD: Non-linear relationship. We're talking about concentration now, is that correct?

MS. SHERMAN: We're talking about emissions and concentration.

DR. GREENFIELD: The concentration of nicotine and there's a linear relationship between the concentration of nicotine and the concentration of RSP? At what time?

Looking at this as an instantaneous release of particulate, the nicotine, and those are linearly correlated?

MS. SHERMAN: Is that your position?

DR. GREENFIELD: No, I'm asking you. Is that what we're talking about?

MS. SHERMAN: We're talking about time average measurements.

DR. GREENFIELD: Time average? No, I don't know of any literature that talks about it not being linear but I haven't look at all the literature, either.

MS. SHERMAN: I don't think anybody can.

I think in your submission on page A-9, you assume certain artificial RSP and nicotine concentrations which have individual ratios which are different from Repace and Lowery's 10-to-1 ratio, although they average to 10-to-1. You then use the individual ratios in a calculation in Table 1 to do some average ETS RSP to nicotine exposure ratio different from Repace and Lowery.

Isn't your calculation based on assumption that the average value of three fractions is equal to the average of their numerators divided by the average of their denominators?

DR. GREENFIELD: The whole purpose of this calculation was to show that by -- since exposure is concentration times time, that the ability to say that if I have any ratio of RSP to nicotine concentrations that I can automatically assume that that same ratio carries over as a ratio of RSP exposure and nicotine exposure is not correct, that based on -- by adjusting the various times I spent in various work arrangements or work conditions, what the RSP concentration, nicotine concentration are in these various times, that I can come out with almost any relationship between exposure and concentration.

If I assume 10-to-1 as a ratio between RSP concentration and nicotine concentration, this does not automatically say that there is a 10-to-1 relationship between exposure to RSP and exposure to nicotine. And that's all this table says. That's all the hypothetical example was. And that's what it says here specifically.

MS. SHERMAN: Would you repeat your answer? I'm not so sure I understood you.

DR. GREENFIELD: Okay. We went through this hypothetical calculation for one purpose only and it says that exactly in our submission, that we wanted to address the question of whether or not an assumed ratio of concentration of RSP and nicotine carries over as the same ratio of RSP exposure to nicotine exposure. And the point that we're making here is that based on the mix of activity of the individual, the time spent in the various activities, you can achieve the time weighted average of that concentration ratio and not have it be exactly the same as the calculated exposure ratio for that same time weighted period.

MS. SHERMAN: I think in your submission on page A-12 you stated that Repace and Lowery's utilization of nicotine adsorption efficiency from a study of ethnic Japanese may be premature because of Wagenknecht's suggestion that there may be a possible black-white difference in nicotine metabolism or cotinine clearance.

DR. GREENFIELD: Yes. That's what we said here.

MS. SHERMAN: Did Wagenknecht make any studies of nicotine metabolism or cotinine clearance in either blacks or whites?

DR. GREENFIELD: I can't answer that because, as I told you, this was a team effort and I would be very happy to have the part of my team that addressed this question submit that kind of answer to you.

MS. SHERMAN: Okay. Well, I don't know if you know the answer to this, but have there been any studies published which have shown that Japanese have different nicotine metabolism or cotinine clearance than their occidental counterparts?

DR. GREENFIELD: Once again, I'd rather submit this.

MS. SHERMAN: That's fine.

(Pause)

MS. SHERMAN: By the way, did you do any monitoring to validate the model that you put forth?

DR. GREENFIELD: Monitoring?

MS. SHERMAN: Yes.

DR. GREENFIELD: We do no monitoring. My company. My group does no field work, no experimental work. We are modelers, mathematical modelers, and what have you. We depend, for example, on data provided in the normal form by EPA, by OSHA, by others, who actually go out and monitor or collect data.

MS. SHERMAN: Well, how do you know whether your model works then?

DR. GREENFIELD: You're talking about validation of the model.

MS. SHERMAN: Yes.

DR. GREENFIELD: Now, which models are you talking about?

MS. SHERMAN: The model that you suggest in your paper.

DR. GREENFIELD: We haven't suggested any models in our paper at all. I'm a little confused now. What model are you referring to?

MS. SHERMAN: Just a minute.

(Pause)

MS. SHERMAN: Well, I take it that you didn't like what we did in terms of any models that we've used but do you have any models?

DR. GREENFIELD: No. It's not that I disliked or didn't like what you did.

MS. SHERMAN: You criticized it.

DR. GREENFIELD: No. I said that in the information provided in your proposed rulemaking that we were left feeling like there was not enough information to make that judgment. There are some criticisms we made based on sources or references that we've cited as well. Both of us make judgments when we do this kind of analysis or this kind of study or this kind of proposal. And it behooves us all, and that's all we're saying, that if we're making assumptions, if we're making judgments, if we're attempting to support regulatory action, that it is very important that things be laid out in a way that anybody reading it can be very clear as to what the assumptions were, why they were made, what judgments were made, et cetera. And that's the point we're trying to make, that to defend your action, to make it credible, that you must be able to both describe, quantify if possible, explain judgments, define assumptions, justify the assumptions made, et cetera.

MS. SHERMAN: Are you familiar with the work of Wayne Ott, who testified earlier here at the hearing?

DR. GREENFIELD: I'm very familiar with Wayne Ott.

MS. SHERMAN: Do you agree with his work?

DR. GREENFIELD: To a large extent, depending on what part of his work you're talking about. If you're talking about things like microenvironments, I think he's done some very, very nice work in that area.

MS. SHERMAN: Okay. So you would agree with his work on microenvironments.

DR. GREENFIELD: I said the work he has done there has been very nice. In face, we've used some of his work in some of the modeling work that we did, certain population activity.

MS. SHERMAN: I believe on page three of your submitted comments you mentioned that there is considerable overlap between chemical components of ETS and chemical substances that normally arise in the operation of a non-industrial work environment. Isn't that correct?

DR. GREENFIELD: I believe that's correct, yes.

MS. SHERMAN: Have you looked into how the combination of any of the 4000 plus chemicals found in ETS may interact with each other? Have you looked into synergism or antagonism or additivity and how it may affect the worker?

DR. GREENFIELD: No, I haven't done any of that but it's precisely that question that I raise with you, has OSHA looked at this. Because the question of what is in that workplace as a result of ETS or any other source of similar chemicals becomes an important question when you talk about how do you protect people from potentially hazardous materials.

MS. SHERMAN: Well, are there other sources for all of the 4000 chemicals found in ETS?

DR. GREENFIELD: I can't answer that. We have provided for you various tables listing some of the components that you have expressed and where they are, what other sources of some of these chemicals are. We have also listed in the appendix a rather lengthy table for other industrial sources of similar chemicals. Now, this is certainly not 4000 but the majority of those 4000 chemicals are trace chemicals, trace elements, trace component themselves and you don't normally look at these as being very important necessarily in terms of the impact on people.

We have taken the ones that you've listed in the OSHA report, the OSHA proposed rulemaking, even though it's mainstream, components of mainstream smoke, we have asked the question where else do you find sources of these chemicals.

MS. SHERMAN: But you would agree that there are some chemicals that are fairly unique to tobacco smoke.

DR. GREENFIELD: I have not done any work on tobacco smoke as such. If you say that, I am prepared to accept it at face value but I certainly can't confirm or deny it.

MS. SHERMAN: I think you also mentioned that on many non-industrial work sites they are located close to industrial work sites and therefore they tend to draw in similar chemical materials which are also similar to what we find in ETS so it would make it difficult to determine the contribution of each source. Is that correct?

DR. GREENFIELD: That's correct.

MS. SHERMAN: Based on your personal experience, could you elaborate on this? What is the likelihood that a non-industrial work site located near an industrial work site would draw in the 4000 plus chemicals found in ETS?

DR. GREENFIELD: Well, once again, if you go back to the table that I gave you in the appendix, which talks about various industries and what they put out in terms of the list of chemicals that you had in the OSHA proposed rulemaking --

MS. SHERMAN: Are you talking about Table 227?

DR. GREENFIELD: Table 2-1. That if I look at that table --

MS. SHERMAN: Excuse me. I said 227 and you said 2-1.

DR. GREENFIELD: I'm sorry.

MS. SHERMAN: Let's get together on this.

DR. GREENFIELD: Fine. If you say -- let me check it and make sure.

(Pause)

DR. GREENFIELD: It's listed as 2-1.

MS. SHERMAN: Okay. Then I was looking at the wrong one. Okay. Please go on with your answer.

DR. GREENFIELD: If you look at that table and you say given the fact that I have what I call a non-industrial work space, an office, and it is close to an industrial source as listed in this table, then in the normal ventilation that goes on in a work space I would be very surprised if you did not draw in the chemicals that were in the ambient environment. Now, the degree to which you draw them in, the concentrations that you wind up with inside, indoors, is a matter of the specifics of the ambient concentration, the number of air exchanges you have and the characteristics of your site. I think you had Lance Wallace here as a witness.

MS. SHERMAN: Yes, we did.

DR. GREENFIELD: Now, Lance has done a lot of work of this sort. So have people at the School of Public Health, Jack Spengler and his people have done work in this area. There's no question that you bring in from the outside concentrations of material from the ambient environment.

MS. SHERMAN: But don't these constituents then add to what is already there from the cigarettes being smoked?

DR. GREENFIELD: Of course they do. And then you have to ask the question, that if I'm talking about the exposure in the individual to any specific one of these chemicals what contribution is being made by that which you draw from the ambient, relative contribution, and what is being provided by ETS. And I think you have to ask that question to get a sense of where the important sources are.

MS. SHERMAN: And on what information are you basing your statement that ETS is a minor contributor to the integrated exposure?

DR. GREENFIELD: I don't think I said it was. I said it could be.

MS. SHERMAN: Oh, okay. Well --

DR. GREENFIELD: I said with the number of additional sources that you have, many of them indoors working full time as opposed to intermittent and uncertain exposures from ETS, it could be a major, major contributor.

MS. SHERMAN: Okay. I'm trying to understand your position. Is the basis of that statement the material in the appendix we just discussed?

DR. GREENFIELD: No.

MS. SHERMAN: Or is there some other basis --

DR. GREENFIELD: No. What I'm saying is that given the fact that you have a large number of sources of similar chemicals both external and internal, that before you make the assumption that ETS is the major contributor to exposure of individuals to those chemicals, that you have to understand what the relative concentrations are from these various sources. And until you do, it's very difficult to make a cost benefit or cost effective strategy as to how to proceed to protect people.

MS. SHERMAN: Okay. But you're making the statement that ETS is a minor contributor to the integrated exposure.

DR. GREENFIELD: I said it could be a minor contributor.

MS. SHERMAN: Okay. I guess I didn't read you're saying it could be. I read your thing as saying that we find that what information does exist indicates that ETS is a minor contributor.

DR. GREENFIELD: Where do read that?

MS. SHERMAN: It's on page five.

(Pause)

DR. GREENFIELD: You left out the parenthetical statement. ETS is a minor contributor for some constituents.

MS. SHERMAN: Well, okay. So is the converse of that true, that for other constituents it isn't?

DR. GREENFIELD: I don't know. But what I am also saying is it behooves a regulatory agency to find out.

MS. SHERMAN: Well, if in fact OSHA were to find that it was a major contributor, then would you think that OSHA should take action based on that finding?

DR. GREENFIELD: Well, you're asking me to speculate. Let me see the results after you've done that and I'll be happy to give you an answer.

MS. SHERMAN: On page one of your comments, you described a mine field of uncertainties associated with complex settings, complex sources, unspecified sinks, complex distributions of concentrations, complex human receptors and lack of adequate supporting data associated with establishing a sense of population exposure. Isn't it true that this uncertainty is associated with ETS when it is distributed throughout the indoor environment?

DR. GREENFIELD: I'm sorry. I don't understand the nature of your question. Yes, I did say what you quoted. What are you asking me now?

MS. SHERMAN: I'm asking you if this uncertainty is associated with ETS whenever it is distributed throughout the indoor environment.

DR. GREENFIELD: I think there's a great sense of uncertainty if you're talking about exposure to ETS in the indoor environment. Now, I don't quite -- I'm not getting the sense of what you're asking me.

MS. SHERMAN: Let me get to the next question.

Wouldn't it be true that some of this uncertainty would disappear when ETS is contained in a designated smoking area?

DR. GREENFIELD: Now, which uncertainty are you talking about?

MS. SHERMAN: All of the uncertainties that you talked about. In other words, the complex distribution, the complex human receptors, et cetera. The question I'm asking is that if you have a controlled environment such as a smoking lounge, don't many of these uncertainties disappear?

DR. GREENFIELD: Some of the uncertainties disappear, certainly. But, now, how do you ventilate this smoking lounge? How would you ventilate it?

MS. SHERMAN: You're talking about how does the proposal?

DR. GREENFIELD: No, you're saying these uncertainties disappear. If I ventilate it in a way that I'm bringing in ambient air with its own load of pollutants in it, then once again, the uncertainty as to what the major contributor is, there's a person in the smoking lounge, in terms of impact on them. That also becomes a question as well.

MS. SHERMAN: But wouldn't you say the issue of trying to decide which components are attributable to the environmental tobacco smoke would go away if you had a smoking lounge?

DR. GREENFIELD: Well, I think we're going around and around. If some of the components that are attributable to tobacco smoke are also present in the ambient air and I draw that ambient air into the smoking lounge and I'm exposing the individuals not to just the smoking that they're doing but also the load that I put into the ambient air. Now, for the smokers, the direct smoker, obviously a lot of the uncertainty disappears. If you're asking me what happens to people outside the smoking lounge, does that uncertainty go away, sure. If there's no ETS, there's no uncertainty except that I am indeed bringing in the ambient air as well and I am also having them exist with what other sources of those constituents still exist in the office environment or the non-industrial environment due to the fact that I still have other sources of those chemicals available.

MS. SHERMAN: I think that you again characterized the dilemma of sources, sinks, streamlines, unknown concentrations, et cetera as OSHA's justification for a performance based ventilation standard. This is a common situation. Consider the laboratory where your environmental samples were sent. Did the chemists try to determine the exact air concentration of every constituent they worked with, including every intermediate compound produced to determine if the work could be performed on the bench without an exhaust hood?

DR. GREENFIELD: Well, I am not an analytical chemist so I wouldn't even think to try and answer a question like that because it's not my profession. I don't know what they do.

MS. SHERMAN: So then you wouldn't know whether chemists regularly depend on their laboratory hoods to mitigate unquantified chemical hazards.

DR. GREENFIELD: Anything I would say would be speculation. I know laboratory hoods would be a way of protecting the laboratory itself from hazardous materials that are being used in that hooded area. I don't know whether they're using them to avoid other contaminants.

MS. SHERMAN: Why do you feel that OSHA should quantify the ETS contribution to the exposure of workers on a chemical-by-chemical basis?

DR. GREENFIELD: Because as long as you have other sources of those chemicals and you're trying to define and defend an effective strategy, then you've got to know what the contribution -- the relative contribution is, ETS, other sources to the same chemicals that you think are hazardous. Otherwise, how can you make the decision that what you've done is produce an effective strategy, particularly when you're talking about cost as well as benefits?

MS. SHERMAN: I think you stated that the dynamic physico-chemical nature of ETS makes it difficult to quantify or measure actual exposures and dose from its constituents separately from the same chemicals emitted by other indoor exposures.

DR. GREENFIELD: Well, that, once again, not being a chemist, I would be happy to have my chemist answer a question like that.

MS. SHERMAN: That is on page six of your statement.

DR. GREENFIELD: Page six. Can you give me which paragraph it is?

MS. SHERMAN: I'll find it.

(Pause)

MS. SHERMAN: I believe it's in the second paragraph, toward the bottom of the paragraph.

(Pause)

DR. GREENFIELD: I would assume that's a correct statement.

MS. SHERMAN: Okay. Well, do these measuring difficulties suggest that OSHA should not be interested in identifying a permissible exposure limit for environmental tobacco smoke?

DR. GREENFIELD: No. I'm not sure I can answer a question like that. All I'm trying to say, all we've tried to say here, is that measuring ETS chemical-by-chemical is obviously difficult. That, however, does not negate the requirement that some consideration be given to the relative contribution of those chemicals in ETS that you think are hazardous as compared to other sources of the same chemicals that are normally found in the workplace. And in essence if you feel that these chemicals are very important to eliminate, then you have to ask yourself not just what I do with regard to ETS but what do I do with all these other sources as well? Because how can I make a judgment if I have sources that are at least equal in magnitude and I'm protecting the human population by eliminating one of the sources and neglecting the other. Now, I assume you'll say, well, they're additive, if I can get rid of part of it, I'm better off. But if I'm really convinced that those are hazardous then I believe it's the responsibility of OSHA to not neglect other major sources of the same chemical.

For example, if I may, suppose you decide that one source of a similar chemical are things like copiers. Does that mean that we should take all the copiers and put them in a copier lounge? And so that the only way that that material gets out or anybody is exposed to it is when they are in there copying and maybe I make arrangements at that time that the copier is not operating, I do it all automatically so the material goes in and it's copied in this copier lounge.

Now, if I'm making that decision as a regulatory agency, I've got to look at what the not just the consequences of my decisions are but whether I'm making a rational, logical decision once I've decided that certain chemicals are hazardous. I must look at where the other sources are as well.

MS. SHERMAN: Would it surprise you to know that the copier manufacturers already recommend that their copiers be in separate settings?

DR. GREENFIELD: Good. Then that's one problem that may have been taken care of. What about all the other sources?

MS. SHERMAN: Well, I suppose we could go through them one by one.

DR. GREENFIELD: One by one. That's right.

MS. SHERMAN: We had the carpet manufacturers here who tell us that there's nothing at all wrong with any carpet.

I think on page eight you stated that the distance from the source, the strength of the source, the aging of the mixture and the ventilation all affect the actual concentrations of ETS.

DR. GREENFIELD: No, it's the other way around. If I'm talking about exposure -- if you're talking about exposure, it's the concentration, distance from the source, so forth and so on. I'm sorry. Let me go back again. If you're talking about concentration, then distance from the source is certainly an important parameters.

MS. SHERMAN: So you agree with that.

DR. GREENFIELD: I would agree with that. Yes.

MS. SHERMAN: Okay. Well, assuming employees have to be in a space for eight hours, don't you think that these dynamic variables that affect concentration might -- that the employer might have a difficult time controlling exposure?

DR. GREENFIELD: Of course, I can't speak for all the employers of the country. If you're talking about controlling the exposure, you're -- well, I guess I'm having difficulty with the concept that you're raising. If an employer is convinced or if OSHA is convinced that the ETS is producing a hazard in the workplace, to the extent that the concentrations that you find in the workplace due to ETS produce exposures that are potentially hazardous, then the question of how you -- whatever process is available to control that concentration is worth looking at. Ventilation, I believe, is possible to reduce the concentration significantly in the workplace in the presence of smoking. There have actually been other techniques that have been developed where individuals at their desks have personal ventilation systems that seemed to be very effective in reducing the amount of cigarette smoke in the workplace.

So I can't answer that. I'm not a ventilation expert. I'm not a designer or what have you.

MS. SHERMAN: Are you familiar with these systems where you have individual ventilation systems at the desk?

DR. GREENFIELD: I have only heard of them.

MS. SHERMAN: So you haven't explored them.

DR. GREENFIELD: No, I have not explored them.

MS. SHERMAN: You don't have any data on their efficacy.

DR. GREENFIELD: That is not in my professional purview.

MS. SHERMAN: Getting back to the dynamic nature of the mixture and all the other uncertainties that you mentioned, don't you think that all of this taken together would make it difficult for OSHA to establish a meaningful permissible exposure limit for environmental tobacco smoke?

DR. GREENFIELD: Since I haven't carried out that kind of an analysis, since I haven't looked in the depth that I would expect you would have to look to answer that question, I can't answer that. All I'm saying is based on what I've seen and what OSHA has produced to date, I've got to raise that as a question.

MS. SHERMAN: Certainly. Going back to the uncertainty question, if in fact we've ever left it, if the outdoor ambient air meets the EPA ambient air standards, would you agree that the uncertainty related to environmental tobacco smoke would be greatly reduced?

DR. GREENFIELD: No, because ambient air quality standards don't touch on a lot of the components that you're talking about, a lot of constituents that you're talking about.

MS. SHERMAN: Which major ones don't they touch on?

DR. GREENFIELD: Oh, VOCs in general. We don't have an ambient standard for polycyclic aromatic hydrocarbons. That which is regulated by standards.

MS. SHERMAN: Excuse me a minute.

(Pause)

MS. SHERMAN: I think on page eight you state that some of the data was based on smoking habits of 40 years ago, based on unfiltered cigarettes?

DR. GREENFIELD: Yes.

MS. SHERMAN: Do the filters significantly change the environmental tobacco smoke?

DR. GREENFIELD: No. Except in the case, as I understand it, where environmental tobacco smoke is made up of both sidestream and mainstream smoke.

MS. SHERMAN: Then they would significantly change it?

DR. GREENFIELD: I can't answer the question of significance.

MS. SHERMAN: I think you're suggesting that concentrations of ETS in the workplace might have been higher in the past?

DR. GREENFIELD: I don't know. I'm saying that the constituents would be different.

MS. SHERMAN: But isn't it also true, since ventilation affects the concentration, if ventilation rates with outside air were higher 40 years ago, that the actual concentration might be the same as today?

We've had lots of testimony at this hearing about how the energy crisis force people to become stingier with their ventilation.

DR. GREENFIELD: They not only became stingy with their ventilation... That's not exactly true. What they did was close the windows, seal off the interior, and pumped air in from the outside. If you're pumping air in from the outside and not filtering it, and 40 years ago or less, while you may have saved on energy, you also may have increased the concentration inside of various other constituents, not just from ETS, but similar chemicals which were now pumped in from the ambient air.

MS. SHERMAN: Which compounds in ETS are most affected by adsorption?

DR. GREENFIELD: I can't answer that, but I can find the answer for you.

MS. SHERMAN: Please.

Could you explain how adsorption affects the concentrations of environmental tobacco smoke compounds in air from a perspective of time?

DR. GREENFIELD: Any sink is going to reduce the concentration of a specific constituent. So if I have a sink for a specific constituent, with time, I would expect to have it removed from the air, except for that which is put back with the sink acting as a source.

MS. SHERMAN: I guess I'm coming back to a question I think I asked you earlier. That is, is there any formula to figure out how this is going to work?

DR. GREENFIELD: Once again, let me send you that paper and you can look at it.

MS. SHERMAN: Okay.

DR. GREENFIELD: You asked me, I agreed to get you some information a few minutes ago. Do you remember, as we were exchanging, I've lost...

MS. SHERMAN: Perhaps I can send you, or perhaps Philip Morris will give you a copy of the transcript.

DR. GREENFIELD: Whomever.

MS. SHERMAN: If you can't get it otherwise, I'll send it to you. So you don't have to worry about taking notes right now.

We've talked a lot today about the difficulty of quantifying and separating out the ETS contribution to exposure. Hasn't this already been done in some respects as scientists have characterized both smoking and nonsmoking environments?

DR. GREENFIELD: I think there certainly has been work on trying to characterize the components of cigarette smoke, or environmental tobacco smoke, mainstream smoke. I don't know to what extent we've really characterized or there has been a characterization of the work environment with regard to specific components of ETS. I may be wrong on this, but I don't know of a great deal of work that's been done in this area.

I judge from what I heard last week, I thought that RJR had done some of this, but I'm really not familiar with that literature.

MS. SHERMAN: I think on page 11 you stated that the main source of VOCs indoors is evaporation from building construction and furnishing material?

DR. GREENFIELD: That seems to be the case, yes.

MS. SHERMAN: Is the VOC emission rate a function of the age of the material?

DR. GREENFIELD: That's an interesting question. As you get into the sick building syndrome there have been many attempts to see if you could take a new building and bake it out, whether or not the emissions would change with time. There have been varying... I've seen varying comments on this. Ones that say yes, you can back it out and others that seem to indicate no, you're stuck with these emissions. With age they might go down, but of course some of them occurred due to painting and what have you, so with age I may repaint again and build up the emissions once again.

I'd be very surprised if they did not vary with time.

MS. SHERMAN: Is there a smoking policy at ICF Kaiser?

DR. GREENFIELD: I can't speak for ICF Kaiser, although I suspect there is. I can speak for my own division.

MS. SHERMAN: Systems Application...

DR. GREENFIELD: Systems Application. In 1986, 1987 when I was president, I instituted a no-smoking policy. So that any of our employees who wish to smoke, we have a very peculiarly shaped building, could either go out onto one of the balconies outside, or to a room that we put aside for smoking purposes.

MS. SHERMAN: Why did you institute that policy?

DR. GREENFIELD: Well, because you've got to understand that in Marin County in California, there's always been a great sensitivity to the natural environment, and we have enough young people in the place who were bothered by the odor, and asked that something be done about it and I acceded to their wishes.

MS. SHERMAN: Did you explore any alternative measures?

DR. GREENFIELD: At that time, no.

MS. SHERMAN: Such as vertical displacement ventilation or smoke eaters or any of these other things we've heard about...

DR. GREENFIELD: If you walked through the place before this policy was instituted, during the height of the complaints, you found a lot of these smoke-eater ash trays around. Not a lot of them, there were not that many people who smoked in our place, but they certainly placed them around in an effort to accommodate the complaints of their colleagues.

MS. SHERMAN: But it apparently didn't do the job.

DR. GREENFIELD: It's more a question of perception than it is actuality. The younger people continued to agitate for it, and it's easier to say yes than no.

As I said, the peculiar building we have, it's more like a train than a building in the sense that we were determined when we built the building that everybody would have an outside office. That means it's a long, narrow building about three stories high. You don't do much vertical ventilation. We have, I think, some 30 heat pumps in the place.

MS. SHERMAN: Did you make windows that open?

DR. GREENFIELD: All the windows open.

MS. SHERMAN: It sounds delightful.

DR. GREENFIELD: Oh, yes.

MS. SHERMAN: In the smoking room that you instituted, is it separately ventilated?

DR. GREENFIELD: No, it is not. At that time it was a way of getting people away from the other people. In actual fact during the nicer time of the year, most people just step outside. This was more a way of providing them with a place they could smoke during the rainy season in California.

MS. SHERMAN: I don't think I have any other questions for you. I'd like to thank you for your time.

Your Honor, the report that I showed Dr. Greenfield I'd like to enter into the record.

JUDGE VITTONE: Any other participant have any questions?

Mr. O'Neil.

Excuse me a second, Mr. O'Neil. The final report called "Toxic Volatile Organic Compounds in Environmental Tobacco Smoke: Emission Factors for Modeling Exposures of California Populations" prepared for the California Air Resources Board, dated October 31, 1994, will be identified as Exhibit 253.

(The document referred to was marked for identification as Exhibit No. 253, and was received in evidence.)

JUDGE VITTONE: Mr. O'Neil?

MR. O'NEIL: Thank you, Your Honor.

I'm Bernard O'Neil, questioning on behalf of Docket 51, Philip Morris.

Dr. Greenfield, in the end of your presentation this morning, in an attempt to help the OSHA panel evaluate what they have done, you mentioned in your discussion that they would need better data to remove the uncertainties existing in their risk assessment of environmental tobacco smoke. Do you recall mentioning that?

DR. GREENFIELD: Yes, I do.

MR. O'NEIL: Could you elaborate for the panel the kinds of new data that you would suggest they look at?

DR. GREENFIELD: There's almost an infinity of data that you need. That's the constant cry of research people, or people who do analysis. So I could go through and enumerate various areas of data requirements ranging all the way from better data on sources through better data on the fate of pollutants in the workspace.

But one area, going back to the discussion with Dr. Ford yesterday, one area that is particularly important, I think, is the area of pinning down in a better fashion the question of confounding variables. Of particular interest to me right now is the one that was mentioned yesterday as being a very important one, and that's the socioeconomic confounding variable which undoubtedly consists of many different components.

But one that has never been mentioned, we've heard education, affluence, what have you. One that has never been mentioned that I think is very important, and there are data or analyses, at least, that suggest it should be looked at further, is the impact of air pollution on things like lung cancer and heart disease, and the effect of the socioeconomic parameters on the exposure of particular groups of individuals in an urban setting to that kind of air pollution.

A recent paper by Dockery and his cohorts, and I have a copy with me, his colleagues at the Harvard School of Public Health, did a very interesting analysis of the impact on mortality due to lung cancer and cardiovascular disease to air pollution in six cities in the United States.

Interestingly enough, when they teased out the smoker from the database, they wind up with a relative risk about equivalent to what EPA found in the ETS relative risk. So you begin to ask a question. If I have a group of people in an epidemiological study, a control group and a case group, and the control group are the never-smokers or nonsmokers and the nonsmokers, as we heard yesterday, tend to be the more economically affluent people, is that group confounded in terms of their reaction by the fact that they live in a less polluted part of the city?

I'm not saying that's definitely true, but there's enough there that I think you'd want to gather more data on it.

MR. O'NEIL: So what you are saying, are you not, is that the socioeconomic status is related to the areas in which you live. The areas in which you live could vary by their exposure to pollution sources in the atmosphere. These pollution sources in the atmosphere may be related to higher risks of some of the diseases in question. Therefore, this whole area should be investigated, and you're suggesting one recent paper which at least in part addresses this question.

DR. GREENFIELD: That's exactly right.

MR. O'NEIL: Thank you, Dr. Greenfield.

Thank you, Your Honor.

JUDGE VITTONE: Thank you, Mr. O'Neil.

MS. SHERMAN: I have another question, please.

JUDGE VITTONE: One more.

MS. SHERMAN: You're not an epidemiologist are you?

DR. GREENFIELD: No, I'm not.

MS. SHERMAN: You're not a social scientist?

DR. GREENFIELD: I'm not a social scientist. But I am a physicist and I have worked in air pollution for some 40 years.

MS. SHERMAN: Could you submit that Dockery paper to the docket?

DR. GREENFIELD: Of course. In fact I can leave it with you if you'd like to have it.

MS. SHERMAN: That would be nice.

JUDGE VITTONE: Thank you, Dr. Greenfield.

Let me just ask you a couple of questions. Ms. Sherman asked you some questions about the smoking policy of your office.

DR. GREENFIELD: Yes.

JUDGE VITTONE: You made a comment that it was easier to say yes than to say no.

What was the reaction of the people who smoked in your office when you imposed this smoking ban?

DR. GREENFIELD: Initially there was grumbling, particularly during the rainy part of the year where they'd have to step outside or walk down a considerable hallway to a smoking lounge.

But first of all, we have very few smokers. Out of 100 people, less than five percent smoked at that time. And the number is smaller now. Not because the ones who did smoke gave up smoking, necessarily, because we have a turnover of people.

In any event, there was certainly initially grumbling, but there was so much support from the other people. We have a very affable group of people in terms of their interrelationship with each other that while the initial grumbling was there and this good natured joshing and kidding, it's become very acceptable.

JUDGE VITTONE: Would part of your answer with respect to the smoking policy be that you live in California, and that counts for a large part of this? Californians are a little different than the rest of us, maybe.

DR. GREENFIELD: Californians are always different.

JUDGE VITTONE: Thank you very much, Dr. Greenfield. I appreciate your time today.

(Thereupon, the witness was excused.)

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

MS. SHERMAN: Your Honor, I was wondering if we could perhaps have a little bit longer for lunch today, and perhaps do lunch now?

JUDGE VITTONE: Is Mr. Tiffany here?

Off the record.

AFTERNOON SESSION
1:20 p.m.

JUDGE VITTONE: On the record.

I wanted to talk, before we take the final witness today, about, the best thing I can call it is the public witness section, or phase two. I was thinking of... Let me just read something I've been penciling in here that I would probably, a statement that I would make at the beginning of the session on Monday.

"We've completed the first phase of the IAQ hearings. The first phase was largely concerned with the scientific data that supports or conflicts with the proposed rule offered by various experts in a variety of disciplines.

"We now begin the second phase of the hearings. I expect the nature of these hearings of this phase will be quite different in terms of information and scope concerning the proposed rule.

"It is not expected that this phase of the hearings will produce evidence on the science that surrounds the proposed rule. Rather, the primary purpose of this part of the IAQ process is to hear the opinions and comments of the general public about the rules and its various provisions.

"Accordingly, the procedures that govern this phase will be quite different from the process that occurred when the scientists, statisticians, economists, and other experts testified in the first phase of the hearings. These procedural rules are designed to afford these citizens an opportunity to express their views in an orderly and efficient manner."

That's what I think the outlines of what we're going to begin are. My understanding, these will be largely citizens who have views on the rule, whether they're affected by the rule or whether they just want to come in and make a comment about the rule. I assume many of them will be people like we had at certain times during the hearing who were small businessmen and citizens on both sides of the issue. People who were in favor of smoking in public places, and people who were opposed to smoking in public places.

Each witness will have a maximum of ten minutes for his or her direct presentation.

Maybe before we get into this, as I understand it, Ms. Sherman, you and Mr. Wasser and others have been having some discussions about the numbers of witnesses and the order of witnesses and how many days we're going to be going. Why don't you tell me what you're thinking about with respect to witnesses, days, and as far as lining up the people who will be testifying at this second phase.

MS. SHERMAN: We have been shooting for a goal of scheduling 11 people per day on the theory that that will be a full day. Now if we find that we're going much faster, perhaps we would have to try to revisit this issue.

We agree with the idea of trying to limit the amount of Cross Examination that should be available.

What were the other things you wanted me to address? I'm sorry.

JUDGE VITTONE: Before we talk about how much examination there's going to be, yesterday after the close of the hearing we had an informal discussion concerning the numbers of people who have so far signed up to testify.

MS. SHERMAN: Yes.

JUDGE VITTONE: As I understand it, we're going to go for the first two weeks -- next week and the following week, and based on the document that I have here from yesterday, there are about nine or ten or eleven people scheduled on each of those days.

MS. SHERMAN: That appears to be the case.

JUDGE VITTONE: You have the list. Do you have any problems with this schedule here?

MS. SHERMAN: As I said, Your Honor, the thing that I'm concerned about and the thing that we discussed off the record yesterday was what happens if large numbers of people start to not show up. Then what we have is we have ourselves scheduled way out past February 28th, and we may only have a trickle of people each day. If that were to happen, I think we're going to have to revisit this issue because I don't think it's an efficient use of your time and or the court reporter's time to have hearings with so few people.

JUDGE VITTONE: I certainly want the days to be as full as possible. Let me reiterate, I am not going to be here every day. I'm going to have substitutes come in. What I plan to do is, I plan to be here one day a week. I'll come in on Monday, this Monday, and go through that day, and then I will have people coming in and substituting for the rest of the week. Then I'll come back the following week for a day.

Mr. Myers?

MR. MYERS: Can we go back? I thought you were doing it in a more orderly fashion. Let's talk about what the procedures are going to be a little bit. Maybe then we can figure out whether 11 makes sense. If we're going to limit the Direct to ten minutes and some limitation on public comment...

JUDGE VITTONE: Maybe we should go off the record.

(Discussion held off the record.)

JUDGE VITTONE: On the record.

Mr. Tiffany.

(Pause)

JUDGE VITTONE: Gentlemen, I want to thank you for your patience during that extended discussion. It's something that we had to get to and had to talk about. Thank you very much.

Mr. Tiffany, would you identify yourself for the record, the name of your organization, and your colleagues, please.

MR. TIFFANY: My name is John Tiffany. I am president of Tiffany-Bader Environmental, Inc., a consulting firm based in Bedminster, New Jersey.

As immediate past chair of the Indoor Environmental Quality Committee of the American Industrial Hygiene Association, AIHA, I am appearing here today on behalf of the association.

Also with me here today on behalf of the association is William Kerbel, a past chair of the Indoor Environmental Quality Committee, and to his left Aaron Trippler, Director of Government Affairs of AIHA.

I regret that Jerry Lynch, President of AIHA is not able to be here today. Due to the rescheduling of our testimony, he was not able to attend.

I want to thank OSHA for allowing AIHA to appear, to discuss OSHA's proposed indoor air quality standards.

I have submitted copies of AIHA's official written comments as well as a written summary of my official testimony for the record.

AIHA is the world's largest association of occupational and environmental hygiene professionals. The nearly 12,000 members of AIHA come from government, labor, industry, academia, and private business.

AIHA is the most diverse professional organization dedicated solely to the prevention of workplace fatalities, injury and illness. AIHA's goal is to bring good science and the benefit of its workplace experience to the public policy process directed at worker health and safety.

AIHA is focusing its comments on the following: How the regulations should be applied, using a performance-based standard, minimizing the regulatory burden, designing indoor air quality compliance programs, health effects of building conditions and operations, environmental tobacco smoke, implementing indoor air quality compliance programs, fully assessing the impact of the standard, and several smaller but no less important issues.

AIHA supports OSHA's overall approach to regulating indoor air quality including environmental tobacco smoke. AIHA favors having an indoor air quality standard applied to all non-industrial work environments as OSHA has proposed. AIHA supports applying ETS provisions to all workplaces, including the indoor and enclosed non-industrial workplaces OSHA proposes to cover. AIHA encourages OSHA to use a performance-based approach rather than a chemical-by-chemical one.

To minimize the regulatory burden of the standard, OSHA should keep only essential information and actions in the main text of the standard or place them in mandatory appendices. It should place desirable or optional elements in the Preamble or in non-mandatory appendices.

My testimony discusses some of the elements of the proposed standard which deserve particular attention. AIHA has written comments to discuss these and other elements of the proposal.

AIHA supports requiring non-industrial work environment employees to have an indoor air quality compliance program as OSHA has proposed. Implementation of a facilities program which is the result from implementing its plan, should be the focus of OSHA's compliance efforts. In other words, OSHA should give its main attention to real world results over paperwork.

The proposal would require having a designated person both knowledgeable in the requirements of the standard and the specific building systems, and with the responsibility to take necessary measures to ensure compliance with the standard. The proposal unnecessarily merges two distinct functions. One function is properly performed by a designated person. Such a person must know the requirements of the standard, be generally familiar with the subject of indoor air quality, and most important, be responsible for and have the authority to implement a facilities compliance program.

Separate from this is the function of a competent person, capable of identifying indoor air quality hazards, and authorized to implement controls promptly. This competent person function is already used by OSHA in its construction industry standards. An employer could have one or more competent person for a facility, but should have only one designated person for it. In this way the line of responsibility for compliance with the standard will be clear.

OSHA should recognize certified industrial hygienists and other comparable qualified professionals as technically competent. AIHA recommends including this recognition in the description of the designated person and building system inspector functions. And if identified explicitly as AIHA is recommending, in the competent person function.

The standard should clearly separate sick building syndrome, building-related illness, and thermal comfort issues. The definition of building-related illness should state that it involves medical involvement for diagnoses.

Thermal and humidity comfort issues should be excluded explicitly from this standard to relieve employers and OSHA of a significant and unnecessary burden. Many compliance procedures related to indoor air quality are actually related to thermal and humidity comfort and are not associated with significant impairment of employees' health. Such complaints should not be addressed here.

Mandating and evaluation of the need to alter building systems without medical verification of complaints of building-related illness is wasteful of employers' and OSHA's efforts. Similarly, when building systems must be altered, the employer should have the flexibility to protect the health of employees by means in addition to those recommended by the evaluator.

AIHA is committed to its position that all nonsmokers should be protected from involuntary exposure to environmental tobacco smoke in their workplaces. AIHA supports banning smoking or providing adequately ventilated designated smoking areas. The standard should apply uniformly to all workplaces, including the indoor or enclosed workplaces such as hospitals and high rise offices, restaurants and bowling alleys that OSHA proposes to cover.

ETS is an eye and upper respiratory airway irritant and can contribute to exasperation of asthma and increased susceptibility to respiratory infections. OSHA should further emphasize such effects in addition to the carcinogenicity of ETS in order to put into perspective the risk of material health impairment.

The body of scientific evidence is sufficient to establish that ETS may produce a small excess risk of lung cancer in nonsmokers as well as other deleterious health effects. This provides a scientific basis for OSHA to enact an ETS standard.

AIHA acknowledges that it is difficult to provide a numerical estimate of the risk in the workplace under actual exposure conditions. OSHA used the scientific information available to it in a reasonable manner. OSHA should discuss the uncertainty about the magnitude of the lung cancer effect, and the even greater uncertainty about the estimates of severe cardiovascular disease and other diseases.

Having hazard communication information in the Preamble or non-mandatory appendix will help industrial hygienists and other users of the standard fulfill their responsibility regarding the risks of ETS to workers, employers, building owners, and building managers.

OSHA should describe scopes of work below which renovation and remodeling are not covered by the standard. Below a deminimus work level, the risk of significantly degrading building air quality is minute. Similarly, for routine work below major renovation or remodeling, periodic notification of building employees, such as annually, may be sufficient to remind them of indoor air quality issues and their rights thereto.

OSHA should delete or restrict the proposal to notified building employees of anticipated adverse impacts of essentially all renovation and remodeling, since essentially, all such work introduces some air contaminants.

Health-related notification will be credible and beneficial only if the work is likely to affect health. In that case, advance notification is appropriate.

OSHA should delete the building employee notification proposed when potentially hazardous chemicals are to be applied. This term is extremely broad, including any level of at least any chemical listed as hazardous by OSHA, EPA, or the Departments of Health and Human Services, Transportation, Commerce or Energy.

OSHA should delete the proposed relative humidity requirement for mechanically cooled buildings. Concerns about mold growth, standing water, and other major ventilation system problems are already addressed on a performance basis in the proposal. OSHA should move air quality testing after routine maintenance on ventilation system, to a non-mandatory appendix, or delete it.

The carbon dioxide testing proposal overlaps the proposed preventive maintenance program. Also, there is not yet scientific consensus on using 800 parts per million of carbon dioxide as the proper indicator of ventilation performance as opposed to use of some other level of carbon dioxide or some other contaminants or system measurements.

OSHA should address microbial contamination in a non-mandatory appendix, along with other compliance plan elements on inspecting, maintaining, operating, and managing building systems. The appendix should give particular attention to medically confirmed building-related illness.

The Preamble significantly underestimates the resources required to implement the standard. The time spent in most facilities will be measured in days, not hours or minutes. Many employers will address quality and liability concerns by having some work modeled as being done by technicians, done by industrial hygienists or other comparably qualified professionals with wage rates several times higher than shown. Both large and small employers and business owners and managers will be affected substantially. Overall, the resource expenditure will likely be more than ten, and perhaps more than 20 times that estimated.

OSHA should clarify responsibilities among employees in multi-employee facilities. The proposed definition of employers as those who control the ventilation or maintenance of premises of other employers, is generally reasonable but has limitations. Specifically, OSHA should avoid holding liable employers unable to effect the environmental practices of other employers, even after good faith efforts to do so.

OSHA should address privacy concerns about making records such as of employee complaints available. It should also address privacy concerns on the transfer of records when an employer goes out of business, especially when there is no successful employer.

OSHA should remove the discussion of asbestos from the standard and continue to address it in its existing asbestos standard.

OSHA should state if the outdoor air pollutants listed as air contaminants, include compounds and levels covered by the Clean Air Act since they may cause material impairment to employees. Employees should not have to address the Clean Air Act,

In conclusion, the American Industrial Hygiene Association supports OSHA's overall approach to regulating indoor air quality, including environmental tobacco smoke. By considering the citations and recommendations we have provided, OSHA should be able to promulgate and implement an effective indoor air quality standard, protective of the health of the nation's workers.

I am open to questions, as is Mr. Kerbel.

JUDGE VITTONE: Thank you, sir.

Ms. Kaplan?

MS. KAPLAN: Mr. Tiffany, how many members does AIHA have?

MR. TIFFANY: Approximately 12,000 members.

MS. KAPLAN: Does the organization publish guidelines of recommended good practice for practicing occupational safety and health professionals?

MR. TIFFANY: Yes.

MS. KAPLAN: Are you a member of ASHRAE?

MR. TIFFANY: Yes, I am.

MS. KAPLAN: ASHRAE is a consensus organization. How is AIHA similar to or different from ASHRAE?

MR. TIFFANY: I don't know the answer to that.

MS. KAPLAN: Indoor environmental quality I take it is just one of the committees of AIHA. There are other committees as well?

MR. TIFFANY: That's correct. There's about 40 technical committees.

MS. KAPLAN: Are you here today representing the entire organization or just that committee?

MR. TIFFANY: I'm here representing the entire organization. That's what I'm tasked to do today.

MS. KAPLAN: Does AIHA have a formal position on environmental tobacco smoke?

MR. TIFFANY: Well, what we put in the comments to this proposal, to this proposed indoor air quality rule, this represents our position.

We also have made statements before this. There was a statement made in May of 1991 in Salt Lake City on environmental tobacco smoke. We've also participated in a coalition that was set up in the fall of '93, in October of '93, to address ETS and the workplace.

MS. KAPLAN: I think you submitted a copy of the May '91 message with your materials. I think that 1991 message took the position that all non-smokers should be protected from involuntary exposure to ETS.

Other witnesses at these hearings in addressing the ETS issue have suggested that employees int he hospitality industries could elect to work in a smoking area and in essence, volunteer to be exposed to ETS.

As an industrial hygienist, is this a recommendation you would make to an employer?

MR. TIFFANY: AIHA doesn't have a position on this issue. This is not covered in AIHA's position paper.

MS. KAPLAN: I guess I'm asking for your opinion as an industrial hygienist.

MR. TIFFANY: Can you repeat the question?

MS. KAPLAN: In discussing the issue of ETS in the hospitality industry, some witnesses here have suggested that instead of all employees being protected from involuntary exposure to ETS, some employees could choose to work in smoking areas. Do you think that would be an acceptable administrative work practice from your point of view?

MR. TIFFANY: I'm not going to do it from my point of view, but let me just repeat that... I didn't quite catch your question. This is what AIHA has said on page five of their comment.

"AIHA is committed to its position that all nonsmokers should be protected from involuntary exposure to environmental tobacco smoke in their workplaces. AIHA supports banning smoking or providing adequately ventilated designated smoking areas as OSHA has proposed.

MR. KERBEL: From a standpoint of an industrial hygienist, one would tend to stay away from having workers decide what they may be exposed to because there would be outside pressures that may exist, and therefore, in order to truly protect the worker, one would want to protect them from those outside pressures -- the cause of concern of losing their job. Of course we wouldn't want to have anybody be put into that position which most likely may occur in certain areas of the world.

MS. KAPLAN: Thank you.

Mr. Tiffany, how many IAQ inspections and remediations do you and your firm carry out annually?

MR. TIFFANY: It varies from year to year. Having been involved with IAQ investigations from 1987, I've been involved with over 200 investigations. Most of those investigations I've done it with a mechanical engineer.

MS. KAPLAN: What types of buildings are these that you've investigated?

MR. TIFFANY: Typically office buildings, some schools, some elementary schools and some colleges, a fe w hospitals. But the vast majority are office buildings.

MS. KAPLAN: What have you found to be the major causes of problems in these buildings?

MR. TIFFANY: Everything, of course, is site-specific. Having said that, one clear, and as you're no doubt aware, there usually is not one factor in problem buildings. But I've found in most of these buildings either the main concern or one of the main concerns was something connected with the heating, ventilation, and air conditioning system, the HVAC system. Which is why I go out with a mechanical engineer on most of these surveys.

MS. KAPLAN: What steps do you take to evaluate the possible IAQ problems?

MR. TIFFANY: It somewhat depends upon the scope of the work. Typically it's a one-day survey. We're not going to come and do a research project there.

For example, one of the things we would do is review the blueprints if they're available, do a visual inspection of the building HVAC system as well as various spaces in the building.

Before getting into the building we try to get as much information as possible about what the complaints are, so to try and target what might be a problem. For example, if people are complaining of headaches, we might try to target carbon monoxide exposures, possibly offgassing of volatile organic compounds which could cause headaches as well.

MR. KERBEL: In the investigation of workplaces, and to determine what health effects may exist, one must go in and asses what the situation is in these given areas. Never, never whether it's an industrial, non-industrial areas, whatever, would one come in and blindly sample for compounds or any other thing, and have some magic recipe of here we come and sample for these pollutants without knowing what was going on in the building.

Essentially, if someone was working in a solvent with solvents, one would look at how they're using solvents. In an electroplating company they may look at acids that are used in baths.

In a building that's a non-industrial building where a process isn't clearly identified so that exposures can then be evaluated, let's say, one must also go into that building and see how that building is functioning, and evaluate whether the building itself is functioning as it was designed to and whether that design is appropriate. Until that initial evaluation is done, really no testing other than general environmental parameters may be addressed. I think that pretty well supports what AIHA's position is on using a performance-based type of investigation.

MS. KAPLAN: Can you give me any idea what the associated costs for remediation of these problems are other than the fees that NIH or other investigator would charge?

MR. KERBEL: Absolutely not. Without knowing what the problem is, one can't assume what the resulting costs of remediation would be unless I misunderstand your question.

MS. KAPLAN: I realize it's a range. Is there any way you can give a range of estimates?

MR. KERBEL: No. It can't be determined unless what the specific nature of the problem is.

MR. TIFFANY: It's a very site-specific issue.

I can give an example of something. I was recently involved with a building where there was a major flood. This is a building that's 500,000 square feet, undergoing HVAC renovation, and unfortunately, they didn't realize that this pipe had water in it when they cut it, so approximately 80,000 gallons of water later. It was also connected in with the sprinkler system so all the elevators shot down to the first floor and locked shut. By the time they could get up to turn it off, it had emptied out two water towers and set off the sprinklers. Within 24 to 48 hours they got rid of all their carpet tiles, all their ceiling tiles that got flooded in about a quarter of the building.

I can't give you exact costs for that, but it certainly must have ranged in easily hundreds of thousands of dollars. Plus there had to be some sampling conducted later on and so on and so forth.

MS. KAPLAN: You've emphasized that the proposed written compliance plan which is Section C of the proposal shouldn't be over-emphasized at the expense of the actual implementation of those steps.

MR. TIFFANY: Could you be more specific?

MS. KAPLAN: You've also, I think, recommended that some of those Section C provisions should be mandatory and others should be placed in an appendix. I wondered if you could specify which you think should be mandatory and which should be...

MR. TIFFANY: Again, this is not myself speaking. This is representing AIHA's comments.

Specifically in C, the indoor air quality IAQ compliance program. Number 3(ii) that says single line schematics or as-built construction documents. It starts with that. We're recommending non-mandatory. We're also recommending that number four should be non-mandatory which starts with "The following additional information if available."

MS. KAPLAN: What would be your reasoning?

MR. KERBEL: The things that are being asked for, first of all, generally don't exist. You're asking for a tremendous burden on most building owners for as-built drawings. As-built drawings, although a very good concept, generally don't exist. It's a nice idea. If they do exist, by you making it into mandatory language, we'd almost assume that you're requiring the building owners to develop some of these as-built drawings after the fact.

MS. KAPLAN: Is that something that's possible to do?

MR. KERBEL: What happens, an as-built drawing. You design, let's say, a ventilation system, and you say that this ductwork is supposed to go from point A to point B and there are certain areas in between.

When the actual construction occurs, problems are generated and it's installed in a different manner than originally was designed, with approvals from everyone.

As-built drawings are then, should be generated to show where these things really do exist. As time goes on offices are generally, you may have an office floor that has a fully open concept for ventilation purpose. No walls. As time went on, walls were put up, for whatever reason. Those drawings should then be updated, continue to be updated.

It's been my experience in the places that I've seen, that 99.9 percent of the buildings that I have investigated don't have any such documents that are up to date, as-built drawings, if you follow what I'm saying.

The HVAC commissioning reports and system reports as well as water treatment logs, and operator training manuals are appropriate, but I think our major concern in writing this is, our concern is that the water treatment goes on, and not necessarily an OSHA inspector comes in and is concerned that this paperwork doesn't exist, even though the practice of treating the water has been done, if you can understand that. That's why we differentiated between the two.

MS. KAPLAN: Between what...

MR. KERBEL: Between what we felt was mandatory and non-mandatory relative to the program elements of your compliance plan.

MS. KAPLAN: So you're suggesting that those be non-mandatory I guess largely because your experience is they're often unavailable.

MR. KERBEL: The effort to put that together is substantial.

MR. TIFFANY: And specifically in a multi-leased space that would be very difficult for employers to profile that. There's a tremendous amount of changes in those tenant spaces over time, and as-builts, whether it's in a multi-leased space or not, as Bill said, are very difficult to obtain.

MS. KAPLAN: How much effort would it take to reconstruct those documents.

MR. KERBEL: I doubt you have them for this building. My assumption, just quickly seeing this building would be a substantial effort of man days, probably a number of months for an engineering study to be done, and just the generation of the as-builts for this building could run anywhere between $50,000. IS that something that's very useful for you? Yeah, it's useful.

Is it worth the $50,000? We didn't think so.

MS. KAPLAN: Do you think if we required it in this standard it might...

MR. KERBEL: Promote other people developing it from this point on?

MS. KAPLAN: Yes.

MR. KERBEL: Hopefully that would be the case. But as we read it, it's almost saying that you're now required to generate as-built drawings for your facility, do you follow? So that all facilities in the United States would be required to generate these as-built drawings, which really don't exist. We're lucky sometimes to find design drawings in a lot of buildings. But certainly as-builts with multi-tenants, multi-tenants doing their own renovation work. The landlord may not necessarily know what's going on in each of the individual floors, nor would the other floors know what's going on in floors which may affect them because they're on common HVAC systems. It's a burden.

We felt that it's good, but not necessarily mandatory.

MR. TIFFANY: It wasn't like we said delete Section C. We picked out what we thought were somewhat onerous tasks to do out of that.

For example, we support the concept of a written narrative description of the facility building systems, for example. A general description of the building and its functions, so on and so forth.

MS. KAPLAN: What about O&M logs? Doesn't there have to be some sort of written direction in that area?

MR. KERBEL: You are requesting requiring that the compliance plan have a central location in a building, that when someone comes into that building they find the designated person. That designated person has this compliance plan. At the same location, all of these other materials exist.

We don't feel that it should be mandatory to have all of those documents at that location. Whether we feel those documents should exist is an entirely different question.

MS. KAPLAN: If they don't exist in the building where are you saying they do exist?

MR. KERBEL: The person who's doing water treatments will have a log of when they've done treatments on the cooling tower, let's say. Does it necessarily mean that the building office on the first floor, whoever the designated person, has that? In a multi-employer site where there are a number of different tenants, will each individual group need to have these water logs based on what the treatment for the entire building has been? From an employer/employee relationship. If company ABC is on the fourth floor and they have use space there, is it important that they have the data generated by the building manager as a whole, who is taking care of the building common space and common equipment? That's the question. We don't think so. That material exists somewhere and should exist. Does it need to exist as part of everyone's designated person's file? No. Not mandatory.

MS. KAPLAN: So you feel that currently... Well you feel this is all information that should exist, but you're just not sure at all that every single one of these documents needs to be in exactly the same place. That's basically what you're saying.

MR. KERBEL: I think it's more than that also, it's the cost involved in trying to generate these.

MR. TIFFANY: Especially with the as-builts.

MS. KAPLAN: Wouldn't having these documents be helpful in helping employers to comply with the Section D with the implementation of the program?

MR. KERBEL: It would be more appropriate that in the compliance plan you identify where you can find these items. The way it's written is, all these items are sitting in a central location.

We would have a problem with OSHA coming in and saying geez, the building works really great. It's really nice. We checked it out. But your problem is you don't have as-built drawings.

Our concern isn't that these documents exist. It's ultimately that the building is functioning the way it's supposed to. That we have a healthy environment.

MS. KAPLAN: Presumably you feel that to some extent there's some correlation there between the building running well and... Maybe not each one of these documents but in general having appropriate documentation available.

MR. KERBEL: It's no like we aren't calling for any documentation.

MS. KAPLAN: You're supporting...

MR. KERBEL: Yeah, a checklist for the visual inspection of the building systems and so on and so forth. We're only touching on a few of the ares there.

MS. KAPLAN: Can you expound on your suggestion that there be both a designated person and a competent person and how the functions of the two would differ and also how the training of the two would differ.

MR. TIFFANY: I'm going to first go to page three of our written comment to see if that can make it clear. Under designated persons. This will be expounding a little bit more than what was in my summary testimony.

The proposal would require that a person who is knowledgeable in the requirements of the standard and the specific buildings systems and who has been given the responsibility to take the necessary measures to ensure compliance with the standard, including implementation of the IAQ compliance program be designated.

The proposal unnecessarily merges two distinct functions. The first function is properly performed by a designated person. In other words, a person who is knowledgeable in the requirements of the standard and the specific building system.

So again to repeat, the first function is properly performed by a designated person responsible for ensuring compliance with the standard. Such a designated person must first know the requirements of the standard; second, be generally familiar with the subject of indoor air quality; and third, be responsible for implementing the facility's indoor air quality compliance program.

This is the appropriate role for a designated person as used in the Environmental Protection Agency's regulation under the Asbestos Hazard Emergency Response Act, the HERA, 40 CFR 763.84 Section G, Section 1.

The second function, should be performed by a competent person as described below, who may be different from the designated person. Competent persons. Certain functions, specifically being capable of identifying indoor air quality hazards, and authorized to implement controls promptly proposed by OSHA to be performed by the designated person, should be performed by a competent person. This competent person function is used in all of OSHA's construction industry standards, 29 CFR 1926.20(B)(2), 1926.32(F). Explicitly in OSHA's recent Lead and Construction Standard, 29 CFR 1926.62(C)(E)(2)(3). And in the EPA's analogous on-site representative and its Clean Air Act regulations for asbestos projects, 40 CFR 61.145, Section C, Section 8.

An employer could have one or more than one competent person for a facility, depending upon its size, the time and location of construction, operation and maintenance activities and other factors. On the other hand, the employer should have only one designated person for the facility's indoor air quality compliance program to keep the line of overall responsibility for ensuring compliance with the standard clear.

An employer may be fortunate enough to have a person who is both technically competent in implementation of an indoor air quality control standard, and in the position of organizational authority to implement the standard. Most employers will not.

The standard should separate the roles of designated person and competent person. This would minimize the burden on employers to either hire a contract for a person with both abilities, or have to change the lines of organizational authority and responsibility when neither would be required if the functions could be separated.

MS. KAPLAN: What sort of training would the designated person have, and how would that differ from the training of the competent person?

MR. KERBEL: We envision the designated person as having someone with organizational authority, having training anywhere from four to 16 hours of training around the requirements of the standard, basic issues surrounding indoor air quality, et cetera. Whereas we're talking about a competent person being more of a professional, whether that being in the areas of industrial hygiene, mechanical engineering, or physicians. Obviously that training is much more extensive.

MS. KAPLAN: Is the basis of your idea here that for maybe smaller employees they could have a designated person without having to have a competent person...

MR. KERBEL: That's correct.

MS. KAPLAN: Or for multi-employer buildings...

MR. KERBEL: Well yeah, the designated person would have at least the training to realize when they needed a competent person to come in and assist.

MS. KAPLAN: The competent person then should be how readily available?

MR. KERBEL: We would say that certainly in larger organizations they would already have competent persons on staff. What this would do is ease some of the burden on small employers who would essentially go to someone who has been defined as competent, and in this way OSHA can assist a small employer by defining what competency is to this end. It gives them some direction to go to the phone book or whatever they need to do to get assistance.

MS. KAPLAN: We've had some suggestions here that in order to ease the burden of the standard on small employers there could be some kind of exemption related to either a minimum area or a minimum number of employees. For example, an employer that had an area less than a certain number of square feet would be exempt from certain requirements of the standard.

Would you agree with this type of suggestion?

MR. TIFFANY: We haven't taken a specific detailed position like that. We do have, on page nine of our comments where we talk about small employers. However, we understand the concerns.

MS. KAPLAN: Are there any other specific suggestions you would have on minimizing the compliance burdens for small employers?

MR. KERBEL: We haven't really addressed that.

MS. KAPLAN: You stated that the standard should clearly separate SBS, BRI, and thermal comfort issues. Could you explain this a little bit further?

MR. TIFFANY: Let me just start with talking about, there are certain parts of the standard that call for work to be performed when building-related illness occurs. One of the things that we would like to see added there is that the definition of building-related illness should be expanded to state that it requires medical involvement for diagnoses. There are several different areas in the standard where that talks about for renovating the HVAC system, for example.

In terms of comfort issues, thermal and humidity comfort issues, we feel they should be explicitly excluded from the standard. The standard should be based on preventing significant impairment of employees' health and should not include minimizing discomfort unrelated to this goal.

The discussion of sick building syndrome in the Preamble, and I'm quoting here from our written comments, "The discussion of sick building syndrome in the Preamble of the proposal is reasonable and can form the basis for developing a definition in the standard."

MS. KAPLAN: As far as the distinction between BRI and SBS, you're saying there should be a medical diagnosis before the HVAC system is evaluated?

MR. KERBEL: No, what we're saying is with building-related illness there is a sound scientific definition and a medical etiology related to the specific diseases, such as Legionnaire's Disease. There is an identifiable agent. There is an identifiable situation and a relief that can be addressed.

With sick building syndrome there is no such thing. There is a multitude of issues that are based on symptoms and that have a commonality to them, and there is relief when an individual leaves a building . This is a lot different than when we're talking about a specific diseases caused by a condition within the building. A specific condition has occurred, a disease has resulted, there is a medical diagnosis that has been made.

When people go on cruises and come out with Legionnaire's disease, it can be identified, what's going on. Sick building syndrome is different than that.

The thermal issues, especially from a recordkeeping standpoint, from an incident standpoint, shouldn't be included. Every time someone complained that it was too cold or too warm, to have to make an entry into a log would be over-burdensome.

MS. KAPLAN: I thought you had suggested that a diagnosis of BRI but not simply SBS symptoms should trigger an evaluation of the HVAC system . Did I misunderstand that?

MR. TIFFANY: What we were attempting to do was to address what's in several different sections. For example in D, compliance program implementation. Number 12 says, under that, "evaluate the need to perform alterations of the building systems to meet the minimum requirements specified in paragraph D of the section in response to employee complaints of building-related illness. We're suggesting that employee complaints, well, how do you know it's building-related illness? The way you know is by having it medically verified.

Again, it's mentioned in Section G, employee information and training. Number two, all employees shall... Number two, signs an symptoms associated with building-related illness, and then requirements under Paragraph D(12) and D(13) of the section, directing the employer to evaluate the effectiveness of the HVAC system, and to take remedial measures to the HVAC system if necessary, upon receipt of complaints from employees of building-related illness.

You can get a lot of complaints. This could go on and on and on, almost on a daily basis. What we're calling for is that it should be medically verified before you go to such a strong measure.

We're not saying that building-related illness doesn't exist. It does. We're saying that you have to document that.

MS. KAPLAN: In all those examples you just read where certain requirements are laid out in terms of BRI, what if that also mentioned SBS symptoms? Would you think any of those requirements are appropriately triggered by SBS complaints?

MR. KERBEL: That would really be speculating at this time. But my feeling personally, not speaking for the association, is that there's a difficulty with the definitions. Building related illness is a condition where there is a known diagnosis of a disease. Sick building syndrome simply identifies a condition or a situation where a number of people are complaining of a condition and there may not be a diagnosis by a medical physician of sick building syndrome.

The third issue is the thermal issue, whether it's hot or its cold or whatever.

Assume that you have a condition where there is a building related illness, Legionnaire's disease. Once there's a diagnosis and there's been an identification of Legionnaire's disease within the building, you should immediately respond with whatever engineering controls are necessary to safeguard the occupants of the building. They're very clearly defined in what you would do.

If you traced it to a cooling tower, you would treat the water in the cooling tower.

With sick building syndrome, so to speak, those answers are not as clearly defined on what the engineering controls are that need to be addressed immediately. You may know what they are. You may not know what they are. You may have to try a number of different things.

With the thermal problems, you're going to have thermal problems in places that have been designed in 1974 and didn't take into account all the computers and all the laser printers and everything else that exists in today's modern office. Those engineering concerns shouldn't be really addressed here.

What we're talking about and what I'm talking about personally, is there are conditions that are building related illnesses that can be lethal, and you have to have the ability to address those immediately. I'm not quite certain that sick building syndrome is part of that definition.

MS. KAPLAN: You suggested that OSHA should take into account privacy concerns in regard to records like when records are transferred because an employer goes out of business. Can you explain what those privacy concerns are?

MR. TIFFANY: I'm going to read what's in our written comments on page ten under miscellaneous issues. Privacy of records.

"OSHA should address privacy concerns about making records such as employee complaints available. It should address privacy concerns on the transfer of these records when an employer goes out of business. The case of not having a successor for an employer which ceases to do business which is omitted from the proposal, should also be addressed for both procedural and privacy considerations."

MS. KAPLAN: Specifically, what would your privacy concerns be about employee complaints?

MR. KERBEL: I can't answer that question at the moment because I wasn't involved in that specific generation of that issue.

From my own feeling, is that we really don't have a specific concern of our own other than there is an issue of privacy that should be addressed. In other words, we think this is something that OSHA should address on the privacy issue. WE don't particularly have a solution to it, or a specific problem with it. But as we read the regulation, it's not addressed.

MS. KAPLAN: you said in your testimony that "OSHA should describe the scope of work below which remodeling and renovation would not be covered by the standard because there is a deminimus work level beneath which the risk of significantly degrading building IAQ is minute."

In your opinion, which remodeling and renovation activities should trigger these requirements and which should be considered deminimum?

MR. TIFFANY: I'm going to just read what is written here. On page six of our written comments under Renovation and Remodeling, "OSHA should provide, first, criteria for scopes of work below which renovation remodeling are not covered by the standard. Second, scopes of work below which periodic rather than project by project notification is sufficient. Below a deminimus level of activity, the risk of significantly degrading building air quality as contrasted with the quality of the air breathed by the mechanical or construction workers which is addressed by other OSHA standards, becomes minute and the full work plan development and building employee notification process becomes unnecessarily burdensome in relation to their potential benefit.

"Similarly, for routine performance activities between the deminimus level and the level of major renovation and remodeling, periodic building employee notification, annually for example, may provide sufficient information to remind notified persons of indoor air quality issues and their rights thereto."

MS. KAPLAN: Why do you feel meeting these requirements would be burdensome?

MR. TIFFANY: AIHA did not specify... Under scope of notification, maybe we can address that, make that more clear.

We say that "OSHA should consider deleting and making non-mandatory or significantly restricting the proposal to notify building employees of anticipated adverse impacts or renovation remodeling on indoor air quality or workplace conditions. Health-related notification will be credible and beneficial in the indoor air quality health arena only if the activity is likely to affect health. In such a case, advance notification is appropriate.

"Virtually all workplace activities including it must be said, occupancy of an area by renovation and remodeling workers, introduce air contaminants into the workplace. Mere introduction of air contaminants independent of type or level, does not warrant notification."

MS. KAPLAN: I guess I have the same question regarding the second statement you just read which is, can you give us any ideas as to which activities you feel could be unhealthful and should trigger these requirements, and which wouldn't? I understand you're xing this is something OSHA should consider, but I'm asking whether you have any suggestions.

MR. TIFFANY: AIHA doesn't have an official statement on that. Speaking as an individual now, for example, if somebody is going to paint a wall in an office, when does that start to click in on this? It just seems to be... A renovation that's going to be a floor of a building has some significant impact if it's a small area. I just think there should be more detail n that.

MR. KERBEL: Construction in a building may involve complete remodeling of a floor. There's going to be significant amounts of, let's say, during demolition, particulate generated. Therefore, the HVAC systems may need to be shut down, isolated, what have you. Large floors may be reconstructed with new materials, allowing for the offgassing of materials, et cetera. Clearly there is a potential for adverse conditions to affect the air quality of the indoors and other areas.

Then we talk about a very small area. The painter comes in and he's going to put some new cove molding on the bottom of the floor. He's going to use an adhesive. He's going to use whatever it is.

Is he going to generate some contaminant? Absolutely.

Is the person who is walking across the carpeting generating some contaminant? Absolutely. He's knocking up whatever's in the carpet into the air. But it's at the level as to believe that it's not going to really affect anyone from merely walking across that carpet or putting that molding on. That type of information should be readily available through the material safety data sheets -- not so much from the carpet issue but from the adhesive being used on the carpet molding.

If the material safety data sheet said use with adequate ventilation and that could be achieved, then you wouldn't necessarily need to notify people who were on, maybe on the same floor on a common air system, but would ever be affected. The determination on that should be done on a case by case basis. At least that's one industrial hygienist's opinion.

MS. KAPLAN: Would you say that in general, I guess Mr. Tiffany said he fines that HVAC systems are probably a major component of IAQ problems. How much of a factor is lack of training in the proper operation and maintenance of the systems?

MR. TIFFANY: I find that to be a major factor.

MR. KERBEL: I agree with that.

MR. TIFFANY: With a VAV system, a variable air volume system, which works on having individual VAV boxes controlled by a thermostat, typically in our northern temperate climate, the way it functions is if it's thoroughly satisfied by the thermostat, then we'll go to a minimum pre-set, hopefully opening on the VAV box.

A lot of times people will complain in office buildings of a cold draft during the heating season. I've been involved with a number of buildings where the maintenance person knows enough to go up and turn a little screw that makes that go completely full shut when it's thermally satisfied, controlling that VAV box, the thermostat. That's all he knows. Later on when they complain about stale, stuffy air, he doesn't know how to undo it.

Another example, I was in a building with 11 roof-top units with people complaining of stale, stuffy air. There was an outside contractor, which is typical for a lot of buildings. This was a building, three stories, approximately 40,000 square feet. A lot of buildings don't have in place engineers. He was coming and changing out the filters and what not.

It ended up that for the last three years before his being there, we were able to ascertain later, approximately three years before that, that all of them had been shut off. So they were getting no outside air through the 11 rooftop air handling units which were constant volume. He didn't know that. He was just going up and changing out filters, which were relatively clean, on a quarterly basis. He was not aware of that.

I didn't determine that myself. That was done with a mechanical engineer. To me it looked... I just didn't know. I don't have that type of detailed knowledge of mechanical systems. Obviously, neither did this outside maintenance contractor.

MS. KAPLAN: What sort of training do you think people who are responsible for HVAC systems should have?

MR. TIFFANY: In the Preamble where you talk about training, one of the comments that AIHA made was not really estimating perhaps the total cost, one of the things we were keying on was the training where on page 16,016 of the Federal Register which has the proposed rule from April 5, 1994, Volume 59, Number 65. It says one-half hour of maintenance worker time for training.

AIHA doesn't specifically say how many hours that should be done, but we clearly think 30 minutes is not enough. Something in the range of one to three days, depending upon how complex the system is. A lot of it has to be site specific, unfortunately.

There are many different types of systems. Perhaps there could be an overall course that can cover many different systems, and therefore, not have to go around and make it site specific at each area. But that would certainly involve more than 30 minutes.

MS. KAPLAN: Who should provide this training? Would there be courses, that sort of thing?

MR. KERBEL: I think what we're discussing also is that there are probably a number of different levels of courses that would be required, or training. One would be for the actual individuals who are maintenance personnel who are running the HVAC equipment. Also those possibly doing custodial or housekeeping where their activities may result in problems if improperly done. A second level may be building owners, managers, and such on more of an executive level, looking at different issues than they have to.

Certainly there is something to be said on keeping professionals aware of the issues involved here, such as possibly if you're an architect, engineers. We've all seen some of the nightmares that have been developed over time.

Who would give those? Again, it would probably be defined, we would suggest that OSHA consider defining within their competent person. We would hope that a competent person is a professional that would be capable of doing all of those.

JUDGE VITTONE: Excuse me a second.

How much longer do you have?

MS. KAPLAN: Twenty to 30 minutes.

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

JUDGE VITTONE: On the record.

Ms. Kaplan?

MS. KAPLAN: I just have one more question on training, which is how often do you feel it should be repeated? Would you say annually, or just when systems change?

MR. KERBEL: Both. Annually and if there are major changes to the system.

MS. KAPLAN: You submitted with your testimony a November '93 AIHA press release announcing that AIHA had joined with the Occupational Health Nurses and the American College of Occupational and Environmental Medicine to form the coalition regulation of workplace environmental tobacco smoke. Have these organizations collaborated on a single workplace hazard before?

MR. KERBEL: NO.

MS. KAPLAN: What was the impetus for your doing that this time?

MR. KERBEL: The purpose was to solicit Department of Labor into addressing environmental tobacco smoke in the workplace.

MS. KAPLAN: So that's sort of the stated purpose of the coalition?

MR. KERBEL: Yes.

MR. TIFFANY: It was the stated. OSHA's addressing it, so...

MS. KAPLAN: Does the coalition represent the members of each of the three parent organizations?

MR. KERBEL: No. You mean does the coalition currently represent the positions of AIHA?

MR. TRIPPLER: Let me see if I can address that.

The coalition was formed to solicit a response from the Department of Labor to address the issue of environmental tobacco smoke and indoor air quality. At that time the three organizations collaborated on coming up with a position in which to send to the Department of Labor, and that was done.

Once the Department of Labor proposed this IAQ standard, the coalition did not take any further action. We did not collaborate at all on any response to the proposal. Each organization submitted their own comments and their own on this actual proposal you have before you. So the coalition has not really been in existence since the time that we solicited DOL to propose a standard.

MS. KAPLAN: Did the Department of Labor respond to the letter you sent?

MR. TRIPPLER: To my recollection, yes.

MS. KAPLAN: Do you know what the response was?

MR. TRIPPLER: I believe they thanked us for our efforts and I think they said something like a proposal would be forthcoming. You're getting back beyond what I can remember.

MS. KAPLAN: The coalition recommended that restricting smoking in the workplace could be based on the measurement in air of an appropriate component of ETS. Do you know if by this the coalition was suggesting a PEL?

MR. KERBEL: We have discussed this, and we developed a task force...

MR. TIFFANY: He's talking now AIHA.

MR. KERBEL: AIHA. Dealing with the statement of the coalition. It was the result of that task force's deliberation, or the feeling of that task force that there was no specific indicator at this time that could be recommended for ETS.

MS. KAPLAN: No specific indicator?

MR. KERBEL: Tact's correct. Any target compound, if you will.

MS. KAPLAN: So then there's not a recommendation for a PEL of any particular level.

MR. KERBEL: The coalition may have said that. Our proposal is, our comments are based on OSHA's proposal. So we're dealing with two different things right now. If you're asking me what the coalition said, for all intents and purposes the coalition really doesn't exist because it's achieved its goal of addressing this topic. Now AIHA has developed its comments to the OSHA proposal.

Within the OSHA proposal, it's our comment that we believe a performance-based standard is preferable to one that deals on a chemical by chemical basis, which essentially would be a PEL type approach.

MR. TIFFANY: In other words, we support OSHA's approach which is source control and engineering control as the most practical and effective approach to ETS.

MS. KAPLAN: So you're saying if the coalition may have made a suggestio that a PEL may have been an appropriate approach, that was before this proposal was promulgated and you would support the tack OSHA took in its proposal over a PEL approach because it's more protective. Is that what you were saying?

MR. TIFFANY: Specifically, to quote from one of the coalition, the statement that came out, it says, "The risk of developing cancer or other health problems from workplace exposure to ETS should be reduced to an acceptable level of exposure as defined by OSHA."

So we said...

MR. KERBEL: That's the coalition statement. I would think we would more appropriately address our comments to the proposal. In our comments to your proposal, we wouldn't subscribe to a PEL for ETS, if that's the question.

MR. TIFFANY: It's a very difficult... To measure any particular component of ETS misses the mark, in essence. I'm saying this now as an individual, not necessarily as AIHA's official statement, though we did, on this ETS task force, address that, where we said there was no sufficient... Bill you have it. No sufficient marker for ETS. That was set up, a task force based on comments to the OSHA proposal.

In other words, this was not written by me, by any means. This was written by a number of different people and subcommittees dealing with different issues.

MS. KAPLAN: When you talk about the task force are you talking about the documents you submitted to us, or are you talking about something different

MR. TIFFANY: Yes, the documents submitted today. Well, resubmitted today. That are specifically AIHA's comments.

MS. KAPLAN: You did say in your testimony more generally that OSHA should continue with a performance-based standard rather than a chemical by chemical one. What would be your basis for this recommendation?

MR. KERBEL: In indoor environments you have a myriad of pollutants or potential for pollutants to be generated. You have a number of different situations and circumstances that can occur. Let's assume that I came in as a compliance person, and had a set number of contaminants to measure on Tuesday, the 24th of January. Those contaminant levels that I would generally find in an office building or in a non-industrial work area, may be very different today than they will be any successive day or any day previous. Things change. What people are working, generally in the non-industrial environment, you don't have consistency with respect to what the concentrations of individual contaminants may be. You don't have consistency with work practices on who's using what, who's wearing what type of perfume, who is doing whatever that you do have in industrial settings.

Therefore, to look at it at a chemical by chemical basis, here is this acceptable level. Is this acceptable, is this acceptable. You can go into a given situation and measure and find that it's acceptable. However, the following day it certainly won't be acceptable because the condition existed for it to be exacerbated. That certainly would be true for microbial contamination.

If you took a sample for airborne molds, you may find very low levels of molds. However, if you opened up the HVAC system, you may find plating of molds inside the unit itself, a nightmare ready to happen, if you will.

Therefore, it's most appropriate to look at, number one, how is a building supposed to function, and then walk through and see if it is functioning in that manner, instead of blindly going in and sampling for all these different levels of these and arbitrarily making acceptable ranges for them.

MS. KAPLAN: You also stated that your experience with IAQ issues has been that an integrated or multi-disciplined approach works best. Could you explain that statement?

MR. TIFFANY: Poor IAQ is not typically caused by one particular factor, most typically, otherwise, they probably would have solved the problem.

Typically, it's -- well, it's kind of hard because a lot of it's site-specific, but one can make generalized statements that a lot of times it'll involve some aspect of the HVAC system, either the design or the maintenance of it, or the operation of it. It could be all three of those.

Or some pollutant source, usually which is not a constant source, it varies over time. It could be a volatile organic compound, it could be carbon monoxide being generated from an interior parking garage. It could be some processes in the workplace such as printing or paint shop that's affecting other areas of the building.

What you need to do is have an understanding of how that building functions. If the building is dynamic, the best approach is to bring in, not necessarily the National Guard on this, but to bring in different trained eyes and trained ears, if you will, to look at different aspects of the building to try and understand that.

That's the concept of a multidisciplinary approach. It typically would be an industrial hygienist and mechanical engineer, though. In some cases, it doesn't always have to be that type of tag team, but it tends to be more successful than solving these problems.

MS. KAPLAN: Are you familiar with the Industrial Ventilation Guide published by the ACGIH?

MR. TIFFANY: Yes.

MR. KERBEL: Yes.

MS. KAPLAN: In scope and focus, are you aware of anymore authoritative guide than this one?

MR. KERBEL: No.

MS. KAPLAN: That guide, in a discussion of general dilution ventilation, warns of some application limitation, including distance from the source to the breathing zone, toxicity of the contaminant, and uniformity of contaminant evolution.

Regarding non-industrial worker exposures, do you believe any of these limitations apply to controlling ETS with general dilution ventilation and delivered by a conventional HVAC system?

MR. KERBEL: Yes. The general dilution ventilation, or essentially general ventilation is used for the purpose of either providing a comfortable thermal environment and, to some degree, the ventilation of removing bioeffulents generated by its occupants, bringing in indoor/outdoor air.

General ventilation is never really used when you're trying to control toxic materials, whatever they may be. In that case, you want to use cost control ventilation, contaminant control.

If I'm generating in a lab and I have some materials that I'm going to be working on, I wouldn't want to reintroduce those materials back into the breathing zone of anyone, nor would I want to have the ventilation such that the vapors would have to pass by my breathing zone in order to be captured by the ventilation system.

So, in terms of contamination, general ventilation is not the preferable method. Source control in indoor air is, and when feasible, because of whatever the reason, maybe you need to have a printing facility in your building, well, those materials shouldn't be dealt with from a general ventilation standpoint.

Your photographic process shouldn't be generated back.

Any type of contaminant you know you are generating in a building, you've just caused yourself trouble, and you should be dealing with it on a contaminant control basis, and that would certainly be true of environmental tobacco smoke.

MR. TIFFANY: There's a hierarchy, too, in industrial hygiene, which is source control and then engineering controls.

MS. KAPLAN: The ACGIH guide recommends that a safe ventilation rate be employed. Does this imply that the ventilation system designer may design for access ventilation as a margin of safety?

MR. TIFFANY: Again, you're talking about with general ventilation?

MS. KAPLAN: Yes.

MR. KERBEL: That you're going to overdesign a system? Is that the question? Just repeat the question to me. I'm sorry, I was thinking of my kid.

[Laughter]

MS. KAPLAN: The guide recommends that a safe dilution ventilation rate be employed. Does this imply that the ventilation system designer may design for access ventilation as a margin of safety?

MR. KERBEL: Yes.

MS. KAPLAN: The guide also recommends that general air movement should keep the source, for example, the cigarette, between the non-smoker and the exhaust return opening.

This would imply some displacement ventilation. Is that correct?

MR. KERBEL: Yes.

MR. TIFFANY: Yes.

MR. KERBEL: What, essentially, you're saying is that you don't want to have the mechanism of removal or the pathway of removal to pass through the breathing zones of everyone breathing.

MR. TIFFANY: It's like you don't work in a canopy hood with hazardous chemicals. It's going to come through your breathing zone. That's why you have --

MR. KERBEL: A good example of that right now is the issues of tuberculosis, how if you had a patient with tuberculosis in a health care facility, you would want the air, not coming from that individual towards you but the opposite direction.

MS. KAPLAN: Is this possible with the conventional mixing HVAC system?

MR. KERBEL: No, it's not.

MR. TIFFANY: No. It's not the purpose of that type of system -- conventional system. They can't deal with strong pollutant sources.

MR. KERBEL: Those type of systems also may not have proper mixing, a number of different reasons. The purpose of those type of ventilation systems are to cool the air, heat the air, provide some type of comfort.

It's not to -- they're not designed to control contaminants, contaminants that have been generated in this case.

MS. KAPLAN: Would you share some of your personal experiences in applying industrial workplace to the non-industrial workplace?

For example, at what exposure level do you recommend mitigation to your client of persistent CO in an office building? What PPM?

MR. TIFFANY: Under the 1989 revisions, we didn't go through, so I'll refer back to the PEL of 50 parts per million, of carbon monoxide, and the ACGIH's TLV threshold limit value, which is 25 parts per million based on 8-hour time-weighted average, TWA.

I don't expect -- if I find 4 or 5 parts per million in an office setting, I get concerned about that in a non-industrial work setting. I don't expect to see it, period.

What I typically find, when measurements are done for something like CO in an office setting, typically, you're not necessarily getting the peak of it. From my own personal experience, a lot of times once we have a better idea perhaps what's causing it, and I found it to be a problem with interior parking garages and buildings where there's a stack effect in some cases, and it overpowers the exhaust.

I'll just take a specific example. We did a two-day survey. The first day it was like a monsoon out in June. It was raining very heavy in June, and the CL levels were 0. This was a three-story building where the basement had 80 vans, service vans.

Coming back the following week, when it was typical weather, one of the things we also had noticed was that the design called for 30 exhaust fans and there only were 11 in the building, down in the basement. So we had noted that also.

When we came back, we made sure we came back early in the morning before the vans went out and carbon monoxide levels down there shot up, using a sensitive electrochemical device; shot up to 130 parts per million.

In the occupied areas, they were in the range of 15 to 20 parts per million, and that persisted for about 3 or 4 hours.

MR. KERBEL: May I expound on this a little?

MS. KAPLAN: Sure.

MR. KERBEL: Threshold limit values, those substances that are used by -- or limits that are used by industrial hygienists are not pass/fail numbers. These are numbers or things that are used by professionals in their evaluations.

OSHA's regulators need PELs because of the nature of the animal, if you will.

In the indoor environment, if you go in some place and you shouldn't be seeing things you shouldn't be seeing. If you go into an industry and they've got gas-fired forklifts and you measure 30 parts per million of carbon monoxide, your eyebrows may not raise that much because you know you've got a combustion source, you expect carbon monoxide.

Whereas, in an office building, if you find 30 parts per million, you're not going to turn around and say, well, it's all right, it's below the PEL. That's silly. You're saying, why is there, it doesn't belong here. And you search back and you look and you find and maybe you find a corroded coil of a heating unit inside or something similar.

In all of these cases, if you start seeing these materials, you first question is why am I seeing this, it doesn't belong here.

MS. KAPLAN: Well, if OSHA was required to define a PEL for environmental tobacco smoke, how would you, as an IH, help a client apply the hierarchy of controls to the workplace?

MR. TIFFANY: The traditional industrial hygiene approach is a hierarchy, as you mentioned, and the first one is source control, so you try to eliminate the source.

MS. KAPLAN: Would substitution be an option?

MR. TIFFANY: For something like cigarette smoke? I don't know what they would substitute with it.

MS. KAPLAN: Isolation?

MR. TIFFANY: It would have be like what OSHA has said in their proposed standard, which is dedicated exhaust, designated smoking area.

When you say "isolation," with the way a general ventilation system works, if you just put someone down the hallway, it's going to circulate.

MS. KAPLAN: What about administrative controls?

MR. KERBEL: Yes, absolutely. May I go back to your question? Did you say, if I were an industrial hygienist and I was going to evaluate the PEL from environmental tobacco smoke what I would do?

MS. KAPLAN: You were going to help a client to apply the hierarchy of controls to meet the PEL.

MR. KERBEL: Fair enough. I would, first, try to find substitution. If I couldn't do that, I would use the other tenets of industrial hygiene, including isolation, as John as remarked. I wasn't sure of the question.

MS. KAPLAN: I think he said, isolation wouldn't be an option, other than the type of designated smoking areas proposed by OSHA.

MR. KERBEL: Certainly, isolation would be an option. If you can isolate contamination, you kept it away from exposure of individuals, as long as someone is not being exposed, you've addressed the issues.

If I'm confusing you, you would have to define what isolation means to me. I'm mistaking what you're saying.

MS. KAPLAN: Suppose OSHA has a PEL for environmental tobacco smoke; another example, you are trying to help a casino client meet that PEL, using all the standard IH practices; as to the exposure of, for example, a blackjack dealer, and this is a similar question, would substitution be an option?

MR. KERBEL: You're saying a PEL for ETS, hypothetically, a numerical value were something of ETS limits? Is that what you're asking me?

MS. KAPLAN: Right. And the blackjack dealer is overexposed.

MR. KERBEL: And I know that he's been overexposed because I've taken enough samples to find a 95 percent confidence level that this is in excess of this theoretical PEL that exists.

Okay. Could you go again? I'm sorry.

MS. KAPLAN: I guess I'm just trying to go through the traditional hierarchy of controls to try to see which might be workable in this kind of situation, and so I was --

MR. KERBEL: Well, the first one that wouldn't work would be measurement.

MS. KAPLAN: Why would that be?

MR. KERBEL: If I'm going to measure what someone's exposure is to a substance, I have to have enough data to identify what the representative exposures is. Now, you said a casino. How many people are at that table at any given time, over an 8-hour period, or whatever time you want to talk about? How many people are smoking, how many cigarettes are they smoking, what type of cigarettes are they smoking?

All of these variables, all of these variables, would not lend themselves for you to take instantaneous readings, or even short-term readings in time, and make evaluations that said, well, this is what it's going to be forever.

I have a confidence that this is what their exposure is all the time. It's just too difficult too do, if at all possible.

Therefore -- and this is basically a tenet of industrial hygiene -- that you don't go after anything and try to make it, you passed, you failed. You try to avoid exposure when it can be avoided in a reasonable manner.

In those cases, I think the isolation issues, the ventilation issues, are the more appropriate way to approach it.

MS. KAPLAN: Well, suppose for the sake of this example that the blackjack dealer -- that there's personal sampling been done, so you do have a measurement and you know that this employee is overexposed.

MR. KERBEL: Assuming that the overexposure is occurring, is I would look for engineering controls to avoid that exposure.

MS. KAPLAN: What types of engineering controls?

MR. KERBEL: The engineering controls would be source control ventilation, removal of the offending problem, identifying it as a nonsmoking area. Essentially, that's it. I either get rid of the source, the problem, or I isolate the individual from the problem.

MS. KAPLAN: If it wasn't possible to remove the source and all these efforts failed, would it be feasible for the blackjack dealer to use respiratory protection?

MR. KERBEL: Would it be feasible?

MS. KAPLAN: Yes.

MR. KERBEL: My personal opinion of whether that would be feasible, my opinion would be it would be very difficult to say, do you want to hit, or something like that, have him understand. I wouldn't think that's feasible.

Say, I misunderstood you, and there would be all kinds of arguments.

MS. SHERMAN: I just have a couple of questions, if you will. I'm Susan Sherman.

Are you familiar with something called smoke-eater?

MR. KERBEL: I believe I am. An electrostatic precipitator?

MS. SHERMAN: I believe that's it. We've gotten some very general testimony about its use in American Legion halls, et cetera.

Do you know what the efficacy of these smoke-eaters is?

MR. KERBEL: No, I don't.

MR. TIFFANY: No, I don't either.

MS. SHERMAN: You've never studied or taken any measurements as to what they will or will not do?

MR. KERBEL: That's correct.

MS. SHERMAN: Thank you.

MS. JANES: I've got a question. In the progression of building from healthy status to problematic status, James Woods testified at this hearing that health problems would problem increase in severity as the condition of the building deteriorated from healthy to problematic.

Do you consider difficulty breathing a severe endpoint?

MR. KERBEL: Yes.

MR. TIFFANY: Yes.

MS. JANES: Do you consider chest pain a severe endpoint?

MR. KERBEL: Yes.

MR. TIFFANY: Yes.

MS. JANES: How about sinus conditions?

MR. TIFFANY: Yes.

MS. JANES: Do you consider these severe because they are medically viable?

MR. KERBEL: And avoidable, possibly.

MS. JANES: And avoidable. I was just going to ask --

MR. TIFFANY: I would just like to say for the sinus condition, like right now, I'm suffering from a cold. I don't think the cold was caused by sick building syndrome or something. So when we're talking about sinuses, some of those conditions can be caused by allergic-like reaction as opposed to just a simple, I hope, cold.

MS. JANES: I have small children, so I know the problem.

MR. KERBEL: In the context of your question, though, my assumption was that you were talking
about --

MS. JANES: Right. As building related problem.

MR. KERBEL: Yes.

MS. JANES: For two of you gentlemen who have been involved in indoor air quality investigations, OSHA has been soliciting IAQ building data throughout this hearing when witnesses have testified who have actually been involved in actual investigations.

Is there any way that you can make some of those investigations available to us?

MR. KERBEL: There's a difficulty -- you're talking now as us, individual, entrepreneurs, if you will?

MS. JANES: As individuals. Yes.

MR. KERBEL: I have a problem with confidentiality.

MS. JANES: You can take off all kinds of identifiers. Basically, we're interested in the type of buildings that you've been in, the types of HVAC systems, and the condition of the maintenance, and the condition of the HVAC system and how it was operated and maintained, et cetera, and whether they had records and all of that kind of stuff.

MR. KERBEL: Yes. I could do that. Again, along with a confidentiality.

MS. JANES: Yes. You can just take black magic marker.

MR. TIFFANY: We would also be willing, as an association, to make a request to our membership to give you that information.

MS. JANES: Okay. OSHA would greatly appreciate that.

JUDGE VITTONE: Thank you, gentlemen. You can provide that in the posthearing comment period.

MR. TIFFANY: Yes, we will.

JUDGE VITTONE: Mr. Ely.

MR. ELY: Gentlemen, my name is Clausen Ely. I'm representing the Tobacco Institute. I'd like to ask you a few questions.

Are any of you gentlemen epidemiologists?

MR. TIFFANY: No.

MR. KERBEL: No.

MR. ELY: Are any of you gentlemen toxicologists?

MR. TIFFANY: No.

MR. KERBEL: No.

MR. ELY: Has your organization performed any epidemiological studies on ETS and health effects?

MR. KERBEL: Not as an organization.

MR. ELY: Has your organization conducted or sponsored any toxicological studies on environmental tobacco smoke?

MR. KERBEL: Not as an organization.

MR. TIFFANY: No. We don't do primary research -- American Industrial Hygiene.

MR. ELY: Has your organization sponsored or conducted any monitoring studies for environmental tobacco smoke in the workplace?

MR. KERBEL: Not as an organization.

MR. ELY: Has your organization conducted an evaluation or analysis of the literature on epidemiological studies of environmental tobacco smoke?

MR. TIFFANY: We looked at various summaries of scientific studies that were issued by credible sources.

MR. ELY: Could you name some of those sources?

MR. TIFFANY: Yes. The Environmental Protection Agency's Final Report, Respiratory Effects of Passive Smoking, dated January 7, 1993, which concludes that ETS is a Class A carcinogen.

NIOSH concluded in 1991, current intelligence, June of 1991, that ETS meets OSHA criteria for classifying substances as potential occupational carcinogens.

Preliminary data from the Centers for Disease Control and Prevention, CDC, National Health and Nutritional Examination Survey, suggested widespread exposure to tobacco smoke. 100 percent of the 800 persons in a representative sample of the U.S. population tested for cotinine had measured levels of cotinine in their serum.

MR. ELY: I don't want to cut you off, but I was just wanting the names --

MR. TIFFANY: And a Surgeon General's report, '86.

MR. ELY: Has your organization, or any of you, conducted an evaluation yourself of the underlying epidemiological studies?

MR. KERBEL: Not as an organization. Individual members have, but not as a --

MR. ELY: Are you familiar with the epidemiological studies that have been conducted on exposure to ETS and the incidence of cancer and heart disease in the workplace?

MR. KERBEL: Am I familiar with them? Yes, I am.

MR. ELY: Do you remember what they generally show?

MR. KERBEL: Generally, that ETS is an eye and upper airway irritant; can contribute to exacerbation of asthma, increase the susceptibility to respiratory infections; that ETS may produce a small excess risk of lung cancer.

MR. ELY: My question related to lung cancer and heart disease, epidemiological studies in the workplace on ETS and lung cancer and heart disease.

MR. KERBEL: In the workplace?

MR. ELY: In the workplace.

MR. KERBEL: No. I'm not familiar with them.

MR. ELY: You're not familiar with those.

Are either of you familiar with those studies?

MR. TRIPPLER: No.

MR. TIFFANY: No.

MR. ELY: Have you done an analysis or an evaluation of the toxicological studies that have been conducted on environmental tobacco smoke in animals?

MR. TIFFANY: I have not, personally.

MR. ELY: Has you organization done any evaluation of that?

MR. KERBEL: Not as an organization.

MR. TIFFANY: No. We did react to the scientific evidence from credible sources, as I mentioned previously.

MR. ELY: Right.

Does your organization have a toxicology committee?

MR. KERBEL: Yes, it does.

MR. TIFFANY: Yes, it does.

MR. ELY: Has that committee looked at this issue and taken a position on it?

MR. KERBEL: I don't know whether the toxicology subcommittee has its own position on the subject, however, they were active in the task force deliberations, which generated our comments relative to the proposal.

MR. ELY: As far as you know, your toxicology committee supported your comments?

MR. KERBEL: That's correct.

MR. ELY: Am I correct in stating that OSHA's proposal, which you support with respect to environmental tobacco smoke, would essentially require a zero level of exposure to nonsmokers of ETS?

MR. KERBEL: We haven't stated that.

MR. ELY: I'm stating that and asking you if you agree with me, that OSHA's proposal, which requires either that smoking be banned or that it be restricted to a separately ventilated lounge, is that essentially a zero exposure level for ETS for nonsmokers?

MR. KERBEL: I'm not sure of the answer to that.

MR. TIFFANY: AIHA doesn't have an official statement on that. What we stated on page 5 and 6 of our written --

MR. ELY: Is it your position, your organization's position, that exposure to ETS at any level above zero poses a significant risk of material health impairment?

MR. KERBEL: No. We have never stated that zero exposure is the required level to achieve in order to have no risk of material impairment.

MR. ELY: So there could be, in your opinion, or your organization's opinion, a level above zero of ETS exposure that would be safe?

MR. KERBEL: We don't have an answer to that as an organization. I can't answer as an organization on that issue.

MR. TIFFANY: We don't have a position on that issue. It wasn't covered in AIHA's position paper.

MR. ELY: Has your organization, in the past, with respect to other substances, supported zero exposure levels or bans, or indoor air contaminants?

MR. TRIPPLER: I don't believe the association has taken a position on the level that you are requesting. We have never come out and said we have a zero ban. We have never come out and said we support a zero tolerance level at this time. We can sure check to see if there was ever a position stated in that way but, to my knowledge, there is no such position at this time.

MR. ELY: I see. There has been some testimony in this hearing with respect to particular constituents of ETS, that those constituents -- let's just take benzene, for an example -- that for some of those constituents, there are existing PELs that OSHA has promulgated.

Let's say, for the moment, that it's accurate to say that the level that is contributed by ETS is lower than that PEL.

Is it your position, your organization's position, that it's still necessary to prohibit smoking even if the constituent levels of ETS are lower than existing PELs?

MR. KERBEL: We haven't addressed it as far as PELs. The position, as I understand it, is that from an industrial hygienist's standpoint, unnecessary exposure to any contaminant is unwarranted.

MR. TIFFANY: So ETS is a mixture of 4000 different chemicals. There's a precedence also for looking at mixtures, like coal tar or mineral spirits, for example.

To isolate out one particular compound or two or five, ETS is a mixture. It's a gas and a particle.

MR. ELY: So your position is it should be treated differently because of potential interactions of those constituents?

MR. TRIPPLER: I think you should repeat the question, please.

MR. ELY: My original question was, assuming that a particular constituent of ETS has an existing PEL, and that constituent that is contributed to the workplace air by ETS is lower than the PEL, is it still your position that you would need to eliminate that exposure entirely?

MR. KERBEL: Yes. And it would be our position that the unnecessary exposure of any individual to contamination, which is unnecessary, is unwarranted. The concentrations of whether that was to be looked at as an individual component and look at it as far as, well, is the benzene level less or more; there are certainly additive, synergistic, or there may even be some -- some effects may cancel each other out.

I wouldn't say that a complex mixture such as tobacco smoke that would be appropriate to look at one specific agent and relate that agent to a PEL that's been generated based on exposure to pure substance.

MR. ELY: Yes. I was using an example, one PEL. There are, of course, many.

MR. KERBEL: Right.

MR. ELY: Is it your organization's position that if there is a permissible exposure limit for a substance, let's say benzene, that any source of benzene in the workplace that contributes to benzene levels in the air should be eliminated?

MR. KERBEL: It's our approach that the concentration of any contaminant, an exposure to any contaminant that's unnecessary, should be reduced to as low a level as feasible, regardless of what PEL is.

MR. ELY: I see. I think you mentioned earlier that your organization itself hasn't conducted any monitoring studies on ETS levels in the workplace. Is that correct?

MR. TIFFANY: Yes.

MR. ELY: Has your organization conducted or sponsored any studies to determine what effect ventilation might have on ETS levels in the workplace?

MR. KERBEL: AIHA does no primary research.

MR. TIFFANY: Right.

MR. ELY: Has your organization reviewed the literature on what monitoring has been done on ETS levels in the workplace and what effect ventilation might have on those levels?

MR. KERBEL: Individual committees may have addressed that, but I am unaware.

MR. TIFFANY: The association, as a whole, has not addressed that and it's not clear whether any individual committees have.

MR. ELY: So your organization is really not in a position at the moment to state whether ventilation would have a reducing effect on ETS levels in the workplace and how much that effect might be?

MR. TIFFANY: That's correct.

MR. ELY: I would like to ask you a couple of questions about particular sentences in your statement.

You say that it is clear that environmental tobacco smoke is an eye and upper respiratory airway irritant and can contribute to exacerbation of asthma and increase susceptibility to respiratory infections.

What is the basis for that testimony?

MR. KERBEL: I don't understand your question.

MR. ELY: What scientific studies were you relying upon to make that statement?

MR. TIFFANY: That was scientific studies that I referred to before.

MR. ELY: These reports?

MR. TIFFANY: Right. Which are summary reports of primary research.

MR. ELY: The EPA report and the NIOSH?

MR. TIFFANY: And the Surgeon General and the CDC.

MR. ELY: Right. You go on to state that: The body of scientific evidence is sufficient to establish that environmental tobacco smoke may produce a small excess risk of lung cancer in nonsmokers as well other deleterious health effects.

Again, was your scientific basis for that statement these reports you're referring to?

MR. TIFFANY: Yes.

MR. ELY: You also go on to state there may be a relationship between ETS exposure and cardiovascular disease. Was your basis for that statement the same reports?

MR. TIFFANY: Yes, as well as the OSHA Preamble to this Proposed Standard.

MR. ELY: You're aware, I take it, that the EPA report did not address cardiovascular effects of ETS exposure?

MR. TIFFANY: That's why I mentioned the OSHA report.

MR. ELY: You mention in your statement: AIHA acknowledges that it is difficult to provide a numerical estimate of the risk in the workplace under actual exposure conditions.

OSHA used scientific information available in a reasonable manner. However, this aspect of the effects of ETS may need further study by scientific bodies, such as the NIOSH concurrent with implementation of the standard.

Could you explain what you're suggesting NIOSH do there?

MR. TIFFANY: Well, not just NIOSH. We feel that more scientific research should reduce uncertainty on this issue; that every toxicological issue has some uncertainty. It's inherent. We're just calling for more research on this.

MR. ELY: But you're calling for a final rule in the meantime?

MR. TIFFANY: Yes. Because we have to react -- AIHA has to react -- to scientific sources from credible sources.

MR. ELY: You also mention, I believe, in your statement that OSHA ought to discuss to a greater degree the uncertainty about the magnitude of the lung cancer and heart disease effects. Is that correct?

MR. TIFFANY: Yes.

MR. ELY: What did you rely upon to conclude that they needed to discuss the uncertainty more than they have now?

MR. KERBEL: The EPA studies are based on a number of different studies. The ones that OSHA looked at, I believe, are 31 epidemiological studies cited; 12 didn't show a positive effect, 5 showed equivocal trend, and 14 were deemed positive.

Most of these reports dealt with spousal exposure in homes, et cetera. Therefore, the extrapolation of that type of data into workplace has some uncertainty that goes along with it.

We feel that that needs to be further addressed.

MR. ELY: Yes. I had mentioned earlier whether you had looked at the literature on ETS and health effects in the workplace. Is it your position that spousal studies are sufficiently relevant to the workplace, that OSHA should rely upon the spousal studies to regulate in the workplace?

MR. KERBEL: We feel that the body -- you'll have to repeat the question.

MR. ELY: There are, as you just mentioned, a body of studies, epidemiological studies, on environmental tobacco smoke and spousal exposure.

MR. KERBEL: Yes.

MR. ELY: There's also a body of epidemiological literature on environmental tobacco smoke and workplace exposure.

MR. KERBEL: Yes.

MR. ELY: Is it your position that the spousal exposure studies are the best ones to rely on in the workplace?

MR. KERBEL: There are only one group of studies that we used to rely on.

MR. ELY: Those were?

MR. KERBEL: The additional studies that were presented by the agencies identified previously by John.

MR. ELY: You mentioned earlier, in response to some of the Agency's questions, that there might be difficulty setting a PEL for environmental tobacco smoke because of the difficulty of measuring environmental tobacco smoke? Is that correct?

MR. TIFFANY: Yes.

MR. KERBEL: Well, that's one of the reasons.

MR. ELY: What is the difficulty in measuring environmental tobacco smoke?

MR. KERBEL: There's no clear, good indicator of exposure.

MR. ELY: It is true, isn't it, that there have been a number of studies in which efforts have been made to measure environmental tobacco smoke?

MR. KERBEL: Yes.

MR. ELY: Including ones by EPA and others?

MR. KERBEL: Yes.

MR. ELY: Do you know what they have used as a surrogate for ETS in those studies?

MR. KERBEL: Various compounds, including nicotine; some have even gone carbon monoxide.

MR. ELY: Have RSPs been used sometimes?

MR. TIFFANY: Yes.

MR. KERBEL: Certainly.

MR. ELY: But it's your position that each of those surrogates is inadequate as a measure of environmental tobacco smoke?

MR. KERBEL: Yes.

MR. ELY: Could you explain, for instance, why nicotine is an inadequate surrogate?

MR. KERBEL: The tobacco smoke itself, mainstream and sidestream, has various components. Particulate phases, vapor phases, gaseous phases. The behavior of any of those individual phases and making the assumption that all of the phases act in the same manner, there really isn't any justification, at this point in time, to assume that.

MR. ELY: Have you or your organization reviewed the literature on studies attempting to measure environmental tobacco smoke exposure through nicotine measurements?

MR. KERBEL: In the air?

MR. ELY: In the air, in the workplace.

MR. KERBEL: I have not, personally.

MR. ELY: Have you reviewed the literature related to measurements in the air of RSPs as a surrogate for environmental tobacco smoke?

MR. KERBEL: I have read studies. I have not done an exhaustive evaluation of what's available.

MR. TIFFANY: Yes. I've read some studies that were published in Indoor Air in '90 proceedings, on monitoring for ETS.

It is also mentioned in the OSHA Preamble to this Proposed Rule, some of these measuring techniques.

MR. ELY: I believe you mentioned earlier in a response to a question from the agency, that a number of existing PELs or substances were set in connection with the industrial workplace.

Is it your Association's position that there should be different PELs for industrial workplaces and other workplaces?

MR. TIFFANY: No.

MR. ELY: Is it your Association's position that the PELs for industrial workplaces are adequate to protect workers in offices and other workplaces?

MR. KERBEL: No.

MR. ELY: What is your position?

MR. KERBEL: The non-industrial environment is an entirely different environment than the industrial environment.

Again, if one were to -- the population is different in the indoor environment, non-traditional. There is certain conditions that may exist in the indoor environment that don't exist in the industrial environment.

TLVs have generally been generated by an evaluation of them as poor substances or exposure to that individual component as a single entity, or maybe a few different things.

In the indoor environment, you can have exposure to its organics where there may be 200 volatile organics, which may be somewhat different than the exposure that's been evaluated or was the basis for the generation of a PEL, originally.

So there is a difference.

To say, however, that there is inadequate protection -- if the same conditions existed in both industries, however, it would be appropriate. Of course, all what I have just said is my opinion and is not necessarily the opinion of the Association.

MR. ELY: I see. So you think there might be some instances in which there would be a justification for having different PELs in office environments and industrial settings?

MR. KERBEL: If you want to use the term, PEL, yes. There may be indications and it may not be from an exposure standpoint.

Again, carbon monoxide. If you found 20 parts per million of carbon monoxide in this room, I would think that we should be alarmed by that, because it doesn't belong in this room, and it certainly is an avoidable situation that it does come into this room.

We don't know what the trends are, what have you. Whereas, in an industry we may be able to more clearly define what those are.

In any case, it's always the appropriate approach to avoid any exposure to any contaminant that's avoidable, you know, that exposure. If an exposure is avoidable, it should be avoidable. That's the basic tenet of industrial hygiene.

MR. ELY: In advocating or in supporting the OSHA propose for smoking ban, except for exceptionally ventilated areas, has your organization done any evaluation of what the cost of that proposal might be to businesses?

MR. KERBEL: No, we haven't.

MR. TIFFANY: Beyond looking at what OSHA says in their Preamble, which they estimate, depending upon the size of the smoking lounge, $4,000 to $25,000, no.

MR. ELY: So you haven't done any independent evaluation of that?

MR. TIFFANY: No. That's correct.

MR. ELY: Have you done any evaluation of whether there would be any effects on productivity of workers or anything along those lines?

MR. KERBEL: (Nodded.)

MR. ELY: That's all I have, Your Honor.

MS. JANES: Judge, may I ask one question?

JUDGE VITTONE: One question. Yes.

Thank you, Mr. Ely. Appreciate it.

MS. JANES: If an individual was exposed to 1.3 butadine, which is listed as a probable human carcinogen, would it matter if they were exposed in their home or in their workplace, whether the carcinogenicity of the compound would change?

MR. TIFFANY: No, of course not.

MR. KERBEL: The threshold of knowing what a save level for a carcinogen doesn't exist also. In any case, exposure to that substance would certainly want to be avoided at all costs, no matter what environment that person was in.

MS. JANES: Thank you.

JUDGE VITTONE: Gentlemen, thank you very much. Appreciate your patience today and putting up with us today. Thank you again. Have a good trip back.

MR. TIFFANY: Thank you.

MR. KERBEL: Thank you.

JUDGE VITTONE: I was provided a copy of their testimony. I guess we should put this into the record. It's testimony before the Occupational Safety & Health Administration, Proposed Indoor Air Quality Standards, Submitted August 13th, Presented January 24, 1995, by the American Industrial Hygiene Association.

This will be Exhibit 255.
(Exhibit No. 255 was marked for identification and received in evidence.)

JUDGE VITTONE: We're quitting early.

MS. SHERMAN: I think we still have a couple more.

JUDGE VITTONE: Okay.

MS. SHERMAN: I think we have a couple of other matters to discuss, Judge.

JUDGE VITTONE: All right.

MS. SHERMAN: Perhaps, I missed it earlier, but did we ever resolve the issue of Professor Hedge's exhibits?

JUDGE VITTONE: No. I do not have it. I don't know what happened to them, unless somebody picked them up and threw them away, or something like that, but I do not have them.

Can we contact him and ask him to submit a second copy?

MS. SHERMAN: I guess I can write a letter to him.

JUDGE VITTONE: I'm terribly sorry.

MS. SHERMAN: Okay. We'll see what we can do on that.

Also, on Friday, I believe, Ms. Ward went on the record about our requests for posthearing submissions from RJ Reynolds.

JUDGE VITTONE: That's correct.

MS. SHERMAN: We did not respond at that time, and I have a short response now, if you think it would be appropriate.

JUDGE VITTONE: That would be fine.

MS. SHERMAN: As I understand it, and I was not at the hearing on Friday afternoon, Ms. Ward questioned whether the material that OSHA had requested would be helpful to the determinations that OSHA must make regarding this rule.

I have taken the opportunity to review the transcript from, I believe it's January 17th, 18th, and 19th, and I've gone through it, to the best of my ability, where the things that we asked for to be submitted, and I think that those things would be useful.

Ms. Ward also suggested that perhaps some of the data were already in the record. I would just not for the record that RJR's submission is voluminous, so much so that while their scientists were testifying, sometimes it was even difficult to locate certain things because there is so much of it.

While we are appreciative of this information and we have read it with some care, if they feel that some of the questions that we asked have already been answered in the record, perhaps they could direct our attention to those exhibits.

I have here a list of what I think was asked for, and I can give it to Ms. Ward now. It doesn't promise to be everything, but it was the best I could come out with from the transcript. This is just us. It does not include anything that Mr. Meyer's might have asked or whoever else questioned you.

So I can make that available.

JUDGE VITTONE: Okay. Thank you. I think that would be helpful.

Is there anything else?

MS. SHERMAN: I guess that we will reconvene?

JUDGE VITTONE: We will reconvene Monday morning, 9:30, here. I will be here Monday, and we will reconvene at that time.

MS. SHERMAN: We will try to have, by Monday, a schedule, typed.

JUDGE VITTONE: Okay. If you have it on Friday, could you give me a call an let me know, and I'll have somebody pick it up?

MS. SHERMAN: Yes.

JUDGE VITTONE: I would appreciate that. Because I'd like to have it before I come here.

MS. SHERMAN: See if you'll show up.

JUDGE VITTONE: So would you, I'm sure.

If you can't, that's okay.

MS. SHERMAN: The schedule that I'm contemplating, Your Honor, will have the person's name, perhaps the company name and address. I don't think we'll put phone numbers on.

JUDGE VITTONE: I don't think you want to.

MS. SHERMAN: Some of these are companies, and to that extent I think it's okay, but some seem to be individuals, and perhaps that's not a good idea.

JUDGE VITTONE: They probably have freely given their phone number, but I'm not sure that people want their phone numbers bandied around. I think that's a good idea not to put it on there.

Is there anything else from anybody else before we break?

[No response.]

JUDGE VITTONE: Thank you very much. It's been a long couple of weeks here, but I think we did okay. I think we did okay.

I will see you Monday morning, 9:30, in this room, right? We're not moving out of this room. This room, Monday morning, 9:30. Thank you again. Have a good long week off.

This document's URL is: http://www.tobacco.org/Documents/osha/950124osha.html


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