NYSA TI Single-Page 1
United States Department of Labor Occupational Safety and Health Administration Public Hearing
Fields
- Named Organization
- American College of Cardiology
- American Heart Association (Voluntary health organization that focuses on cardiac health)
Voluntary health organization that focuses on cardiac health and stroke. AHA occasionally teams with tobacco retailers to engage in promotions/fund-raisers (see http://www.smokefree.net/doc-alert/messages/247136.html and http://www.rawbw.com/~jpk/stand/Pictures.html).- American Journal of Public Health (periodical)
- ASH (Action on Smoking and Health)
Action on Smoking and Health- Beverly Hills Restaurant Association (Industry front group)
Set up c. 1988 by the Tobacco Institute to clandestinely fight a local smoking restriction (TI00380927-0949, Pag. -0946).- Building Owners and Managers Association (BOMA)
- *Center for Disease Control (Use United States Centers for Disease Control and P
Now Centers for Disease Control and Prevention, Formerly Communicable Disease Center- Center for Indoor Air Research (CIAR) (Industry formed/funded air research organization)
Nonprofit organization funded by the tobacco industry. CIAR was formed in March 1988 by tobacco companies "to sponsor "high-quality research on indoor air issues and to facilitate communication of research findings to the broad scientific community."- Consumer Reports (magazine that tested tar content in 50s)
- *Department of Labor (use United States Department of Labor)
- Environmental Protection Agency (EPA)
- EPA Science Advisory Board (unit of EPA)
- Federal Register (publication)
- Federal Trade Commission (Enforcement agency for laws against deceptive advertising)
Enforces laws against false and deceptive advertising, including ads for tobacco products. Ensures proper display of health warnings in ads and on tobacco products;collects and reports to Congress information concerning cigarette and smokeless tobacco advertising, sales expenditures, and the tar, nicotine, and carbon monoxide content of cigarettes.- Health and Welfare Canada
- Healthy Buildings International (industry-funded ventillation experts)
Worked closely with the industry to encourage corporations not to ban smoking but to look for other causes of air pollutions. Used the term "Sick Building Syndrome". Founder: @robertson_gray- Honeywell
- McGill University (Prestigious Montreal university which cooperated with the in)
Helped the tobacco industry obscure the link between secondhand smoke exposure and illness- National Restaurant Association
- Oak Ridge National Laboratory
- Occupational Safety and Health Administration (Held hearings in 1994 to ban smoking in workplaces)
OSHA opened hearings in September 1994 on a proposal that amounts to a virtual ban on smoking in every workplace in the nation- Occupational Safety and Health Administration (OSHA)
- Philip Morris & Co. Ltd. (Cigarette manufacturer, incorporated in U.S. in 1902)
Philip Morris & Co. Ltd.., was incorporated in New York in April of 1902; half the shares were held by the parent company in London, and the balance by its U.S. distributor and his American associate. Its overall sales in 1903, its first full year of U.S. operation, were a modest seven million cigarettes. Among the brand offered, besides Philip Morris, were Blues, Cambridge, Derby, and a ladies favorite name for the London street where the home companies factory was located - Marlborough.- R.J. Reynolds Corporation (second tier subsidiary of RJR Industries)
- Roper Organization (Consumer Research/Public Relations Org.)
Interested in finding out what drives consumer behavior; surveys consumers on their prime areas of concern; assists corporations with reputation-building and public image based on its findings.- Stanford University
- Tobacco Institute (Industry Trade Association)
The purpose of the Institute was to defeat legislation unfavorable to the industry, put a positive spin on the tobacco industry, bolster the industry's credibility with legislators and the public, and help maintain the controversy over "the primary issue" (the health issue).- United States Department of Labor
- *University of California (use specific branch)
- University of California San Francisco
- University of Utah
- World Health Organization (Concerned with global public health)
International organization concered with public health worldwide - American Heart Association (Voluntary health organization that focuses on cardiac health)
- Named Person
- Axelrad, Bob
- Enstrom, James
- Feinstein, Alan
- Foote, Emerson (Ad exec.; Promoted Lucky Strikes in 1930s)
- Glantz, Stan
- Glantz, Stanton
- Glantz, Stanton A.
- Grossman, Bill
- Grossman, Ted
- Hammond, Kathy
- Harrington, Bob
- Harrington, Robert
- Hedge, Alan (industry consultant)
1994 Used by industry to discuss the irritation issus - i.e. dose response. Proposed consultant to comment on Federal OSHA proposal on workplace smoking.- Hills, Sierra Foot
- Lowe, Michael
- Mellon, Andrew W.
- Rupp, John P. (TI Communication Committee, Covington & Burling lawyer)
TI Communication Committee- Sherman, Susan
- Smith, Lisa
- Tyson, Pat
- Vittone, John
- Ward [Root], Mary Elizabeth, J.D. (RJR, Associate General Counsel)
Mary Ward was Associate General Counsel for R.J. Reynolds. (PMI's Introduction to Privilege Log and Glossary of Names, Estate of Burl Butler v. PMI, et al, April 19, 1996)- Weinberg, Myron
- Wells, A. Judson (physical chemist)
studied indoor air quality- Wexler, Lawrence M. (researcher, New York Medical College)
- Enstrom, James
- Master ID
- TI10111465-1821
Related Documents: - Date Loaded
- 16 Mar 2005
- Box
- 8820
Document Images
UNITED STATES DEPARTMENT OF LABOR
OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION
PUBLIC HEARING
PROPOSED STANDARD FOR INDOOR AIR QUALITY
PAGES: 279 through 634
PLACE: Washington, DC
DATE: September 21, 1994
BAYLEY REPORTING, INC.
OFFICIAL FEDERAL REPORTER8
Washington, DC 20009
(~0~) ~,~.77S7 (S00) 36S-S~
TI1011-1465
UNITED STATES DEPARTMENT OF LABOR
OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION
PUBLIC HEARING
PROPOSED STANDARD FOR INDOOR AIR QUALITY
Wednesday,
September 21, 1994
Andrew W. Mellon Auditorium
Constitution Avenue, NW
Washington, D.C.
The above-entitled matter came on for hearing,
pursuant to notice, at 9:00 a.m.
BEFORE: HONORABLE JOHN VITTONE
Administrative Law Judge
TI1011-1466
AGENDA
Questioning by Audience:
Ted Grossman
Myron Weinberg
John Rupp
Robert Harrington
Ms. Sherman's Answer to Request
PAGE
283
320
322
372
381
OSHAWitnesses:
Stanton A. Glantz, PhD
Questioning by Audience:
Jim Dinegar
Pat Sirridge
John Rupp
Ted Grossman
Michael Lowe
Ms. Sherman
382
433
441
486
559
597
626
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
T!1011-1467
NO~-E
WRITTEN SUBMISSIONS
281
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
T11011-1468
EXHIBIT NO.
16
!7
18-22
A
B
F(2)
EXHIBITS
IDENTIFIED
428
488
501
516
530
538
549
551
551
RECEIVED
428
499
502
282
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
TI1011-1469
1
2
3
4
5
6
7
8
9
I0
ii
12
13
14
15
16
17
18
19
20
21
22
23
24
25
PROCEEDINGS
JUDGE VITTONE: On the record.
283
9:03 a.m.
We recessed last night, and we were having some
questioning by Mr. Grossman of the OSHA panel. We will
resume today, finish up with Mr. Grossman, and then resume
again with Mr. Rupp and Mr. Weinberg has also asked, he said
he has one additional question he would like to have asked,
and I told him I would let him do that after Mr. Rupp. So
if you're ready, Mr. Grossman, we will resume.
MR. GROSSMAN: Thank you very much, Your Honor.
When we broke off yesterday we were comin~ to the
question of the Agency's decision to use the Fontham study
as the only study in crafting a risk ratio for lung cancer
as a result of ETS exposure in the work place.
Could someone articulate to me the reasons why the
Brownson study was not used? Mr. Martonik?
MR. MARTONIK: I don't remember us saying that the
Fontham study was the only study that had information
regarding occupational exposure. I think that...
MR. GROSSMAN: That wasn't the question. The
Federal Register says that the risk ratio that was derived
is based upon the Fontham study, and the risk ratio for
heart disease is based on the Helsing study. I'm asking why
the Brownson study, rather than the Fontham study was not
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
Ti1011-1470
1
2
3
4
5
6
7
8
9
I0
ii
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
284
used as th~ basis for calculating the risk ratio.
MR. MARTONIK: Because we thought the Fontham
study provided better information regarding the exposure of
workers to ETS.
MR. GROSSMAN: On what basis?
MR. MARTONIK: On the basis of reading the
studies.
MR. GROSSMAN: On what basis in the studies? What
factual basis separated the Fontham study from the Brownson
study?
MR. MARTONIK: Dr. Silverstein will answer that.
DR. SILVERSTEIN: I actually want to clarify
something in response to the first part of your questioning,
which is that while we chose to use the Fontham study for
particular calculations, it's not by any means the only
study that has risk ratios of the same order of magnitude
that we think are important and informative and are useful
in our determination. Which...
MR. GROSSMAN:
occupational study...
07JDGE VITTONE:
the answer get completed.
Are you familiar with any other
Gentlemen, gentlemen. Let's let
Let's let the question get
completed. Then we'll deal with it.
Are you finished with your answer, Mr.
Silverstein?
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
Tl1011-1471
1
2
3
4
5
6
7
8
9
10
ii
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
285
DR. SILVERSTEIN: Just about. I was going to say
that this was a particularly useful study, but by no means
the only useful study.
evidence.
MR. GROSSMAN:
It's part of a larger body of
Could you explain to me why the
Brownson study was not used as the principal basis for
determining a risk ratio?
MR. MARTONIK: Mrs. Janes will answer that.
MS. JANES: The Fontham study was by far a
superior study to the Brownson study. Not only did she
validate current tobacco use through cotinine measures, they
also looked at dħet factors, and they also looked at other
potential confounding factors and tried to control for them
in both the design of the study and the analysis of the
study. It was a multi-center study. Cases from different
parts of the country, where Brownson was based in Missouri.
Anyway, we went through our analysis and
determined that for risk assessment purposes the Fontham
study was by far better.
In the weight of evidence analysis that we used,
both the Brownson and the Fontham study both played a part
in that, but for the risk assessment, which is what your
question relies upon, that is why we chose the...
MR. GROSSMAN: Let's break that down into several
parts. You referred to cotinine measurements.
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
TII011-1472
1
2
3
4
5
6
7
8
9
I0
ii
12
13
14
15
16
17
18
19
20
21
22
23
24
25
286
MS. JANES: Yes, sir.
MR. GROSSMAN: That was an alleged test to
determine whether there was bias in the determination of who
was and who was not a smoker, is that correct?
MS. JANES: Yes, sir. It was...
MR. GROSSMAN: The purpose was to screen out
people who were actually smokers as opposed to people who
might have been exposed to passive smoke.
MS. JANES: Yes.
MR. GROSSMAN: The cotinine measurements were made
on people who had already been determined to have lung
cancer, is that correct?
MS. JANES: And on their controls.
MR. GROSSMAN: But as far as people with lung
cancer were concerned, the cotinine measurements were made
on people who already had lung cancer, is that correct?
MS. JANES: Yes, it is. But it was also...
MR. GROSSMAN: And is it also correct...
JUDGE VITTONE: She was still giving her answer.
MS. JANES: But Fontham looked at both cotinine
measures in both their cases and their control group.
MR. GROSSMAN: I'm talking now only about the
cases, and you can understand that the questions relate only
to the cases.
The cotinine tests were on people who already had
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
TI1011-1473
1
2
3
4
5
6
7
8
9
I0
iI
12
13
14
15
16
17
18
19
20
21
22
23
24
25
287
lung cancer, and the cotinine tests measure, at best, the
last 72 hours of use of cigarettes, is that correct?
MS. JANES: Yes, it is.
MR. GROSSMAN: Could you explain to me and for the
record how a test that determines whether people may have
smoked cigarettes within~the last 72 hours, involving people
who are already hospitalized for lung cancer, can determine
whether those people have, during the history of their
lives, been smokers at any time?
MS. JANES: As you are well aware, most of the epi
studies did both, prospective and case control studies, did
not even take any kind of [bio] monitoring data and this is
the only study on lung cancer.
MR. GROSSMAN: That wasn't my question.
Could you explain for the record how a test that
measures cotinine which may measure the use of cigarettes
within the last 72 hours, could determine or check whether a
person at any time during his or her life time was an active
smoker?
MR. MA~TONIK: I believe she answered your
question. She gave you information that cotinine levels
result from exposure to environmental tobacco smoke...
MR. GROSSMAN: You're saying that the answer to
the question is it is impossible based upon cotinine tests
to make that determination. Is that right?
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
Tl1011-1474
1
2
3
4
5
6
7
8
9
i0
ll
12
13
14
15
16
17
18
19
20
21
22
23
24
25
288
MS. JANES: It was linked with the questionnaire
data that she was asking them as well.
MR. GROSSMAN: There's questionnaire data in all
of the tests. I'm asking about the cotinine measures.
Could you explain for the record whether a cotinine test
administered to a person in the hospital who has already
been diagnosed with lung cancer, can test whether that
person at any time during his or her life.was an active
smoker?
MR. MARTONIK: Dr. Silverstein will answer this
question.
DR. SILVERSTEIN: The answer is that that"
information does not allow you to make a direct judgment
about past smoking behavior, but when you combine the
biological information with the questionnaire information,
you can make reasonable presumptions, and this is the best
available evidence to make those kinds of judgments from,
and we think it was useful and appropriate.
MR. GROSSMAN: All of the tests use the other
data, is that correct? All of the studies that you referred
to use questionnaires to determine whether people were
smokers during their lives?
MS. JANES: IT's either questionnaire or direct
personal interviews.
MR. GROSSMAN: And the Brownson study questioned,
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
T! 1011-1475
1
2
3
4
5
6
7
8
9
10
II
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
289
in many cases, numerous individual to determine the smoking
patterns of those under study, is that correct?
MR. MARTONIK: We can't recall that.
MR. GROSSMAN: Let me go on to something else.
In the Fontham study, the researchers who
questioned people as to whether they were exposed to ETS,
were not blinded, is that correct? They were aware of
whether the person involved had already been diagnosed with
lung cancer.
MS. JANES: I don't recall that. That may or may
not be the case.
MR. GROSSMAN: If it were the case, if the
researchers weren't blinded, that would add an element of
bias to the study, is that correct?
MS. JANES: It may or it may not.
MR. GROSSMAN: It's something to...
MS. JANES: It may or may not.
MR. GROSSMAN: It's something to take into
consideration isn't that the case?
MS. JANES: Of course.
MR. GROSSMAN: Are you familiar with the study by
Fontham and Correa and others on the effect of heavy beer
and alcohol consumption on lung cancer in non-smokers?
(Pause)
MR. MARTONIK: We're not familiar with that.
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
T!1011-1476
!
2
3
4
5
6
7
8
9
I0
iI
12
13
14
15
16
17
18
19
20
21
22
23
24
25
290
MR. GROSSMAN: Fontham and Correa found a risk
ratio of 5.3 after controlling for smoking, for people who
drink more than four beers per day, for lung cancer, based
on a study in Uruguay. Fontham did not control alcohol
consumption or beer consumption in her study on occupational
exposures to ETS and lung cancer, is that correct?
MR. MARTONIK: You made a statement regarding
studies and...
MR. GROSSMAN: We can provide you with the Fontham
and Correa...
MR. MARTONIK: If you do that we will look at it
and consider it.
MR. GROSSMAN: I made the statement, and then I
asked a question. My only question is they did not control
for drinking, in that study...
MR. MARTONIK: I'm still at a loss to understand
how a statement regarding the study regarding individuals
exposed to or using alcohol has any relationship to your
question...
MR. GROSSMAN: Let me explain it then, I thought
it was obvious.
If the individuals with lung cancer were heavy
drinkers, and those without were not, the drinking habits
alone could account for any difference in incidence of lung
cancer among the so-called exposed and unexposed population.
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
TI1011-1477
1
2
3
4
5
6
7
8
.9
I0
ii
12
13
14
15
16
17,
18
19
2O
21
22
23
24
25
291
I'm asking, whether a confounder of drinking was taken into
account by Fontham's study considering that Fontham in
another published article found a risk ratio of 5.3 for
heavy drinking.
MR. MARTONIK: Ms. Janes will answer the question.
MS. JANES: We're not familiar with Fontham's
previous paper. However, in the paper in question, she did
control for diet.
MR. GROSSMAN: Not for drinking.
MS. JANES: For normal diet.
MR. GROSSMAN: Is there any indication that she
controlled for alcohol consumption?
MS. JANES: We'll have to check. We're
not sure.
MR. MARTONIK: We can't recall.
MR. GROSSMAN: All right, why don't you check.
I
think the record is clear that she did not.
MS. JANES: But we will check.
MR. GROSSMAN: Are you familiar with studies on
the association between Chinese cooking and abno carcinoma
including, for example, the Lam study published in 19857
MR. MARTONIK: We can't recall that.
MR. GROSSMAN: There are many published studies on
the extremely high incidence of abno carcinoma of the lung
among Chinese women of first generation in the United States
and Japan who have a lifetime of cooking Chinese food. The
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
TI1011-1478
1
2
3
4
5
6
7
8
9
i0
ll
12
13
14
15
16
17
18
19
20
21
22
23
24
25
292
Lam study that was published in '85 showed a risk ratio of
14.7 for abno carcinoma of the lung.
A large percentage of the population studied in
Fontham are first generation Chinese-Americans in San
Francisco, is that correct?
MS. JANES: I don't recall what the percentage of
the... I know a couple of her study bases were in
California.
MR. GROSSMAN: Almost 80 percent of the subjects
in her study are in California, isn't that correct?
MR. MARTONIK: You cited the study.
How many
people were studied in the Lam study?
MR. GROSSMAN: In what study?
MR. MARTONIK: The Lam study that you cited.
MR. GROSSMAN: I don't have the full number who
were studied, but the statistical significance ratio, the 95
percent confidence level, was way over one. I think it ran
from six to 30 or 40.
MS. JANES: Do you have evidence that indicates,
sir, that the cooking habits of Chinese in America are the
same as those in China?
MR. GROSSMAN: Yes. First generation. There are
many published studies on first generation Chinese.
MR. MARTONIK: We'll look at the report.
MR. GROSSMAN: If you will look at the Fontham
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
TI1011-1479
!
2
3
4
5
6
7
8
9
i0
II
~2
13
14
15
16
17
18
19
20
21
22
23
24
25
study, do you have a copy of the Fontham study with you?
(Pause)
MR. MARTONIK:
MR. GROSSMAN:
293
Yes, we have it.
If you'll notice, under race/ethnic
group on page 39 of the study, 266 of the respondents were
white; 44 were black; 32 were Hispanic; and 67 were Asian;
ll were other. Do you think that's reflective of the United
States as a whole?
MR. MARTONIK: We thought it was a good enough
indication to use as a study for our risk assessment.
MR. GROSSMAN: I see.
The colon cancer controls, 240 were white, versus
35 Asian. The ratio was entirely different by a factor of
two between the controls and the studied population. Did
you consider that in reviewing the Fontham study?
MR. MARTONIK: As a general matter, we reviewed
the study and thought it was appropriate to use...
MR. GROSSMAN: That's not the question. I'm
asking whether you reviewed that particular issue.
MR. MARTONIK:
reviewed...
MR. GROSSMAN:
it to any extent?
MR. MARTONIK:
MR. GROSSMAN:
We can't recall to what extent we
Can you recall whether you reviewed
Yes, clearly we've reviewed it.
You reviewed the fact that there
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
TI 1011-1480
1
2
3
4
5
6
7
8
9
l0
ll
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
294
was an unusual proportion of Chinese-Americans.in the lung
cancer group and a lower proportion in the control group?
MR. MARTONIK: My recollection of almost every
epidemiology study, there's always some finding or Some
factor that makes it somewhat difficult to interpret as a
broad base...
MR. GROSSMAN: That's not the question. Did
you
consider that particular issue?
MR. MARTONIK: Yes, we have.
MR. GROSSMAN: And how did you factor that into
account? Did you ask Fontham to provide information on the
method by which the controls were screened and the
individual cases were chosen?
to Dr...
MR. MARTONIK:
MR. GROSSMAN:
We read the study. We did not talk
So you don't know anything about
the study except what appears on the face of the study, is
that accurate?
MR. MARTONIK: No, we have other information in
the record regarding that study. We have descriptions of
the study and criticisms of the study by several experts who
reviewed the literature ....
MR. GROSSMAN:
MR. MARTONIK:
MR. GROSSMAN:
Now...
EPA is one of those groups.
When you say that you have other
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
T!1011-1481
2
3
4
5
6
7
8
9
I0
II
12
13
14
15
16
17
18
19
20
21
22
23
24
25
things in the record, you haven't read everything in the
record, have you?
MR. MARTONIK:
MR. GROSSMAN :
295
OSHA is familiar with the record.
Yesterday you said you hadn't read
PM's fine submissions, you said you hadn't read RJR's
submission of a meta analysis of occupational studies which
was submitted long before this rulemaking began more than a
year ago and was hand delivered. So tell me, which studies
have you read that you can point me to that consider the
question of the over-representation of Chinese-Americans and
Asian-Americans in the study, and particularly in the group
that had cancer.
MR. MARTONIK: I think I answered your question.
I said we looked at the EPA study.
MR. GROSSMAN: The EPA study is the only other
one. You're not suggesting that the EPA study comments upon
this issue, are you?
MR. MARTONIK: I'm saying that we considered these
issues in terms of all comments that we had available prior
to the time we published this proposal.
MR. GROSSMAN: What you're saying is you cannot
point me to anything other than the Fontham study on which
you considered the issue of over-representation of Asian-
Americans in the Fontham study...
MS. SHERMAN: Your Honor, I believe that
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
Tl1011-1482
4
5
6
7
.8
i0
II
12
13
14
15
16
17
18
19
20
21
22
23
24
25
question's, been asked several different times...
MR. GROSSMAN: It has, and it has not been
answered.
answered.
Grossman?
MS. SHERMAN:
JUDGE VITTONE:
296
...in several different ways, and
What do you have to say Mr.
MR. GROSSMAN: I have asked a number of times, but
I've not gotten an answer to the simple question of whether
they iooked at anything other than the Fontham study to
consider the issue of over-representation of Asian-Americans
in the lung cancer group in the Fontham study.
JUDGE VITTONE: Let's have a clear answer to it
this time so we can move on to another issue.
MR. MARTONIK: Yes.
MR. GROSSMAN: Identify every other thing that you
looked" at to consider that particular issue.
I'm not prepared to do that right
MR. MARTONIK:
here and now.
MR. GROSSMAN:
MR. MARTONIK:
asking me.
MR. GROSSMAN:
Identify anything.
I don't understandwhat you're
Well, you didn't have the
underlying Fontham data, you didn't correspond with Fontham.
DR. SILVERSTEIN: We're not prepared to fully
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
TI 1011-1483
1
2
3
4
6
7
8
9
i0
ii
12
13
14
15
16
17
18
19
20
21
22
23
24
25
297
answer you~ question right now. We will investigate this
further and gather the appropriate information, look at it,
and reach some judgments about it.
In order to do that, I'd like you to clarify
something. You've confused me a little bit. Sometimes
you're referring to Chinese, sometimes to Chinese-Americans,
and sometimes to Asian-Americans. I'm not sure what you
really have in mind. Certainly Asian-Americans are not the
same as Chinese.
MR. GROSSMAN: First generation Chinese-Americans
are the subject of interest for that.
DR. SILVERSTEIN: But the table, when you referred
to a table from the study, you referred to a percentage of
Asians. That's not the same as Chinese, is that correct?
MR. GROSSMAN: Asians are not necessarily the same
as Chinese. All Chinese are Asians, but not all Asians are
Chinese.
DR. SILVERSTEIN: So it's going to be a little bit
hard to respond to your question since it's hard to
understand exactly what you're getting at. Maybe you can
clarify that.
MR. GROSSMAN: Let me clarify it for you, doctor.
A risk ratio as determined by you of 1.34 indicates a 34
percent increase in an exposed group versus the unexposed
group, is that correct?
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
T!1011-1484
1
"3
4
5
6
7
8
9
I0
ii
12
13
14
15
16
17
18
19
20
21
22
23
24
25
298
DR. SILVERSTEIN: I was simply asking you to
distinguish between...
MR. GROSSMAN: Let's...
DR. SILVERSTEIN: ...Asian and Chinese.
MR. GROSSMAN: Let's work this through, since it
relates to your question.
A risk ratio of 1.34 indicates a 34 percent
increase in the exposed group, is that correct?
DR. SILVERSTEIN: Yes.
MR. GROSSMAN: A risk ratio of 14.7 indicates a
1,470 percent increase, is that correct?
DR. SILVERSTEIN: That's correct.
MR. MARTONIK: That's correct.
MR. GROSSMAN: If a group, and that 1,470 percent
increase is a factor many, many times higher than a 34
percent increase, is that correct?
DR. SILVERSTEIN: It's higher.
MR. GROSSMAN: It's a very powerful confounder, is
that correct? If it is present.
DR. SILVERSTEIN: You haven't described what the
confounder is.
MR. GROSSMAN: The confounder is Chinese cooking,
a life time of Chinese cooking.
DR. SILVERSTEIN: I'm not sure that that, in fact,
is a confounder in the studies that you're describing.
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
Tl1011-1485
1
2
3
4
5
6
7
8
9
I0
ii
12
13
14
15
16
17
18
19
2O
22
23
24
25
299
MR. GROSSMAN: You didn't look to see if it was,
isn't that correct, though?
DR. SILVERSTEIN: I'm saying I have no information
that that is, in fact, a confounder.
MR. GROSSMAN: You have no information that it is
not a confounder, is that correct?
DR. SILVERSTEIN: That's correct.
MR. GROSSMAN: And notwithstanding the unusual
representation of Asian-Americans in the study, you made no
attempt to find out if it was a confounder.
DR. SILVERSTEIN: I'm unaware of the extent to
which dietary histories were gathered and evaluated.
MR. GROSSMAN: Thank you very much.
That, by the way, is not dietary. It's a question
of cooking, not eating. It's a separate question. It's not
a question of a life time of eating Chinese food, it is
cooking Chinese food.
DR. SILVERSTEIN: Okay.
MR. GROSSMAN: Are you familiar with maps of the
United States indicating the presence of cancer hot spots
for lung cancer?
DR. SILVERSTEIN: Yes.
MR. GROSSMAN: You're aware that three of the
principal cancer hot spots in the United States are the New
Orleans/Baton Rouge area, the Beaumont/Houston area, and the
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
TI1011-1486
5
6
7
8
9
i0
II
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
300
Oakland/San Francisco area? As well as...
DR. SILVERSTEIN: I don't know how you really
define a hot spot, but there are several sectors in the
United States where there are increased cases...
MR. GROSSMAN: And those increases are correlated
with the presence of petrochemical plants, isn't that
correct?
DR. SILVERSTEIN: No, there's a large literature
that's investigated that question, and there are many
different views about the relationship between cancer in
those areas and the presence of petrochemical plants or
exposure to petrochemicals.
MR.GROSSMAN: The Center for Disease Control
publishes annual maps of lung cancer incidents in the United
States, and those maps are not necessarily related to
similar maps of cigarette consumption, isn't that correct?
It's a matter of public record.
MR. MARTONIK:
MR. GROSSMAN:
looked at it?
MR. MARTONIK:
MR. GROSSMAN:
We don't know the answer to that.
Have you studied it? Have you
Looked at?
Have you looked at it to see
whether the areas used by Fontham were cancer hot spots as
determined by the Center for Disease Control?
MR. MARTONIK: We generally reviewed the studies,
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
TI1011-1487
1
2
3
4
5
6
7
8
~9
i0
Ii
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
301
and any faGtor that we thought was relevant was reviewed.
MR. GROSSMAN: That isn't an answer. Just answer
the simple question.
Did you look at the charts of the Center for
Disease Control to determine cancer hot spots?
MR. MARTONIK: My understanding is that the
controls for those studies came from the same area...
MR. GROSSMAN: That isn't an answer to the
question.
DR. SILVERSTEIN: The answer is that when studies
are evaluated for their validity, one of the normal things
that is done and routine things that's done is to consider
whether the control groups are appropriate. And in making
theconsideration of whether control groups are appropriate,
you take into account factors such as the one that you just
mentioned. So it is fair to say that we considered that and
we de~ermined that the control groups were appropriate.
MR. GROSSMAN: The control group is a separate
issue. Did you look to see whether the foci of the Fontham
study were cancer hot spots as indicated by the Center for
Disease Control.maps and charts?
MR. MARTONIK: We are familiar with those maps,
we've taken them into consideration. We've also considered
the types of cancer that was observed in those hot spots as
a general matter. And we thought our approach was
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
Ti1011-1488
1
2
3
4
5
6
7
8
9
i0
ll
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
sufficient_to publish this proposal.
MR. GROSSMAN: That's not the question. I've
spent 15 minutes trying to get an answer to a simple
question.
MR. MARTONIK:
The answer is yes.
MR. GROSSMAN:
MR. MARTONIK:
MR. GROSSMAN:
302
We've been saying the answer. Yes.
You looked at the maps.
Yes.
Okay, and when you looked at the
maps, was Atlanta a hot spot? That's one of the foci of
the...
MR. MARTONIK: We don't recall.
DR. SILVERSTEIN: Can you define hot spot?
MR. GROSSMAN: Yes, it's red on the chart.
MR. MARTONIK: I think I already asked him that
and he didn't say what it was. He didn't say...
MR. GROSSMAN: Let's move on.
Was any attempt made in the Fontham study to
control for proximity to petrochemical plants?
MR. MARTONIK: I don't know what you mean by an
attempt by Fontham.
MR. GROSSMAN:
residential proximity to petrochemical plants?
MR. MARTONIK: To our knowledge, only to the
extent that the controls were local controls.
Did the Fontham study control for
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
T!1011-1489
!
2
3
4
5
6
7
8
9
i0
II
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
MR. GROSSM3hN:
MR. MARTONIK:
MR. GROSSMAN:
303
Local within the metropolitan area?
Yes.
You're familiar with the Brownson
study generally. It is on several hundred non-smoking women
who have lung cancer in Missouri. It came from more than
one city, is that correct? It came from throughout the
state?
MR. MARTONIK:
MR. GROSSMAN:
We don't immediately recall.
Wouldn't that be of interest if you
say the need for more than one center is a good way of
assessing the accuracy of the study?
MR. MARTONIK: It would be of interest, yes.
MR. GROSSMAN: The Brownson study is one of
several papers that were published that compared, that
attempted to determine the exposures of the non-smoking
women who ended up with lung.cancer in Missouri. The
studies include one on occupational exposure published in
1993 in Cancer Causes and Controls. Are you familiar with
that study?
MR. MARTONIK:
MR. GROSSMAN:
We don't know.
That published study that I've just
cited to you indicated that use of pesticides showed a risk
ratio, an observed risk of 3.1, which was statistically
significant. 1.3 to 7.5, 95 percent confidence level. Do
you know if any of the studies that you were relying upon
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
Ti1011-1490
1
2
3
4
5
6
7
8
9
I0
Ii
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
304
have attempted to control for the confounder of pesticide
use?
MR. MARTONIK: We believe that the different
studies chose control groups which could have accounted for
those types of factors.
MR. GROSSMAN: You believe that they could have.
Do you know whether they did or not?
MR. MARTONIK: As a matter of fact, all the
studies did ~se control groups, and the control groups
contained information regarding the background risk of
various cancers.
MR. GROSSMAN: The whole question of confounders,
I don't need to tell you, can't be scripped away by saying
there was a control group. The question is whether the
control group had the same exposure to pesticides.
MR. MARTONIK: We don't know that the study
contained a specific account of potential pesticide
exposure.
JUDGE VITTONE: Excuse me, Mr. Grossman. You're
coming up on 30 minutes.
MR. GROSSMAN: I haven't even gotten off this
~irst area because I'm not getting straight answers to
simple questions. Instead, I'm getting self-serving
responses.
MS. SHERMAN:
I think, Mr. Grossman, you're just
BAYLEYREPORTING, INC.
(202) 234-7787 (800) 368-8993
TI1011-1491
1
2
3
4
5
6
7
8
9
i0
ll
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
305
not willin9 to accept the answers.
MR. GROSSMAN: No, no. The question, have you
reviewed a study, does not require a paragraph answer.
MS. SHERMAN: That was asked and answered three
times. You just kept on asking the same question in
different ways.
MR. GROSSMAN: I'm going to move off the subject
and try to move as fast as I can. I think it's extremely
difficult this morning to obtain a simple answer to a simple
question, but I'm going to move as quickly as I can.
JUDGE VITTONE: Let's not argue back and forth
between the witnesses and between counsel. Let's try to ask
the question as simply as possible and directly, and let's
try to give as simple and direct an answer as possible.
MR. GROSSMAN: All right.
JUDGE VITTONE: Considering the other people and
the schedule that we've got to try to adhere to today, I'm
going to ask that you try to finish up by a quarter till,
okay?
MR. GROSSMAN: I'll go as quickly as I can.
Yesterday, Dr. Silverstein, at the beginning of
your comments in your opening statement, you made several
comments about the chemical composition of ETS. You said it
had 4,000 identified components. Do you recall making that
statement?
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
TI1011-1492
1
2
3
4
5
6
7
8
~9
l0
Ii
12
13
14
15
16
17
18
19
20
21
22
23
24
25
3O6
DR. SILVERSTEIN: Yes.
MR. GROSSMAN: Four thousand chemical components
haven't been identified in ETS, have they?
DR. SILVERSTEIN: Excuse me?
MR. GROSSMAN: Four thousand chemical components
haven't been identified in ETS, have they?
DR. SILVERSTEIN: A very large number have. I
can't tell you what the exact number is without referring to
the literature.
MR. GROSSMAN: The literature is quite clear.
There are 4,000 that have been identified in mainstream
smoke, but we're not even in the hundreds.
DR. SILVERSTEIN: Excuse me?
MR. GROSSMAN: We're not even in the hundreds in
ETS yet, are we?
DR. SILVERSTEIN: I think there are a very large
numbe~, and I can't tell you what that number is.
MR. GROSSMAN: And it's based upon your belief
that there is a very large number that you are going ahead
with this rulemaking, is that correct? It's based upon your
belief that there are about 4,000.
DR. SILVERSTEIN: The fact that there are a large
number of hazardous chemicals including many carcinogens in
environmental tobacco smoke is an element that we consider
important, but not determinative of...
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
T! 1011-1493
1
2
3
4
5
6
7
8
9
I0
ll
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
307
MR. GROSSMAN: ETS has not been determined to be
identical to mainstream smoke, has it?
DR. SILVERSTEIN: No, they contain different
components and different concentrations.
MR. GROSSMAN: And ETS is not identical to
sidestream smoke.
DR. SILVERSTEIN: No, it's not.
MR. GROSSMAN: It's not identical in concentration
and it's not identical in phase distribution, isn't that
correct?
DR. SILVERSTEIN: They're very similar and contain
many of the same components, but the exact answer to your
question is they're not identical.
MR. GROSSMAN: Dr. Silverstein, you said in your
earlier remarks yesterday, and I applaud them on this point,
that it makes no difference where a chemical comes from, the
Agency is not interested in, I'll quote it to you directly.
You said, "If the source of these airborne chemicals were
production machinery or raw materials, ironically, few would
question the legitimacy, indeed, the urgency of establishing
rules to protect workers from exposure," and you were
referring to carbon monoxide, formaldehyde and benzine. Do
you recall that testimony?
DR. SILVERSTEIN:
in my testimony.
I didn't use the word ironically
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
TI1011-1494
5
6
7
8
9
i0
ii
12
13
14
15
16
17
18
19
20
21
22
23
24
25
308
MR. GROSSMAN: It's in your printed...
DR. SILVERSTEIN: I know I didn't say it, but
other than that, you've quoted correctly.
MR. GROSSMAN: Dr. Silverstein, I agree with that..
Could you tell me what the current limits are as set by OSHA
on benzine in the atmosphere?
MR. MARTONIK:
one part per million.
MR. GROSSMAN:
The permissible exposure limit is
That makes no difference what the
benzine comes from, is that correct? Benzine in the work
place.
MR. MARTONIK: That's not true. There is" an
exemption for gasoline stations.
MR. GROSSMAN: Outside of gasoline stations can
have a higher level, is that correct?
MR. MARTONIK: Yes.
MR. GROSSMAN: But apart from gasoline stations,
it makes no difference where the benzine comes from. You
have set a PEL for benzine. And if the benzine level came
from cigarettes, it wouldn't make any difference than if it
came from some industrial process, is that correct? Isn't
that what you said, Dr. Silverstein, in your testimony
yesterday?
DR. SILVERSTEIN: No, I did not say that. You're
asking a different question. We said a permissible exposure
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
T!1011-1495
1
2
3
4
5
6
7
8
9
i0
ii
12
13
14
15
16
17
18
19
20
21
22
23
24
25
309
limit for benzine when measurements are taken that indicate
levels of exposure. It does not matter what the source was.
MR. GROSSMAN: Has any ETS study ever found levels
of benzine approaching those that are allowed by OSHA coming
from ETS in the work place?
DR. SILVERSTEIN:
not.
I don't know. I would expect
MR. GROSSMAN: So the reason for regulating ETS in
the work place is not the presence of benzine in ETS, isn't
that correct?
MR. MARTONIK: I would not...
DR. SILVERSTE~N: Not in the sense that benzine is
present at the levels that the benzine standard is meant to
cover. It is entirely possible that benzine plays a role in
some manner in the carcinogenic properties of environmental
tobacco smoke.
MR. GROSSMAN: Are you saying that it makes a
difference that the benzine in this instance is coming from
a smoldering cigarette rather than from some other source?
DR. SILVERSTEIN: I didn't say that.
MR. GROSSMAN: Are you~familiar with the level set
for carbon monoxide in the work place?
MR. MARTONIK: OSHAhas a standard for carbon
monoxide in the work place which is 50 parts per million.
MR. GROSSMAN: And if carbon monoxide in the work
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
TII011-1496
1
2
3
4
5
6
7
8
9
i0
Ii
12
13
14
15
16
17
18
19
20
21
22
23
24
25
310
place wer~ to reach that level, OSHA would enforce its rules
regardless of whether the carbon monoxide came from
smoldering cigarettes, or from industrial machinery, or from
another sources, is that correct?
MR. MARTONiK: Yes, we would.
MR. GROSSMAN: Carbon monoxide is carbon monoxide.
It's a chemical, correct?
MR. MARTONIK: That's correct.
MR. GROSSMAN: Formaldehyde is formaldehyde;
toluene is toluene; benzine is benzine, correct?
MR. MARTONIK:
MR. GROSSMAN:
source is?
MR. MARTONIK:
MR. GROSSMAN:
all of these substances?
MR. MARTONIK:
MR. GROSSMAN:
That's correct.
It makes no difference what their
That's correct.
You regulate all of these sources,
Yes, we do.
Not only that, your IAQ standard
would further lower the presence of these substances in the
work place, regardless of whether smoking took place Or not,
is that correct?
MR. MARTONIK:
MR. GROSSMAN:
MR. MARTONIK:
MR. GROSSMAN:
That's not correct.
It would not?
Would you repeat the question?
Yes. Your IAQ standards would tend
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
T! 1011-1497
1
2
3
4
5
6
7
8
.9
I0
Ii
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
311
to lower the actual presence of these environmental
pollutants in the work place, regardless of whether smoking
was taking place?
DR. SILVERSTEIN: In the way that you state it,
that's correct. It would tend to have that effect. The
effect would be in that direction. I don't think we can
comment on the quantitative nature of those effects.
MR. GROSSMAN: I'd like to turn your attention, if
I may, to page 15,989 of the Federal Register.
Ladies and gentlemen, yesterday you were saying
that the period and area of greatest exposure for most
workers to ETS is in the work place itself. I'd like to
address you to the first paragraph on the left, below Table
III-9. Where you say "work breaks and meals at work, where
the work activity is most closely associated with ETS
exposure, 51 percent and 35 percent respectively, versus 27
perce~t for work per se," do you see that?
DR. SILVERSTEIN: Yes.
MR. GROSSMAN: Then you say, "In other words, non-
smokers experienced ETS exposure in break areas more than in
general work areas," do you see that?
DR. SILVERSTEIN: That's what it says.
MR. GROSSNLAN: I'd like to point your attention to
the far right column on the same page, just below the same
table where you say the percentage of subjects exposed to
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
TI 1011-1498
1
2
3
4
5
6
7
8
9
I0
II
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
312
ETS at both work and home was 29 percent; percentage of
subjects exposed at home but not work was seven percent;
percentage of subjects exposed at work but not at home was
49 percent; percentage of subjects exposed neither at home
or work was 15 percent.
As I understand it, what you are saying is that 51
percent, this is from the left hand column, of workers
studied in this group, were exposed to ETS at some level,
which was not identified, during dining; 36 percent at home,
35 percent during breaks, and 27 percent during work per se.
Is that accurate? Is that what you say here?
MR. MARTONIK:
(Pause)
MR. MARTONIK:
Just one moment, please.
We don't recall... There are a lot
of numbers you cited, and we tried to compare...
MR. GROSSMAN: On the left hand column you say 51
percent of workers are exposed during dining; 35 percent
during breaks. On the right hand column you have 29 percent
and seven percent who were exposed at home. That's a total
of 36 percent. Then again in the left hand column. That's
27 percent exposed during work per se.
MR. MARTONIK: Yes, those are different...
MR. GROSSMAN: So what you found was that the time
during the day when workers were least likely to be exposed
to ETS was when they were actually working at their desks,
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
TI1011-1499
1
2
3
4
5
6
7
8
9
i0
II
12
13
14
15
16
17
18
19
20
21
22
23
24
25
is that co2rect?
(Pause)
MR. MARTONIK:
MR. GROSSMAN:
313
That's what the study shows.
And that's the study that you rely
on in your Federal Register citation, is that correct?
MR. MARTONIK: There are other studies that were
described, and we relied on that study in part.
MR. GROSSMAN: Have you made any effort to
determine the level of risk, if any, from exposure at work
stations per se, to workers?
MR. MARTONIK: Not per se, no.
MR. GROSSMAN: Have you made any effort to...
It's accurate to say, isn't it, that you've made
no effort to determine whether risks would be significant to
workers if smokers were separated during working hours, and
if your ventilation standards were enforced?
MR. MARTONIK: The answer to that is no, we did
consider various alternatives for reducing exposure to
environmental tobacco smoke.
MR. GROSSMAN: The numbers that you cite, 5~
percent for exposure during meals; 36 percent for exposure
at home; 35 percent during breakS, compared to 27 percent at
work, indicate that the level of risk that you're referring
to is similar to the risk of living in our modern society
generally, is that correct?
BAYLEYREPORTING, INC.
(202) 234-7787 (800) 368-8993
Tl1011-1500
1
2
3
4
5
6
7
8
9
i0
II
12
13
14
15
16
17
18
19
20
21
22
23
24
25
_MR. MARTONIK:
MR. GROSSMAN:
generally.
correct?
314
I don't know. I'm not certain.
Exposure to ETS is a part of life
It is not unique to the work place, is that
MR. MARTONIK: That's correct.
MR. GROSSMAN: It's similar to exposure to
environmental pollutants living in a city as opposed to
living in the country, is that correct?
MR. MARTONIK: I don't believe that's true.
MR. GROSSMAN: You don't believe it's true in
terms of its carcinogenicity or in terms of its being a
generalized exposure?
MR. MARTONIK: In terms of having some study that
shows that there is this difference.
MR. GROSSMAN: Study showing which difference?
MR. MARTONIK: I thought the question was to what
extent we made efforts to gather studies to explain the
difference in types of exposures regarding city dwellers and
rural dwellers and people in the house and work place.
MR. GROSSMAN: But in the same sense that there
are different societal exposures that come from life in the
city as opposed to the country...
MR. MARTONIK: We agree with that, yes.
MR. GROSSMAN: And exposure to ETS is the same
kind of thing, is that correct?
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
TI1011-1501
1
2
3
4
5
6
7
8
9
10
ll
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
315
MR. MARTONIK: That's what I said, I don't know
whether that's the case or not. If you have some evidence
on that we'd like to look at it.
JUDGE VITTONE: Mr. Grossman, if you'd wrap up
this point, then we're going to move on.
MR. GROSSMAN: All right.
Yesterday I asked about any findings regarding a
level below which the authors that you have relied upon have
found that there would be no risk or no significant risk of
lung cancer. I cited to Mr. Repace, which raised a question
as to where it came from. I would point for example, to
Volume 13 of risk analysis, number four, 1993, an article
entitled "An Enforceable Indoor Air Quality Standard for
Environmental Tobacco Smoke in the Work Place." And Dr.
Repace, what you said in this, in fact it's in the head
note, "Modeling of the lung cancer mortality risk from
passive smoking suggests that deminimus, that is acceptable,
ten to the minus six power risk, occurs at an eight hour
time weighted average exposure concentration of 7.5
nannograms of ETS nicotine per cubic meter of work space air
for a working life time of 40 years."
Now, has this Agency made any attempt to determine
whether separation of smokers would produce a typical
exposure concentration of 7.5 nannograms of ETS nicotine per
cubic meter of work space air or less?
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
Tl1011-1502
1
2
3
4
5
6
7
8
9
I0
Ii
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
316
.MR. MARTONIK: Dr. Silverstein will answer that.
(Continued on the nxt page. )
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
T! 1011-1503
1
2
3
4
5
6
7
8
9
i0
Ii
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
317
. DR. SILVERSTEIN: We have not made a specific
independent determination of that, but I would not that, in
Dr. Repace's study, his conclusion is that dilution
ventilation and other means short of the kinds of measures
in our proposal, would be insufficient to provide protection
without those levels.
Now, Dr. Repace, in this study, made an
interesting and important effort to determine a level below
which there would be insignificant risk that might be used
to establish a permissible exposure limit.
OSHA has not concluded that that study, in fact,
has adequate validity in all regards to reach a conclusion
of that sort, but we do note that Dr. Repace believes that
an appropriate level of exposure is so low that the only
need, the only effective means, of protecting workers would
be to ban smoking or limit it to enclosed exhausted rooms.
MR. GROSSMAN: In determining the level of
exposure, yesterday we began talking about exposure. You
told me that a well conducted personal monitoring study was
among the best type of ways to monitor levels of exposure.
DR. SILVERSTEIN: We indicated that a personal
monitoring program that meets all the relevant industrial
hygiene criteria is often the best evidence available, but
that, in many cases, personal monitoring results can be
misleading.
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
Ti1011-1504
1
3
4
5
6
7
8
9
I0
ii
12
13
14
15
16
17
18
19
20
21
22
23
24
25
318
. MR. GROSSMAN: Now, let me just ask what a well
constructed study would be --
JUDGE VITTONE:
want to move on.
MR. GROSSMAN:
Just finish this up, because I
All right. Let me just ask what a
well constructed study will be, and then I'll be done.
Thank you, Your Honor.
A well constructed study, I assume, would have
credible investigators?
DR. SILVERSTEIN: Investigators are credible if
they do well-conducted studies, so it's a circular kind of
proposition.
MR. GROSSMAN: All right. If you have a large
number of people under analysis?
DR. SILVERSTEIN: Not necessarily.
MR. GROSSMAN: It wouldn't necessarily need a
large number?
DR. SILVERSTEIN: It depends on what you're using
the personal monitoring results for.
MR. GROSSMAN: Would it be multicenter?
DR. SILVERSTEIN: I'm not sure what that term
means in this context.
MR. GROSSMAN: Would it be conducted in more than
one work place and in more than one part of the country?
DR. SILVERSTEIN: Not necessarily. It depends on
BAYLEYREPORTING, INC.
(202) 234-7787 (800) 368-8993
T! 1011-1505
1
2
3
4
.5
6
7
8
9
!0
ii
12
13
14
15
16
17
18
19
20
21
22
23
24
.25
319
what it wo.uld be used for. It could be a laboratory study.
MR. GROSSMAN: Would it necessarily be able to
discern the relative contribution of environmental
substances from cigarettes as opposed to the underlying air?
DR. SILVERSTEIN: I don't under the question.
MR. GROSSMAN: It would be able to discern the
relative contribution of ETS to air in the home and in the
work place and compare them?
DR. SILVERSTEIN: I'm afraid I don't understand
the question. I don't understand how that relates to the
quality of a personal monitoring sample.
MR. GROSSMAN: Well, that relates to the. question
of your use of home spousal studies.
DR. SILVERSTEIN: Are you still asking about the
Repace study?
MR. GROSSMAN: No, I'm not asking about that.
DR. SILVERSTEIN: You shifted to a different
area?
MR. GROSSMAN: All I'm asking about is what a
well-conducted personal monitoring study would entail.
Could you tell me what a well-conducted personal monitoring
study would entail?
DR. SILVERSTEIN: If we have to -- it would take
some time to discuss the principles of industrial hygiene.
MR. GROSSMAN: Why don't you just explain for the
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
TI1011-1506
5
6
7
8
9
i0
ll
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
320
record wh~t you believe a well-conducted personal monitoring
study would entail?
DR. SILVERSTEIN: I think that you have to
consider issues such as sampling strategy, the analytic
techniques, the quality of the laboratory involved,
statistical methods of evaluation, and a variety of other
factors; consideration of sampling in relation to the type
of work and type of sources of exposure is an important
consideration.
JUDGE VITTONE:
DR. SILVERSTEIN:
All right, gentlemen.
I can't give you a definitive
and thorough discussion of industrial hygiene principles
right now.
JUDGE VITTONE:
MR. GROSSMAN:
JUDGE VITTONE:
All right. Thank you very much.
Thank you.
Thank you, Mr. Grossman.
Mr. Rupp, I know you said you were next, but
Mr. Weinberg said he only has one question, so if you'll
give me a second here and let Mr. Weinberg get his one
question in.
Mr. Weinberg, identify yourself for the record.
MR. WEINBERG: The Washington Technical
Information Group, No. i0, Myron Weinberg.
Yesterday, when I asked a series of questions
after you had introduced the idea that an important part of
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
Ti1011-1507
1
2
3
4
5
6
7
8
.9
I0
II
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
321
any study ~s the establishment of dose response
relationship, and when I asked that question, I asked if you
had considered, or you indicated that you had considered,
dose response and discussed it in the proposal.
Last night, I re-read the proposal, and I'm
asking now if you could identify for me, specifically, in
the proposal on what page you discuss those responses.
MR. MARTONIK: The proposal speaks for itself.
It discusses the studies that we've used and the studies
also speak for themselves. I'm going to ask Dr. Silverstein
if he could elaborate on this.
MR. WEINBERG: Thank you.
DR. SILVERSTEIN: I want to just refer you back
to something that I mentioned yesterday, a paper that was
published by Dr. Dimetrius Trichopoulos who reviewed many of
the studies that are in question here, and has finding and
concllsion that in at least 12 of the positive studies,
there was clear evidence of a dose response trend, and he
goes on to explain why this couldn't be accounted for by
various forms of confounding, and he has a long list of
references. This was a study published in August of 1994.
MR. WEINBERG: So you're saying that, in order to
determine OSHA's discussion of dose response, I have to read
Trichopoulos' paper?
DR. SILVERSTEIN: No. I think that you could
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
TI1011-1508
1
2
3
4
5
6
7
8
9
i0
Ii
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
322
read, as w~ did, the papers themselves, and study the
record, as we will do, and we will continue to do. We will,
in our final rule, present what we believe will be adequate
discussion of these issues.
MR. WEINBERG: Okay. So, in the current rule,
there is no OSHA discussion of the dose response issue?
DR. SILVERSTEIN: Only what you've seen in the
Federal Register.
MR. WEINBERG:
JUDGE VITTONE:
Thank you.
Mr. Rupp.
MR. RUPP: Good morning.
JUDGE VITTONE: Just identify yourself again for
the record, you don't have to identify everybody.
MR. RUPP: Okay. My name is John Rupp from
Covington and Burling.
Because of limitations on time yesterday, I had
to move rather rapidly over a number of issues. I don't
intend to cover any of the questions I asked yesterday, but
I would like to complete our discussion of a couple of
issuesbefore I move to some newthings, if that's
satisfactory to the panel.
A couple of people have referred in their
questions to the Brownson study. I want to refer to it now,
but for quite a different purpose, if you'll indulge.
I listened carefully to the discussion yesterday
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
Tll011-1509
1
2
3
4
5
6
7
8
9
I0
II
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
323
of the categories into which individual studies had been
placed, positive, equivocal positive trend and equivocal,
and, frankly, I still don't understand how studies got in
various places.
I'm not going to ask you to re-read the Brownson
study at this point, because that, obviously, will take too
much time. Let me ask you, instead, to assume what I'm
going to say is correct, and then I'd like to ask you
whether, if this is correct, a study like Brownson, a study
of the hypothetical sort, is appropriately characterized as
a positive study. Is that fair?
MR. MARTONIK: We'll try.
MR. RUPP: So far as the work place is concerned,
our hypothetical study states that, in general, there was no
elevated lung cancer risk associated with passive smoke
exposure in the work place.
So far as the spousal smoking index is concerned,
which OSHA, of course, has favored in all other respects in
this rulemaking, Brownson reported an overall relative risk
of one, on the dot.
Of the 28 separate risk estimates for ETS and
lung cancer among adults, reported in this study, we're
discussing, five were significantly positive, albeit weakly
so; 7 were significantly negative, and the remaining ii were
also negative but were not significantly negative, had a 95
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
TI1011-1510
1
2
3
4
5
6
7
8
"9
i0
li
12
13
14
15
16
17
18
19
20
21
22
23
24
25
324
percent confidence interval.
For childhood exposure, we have 16 relative risks
in our hypothetical study, all of those were negative, 9 of
them significantly negative.
Would that be a positive study, an equivocal
positive trend study, or an equivocal study?
DR. SILVERSTEIN: You posed a very complicated
set of facts, and we would have to consider them carefully.
We would not want to do that casually.
MR. RUPP: Well, in all other respects, when
there is discussion in the text about individual studies,
OSEA has focused on spousal smoking as the index of
exposure. Is that correct? That obviously is correct.
Would you agree, for the record, that is correct?
MR. MARTONIK: Would you state the question
again?
MR. RUPP: Yes. Let's limit our attention, to
make it simpler, just to lung cancer.
The index of exposure on which OSHA has chosen to
focus in discussing lung cancer is spousal smoking. That is
the index of exposure. Is that correct?
DR. SILVERSTEIN: What do you mean by "index of
exposure" ?
MR. RUPP: That is, in determining whether a
person was exposed or not exposed.
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
Ti1011-1511
1
2
3
4
5
6
7
8
9
10
ll
12
13
14
15
16
17
18
19
20
21
22
23
24
25
325
.MR. MARTONIK: No. We looked for all studies
that gave us information on the toxicity of --
MR. RUPP: That's not what I'm asking you.
My time is limited, so I'm going to be pointed as
I can with you in my questions --
MR. MARTONIK: Okay.
MR. RUPP: -- and if you'll be as pointed as
possible in your responses, you'll be rid.of me rather
quickly.
You have categorized studies with various
headings. In lung cancer, those headings are positive
equivocal, positive trend, and equivocal.
The index of exposure that is discussed in the
Preamble is spousal smoking.
Now, in the hypothetical study that I've
mentioned, that index, the relative risk for that index is
i. Would that be a positive study, an equivocal positive
study, or an equivocal study, or do you need more
information?
DR. SILVERSTEIN: I think we need more
information.
MR. RUPP: Okay. What kind of information do you
need, because -- Doctor, what I'm trying to understand is
how studies got into various categories. I'm not trying to
quiz you about an individual study.
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
Tl1011-1512
1
2
3
4
5
6
7
8
9
I0
ll
12
13
14
15
16
17
18
19
20
21
22
23
24
25
326
o DR. SILVERSTEIN: I think that Ms. Janes
described yesterday at some length the criteria that we used
in determining whether a study had meaning for these
purposes.
MR. RUPP: Right. And I have reviewed that part
of the transcript and, frankly, it simply is .not
understandable. I take it this was a pivotal factor in the
analysis, or an important factor in the analysis, to just as
briefly as you can but as fairly as you can, I would explain
Ms. Janes explaining to me again how studies got into the
individual categories.
What kind of factors, generically, were taken
into account?
MR. MARTONIK:
question.
MR. RUPP:
MS. JANES:
Ms. Janes will answer your
Thank you very much.
OSHA assessed the available data to
determine whether or not, on a study by study basis, that it
could either support or not support an association between
exposure and disease.
Now, the classification that was used, basically,
of the positive study, was defined as a study that was well-
designed and conducted. The results were internally
consistent and showed statistically significant positive
association.
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
TI1011-1513
1
2
3
4
5
6
7
8
9
10
ii
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
327
.An equivocal study, on the other hand, the
results were not internally consistent, they were not
statistically significant, and can support nor refute the
existence of an association between exposure and disease.
A non-positive study, of which there were none,
shows no correlation at all between disease and exposure.
Now, the equivocal trend for that, you can judge
that there may have been a trend in the data, but they did
not attain statistical significance, but there was a trend,
and so that's how they were determined to be equivocal and
positive trends.
MR. RUPP: Okay. That's very helpful.
Now, let me pursue that with you another step or
two, if I may, and I think maybe that will complete that
aspect of the questioning, at least from me.
You say, first, the study has to be well
designed. You did put the Brownson into the positive
category so I assume that meant that you concluded it was a
well-designed study?
MR. MARTONIK: Debby, you can answer that.
MR. RUPP: Ms. Janes, I'm looking at page 15993.
That's the only page to which I need to refer on this
question.
MS. JANES: Okay. The Brownson study was one of
many that we judged to have been well designed.
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
TI1011-1514
1
2
3
4
5
6
7
8
9
i0
II
12
13
14
15
16
17
18
19
20
21
22
23
24
25
328
_M~. RUPP: Thank you.
Did you conclude -- I take it you did, in light
of your discussions -- that the results of the Brownson
study were internally consistent?
MS. JANES: For spousal exposure, they were
internally consistent, yes.
MR. RUPP: Okay. Did you conclude that for
spousal smoking, index of exposure, that the results were
statistically significant?
respect?
MS. JANES:
MR. RUPP:
MS. JANES:
MR. RUPP:
Yes, we did.
Above i?
Yes, we did.
Would you have been in error in that
MS. JANES: No, I don't believe so.
MR. RUPP: The fact is that the Brownson study,
spousal smoking index of exposure is one on the money --
one?
DR. SILVERSTEIN: We don't agree with that
characterization of that study.
MR. RUPP: Okay. Would you be prepared to look
at that study again, in light of what I have said?
DR. SILVERSTEIN: I think we have.
MR. RUPP: You've looked at it again?
MR. MARTONIK: Yes.
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
Tl1011-1515
i
2
3
4
5
6
7
8
.9
i0
ii
12
13
14
15
16
17
18
19
20
21
22
23
24
25
329
-MR. RUPP: What do you believe the relative risk
is for the spousal smoking index of exposure in the Brownson
study?
MR. MARTONIK: I don't recall at this time, but
we have some information that could help you.
MR. RUPP: I thought Dr. Silverstein said that
you had looked at the spousal smoking index again, and it's
different than I have represented it to be.
MS. JANES: You are representing that subfraction
of occupational data that it had. We are referring to the
spousal.
MR. RUPP: No, I'm not. No. I'm talking about
spousal smoking -- not occupation, spousal.
MS. JANES: Dr. Brownson,~ in reviewing his own
study, said that exposure of more than 40 pack years
duration increased the risk of lung cancer among nonsmokers
by approximately 30 percent.
MR. RUPP: That's not what I've asked you. I've
asked you whether you said that the spousal smoking data in
the Brownson study was internally consistent, and that is
the index you relied upon, and I'm asking you, what is the
relative risk for spousal smoking in the Brownson study?
I've suggested that it is a point.
MS. JANES: Dr. Brownson just -- I read you the
quote, it was 1.3.
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
Ti1011-1516
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
330
.MR. RUPP: Would you read that quote to me again,
please, and where is that quote from?
MS. JANES: It's the American Journal of Public
Health, November 1992, Volume 82, No. ii, and it's page --
JUDGE VITTONE: Ma'am, could you keep your voice
up, please?
MS. JANES:
kids.
I'm sorry. I only do that with my
On page 1527.
MR. RUPP: And he is talking there about the
spousal smoking index of exposure?
MS. JANES: Yes, he is.
MR. RUPP: If we can convince you that you're
reading that study incorrectly, would you be prepared to
take another look at it?
MS. JANES: OSHA will evaluate all the studies
again, along with any new data that have come in since the
publication of the proposal.
MR. RUPP: When you're talking about internally
consistent or inconsistent studies, I take it what you're
talking about whether, on various index of exposures, you're
getting an equivocal result, a significant and positive
result, or a significantly negative result?
DR. SILVERSTEIN: I don't understand that
question.
BAYLEYREPORTING, INC.
(202) 234-7787 (800) 368-8993
T11011-1517
1
2
3
4
5
6
7
8
9
I0
ii
12
13
14
15
16
17
18
19
20
21
22
23
24
25
331
-MR. RUPP: Ms. Janes indicated to me that one of
the factors one looks at in determining whether a study is
positive is the internal consistency of the result, as well
as the statistical significance of the result. I'm asking
what I thought was a simple question.
What you are looking for is really whether
they're all positive, whether they're around the middle of
equivocal or whether they're all negative, or whether there
is a mismatch? Is that right, given various indices of
exposure?
DR. SILVERSTEIN: I would like to answer your
question directly. I'm not trying to be evasive, but I
really am having trouble following the questions.
MR. RUPP: All right. Let me try to ask --
DR. SILVERSTEIN: Certainly, it's true that
typically studies that have any complexities at all have
many different subparts and subanalyses, and in many studies
that are deemed convincingly positive as a whole,
particularly for specific purposes, they may very well have
negative or inclusive findings in various subparts.
In other words, to conclude that a study is
"meaningful, that it's positive, that it's valid for a
particular purpose, does not require that in every subpart
there is a similar positive finding.
MR. RUPP: Fair enough. Would this be a study
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
TI1011-1518
1
2
3
4
5
6
7
8
9
i0
ii
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
332
that you wDuld regard to be internally inconsistent a study,
that has 28 separate risk estimates for ETS and lung cancer
among adults, of which 5 are significantly positive, 7 are
significantly negative, the remaining ii are negative but
not statistically significantly so, and on the 16 other
indices of exposure, 9 are significantly negative, the
others are not significantly positive or negative.
Is that a study that has internal consistency?
DR. SILVERSTEIN: Again, you've posed an
extremely complicated set of facts, and I think that it's
fair to say that you're describing a study that is complex,
and requires care in evaluation and interpretation; but not
one that is necessarily internally inconsistent.
MR. RUPP: Not necessarily internally
inconsistent, because if you focus on one index of exposure
that is, by definition, consistent? The result is what it
is?
DR. SILVERSTEIN: You may have two very different
kinds of evaluations embodied in a study that provide
different results. They may be consistent with one another.
In some cases, this is true for much of the
literature that we've been discussing the past couple of
days. Some of the studies, particularly the spousal
studies, have high validity often and have been well done
and allow an adequate basis for conclusions, where much of
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
TI1011-1519
1
2
3
4
5
6
7
8
9
I0
II
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
333
the work p~ace data is inadequate.
In some cases, we're talking about a very small
sample size, inadequate study design, et cetera.
In that kind of a circumstance, the fact that one
study is positive and the other one has a relative risk of 1
or less than l, does not mean that there is internal
inconsistency.
The differences are not necessarily inconsistent.
MR. RUPP: A red flag starts to go up, does it
not, when you have statistically significant, positive
results and statistically significant negative results?
DR. SILVERSTEIN: This is invariably the case
with the sciences that are used to evaluate all the
questions under consideration here.
MR. RUPP: All right. Let me ask a couple of
questions about how the expert panel was chosen, and the
reason I ask it, so that there is no hidden agenda here, is
that a number of our detailed questions have been referred
and told we'll get extra insight into these issues from
experts whom OSHA has asked to join us over the exceeding
days.
Wa~ there a written set of criteria that OSHA
drew up in deciding who should be chosen and who not?
MR. MARTONIK: No, there was not.
MR. RUPP: All right. Because I really don't
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
T11011-1520
1
2
3
4
5
6
7
8
.9
10
ii
12
13
14
15
16
17
18
19
20
21
22
23
24
25
334
want to coyer ground already covered, let me try to
summarize quickly what I think you have said already on this
point; ask you whether you agree and then ask a couple of
follow-up questions so we don't use our time inefficiently.
What I understand you to have said thus far is
that you look for people that you believe to have expertise,
and if their view was the same on the various issues as
OSHA's preliminary view, that was a plus rather than a
minus.
I want to ask you about additional criteria or
additional considerations you may or may not have had, and
see whether or not these are factors. Fair enough?
MR. MARTONIK: Fine.
MR. RUPP: Okay. If the particular person has a
long history of activity in the Smokers Rights Movement,
anti-smoking activities has been a long-time officer of
anti~~moking organizations, is that a positive or a negative
or not of any consequence?
MR. MARTONIK: We really didn't -- we didn't look
at that.
MR. RUPP: Would a factor in your consideration
be whether you were able to conclude on the basis of
materials that have been written and you knowledge of the
person that the person could bring an objective and bias
viewpoint to the table?
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
TI1011-1521
1
2
3
4
5
6
7
8
9
10
ii
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
335
MR. MARTONIK: The answer to that is yes.
MS. JANES: Excuse me a second.
Did you say objective and biased?
MR. RUPP: Objective and unbiased viewpoint to
the table. The answer is yes.
If a particular individual had been a founder of
a national anti-smoking organization back in the mid-'80s,
let's say, and had been involved in countless campaigns
against smoking since that time, would that be any kind of
red flag for you?
MR. MARTONIK: One second.
[Pause. ]
MR. MARTONIK: The answer is no, we didn't look
at that; we based our decision on the expertise of the
individual, in terms of their writings and publications.
MR. RUPP: Okay, but my question is slightly
different. If that were established on the record to your
satisfaction, would that be a red flag for you in assessing
objectivity and the degree of reliance you could place on
those views?
MR. MARTONIK: No.
MR. RUPP: And the same is true in terms of
people whom OSHA might reach out to ask them to assist in
the writing of the preamble or the final rule or the
explanation of the final rule?
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
Ti1011-1522
5
6
7
8
9
I0
ii
12
13
14
15
16
17
18
19
20
21
22
23
24
25
336
MR. MARTONIK: Yes.
MR. RUPP: So long political involvement in
antismoking organizations would not be a particular factor
one way or the other?
MR. MARTONIK: No, it would not.
MR. RUPP: What if the person had been paid
repeatedly for participating in litigation against the
tobacco industry; would that be a factor?
MR. MARTONIK: No.
MR. RUPP: Would that be something you would care
to know anything about?
MR. MARTONIK: Personally, we didn't have the
access to that information; it would be relevant.
MR. RUPP: Irrelevant or relevant?
MR. MARTONIK: Irrelevant. Not relevant.
MR. RUPP: And do you believe it's also
irrelevant under the federal conflict of interest rule?
MR. MARTONIK: Well, there's a lot of people that
earn money by working, and some people work in the
university and other people at different places.
We simply read the literature ourselves, obtain a
preliminary perspective regarding the health effects, and
when it comes time for putting together the proposal, we
sometimes try to find someone to help answer some of the
questions, and we do this by using a witness.
BAYLEYREPORTING, INC.
(202) 234-7787 (800) 368-8993
Tl1011-1523
!
2
3
4
5
6
7
8
9
10
Ii
12
13
14
15
16
17
18
19
20
21
22
23
24
25
337
. Primarily, I said, we look at the individual's
publications, their expertise, their positions. We also
talk to them about their interpretations of some of the
studies.
MR. RUPP: But you never ask them whether they
believe -- let me tell you, we are so often asked when we go
on a jury "whether you believe if you can be objective in
your evaluation of the evidence you're about to hear";
that's not a question that OSHA asks of people who it
considers hiring for --
DR. SILVERSTEIN: These are people who we think
will be objective.
MR. RUPP: But you never ask them that question?
DR. SILVERSTEIN: Whether -- we don't ask -- you
want to know whether we ask --
MR. RUPP: Whether they believe they can do the
kind of job that OSHA is supposed to do, which is an
unbiased view of the pertinent evidence and an evaluation of
the alternative.
DR. SILVERSTEIN: We can't give you a list of ten
questions that we ask everybody who is considered to provide
expert testimony.
We ask a -- we have discussions, we evaluate the
available information, we make a judgment, and part of that
judgment is whether we believe somebody has sufficient
BAYLEYREPORTING, INC.
(202) 234-7787 (800) 368-8993
TI1011-1524
1
2
3
4
5
6
7
8
9
i0
ii
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
338
expertise,, and objectivity to se~Je the purpose.
MR. RUPP: How do you determine whether that
person has objectivity if you are going to ignore the kind
of factors that I've described?
DR. SILVERSTEIN: I'm not sure that I understand
what you're driving at.
MR. RUPP: Let me give you two. A person is a
founder of an anti-smoking rights organization in
California, has been involved nearly full-time in anti-
smoking campaigns since the mid-80s. Does that say nothing
about -- let's call it bias, without using it in a negative
way.
DR. SILVERSTEIN: Absolutely not.
MR. RUPP: Okay.
DR. SILVERSTEIN: Are you suggesting otherwise?
MR. RUPP: I'm just trying to get information to
see what kind of standards OSHA is applying.
JUDGE VITTONE: Excuse me, let me interrupt right
here.
Off the record.
[Discussion off the record]
MR. RUPP: Thank you, Your Honor.
A series of questions were asked, again which I
do not propose to repeat, about the process that OSHA has
gone through to try to evaluate the record that's been
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
TI1011-1525
1
2
3
4
5
6
7
8
9
i0
ii
12
13
14
15
16
17
18
19
20
21
22
23
24
25
339
accumulating thus far.
I think there are some loose ends in this area,
and to help us figure out how best to communicate with you,
that really is the spirit in which I ask the following
series of questions; so if you'll indulge me.
On the risk assessment issues, OSHA cited the
private docket, the No. 8 docket a total of 94 times. That
is, the docket that had been put together by OSHA itself.
The entire public document was cited once.
How did you go about the process of reviewing all
of the comments that were submitted in response to the RFI,
and why were not more of those materials cited in the
preamble?
MR. MARTONIK: To the extent that you believe
that some failure to cite papers is relevant towards us
making a correct decision, I hope you bring that to our
attention, and will go back and look at these other studies,
and see whether or not we made the correct decision by not
citing them or not.
MR. RUPP: Well, in the exposure section -- let's
take another example. In the exposure section, OSHA cited
the comments from sources like Mr. Repace who has been
discussed here, a total of 60 times.
The entire public document, which is replete with
submissions on exposure, current exposure, was cited four
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
T11011-1526
1
2
3
4
5
6
7
8
9
I0
ii
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
340
times. And I think two of those were citations to Jenkins
and Garrin at Oak Ridge National Laboratory, which I think
those gentlemen submitted to you.
What accounts for that? Did you take the public
comments into account in trying to assess degree of current
exposure to ETS in the work place? And if so, why were
those other materials not cited or discussed?
MR. MARTONIK: We believe we looked at the record
as we needed to look at it to publish this proposal. But
some of the statistics that you cited, I'm not sure what you
were asking. You said that we cited Repace 60 times?
MR. RUPP: No, no. From the private docket.
MR. MARTONIK: Okay.
MR. RUPP: Let me ask the question this way, Mr.
Martonik:
Did you, or are you prepared now, to instruct the
staff who will be doing the follow-up work on this standard
to pay attention to the public record and try to take it
into accqunt; and if disagreement, to indicate that there is
disagreement?
MR. MARTONIK: Yes; and the purpose of the
hearing is for you to give us your criticisms of our former
approach that we published in the Federal Register.
MR. RUPP: I asked you a couple of questions
yesterday about COPD, and then because of time I moved off
BAYLEYREPORTING, INC.
(202) 234-7787 (800) 368-8993
Tl1011-1527
1
2
3
4
5
6
7
8
9
I0
ii
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
341
to other t~ings. Let me complete that discussion.
In the preamble on COPD, one study is cited, and
that is the Greek study published by Kalandidi and
coworkers.
Is OSHA aware of any other studies on ETS and
COPD that would support a finding of an association between
the incidence of COPD and exposure to ETS other than the
Kalandidi study?
MR. MARTONIK: I believe that's all we cited, and
that's all we know about.
MR. RUPP: Is OSHA -- I take it you are aware of
the fact that the Kalandidi study is available, presumably
to you as well as to us, only in the form of a brief letter
to the editor that no peer-reviewed report of that study has
appeared in the scientific literature.
MR. MARTONIK: We can't recall that.
MR. RUPP: The Kalandidi letter, reported an
adjusted odds ratio of 2.5 with a 90 percent confidence
interval stemming from 1.3 to 5, for a COPD among Greek
women smokers married to husbands who smoked less than one
pack of cigarettes per day.
That relationship, however, disappeared for women
married to husband who were reported to be heavier smokers.
I'm interested in knowing why that rather odd fact was not
discussed in the preamble or taken into account before OSHA
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
Tl1011-1528
1
2
3
4
5
6
7
8
9
i0
II
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
342
reached a positive finding with respect to ETS and COPD.
MR. MARTONIK: We can't recall the specifics of
the study, but we hear what you're saying and we will take
into account your criticism.
MR. RUPP: If you have a negative dose response
trend, I take it you would agree, at least generically, that
that's certainly a red flag; is it not?
MR. MARTONIK: We agree that that sort of
information has to receive more careful attention, but is
not necessarily something that would discount the whole
effect.
MR. RUPP: Isn't one of the hallmarks of
scientific inquiry, and particularly important to regulatory
agencies, that the results of studies, particularly studies
that appear only as letters to the editor without a full
reporting of results and without having gone through peer
review, have been replicated by other investigators at some
time?
DR. SILVERSTEIN: That would be one of the
elements in the longer list --
MR. RUPP: Pretty important --
DR. SILVERSTEIN: -- that was discussed.
MR. RUPP: Pretty important one, though, wouldn't
you agree? Replication of study results by some
investigator somewhere over the course of human history?
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
Tl1011-1529
1
2
3
4
5
6
7
8
9
i0
ii
12
13
14
15
16
17
18
19
20
21
22
23
24
25
343
. DR. SILVERSTEIN: If present, useful; if not
present, not necessarily a problem.
MR. RUPP: What relevance does a letter to the
editor on a small group of Greek women, married to smoking
husbands, have to do -- have to exposure to environmental
tobacco smoke in the United States work place in 1994?
DR. SILVERSTEIN: The Panel is not prepared to
discuss that study in detail. We don't have the information
that you're seeking. You're bringing to our attention what
you perceive to be a shortcoming, and we have an obligation
to take your concerns seriously, and to look into them.
MR. RUPP: I appreciate that, and I'll heave,
then, with one other quote from you and ask you if something
you also would be prepared to pursue.
The letter to the editor by Kalandidi provided no
diagnostic details, and let me refer to one of the commen~s
that was submitted that has been submitted to OSHA, and ask
you whether you'd be prepared to look into this as well.
And I quote:
The author's experience -- referring
to Kalandidi -- of having obtained a
cohort of 103 non-asthmatic, never-
smoking women with C0PD at a single
institution over a two year period is
so unique, even for a chest hospital,
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
TI1011-1530
1
2
3
4
5
6
7
8
9
I0
II
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
344
_ 559 as to raise significant questions
regarding the criteria used to
establish a diagnosis.
Is that something you'd be prepared to look into as well?
DR. SILVERSTEIN: It was a fairly complicated
statement. The general answer is that we will look into the
issues that you're raising.
MR. RUPP: Thank you.
(Continued on the next page.)
BAYLEYREPORTING, INC.
(202) 234-7787 (800) 368-8993
Tl1011-1531
1
2
3
4
5
6
7
8
9
i0
II
12
13
14
15
16
17
18
19
20
21
22
23
24
25
345
_MR. RUPP: In the Preamble, on page 15983, as
well as on 15982, there is a discussion of various forms of
anecdotal evidence, presumably provided to OSHAby
individuals who believe that they were suffering from
exposure to ETS and those anecdotal reports are discussed in
connection with the issue of irritation that we did discuss
yesterday.
Do you see those passages?
MR. MARTONIK: You mean, the bathrooms were dirty
and smells?
MR. RUPP: Those are the kinds of things. One
person says the combination of asbestos exposure, plus
secondhand smoke from my coworkers pose a health risk to me.
One woman has apparently been told by her doctor
that coworkers smoking may be problematic, that sort of
thing.
MR. MARTONIK: I don't see the smoking
references. Is that on page --
MR. RUPP: You might want to 'look, in particular,
at 15983, and in the middle paragraph, under the heading,
"Environmental Tobacco Smoke", and the paragraph begins many
case reports of severe material impairment of health due to
occupational exposure to ETS have been reported to go
through submissions to the Indoor Air Docket.
Do you see that sentence?
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
TI1011-1532
1
2
3
4
5
6
7
8
9
10
ll
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
346
-MR. MARTONIK: Yes.
MR. RUPP: When a layman writes into you and says
these kind of things, they're not a doctor, there's no
evidence that they have actually investigated what's in the
air and their work place, they're not a scientist of any
sort, they haven't revealed what their interest is, apart
from what the letter reflects, how much weight does OSHA
typically put on anecdotal evidence of the sort we've been
discussing?
DR. SILVERSTEIN: I think that depends on the
full circumstances, the nature of the report, the nature of
the problems raised, the person or people who are making the
reports.
There's a spectrum that ranges from pure
speculative anecdote at one end to a well-described case
report at the other end. And we would put greater weight on
the more carefully-described case reports. Descriptive
information is certainly valid and useful and important to
inform our decisions.
MR. RUPP: But, particularly, a case report from
a clinician, a clinician who actually has investigated the
circumstances is qualified to make a diagnosis, has the
pertinent expertise and has documented his or her findings.
Those are the kind of anecdotal case reports I
would think might be of importance.
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
T!1011-1533
1
2
3
4
5
7
8
9
I0
Ii
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
. DR. SILVERSTEIN:
would have some importance.
347
The kind you just described
MR. RUPP: All right. Now, let me focus on one
of these, and maybe I can get some guidance of the sort I'm
seeking in response to questions about this. I picked this
at random, frankly.
"By the time I finish my lunch, my eyes are
tearing, my nose is plugged and I have a headache."
That's said in connection with ETS. What can we
make of that, in view of the fact that we know nothing about
the configuration of the room, the extent of the
ventilation, ultimate sources of pollutants, materials that
may be in the air, who this commenter is, what his or her
interests may be, whether this person has hidden agendas or
not.
Now, we've talked about COPD, and the entire
scientific discussion is about a paragraph. These anecdotal
reports go on for the better part of a page. I'm trying to
figure out, is this the sort of thing that we ought to be
providing, for example, of people in cafeterias who say that
they're much happier when they're permitted to smoke in the
cafeteria, that they feel better after they've had a
cigarette at lunch?
Is that important? Do you place any weight at
all on this?
BAYLEY REPORTING, INC.
(202) 234-7787 {800) 368-8993
TI1011-1534
5
6
7
8
9
l0
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
348
If not -- I hope the answer is no -- what's it
doing here?
DR. SILVERSTEIN: If you would like to provide
the kind of anecdotal information you're describing, you're
welcome to do that.
MR. RUPP: I appreciate that.
DR. SILVERSTEIN: By itself, the kind of a
statement that you read or paraphrased, does not carry great
weight in the totality of our judgmental process.
MR. RUPP: Can those who have an interest in this
and believe the agency is off on the wrong foot, can we
safely ignore this kind of material and communicate with you
about scientific reports and documented case reports by
experts and clinicians?
Can we assume that this is window dressing that
we need not really attend to this kind of material, thah the
Agency is going to be looking for better evidence than this
kind of thing?
DR. SILVERSTEIN: In some cases, we'll certainly
pay little attention, in the process of making a judgment,
to individual reports and anecdotes.
When the report is by laymen, can we assume
that --
DR. SILVERSTEIN: No, I don't --
MR. RUPP: -- that they're reporting on
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
TI1011-1535
1
2
3
4
5
6
7
8
9
I0
Ii
12
13
14
15
16
17
18
19
20
21
22
23
24
25
349
scientific, phenomena, what their diagnosis is, for instance?
DR. SILVERSTEIN: No. I don't think it's fair to
assume that all reports by lay people have no meaning. It
depends on the circumstances in which they're provided.
MR. RUPP: Would you agree with me that if OSHA
is required to rely upon the best available evidence, that
undocumented case reports from laymen on scientific and
medical issues would never remotely, in any courtroom,
anywhere in this country, qualify as the best evidence?
DR. SILVERSTEIN: We are required to make
judgments based on the best available evidence. That
involves a whole combination of things. There is a value
and a place to case reports in the whole body of evidence,
in that they can be corroborative of more comprehensive
scientific investigations --
MR. RUPP: But if you don't know -- I'm sorry --
but if you don't know the circumstances, whether the person
knew anything about the ventilation system, what other
pollutants were in the air, the temperature, the humidity,
whether they are qualified to make any of the judgments, how
can they be corroborative?
DR. SILVERSTEIN: Oh, look, I --
MR. RUPP: Are we in a situation where --
DR. SILVERSTEIN: -- I really --
MR. RUPP: Let me finish my question.
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
T!1011-1536
1
2
3
4
5
6
7
8
9
I0
ii
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
350
Aren't we there in a situation, where kind of
you're at risk of garbage in and garbage out? You don't
know what you're dealing with, and so it can corroborate
anything.
DR. SILVERSTEIN: I really don't want to appear
defensive about this.
MR. RUPP: Yes.
DR. SILVERSTEIN: There are anecdotes that have
no value in the process of reaching a judgment of this
importance. That doesn't mean that we should be completely
silent about the nature of comments that we have received.
I think we do have an obligation to indicate how
we consider them in the process, and there may be statements
of that sort that are in this Preamble that, in fact, we
place no weight on whatsoever -- no value on whatsoever --
but we have not made clear.
MR. RUPP: That's really what I'm pursuing here.
DR. SILVERSTEIN: That may very well be the case,
and I appreciate your pointing that out to us.
MR. RUPP: That's really what I was trying to
pursue, the decision criteria that OSKA wants to utilize,
because that tells us a good deal about how we ought to be
examining people in the future and what kind of material we
should be providing to OSHA.
All right. There is in the current record data
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
TIl011-1537
1
2
3
4
5
6
7
8
9
l0
Ii
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
351
from 7 large North American data bases documenting the
causes, or attempting to document the causes of the sick
building syndrome, involving literally thousands of
buildings, including, in particular, the irritation aspect
of the sick building syndrome.
The data bases to which I'm referring are those
by NIOSH. OSHA itself has reflected, I'm happy to say, in a
presentation made by Mr. Martonik, at the October 1992
Business Council on Indoor Symposium in Washington, D.C.;
Health and Welfare Canada; Healthy Buildings International;
Honeywell; Sterling & Associates, and Clayton,
International.
Very few of those, which go, of course, well
beyond anecdotal, reports of comfort or discomfort, are
discussed, described, or cited in the OSHA Preamble. Why
has OSHA chosen, or appeared to have chosen, to place so
little weight on the systematic investigation of the causes
of Sick Building syndrome?
DR. SILVERSTEIN: I don't think it's fair to
conclude that we have not placed sufficient weight on the
more important and more persuasive kind of reports. Now, it
may be that we did not fully describe, or adequately
describe, the weight that we attached to different kind of
findings, and, again, I appreciate your pointing that out to
us.
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
TI1011-1538
5
6
7
8
9
I0
II
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
352
. If it is the case that we need to do a better job
in the final Preamble to a standard in describing that basis
of our conclusions in this regard, I think we should do
that.
MR. RUPP: I appreciate that, and I've listed
them. Of course, you'll find them in the transcript.
Let me follow up with a couple of related but
different questions.
In several of those large data bases, the
question of irritation from ETS was pursued, and the
findings ranged between 2 and 6 percent of the problem
buildings, having documented a problem of irritation
relating to ETS.
Other aspects of the findings of a couple of
these were discussed; for example, that ventilation is the
predominating problem, tends to be reported to be a problem
in more than 50 percent of the sick buildings.
But the cigarette aspect is never mentioned in
connection with any of those data bases, and I'm wondering
DR. SILVERSTEIN :
paying attention.
MR. RUPP:
construct that again.
DR. SILVERSTEIN:
I'm sorry, I was -- I was not
I'm not sure I could possibly
And I know time is of a premium
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
T! 1011-1539
1
2
3
4
5
6
7
8
9
10
II
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
353
here.
MR. RUPP: It is.
In the data bases we've been talking about,
Doctor, cigarette smoking, in a number of cases, was
pursued; that is, a number of the data bases made a
systematic -- the investigators made a systematic effort to
look at the extent to which cigarette smoking might be a
contributing factor in the incidence of the Sick Building
syndrome, and it was found to be a contributing factor in 2
to 6 percent of the cases.
Now, in the case of a couple of those reports,
the investigators indicated that they believed that that
could be solved by getting ventilation up to standard, but
let's leave that aside for the moment.
My question is, why was that aspect of those data
bases not even described, particularly in connection with
irritation and discomfort, which is an issue discussed with
respect to ETS, in the Preamble?
DR. SILVERSTEIN: We did not find those matters
persuasive. Now, perhaps we should have described our
reasoning in more detail.
MR. RUPP: Would you describe your reasoning now?
DR. SILVERSTEIN: Well, I said that we did not
find that persuasive, and I'm not prepared to discuss that
in detail, however, we will have expert witnesses who are
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
Tl1011-1540
1
2
3
4
5
6
7
8
9
l0
ll
12
13
14
15
16
17
18
19
20
21
22
23
24
25
354
prepared to go into these issues regarding Sick Building
syndrome at much greater length.
You will have the opportunity to hear NIOSH
testimony and to discuss these matters with them as well.
MR. RUPP: And I look forward to that.
Did you find those discussions less persuasive
than the anecdotal reports that I've described; for example,
the person who writes in about her headache and her ~lugged
nose after lunch? Because you discuss that, but you don't
discuss --
DR. SILVERSTEIN: No, I understand --
MR. RUPP: -- the data bases of thousands of
buildings.
DR. SILVERSTEIN: I understand. You're
questioning our judgment in what we put in and what we left
out of the record.
MR. RUPP: That's precisely so.
DR. SILVERSTEIN: I've already acknowledged that
I think we have an obligation to do somewhat better when we
prepare and publish final materials.
MR. RUPP: There is a study by Dr. Alan Hedge
that was submitted in connection with the RFI, because I
found it in the public document; and then I noticed that
another filing was made by Dr. Hedge in connection, in
response, to the Notice of Proposed Rulemaking.
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
T!1011-1541
1
2
3
4
5
6
7
8
.9
i0
!I
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
355
Dr. Alan Hedge investigated the effects of
various smoking policies on indoor air quality and Sick
Building syndrome among 3155 office workers in a total of 18
commercial buildings.
The 5 different smoking policies investigated by
Dr. Hedge follows.
Smoking completely prohibited;
Designated smoking areas equipped with local
filtration;
Designated smoking areas with no special
equipment;
Designated smoking areas with separate
ventilation; and,
Smoking allowed in open plan cubicle spaces and
offices.
Now, I have a couple of questions about this, but
let m~ start, first, by asking you this.
The kind of alternative smoking regimens that
Dr. Hedge investigated are precisely the kind of alternative
approaches to smoking that the Agency would feel itself
obligated to look into.
DR. SILVERSTEIN: You were asking a question?
MR. RUPP: Yes.
Is that correct? That is, Dr. Hedge looked at a
variety of different options and then tried to measure the
BAILEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
T11011-1542
1
2
3
4
5
6
7
8
9
I0
II
12
13
14
15
16
17
18
19
20
21
22
23
24
25
356
effect on 9mployee comfort, on the incidence of the sick
building syndrome, on a variety of other indices.
This kind of systematic investigation of
alternatives, I would think, is precisely the kind of task
that OSHA would set for itself in this rule making. Do I
misperceive this?
DR. SILVERSTEIN: This is one of the reasons why
we have I0 weeks of hearings scheduled, so we can explore
some of these matters in great detail.
MR. MARTONIK: Another factor in the proposed
regulatory text was that we were trying to reduce risk, not
only to irritation but also to other diseases, such as
cancer.
MR. RUPP: Yes. But there is a long discussion
in the Preamble of the issue of irritation, which you and I
discussed yesterday, of course.
MR. MARTONIK: Yes. Yes.
MR. RUPP: We had some trouble agreeing that
irritation was a dose-related phenomena. I think ultimately
you agreed, but I wasn't quite sure. We'll have to review
the transcript.
Dr. Hedge took a look at that issue, and he found
that when you had these various types of smoking regimes,
looked at in several buildings with a set of investigators
who were qualified to look at the issue, over 3000 office
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
Tl1011-1543
1
2
3
4
5
6
7
8
9
i0
Ii
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
357
workers, h~ was finding no difference in the reporting or
the incidence of symptoms, and I'll quote to you:
"Prohibiting smoking will not necessarily reduce
the prevalence of sick building syndrome problems in
offices."
The question I have is, why was that material,
which was submitted in response to the RFI, not discussed in
the Preamble, when there was plenty of spgce to discuss
anecdotal reports?
DR. SILVERSTEIN: With regard to Sick Building
syndrome or lung cancer?
MR. RUPP: And ETS irritation. And ETS.
irritation.
DR. SILVERSTEIN: Well, with regard to
environmental tobacco smoke, you know that our primary
concerns are with lung cancer and cardiovascular disease.
MR. RUPP: I asked you yesterday, and it would
have saved just such tremendous amount of time, and I'll ask
you again today.
If the agency is not going to try to regulate ETS
based on comfort or irritation, this would be a very good
time to say so, because, otherwise, all of these questions
are pertinent.
DR. SILVERSTEIN: You're asking whether or not we
are not prepared to regulate --
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
Tl1011-1544
1
2
3
4
5
6
7
8
9
i0
Ii
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
358
.MR. RUPP: ETS on the basis --
DR. SILVERSTEIN: -- ETS on the basis of
irritation alone?
MR. RUPP: -- of reports -- correct. That's
correct. Simple question.
DR. SILVERSTEIN: That's not our intent at this
time, but we do intend to consider the full range of health
effects and to make our decisions based on the full record
as it evolves during the public process.
We still have an-opportunity to regulate
environmental tobacco smoke on the basis of its carcinogenic
properties, on the basis of its cardiovascular properties,
on the basis of its allergic properties, on the basis of its
irritative properties, and we can do that for -- we can
choose any one of those as the basis for our regulation if
we determine there's a significant risk associated with
them, or we can choose some combination of those effects as
the basis for a final regulation.
MR. RUPP: But I take it that what you've just
told me is tha~, thus far, you have not seen sufficient
evidence of irritation so far as ETS is concerned to justify
constructing a regulation on that basis.
DR. SILVERSTEIN: We indicated that there is
evidence in the record that we believe shows that irritation
that is sufficient to be a material impairment of health,
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
TI 1011-1545
1
2
3
4
5
6
7
8
9
i0
ii
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
359
may be related to environmental tobacco smoke exposures in
the work place setting, and that, therefore, it is relevant
to pursue those considerations during this process.
We have not reached a conclusion yet.
MR. RUPP: Okay. Fair enough.
Would a study like Dr. Hedge's study be pertinent
in that regard?
DR. SILVERSTEIN: I'm not personally familiar
with that study. From the description you gave, it probably
is a pertinent study. Whether or not it is determinative in
some regard, I don't know at this time.
MR. RUPP: And the large data bases that I've
described would also be pertinent?
DR. SILVERSTEIN: I think that would probably be
the case, yes.
MR. RUPP: All right.
Dr. Demitrius Mosendreus has published at least
one article, perhaps two, and they are also in the record,
and they were submitted in response to the RFI, showing that
when people could not see the ETS to which they were exposed
because of the use of plants or low visual barriers, self-
reports of irritation from ETS declined to true almost
background levels to insignificance.
Is that the kind of evidence that you would be
prepared to take into account?
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
Ti1011-1546
1
2
3
4
5
6
7
8
.9
10
ii
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
360
. DR. SILVERSTEIN: Yes.
MR. RUPP: Is there some substance in ETS, either
in the gas phase or the particulate phase, that is less
amenable to dilution by ventilation than would be the case
for any other gas or particle, from whatever source?
MR. MARTONIK: There are differences with the
particulate.
MR. RUPP: But not the gas?
MR. MARTONIK: But not necessarily the gas, if
the gas is a --
MR. RUPP: And is the difference a
particulate -- I'm sorry?
MR. MARTONIK: If the gases are stable compounds,
there won't be any difference.
MR. RUPP: Okay.
MR. MARTONIK: Some gases may change to another
compound on their own, and, if that's the case, there would
be a difference in gases and how we would reduce their
concentration in the atmosphere.
MR. RUPP: But that can be true regardless of
source, correct?
MR. MARTONIK: Yes.
MR. RUPP: Okay. With respect to particulates,
ETS particulates tend to be on the smaller size of the size
range. Is that correct?
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
Ti1011-1547
1
2
3
4
5
6
7
8
9
I0
ll
12
13
14
15
16
17
18
19
20
21
22
23
24
25
361
correct?
MR. MARTONIK: Yes.
MR. RUPP: Tend to be 3.5 microns or less,
MR. MARTONIK: I believe that's true.
MR. RUPP: Let's assume that's true for the
present, and if you find that that's not so, perhaps you
could let us know.
MR. MARTONIK: Yes. That sounds right.
MR. RUPP: That is not atypical of the products
of combustion, generally, is it not? The products tend to
be on the smaller end --
MR. MA~TONIK: That's correct. It's not
atypical. It's in the same range.
MR. RUPP: Same range.
MR. MARTONIK: Yes.
MR. RUPP: I notice that OS~L~ has not, in its
indoor air quality rule, proposed to require --
MR. MARTONIK: I'm sorry, sir. We have a little
confusion here.
MR. RUPP: Okay. We have a little confusion.
DR. SILVERSTEIN: Searching for papers.
MR. RUPP: Okay.
MR. MARTONIK: Go ahead.
MI~. ~UPP: I notice that OSHA has not, in its
indoor air quality rule, proposed to require restaurants to
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
T!1011-1548
1
2
3
4
5
6
7
8
9
I0
Ii
12
13
14
15
16
17
18
19
20
21
22
23
24
25
362
enclose thgir kitchens in a separately ventilated room,
vented to the outside, to which members of the general
public or workers are not permitted to go in.
That is, you're relying on general dilution
ventilation in the case of combustion from restaurant
kitchens?
MR. MARTONIK: No.
said that.
I don't think we necessarily
DR. SILVERSTEIN: Can you point out what you're
referring to?
MR. RUPP: Well, if that's not so, I do
appreciate simply an explanation that it is not so and why
I'm misreading it.
MR. MARTONIK: All right.
[Pause.]
Yes. "When general ventilation is inadequate to
control air contaminants emitted from point sources within
work spaces, the employer shall implement other control
measures, such as local exhaust capture, exhaust
ventilation, or substitutes." That's paragraph E(2) (ii).
MR. RUPP: Is OSKA contemplating the requirement
that all restaurants be -- the kitchens be sealed with
separate exhaust to the outside and --
MR. MARTONIK: No, we're not.
MR. RUPP: -- equipped exhaust?
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
T11011-1549
!
2
3
4
5
6
7
8
9
i0
ll
12
13
14
15
16
17
18
19
20
21
22
23
24
25
363
-MR. MARTONIK: No, we're not.
MR. RUPP: What about office cafeterias? Any
consideration of that issue?
MR. MARTONIK: That they be sealed?
MR. RUPP: That they be sealed off in the way a
smoking room would have to be sealed off?
DR. SILVERSTEIN: Only if people would be -- only
if they would be designated as tobacco smoking areas.
MR. RUPP: Right. But, as cooking areas, they're
not required to be sealed off?
DR. SILVERSTEIN: Correct.
MR. RUPP: Office cafeterias?
MR. MARTONIK: Correct.
MR. RUPP: So, indeed, there need be no partition
between the cooking area of the cafeteria in my office
building, where this is one?
MR. MARTONIK: That's correct.
DR. SILVERSTEIN: Right.
MR. RUPP: Has OSHA not cautioned in the past,
including in the 1980s, an identification classification and
regulation of potential occupational carcinogens against
characterizing as positive, any epidemiologic study
reporting a relative risk increase of less than 50 percent?
MR. MARTONIK: Just a second.
[Pause.]
BAYLEYREPORTING, INC.
(202) 234-7787 (800) 368-8993
TI1011-1550
5
6
7
8
9
i0
II
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
that.
364
.My recollection of the standard is it doesn't say
MR. RUPP: That document does not say that; does
not caution against --
MR. MARTONIK: No.
MR. RUPP: -- characterizing as positive?
MR. MARTONIK: Cautioning in the Preamble or the
text and the regulations?
MR. RUPP: I'm sorry to say I don't recall
specifically whether it's in the Preamble or the text. What
I do recall is there is a statement in that document that
cautions against characterizing as positive any
epidemiologic study reporting a relative risk increase of 50
percent or less.
MR. MARTONIK: That's probably true. In the
Preamble, there's probably comments made indicating low
power of many epidemiology studies. I don't believe that,
however, is a finding that OSHA made in terms of
promulgating a specific provision to cover that
circumstance.
DR. SILVERSTEIN: A relative risk of above i and
less than 1.5 can be extremely important for protection of
public health, particularly with high prevalence diseases
and high attributable risk.
MR. RUPP: But they're also quite fragile, aren't
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
TI1011-1551
1
2
3
4
5
6
7
8
.9
I0
Ii
12
13
14
15
16
17
18
19
2O
21
23
24
25
365
they? Tha~ is, when you get down to weak associations,
those are precisely the ones that can be subject to biasing~
and confounding factors --
MR. MARTONIK: Oh, when you --
MR. RUPP: Let me finish my question.
That 1 -- when you're below 1.5, you need to do a
particularly careful job, at minimum, of looking at biasing
and confounding factors and other explanatory variables.
MR. MARTONIK: No. You're completely confusing
two fundamental epidemiologic and biostatistical concepts.
One --
MR. RUPP: Well, let --
MR. MARTONIK: No, let me explain.
MR. RUPP: Yes.
MR. MARTONIK: You're confusing the level of risk
with the statistical strength of association. A relative
risk ~f 1.1 -- in other words, a i0 percent excess, can be
derived from a study of enormous power, and if that i0
percent excess is overlaid on a disease of high prevalence,
for example, cardiovascular disease, the public health
impact may be enormous, and the findings may be absolutely
persuasive.
MR. RUPP: Let's take that in two steps, which
is, I take it from a scientific standpoint how one has to
take it.
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
Tl1011-1552
4
5
6
7
8
9
I0
ll
12
13
14
15
16
17
18
20
21
22
23
24
25
366
.The first step you engage in is hazard
identification. You determine whether there is, in fact,
any kind of hazard at all that has been demonstrated. For
that, one looks primarily at the relative risk.
Then you look at the extent of the hazard and the
population exposed to the substance, and for that you look
at degree of exposure. You've discussed both. I'm focusing
on the first. Whether a hazard has been found to exist at
all.
You cited a relative risk ratio of i.I. Would
you agree that OSHA has repeatedly cautioned in the past
against attaching or characterizing even as positive
relative risks of i.i; indeed, 1.5 or below?
MR. MARTONIK: No, I wouldn't say that.
DR. SILVERSTEIN: No.
MR. RUPP: Let me quote you from the document
that I just referred to.
OT/DGE VITTONE: Mr. Rupp --
MR. RUPP: Yes.
JUDGE VITTONE: -- give them an opportunity to
finish their answer.
Have you finished your answer?
DR. SILVERSTEIN: I was going to be repetitive,
Your Honor.
MR. RUPP: Okay. Well, I'll try not to be, but
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
TI1011-1553
1
2
3
4
5
6
7
8
9
i0
II
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
367
I'll just .quote to you --
JUDGE VITTONE: I'm even permit you to be
repetitive.
[Laughter]
MR. RUPP: We should put up little signs. He's
been repetitive once, twice, three times. When he's
relatively even, we're okay.
JUDGE VITTONE: I can just hold up a sign that
says Champion No. 2.
MR. RUPP: Right.
JUDGE VITTONE: All right. This could be like
baseball. Three strikes and you're out.
MR. RUPP: Exactly.
JUDGE VITTONE: Okay?
MR. RUPP: Let me quote to you from the OSHA's
1980 publication, identification, classification, and
regulation of potential occupational carcinogens, quote:
"As OSMA's past record and conclusions
demonstrate, epidemiology studies that report relative risk
increases of 50 percent or less must be subjected to a
higher standard for evaluation than studies reporting a
substantially higher risk increase because such studies
claim, in essence, define risks that most of the scientific
community agrees, and OSHA repeatedly has officially
concluded, are seldom, if ever, detectable, through
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
T!1011-1554
368
1
2
3
4
5
6
7
8
9
i0
ll
12
13
14
15
16
17
18
19
20
21
22
23
25
epidemiologic methods."
Isn't that exactly what I've been saying?
DR. SILVERSTEIN: No, I don't think so. You
indicated that -- I mean, what you've read is a statement
that says we have to be careful about evaluating the
importance of findings of relative risk. I would agree with
that.
MR. RUPP: And particularly of 1.5 or less?
DR. SILVERSTEIN: I wouldn't -- you're reading
from a 1980 document. Is it from the Preamble or is it from
the standard?
MR. RUPP: Again, and I answered the same with
respect --
DR. SILVERSTEIN: You know, I'm not sure exactly
where you're reading from, but I certainly wouldn't have
written that document in that way.
MR. RUPP: Has this document been withdrawn by
the Agency?
MR. MARTONIK: The regulatory text has been in
place. There's a provision or two that have been withdrawn.
M~. RUPP: I'm not aware that this provision has
been withdrawn.
MR. MARTONIK: The Preamble, itself, is
supportive of the provisions, and it speaks simply to its
own content, and we wouldn't really withdraw a Preamble in
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
TI 1011-1555
1
2
3
4
5
6
7
8
9
i0
iI
12
13
14
15
16
17
18
19
20
21
22
23
24
25
369
any way. .
DR. SILVERSTEIN: And I think you're aware that
since that document was written, there have been two
important Supreme Court cases of benzene and the cotton dust
decisions that have resulted in the Agency giving
considerable additional thought to issues regarding
significant risk and its demonstration.
MR. RUPP: Yes. But the benzene decision came
after a rule making conducted pursuant to a standard that
you are now having trouble accepting as an appropriate
standard, and the benzene court said that OSHA had been much
to lax in its standards.
DR. SILVERSTEIN: No. You're not describing the
standard, you're referring us to a discussion of the
principles of epidemiology and related decision-making.
There's been a great deal of thinking about the appropriate
way to make decisions since 1980.
MR. RUPP: All right.
JUDGE VITTONE: Mr. Rupp, excuse me a second,
sir.
MR. RUPP: Yes.
JUDGE VITTONE:
much longer?
You're coming up on an hour. How
MR. RUPP: I can get by with 15 more seconds.
JUDGE VITTONE: 15 more seconds?
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
TI1011-1556
1
2
3
4
5
6
7
8
9
l0
ii
12
13
14
15
16
17
18
19
20
21
22
23
24
25
370
.MR. RUPP: Yes. I have one question.
JUDGE VITTONE: Take a minute. Take a minute.
MR. RUPP: A number of questions were asked
yesterday concerning how this proposed rule might work in
practice, a smoking ban here, a smoking ban there; have you
thought that through, what are the implications?
And the question is this: And you've agreed to
think about all of those, this is true?
DR. SILVERSTEIN: We did not agree to think about
a smoking ban here, a smoking ban there. That's not a fair
characterization of what we testified to.
MR. RUPP: Let's say smoking restricted here,
smoking restricted there.
DR. SILVERSTEIN:
and accurate.
MR. RUPP: Okay.
Is that a fair characterization?
That would be much more precise
What would a violation cost
when the Agency makes its final determination? If somebody
smoked a cigarette in a place that was deemed to be a
prohibited area, what is the cost of a violation?
DR. SILVERSTEIN: I think that depends on the
nature of the violation and the circumstances. It depends
on whether it meets the criteria for a serious violation of
the law or whether it is a wilful violation or --
MR. RUPP: What's the --
DR. SILVERSTEIN: -- whether it is a -- excuse
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
T! 1011-1557
1
2
3
4
5
6
7
8
9
i0
ii
12
13
14
15
16
17
18
19
20
21
22
23
24
25
371
me -- whet~er it is a repeated violation; whether there are
multiple instances of the violation, and then we -- I'm not
prepared to give you full details. We can certainly provide
it to you.
MR. RUPP: What is the --
DR. SILVERSTEIN: We have written records -- or
written guidelines -- most of which is statutorily
determined, that govern the way we calculate penalties, and
then we use a variety of correction factors to adjust those,
so those are adjustments for good faith, for example, and
there are adjustments based on the size of the enterprise,
and there are other factors used as well.
I am not able, from memory, to quote you the
table of penalties. We can certainly provide that into the
record, if you would like.
MR. RUPP: Would you be prepared to do that?
DR. SILVERSTEIN: Absolutely.
MR. RUPP: Is your recollection the same as mine,
that a single violation would cost $7,000 -- cost up to
$7,000.
DR. SILVERSTEIN: A single violation, in some
circumstances, of some types, can cost $7,000, but that
number is in those tables, but it's more complicated than
that.
MR. RUPP: Thank you, Your Honor.
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
T!1011-1558
1
2
3
4
5
6
7
8
.9
i0
12
13
14
15
16
17
18
19
20
2!
22
23
24
25
372
.JUDGE VITTONE: Thank you, Mr. Rupp.
I believe that completes our examination of the
OSHA panel. Why don't we take a 10-minute recess at this
time, and we will return.
[Recess]
JUDGE VITTONE: I had a request from a
representative of the National Restaurant Association. He
has a few questions for the OSHA panel.
Before proceeding with Dr. Glantz, we will go to
that individual. Sir, would you come forward to the podium
and identify yourself and your representation, please.
MR. HARRINGTON: Thank you. My name is Bob
Harrington. I'm the Director of Technical Services for the
National Restaurant Association, headquartered here in
Washington, D.C.
I would like to thank Your Honor and the panel,
and e~pecially Dr. Glantz, for granting this light bi~ of
extra time in this morning's testimony.
I've got three brief questions that I would like
to ask the panel, and I promise that I will stay within that
brief format.
Other than the references to smoking complaints
and ETS exposures that are discussed in the Preamble and
rationale of the IAQ standard, we were unable to find any
reference in that supporting material, to any case studies
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
TI1011-1559
1
2
3
4
5
6
7
8
9
I0
ll
12
13
15
16
17
18
19
20
21
22
23
24
25
373
or incidence or outbreak reports, regarding other interior
air quality problems in restaurants.
My first question to the panel is, do you have
any reports of any interior air quality problems that were
studied in restaurants?
MR. MARTONIK: Other than in environmental
tobacco smoke?
MR. HARRINGTON: Other than the environmental
tobacco smoke question.
MR. MARTONIK: I don't believe we have a specific
study to indicate problems in restaurants.
MR. EARRINGTON: A follow-up question w~uld be,
if you do not have any specific studies to indicate specific
problems with specific contaminants in our specify industry,
what is the rationale for extending that leap from general
~entilated office building settings to a very unique and
very particular ventilation setting, namely, restaurants?
MR. MARTONIK: I think there's evidence on the
record that shows that ventilation systems are going to have
many problems if they're not maintained and that finding
applies generically across all industry sectors, and indoor
work environments -- on industrial work environments.
MR. HARRINGTON: Thank you.
The next question that I had again refers to some
broad, general comments that were made throughout the
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
Ti1011-1560
1
2
3
4
5
6
7
8
9
I0
11
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
374
Preamble and the rationale, that repeatedly defined or
represented BRI -- building-related illness -- and the
various diseases and conditions and syndromes that go to
making up BRI, who were repeatedly characterized as ill-
defined, or difficult to characterize or often confused with
the common cold, et cetera.
The question becomes obvious: If OSHA can't
define it, how can an employer?
MR. MARTONIK: Yes. What you're talking about is
the Sick Building syndrome.
MR. HARRINGTON: No, sir. I'm speaking of BRI.
BRI was specifically characterized as difficult to
characterize.
MR. MARTONIK: Okay. The difference between BRI
and Sick Building syndrome is with BRI, there's a medical
diagnosis that a certain exposure caused an effect, and
that's the definition. In some cases, there may be some
ill-defined diseases, but if, for instance, some reaction,
such as an allergic response to a contaminant in the
building is observed, however, the individu-al shows general
characteristics of being a topic, it's sometimes difficult
to determine specifically the source of that allergic
response.
It can be found, however, and it is found, but we
have no made a quantitative estimate at this time regarding
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
TI1011-1561
1
2
3
4
5
6
7
8
9
i0
ll
12
13
14
15
16
17
18
19
20
21
22
23
24
25
375
those types of responses, but hopefully the rule making will
give us some additional information on those types of
situations.
MR. HARRINGTON: I'm not quite sure the question
was answered.
In the Preamble, it defined hypersensitivity as
being one of the components --
MR. MARTONIK: Yes.
MR. HARRINGTON: -- of BRI, and noted that there
was as much as a 70 percent difference between reported
symptoms and determined attack rates.
MR. MARTONIK: Yes.
MR. HARRINGTON: On the section of Legionellosis,
it indicated that it was underreported because it was so
difficult to diagnose. Yet, in the proposal itself, it
requires an employer to, first, make signs and symptoms of
anything that might be present in the building available to
employees, and then to evaluate reports of those signs and
symptoms and take whatever remedial measures are necessary.
My question to you is that if professional
epidemiologists and professional clinicians cannot make that
distinction reliably, as indicated in the Preamble, how can
an employer be expected to do so under penalty of
enforcement?
MR. MARTONIK: What the standard does is ask for
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
TI1011-1562
2
3
4
5
6
7
8
9
I0
ii
12
13
14
15
16
17
18
19
20
21
22
23
24
25
376
certain types of information that would be used, and I think
we give a day of how it should be used, to investigate
possible causes in the building.
MR. HARRINGTON: So the employer cannot make that
evaluation and remedial action, as indicated?
MR. MARTONIK: Yes. The standard simply sets up
a procedure for ensuring that the ventilation system is
maintained, and sources are controlled. It also says that
when there's evidence through worker compliance, there's a
potential problem that could be ventilation related. The
employer is asked to make a determination whether it is.
MR. HARRINGTON: Yes, sir. And how does the
employer make that determination?
MR. MARTONIK: There are documents in the record
that explain that. Worldly have reports that certain
complaints were received by building owners, and these
reports in the records show that investigation was made, and
there were determinations made, whether it was building
related or not.
MR. HARRINGTON: You're telling me what's there,
but I'm still not getting an answer to my question.
One of my duties is to write advisory pamphlets
and documents for our 28,000 member companies so that they
can stay in compliance with the law.
How do I tell my member companies to evaluate and
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
T! 1011-1563
1
2
3
4
5
6
7
8
9
i0
II
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
377
take remedial action against indoor air quality problems?
How do I determine which headache, which runny nose, which
itchy eyes are due to pollen outside and which are due to an
indoor air quality problem inside?
MR. MARTONIK: Yes. As a guideline for making
those determinations, EPA and NIOSH have published a
document that describes operating a system to maintain good
air quality in the building, and I believe those guidelines
could answer some of your questions.
MR. HARRINGTON: You come back to telling me how
to operate the system, sir, but you're not answering the
question: How do I evaluate the reported symptoms? How do I
tell which set of runny noses is due to outside pollen and
which set is due to an indoor contaminant?
How does a lay employer, with no particular
medical or epidemiological training, make that distinction?
Because that's what the standard says to do.
MR. MARTONIK: I don't think that the standard
requires that every complaint be diagnosed. I think the
standard says that when there appears to be building-related
problems which are described in the guidance documents, then
there needs to be an investigation as to the possible cause
of that.
I don't believe the standard always requires and
tell investigations if, in fact, the building has been
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
TI1011-1564
1
2
3
4
5
6
7
8
9
I0
II
12
:1.4
20
2l
22
23
24
25
378
recently inspected and found to have inadequate -- have
adequate performance.
MR. HARRINGTON: I won't belabor the point, but I
would note for the record that the Preamble, again, notes as
many as 17 separate symptoms for the one condition of
hypersensitivity. I again point out that we're asking lay
employers with no professionalism to make the distinction.
MS. SHERMAN: Your Honor, this. gentleman will
make his presentation in his testimony.
JUDGE VITTONE: That's fine.
Go on, Mr. Harrington.
MR. HARRINGTON:
JUDGE VITTONE:
MR. HARRINGTON:
Thank you.
Do you have another question?
The last question is to verify
that, on the smoking question, as we read the proposal, it
requires that smoking either be prohibited in all work
places or that a designated smoking area be established with
direct exterior ventilation and maintained under negative
pressure. Is that correct? Am I reading that right?
MR. MARTONIK: That's correct. Yes.
MR. HARRINGTON: And that no employee may enter
that smoking area when smoking is occurring?
MR. MARTONIK: That's correct.
MR. HARRINGTON: That is correct.
In a traditional table service restaurant, then,
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
TI1011-1565
1
2
3
4
5
6
7
8
9
I0
Ii
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
379
what OSHA is proposing is, in effect, a ban of smoking in
restaurants?
MR. MARTONIK: I think Dr. Silverstein addressed
some of these issues yesterday and said that there's a
possibility that restaurants can operate in ways that
satisfy their customers.
However, I can tell you that we want to be
sensitive to these concerns. And while we proposed these
provisions, we're willing to listen to the concerns of the
public and willing to make changes to the final standards,
based upon the communications we're having for the next
three months.
MR. HARRINGTON: Thank you. And my final
one -- and I, again, appreciate your indulgence -- is the
question of how OSHAevaluated the economic impact of this
action, specifically on the restaurant industry.
MR. MARTONIK: All right. What about it?
MR. HARRINGTON: I'm wondering how you reached
the conclusion that it would or would not have a significant
economic impact. We have some material that we will present
in our formal presentation that shows a significant impact,
but we didn't see that in the background and rationale.
MR. MARTONIK: Yes. OSHAused some building
surveys to define the number of buildings and similar
characteristics, and had some data to show to what extent
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
Tl1011-1566
1
2
3
4
5
6
7
8
9
i0
ii
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
380
and adequate indoor air quality program exists. We did some
estimates as to how many programs need to be improved.
MR. HARRINGTON: Excuse me. Yes, sir. We saw
that for the general health effect.
MR. MARTONIK: Yes. Well, the answer -- this is
the general answer. For those buildings where we thought
there needed to be some improvement, we added a cost to
those buildings in terms of a certain amount per square foot
for improvement of their program.
The breached industry sectors, number of
buildings that we've estimated, and the cost of improving
the ventilation system and maintaining it for those 30
percent of buildings we've identified as problem buildings,
and general maintenance costs, with the standard for the
other two-thirds, and those two numbers were added together
and placed in this table on page -- is it 16922 -- 16022.
We also took a look at the general profits in
those sectors those sectors and made a determination that
the standard was economically feasible as a preliminary
finding.
time.
MR. HARRINGTON:
JUDGE VITTONE:
MR. HARRINGTON:
Thank you.
Thank you, Mr. Harrington.
Again, I appreciate the extra
JUDGE VITTONE: Okay. We have now completed the
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
TI1011-1567
1
2
3
4
5
6
7
8
9
i0
Ii
12
13
14
15
16
17
18
19
20
21
22
23
24
25
381
examination of the OSHA Panel.
MS. SHERMAN: Your Honor?
JUDGE VITTONE: Yes, Ms. Sherman.
MS. SHERMAN: If I might, there was a piece of
information that was requested yesterday, and I now have the
answer, which I would like to read into the record.
There was some question as to what percentage of
the workforce is non-white. My sources tell me that, as of
April 1994, 15 percent of the workforce is non-white, and
the source of this information is the BLS employment
earnings for June 1994.
JUDGE VITTONE: 15 percent non-white.
Is there any further breakdown for, I guess, the
non-white percentage of the population?
MS. SHERMAN: I'm sure there is, but that wasn't
given to me. If you think it's important, we can probably
provide that.
JUDGE VITTONE: I think it might be important,
just for the completion of the record, to figure out how
many of that is Caucasian Americans, or whatever.
MR. GROSSMAN:
JUDGE VITTONE:
MR. GROSSMAN:
Your Honor?
Mr. Grossman.
Thank you. Yesterday, also, I had
asked and I had been told that we would receive results by
last night for the proportion of the workforce and the
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
TI1011-1568
1
2
3
4
5
6
7
8
.9
i0
ll
12
13
14
15
16
17
18
19
20
21
22
23
24
25
382
number of people in the workforce who work indoors. That
was with regard to one of the tables that was contained in
the Federal Register. Are those numbers available now?
them?
MS. SHERMAN:
MS. E1-MeKAWI:
I don't -- Sinaia, do you have
For the record, we did not say we
were going to submit them today.
submit them.
MR. GROSSMAN:
MS. EI-MeKAWI:
them today, but --
We said we were going to
Do you have the numbers?
I don't have them. We don't have
MS. SHERMAN: They will be submitted to the
record. Ms. Ei-MeKawi's memory is the same as my own, that
we said we would supply them when we. had them.
MR. GROSSMAN: All right. Thank you.
STANTON A. GLANTZ, PhD
JUDGE VITTONE: Are we ready to proceed now with
Dr. Glantz?
MS. SHERMAN: I am.
J~DGE VITTONE: Dr. Glantz, would you come
forward, please?
Can I get an estimate of how long his direct
presentation will take?
MS. SHERMAN: I believe it will take 45 minutes,
Your Honor, about.
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
TI1011-1569
1
2
3
4
5
6
7
8
9
i0
Ii
12
13
14
15
16
17
18
19
20
21
22
23
24
25
383
_JUDGE VITTONE: Okay. I have approximately I0
minutes to 12. We will complete his presentation, then we
will break for lunch.
DR. GLANTZ: I'll talk as quickly as possible.
JUDGE VITTONE: All right. I guess you're going
to ask him some preliminary questions to identify him and
everything?
MS. SHERMAN: No. I'm going t9 let him do that.
JUDGE VITTONE: Okay.
Dr. Glantz, are you going to be using this thing
behind me?
DR. GLANTZ: Yes.
JUDGE VITTONE: All right.
to do that, I'll move out of your way.
Whenever you're going
DR. GLANTZ: Well, I'll be doing it almost
immediately.
JUDGE VITTONE: Okay.
[Laughter]
JUDGE VITTONE: Then I'll move immediately.
Sir, would you identify yourself for the record,
and give the name of the institution that you represent
today?
DR. GLANTZ: My name is Stanton A. Glantz. I am
testifying at OSHA's request. I am a professor of medicine
at the University of California, San Francisco.
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
T11011-1570
1
2
3
4
5
6
7
8
9
i0
II
12
13
14
15
16
17
18
19
20
21
22
23
24
25
384
.Can you turn this down just a little bit, because
I can hear myself too loud.
JUDGE VITTONE: Okay. You have a speaker right
behind you. If we could ask the audio people, if it's
possible to turn this one down, behind you.
Dr. Glantz, you have submitted already for the
record a statement with respect to this Proposed Rule? Is
that true, sir?
DR. GLANTZ: Yes..
JUDGE VITTONE: On August ii, 1994?
DR. GLANTZ: Yes.
JUDGE VITTONE: All right. If you're ready, sir,
you may proceed.
My name is Stanton Glantz. I hold a PhD in
Applied Mechanics and Engineering Economics from Stanford
University, where I wrote may doctoral dissertation on
cardiac muscle. I am now a Professor of Medicine, a member
of the Cardiovascular Research Institute, and member of the
Institute for Health Policy Studies, as well as the Graduate
Group in Biostatistics at the University of California.
I also am an associate editor of the Journal of
the American College of Cardiology, one of the two leading
clinical cardiology journals, where I have primary
responsibility for assessing methodological issues of the
studies we publish.
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
T11011-1571
1
2
3
4
5
6
7
8
9
i0
Ii
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
385
. I am also a member of the California State
Scientific Review Pan on Toxic Air Contaminants, a body
analogous somewhat ot the EPA Science Advisory Board, which
is charged with reviewing risk assessments on toxins
proposed by the State of California for regulation. So, I
am also generally familiar with risk assessment.
I have been asked to come to this hearing today
and testify about two areas in which we've conducted work or
work which I've reviewed.
One deals with the effects of passive smoking on
heart disease and the evidence demonstrating that passive
smoking causes heart disease; and,
Second, some studies we've done on the effects of
restaurant restrictions on smoking, on restaurant revenues.
Before going into the specific evidence that I
wish to present, I'd like to offer a couple of general
comments on what constitutes proof, in my opinion, because I
am going to conclude, and have concluded, that passive
smoking causes heart disease.
When you look at scientific evidence, you have to
look at all of the evidence. There is no such thing as a
perfect scientific study. I think that any piece of work
that's ever been published, given enough time, a competent
scientist could find something to complain about.
What we have listened to, I think, in much of
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
TI1011-1572
1
2
3
4
5
6
7
8
9
i0
ii
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
386
cross examination so far of OSHA is the kind of dealing with
what I would consider, in many cases, scientifically trivial
points. Not all of them. There are some things in the OSHA
Federal Register item that I suggested they change, but, for
the most part, you have to look at all of the evidence.
When you deal with heart disease and passive smoking, I
believe the case is particularly compelling, because there
is a whole range of evidence.
It is not just epidemiological studies, which you
can criticize as being observational and confused by
possible confounding variables, despite your best efforts to
control for them.
It's not just clinical studies which deal with
showing acute effects of passive smoking on the heart and on
exercise performance.
It's not just animal studies, which you can avoid
all issues of confounding and extraneous variables where you
control everything and you can induce heart disease like
changes in animals with relatively short-term exposures to
secondhand smoke, and you also have biochemical evidence,
which at least is beginning to help us understand the
underlying chemical and cellular mechanisms by which
secondhand smoke --
JUDGE VITTONE: Excuse me, Dr. Glantz, let me
interrupt you just a second.
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
Tl1011-1573
1
2
3
4
5
7
8
.9
I0
ll
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
387
-Are you going to use this slide?
DR. GLANTZ: Yes. Yes.
JUDGE VITTONE: Okay. If you're not going to use
the slide, move it on.
DR. GLANTZ: I will. The -- oh, you broke my
train of thought there.
The important point is that if you take any link
in this chain of evidence, you can argue that it's not
relevant, you can argue that a test tube isn't a restaurant;
you can argue that and and animal isn't a human; you can
argue that a person in a laboratory isn't in ~ work place;
you can argue that the epidemiological studies, like all
observational @tudies, aren't perfect.
But when you put it all together, there's an
extremely compelling case, and the thing that I think OSHA
attempted to, which I applaud them for, is to look at all of
the evidence.
Now, it's important, and the representatives of
the tobacco interests here, as they have for years, are
saying there is no proof, and I think it's important in
considering the evidence in the record, and, as OSHAmakes
it rule, to really look at and put this into some historical
context.
The tobacco industry --
MS. SHERMAN: Professor Glantz, would you please
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
TI1011-1574
1
2
3
4
5
6
7
8
9
i0
II
12
13
14
15
16
17
18
19
20
21
22
23
24
25
388
identify each slide as you talk about it, for the record?
DR. GLANTZ: Okay. I've actually created a list
of hard copies of the slide. Okay.
This slide is a Philip Morris ad, "How Science
Lost Out to Politics on Secondhand Smoke".
Many of the arguments which we have heard and
which I expect to be asked about it in this proceeding have
been spelled out quite nicely in a series.of four ads, which
I'm going to show you on four slides, that Philip Morris has
run and Reynolds and other tobacco interests have run
similar ads recently, how science and politics collided and
balanced reporting, was a casualty, for example; how to spot
flaws in secondhand smoke stores.
What I would like to make clear for the record is
that this is nothing new on the part of tobacco interests.
this is an ad. Here's what's being said now
about tobacco smoke in the air, that the Tobacco Institute
ran nationwide in 1981 or 1982, attacking the Takisi
Hirayama study, the first really large-scale, good study
done in Japan, which demonstrated that passive smoking
caused lung cancer.
The issues which are raised are the same kind of
issues we've heard about today.
But you can go back even further. This is an
advertisement run by the Tobacco Institute in 1967, I
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
TI1011-1575
!
2
3
4
5
6
7
8
9
I0
II
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
389
believe, attacking the original Surgeon General's report,
stating that smoking caused cancer in smokers.
If you compare the 1967 ad with the recent ad,
you'll find that the themes are identical, and I think this
is very important in considering the material that is being
put into the record.
For example, in the recent Philip Morris ads, it
said James Enstrom, a professor of epidemiology at UCLA,
notes thousands of studies have been done, and this is a
real problem.
If you go back to the old ad in the '60s, it
says, from the outset, few bold scientific spirits insisted
smoking and health --which was the original Surgeon
General's report in '64 -- failed to prove that cigarettes
caused lung cancer.
And it goes on, and it says, they have ignored
Professor K.A. Brownlee's critique of the evidence, and that
there are all kinds of conflicting views. Same message.
In the Philip Morris ad, Yale epidemiologist,
Alan Feinstein, cautioned scientists against automatically
believing everything the good guys say and rejecting
everything the bad guys say. He says: If public health
epidemiologists want to avoid becoming a branch of politics
rather than science, they need to not do this.
Back in '64, it says, since publication in 1964,
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
Tll011-1576
!
2
3
4
5
6
7
8
9
I0
II
12
13
14
15
16
17
18~
19
20
21
22
23
24
25
390
of smokin~ and health, which, through a kind of guilty by
statistical association, condemned the use of cigarettes,
officialdom has done its best to pick a fight, and the same
kind of criticism is being made of OSHA today.
Finally, how science lost 5ut to politics on
secondhand smoke in the current ads; and in the old ads,
Emerson Foote, who headed the movement, or reaccused the
Public Health Service of placing the strident claims of the
pitchman against the unobtrusive quest for truth.
So the kind of things that are being said today
are no different than what was said 30 years ago.
The evidence that active smoking causes cancer, I
think is completely untested in the scientific community,
save a few people, most of whom are tied in one way or
another to the tobacco industry.
The same situation exists, I think, today, with
regard to passive smoking, and that's an important thing to
understand.
Another important thing that you need to look at
when 3udglng scientific evidence is consistency. There was
never, as was pointed out by one of the OSHA witnesses,
complete consistency in anything. It's not the nature of
life.
But there's a broadly consistent message in the
passive smoking literature.
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
T11011-1577
1
2
3
4
5
6
7
8
9
i0
ii
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
391
.And, in fact, another important point is that the
methodological approaches which have been used and accepted
in the scientific community on this question, are generally
consistent.
That, I think, contrasts dramatically with the
evidence put forth, or the comments put forth, in many of
the submissions made by the tobacco industry and its
consultants into the record so far.
I have not read it all. I have seen some of it.
I've been struck at how sometimes the statements criticize
meta analysis or when they don't like the findings; at other
times, they use it.
In some states, sometimes work is criticized
severely for not adjusting for possible confounding
variables. Other evidence is put forth supportive of the
position being advanced, which ignores the same confounding
variables.
In some cases, the use of animal data is soundly
criticized, in other cases it's used.
I would urge OSHA, in considering the record, to
apply some rule of consistency to the materials that are
being submitted to the record by everyone. I think, in
particular the materials being submitted by people critical
of the standard, that the level of consistency in the
approach, which is advanced in these materials, is an
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
TI1011-1578
1
2
3
4
5
6
7
8
l0
II
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
392
important thing to consider when dealing with their accuracy
and their veracity, because things cannot be both black and
white at the same time, even if different people are making
the allegations.
What I would like to do -- I'm going to skip
through this. Actually, I won't.
The last thing that I think is very important for
OSHA to remember is that, in looking at the literature, one
has to consider the source, and I'm sure we'll be having
extensive questions about that, in fact.
But, in 1978, a poll done for the Tobacco
Institute, which was subpoenad by the Federal Trade
Commission, done by the Roper Organization, which
highlighted the passive smoking issue was a serious problem
for the industry, said:
The strategic and long run antidote to the
passive smoking issue is developing and widely publicizing
clear-cut credible medical evidence that passive smoking is
not harmful to the nonsmoker's health.
Now, this is a tall order, because it is harmful
to the nonsmoker's health. The OSHA draft rule, outlined
much of the evidence. There's a huge literature in this
area, and this created real problems.
One of the things that has happened is there have
now come to be a serious of publications put on by the
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
TI1011-1579
1
2
3
4
5
6
7
8
9
10
II
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
393
Tobacco Institute which looked quite legitimate on their
face, such as this thing, Environmental Tobacco Smoke,
proceedings of the International Symposium at McGill
University.
Now, this was a meeting organized by tobacco
interests and, Io and behold, if you look in one of Philip
Morris's submissions, you see a quote from this meeting, at
an ETS conference held at McGill University, in 1989.
Lawrence Wexler said:
Based on the available evidence, it is this
author's opinion that it has not been demonstrated that
exposure to ETS increases the risk of cardiovascular
disease.
Now, I'm not saying that simply because something
is funded by that tobacco industry, it is bad. In fact,
some important corroborating evidence on our work, that I'll
talk about, was funded by the industry's Center for Indoor
Air Research.
But it's important to distinguish between
scientific work published in legitimate peer review journals
and things like this, and I would urge OSMA to be very
careful, in assessing the submissions, to make the
distinctions between symposia publications and other related
things and things published in the independent peer reviewed
literature, because there's been a fair amount of research
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
TI1011-1580
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
394
done, not Dnly on the passive smoking issue but also on
drugs and other areas, showing that there's a distinct
difference in the quality of the work published in these two
modes.
That's sort of a long preamble, motivated by
sitting here for the last day and a half.
To get onto the specific question of the effects
of secondhand smoke, or ETS, on the heart, as I mentioned,
there's a broad range of evidence. There are changes in how
well someone can exercise. There's an increased risk of
irregular heartbeats.
There's effects on blood platelets and blood
chemistry. There's evidence that breathing secondhand smoke
damages the lining of coronary arteries, and other arteries,
which is the initiating step in atherosclerosis.
There's evidence that constituents in the smoke,
such as carbon monoxide, reduced the ability of the blood to
get oxygen to the heart. At the same time that nicotine
makes the heart work harder, nicotine and other elements in
the smoke also promote vasospasm. They make coronary
arteries get smaller.
So when you put all of these things together,
plus other evidence I'm going to talk about, this really
provides very strong evidence in the observed, roughly 30
percent increase in the risk of heart disease death observed
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
Tl1011-1581
1
2
3
5
7
8
9
I0
II
12
13
15
16
17
18
19
2O
21
22
23
24
25
395
in passive-smokers.
Now, I'm going to quickly go through some of the
high points of this evidence, beginning at the most
fundamental level, at the molecular level.
MS. SHERMAN: Let the record reflect the slide.
DR. GLANTZ: I'm sorry.
This is the slide, cells use oxygen to make ATP.
One question I'm sure you've all laid awake
nights wondering about, is why is that you need to breathe.
And the reason -- I mean, that's what professors are paid to
do.
You need to breathe to get oxygen, and this
oxygen, then, is carried by your blood to your cells. It's
absorbed into your cells, and is one of the raw materials
that mitochondria, which are elements in the cell, use to
make a molecule called adenosine triphosphate -- ATP --
which is like the battery that makes muscles work, that
makes the membranes, that control how the heart cells and
others cells work.
There's good experimental evidence that
secondhand smoke exposure reduces the ability of heart
muscle to make ATP. This is done through a series of
chemical reactions that are mediated by things called
enzymes, which are like little chemical factories.
Experiments have been done -- can people see this
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
TI 1011-1582
1
2
3
4
5
6
7
8
9
i0
ii
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
396
slide?
VOICE: Not very well.. Can you identify that?
DR. GLANTZ: This is the effect of ETS on
myocardial oxidase systems.
Could we turn the lights down, in particular
these lights here.
VOICE: I think it's going to be difficult to do
that if this thing is going to be supportive.
DR. GLANTZ: Okay. Well, I don't know what to
do. Maybe everyone could move up to the front and squint.
VOICE: Go ahead.
DR. GLANTZ: This is an experiment that was done
with rabbits -- again, rabbits are not people -- in which
rabbits were exposed to secondhand smoke, and there were
three or four groups.
There was a control group that breathed clean
air; one group that breathed secondhand smoke for 30
minutes; one that breathed secondhand smoke for 30 minutes,
twice a day for two weeks, and one that breathed secondhand
smoke 30 minutes, twice a day, for 8 weeks.
Then what the investigators did was they took the
rabbits, they sacrificed them, they took their hearts out,
extracted these enzymes from the mitochondria -- and I just
realized that the label was left off the top; I was trying
to make you a fancy slide here.
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
T!1011-1583
1
2
3
4
5
6
7
8
9
I0
Ii
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
397
.The first frame of the slide talks about -- oh,
dear, I don't have the original -- there are three enzymes
in the process -- and I'm just trying to recall which is
which. That, I'll have to look up.
But the point is, the oxygen goes in the left;
gets processed through these three enzymes, and ATP comes
out the right.
The secondhand smoke had no effect on the first
two enzymes' activities, but the third enzyme in the chain,
the activity of a single, 30-minute exposure, cut the
activity of this enzyme by about a third, and continuing
exposure continued to reduce the activity in a dose-
dependent manner.
As we've heard, the presence of a dose effect is
often very important, to the point that 8 weeks of exposure
for 1 hour a day, about cut the activity in half.
What this means is that of the oxygen getting to
the heart muscle, the heart was greatly compromised in its
ability to turn that oxygen into ATP, the molecule that is
needed to make the heart work.
Now, another kind of short-tez-m effect which has
been demonstrated on secondhand smoke is effect on blood
platelets. Blood platelets are elements of your blood that
get sticky when you cut yourself and form a clot, and that's
good if you don't want to bleed to death when you're cut,
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
TI1011-1584
1
2
3
4
5
6
7
8
9
I0
Ii
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
398
but it's bad if the blood platelets are activated
inappropriately.
If the platelets are activated inappropriately,
that can lead to a blood clot in the blood itself, called
the thrombus, which, if it lodges in a coronary artery, is a
heart attack, and also activated platelets appear to damage
the lining of the coronary arteries which, again, is the
initiating step in atherosclerosis.
MS. SHERMAN: Let the record show that Dr. Glantz
is talking about Figure i and Figure 4.
DR. GLANTZ: Okay. I'm sorry.
This is the slide which shows platelet activity
among smokers and nonsmokers, labeled Figure 3 and Figure 4,
actually.
MS. SHERMAN:
DR. GLANTZ:
Oh, excuse me.
This, on the left side of the slide,
is an experiment in which smokers' platelet activity was
measured and nonsmokers, and this scale, smaller numbers
mean stickier platelets -- more activated platelets.
The first thing to note is that the smokers have
stickier platelets than the nonsmokers. This is thought to
be one of the mechanisms by which active smoking causes
heart disease.
The smokers, then, smoke two cigarettes --
actively smoke two cigarettes. There was no significant
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
TI 1011-1585
1
2
3
4
5
6
7
8
9
10
iI
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
399
change in platelets in the smokers were already as activated
as they could get.
The nonsmokers, on the other hand, just two
cigarettes, their platelets became significantly more
activated, to the point that they were not significantly
different from smokers.
Now, on the right is another experiment in which
people sat in a hospital waiting room for about 30 minutes,
after people had been smoking, and there was no active
smoking going on at the time, but there had just previously
been.
Again, breathing secondhand smoke has no effect
on the smokers' platelets, but breathing secondhand smoke
significantly activated the nonsmokers' platelets, to the
point that they weren't significantly different from that of
a smoker.
Now, there are several important things about
these findings.
The first thing is that smokers and nonsmokers
respond differently to the toxins in cigarette smoke, and
that's a very, very important point, because one argument
which is often made is that the dose of secondhand smoke
that a nonsmoker gets is small compared to the dose of smoke
that a smoker gets.
This is absolutely the case. Secondhand smoke,
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
T11011-1586
1
2
3
4
5
6
7
8
9
i0
ii
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
4OO
while more. toxic at an elemental level than primary smoke,
the smoker gets a much higher, more concentrated dose.
In terms of the platelet activity, a very low
dose, short exposure, at realistic levels, has big effects
on the nonsmoker.
So I think that, as a general rule, extrapolating
from the effects of smoking on the hearts of smokers to
those of nonsmokers, is something you need to do very
cautiously.
I think this points to the fact -- and there are
many other platelet studies I'm not presenting here which
are cited in my submission and in the OS~IA statement -- that
show similar things.
That the dose response relationship for effects
on platelets on nonsmokers is probably very, very steep, and
so low doses have big effects, and that's very important.
This shows some corroborating animal evidence
that we did. This is the slide labeled, The Effect of ETS
on Platelets, from a study we published, Zhu, et al --
that's Z-h-u -- where rabbits were exposed to secondhand
smoke. It was secondhand Marlboro smoke for 6 hours a day,
5 days a week, for i0 weeks.
Before the exposure, there was no difference
between the control group who breathed clean air or low does
group and the high dose group. The high dose was like a
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
T11011-1587
1
3
4
5
6
7
8
9
i0
ll
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
401
very, very-smokey bar.
After the 10 weeks of exposure, the bleeding
time, that is, if you prick the rabbit's ear and measure how
long it takes to stop bleeding, which is another measure o£
platelet activity, was significantly shortened in the low
and the high dose groups by almost identical amounts.
What this says, again, is that platelets are very
sensitive to secondhand smoke, and that as the dose gets
very high the additional effects that you get are smaller.
I think OSHA needs to be very concerned about low exposures.
This is other results, a slide labeled, Effects
of ETS on Lipid Deposits. This was the main purpose of the
study I just mentioned. We then took these rabbits and
removed their aortas and their pulmonary arteries, which are
the two large arteries, and stained them and looked for the
amount of fat deposits. Fat build up is what causes
coronary disease or heart disease.
We found, again, a nice dose dependent increase
with jus~ 10 weeks of exposure. This is a total, I believe,
of 300 hours of exposure which, even for a rabbit, 300 hours
is not a long time. We got about a doubling of the amount
of fat deposited in the arteries of these rabbits, with just
i0 weeks of secondhand smoke exposure.
Now, this is exactly what you would expect, given
the epidemiological studies.
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
TI1011-1588
1
2
3
4
5
6
7
8
.9
10
ii
12
13
15
16
17
18
19
20
21
22
23
24
25
402
Now one criticism that could be raised of that
study was that that rabbits were uptight. They were stuck
in cages, breathing secondhand smoke, not something that I
would care to do, and being uptight, increases the levels of
catecholamines, which themselves can affect the risk of
heart disease.
Now, this slide, which has the label "Aorta
Pulmonary Artery" on it, is a study that we did by Sun,
et al., where we used the same animal model of
atherosclerosis, except we gave one group of rabbits plain
water to drink and another group of rabbits water with a
drug called Metoprolol, which blocks the effects of
catecholamines.
What we found was, indeed, the yellow -- this is
the aorta and the pulmonary artery; again, the percentage of
the artery covered by lipids, fat deposits, and, again, the
group'drinking plain water had a significant increase in the
lipid deposits in both their aorta and pulmonary artery.
The Metoprolol depressed the amount of lipid
deposits, having this beta blocker was protective against
building up fat deposits in these arteries, but the effect
of secondhand smoke, the red lines, still persisted.
So blocking the effects of the fact that the
rabbits may have been uptight, reduced the effect, but it
did not block the effect of ETS. The catecholamine effect
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
TI1011-1589
1
2
3
4
5
6
7
8
9
I0
II
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
403
is independent of the ETS effect.
There are other important animal studies
illustrating the effects of secondhand smoke, which I think
bear importantly on the rule making process, in fact.
When someone has a heart attack, they develop
something called a reperfusion injury. This is a slide
that's labeled "Segment Shortening" on the vertical axis.
What happens in reperfusion injury is you block
the flo to the heart muscle, and then the flow is reopened,
because of angioplasty or it reopening on its own or
something -- some kind of treatment.
During the period that the heart is not'getting
enough blood, you get a build up of free radicals. Free
radicals are very, very active chemical compounds. There's
a lot of free radicals in cigarette smoke, in fact, although
it's not clear whether all of them are absorbed in the
lungs, but also the heart itself naturally creates free
radicals, and there are enzymes in the heart which scavenge
these free radicals. This happens naturally.
But this is an experiment with a dog, where this
is measuring how well the heart muscle, the vertical axis,
is shortening, and it's shortening I00 percent.
One of the coronary arteries -- the arteries
serving the heart is blocked for a few minutes and then
released. What you can see with the open circles here is
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
TI1011-1590
1
2
3
4
5
6
7
8
9
I0
ii
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
404
that you only get about half as much shortening of the heart
muscle after the blockage than you did before, even though
you've restored flow to the heart. That's what a
reperfusion injury is.
If you give the dog intravenous nicotine
equivalent to about one cigarette, it doubles the
reperfusion injury deficit. The muscle only recovers to
about a quarter of its original functionality.
So, nicotine, and fairly low doses of nicotine,
appear to make reperfusion injuries worse. I think that
this is an important issue that OS~i~ needs to consider in
its rule making because the focus of most of what's been
said so far has been on heart disease mortality, but I think
you also need to think about morbidity, because there are
people in the work place who have heart disease, maybe
because of passive smoking, maybe because they ate too much
ice cream.
If they are at risk and have compromised coronary
flow, the nicotine in the air may be having adverse effects
on it. The fact that this is operating through the nicotine
effects on free radicals is demonstrated in this slide,
which at the bottom says, MPG + Saline, where the same
experiment was done, except at the same time the nicotine
was given -- or, actually, before the nicotine was
given -- a chemical MPG, which is a free radical scavenger,
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
TI1011-1591
1
2
3
4
5
6
7
8
9
10
ll
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
4O5
was given 2o the dog, and the nicotine effect was blocked.
So, again, this is a big effect. It's doubling
the effect of reperfusion injury in these animals.
Now, taking the next step up the evidentiary
ladder, this is another study that we did. It's labeled
infarct mass over risk area on the vertical axis, where we
exposed rats to secondhand smoke. Again, we used secondhand
Marlboro smoke, six hours a day, five days a week, and we
had a group of control rats and a group exposed to
secondhand smoke for three days or 18 hours, 3 weeks, or 6
weeks, which, for a total of 180 hours.
Then we tied off the coronary artery for, I
believe, 15 minutes, maybe a little bit longer, and then
released it and looked at how big the infarct was; how much
of the heart muscle actually died.
In the control rats, which were breathing clean
air, about a third, 35 percent or so, of the at-risk muscle,
the muscle perfused by the artery in question, died.
With the secondhand smoke rats, we got a nice
dose dependent increase in the amount of dead muscle, with
180 hours of exposure, nearly doubling the size of the
infarct.
What this says to me is there are no confounding
variables here. This is a completely controlled experiment,
and these rats are suffering worse heart attacks because of
BAYLEYREPORTING, INC.
(202) 234-7787 (800) 368-8993
TI1011-1592
5
6
7
8
9
I0
ii
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
406
the ETS exposure.
Again, I think OSHA needs to consider this
evidence, because there are people who have existing heart
disease in the work place and exposure to ETS could very
well worsen any heart attack that they were to have, in
addition to perhaps playing a role and precipitating it.
Finally, you come to the epidemiological
evidence. There are two broad categories of epidemiological
evidence available on passive smoking. There is both
fatalities, which have been discussed so far, and also non-
fatal events. We now have enough data in the literature to
talk about both of them.
This slide, labeled Passive Smoking and Heart
Disease Deaths, summarizes all of the available studies that
are published, that I can find -- published as papers -- and
there are 12 of them, some of men, some of women.
The scale here is a logarithmic scale of the
relative risk, with one being the relative risk that would
be observed if there was no effect of secondhand smoke on
the heart.
You can see that all of the studies that were
done, the little horizontal line is a measure of the point
estimate; that is, the relative risk that was computed, and
all of them, except for one -- the one by Butler -- shows
relative risks above i. So we have Ii of 12 studies showing
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
Tl1011-1593
1
2
3
4
5
6
7
8
.9
-i0
ii
12
13
14
15
16
17
18
19
20
21
22
23
24
25
4O7
an elevation in risk.
Now, the problem that you have, and this has been
discussed at great length in the cross examination of OSHA,
and I'm sure we'll discuss more, is that whenever you do an
observational study; indeed, whenever you do any study,
there is uncertainty in the outcome.
That uncertainty is due to the fact that there is
underlying biological variability in the population, and
it's part of the random sampling process. There's nothing
you can do about it. I mean, that is just part of the
sampling process. It's not an issue of confounding or bad
study design, it's just built into statistics.
So ~h@t statisticians compute is something called
the confidence interval. What I have drawn here on this
slide, the vertical bars, are the two-tailed, 95 percent
confidence intervals for each of these studies, and a couple
of them go off the top.
Now, if you look at them, several of these
studies have confidence bands, which include I, so looking
at the study all by itself it does not provide sufficient
evidence to conclude that passive smoking causes heart
disease, at least the ones which include I.
It is important to emphasize, however, that the
true risk could be anywhere in the confidence interval. So,
for example, if we take the Garlan study, which I'm just
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
TI 1011-1594
1
2
3
5
6
7
8
9
l0
ii
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
408
taking because it's the first one, it's true that its 95
percent confidence interval includes i, but it also includes
i0.
While there has been a great deal of discussion
about the fact that the risk of heart disease and passive
smoking might only be I, it's just as true that it could be
i0. That's an equally valid statement to make and one which
hasn't been made in these proceedings.
In fact, this bears on the issue of how the risk
assessment should be done.
There was some questioning yesterday about the
issue of uncertainty, and there is uncertainty in this
process. But OSHA, so far, has simply been presenting the
results of the best point estimate, when, in fact, it might
ought to consider the upper 95 percent risk assessments to
be health protective. That is something done by many groups
when dealing with an environmental and work place toxins.
I think OSHA may well be, at least according to
standard procedures, underestimating the risks using the
procedures that they're using so far.
Now, what the EPA did with this, and what I've
done -- or not this, but what the EPA did with lung cancer
and what I have done here and others -- is done a meta
analysis, because one problem you have is you have 12
studies here and ii of them are positive, what do you do?
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
Ti1011-1595
1
2
3
4
5
6
7
8
9
I0
Ii
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
409
Do you just look at each one, one at a time, and try to
figure out what's wrong with each one and reject them, or
say a lot of them didn't reach statistical significance?
I think that would be irresponsible. The proper
thing to do, I think, is to look at all of the evidence and
to look at it at once. When you do that, you end up with a
pooled estimate of the relative risk of around 1.3, with a
very narrow confidence band because your effective sample
size is very large.
The main reason for wide confidence intervals is
just generally -- the study wasn't big, because it's very
hard and expensive to do very large studies, and when you
pool them, you end up with, effectively, a very large study,
so a very narrow confidence interval.
When you look at the-P value associated with the
statement: Passive smoking increases the risk of heart
disease, the P value associated with that is about .0003, so
there's less than 3 chances in I0,000, of getting that
result just by accident.
Now, I'd like to very briefly address the issue
of meta analysis, because that's something that's been the
subject of a great deal of the discussion.
I guess before I do that, I'd like to offer one
comment on OSHA's analysis, using the Helsing and Fontham
studies.
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
TI1011-1596
1
2
3
4
5
6
7
8
9
I0
II
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
410
. There are basically two approaches that you can
use to doing a risk assessment when you're dealing with an
environmental toxin.
One approach is to combine all of the reasonable
studies and do a meta analysis and come up with an overall
risk assessment, which is what I've done here and what the
EPA did. The EPA was roundly criticized, I believe
unjustly, for doing a meta analysis, and so what OSHA did
was the other reasonable thing, which was to pick the best
available study and go with that.
Frankly, I would have done it the other way, but
it doesn't matter, because if you look at the results from
the best available studies, the Helsing and the Fontham
studies, and compare the relative risks which they observed
with what you get from the meta analysis, they're very, very
close, and that's what you would expect, if there's a real
effect, which there is.
So, in presenting this discussion of meta
analysis, I think the difference between the way OSHA did
their risk assessment and what I'm presenting here is a
matter of scientific taste. It's not something that really
matters in a substantive way.
To put all of this in context, let's deal with
something a little less exotic, and that is, flipping a
coin. If I have a coin and allege that it's fair, there's a
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
T11011-1597
1
2
3
5
6
7
8
9
I0
ll
12
13
14
15
16
17
18
19
20
21
22
23
24
25
411
50-50 change of getting heads or tails on any given flip.
If I just flip the coin once, you cannot tell if
the coin is fair, you do not have a big enough n, you do not
have enough statistical power.
If I flip the coin 12 times and it comes up ii
times, I doubt that there's a soul in the audience that
would want to bet that it would come up the other way, no
matter how much money I offered. The conclusion is that the
coin isn't fair.
Now, is it possible to flip a coin 12 times and
get ll tails? Yes, it's possible. It's just not very
likely, and that's why people say it's not fair. The reason
is the probability of getting ii tails on 12 flips is only 3
in 1,000.
You can do the similar thing. This is a little
simpler than what I presented on the slide with the epi
studies, for heart disease.
If ETS doesn't cause heart disease, there's a 50-
50 chance of seeing an increased risk in any given study.
Half of them should have showed risk, showed risk
below I; half of them would show risk above i, more or less.
There are 12 studies in ETS and the risk of heart
disease death, and there's a higher risk of death in II of
them. Conclusion: ETS increases the risk of heart disease
death, because the probability of getting Ii positive
BAILEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
T11011-1598
1
2
3
5
6
7
8
9
10
II
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
412
studies ottt of 12 is only 3 in I000.
MS. SHERMAN: Let the record show that the slide
is labeled, Meta Analysis of ETS and CHD.
DR. GLANTZ: Yes. I apologize. I'm used to
talking to medical schools not legal forum.
Finally, there's an issue related to this, and
much hay has been made about this, about how you should do
the hypothesis testing. This is something that I get to
about the end of the course I teach on this stuff that you
see, and that is the distinction between i- and 2-tailed
hypothesis testing.
I have presented the 2-tailed 95 percent
confidence intervals in the slide earlier, and one I'll show
you again.
That's really, I think, the wrong thing to do,
because I am not aware of anyone who has said that breathing
secondhand smoke is protective of getting heart disease or
cancer or anything else.
I am unaware of any evidence that breathing
secondhand smoke is a positive good or a therapeutic agent
in terms of heart disease.
So, really, the question you ought to ask is,
smoking increases the risk of heart disease. When you do
that, really the appropriate thing to do is to put all of
your risks at the bottom end of the confidence. So
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
T!1011-1599
1
2
3
4
5
6
7
8
i0
ii
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
413
really one. ought to use a 1-tailed test and test the
hypothesis -- passive smoking increases the risk of heart
disease, not passive smoking changes the risk of heart
disease.
The P value associated with a l-tailed test is
half that of the corresponding 2-tailed test.
So the lower bound of the 90, 2-tailed 90 percent
confidence interval is in exactly the same place as the
lower bound of a 1-tailed 95 percent confidence interval, so
I believe, in preparing the slide, that before I was, in
fact, giving you a statement which makes the evidence look
weaker than it is. This is the slide labeled Statistical
Hypothesis Testing.
For the record, let it be said that the OSHA
staff is holding up a sign saying, label the slide. Thank
you.
Now, in addition to the data showing that -- oh,
one other thing.
There are three studies -- three of the
epidemiological studies which show an increase -- a
statistically significant increase -- with 95 percent
confidence, in fact, a two-tailed 95 percent confidence, on
the risk of getting heart disease.
Those three studies taken alone, I think are
sufficient to conclude that passive smoking causes heart
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
TI1011-1600
1
2
3
4
5
6
7
8
9
I0
II
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
414
disease, because the probability of getting three positive
studies -- statistically significant positive studies -- at
the 95 percent level, is only about 1 in i0,000.
Again, if there is no real effect, then we should
not find statistically significant results as often as we
do.
Now, the question you ask is what about all the
so-called negative studies, the ones that do not reach
statistical significance?
There are two issues in doing statistical
hypothesis testing that one needs to be concerned about:
Controlling against false positives, which is
what the P value does; and controlling against false
negatives, which is what is done by computing the so-called
statistical power of the study. That is, the ability of the
study to report a statistically significant effect if one
really exists.
One of the problems with almost all of the
studies on passive smoking and heart disease is they weren't
very big, and so the power was low, often less than l0
percent, meaning a 10 percent chance of actually detecting a
real effect.
So I think one needs to be very cautious in
interpreting studies that do not reach statistical
significance. On the other hand, if it does reach
BAYLEYREPORTING, INC.
(202) 234-7787 (800) 368-8993
T11011-1601
1
2
3
5
6
7
8
9
10
II
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
415
statistica~ significance in the face of low power, than you
can be reasonably confident in the finding, although that's
what the hypothesis testing complications control for.
Finally, I have a slide here called, Passive
Smoking and Heart Disease Non-Fatal Events. There's a bunch
of studies here. I think there's 12 here, too, where people
looked at non-fatal endpoints.
Non-fatal myocardial infarction. I believe some
looked at malignant arrhythmias.
Again, all but one of the studies showed some
elevation in risk. When you pool them together, you get
about a 1.3 relative risk with a little broader confidence
interval. I think the fact that you come up with similar
estimates for non-fatal, as you do fatal events, is
consistent, as one would expect, given the nature of heart
disease.
Because one of the things which determines
whether you die when you have a heart attack is, part of it
is how bad it is, but part of it is also how quickly you get
to a hospital and get treated.
So I would expect to see roughly the same
incidence of non-fatal as fatal events, if passive smoking
is causing or aggravating them, as I believe the clinical
and experimental evidence supports.
So I haven't summarized everything which is in
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
Tl 1011-1802
1
2
3
4
5
6
7
8
9
I0
II
12
13
14
15
16
17
18
19
20
21
22
23
24
25
416
the testimony. There are other effects of passive smoking
on exercise, which is what you would expect if the heart is
not working very well.
But when you put all of the evidence together,
you have what is, in my view, and I think the consensus of
the scientific community who has looked at this, including
the American Heart Association, which has done two
independent analyses of the literature now, is that there is
a very strong case that passive smoking causes heart
disease, that passive smoking aggravates heart disease.
The roughly 30 percent increase in risk, which is
reported in the epidemiological studies is consistent with
what you would expect.
Now, the net effect of this on a population basis
is very, very important. There's been a lot of talk about
lung cancer, in particular, in response to the EPA report.
But lung cancer -- this is a slide labeled, Deaths from
Passive Smoking. I'm being smiled at, for the record,
because they did not have to hold the sign up.
You get about 3,000 to 4,000 deaths. But when
you take the excess heart disease risk, the 1.3 risk, and
spread it out over the exposed population, we have
previously estimated, based on Wells' work, that you would
get 37,000 heart disease deaths. So the heart disease is
about I0 times a bigger problem than lung cancer.
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
T11011-1603
1
2
3
4
5
6
7
8
9
I0
ii
12
13
14
15
16
17
18
19
20
21
22
23
24
25
417
. Wells' recent paper, which updates these numbers,
comes up with even higher population risks. He'll be
testifying later.
But if you look at this slide, labeled, U.S.
Deaths in 1989, you see that passive smoking is a
tremendously important problem. It's the third leading
preventable cause of death.
Active smoking, of course, is the leading
preventable cause of death, with about 420,000 deaths.
Alcohol is second; passive smoking is third. It
beats out accidents, AIDS, suicide, homicide, illegal drugs,
and it's a tremendously important problem. It's a public
health problem and it's a work place problem.
That concludes the comments I have on heart
disease. I'd like to quickly go on and talk a little bit
about a study we've done of the economic impacts of tobacco
regulations on smoke-free restaurant ordinances on the
restaurant business.
This slide, What if they Passed a Law That Took
Away 30 Percent of Your Business, is an ad that the Tobacco
Institute ran in some restaurant trade publications.
It says: What happens if your state legislature
or city council bans smoking in restaurants? You'll lose
business, maybe as much as 30 percent of your business,
according to a survey in Beverly Hills, which was
BAYLEYREPORTING, INC.
(202) 234-7787 (800) 368-8993
TI1 O11-1604
1
2
3
4
5
6
7
8
9
l0
iI
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
418
considerin~ such an ordinance.
This claim of a 30 percent drop in business has
been made over and over and over again in debates over local
ordinances. I was invited a couple of years ago -- about
three years ago now -- to testify in Los Angeles about our
heart disease work at a public hearing on a restaurant
ordinance down there, and the Tobacco Institute brought in a
restauranteur, I remember, wearing a big poufy restaurant
hat, who said, never mind all this science; if you pass
this, I'll go bankrupt. They'll be a 30 percent drop in
business because of what happened in Beverly Hills.
What happened in Beverly Hills was an ordinance
was passed there. It was the first ordinance in the State
of California requiring smoke-free restaurants, the second
in the country. The first had been Aspen some years
earlier.
Shortly after it passed, there were loud claims
of a 30 percent drop in business, and the ordinance was
subsequently repealed.
Now, it later came out that the Beverly Hills
Restaurant Association, which was making these claims, was
created by the Tobacco Institute. While repealing the
ordinance was a bad thing for public health, it was a good
thing for science, because it created a wonderful natural
experiment to see what happened.
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
TI1011-1605
1
2
3
4
5
6
7
8
9
i0
Ii
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
419
.Now, at the time, I just couldn't believe this 30
percent number because the smoking prevalence in California
then was around 25 or 27 percent. In rich communities, it's
lower, and it was very hard for me to believe that people
who were nonsmokers were avoiding restaurants because they
couldn't complemnt their dining experience with toluene and
formaldehyde.
I was stomping around in the lobby after the
hearing, and I said, I wish you could get some objective
data on this, I wish you could get the sales tax data. Lisa
Smith, who, up until then I hadn't known, came up to me and
she said, oh, that's a matter of public record.
So we went and we got the sales tax data. This
slide labeled Beverly Hills, shows what actually happened in
Beverly Hills when they passed their ordinance.
The vertical axis is sales/restaurant sales in
millions of dollars, as reported to the California Board of
Equalization, which is the sales tax authorities.
The horizontal axis is time in years, and the
open points are when there wasn't an ordinance, and the two
solid points, labeled truth, are what the actual sales are,
as reported to the tax authorities in California.
Now, had there been a 30 percent drop, you would
have seen the blue line labeled "TI Claim." The claim of a
30 percent drop is, in this case, in science, has a
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
TI 1011-1606
1
2
3
4
5
7
8
9
i0
iI
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
420
technical ~erm for this. It's "Y". It just didn't happen.
This is, I believe, the best data you can get, because it's
comprehensive. It includes every restaurant in the city,
and it's collected by people who don't care about the
outcome.
It's collected by the state sales tax authorities
who have no interest, as best as I can tell, one way or the
other, in the question of the effects of 9moking on
restaurant sales.
Now, .subsequent to that, in the May 1994 issue of
Consumer Reports, there was an article, entitled, "Public
Interest Pretenders," which talked about phony public
interest groups and about a third of the article dealt with
the tobacco industry's phony groups', but there is an article
in there which I recommend to OSHA's reading, entitled,
"Self-Serving Surveys: The 30 Percent Myth," which goes
through and documents how this number was then regenerated
for the City of Bellflower, and that claim was used, again
to get the ordinance repealed, in fact, successfully.
If I could just go back -- I'm returning to the
Beverly Hills slide for one minute.
It's very important. If the ordinance had had an
effect, then you would have seen sales drop, or if it had
been good for business, they would have gone up, but it
didn't do anything.
BAYLEYREPORTING, INC.
(202) 234-7787 (800) 368-8993
TI1011-1607
1
2
3
4
5
6
7
8
9
i0
ii
12
13
14
15
16
17
18
19
20
21
22
23
24
25
421
.Then when the ordinance is repealed, there should
have been another sudden change which didn't occur. So the
fact that the ordinance was only enforced for a short
time -- actually, for a little under two quarters --
actually, from a scientific point of view, makes the case
much stronger.
Now, we have subsequently collected the sales tax
data from 15 cities. This is a slide that says Lodi on top,
showing four of the cities. We have located the sales tax
data from all 15 cities in the United States, which have had
100 percent no smoking in restaurant ordinances on the books
long enough to get a year's worth of data.
Now that means you have to wait about two years
after the ordinance passes, because you need to wait for a
year for time to pass, and then it takes the tax authorities
nearly a year to get the data collected, clean it up, and
publish it so it becomes available, so there are about, I
believe, over 100 such ordinances now. I think well over
100.
We studied, at the time that we did this work a
few months ago, 15, but I want to stress this is all of
them. There's no selectiveness of data.
If you look at these cities -- Lodi is a rural
community; a small rural community. Palo Alto is a
relatively well to do college and high tech community in the
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
T!1011-1608
1
2
3
4
5
6
7
8
9
l0
II
12
13
14
15
16
17
18
19
20
21
22
23
25
422
Sacramentq Peninsula. Paradise is a very small retirement
community up in Northeast California. Roseville is a sort
of semi-rural community, although it's become part of the
Sacramento metropolitan area.
If you look on these, we also went back five
years -- at least five years -- before the ordinance went
into force, to establish any underlying secular trends,
seasonal variation, things like that.
Those are the open points, and the solid points
they're witnessesing when the restaurant is smoke free.
If you look at these -- this is Ross, which is a
very well to do community in Marin County, north of San
Francisco -- there's a period of about two years where
there's no data, because Ross is a small community and the
Board of Equalization doesn't report the data unless there's
a minimum number of restaurants reporting for privacy
reasons, so there was a period of no data.
San Luis Obispo is a college town in Southern
California.
The next town, labeled at the top, Auburn. This
is upside down. But since there was no change, the lines
are still flat.
Auburn is up in the Sierra Foot Hills.
Bellflower is a bedroom community in the LA
Basin, which, actually, the ordinance was repealed base on a
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
Ti1011-1609
1
2
3
4
5
6
7
8
.9
I0
ii
12
13
14
15
16
17
18
19
20
21
22
23
24
25
423
claim of 39 percent loss of business. If you look at the
slide, you see the four quarters the ordinance was on
effect, and then when it was removed, there was no change.
Beverly Hills, I've already talked about.
E1 Cerrito is a suburban community in San
Francisco.
Finally, we looked at the three communities in
Colorado, which at least according too their city clerks,
have smoke-free laws.
Aspen, which was the first city in the country to
do this, Snow Mass and Telleride; and if you just look at
these, you can see there wasn't an effect.
Now, we did a whole bunch of statistical
analysis, and the analysis that we did with 80 percent power
detected, a half percent change, and we found no significant
change.
Finally, I'd like to just address the issued of a
PEL, because this has been discussed at some length, and I
think OSHA should not establish a PEL. There are many
reasons that that's wrong.
The first reason is that I don't know of any work
product or anything, like a slide carousal, or a paper, or a
coat, which requires the presence of cigarette smoke in the
air to manufacture.
It's not an integral part of the manufactured
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
TI1011-1610
1
2
3
4
5
6
7
8
9
i0
ii
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
424
process. ~n fact, it is a gratuitous work place pollutant,
and there are already thousands of businesses which by law
or voluntarily have removed it without compromising their
ability to produce slide carousals, paper, laser pointers,
or any other product.
The second thing is, as has been pointed out by
various people, ETS is a very complicated mixture. There
are thousands of components in ETS. The number has been
generally identified. Every single component has not.
We know in terms of the cardiovascular effects,
that there is not any one thing in the smoke which causes
the problems.
The nicotine causes some of the problems; the
polycyclic aromatic hydrocarbons in the smoke, particularly,
benzopyrene seems to cause problems; the carbon monoxide is
an issue. But there are many, many other things that have
demonstrated effects on the cardiovascular system of smoke
exposure, but where the specific elements can't be
identified. In fact, probably many of the different
elements have synergistic effects that are different than
their individual effects.
I think it would be virtually impossible to
identify any one specific marker that could be used to write
a defendable stand.
Furthermore -- and this was brought you a bit in
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
T11011-1611
1
2
3
4
5
6
7
8
9
I0
ii
12
13
14
15
16
17
18
19
20
21
22
23
24
25
425
the questigning yesterday -- it's very hard to find one
thing which can be used to measure the exposure to all of
the thousands of things in the cigarette smoke.
There are big particles, there are little
particles, there are gases. These components have different
residence times and distribution times. If you were to pick
one -- and some of them, many of them, are not unique to
ETS, in fact. If you were to just simplZ pick one or two of
them, it would be very, very difficult to justify that in
terms of all of the effects.
Finally, the PEL really isn't necessary because
ETS isn't required to make any. To me, given the broad
range of risks and the risks associated with ETS are
hundreds to thousands of times higher than the risks of most
other work place contaminants and air pollutants we deal
with, that it just seems that's an unnecessarily complicated
step, and it's something which would lead to a rule which
would be much more expensive and much harder for people to
enforce.
Finally, one comment related to that is, in the
OSHA statement, in the Federal Register, there's discussion
of using a pharmacologically-based kinetic model -- PBPK.
Say it three times, fast.
Anyway, I think that is not a good idea. The
pharmacokinetically-based models are very complicated. I
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
T!1011-1612
1
2
3
4
5
6
7
8
9
I0
II
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
426
think thatj given the many, many different constituents of
cigarette smoke that exists and their different biological
effects, it would be very hard to defend.
They often require making a tremendous number of
implicit assumptions, which are often very hard to validate,
and they're usually used when you lack real exposure data
and real epidemiological data.
That's not the case with ETS. We have real
exposure of real people and real environments at real levels
and consistent and strong epidemiological data that can be
used for attributable risk calculations. I really urge you
to do that.
I think you're just making things much more
complex to no scientific gain, and probably a scientific
loss if you do that.
Finally, I would like to show you this pack of
cigarettes, which I picked you in Canada a couple of weeks
ago. It's a pack of Camel's made by RJ Reynolds, made in
the USA. For the record, it says in bright, white letters
on a black background: Tobacco Smoke Causes Fatal .Lung
Disease in Non-Smokers.
Now, I'm not here to talk about lung cancer, but
it would seem to me that if the evidence, which is including
the evidence that OSHA deals with, were not strong, the
Canadian Government wouldn't have told RJ Reynolds and all
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
TI1011-1613
1
2
3
4
5
6
7
8
9
I0
12
13
14
15
16
17
18
19
20
21
22
23
24
25
427
of the other companies that they needed to put this on their
cigarette packages.
OSHA is not alone in the scientific community in
concluding that passive smoking is dangerous. The EPA has
said it, the Surgeon General has said it, who has been
accused of saying it for political reasons many times, by
the tobacco interests.
The World Health Organization has said it, and
large numbers of independent scientific bodies have reached
the conclusion.
The evidence on heart disease is newer than the
evidence on lung cancer, so there aren't as many of these
bodies that have yet had a chance to review the evidence,
but the American Heart Association has put out two position
statements saying passive smoking is an important cause of
heart disease and the World Health Organization has, as well
as in Australia. They have done it in a few other places,
too.
I think 0SHA, in their Proposed Rule Making,
there are many details that I think deserve attention, but
you are basically on the right track, and you are acting
totally consistently with the predominant view of the
scientific community. I applaud you for your actions in
this area.
JUDGE VITTONE: Could you turn that off?
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
TI1011-1614
1
2
3
4
5
6
7
8
9
I0
11
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
428
.DR. GLANTZ: Sure.
JUDGE VITTONE: Thank you, Dr. Glantz.
We are going to break for lunch, but before we
do, would the people who like to cross examine Dr. Glantz
please stand.
One, two, three, four, five -- five or so. Okay.
Thank you very much, gentlemen. We'll get back
to you.
MS. SHERMAN: Your Honor, I would like to enter
into the record as Exhibit 16, Dr. Glantz's testimony and
slides.
JUDGE VITTONE: Okay. Exhibit 16, the testimony
and the slides, will be received into evidence.
(The document referred to.was marked for
identification and received into evidence as
Exhibit 16.)
DR. GLANTZ: Could I just say the material that I
gave Ms. Sherman had a couple of other slides I pulled out
to try to shorten, so I can either remove those now or you
could --
JUDGE VITTONE: You can do that over the lunch
break.
one.
MS. SHERMAN: Yes, please remove them.
JUDGE VITTONE: Okay. It is now five minutes to
Let's plan on returning at -- let's make it one hour.
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
T11011-1615
1
2
3
4
5
6
7
8
9
I0
Ii
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
Five minutgs until two, we'll start right then.
(Whereupon, a luncheon recess was taken.)
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
429
Tl1011-1616
1
2
3
4
5
6
7
8
9
I0
ll
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
430
AFTERNOON SESSION
(2:05 p.m.)
JUDGE VITTONE: We concluded before the lunch
break with direct presentation of Dr. Glantz. I have had an
indication from different representatives that they intend
to question Dr. Glantz.
Let me touch on a topic so we can figure out what
our planning should be for the rest of this day.
MR. Serridge, Mr. Lowe, Mr. Rupp, Mr. Grossman,
how much time do you estimate do you think you need for
Dr. Glantz?
Mr. Rupp?
MR. RUPP:
JUDGE VITTONE:
Mr. Sirridge?
MR. SIRRIDGE:
JUDGE VITTONE:
Mr. Lowe.
MR. LOWE: 30 minutes.
JUDGE VITTONE:
MR. GROSSMAN:
JUDGE VITTONE:
1-i/2 hours.
Hour and a half.
45 minutes.
45 minutes.
Mrl Grossman.
Less than 30.
Less than 30.
MS. SHERMAN: Your Honor, is it possible to move
the questionnaire's podium over a little bit, so we might
see the questioners also?
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
T!1011-1617
1
2
3
4
5
6
7
8
9
I0
ii
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
431
JUDGE VITTONE: We may have a problem with the
table, but if that's possible, I would like to do that, if
we could move that podium over.
MR. DINEGAR:
JUDGE VITTONE:
MS. SHERMAN:
questioners.
JUDGE VITTONE:
It'll take about I0 minutes.
Oh.
I would like to be able to see the
What other? By my calculations,
I've got 3-1/2 to 4 hours of examination that the parties
would prefer to do.
MS. SHERMAN:
JUDGE VITTONE:
Did that include Boma?
Representative Boma indicated to
me that his questioning would be relatively brief.
Is that right, sir? About 10 minutes. Yes.
MS. SHERMAN: Okay.
JUDGE VITTONE: Okay. Can you see if you can get
that done real quickly? I'm sorry. We're going to be in a
recess for another five minutes.
[Recess]
JUDGE VITTONE: We're back on the record, please.
Ms. Sherman, are you okay there?
MS. SHERMAN: Yes. Thank you.
JUDGE VITTONE: All right. Will the
representative for Boma please come forward?
I'm sorry, sir. Can you step aside? Mr. Tyson,
BAYLEYREPORTING, INC.
(202) 234-7787 (800) 368-8993
T!1011-1618
1
2
3
4
5
6
7
8
9
I0
II
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
432
can you ta~e the mike, please?
You want to take that up this afternoon? You
don't want to wait until tomorrow?
MR. TYSON: I believe it would be better to take
it up now, Your Honor.
JUDGE VITTONE: Okay.
MR. TYSON: I'm Pat Tyson, representing Philip
Morris. We would like the scheduling of these hearings
changed somewhat. We will note that, in the history of the
Agency, it's never had hearings running the length of time
that these are proposed to run.
The number of witnesses, the number of comments
involved in this rulemaking are very extensive and far
beyond anything the Agency has dealt with before. The
concept of an uninterrupted, or barely interrupted, string
of daily sessions of the hearing, I think is more than any
of us should be required to bear, and would request, with
all due respect, that we go to a schedule of two weeks of
hearings, a week off, two weeks of hearings, a week off.
That would allow us to adjust schedules
throughout the course of the hearing as it goes along to
compensate for situations where we take longer than we
originally
scheduled -- or the agency originally scheduled, with
respect to cross examination of witnesses, and would allow
BAYLEYREPORTING, INC.
(202) 234-7787 (800) 368-8993
T11011-1619
1
2
3
4
5
6
7
8
9
I0
ii
12
13
14
15
16
17
18
19
20
21
22
23
24
25
433
more changgs in the scheudling as it goes through.
I would urge Your Honor to consider that request.
MS. SHERMAN: Your Honor --
JUDGE VITTONE:
heard on that?
MS. SHERMAN:
JUDGE VITTONE:
Anyone else who wishes to be
I do.
Okay. But let me get the people
in the audience. I was going to go to you. Believe me.
MS. WARD: Your Honor, I'm Mary Ward from
Reynolds Tobacco, and I would only like to add that we join
Philip Morris in this request or motion.
JUDGE VITTONE: Thank you.
MR. RUPP: Your Honor, John Rupp from Covington
and Burling. We also endorse the recommendation. We have,
in addition to the reasons that Mr. Tyson gave, we just
think that we're all going to be able to do a more organized
and workmanlike job, probably saving time in the long run,
if we're given a chance to prepare properly.
It's on that basis, in addition to those the
Mr. Tyson mentioned, that we strongly support the
recommendation as well.
JUDGE VITTONE:
MR. DINEGAR:
Anyone else from the audience?
Jim Dinegar with the Building
Ordinance and Managers Association. I recommended,
actually, that we keep individual comments to I0 minutes,
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
Ti1011-1620
1
2
3
4
5
6
7
8
9
I0
ii
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
434
and that'~ the rule, regardless of how many parties they're
purporting to represent, and this hearing will move along
just fine.
JUDGE VITTONE: You mean in the direct
presentation?
MR. DINEGAR: Direct presentation, i0 minutes per
person.
JUDGE VITTONE: But do you not support Mr.
Tyson's motion for adjusting the sckedule?
MR. DINEGAR: We wouldn't need an adjustment in
the schedule if we were able to keep to i0 minutes per
person, but it may be an amendment of his proposal.
JUDGE VITTONE: All right. Thank you, sir.
MS. SHERMAN: Yes, Your Honor.
JUDGE VITTONE: Ms. Sherman.
MS. SHERMAN: Susan Sherman for the Department of
Labor. I'd like to oppose Mr. Tyson, et al, motion. We've
scheduled this hearing carefully. We have an interest in
bringing it to a close expeditiously, and I think that it
would be far more disconcerting to the people who have
already been scheduled and made their plans, to rescheudle
it at this point. So, at least at this point, I would like
to oppose the motion.
JUDGE VITTONE: What's the total number of
witnesses so Ear that are scheduled?
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
Ti1011-1621
!
2
3
4
5
6
7
8
9
i0
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
435
. MS. SHERMAN: 270.
JUDGE VITTONE: 270. Right now, we are scheduled
to go through the week of December 2nd, which is a Friday.
DR. GLANTZ: Your Honor, this is Stan Glantz.
Could I say something on behalf of at least.one, as a
witness? I think rescheduling the hearing could be very
difficult for a lot of the people like me whose schedules
get locked in months in advance.
I think if this had been moved, it would have
caused real serious problems for me and I think many of my
colleagues, who have other commitments, which are often made
way in advance, may have a hard time adapting to changes.
MR. RUPP: Your Honor, it's precisely for the
reason that Dr. Glantz has stated that I think Mr. Tyson has
made the recommendation. We're at the second day of the
haering, and already two people have had to be rescheduled,
with a couple of hours worth of notice.
If one of those had come in from California, that
would have been most unfortunate. We're trying to avoid a
situation where we have a freight train moving down the
track and there's no couples -- that is, if somebody gets
back up, the whole train is disturbed, and everybody has to
be notified, often with very short amount of notification.
So we're trying to give a little bit of latitude
so people can plan on the schedule that is set, in trying to
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
T11011-1622
1
2
3
4
5
6
7
8
9
I0
Ii
12
13
14
15
16
17
18
19
20
21
22
23
24
25
436
reach a bi~ more reasonable and workmanlike schedule in the
process of doing so.
I appreciate Dr. Glantz's observation, and I
would say to him that's precisely why Mr. Tyson has made the
suggestion he has made.
MS. SHERMAN: Your Honor, I would suggest that
perhaps it would be better to revisit this issue after the
witnesses that OSHA has invited have finished testifying,
and we could get perhaps a better idea of how long a typical
day will take us.
JUDGE VITTONE: The present schedule, right now,
is to go until the week of October -- well, until Friday,
October the 14th, and then there will be a break for one
week, and then we will resume, and then continue until I
guess almost the Thanksgiving holidays.
Then continue until Tuesday, November 22nd, then
break for the Thanksgiving holiday, and resume the next week
and go until December 2nd.
My experience, this is the -- I've been with the
Department, I guess, almost 7, 8 years now. This is the
first time that you've had this kind of a real tight
schedule in these kind of proceedings. I can understand why
you need, or you believe you want to push, and get on and
get all of this testimony and evidence in the record.
I'll tell you what I'm going to do. I'm going to
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
Ti I 011-1623
1
2
3
4
5
7
8
9
i0
ii
12
13
14
15
16
17
18
19
20
21
22
23
24
25
437
not rule ~ight now, but I'm going to take a look at the
schedule and the calendar tonight. I think if there could
be a little bit more break time worked in here, it would be
helpful. Not particularly to me. I guess I'm the last
person in the room that really needs the help, at this
point.
I'm thinking of the OSHA people, the witnesses,
and all of the people who. are going to have to travel, some
from, I guess, apparently across the country, like
Dr. Glantz here, to testify.
I'd like to take a look at this a little bit more
closely and take a look at the calendar and make a decision
after I've had a chance to look at that, a little better.
We'll take it up again tomorrow.
Thank you very much. I appreciate it.
Okay. Now to Dr. Glantz.
Representative from BOMA. Please identify
yourself, again.
MR. DINEGAR: Jim Dinegar, Vice President for
Government Affairs, with Building Owners and Managers
Association, No. 1 on the hearing docket.
Dr. Glantz, the EPA risk assessment has generated
a great deal of controversy, and I wanted to ask you a
number of questions. Page 1 of your testimony and page 2 of
your testimony refer to EPA's risk assessment.
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
T!1011-1624
1
2
3
4
5
6
7
8
9
I0
Ii
12
13
14
15
16
17
18
19
20
21
22
23
24
25
438
. You state that, in recent years, most of the
public discussion on the health effects of passive smoking
has dealt with lung cancer, probably because of the
controversy, et cetera, regarding the 1992 Environmental
Protection Agency risk assessment of environmental tobacco
smoke and lung cancer.
You go on to state, it says: "In fact, heart
disease is actually a much more important endpoint of
passive smoking than lung cancer; whereas ETS causes 3000 to
5000 lung cancer deaths annually, it causes 30,000 to 60,000
heart disease deaths annually.
Are you aware of any study underway at EPA that
would be a corrollary to their report on passive smoking as
it related to lung cancer deaths, that includes the
information regarding your assertion on 30,000 to 60,000
heart disease deaths per year?
DR. GLANTZ: A£ this point, I do not believe the
EPA is doing that. I've suggested that I think it would be
a good idea for them to, but I do not believe that any such
project, as yet, has been initiated. That may be wrong, but
I don't know that they've actually started.
MR. DINEGAR: The term -- not being a scientist
or working for a EPA -- but the term "Group A Carcinogen"
was the label put on the deaths of the 3000 to 5000 llung
cancer deaths per year. Is there a corrollary term that
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
TI1011-1625
1
2
3
4
5
6
7
8
9
i0
II
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
439
would be used at the level of 30,000 to 60,000 heart disease
deaths per year?
DR. GLANTZ: Some. I'm not a representative of
the EPA, and I'm not totally familiar with all of their
specific terminology. I do not believe so. The different
categories for carcinogens have to do with the nature of the
data and the evndns supporting that conclusion, and I do not
believe similar groupings have been developed in heart
disease epidemiology.
MR. DINEGAR: On page 32, then, of your
statement --
DR. GLANTZ: If I could just add, the Group A
classification doesn't have anything to do with the number
of deaths. It has to do with the nature of the evidence
that it is a carcinogen, rather than how bad a carcinogen it
is.
MR. DINEGAR: Thank you. On page 32,
reversibility of effects. You state, like the effects of
active smoking, the effects of passive smoking on the heart
represent a combination of acute toxicity and long-term
damage.
To the extent that the effects of passive smoking
on the heart represent acute toxicity, removal of exposure
of the individual to secondhand smoke will result in a
commensurate reduction in the risk of adverse health
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
TI1011-1626
1
2
3
4
5
6
7
8
9
i0
ii
12
13
14
15
16
17
18
19
20
21
22
23
24
25
440
consequencgs.
With that in mind, as we talk about the improved
productivity associated with OSHA's proposal on indoor air
quality and that perhaps the removal of exposure to
secondhand tobacco smoke, would you expect, or could you
argue that there would be improved productivity as a result
from eliminating exposure to the environmental tobacco smoke
situation, as you assert happens in the area of improved
exercise on page 8?
DR. GLANTZ:
MR. DINEGAR:
Yes.
Ventilation.
Tobacco companies
would have you believe that increasing ventilation---
DR. GLANTZ:
MR. DINEGAR:
DR. GLANTZ:
MR. DINEGAR:
Where -- you're not quoting me?
No.
No.
Tobacco companies would have you
believe that increasing ventilation indoors -- and I
represent the office building industry -- would magically
preclude the involuntary inhalation of environmental tobacco
smoke.
Do you see any evidence that suggests increasing
the ventilation rate of the outside air being brought
indoors would, in fact, preclude or eliminate exposure at
safe levels to involuntary tobacco smoke?
MR. DINEGAR: Thank you.
BAYLEYREPORTING, INC.
(202) 234-7787 (800) 368-8993
TI1011-1627
1
2
3
4
5
6
7
8
9
i0
ii
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
441
JUDGE VITTONE: Thank you, sir.
The next person to question Dr. Glantz,
Mr. Sirridge.
Again, sir, I remind you, please identify
yourself and who you represent.
MR. SIRRIDGE: Your Honor, Mr. Tyson did the
introductions yesterday and listed a series of numbers,
under which he and I were questioning yesterday. Should
do that again or hand it to the reporter as I finish?
right?
JUDGE VITTONE:
MR. SIRRIDGE:
JUDGE VITTONE:
the reporter?
MR. SIRRIDGE:
You've identified the same 17,
Same 17, yes.
Okay. Why don't you hand it to
I'll hand it to the reporter.
to OSHA?
My name is Pat Sirridge.
Good afternoon, Dr. Glantz.
Dr. Glantz, did you volunteer to be a consultant
DR. GLANTZ:
MR. SIRRIDGE:
became one?
DR. GLANTZ:
No.
How did it come about that you
I had been in communication with
OSHA for sometime over the last few years -- not intimate
communication but the kind of communication you would have
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
T!1011-1628
1
2
3
4
5
6
7
8
9
i0
ii
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
442
with a scientific colleague, and had, from time to time,
been in Washington and met with some of the OSHA staff to
discuss our ongoing research, and the issue of.passive
smoking, generally, and so that's how I met several.
As OSHA started working on their risk assessment
and other document, I was contacted several times and asked
for reprints of our research and suggestions of other
scientists who had been working the area, which is, again, a
sort of standard scientific interchange.
At some point last summer, I was asked if I would
be interested in testifying --
MR. SIRRIDGE: But in correspondence --
DR. GLANTZ: -- and I responded yes.
MR. SIRRIDGE: Excuse me.
DR. GLANTZ: And I said I would.
MR. SIRRIDGE: But in correspondence you offered
to be a consultant.
DR. GLANTZ: No. No.
MR. SIRRIDGE: You didn't?
DR. GLANTZ: No.
MR. SIRRIDGE: You offered to give any help you
could, in correspondence?
DR. GLANTZ: I mean, I don't remember ever -- I
don't even actually remember writing letters, but if I did,
I probably included a sort of standard statement at the end,
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
Ti1011-1629
1
2
3
4
5
6
7
8
.9
i0
Ii
12
13
14
15
16
17
18
19
20
21
22
23
24
25
443
I put
that if I can help you in an way, please let me know.
that on most letters when I send reprints and other
scientific materials out, as a courtesy to the people who
asked.
I did not particularly -- I did not actively seek
my role in this hearing at all.
MR. SIRRIDGE: Putting the hearing aside, how
about actively seeking a role as a consultant?
DR. GLANTZ: No.
MR. SIRRIDGE: How many years have you worked
with Mr. Repace of the Environmental Protection Agency?
DR. GLANTZ: Well, I have known Mr. Repace since
the '80s. I met him as one would meet a scientist. The
only actual work that I would say I have done with him is he
loaned us his piazo balance to make some exposure
measurements in our rabbit and rat studies, and came to
San F~ancisco and showed us how to use it. We've never
formally collaborated on any scientific work.
MR. SIRRIDGE: But he has offered comments and
you have had dialogues regarding papers you have written, or
at least --
DR. GLANTZ: Sure. Sure. And I've done that --
well, before we publish any of our papers, we circulate it
to many knowledgeable experts and ask them for criticisms
because it's always better to get the cricisms ironed out
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
TI1011-1630
1
2
3
4
5
6
7
8
9
I0
I!
12
13
14
15
16
17
18
19
20
21
22
23
24
25
444
before yo~ submit a paper for publication, rather than to
have the reviewers mark it out for you.
MR. SIRRIDGE: Was it Mr. Repace who alerted you
about the OSHA matter and their pending risk assessment?
DR. GLANTZ: I don't remember how I found out
about it. I know that the Action on Smoking and Health
Organization -- no, in fact, I think not. I think I heard
about it when I heard that ASH was going to sue OSHA over
this issue.
MR. SIRRIDGE: Now, you have worked with
Mr. Repace on your submissions to the Environmental
Protection Agency, the submission you were just talking
about a few minutes ago.
DR. GLANTZ: What submission to the Environmental
Protection Agency?
MR. SIRRIDGE: The submission of your 1991
article on passive smoking and heart disease.
DR. GLANTZ: I was requested to write the chapter
in question by Bob Axelrad, who was Mr. Repace's boss at the
EPA.
MR. SIRRIDGE: And you did submit your article?
The 1991 article?
DR. GLANTZ: For the record, the document in
question is a chapter written -- or if this not correct,
correct me -- it's a chapter that was written for an EPA
BAYLEYREPORTING, INC.
(202) 234-7787 (800) 368-8993
Tl1011-1631
1
2
3
4
5
6
7
8
9
i0
ii
12
13
14
15
16
17
18
19
20
21
22
23
24
25
document, called The Compendium of Technical Information
under Environmental Tobacco Smoke, if that's what you're
talking about.
MR. SIRRIDGE: No. Actually, it's your own
article.
do with --
445
DR. GLANTZ: Oh, our own article? Had nothing to
MR. SIRRIDGE: The circulation.
DR. GLANTZ: The circulation article had nothing
to do with the EPA or Mr. Repace.
MR. SIRRIDGE: You submitted it to the EPA?
DR. GLANTZ: They asked me for a copy. "I
give -- I mean, we give reprints to anyone who asks for it.
MR. SIRRIDGE: So the answer is yes?
DR. GLANTZ: I didn't work with them. I was
asked for a copy of the paper, and I sent it to them, as I
would to you.
MR. SIRRIDGE: Thank you.
Dr. Glantz, I take it you've also worked and
traded ideas and discussed these issues with Dr. Judson
Wells?
DR. GLANTZ: Certainly. He's, I think, one of
the finest sciencests in the world, working in this area.
MR. SIRRIDGE: He will be here later as an OSHA
consultant, correct?
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
Tll 011-1632
1
2
3
4
5
6
7
8
9
I0
Ii
12
13
14
15
16
17
18
19
20
21
22
23
24
25
446
. DR. GLANTZ: Yes. That's my understanding.
MR. SIRRIDGE: This is Mr. Repace sitting over
here, on the Panel for OSHA, who's apparently on detail from
EPA to OSHA? Is that your understanding?
DR. GLANTZ: Yes. My understanding is OSHA
wanted the finest scientist in the world to work with them,
and I think Mr. Repace is probably the leading authority on
ETS exposure in the world.
MR. SIRRIDGE: You are, of course, aware that he
has also worked with Dr. Wells?
DR. GLANTZ: I don't -- that, I have no
knowledge.
MR. SIRRIDGE: Would that surprise you?
DR. GLANTZ: No. Because scientists working in
similar areas communicate.
MR. SIRRIDGE: You've also worked with Dr. Kathy
Hammond, correct?
DR. GLANTZ: We have -- Kathy Hammond has done
the nicotine -- or done some of the chemical assessments for
exposure for our rabbit and rat study. She wasn't an active
collaborater with us. We simply obtained the measuring
little wafers, and sent them back to the laboratory for
reading, so we determined that was the best place.
Really, she was purchasing us. The University of
California purchased the service from her. I wouldn't know
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
T11011-163.3
1
2
3
7
8
9
I0
ii
12
13
14
17
2O
21
22
23
24
2H
447
the woman ~f she walked in.
MR. SIRRIDGE: You've never had a conversation
with her?
DR. GLANTZ: Never, that I remember.
MR. SIRRIDGE: That you recall?
DR. GLANTZ: In fact, I'll say never.
Now, I take it, you've
By the way, Dr. Hammond
MR. SIRRIDGE: All right.
also worked with Dr. Neil Benowitz.
is testified to schedule here.
DR. GLANTZ: Yes.
MR. SIRRIDGE: Don't you recall that?
DR. GLANTZ: She's on the list, yes.
MR. SIRRIDGE: I'm sorry?
DR. GLANTZ: Yes, she's on the list.
MR. SIRRIDGE: Thank you.
You have also worked with Dr. Neil Benowitz?
DR. GLANTZ: No. Dr. Benowitz is at the
University of California, San Francisco, as I am, and he is
an expert on nicotine and cotinine and other related
materials, and his lab has read some blood samples for us,
but he wasn't an active collaborator in our work. He simply
ran the samples for us, and he gave us the numbers, and we
paid for it.
I've met with him from time to time. I mean,
he's probably the world's authority on nicotine addiction
BAYLEYREPORTING, INC.
(202) 234-7787 (800) 368-8993
T11011-1634
1
2
3
4
5
6
7
8
-9
I0
II
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
448
and nicotine pharmacology, and I have, from time to time,
been asked questions about these areas, and I've gone to
Neil to find out what he thinks the right answers are
because he knows more than I do about that.
MR. SIRRIDGE: Do you know whether the OSHA
officials were aware that you had worked with all these
other people before?
DR. GLANTZ: I think it's not accurate to
characterize me as having worked with these people. I have
discussed matters with them, as I have probably thousands of
other scientists.
It not an accurate -- I mean, to me, when a
scientist works with someone else, they write papers
together, they collaborate directly and intimately in the
collection of data and the analysis of it, and I have not
worked with them in that sense.
I have used them as resources, as I have used
many people as resources. And I have sometimes circulated
drafts of papers to some of these people for their comments
because I value their judgment, but that's not working with
someone.
If that's the case, then I've worked with a very
long list of people. I think the characterization you're
offering is not accurate.
MR. SIRRIDGE: Dr. Glantz, your views on
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
T!1011-1635
1
2
3
4
5
6
7
8
9
I0
II
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
449
environmental tobacco smoke and heart disease have been well
established for years. Isn't that true?
DR. GLANTZ: Well, our first paper was, I think,
published in January of '91, and that laid out our opinions,
and since then the evidence has continued to accumulate, and
I haven't seen anything that would lead me to change my
mind, in general.
If the evidence were to change, I would change my
views of this. If you think that's not true, I would
suggest you contact Bill Grossman at Harvard, and ask him
how, when he presented compelling evidence to me, that
ischemia changes the rate of relaxation of the --
MR. SIRRIDGE:
DR. GLANTZ:
MR. SIRRIDGE:
Excuse me --
-- left ventricle --
-- a second.
DR. GLANTZ:
MR. SIRRIDGE:
DR. GLANTZ:
MR. SIRRIDGE:
DR. GLANTZ:
Well, this is an important --
No, no. I think you're --
-- No, I want to establish --
Dr. Glantz --
Okay.
JUDGE VITTONE: I think your answer is going well
beyond what the question called for.
Mr. Sirridge, this may be very interesting --
MR. SIRRIDGE: I have one final question.
JUDGE VITTONE: -- but I don't see how it's
BAYLEYREPORTING, INC.
(202) 234-7787 (800) 368-8993
T11011-163,6
1
2
3
4
5
6
7
8
9
I0
II
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
450
contributiDg to the record.
MR. SIRRIDGE: I'm sorry?
JUDGE VITTONE: I'm not sure how we are
contributing to the record with this.
MR. SIRRIDGE:
just had one question --
JUDGE VITTONE:
MR. SIRRIDGE:
I agree with that, Your Honor. I
Sure.
-- which I was.leading up to that
took me quite a while to get there.
The question was: If OSHA was looking for someone
in 1992 to offer an open-minded view on ETS and
cardiovascular disease, that person would not have'been you,
correct?
DR. GLANTZ: No. I don't agree with that
statement at all. I think that, as I said in my opening
testimony, that a scientist should go where the data takes
them and look at the evidence as it exists. And they came
to me as someone who had done that and as an e~ert.
I also think it's not fair to say they came to me
in 1992. I didn't get involved in this process until last
summer sometime, and, prior to that, my discussions with
people at OSHAwere purely collegial and exchanging
information with other interested scientists.
So I do not think that the characterization
you're offering in my relationship with OSHA is accurate.
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
T! 1011-1637
1
2
3
4
5
6
7
8
9
I0
II
12
13
14
15
16
17
18
19
20
21
22
23
24
25
451
.MR. SIRRIDGE: Doctor, I was directed yesterday
to address my questions to you today on certain studies that
came up with respect to the effects of environmental tobacco
smoke and heart disease. Specifically, the study of
Helsing, et al.
DR. GLANTZ: Yes.
MR. SIRRIDGE: Doctor, there are numerous risk
factors for coronary heart disease.
DR. GLANTZ: Yes.
MR. SIRRIDGE: In fact, heart disease is viewed
as a multifactorial disease?
DR. GLANTZ: Yes.
MR. SIRRIDGE: You're familiar with the
publications of Drs. Hopkins and Williams? They're
cardiologists at the University of Utah and have published
several works on the different risk factors for heart
disease?
DR. GLANTZ: Not specifically. You'd have to
show them to me. I don't memorize every paper, but I don't
have that one.
MR. SIRRIDGE: You remember the one paper they
did on some 246 risk factors of heart disease?
DR. GLANTZ: I don't specifically remember that
paper. I have a seen a list like that. I think it was
silly, frankly, because what they did was they took, for
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
Ti1011-1638
1
2
3
4
5
6
7
8
9
I0
ii
12
13
14
15
16
17
18
19
20
21
22
23
24
25
452
example, e~evated cholesterol levels and broke it into a
large number of different elements.
In the normal use of the term "risk factor", they
were double, triple, quadruple, and quintuple accounting
things, so if it's the list I believe it is, I think it was
sort of a silly, actually.
MR. SIRRIDGE: I'm more prtre interested in the
article they wrote for cardiology clinics in 1986, where
they identified the major cardiovascular risk factors.
DR. GLANTZ: Well, it's very hard for me to
comment on an article I don't have in front of me.
MR. SIRRIDGE: Let me just read you this and see
if refreshes you at all, since, I take it, you do keep track
of the cardiology literature.
"The most important risk factors for
cardiovascular disease include age, sex, strong positive
family history, cgsmkg, cystolic and diastolic hypertension,
plasma levels of total and high density, lipoprotein, HDL,
cholesterol, diabetes, and obesity. Some would include the
Type A coronary personality. All of these major risk
factors should be considered in assessing an individual's
risk."
DR. GLANTZ: I think that's an accurate clinical
statement.
MR. SIRRIDGE: Doctor, how many of those major
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
T!1011-1639
1
2
3
4
5
6
7
8
.9
I0
iI
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
453
risk factors were taken into account in the Helsing study?
That's the study which OSHA used for its risk assessment as
the bass for the computations.
DR. GLANTZ: I'll need a minute. I haven't
memorized all these papers, so I'll need a minute.
MR. SIRRIDGE: That's fine. I didn't expect you.
to answer right away.
[Pause.]
DR. GLANTZ: Okay. Age, which is by far and
away, the most important of the confounding or other risk
factors.
Housing, which is a measure of socioeconomic
status, and marital status and education, which is also an
important measure of socioeconomic status, and several of
the other variables that you mentioned tend to be correlated
with socieconomic status.
MR. SIRRIDGE: So age and sex were the only ones?
DR. GLANTZ: No. I didn't say that.
MR. SIRRIDGE: Of the list.
DR. GLANTZ: Well, no, that's not true. You have
to realize that these variables are not independent of each
other. Cholesterol, your dietary activities, things like
that, are correlated with socioeconomic status, is an
indirect measure of several of those other points.
MR. SIRRIDGE: Is diabetes related so
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
TI1011-1640
1
2
3
4
5
6
7
8
9
i0
ii
12
13
14
15
16
17
18
19
20
21
22
23
24
25
socioeconomic status?
DR. GLANTZ:
question.
MR. SIRRIDGE:
history?
question.
DR. GLANTZ :
454
I don't know the answer to that
All right. Strong positive family
I don't know the answer to that
MR. SIRRIDGE: Type A personality or Type A
behavior pattern?
DR. GLANTZ: I would speculate that that's
correlated with socioeconomic status, but I can't state that
as a fact.
MR. SIRRIDGE: Doctor, didn't the authors admit
themselves, that it was a weakness of their study that they
had included traditional risk factors for heart disease?
DR. GLANTZ: No. They said that it was a
weakness, that they didn't include all the risk factors.
This is the point I was trying to make in my testimony, that
you really can't -- you shouldn't, I don't believe, look at
each study in isolation.
The fact that the Helsing study came up with
results which not as large a study, and it came up with
results which are not all the different than what you get
from an analysis of all the studies, says to me that these
other variables really aren't playing a real important role.
BAYLEY REPORTING, INC.
(202) 234-7787 (800) 368-8993
TI1011-1641
1
2
3
4
5
6
7
8
9
I0
ii
12
13
14
15
16
17
18
19
20
21
22
23
24
25
455
.MR. SIRRIDGE: You're saying, all these others
variables that we talked about, are not playing an important
role?
DR. GLANTZ: I'm saying that these other
variables are not playing an important role in terms of the
effects of passive smoking on heart disease. I'm not saying
that they are not important for heart disease. They are
important for heart disease.
But as I showed in the Metoprolol study with the
rabbits, just because other things are important that
doesn't mean ETS isn't.
MR. SIRRIDGE: And you're using your rabbit study
to comment on the risk factors as they affect humans in
epidemiologic studies?
DR. GLANTZ: No. I'm using it to illustrate the
point that things should be independent risk factors.
MR. SIRRIDGE: In fact, these are independent
risk factors, some of them, aren't they? They're considered
independent risk factors for heart disease.
DR. GLANTZ: They're not all strictly independent
of each other, but clinically, people think that way, that a
lot of them are correlated. They're correlated with
socioeconomic status.
MR. SIRRIDGE:
DR. GLANTZ:
We had a discussion --
The point, just to be clear in the
BAYLEYREPORTING, INC.
(202) 234-7787 (800) 368-8993
T11011-1642
1
2
3
4
5
6
7
8
9
i0
ll
12
13
14
15
16
17
18
19
2O
21
22
23
24
25
456
answer, that I was trying to make is the fact that passive
smoking is not the only risk factor for heart disease, which
I don't know anyone who would assert that. No one.
Certainly not me.
It doesn't mean that it is not a risk factor for
heart disease. If you were to consult the American Heart
Association's statement on the subject and circulation, they
add passive smoking as an independent risk factor. They
don't say, passive smoking causes hear disease, so it
doesn't matter what your cholesterol and triglycerides are,
and they're correct.
MR. SIRRIDGE: Doctor, did any of the
epidemiologic studies that you have reviewed over the
years -- and you've reviewed them all?
DR. GLANTZ: Yes.
MR. SIRRIDGE: Did any of those studies deal with
cardiovascular research in Hispanics, Asian Americans or
black males?
DR. GLANTZ: Excuse me.
[Pause. ]
DR. GLANTZ: Again, I need to just take a look.
I don't have all this memorized.
There is data from Asians. The studies done in
Asia -- the studies that I'm aware of did not specifically
look at those subgroups, which is not at all unusual. There
BAYLEYREPORTING, INC.
(202) 234-7787 (800) 368-8993
T!1011-1643
