OSHA: Proposed Standard For Indoor Air Quality: ETS Hearings, January 12, 1995
OSHA: Proposed Standard For Indoor Air Quality: ETS Hearings, January 12, 1995
UNITED STATES DEPARTMENT OF LABOR
OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION
PUBLIC HEARING
PROPOSED STANDARD FOR INDOOR AIR QUALITY
Thursday, January 12, 1995
Department of Labor
Washington, D.C.
The above-entitled matter came on for hearing, pursuant to notice, at 10:00 a.m.
BEFORE: HONORABLE JOHN VITTONE
Administrative Law Judge
AGENDA
PAGE
Consultants in Toxicology
Gordon W. Newell 10965
Questions:
Ms. Sherman 10974
Mr. Klock 11021
Mr. McNeely 11031
Judge Vittone 11042
Mr. Andrade 11045
Ms. Sherman 11066
EXHIBITS
EXHIBIT NO. IDENTIFIED RECEIVED
221 11070 11070
P R O C E E D I N G S
10:15 a.m.
JUDGE VITTONE: We resume hearings today into the proposed rule on indoor air quality by the Occupational Safety and Health Administration.
Our first witness is Dr. Newell.
Sir, would you come forward, please?
(Pause)
JUDGE VITTONE: Good morning, sir.
DR. NEWELL: Good morning, Your Honor.
JUDGE VITTONE: Would you state your full name, please?
DR. NEWELL: I am Gordon W. Newell, and I'm appearing here at the request of Philip Morris.
JUDGE VITTONE: What's the name of your company?
DR. NEWELL: Consultants in Toxicology.
JUDGE VITTONE: Okay, sir.
How long is your presentation going to be?
DR. NEWELL: Fifteen minutes or a little less, perhaps.
JUDGE VITTONE: And you have one slide?
DR. NEWELL: One overhead.
JUDGE VITTONE: Whenever you want to do it, we'll slide that thing out there.
DR. NEWELL: Sure.
JUDGE VITTONE: If you're ready, you can begin.
DR. NEWELL: Thank you.
I am Dr. Gordon W. Newell, consulting toxicologist.
Earlier, I was asked by Philip Morris to comment on and review the animal studies which address the issue of tobacco smoke and lung cancer as cited on OSHA's rulemaking, regarding indoor air quality.
I wanted to emphasize here, however, the views and the opinions expressed are mine and mine alone.
Your Honor, I am pleased to have the opportunity to testify here today on certain aspects of the OSHA proposed rulemaking governing indoor air quality in the workplace.
I obtained my PhD in Biochemistry from the University of Wisconsin in 1948, after which I served for two years as a biochemist and coordinator of clinical studies at Wallace & Turnen Company in New Jersey.
Although toxicology was not recognized at that time as a scientific discipline, it turned out that my thesis work involved the study of a toxic component formed in wheat flour during processing and prior to baking. The isolated chemical was found to cause convulsions and running fits in dogs.
In 1950 I joined the staff of the Stanford Research Institute, now known as SRI International. During the ensuing 28 years, I directed the development of one of the first research and testing toxicology departments in the country, which included aquatic toxicology as well as in vitro and in vivo mutagenesis laboratories. The staff grew to a core of more than 50 professionals and technical support personnel.
From 1978 to 1982 I served as Associate Executive Director, Board on Toxicology and Environmental Health Hazards, the National Research Council, National Academy of Sciences. Here, studies were conducted by expert committees on health issues as requested by Congress, as well as various departments and agencies of the government.
In 1982 I returned to California and assumed the position of Senior Program Manager for Health Studies at the Electric Power Research Institute. Programs studied here included the biological effects of electromagnetic fields, occupational risk assessment of PCBs, the biological significance of coal-produced fly ash, and other subjects.
Since 1988 I have been a consultant in the area of general and environmental toxicology.
The comments I offer today are based on my experience as a scientist and research manager, as well as extensive services and advisory roles to numerous public and private organizations. These have included, among others, service on various EPA advisory and review committees, members on the Science Advisory Board of the National Center for Toxicological Research, member of the Board of Directors of the Toxicology Laboratory Accreditation Board, and a member of the administrative panel on laboratory animal care for more than six years, the Stanford Medical School, as well as numerous other activities.
Among my professional members are the Society of Toxicology, member and chair of various committees; the American College of Toxicology, former president and counselor; the Environmental Mutagen Society, also a former president and counselor; Society for Risk Analysis, member of the organizing committee and a member of its initial scientific advisory council; and I am pleased to be a Fellow in the Academy of Toxicological Sciences. This is a peer recognition society based on one's contributions to the field.
I've served on the editorial boards and as a peer reviewer of manuscripts for various scientific journals, including risk analysis, regulatory toxicology and pharmacology, inhalation toxicology, mutation research, and food and chemical toxicology. I have published over 80 scientific papers, authored some 200 scientific reports for clients, have been an invited speaker at many and numerous international meetings and conferences.
On July 15th I submitted a written statement of my views to the record. That submission included commentary about each of the animal studies cited by OSHA as evidence that environmental tobacco smoke, that is ETS, should be recognized as a primary carcinogen for lung cancer, and my reasons why such a designation was improper.
Today my comments will be focused on the broader aspects of acceptable experimental design and the test parameters which have become the basis for regulatory decisionmaking. I'll also touch on certain animal studies cited in the OSHA document on indoor air quality, plus other relative animal studies. Because there are only a few animal experiments which have investigated ETS as such, much of the OSHA literature citations involve experiments with direct exposure to tobacco smoke.
I have conducted an in-depth review of the animal studies cited in the referenced document, as well as other relevant animal smoking studies. From my review of the available research papers, I conclude the data are insufficient to support a finding that an association exists between environmental tobacco smoke and lung cancer.
Let me repeat that. From my review of the available research data, I conclude that the data are insufficient to support a finding that an association exists between environmental tobacco smoke and lung cancer. And from the numerous cigarette inhalation studies with mice, rats, rabbits, dogs, hamsters, monkeys, ecologically realistic animal studies have generally failed to support the hypothesis that fresh tobacco smoke causes lung cancer in these species.
Taking into account the previous statement, it is difficult to conclude that ETS, a product of lesser concentration and of different composition than mainstream tobacco smoke, could cause cancerous lesions in the lung.
For the proposed regulation concerning ETS to be credible, it will have to be supported by adequate and factual health data to justify the establishment of standards.
It is here where I have difficulty in agreeing with OSHA's interpretation of ETS as a primary lung carcinogen. When a regulation is established, it must be based on verifiable information which can be repeated by others. Thus the need for criteria and standards.
Today I have one visual overhead for you.
(Slide shown)
In this overhead there is presented the basic criteria which the NTP uses in the design of studies to define whether material is to be classified as a carcinogen. The EPA relies on the NTP to identify carcinogens through the use of established standards. These standards must be met with identifying carcinogens, which subsequently will be listed as health hazards in the occupational environment.
You will see there, these are just some of the basic criteria. There are many more detailed aspects that the NTP requires to be followed in conducting any of their bioassays. It requires an experimental design that is well conducted. Well conducted means that the animals are housed under the general standards that the National Academy of Sciences in their report on the use of animals, is necessary. In fact today unless you get approval and accreditation through AAALAC, the American Association and Accreditation of Laboratory Animal Care, you probably would not be able to qualify to even do any of the studies for NTP.
According to these criterion today, you need at least three dosage groups so that you can demonstrate if there is a response, it's a dose-related response, and have adequate numbers of animals of both sexes of each, both mice and rats. As you can see, they want to be able to see if it does cause malignancies, that these are dose-related. Also, the NTP uses, although I don't necessarily always agree with it, but it's in their basic premise that a combination of benign and malignant neoplasms is a way to also justify whether or not a material is considered as a carcinogen.
That's all we need on that.
JUDGE VITTONE: Excuse me doctor, could you wait one second?
DR. NEWELL: Surely.
(Pause)
DR. NEWELL: May I say that none of the animal studies cited in the OSHA document on indoor air quality meet the criteria for establishing the carcinogenicity of a test substance, in particular, ETS.
It is appropriate here to review the several tobacco smoking studies that have been conducted with beagle dogs. First of all, let me say there are number of investigations which are reported in the literature and have been demonstrated that the beagle is susceptible to chemical carcinogens, with the resultant development of lung cancer. Particularly, a reference is cited from Health Physics, Volume 42, page 33, 1987.
Auerbach et al conducted two smoking studies with beagles. Conclusions from the first study claimed the dogs developed interstitial fibrotic and granulomatous lesions. I have discussed this particular study in my written submission earlier.
A review of the histopathology by J. L. Abrams at UCLA, that's the University of California at Los Angeles, and the American Review of Respiratory Diseases, Volume 119, page 197, 1979, showed the presence of magnesium silicate particles, that is talc, in the lung tissue -- not tumors.
Another reviewer of the Auerbach study, a paper by Herst and Hattendorf which appeared in Veterinary Pathology in Volume 10, page 385 in 1973, noted that dogs used by Auerbach came from the same breeder as used by the reviewer. This reviewer stated that they histology of the lungworm lesions in his dogs' lungs were similar to the histopathology noted by Auerbach.
It's interesting also that a second two year study with beagles, and also these dogs were tracheotomized, by the Auerbach group, a paper being authored by Fraska, Auerbach et al, and it appeared in Experimental Molecular Pathology, Volume 21, page 300 in 1974. This paper made no claim of carcinogenesis due to chronic exposure to cigarette smoking. Further an NCI-supported cigarette smoking study with tracheotomized beagles initiated at Battell Northwest Laboratories in Washington State, and subsequently moved to the Bornstein Laboratories in Maryland, was terminated after six years of exposure when no carcinogenic effects had been noted. Although the government promised to provide a histopathology report on the dogs in the study, after more than ten years, none has appeared.
Also an NCI smoking study initiated in 1978 with tracheotomized beagles at Hazelton Laboratories America, Vienna, Virginia, was discontinued after two years. Extensive histopathology studies were done on various tissues, but there were no adverse effects on the cardiovascular system due to the experimental design which included cigarette smoking, added carbon monoxide, and the use of low and high nicotine containing cigarettes.
Also, there was no mention of lung tumors in the smoke-exposed beagles. Results of the study have never appeared in a scientific journal. It was only through the use of the Freedom of Information Act process with a summary report through NCI made available.
My main purpose in appearing here today is to emphasize the importance of quality research, where a goal of such research is determined if a biological effect due to treatment may occur, and if an effect is demonstrated is it repeatable with an evident dose response? Often experiments are undertaken in an attempt to cause an adverse effect. Such experimental efforts are far from objective, a really prejudicial effort.
Most of the studies referenced in the April 5, 1994 OSHA proposed rulemaking document, were not conducted with ETS, did not demonstrate the development of malignant lung tumors, did not approach the basic material used by the National Toxicology Program for investigating possible carcinogenicity, nor is there available a long term study which has investigated the potential carcinogenicity of ETS.
Thus in my judgment, OSHA's position that ETS is a primary lung carcinogen is scientifically insupportable.
Thank you.
JUDGE VITTONE: Thank you, sir.
Ms. Sherman?
MS. SHERMAN: Yes.
JUDGE VITTONE: Excuse me, can I have that slide?
DR. NEWELL: Sure. I have a hard copy if you'd rather.
JUDGE VITTONE: Yes.
Okay, Ms. Sherman. I'm sorry.
MS. SHERMAN: Thank you.
You attended the University of Wisconsin in Madison?
DR. NEWELL: I did. That was the only University of Wisconsin campus at the time.
MS. SHERMAN: Well, I did too.
DR. NEWELL: Good. Good company.
MS. SHERMAN: Yes.
JUDGE VITTONE: Lousy football team.
(Laughter)
MS. SHERMAN: I noticed that in your notice of intention to appear you said you were a PhD, and then F-ATS. What is...
DR. NEWELL: Academy of Toxicological Sciences. I referenced that in my presentation.
MS. SHERMAN: F dash...
DR. NEWELL: Academy of Toxicological Sciences, ATS.
MS. SHERMAN: Okay.
What is that Academy for Toxicological Sciences?
DR. NEWELL: That is a peer recognition society which has established criteria for recognizing those people that are considered leaders in the field of toxicology. It is not an organization which brings people to it on the basis of a test, but rather on the basis of performance and what people have done in terms of publications, participation, and scientific activities, recognition by their peers, such as on various advisory committees, be they for NIH, EPA, or even in the private sector. All these things are put together on a factor rating of up to 100 points. Those people that get 70 or more points, they're accepted into the society.
Every five years, one is requested to resubmit what they've been doing in the interim, in order to make sure that you're still an active member of the field.
MS. SHERMAN: For how long have you been a member of this organization?
DR. NEWELL: A member as such, as being accepted. I think it's about seven years now. However, I was a part of a group that actually was involved in organizing this society. I was part of that for probably seven or eight years. Then when it was thought appropriated, and suggested that I should consider becoming a member, I withdrew from any participation and let the judges make their own decision.
MS. SHERMAN: Is this a society where one self-nominates, or must one be nominated by a peer?
DR. NEWELL: The organization has an application form and you feel free to fill this out. However, any applicant is given guidance with regards to the kinds of criteria that they must meet, and they're discouraged to even apply if they don't really feel like they meet the four basic parts of the criteria selection.
MS. SHERMAN: Can one just fulfill one of the four criteria and still get into the society?
DR. NEWELL: Not really. First of all, there are various points that are given. You can even be accepted if you have a master's degree and not a doctorate. But also one of the aspects required is to show a progression in your professional field over time, and also what kind of publications have you produced for the printed record, so to speak.
MS. SHERMAN: Must one do original research?
DR. NEWELL: Yes.
MS. SHERMAN: What original research have you done?
DR. NEWELL: Considerable. I have the various publications in my CV which, unfortunately, I do not have an up-to-date copy of it. I'd be glad to send it to you.
MS. SHERMAN: I'd appreciate that.
DR. NEWELL: One of the first things that appeared, I was fortunate to work with one of the outstanding scientists, biochemists at the time I was in graduate school, Conrad Elvin, who you may or may not have heard of; and subsequently, going from chairman of the department, was president of the university for a number of years.
MS. SHERMAN: I recognize seeing the name on a list.
DR. NEWELL: We did a number of studies with this running fits in dogs problem, working with wheat protein. That resulted in at least five or six peer-reviewed publications.
Did a lot of work on colon estrates inhibiting compounds, including work that was actually an NIH grant that we looked at the mechanism of colon estrates inhibition, and did patterns by injection of the compounds into the rabbits, and then taking blood samples and looking at the level of colon estrates over time. Some of the chemicals we looked at were permanent inhibitors, others were transitory and the like. That's all in the public literature.
A number of papers appeared in mutagenesis types of studies, particularly with animal reproductive studies where you're looking at the effects of a chemical causing permanent changes in the genetic structure so you get abnormalities and so forth, and the offspring, those that are dead at birth and the like.
MS. SHERMAN: Have you done any original research in the field of environmental tobacco smoke?
DR. NEWELL: No, I haven't. I might say, Ms. Sherman, the reason for that is that I've really been out of the laboratory for about 15 years. As a result, have been not in a position to do original research, as such.
MS. SHERMAN: That's why I asked you the question about the ATS. You said earlier that you had to sort of re-up this application every five years in this organization,a nd I asked if one needed to do original research, and you said yes. So it doesn't matter how long ago the original research was for membership in this organization?
DR. NEWELL: Not really, no. You're looking at what other peers have reviewed before it's published to consider whether it's worthy of appearing in the scientific literature.
MS. SHERMAN: Okay, but...
DR. NEWELL: ETS as a subject wasn't really around when I left the laboratory.
MS. SHERMAN: And you have done no original research in the field of tobacco smoke?
DR. NEWELL: No, I haven't.
MS. SHERMAN: You're not an industrial hygienist, correct?
DR. NEWELL: That's right.
MS. SHERMAN: Consultants in Toxicology, this is a company which you own?
DR. NEWELL: Consultants in Toxicology is a name I gave to my activity. It's a one-man operation.
MS. SHERMAN: I see.
How long have you been Consultants in Toxicology?
DR. NEWELL: Well, since the middle of '86 as a formal organization, although I'd been doing consulting for various clients for probably 20 years.
MS. SHERMAN: But now you do this full time?
DR. NEWELL: Well, full time as a retired person, yes.
MS. SHERMAN: You devote all of your work time to this, as opposed to all of your time.
DR. NEWELL: Right.
MS. SHERMAN: When did you first become interested in the issues relating to tobacco smoke and environmental tobacco smoke?
DR. NEWELL: I would say probably when I became aware of the developing report that EPA was going to put out on this.
MS. SHERMAN: When was that?
DR. NEWELL: Actually in the middle of '92. There was a request that came out through an Assistant Secretary of the Science Advisory Board asking for input of information from the scientific literature would be helpful. They listed various areas, and one of them was animal type studies. Because of that, and because of my concern about quality of research in the laboratory, I did an extensive review of the literature, which included looking at the foreign literature from about 1986, I believe, from that time until '92. There were a series of papers that were cited and reference and discussed.
MS. SHERMAN: Did you do this pro bono, or were you representing a client?
DR. NEWELL: I was representing a client at that time.
MS. SHERMAN: Was it a tobacco-related client?
DR. NEWELL: Yes, it was. But it was basically because of my interests and concerns about the kinds of experiments reported in the literature.
MS. SHERMAN: I believe your testimony primarily concerned the animal studies here today.
DR. NEWELL: Specifically, yes.
MS. SHERMAN: Do you believe that active smoking causes lung cancer in humans?
DR. NEWELL: I believe that smoking as such has a high risk factor for causing cancer in humans. As a causation aspect that has not been demonstrated to my satisfaction.
MS. SHERMAN: What would it take to demonstrate it to your satisfaction?
DR. NEWELL: I believe that there are various studies that need to be done, and I haven't seen them, and I really would like to get back to the issue that we have here that I came and... I want to focus on the papers that I reviewed and the comments and I'd be glad to discuss those.
MS. SHERMAN: Does the ATS have any position on tobacco smoke or environmental tobacco smoke?
DR. NEWELL: No, it doesn't. It's not a society, as such, as you might think of the Society of Toxicology or American Toxicology Society. These organizations have annual meetings, people present papers, you have symposia and so forth. ATS is an organization that recognizes people because of their contributions to the field.
MS. SHERMAN: But you're also a member of the Society of Toxicology?
DR. NEWELL: I'm a charter member, yes.
MS. SHERMAN: And do they have a position on environmental tobacco smoke or tobacco smoke?
DR. NEWELL: Not that I know of, no.
MS. SHERMAN: Do you know whether there are carcinogens present in cigarette smoke?
DR. NEWELL: There are some that have been listed.
MS. SHERMAN: Are you familiar with the literature on that subject?
DR. NEWELL: Generally speaking, although I don't believe that kind of an aspect is related to what we're talking about here.
MS. SHERMAN: In an earlier submission by WashTech, evidence was presented about animals who were exposed to environmental tobacco smoke for 90 days who exhibited reversible cellular changes in their nasal cavities and pulmonary tree. The studies reported hyperplasia. Is this effect part of the normal progression of normal cells to cancerous cells?
DR. NEWELL: Not necessarily. It's response of an irritation, and often an adaptation due to an irritation. I believe you're referring to the paper by Coggins et al that appeared in one of the SOT Journals in 1992. The authors there, if you recall, had two sets of groups. One that was sacrificed at the end of 13 weeks and then there was another group that was held for a recovery period, I forget whether it's six weeks or another 13 weeks. The hyperplasia and the like that was noted at the time when the exposure was discontinued, had completely disappeared in those animals that had been held over for a longer period of time.
Sure, it's a biological effect, but it's not a serious adverse effect. In other words, if you take the stress away that has no permanent type of effect.
MS. SHERMAN: So you feel that it was stress-related and it wasn't related to the substance to which they were exposed?
DR. NEWELL: Not necessarily. How do you define stress?
MS. SHERMAN: You're the one who just used the term.
DR. NEWELL: I didn't say so.
MS. SHERMAN: I thought you did, I'm sorry.
DR. NEWELL: No, I said that this was due to the exposure and the irritation that came from the repeated... And the hyperplasia, as I say, is reversible, so it's not a serious effect.
MS. SHERMAN: But it's possible that it can lead to a more serious effect, is it not?
DR. NEWELL: Yes, and I think you're given the opportunity there to, as you've heard from many people who have sat in my place, that the dose determines the poison. In other words...
MS. SHERMAN: Yes, I've heard that before.
DR. NEWELL: I bet you have. It comes way back from early times.
So in some cases you will get no response. In other cases, you may have an effect that goes on. I don't think you can make any judgments about the long term effects from the tissues that were found to have some metaplasia in the Coggins study. Also it's important to put on the record that there were three dosage levels. The two lower levels showed absolutely no adverse histopathology.
MS. SHERMAN: Are you familiar with the CIIT animal bioassays related to formaldehyde?
DR. NEWELL: Yes, but I don't see how they appropriately fit in with my comments here, but yes, I am.
MS. SHERMAN: Well, it seems to me that in those cases you had hyperplasia and metaplasia that did progress to more serious changes.
DR. NEWELL: That's not true completely. Some of them did at the highest level, 15 parts per million, but at the lowest level, five parts per million, which incidentally, other people have been exposed to that. You and I couldn't stand that environment for even a minute or two, it is so irritating to humans. Yet rats lived in there for their lifetime and all they showed was a little bit of hyperplasia, but nothing progressed further in that lower dosage group.
MS. SHERMAN: Might that not be because there weren't all that many rats in each group?
DR. NEWELL: I don't know how many... They had something like 50 males and 50 females in each group. It was a large number. It certainly met the standards of the ETP design.
MS. SHERMAN: Do you disagree with general toxicological protocols where you expose animals to relatively high doses in experiment design?
DR. NEWELL: I know what you're leading to, and that certainly is the approach and the defense of that position as you well, I'm sure, have heard is that well, we've got to make sure that we don't overlook something, so let's does animals at the maximum. Essentially the maximum tolerated dose.
I don't have too much trouble with that as long as we have several different doses. You can see if there is a dose response or not. There are many studies in the literature today which will show, in effect, the very highest level. Generally there is an attempt to try, on these long term studies, to assure that an experiment causes no more than a 15 percent of death just because of the toxicity of the chemical.
MS. SHERMAN: At any dose level?
DR. NEWELL: Pardon?
MS. SHERMAN: At any dose level.
DR. NEWELL: That essentially is the maximum tolerated dose backed off a bit so that you have a sufficient number of animals that can go through the experiment.
But what I'm saying is, it's important, just because you get something at that highest level dose, very frequently you see nothing, particularly with non-genotoxic type of chemicals. You do get, particularly you get the irritation, and I'm sure people have cited the work that Bruce Ames has published on in the literature in this relationship. And others, the University of Nebraska has also published the same kind of work.
MS. SHERMAN: If you only have 100 animals in each test group -- 50 males and 50 females -- and you see statistically significant effects in the top two dose levels, do you think that allows you to conclude that there is no effect in the lower dose level?
DR. NEWELL: Certainly that's on the basis which I have to go with the information that's available to you. Sure, it would be desirable if you had 1000 animals per dose level, and that kind of thing was done at NCTR years ago.
MS. SHERMAN: However, that's rarely done, right?
DR. NEWELL: The mega-mouse study. And it ended up with more complications than people have still been able to well sort out and sift out.
MS. SHERMAN: So it's not common to have animal cohorts where you have say 5,000 animals at any particular dose level. It's not practical.
DR. NEWELL: It's not cost effective. People can't afford to handle that sort of large numbers. I know of no study other than the NCTR mega-mouse study that approached anything like that.
MS. SHERMAN: So we make certain assumptions about the shape of a curve based on relatively small sample sizes, and a limited number of dosing regimens.
DR. NEWELL: I would say a small sample size is when you try to draw conclusions from five or six animals in a test group. I think when you get up to 50 or 100 animals, or 70 animals per dose level, you're getting a realistic response. Remember, animals are in-bread, hopefully, to minimize a lot of variations. That's not always true, unfortunately, but still it's a lot better than getting random animals off the street or out of the woods, as some people go for.
MS. SHERMAN: Clearly.
However, if the effect that one thinks one will see would translate into say a risk of three per thousand, and one only has 50 animals in a dosing group, the effect may be there and it may not be seen, wouldn't you agree?
DR. NEWELL: It's very possib