HOUSE COMMITTEE ON ENERGY AND COMMERCE
HEALTH AND ENVIRONMENT SUBCOMMITTEE
STATEMENT OF HON. THOMAS J. BLILEY, JR.
JULY 21, 1993
Mr. Chairman, I am testifying today in order to report to the
Subcommittee the results of my extensive investigation of the EPA's handling
of the controversy surrounding environmental tobacco smoke or "ETS". As you
know, in the past the Oversight and Investigations Subcommittee of this
Committee has conducted hearings on EPA's abuses of government contracting
requirements. So pervasive is the level of abuse that Chairman Dingell has
characterized EPA's pattern of contract mismanagement as a "cesspool". EPA's
Inspector General recently has confirmed that such abuses also have taken
place in connection with a number of EPA contracts involving ETS, and the O
and I Subcommittee's own investigation is continuing.
In addition to various contractual improprieties, however, my own
investigation suggests that in its consideration of ETS, the Agency has
deliberately abused and manipulated the scientific data in order to reach a
predetermined, politically motivated result. EPA's risk assessment on ETS
released in January of this year claims that ETS exposure is responsible for
approximately 3,000 lung cancer cases per year in the United States.
Analysis of the risk assessment reveals, however, that EPA was able to reach
that conclusion only by ignoring or discounting major studies, and by
deviating from generally accepted scientific standards.
EPA's willingness to distort the science in order to justify its
classification of ETS as a "Group A" or "known human" carcinogen seems to
stem from the Agency's determination early on to advocate smoking bans and
restrictions as a socially desirable goal. EPA began promoting such policies
in the mid-to late 1980s, ostensibly as part of its efforts to provide
information to the public on indoor air quality issues. The Agency then
decided to develop the ETS risk assessment to provide a scientific
justification for smoking bans. The risk assessment thus was never intended
to be a neutral review and analysis of the ETS science. Rather, it was
intended from the start to function as a prop for the Agency's predetermined
policy.
Not surprisingly, therefore, the process at every turn has been
characterized by both scientific and procedural irregularities. In addition
to the contracting violations mentioned at the outset, those irregularities
include conflicts of interest by both Agency staff involved in preparation of
the risk assessment and the members of the Science Advisory Board panel
selected to provide a supposedly independent evaluation of the document. I
will not itemize each and every one of these improprieties. Instead, I ask
consent that a memorandum providing full details of the history of EPA's
handling of ETS be included in the record. The memorandum summarizes the
results thus far of my investigation into the Agency's handling of ETS and is
based on publicly available documents, extensive correspondence between
myself and former Administrator Reilly, and interviews conducted by my staff
with the responsible EPA officials.
The ETS risk assessment is far from an isolated example of EPA's
approach to the use of science in policy making. The Agency's propensity to
scare the public first and ask scientific questions later is both notorious
and well-documented. Alar, dioxin and the removal of asbestos from schools
are other examples. In fact, concern that EPA's pursuit of media headlines
rather than good science was undermining the Agency's credibility caused
former Administrator Reilly to convene an expert panel in early 1991 to
assess EPA's use of science. The expert panel issued a report in March 1992
entitled "Safeguarding the Future: Credible Science, Credible Decisions."
The report states that "[c]urrently, EPA science is of uneven quality and the
Agency's policies and regulations are frequently perceived as lacking a
strong scientific foundation." The expert panel also cautioned EPA, in terms
that are directly relevant to the Agency's work on ETS, that "science should
never by adjusted to fit policy, either consciously or unconsciously."
Unfortunately, in the case of ETS there appears to have been a conscious
misuse of science and the scientific process to achieve a political agenda
that could not otherwise be justified.
EPA betrays its own lack of confidence in its tortured statistics by
refusing to incorporate the results of the ETS-lung cancer study by Brownson
and coworkers. The Brownson study, one of the largest and best designed
studies ever conducted, was funded in part by the National Cancer Institute.
The study looked at exposure to ETS in a variety of settings, at home, at work
and in social environments. The study reported no significant association
between ETS and lung cancer among nonsmokers in spousal or work settings or
from childhood. Even using the highly questionable statistical methods adopted
by EPA in the ETS risk assessment, inclusion of the Brownson study would show
no significant risk of lung cancer from exposure to ETS.
Evidently, publication of the Brownson study caused no small degree of
consternation at EPA. In order to avoid incorporation of the Brownson
study's results into the risk assessment and invalidating EPA's claim that
the epidemiology shows a significant risk, EPA rushed to issue the final
report in early January. Mr. Chairman, given this sort of behavior, in my
judgment we must be very cautious about allowing scientific pronouncements
from EPA to drive public policy decisions.
______________________________________________________________________________
EPA AND ENVIRONMENTAL TOBACCO
SMOKE: SCIENCE OR POLITICS?
I. INTRODUCTION
With almost unprecedented fanfare, the Environmental
Protection Agency ("EPA") released at a news conference on January 7, 1993,
a risk assessment on tobacco smoke in the air -- often referred to as
environmental tobacco smoke ("ETS"). According to the EPA risk assessment,
ETS is a "Group A" or "known human" carcinogen that is responsible each year
for approximately 3,000 cases of lung cancer among nonsmokers residing in the
United States. The risk assessment also claims that ETS is a cause of
respiratory problems in infants living in homes in which one or both parents
or some other family member smokes.
Not surprisingly, the claims contained in EPA's risk
assessment on ETS generated substantial publicity, with most major
newspapers, television news program and radio stations devoting substantial
attention to EPA's conclusions. The publicity was, in part, a natural and
expected response to the rather dramatic claims made in the EPA report. But
EPA officials and staff, joined by Secretary Sullivan of the Department of
Health snd Human Services ("HHS"), also left no stone unturned to ensure
heavy media coverage of the report. The EPA/HHS campaign was seeded by
periodic "leaks" of drafts of the report, and those leaks were followed with
a heavily promoted press conference and individual interviews.
The EPA/HHS representatives made clear at their January press
conference that they hoped that the EPA report would lead to additional
smoking restrictions by private entities as well as by government at all
levels. If the conclusions of the report are valid, that hope is certainly
understandable. At the same time, however, if the claims made in the report
are invalid, as appears to be the case, the likely consequence will be
additional unjustified harassment of and discrimination against smokers -- a
consequence that received little attention at the January press conference.
The assumption that often is made is that smoking
restrictions and other comparable measures are essentially costless.
Increasingly, that assumption has been shown to be incorrect. Whether
measured in terms of the number of people who are fired or are not hired
because they smoke, by unjustified feelings of guilt among smokers or by the
erosion of courtesy and tolerance, the campaign against smoking is not the
no-lose proposition it often is portrayed as being.
In Washington, D.C., for example, which has adopted workplace
smoking restrictions, the consequences of the ETS controversy are
unmistakable. At all hours of the working day, people can be seen, even in
the middle of winter, huddled near the doorways of office buildings smoking
cigarettes. In fact, some employers -- in Washington, D.C., and elsewhere --
have gone so far as to require current and prospective employees to submit to
a urine test, looking for the telltale sign of nicotine.
Over the past several years there has been increasing
concern about the politicization of science and other problems at EPA. A
two-year investigation by the Subcommittee on Oversight and Investigations of
the House Energy and Commerce Committee has uncovered disturbing evidence
encompassing everything from cronyism in the award of government contracts to
systematic bias in the collection, review and presentation of scientific
data. Instead of evaluating scientific issues objectively and providing
balanced information to the public, EPA has been found on a number of
occasions to have manipulated or suppressed data in a manner that has
resulted in unnecessary alarm and confusion.
Mounting concern about EPA's misuse of science prompted
former EPA Administrator William Reilly to convene an expert panel in 1991 to
review EPA's handling of scientific issues and to recommend improvements.
The expert panel, which was comprised of eminent scientists from leading
institutions across the country, issued a report in March 1992 entitled
"Safeguarding the Future: Credible Science, Credible Decisions." The report
confirmed that, "[c]urrently, EPA science is of uneven quality, and the
Agency's policies and regulations are frequently perceived as lacking a
strong scientific foundation" (p. 4).
The expert panel also cautioned EPA that "science should
never be adjusted to fit policy, either consciously or unconsciously"
(p. 38). Unfortunately, that is precisely what appears to have happened in
the case of the risk assessment on ETS -- the abuse of science and the
scientific process to further a political agenda. However one views
cigarettes and smoking, EPA's misuse of science and disregard for proper
legal and scientific procedures should be cause for alarm. In fact, EPA's
handling of ETS sets a disturbing precedent for the Agency's consideration of
future controversial scientific questions, raising questions about EPA's
ability to separate science from politics in carrying out its mission.
As the editor of "EPA Watch" recently observed in response to
EPA's release of the ETS report:
It's now open season on whatever contam-
inant the EPA chooses to label the killer
contaminant of the week, with the effect
that once again, Americans are going to be
stampeded into fearing a substance for
reasons which upon close inspection are
scientifically indefensible.(1)
The discussion that follows describes EPA's activities with
respect to ETS -- the procedures the Agency has utilized and the problems
that have infected the process from the beginning.
II. THE HISTORY OF EPA'S INVOLVEMENT IN THE ETS CONTROVERSY
A. Putting EPA's Role Into Context
In order to understand EPA's role in the ETS controversy, one must
understand how the "passive smoking" issue emerged in the first place.
According to Richard Daynard, a well-known antismoking activist, the
organized movement to eradicate smoking has proceeded in three distinct
phases.(2) During the first phase, activists attempted to persuade smokers
to stop smoking on the ground that smoking was bad for the smoker. Although
many smokers did stop smoking for that reason, others continued. During the
second phase, activists attempted to make smokers feel guilty about their
enjoyment of smoking. Again, however, many individuals continued to smoke.
The third and current phase, according to Daynard, marked a more fundamental
strategic shift. In this phase, the movement began to focus on the
"development" of "evidence" about ETS. If people can be persuaded to believe
that tobacco smoke is harmful to nonsmokers, it becomes easier to persuade
both private entities and government authorities to restrict or ban smoking.
According to Stanton Glantz, founder of Californians for Nonsmokers' Rights
(later christened Americans for Nonsmokers' Rights), the target of such laws
is the smoker rather than the nonsmoker. "Although the nonsmokers' rights
movement concentrates on protecting the nonsmoker rather than on urging the
smoker to quit for his or her own benefit, [antismoking legislation] reduces
smoking because it undercuts the social support network for smoking by
implicitly defining smoking as an antisocial act."(3)
Neutral and dispassionate scientific inquiry often yields
inconvenient results from the perspective of the social activist. So it has
been for EPA with Alar, PCBs and dioxin, to cite only a few examples. ETS
must now be added to the list.
The scientific data simply do not support EPA's
classification of ETS as a "Group A" carcinogen. Of the more than 30
epidemiologic studies of marriage to a smoker and lung cancer among
nonsmokers, the overwhelming majority report no statistically significant
association. The studies focusing on ETS exposure in the workplace also
generally have not reported a statistically significant increased risk. The
most recent and largest U.S. case control study, by Brownson and coworkers,
confirms the general no-association pattern.(4) Although the Brownson study
was published in November 1992, two months before EPA completed its report on
ETS, the EPA report failed even to cite the Brownson study. The reason,
undoubtedly, is that EPA's conclusions on lung cancer could not survive
inclusion of the Brownson data.
Even without the Brownson data, the classification of ETS as
a Group A carcinogen required substantial stretching by EPA. To reach that
conclusion, the EPA report combined eleven spousal smoking studies from the
United States in a so-called "meta-analysis." Of the eleven studies,
however, ten reported no statistically significant increase in cancer among
nonsmokers purportedly exposed to ETS. To ensure that the meta-analysis
would produce the desired results, therefore, EPA had no choice but to
manipulate the numbers.
Although in the past EPA and the scientific community have
used a 95% confidence interval as a means of ensuring that study results did
not occur by chance, EPA adjusted the confidence interval downward -- to
90% -- in its report on ETS. As James Enstrom, an epidemiology professor at
the University of California, Los Angeles, explained, "[t]hat doubles the
chance of being wrong."(5) To put it in lay terms, EPA's statistical
maneuvering is the equivalent of moving the goal lines at a football game in
order to score more touchdowns. The implications of EPA's willingness to
lower scientific standards in selected cases are profoundly troubling. As
Michael Gough of Congress's Office of Technology Assessment has pointed out,
"[y]ou cannot run science with the government changing the rules all the
time."(6)
The only claim made in the EPA report for which there is at
least statistical support is that ETS can affect the respiratory health of
very young children. Most of the studies on that issue are so flawed,
however, that it is premature to conclude that the association is causal in
nature. In the final analysis, it must be remembered that epidemiologic
studies can show only a statistical association. They cannot prove
causality. After all, there is a strong association between increased life
expectancy and increased consumption ofjunk food in affluent countries but no
one contends that one is the cause of the other. In fact, many argue the
converse.(7)
In light of the weaknesses in the pertinent data, the
procedures that have been utilized in "developing the case against ETS" take
on a special significance. As one of the world's leading epidemiologists,
Dr. Alvan Feinstein of Yale University Medical School, put it in a recent
article:
In the investigations of [ETS], * * * the
various studies are contradictory, some
going in positive directions and others
not. The inconvenient failure of the
evidence to comply with a prime requisite
of scientific reasoning for causality,
however, has not inhibited the causal
accusations. The "prosecution" has simply
ignored the inconvenient results and
emphasized those that are (in a memorable
term) "helpful."(8)
A report produced by the Advocacy Institute, a major
antismoking organization, entitled "Media Strategies for Smoking Control:
Guidelines" (NIH 1989), provides a striking illustration of this strategy.
Behind every story detailing the "risks" of ETS, the report stated, could be
found "[a] scientist wise in the way of 'creative epidemiology,' i.e., the
presentation of data -- both scientifically sound and artful -- so as to
catch the glint of media attention * * *" (NIH Report at 7). The report
describes "creative epidemiology" as follows:
Michael Daube, who coined the term,
defines creative epidemiology as "the
ability of the good epidemiologist to
rework data so that what is essentially
the same information can be presented in a
new and interesting form." Thus creative
epidemiology marries the science of the
researcher with the art and creativity of
the media advocate (id. at 21-22).
Similarly, Jonathan Samet of the University of New Mexico
recently acknowledged that there is much that we do not know and indeed may
never know about whether ETS poses a health risk. Notwithstanding those
evidentiary deficiencies, however, Dr. Samet made clear that "[i]n the case
of environmental tobacco smoke, it would be unfortunate if potentially
irresolvable scientific uncertainties thwarted control."(9)
As a result of this strategy, there is enormous pressure on
researchers and scientific bodies investigating ETS to come up with the
"right" conclusion. The Brownson study, for example, apparently caused
considerable dismay because it produced the "wrong" results. Defending his
decision to publish the study, Dr. Brownson lamented, "I wish our findings
had gone in the exact pattern the public health community would like * * *.
But one of the criticisms of medical research is that the only thing findings
ever show is some kind of health risk. I feel it's important to publish
findings, no matter what they show."(10) Dr. Brownson's eagerness to please
the public health community is widely shared. His willingness to release
data not in accord with the political objectives of that community
unfortunately is not.
Again, Dr. Feinstein of Yale has offered a revealing insight.
According to Dr. Feinstein:
[I]n the current fervor of anti-smoking
evangelism, what young scientists would
want to risk their career and what older
scientists would want to risk their
reputation by doing anything that might be
construed as support for the "bad guys" of
the tobacco industry? What governmental
agency would fund research in which the
established "accepted" anti-smoking
doctrines were threatened by a study
proposed by someone -- an obviously
deranged skeptic -- who wanted to do an
unbiased, objective investigation?
(p. 304).
In the same article, Dr. Feinstein revealed that he "recently [had] heard an
authoritative leader in the world of public health epidemiology make the
following statement: "Yes, it's rotten science, but it's in a worthy cause.
It will help us get rid of cigarettes and become a smoke-free society"
(p. 303).
Because the debate over ETS has been caught up in the larger,
highly emotional controversy about active smoking, the role of EPA in
collecting, evaluating and disseminating scientific information about ETS
becomes even more important. The Superfund Amendments and Reauthorization Act
of 1986 ("SARA") gave EPA the role of "providing information and guidance" to
the public on indoor air and radon. 42 U.S.C. Sec. 7401 note. SARA required
EPA's research agenda to be reviewed by the Agency's independent Science
Advisory Board ("SAB"). The SAB consists of scientists from outside EPA
whose role is to assess the factual and theoretical bases for EPA's research
and reports. The SAB is supposed to operate as a check on the Agency's use
of science in the formulation of regulatory policy -- to ensure that
objective scientific inquiry is not subverted to serve political rather than
scientific ends. Unfortunately, the SAB has not operated as intended in the
case of ETS. As a result, there has been little or no brake on the
antismoking proclivities of individual EPA staff members.
B. Early EPA Staff Initiatives Concerning ETS
EPA's policy of promoting restrictions on smoking seems to
have begun with James L. Repace, an "environmental protection specialist" in
EPA's Indoor Air Division. In 1980, even before the first major ETS health
claims appeared in the scientific literature, Repace wrote with A.H. Lowrey
an article reporting on particulate matter in the air of various environments
such as bars, restaurants and bingo parlors, without distinguishing whether
those particulates were from ETS or some other substance or activity.(11)
The only "office" measurements made by Repace were in an experimental,
enclosed room in which thirty-two cigarettes were smoked in less than one
hour, generating ETS levels grossly in excess of those encountered in the
real world. Subsequent research has discredited both the methodology and
concluslons of the 1980 Repace study.(12) On the basis of these
observations, however, the article claimed that "indoor air pollution from
tobacco smoke presents a serious risk to the health of nonsmokers * * *
[that] deserves as much attention as outdoor air pollution."(13)
A few years later, Repace published (again with A.H. Lowrey)
an article purporting to show that ETS was riskier than "all regulated
industrial emissions combined."(14) This second article by Repace and
Lowrey, which represented a crude attempt at quantitative risk assessment,
has been roundly criticized by both government and private sector
scientists.(15)
Repace's extensive work with political advocacy organizations
such as the Group Against Smoke Pollution ("GASP") and Action on Smoking and
Health ("ASH") and his private and professional focus on smoking raise
questions about Mr. Repace's ability to evaluate indoor air issues in a
balanced manner. Since the 1970s, Mr. Repace also has been appearing as a
paid witness in numerous lawsuits and testifying before various legislative
bodies to support governmental restrictions on smoking. Consider in this
regard Mr. Repace's statements to the press in reaction to the defeat of an
antismoking legislative proposal in Maryland:
People aren't going to stand for this.
Now that the facts are clear, you're going
to start seeing nonsmokers becoming a lot
more violent. You're going to see fights
breaking out all over. Washington Star,
April 5, 1980, p. D-l.
Based on my own experiences with Mr. Repace, I do not find
these accounts surprising. In 1991, at the invitation of EPA Administrator
Reilly, my staff interviewed several EPA employees as part of my and the
Oversight Committee's efforts to gather the facts about EPA's procedures in
preparing ETS-related documents. When he presented himself in my office,
however, Mr. Repace categorically refused to answer any questions. He was
accompanied by John Banzhaf, ASH's Executive Director, and Mr. Nantkes of the
EPA General Counsel's office. Both were said to be serving as Mr. Repace's
attorneys. Within minutes after Mr. Repace left my office, my staff received
inquiries from the media characterizing my efforts as "intimidation."
During the late 1980s, Mr. Repace became the driving force
behind EPA's push to classify ETS as a "Group A" carcinogen. He began by
outlining plans for two reports designed to promote the elimination of ETS.
Although his plans personally to draft a "handbook" on the subject were not
realized, Repace assumed primary responsibility for two longterm projects --
an "ETS literature compendium" and an "ETS workplace smoking policy guide,"
as well as a smaller project, an "ETS fact sheet." These projects were meant
to further the agenda first announced in Repace's 1980 article.
Even as Mr. Repace expanded his activities within the Indoor
Air Division, he was traveling around the world, at the invitation and
expense of smoking organizations, to appear at various conferences and media
events to promote antismoking restrictions. For example, Mr. Repace traveled
to New Zealand in l990 to support antismoking legislation in that country.
Press coverage of his activities there was typical of Mr. Repace's media
appearances, including the identification of Mr. Repace as an EPA employee
unaccompanied by the required disclaimer that his views did not then reflect
an official EPA position.
In numerous media interviews, Mr. Repace has made the
baseless assertion that 50,000 people in the U.S. die each year from exposure
to ETS and has left the clear impression that these views reflect EPA's
official position rather than his personal views. Such demonstrated bias
would create a serious conflict of interest issue at any regulatory agency,
apparently with the exception of EPA, most likely leading to the official's
recusal from further involvement in the issue in question. In fact, Mr.
Repace continued to play a key role in the preparation of documents for the
public that were represented as neutral and dispassionate analyses of the
facts pertaining to ETS despite the advocacy role he was playing in his
"private capacity."
C. How EPA Used Its Role In Indoor Air Research
To Further An Antismoking Agenda
1. The ETS "Fact Sheet"
In 1989, Repace prompted the Agency's publication of a "Fact
Sheet" on ETS. Despite its name, "Indoor Air Facts Number 5" made
extravagant health claims about ETS, going far beyond the conclusions of the
1986 reports of the National Academy of Science ("NAS") and Surgeon General
on the same subject. For example, it claimed that exposure to ETS was linked
to heart disease, when both the NAS and Surgeon General had found that the
available studies did not support that claim.
The "Fact Sheet" also took certain statements in the 1986
Surgeon General's report out of context in order to claim a consensus that
"passive smoking significantly increases the risk of lung cancer in adults"
(p. 1). Whereas the Surgeon General and NAS reports had emphasized critical
limitations on their findings of a possible connection between exposure to
ETS and lung cancer, the "Fact Sheet" ignored those limitations and treated
the purported relationship as irrefutable.
The "Fact Sheet" also failed to note that even the limited
conclusions of the Surgeon General and NAS reports had been strongly
criticized and that other reviewers -- including the World Health
Organization's International Agency for Research on Cancer -- had reached
different conclusions based upon the same data. See, e.g., "IARC Monograph
on the Evaluation of the Carcinogenic Risk of Chemicals to Humans: Tobacco
Smoking," vol. 38, p. 308 (1986). Furthermore, a number of other studies and
reviews published since 1986 contradicted the findings of the Surgeon General
and NAS reports with respect to the purported relationship between ETS and
lung cancer.(16) None of these was mentioned in the "Fact Sheet."
Finally, the "Fact Sheet" characterized ETS as "a major
contributor of particulate indoor air pollution" (p. 2) while failing to
mention the numerous studies showing that inadequate ventilation is the
single most important cause of indoor air pollution. Significantly, no SAB
panel or expert committee ever reviewed the "Fact Sheet's" claims. Instead,
the document was distributed freely to the public as if it contained the
official, carefully considered policy of the U.S. government rather than
simply the personal opinions of Mr. Repace.
2. What EPA Doesn't Know
Paradoxically, EPA elsewhere was quite candid in
acknowledging the gaps in its knowledge about ETS. EPA's 1987 report to
Congress, for example, recognized that indoor air quality is not only a
matter of specific pollution sources but also of the ways in which buildings
are designed, operated and used. EPA's indoor air quality program
purportedly was designed to "address the problem from both perspectives"
(P. 8).
In its 1989 report to Congress, EPA indicated that it had
"moved to establish a research program to remove the scientific
uncertainties" identified in the 1986 NAS report on ETS (vol. I, p. 42). In
the same report EPA acknowledged that "[a]ctual human exposure to many of
these [indoor air] pollutants is at this time not well understood" (vol. III,
p. 11). The 1989 report also emphasized the need for ventilation research,
noting that the "entire building system is implicated in issues of indoor air
quality" (vol. III, p. 39) and that much more research is needed concerning
the numerous variables that determine indoor air quality (id. at 36-39).
At this point, I, among others, expressed concern that there
appeared to be a contradiction between EPA's conclusions on ETS in the "Fact
Sheet" and the Agency's recognition elsewhere that there were large gaps in
its knowledge about ETS. In response, EPA's Assistant Administrator for Air
and Radiation, William Rosenberg, denied that there was any scientific doubt.
In a June 1989 letter to Senator Warner of Virginia, Mr. Rosenberg stated
that "[t]he evidence, in our view, is conclusive for lung cancer and for
respiratory symptoms in children" and that "ETS has been shown to cause
cancer and other health effects in healthy nonsmokers."
The "Fact Sheet" and Mr. Rosenberg's letter make clear that
the Agency had reached firm conclusions concerning ETS without the benefit of
either SAB review or public comment. Aside from the question of whether this
position was scientifically justified, it is unclear why the Agency then
decided to spend millions of dollars to conduct a formal "risk assessment" on
ETS for the ostensible purpose of determining whether ETS does indeed pose a
risk to health.
3. The ETS Technical Compendium
In November 1989, EPA released a draft ETS "technical
compendium," the second of the Agency's documents concerning ETS. Conceived
originally as a reference document, the compendium consisted of ten (later
eleven) chapters on a variety of subjects not always directly related to ETS.
With the exception of a draft chapter on "Exposure Assessment of Passive
Smoking" by Mr. Repace, the compendium articles were solicited from
scientists and consultants outside the Agency.
Although ostensibly a collection of scientific information
about ETS, the first chapter, written by Thomas E. Novotny, claimed, based on
public opinion polls, that the public increasingly believes that ETS is
harmful to health and therefore supports smoking restrictions. But public
opinion and acceptance of smoking restrictions are obviously irrelevant to
the scientific and technical issues of whether the restrictions are justified
in the first place. In addition, public opinion on scientific issues often
is shaped by dramatic reporting, not by familiarity with the science itself.
EPA scientists should have recognized that using public opinion to support a
scientific hypothesis -- and ultimately, new regulations -- was
irresponsible. That is particularly so when individual agency employees had
played such a pivotal role in forming the very public opinion upon which they
now were proposing to rely.
In addition to the chapter on trends in public attitudes, the
compendium contained other articles on active smoking and on economic issues
surrounding workplace smoking. The only unifying theme of the compendium is
that, in the Agency's view, smoking and ETS are "bad." Like most of the
Agency's outside contractors on ETS, many chapter authors for the compendium,
including Stanton Glantz, Jonathan Samet, and, of course, James Repace -- had
long been active in the antismoking movement.
Although styled (and later defended by the Agency) as a
scientific reference document, the compendium was in fact designed as an
advocacy document for smoking restrictions. The preface to the compendium
indicated that it was intended to be distributed to scientists, public
officials, legislators and those in the private sector who are or may be
concerned about ETS. The overall purpose was to "provide information
necessary to allow the public, government agencies, and the building industry
to make well-informed choices regarding exposure to ETS" (p. 2). The letter
accompanying the draft compendium indicated that the compendium was an
"integral component of [EPA's] ETS strategy," which was to include a separate
"policy-maker's guide" that in turn would be a simplified version of the
compendium.
It is hard to see how policymakers could make "well informed"
choices on the basis of the information contained in the compendium or the
simplified version known as the "policy guide." Both the compendium and the
policy guide were initiated and drafted long before the Agency had prepared a
formal risk assessment on ETS. By these actions, EPA violated the public
trust in three ways. First, EPA conducted an end run around the statute
creating the SAB review mechanism. In doing so, it not only threatened the
integrity of the SAB review process but ran the risk of alarming the public
for no good reason. In addition, EPA deliberately permitted policy to drive
science rather than the other way around. As the "Fact Sheet" demonstrated,
EPA started with the restrictive policy it wanted to promote and then worked
backward to "develop" the scientific conclusions necessary to justify that
policy. Finally, even though it has no statutory authority to regulate
smoking, EPA's Indoor Air Division sought to become the de facto federal ETS
regulatory authority by using the "Fact Sheet," the compendium, the policy
guide and the ETS risk assessment to frighten employers and state and local
regulators into imposing additional restrictions on smoking.
4. Bias In Preparing The Compendium
Although still in draft form and not reviewed by the SAB, the
compendium received widespread media attention. Robert Axelrad, Director of
the Indoor Air Division, had asserted unequivocally in a May 8, 1990, letter
to The Tobacco Institute's counsel that EPA was "not interested in promoting
any media attention to the documents while they are in draft form and will do
everything possible to assure that they are not construed as EPA policy."
Notwithstanding Mr. Axelrad's assurances, the compendium was leaked to the
press and its more sensational claims openly publicized prior to any
scientific review of the document's contents. According to a February 1993
report by the General Accounting Office ("GAO"), EPA staff in April 1991,
before EPA had completed its own internal review of the document, improperly
sent a draft of the compendium to several external reviewers, including
Stanton Glantz. Glantz, an outspoken antismoking activist since the 1960s,
immediately proceeded to provide a copy to an Associated Press reporter.
According to the GAO, Glantz claims that his release of the report was simply
a "mistake."
Most disturbing was the public dissemination of the chapter
on cardiovascular disease. Glantz, one of the authors of that chapter,
appeared in Boston -- again with James Repace -- at the World Conference on
Lung Health in late May 1990 and gave both a presentation and news interviews
on that chapter. Dr. Glantz used the occasion to repeat and underscore the
unsupported claim that more than 30,000 nonsmoking Americans die of heart
disease each year as a result of exposure to ETS.
This activity made a mockery of EPA's procedures for ensuring
that its policy documents receive a full and fair review before they are
finalized. Glantz has a long record of public statements demonstrating his
commitment to that political agenda, notwithstanding the lack of scientific
support for his claims concerning ETS. While his training is in mechanical
engineering rather than medicine or some other relevant discipline, he has
pontificated on every conceivable smoking-related topic, such as advertising
and economic issues, about which he plainly can make no claim to professional
competence.
To cite one example, Dr. Glantz's organization stated in its
1983 annual report that "irrefutable medical and scientific evidence has
confirmed what millions of nonsmokers have intuitively known for a long time:
Tobacco smoke * * * poses a serious health risk for nonsmokers who breathe
secondhand smoke." Thus, Dr. Glantz's mind was closed on the
ETS/cardiovascular disease issue three years before the 1986 reports of the
Surgeon General and National Academy of Sciences both determined that there
was insufficient evidence to support the claim that exposure to ETS presents
any increased risk of heart disease.
At an April 1990 antismoking conference in Perth, Australia,
Glantz made a series of revealing comments. First, he noted that "it's very
nice to see that the same ideas that a few of us were advocating in 1983
which were viewed as so strange, radical and hopeless have now really become
very mainstream." A self-described "lunatic" on the issue, Dr. Glantz then
excoriated the American Cancer Society for its alleged decision to terminate
an employee for intemperate behavior in connection with a local smoking
ordinance. "He [the employee] may be a little impolitic which I of course
view as a plus. But you know activists need [to be] rewarded[.] * * * I had
no objection to all the people who were given awards on the first day [of the
conference], but I did notice that there was not a single lunatic among
them * * *." He further confessed that "[t]he main thing the science has
done on the issue of ETS, in addition to help people like me pay mortgages,
is it has legitimized the concerns that people have that they don't like
cigarette smoke. And that is a strong emotional force that needs to be
harnessed and used." Glantz concluded by stating that "we are all on a roll
and the bastards are on the run and I urge you to keep chasing them."
I expressed my concern to Mr. Reilly that the selection of
Dr. Glantz to write part of the ETS compendium was a grave error in judgment.
Glantz's involvement, coupled with leaks of information and inadequacies in
the review process, led me to conclude that the Agency's procedures had been
seriously compromised.
In response, Mr. Reilly assured me that the SAB would be
given an opportunity to review the technical compendium and that EPA had not
yet decided whether Glantz's chapter would be included in it. Ultimately,
however, the technical compendium was not reviewed by the SAB and Mr. Reilly
subsequently took the position, contrary to the Agency's prior statements,
that the compendium was not a basis for the policy guide or risk assessment.
5. EPA Reneges On Its Pledge To Permit The
SAB To Review The Technical Compendium
Despite Mr. Reilly's repeated oral and written assurances,
the SAB was never given an opportunity to review the compendium. In early
1991, EPA switched course and began to act as if the compendium had never
been written. In a letter to me, Mr, Reilly claimed that SAB review of the
compendium was unnecessary since the compendium had "no direct bearing on
future agency action." When he was questioned by the House Commerce
Committee's Subcommittee on Health and the Environment in April 1991, EPA's
Deputy Administrator Henry Habicht could only say the compendium was "on a
separate track."
That the technical compendium got onto "a different track" is
curious, considering especially that when the SAB finally did review the
policy guide in December 1990, it requested a "supporting document that
explicitly states the technical basis for each of [the policy guide's]
summary statements on the state of scientific knowledge." As noted above,
EPA originally intended the policy guide to be a simplified version of the
compendium. When I asked Mr. Reilly "[w]hat led the agency to redefine the
role of the technical compendium," the answer was that the media had
interpreted its release to the public as EPA endorsement of the draft
document's content. As EPA staff had rather disingenuously told the media at
the time the compendium was leaked, that interpretation was inappropriate.
The Associated Press reported on May 29, 1991 that --
[m]uch of the controversy over the report
has focused on the estimate of 37,000
heart disease deaths attributed to
secondhand smoke. That section was
written by Stanton Glantz and Dr. William
Parmley of the University of California,
San Francisco.
"Thirty-seven thousand may be a figment of
Stan Glantz's imagination and William
Parmley's imagination, or it may be a real
estimate," said Axelrad [Director of EPA's
Indoor Air Division].
"Any effort or any attempt to imply any
kind of endorsement or acceptance by EPA"
of the death estimates in the technical
compendium "is at this time totally
inappropriate," he said.
D. The ETS "Policy Guide"
In June 1990, EPA released formally the first draft of its
policy guide, entitled "Environmental Tobacco Smoke: A Guide to Workplace
Smoking Policies." The guide's stated purpose was to provide government and
private sector decision makers with information on the technical basis for
controlling exposure to environmental tobacco smoke and to describe a variety
of technical and policy options for instituting effective smoking
restrictions.
It has never been clear why EPA prepared and released a risk
management document like the policy guide and before that, the "Fact Sheet"
and compendium, in advance of any final scientific assessment of the supposed
"risk" to be managed. Ordinarily, an agency concerned with public health
responds to allegations that a particular substance presents a risk to health
by conducting a formal analysis of the scientific data called a "risk
assessment." This assumes, of course, that the agency has statutory
authority to regulate that substance. If the risk assessment justifies the
conclusion that a significant risk exists, the next step is to develop
policies or regulations to mitigate that risk. As the National Academy of
Sciences/National Research Council has recognized, risk assessment is
concerned with defining the health effects of exposure to hazards, while risk
management is the process of selecting the most appropriate policy
alternative by integrating risk assessment results with engineering data and
social, economic and political concerns.(17)
Obviously, if the risk from ETS at levels typically
encountered in the workplace was found to be minimal, there would be no
justification for recommending, as did the "Fact Sheet" and policy guide,
that smoking be prohibited except in separately ventilated areas. Even
Administrator Reilly recently conceded in a letter to me that "beginning the
development of an Agency risk assessment after the commencement of work on
the draft policy guide gave the appearance of the very situation -- i.e.,
policy leading science -- that I am committed to avoid."
Equally troubling is the fact that the guide even went so far
as to encourage ETS-based lawsuits by employees against their employers. In
doing so, the policy guide grossly overstated the legal significance and
precedential value of the handful of cases favorable to the policy guide's
viewpoint while understating the significance of the vast majority of others,
which were not.
The perception that the EPA policy guide on workplace smoking
crosses the line from information into advocacy is not mine alone. ICF
Incorporated, which functioned as the nominal prime contractor for
preparation of the policy guide, recently provided me with a marked-up copy
of the guide purporting to reflect ICF's own handwritten editorial comments.
I discovered that my concerns about the tone and emphasis of the legal
discussion in the policy guide were shared by ICF's own internal reviewers.
Marginal comments on this section included such observations as "it seems
really weird to have a much lengthier discussion on litigation than on the
effectiveness of various mitigation alternatives" and "this discussion is too
rah-rah -- this chapter should be more objective in tone." For reasons that
have never been explained fully, however, ICF apparently was not asked to
comment on the draft prior to its public release in June 1990, even though
ICF supposedly supervised the preparation of this document by its
subcontractor, the Smoking Policy Institute. As will be discussed later,
many questions remain about the Smoking Policy Institute's role in preparing
the policy guide.
The SAB's eventual review of the scientific conclusions in
the policy guide was incomplete at best. Prior to the guide's release, EPA
had decided to limit the SAB's review to those parts that referred to the
risk assessment, to ensure that the latter was "properly characterized."
Since the SAB had not yet seen a risk assessment draft it could approve, one
must question how it could make sure that the policy guide properly
characterized it. Moreover, the policy guide covered a much broader range of
issues than the risk assessment. The policy guide had been drafted based on
the technical compendium, which, as I have explained, EPA has never given to
the SAB to review, and which makes many more health claims than does the ETS
risk assessment. These include unsupported assertions that ETS has been
shown to cause cardiovascular disease and suggestions that ETS has been
associated with brain cancer.
Such extravagant claims are at odds with EPA's private
admissions to other government officials that "[w]e know very little about
ETS exposure in the workplace, and cannot estimate the relative significance
of workplace vs. home vs. all other sources of exposure; nor can we clarify
the significance/role/impact of exposure to other pollutants (e.g., radon and
other air carcinogens) in addition/conjunction with ETS exposure."(18) If
EPA knows "very little" about ETS exposure in the workplace, it is difficult
to understand why it would decide to issue a workplace policy guide. EPA
cannot assert, as it did repeatedly in the policy guide, that only smoking
bans or separately ventilated smoking lounges are appropriate without
occupational exposure data. In the absence of such data, the policy guide's
recommendations necessarily reflect only the personal preferences of the
guide's authors. I expressed these concerns many times in writing to EPA
Administrator Reilly and received noncommittal replies.
E. Irregularities In Contract Award Procedures
The selection of the policy guide's author, Robert Rosner of
the Smoking Policy Institute ("SPI"), raises further questions about the
document's objectivity and reliability. SPI is in the business of
counselling employers on the implementation of smoking policies and operating
smoking cessation clinics. This organization therefore had a vested
financial interest in conveying the impression in the policy guide that
employers without smoking policies or cessation programs were at risk of
lawsuits or worse.
In addition, Mr. Rosner had no technical background in any of
the areas on which the policy guide purported to reach definitive
conclusions.(19) These include the possible health effects of exposure to
ETS (and other indoor air components), the legal ramifications of workplace
smoking policies, public attitudes toward smoking, and the claimed economic
consequences of permitting smoking in the workplace.
Apart from this obvious conflict of interest and lack of
necessary qualifications, the award of the SPI subcontract appears to have
violated federal procurement regulations, an impropriety EPA has recognized
only grudgingly. As ranking minority member of the Subcommittee on Oversight
and Investigations of the House Committee on Energy & Commerce, I uncovered
evidence that SPI was improperly sole sourced on the subcontract, and that
the choice was made by Indoor Air Division officials at EPA rather than by
the prime contractor, ICF Incorporated. This abuse of the contracting
process, as well as the conflict of interest noted above, has been brought to
the attention of the EPA Inspector General.
Under federal regulations, an agency may not specify the use
of a certain subcontractor without competitive bidding. In the case of the
policy guide, EPA staff first solicited the Smoking Policy Institute for the
job and then sought to funnel the work through the main contractor, ICF
Incorporated. In fact, Robert Axelrad telephoned SPI's Rosner in mid-1988,
before getting ICF involved, and told Rosner that EPA had $30,000 to spend on
the project for that fiscal year and also would provide funding the following
year. On July 23, 1988, Mr. Axelrad followed up with a bid solicitation
letter to Mr. Rosner:
The attached stack of material represents
the current status of the technical manual
on environmental tobacco smoke which we
discussed in our telephone conversation on
the 11th.
As you will see from a review of this
material, substantial portions of the
manuscript are still to be written/
assigned/edited. What I am looking for is
someone who can take the lead role at this
stage in ensuring that the document is:
a) conceptually sound; [and] b) a useful
addition to the body of knowledge
available on environmental tobacco smoke
at a reasonable cost. This would entail
managing the entire process from this
point to completion of a camera-ready
manuscript.
If you are interested in taking on the
task, please send me a letter describing:
1. The conceptual changes you would
make, and a revised outline
reflecting your suggested changes;
2. A brief description of tasks which
you perceive to be necessary to get
from here to there; and
3. A reasonably detailed all-inclusiue
budget for accomplishing the above.
As I mentioned to you on the phone, I have
approximately $30K to begin the project
this fiscal year and am prepared to put
limited funds into the effort next year.
An arrangement was made in August 1988 that SPI would be paid
by making SPI a subcontractor to ICF.(20) The "justification" memo that ICF
wrote to support the sole-source subcontract stated that SPI was uniquely
qualified. There was no support for that claim, however, nor any indication
that ICF had made any evaluation of SPI. The drafts of the policy guide
written by SPI were not even copied to ICF but went straight to Mr. Axelrad
at EPA.
The only copy of the policy guide commented upon by ICF was
the draft released publicly in June 1990. This raises questions about Mr.
Reilly's statement to me in March 1992 that "ICF's role was, and is, more
than simply a conduit for payments to the Smoking Policy Institute. In
addition to providing comments on the various drafts prepared, ICF managed
much of the external review process * * *." The documents from ICF's files
recently turned over to me suggest that, far from commenting on "various
drafts," ICF's first opportunity to comment on the policy guide occurred when
the document was released for public comment. In sum, ICF file documents
confirm that its involvement began only after the policy guide was released
publicly -- and after I had begun to raise questions about the propriety of
the SPI contract.
The situation with SPI further underscores the fact that a
risk assessment was crafted to justify a policy that had been adopted long
before. The record clearly shows, first, that EPA staff hand-picked SPI to
prepare documents that would advocate workplace smoking restrictions long
before any assessment of the science had been completed; second, that EPA
arranged for SPI to be signed up as a subcontractor to ICF to circumvent
applicable federal procurement requirements; and finally that, in this way,
taxpayer funds helped produce what is essentially a marketing and promotion
aid for SPI's business.
Unfortunately, the SPI contract appears to be but one example
of a more general pattern of contractual problems at EPA. In light of
widespread revelations about EPA's contracting practices, on July 8, 1992,
Chairman Dingell convened the House Commerce Committee's Subcommittee on
Oversight and Investigations to conduct hearings on "The Collapse of Contract
Management at the U.S. Environmental Protection Agency." The majority of the
hearing was devoted to a number of instances of contractual abuse and
mismanagement at EPA that had been identified by the GAO and the EPA
Inspector General.
Whether the problems with the SPI subcontract would have come
to light absent a congressional investigation is an open question. The
replies that I received to my inquiries to Mr. Reilly as late as March 1992
were less than forthcoming. In a letter to me dated March 24, 1992, for
example, Mr. Reilly unequivocally stated that --
[w]e do not agree that the subcontract
issued to the Smoking Policy Institute
(SPI) was issued in violation of Federal
procurement law. * * * These contracts
were competitively awarded in full
compliance with all Federal contract laws.
The smoking policy guide was well within
the scope of the [ongoing EPA/ICF]
contracts and ICF's selection of the
Smoking Policy Institute was proper based
on their determination that the SPI had
unique or specialized experience in this
area.
Mr. Reilly also stated without qualification that "[t]he Smoking Policy
Institute was not selected by EPA staff but by ICF," even though Mr. Axelrad
had told my staff six months earlier that EPA staff had selected SPI.
Even more curiously, at the Oversight hearing on July 8,
1992, Mr. Reilly repeatedly claimed that he lacked knowledge about how SPI
was selected, the nature of SPI's supposed "specialized experience," the fact
that SPI was in the business of promoting workplace smoking restrictions, or
any other information pertinent to the unqualified statements he had made in
his March 24, 1992, letter to me. It is impossible to square these oral
statements with the prior and quite detailed assurances Mr. Reilly had
provided to me in writing.
Since then, EPA has reversed its earlier public position that
the SPI contract was awarded properly. At the July 8 hearing, the Agency's
own Chief Financial Officer acknowledged that "this might very well be an
improper contracting practice. It may be a pass-through and the designating
of the $30,000 may also be improper." Mr. Reilly's most recent letter to me
dated July 31, 1992, attaches a memorandum from Mr. Axelrad to his supervisor
at EPA, Eileen Claussen. Mr. Axelrad's memorandum acknowledges that his
decision to contact SPI outside normal procurement procedures was
inappropriate and that his recommendation "probably" caused ICF to select SPI
as the subcontractor. Mr. Reilly indicated at the July 8 hearing that he had
requested an investigation by EPA's Inspector General of the apparent
conflict of interest and other improprieties in the award of the SPI
contract. Congressmen Dingell and I made a similar request and asked that
the Inspector General report his findings to the House Subcommittee on
Oversight and Investigations.
In March 1993, the Inspector General sent me a letter setting
forth his findings. In that letter, the Inspector General states as follows:
We believe the award [of the contracts to SPI]
was tainted in how it was processed. First,
there was no attempt by ICF to seek competi-
tion. Second, the actions by an EPA program
official gave the appearance that he, rather
than ICF, selected the subcontractor.
The Inspector General also found that "the EPA believed that "it may have
been 'unauthorized action' under the EPAAR [EPA Acquisition Regulations]."
The Inspector General also indicated that "the procurement should not have
proceeded on a non-competitive basis."
EPA's contracting improprieties in connection with the
preparation of the four ETS documents are not confined to the policy guide.
In June 1993, the Inspector General reported to me that similar abuses had
occurred in connection with several of the ETS risk assessment subcontracts.
The most egregious of these appears to be the subcontract between ICF, once
again the prime contractor, and Kenneth G. Brown, Inc., which drafted most of
the critical sections on lung cancer. The Inspector General states that in
the case of the Brown subcontract, "EPA program personnel and ICF simply
circumvented the contracting officers" altogether, clearly a violation of
proper procedures. Like the SPI subcontract, the Brown subcontract also was
awarded on a non-competitive basis, and the only justification for that
decision that could be found was an undated and unsigned "sole source
justification" file memorandum.
F. The Science Advisory Board's Review Of
The Risk Assessment
The first drafts of the ETS risk assessment and the workplace
policy guide were released for public comment in June 1990. At the same
time, EPA transmitted the drafts to the SAB, requesting formal review. A
hearing before a subpanel of the SAB was held in December 1990. The subpanel
reported the results of its review to the SAB Executive Committee in April
1991. The risk assessment was sent back to EPA with directions that it be
revised extensively. After major rewriting, a second draft was released in
June 1992 and a second SAB hearing was held before essentially the same
subpanel in July of that year. Following the SAB's report to the SAB
Executive Committee in October 1992, the final risk assessment was released
on January 7, 1993.
At both the public hearings and in written comments, the
validity of most of the risk assessment's assertions was criticized by a
number of scientists with expertise in the relevant disciplines.
Unfortunately, most of these criticisms were ignored for reasons having
nothing to do with science and everything to do with politics. Although the
SAB is supposed to function as an independent and unbiased review body, in
the case of the ETS risk assessment it became apparent early on that the SAB
review process itself had become as intensely politicized as the rest of EPA.
1. How The Panel Was Selected
The EPA Science Advisory Board is intended to serve as an
independent review body composed of impartial experts from outside the
Agency. Its function is to ensure Agency accountability and integrity in the
use of science.(21) In addition to the seven standing members of the SAB's
Indoor Air Quality and Total Human Exposure Committee, the decision was made
at EPA to select nine scientists to serve in an ad hoc capacity on the panel
that was to review the draft ETS risk assessment and policy guide. Because
they were to review work that had been developed and put forward by Agency
staff and others with vocal antismoking records, their ability to conduct a
fully objective critique was essential. Therefore, at the outset I expressed
concern to EPA that the selection process be above reproach. I also urged
EPA to apply certain -- I thought self-evident -- criteria to ensure
objectivity.
My suggestions included that (1) the SAB panel be limited to
recognized authorities with relevant specialties; (2) the members should not
have participated in the development of the technical compendium, the policy
guide, or the risk assessment, or have already provided comments on them,
including serving as EPA contractors or grantees; and (3) they should not
have become enmeshed in the political controversy surrounding ETS by having
testified for or against smoking restrictions, or by having been active
members of groups that had taken a position on the broader issues concerning
smoking.
EPA squarely rejected the second and third criteria. In his
reply to me, Mr. Reilly stated it was EPA's belief that there was merit in
having individuals who were previously involved, promising that "the extent
of any prior involvement will be publicly disclosed at the meeting." In
fact, that was not fully done. Regarding activists' filling SAB positions,
Mr. Reilly also promised that "should technical conditions require the
presence of such an individual on the panel, he or she would be balanced by
the presence of an individual who could represent the opposing point of
view."
Unfortunately, the panel ultimately was not balanced in the
way Mr. Reilly had suggested. Not one of the candidates suggested by the
tobacco industry was even contacted for inclusion on the panel. In contrast,
three of six persons suggested by antismoking organizations were chosen,
including Dr. David Burns.
The selection of Dr. Burns was especially puzzling, given
that Mr. Reilly had assured me shortly before Dr. Burns' selection that
"experience has shown that the deliberative process is generally not aided if
extreme views are represented on the panel itself." Long before EPA
appointed him to evaluate the scientific data on ETS, David Burns was
spending by his own reckoning half of his time in the antismoking movement.
He had claimed in 1988, for example, that ETS caused 3,000 deaths per year
(Nonsmoking Ordinance, So Far, Proves To Be No Hazard To Economic Health, Los
Angeles Times, January 8, 1989, sec. 2, p. 1). He also had testified in
several cases in favor of local antismoking measures -- including a 1987
initiative in Del Mar, California that would have banned smoking outdoors, on
city sidewalks and in beach areas (UCSD Expert is Smoking's Archenemy, Los
Angeles Times, August 21, 1989, sec. 2, p. 1). In addition, Dr. Burns had
testified in favor of a tobacco advertising ban that a Canadian trial court
subsequently held to be a violation of the free speech guarantee of the
Canadian Constitution (RJR-MacDonald Inc. v. Le Procureur General du Canada,
No. 500-05009755-883 (Superior Court of Quebec, July 26, 1991)).(22) In that
testimony, Dr. Burns stated that --
- in the two years he worked for the National
Clearinghouse on Smoking and Health, he had
helped devise programs to discourage smoking;
- he had served on the American Cancer Society
committee responsible for setting policy on
tobacco issues;
- he had served as senior scientific advisor for
the 1986 Surgeon General's report on ETS and
regarded that work as part of his antismoking
efforts;
- he is a consultant to plaintiffs' counsel in
tobacco product liability cases.
In his Canadian testimony, Dr. Burns acknowledged that his
activities are part of an effort to "see smoking behavior disappear from
society" (transcript at p. 10470). He acknowledged that "much of the work
that [he did] within the university is to teach on * * * the means by which
tobacco can be controlled within society" (id. at 4964). Dr. Burns
demonstrated his dogmatism when he said that there "is no credible scientist"
who would disagree with his views. Finally, Dr. Burns made clear that his
single-minded focus is on promoting and supporting restrictions on the use of
tobacco in any public place in order to penalize smokers for their decision
to smoke.
- [I]n order to modify smoking behavior, one
needs to look at * * * changing the public
image of tobacco, changing the locations in
which tobacco can be used, to create an
environment in the larger society that actually
discourages rather than encourages the use of
this product (id. at 10462).
- [T]he key * * * is not simply providing
the information * * * it's also to change
the larger environment in which that
individual functions to make it less
conducive to using cigarettes and more
rewarding to not use cigarettes (id. at
10462-463).
- I'm also not particularly inclined to testify
to issues relating to the benefits, if you
will, of tobacco or to any of the open
scientific questions * * * (id. at 4999).
- And to the extent that [the Del Mar smoking
ordinance] changes the image of the cigarette
smoker and changes the psychological and
sociologic rewards of cigarette smoking, then
one -- then it contributes to changing the
environment in which smoking occurs (id. at
10514-515).
By his own testimony, therefore, Dr. Burns is incapable of
even discussing the "open scientific questions" concerning tobacco use, let
alone evaluating scientific data relevant to those questions in an objective
manner. I would add, by the way, that Dr. Burns himself has not conducted or
published any original scientific research on ETS.
Some at EPA recognized, if belatedly, that Dr. Burns'
inclusion on the SAB panel would not be appropriate. In addition to the
problems previously mentioned, Burns had been involved in reviewing and
commenting on earlier versions of the risk assessment and could hardly be
expected to be objective in evaluating a report reflecting his own
substantial input. On October 22, 1990, the New York Times reported that SAB
Staff Director Dr. Donald Barnes had acknowledged that Dr. Burns was not
suitable for membership because of his demonstrated bias against smoking.
Imagine my surprise when, only two days after the New York Times story
appeared, Mr. Reilly informed me that Dr. Burns would be included on the
panel after all!
The decision not to include Dr. Burns had been followed
immediately by claims in the press by antismoking activists that Dr. Burns
had been dropped because of political pressure from the tobacco industry. At
the same time, the press also was reporting that some committee members had
acted as advisors or peer reviewers for the Council on Indoor Air Research
("CIAR"), a research organization that receives funding from the tobacco
industry. Allegations were made that these committee members were biased as
a result of their association with CIAR. In fact, the allegations were
baseless. Four of the six people with CIAR associations already were
standing SAB committee members, and not one had been suggested by the tobacco
industry. Regardless of the falseness of the charges, public reporting of
them placed pressure on the members not to criticize the Agency's drafts lest
they be seen as "biased" in favor of the tobacco industry. As one of these
individuals, SAB panel chairman Dr. Lippmann, candidly admitted to the press,
"[i]t's not that I'm a tool of industry. I'm a bigger tool of government.
I've been working for the EPA longer. I have more to lose by offending the
EPA than industry."(23) Another panelist, James Woods, promised the
Associated Press on November 20, 1990 -- well before the SAB hearing -- that
"the comments he intends to make on the EPA report will demonstrate that he
is not biased toward tobacco companies. 'Wait and see what I say at the
hearing.'"
At this point the process had become so deeply enmeshed in
controversy that an objective review by the panel was no longer possible. As
a consequence, the only responsible course of action would have been to
reconstitute the panel. Even the New York Times called for such a move, in
an editorial entitled "Objectivity Up in Smoke." In response, the EPA simply
proceeded as if no problem existed.
During my investigation, we learned from both Donald Barnes,
the SAB staff director, and Robert Flaak, his assistant, that Mr. Flaak
deliberately went around his boss, Dr. Barnes, to Dr. Lippmann and enlisted
his support in overruling Dr. Barnes' decision not to invite Dr. Burns to
join the panel. It would not be unreasonable in these circumstances for a
scientist in Dr. Lippmann's position to fear the public consequences of a
refusal to give in to the demand of the antismoking lobby on this issue.
There also were suggestions that Dr. Lippmann and Mr. Flaak may have met with
at least one reporter who had written a series of articles on ETS prior to
the December 1990 SAB meeting to discuss the press coverage the meeting might
generate based upon the panel's conclusion. Many unanswered questions remain
about Mr. Flaak's behind-the-scenes role in conducting off the-record
meetings with antismokers and other activities in connection with the panel's
composition.
There are questions about the objectivity of other SAB panel
members. As mentioned earlier, Jonathan Samet of the University of New
Mexico had stated that uncertainties regarding ETS scientific data should not
interfere with tobacco control efforts. Like Burns, Samet also had been
involved in reviewing earlier drafts of the risk assessment. Before that, he
had played a major role in drafting or reviewing portions of the technical
compendium and policy guide. In addition, eight of the fifteen panel members
were themselves responsible for scientific studies relied upon in the first
or second drafts of the risk assessment -- hardly the type of circumstances
that ensure independent evaluation.(24)
In response to my written and oral communications of concern
about these developments, Mr. Reilly blithely assured me that "the panelists
are well qualified to deal with the technical issues that are being directed
to them. To the degree that there are differing scientific views on the
information under review, the SAB process * * * allow[s] for and mandate[s] a
balanced, open discussion of the issues, with ample opportunity for input
from and observation by the public." Of course, all the discussion and
"input" in the world will not sway a mind already closed on the issue in
question. Ultimately, moreover, no such discussion was permitted and input
from the public was sharply limited.
When I pressed Mr. Reilly on these points, he replied with a
series of non sequiturs. Stating that "it is not easy to select a panel of
experts on any 'highly charged emotional and political issue' such as ETS,"
he then asserted without further explanation that the SAB panel would be
capable of providing objective advice and that to delay the process to
reconstitute the panel would "not serve the public interest." How the public
interest was served by EPA's pressing ahead despite the problems that had
arisen has never been explained. Interestingly, Mr. Reilly made no attempt
to deny or refute the specific allegations made against Dr. Burns and other
panel members.
Equally disturbing, I have learned recently that, as the SAB
considered the first draft of the risk assessment, Dr. Steven Bayard, the EPA
staff member with principal responsibility for the document, was providing
"enthusiastic" support to a grant proposal by Dr. Stanton Glantz and his
associates in California for a project designed explicitly to discredit any
scientist who has consulted on the ETS issue for the tobacco industry and
expressed critical views with regard to the risk assessment. As discussed
earlier, Dr. Glantz prepared a chapter of the ETS technical compendium and is
a well-known and vocal antitobacco activist. The grant proposal seeks to
study "[t]he tobacco industry and scientific research." The purpose of the
study is to arrive at "[a]n understanding of tobacco industry tactics for
influencing research on ETS" by identifying whether particular scientists are
"funded by the tobacco industry." That Dr. Bayard's January 10, 1991, letter
in support of that application offered to continue to cooperate actively with
Glantz and his associates at a time when the risk assessment was still under
SAB review raises questions about the EPA staff's approach to resolving
legitimate scientific criticisms of their work. Rather than addressing those
criticisms on the merits, Dr. Bayard's endorsement of the Glantz proposal
creates the impression that he is more interested in silencing his critics.
Dr. Bayard's participation in this effort is even more
alarming given his role in the selection of SAB panelists. Mr. Reilly
repeatedly shunted aside bias concerns on the ground that the procedures for
selecting SAB members are intended to ensure that members "are free from
legal and perceived conflict-of-interest." Later on, however, I wrote to EPA
asking for an explanation of how the ETS panel was being selected. In
response, EPA informed me that the candidates were being selected by Dr.
Bayard, with assistance from Robert Axelrad and James Repace.
2. The Initial SAB Hearing
Despite Mr. Reilly's promises, the SAB panel meeting on
December 4-5, 1990, was conducted in a manner that effectively prevented
scientific viewpoints critical of the two draft ETS documents from being
given anything resembling a full and fair hearing. Less than two hours were
allowed for presentations by scientists critical of the report. Certain
attendees who had personally requested time from the Chairman were foreclosed
from speaking under the agenda that had been formulated. The input of
several critical points of view was lost, as well as the opportunity for the
panel to ask questions and to conduct a dialogue with other scientists. In
contrast, twice as much time was given to antismoking organizations.
Although there certainly was enough time to accommodate all who had asked to
speak, several scientists who had expressed doubts about the risk assessment
and policy guide were denied the chance. No explanation was given for the
failure to accommodate these speakers or why the SAB hearing was conducted
with such rigidity. Most SAB review panels are conducted in an open and
collegial manner that encourages vigorous discussion of all competing
scientific viewpoints.
Two of the ETS panel members who agreed to review the report
did not even attend the first day of the meeting, which was the only time
reserved for public comment. Other panel members openly admitted that they
had not read any of the written submissions. The panel members did not
address or acknowledge the many public comments in their written reviews.
No presentations were permitted on the risk assessment
chapter dealing with the respiratory health of children. Without providing
any opportunity for public comment, EPA had transmitted to the SAB a new
"draft report with a detailed description and analysis of 26 studies" on
childhood exposure to ETS. Not surprisingly, the document failed to discuss
any studies that did not support EPA's preferred conclusions. By inserting
it at the last moment and preventing public discussion of the topic at the
hearing, meaningful public scrutiny of the Agency's conclusion was excluded.
The negative perception created by the SAB was heightened by
the Chairman's summary remarks and statements by him and others to the press
after the panel adjourned, misleadingly suggesting that the panel had reached
a "consensus" on the classification of ETS as a human carcinogen. As the
transcript of the meeting shows, there was no such "consensus." Several
panel members criticized the draft in key respects. Dr. Jeffrey Kabat, for
example, repeatedly questioned important aspects of the methodology used in
the draft as well as its treatment of specific studies before concluding that
classifying ETS as a Group A carcinogen could be "rash" (II, p. 15). Dr.
Kabat stated that "the observations on nonsmokers that have been made so far
are compatible with either an increased risk from passive smoking or an
absence of risk or I would say that with a risk that's so small that maybe
it's not -- you can't measure it with certainty" (ibid). Others on the panel
expressed similar reservations about the draft's conclusions.(25)
The advisory panel also did not consider a number of
pertinent studies, including a study by one of its own members, Dr. William
Blot of the National Cancer Institute. Dr. Blot had served, along with Dr.
Wu-Williams, as one of the principal investigators on one of the largest
studies ever conducted on ETS and lung cancer among nonsmokers. However, the
new study was not discussed by the panel, even though the study had been
accepted for publication in the British Journal of Cancer before the panel
met. Amazingly, Dr. Blot himself did not mention the study, which reported
no health risks from ETS.
After the panel meeting, Dr. Lippmann held a press conference
to announce the conclusion that ETS "should be classified as a Class A
carcinogen." The impropriety of a supposedly impartial scientific expert
attempting to frighten the public on the basis of an incomplete and
unsupported document speaks for itself. But Dr. Lippmann compounded this
breach by misrepresenting the panel's conclusions concerning the strength of
the evidence. Among other remarks, Lippmann stated that "if anything, [the
evidence] suggests that it is more potent than we had thought" (Evidence
Shows That Tobacco Smoke Causes Cancer, Head of EPA Panel Says, Bureau of
National Affairs, Daily Report for Executives, December 7, 1990, p. A8).
Perhaps realizing that he had gone too far, Lippmann subsequently tried to
qualify his remarks but succeeded only in being inconsistent. "[T]his is a
classic case where the evidence is not all that strong." Nonetheless,
Lippmann asserted, the "weight of the evidence" supports the risk
assessment's conclusions (Passive Smoke A Cause of Cancer, Panel Concludes,
The Washington Post, December 6, 1990, p. A9).
3. SAB Executive Committee Meeting, April 1991
Dr. Lippmann presented the SAB panel's report to the SAB's
Executive Committee meeting in April 1991. This report was curious for
several reasons. First, the SAB concluded that the worldwide epidemiologic
data on ETS were too weak and inconclusive to support the draft risk
assessment's conclusion that ETS is a cause of lung cancer in nonsmokers. In
addition, the panel did not endorse the Agency's quantitative lung cancer
analysis, noting that the "real" number "may be greater or less than the
number EPA cites."
After concluding that the rationale underlying the EPA
staff's conclusions about lung cancer could not be sustained, however, the
SAB could not bring itself to take the logical, if politically unpalatable,
next step and reject EPA's conclusions regarding ETS and lung cancer among
nonsmokers. Instead, the SAB endorsed the conclusion that ETS is a "Group A"
carcinogen while taking the extraordinary step of urging the EPA staff to
attempt to "make the case" against ETS based on extrapolation from data
concerning active smoking. In essence, the Agency was being encouraged to do
the science backwards -- to maintain its conclusion while going about the
task of finding support for it.
Not surprisingly, the SAB report did not acknowledge that EPA
had largely ignored its own "Guidelines for Carcinogen Risk Assessment,"
51 Fed. Reg. 3394 (September 24, 1986), in order to reach its apparently
predetermined position. Among many violations of the guidelines, EPA had
failed to rule out the possibility of bias and other flaws in the ETS studies
and also had failed to consider animal studies and other non-epidemiologic
data.
The SAB's report feebly suggested that the panel "had some
difficulty in applying the 'Guidelines for Carcinogen Risk Assessment', as
they are currently formulated," to the ETS data. Particular attention was
given to the report's statement that "[i]f the guidelines for Carcinogen Risk
Assessment can be used to cast doubt on a finding that inhalation of tobacco
smoke by humans causes an increased risk of lung cancer, the situation
suggests a need to revise the guidelines" (SAB Rep. 28). This prompted one
member of the SAB Executive Committee to note that it sounded a little like
saying "if the data doesn't fit the guidelines, the guidelines should be
changed." Nevertheless, the Committee accepted the panel's Group A
designation despite the clear failure of the data to satisfy the Agency's own
guidelines.
Following the Executive Committee meeting, Dr. Lippmann once
again spoke to the press about the SAB's conclusions. This time Dr.
Lippmann's statements were considerably more restrained than his remarks at
the December 1990 press conference. This time he stated that "occasional,
light exposure [to ETS] is not likely to cause any harm" (United Press
International, April 19, 1991). Dr. Lippmann also observed that in his view
the risk due to ETS exposure is "probably much less than you took to get here
through Washington traffic" (Washington Times, April 19, 1991, p. A-3). On
three separate occasions my staff asked Dr. Lippmann, "if one were to apply
the guidelines as written could you classify ETS as a Class A known human
carcinogen?" On all three occasions, Dr. Lippmann failed to respond to the
question. The next day, however, Dr. Lippmann stated at a meeting outside
the glare of media attention that if the guidelines were applied strictly
there was no clear mechanistic basis for calling ETS carcinogenic.
4. The Second Draft Risk Assessment
EPA staff spent the next year and a half attempting to "make
a case" against ETS. The revised risk assessment draft was over 600 pages
long, finally being issued on the afternoon of June 18, 1992.(26)
Incredibly, however, EPA gave the public just nine working days to comment on
it even though the report had doubled in length and a whole new set of flaws
had been introduced. Even the Science Advisory Board panel had only until
July 20 to review the revised draft and consider outside comments before the
public review meeting.
The second draft risk assessment was even more curious than
the first. As an EPA health scientist who contributed to the draft admitted,
the Agency staff had engaged in some "fancy statistical footwork" in the
revised risk assessment in order to "fashion [an] indictment" of ETS
(Science, vol. 257, p. 607 (July 31, 1992)). In the prior draft, EPA's
calculations had showed that the epidemiologic studies based on U.S.
populations showed no statistically significant association between ETS and
lung cancer among nonsmokers. In order to reach a statistically significant
result in the first draft, EPA therefore had included in its calculations all
of the studies of ETS conducted worldwide to tilt the balance in the favored
direction. Both EPA and the SAB rejected out of hand arguments by critics
that the risk assessment should have considered only the U.S. studies.
When EPA staff was revising the risk assessment, however, it
was confronted by the Wu-Williams/Blot study, which had been conducted in
China and reported a statistically significant negative association between
marriage to a smoker and lung cancer among nonsmokers -- the exposure
scenario relied upon in the initial risk assessment draft. Inclusion of the
Wu-Williams/Blot study in EPA's analysis would have forced EPA to reverse its
conclusions about ETS and lung cancer. At the same time, however, EPA had
obtained preliminary data from a large U.S. study that, with some massaging,
could be used to support its calculations of risk based exclusively on the
U.S. studies.
Accordingly, EPA entirely reversed course and decided in the
second draft to disregard the non-U.S. studies. Instead, EPA used the U.S.
studies only. The Agency also adopted an entirely new standard of
statistical significance, presumably because the one used in the prior draft
would not have yielded the desired results, even with the inclusion of the
new, if incomplete, U.S. study.(27) Only by manipulating the numbers in a
manner that violated well-accepted statistical methods was EPA able to claim
in the second draft a barely significant association in the U.S. studies.
The new draft also relied on the argument suggested by the
SAB that because active smoking had been associated with increases in risk,
ETS exposure also must be a risk factor. The problem with this argument --
that ETS is in many respects a very different substance and is encountered at
far lower levels -- was acknowledged in the revised report.(28) At the same
time, however, its significance seemed to escape those responsible for the
report's conclusions.
Similarly, the second draft risk assessment announced that
ETS exposure had been established as a cause of respiratory disease in
children. The first draft risk assessment had stated that the data were too
inconclusive to draw an inference of causation. No new information became
available between the release of the first and second draft risk assessment
to support this shift in the Agency's position. Apparently, EPA staff took
the SAB's earlier suggestion that it consider "strengthening" the report's
conclusions concerning children as a license to sensationalize further the
Agency's claims about ETS.
The SAB held public hearings on the revised risk assessment
on July 21 and 22, 1992, after having denied requests for more time to submit
public comments on these and other problems. The panel submitted its report
approving the second risk assessment in October. The panel's conclusions
make absolutely clear that it was unconcerned with the scientific soundness
of the report's underlying rationale. A brief comparison of the SAB's
actions following its first and second review of the risk assessment confirms
that the SAB actually disregarded its earlier findings in order to embrace
the desired conclusion.
- The SAB concluded in its second review that
extrapolation from active smoking data could
not, after all, serve as the sole or predomi-
nant basis for the conclusion that ETS is a
Group A carcinogen.
- The SAB had concluded in its first review that
the epidemiologic data were too weak to support
the inference that exposure to ETS causes lung
cancer in nonsmokers. The SAB reversed its
position in its review of the second draft risk
assessment once it became clear that active
smoking data could not provide an alternative
basis for that conclusion.
- The SAB concluded in its review of the first risk
assessment that all studies of ETS and lung cancer
conducted worldwide should be included. In the
second review, the SAB decided that EPA need only
include the U.S. studies. Had the Agency and the
SAB adhered to their original decision to use all
ETS studies, the meta-analysis would not have shown
a statistically significant risk.
- The SAB nonetheless concluded that the Agency
had established that ETS is a Group A carcino-
gen responsible for approximately 3000 lung
cancer cases every year in the United States.
In the first review, the SAB had concluded that
the data were too uncertain for EPA to attach a
specific number to the deaths supposedly
attributable to exposure to ETS.
Put simply, the SAB concluded that ETS is a Group A
carcinogen even though neither of the two rationales advanced by EPA staff to
justify such classification is scientifically defensible. The first review
determined that the spousal smoking studies were too weak to support an
inference of causation. The second review concluded that the active smoking
data could not be used as an alternative ground. Nonetheless, the SAB
decided that the total "weight of evidence" supported a Group A
classification.
Following the SAB's October report, EPA staff rushed to
revise and release the final risk assessment. The Agency's haste apparently
was motivated in part by the impending change in the Administration. Perhaps
of even greater concern to EPA, however, was the release of the Brownson
study discussed above. The fact that the largest U.S. case-control study
ever conducted reported no statistically significant association between ETS
exposure and lung cancer incidence casts further doubt on EPA's claims. Had
the Brownson study been included in EPA's analysis, the Agency's calculations
would not have shown a significant risk from ETS even using the Agency's
highly suspect statistical methodology. Rather than face this embarrassment,
EPA rushed to release the report without considering the Brownson study on
the pretext that "it had to stop somewhere."(29)
Together, EPA and the SAB have undermined the process by
which risk assessments ought to be conducted: first, by ignoring the
substantial scientific controversy about what the ETS studies actually show;
and, second, by conducting the forum where that controversy should have been
thoroughly aired as a mere rubber stamp proceeding. As a result, EPA's
preparation and review of the risk assessment have given the appearance of a
scientific show trial to legitimize a predetermined policy.
III. CONCLUSIONS
EPA's handling of ETS is a symptom, albeit a very severe one,
of larger agency problems. These problems encompass not only widespread
abuses in the award and oversight of government contracts but also the
Agency's general approach to the use of science in policy making.
In fact, EPA's risk assessment process as a whole has come
under fire. In response, top EPA management moved to revamp internal
guidelines governing EPA's use of science in risk assessments. In February
1992, Deputy Administrator Henry Habicht issued a document providing
agency-wide guidance on science policy in risk assessment and risk
characterization. Mr. Habicht noted that significant information often was
omitted as assessment documents were passed along in the decision-making
process, and that "EPA risk assessors and managers need to be completely
candid about confidence and uncertainties in describing risks and in
explaining regulatory decisions."
The guidance also drew from principles articulated earlier by
the Risk Assessment Council in November 1991, such as the following.
For users of the assessment and for
decision-makers who integrate these
assessments into regulatory decisions, the
distinction between risk assessment and
risk management means refraining from
influencing the risk description through
consideration of non-scientific factors --
e.g., the regulatory outcome -- and from
attempting to shape the risk assessment to
avoid statutory constraints, meet
regulatory objectives, or serve political
purposes. Such management considerations
are often legitimate considerations for
the overall regulatory decision * * * but
they have no role in estimating or
describing risk.(30)
In other words, science should drive policy, not the other way around.
In addition to the new risk assessment guidance, as I
mentioned at the outset, the EPA Administrator also had convened an expert
panel to assess EPA's use of science, which issued an important report in
March 1992 entitled "Safeguarding the Future: Credible Science, Credible
Decisions." The report confirmed that "[c]urrently, EPA science is of uneven
quality, and the Agency's policies and regulations are frequently perceived
as lacking a strong scientific foundation" (p. 4).
The expert panel also cautioned EPA, in terms that are
directly relevant to the Agency's work on ETS, that "science should never be
adjusted to fit policy, either consciously or unconsciously" (p. 38).
Unfortunately, in the case of ETS there appears to have been a conscious use
of science and the scientific process to achieve a political agenda that
could not otherwise be justified.
While we should applaud the promised willingness of EPA to
clean house and revise its methods, we also must question why that was not
done in the case of the ETS risk assessment. In his February 1992 policy
memorandum, the Deputy Administrator wrote, "we do not expect risk assessment
documents that are close to completion to be rewritten" (p. 5). It is
difficult to understand why, after acknowledging serious deficiencies in
EPA's use of science, the Agency would refuse to correct the flaws in risk
assessment projects then under way. Similarly, EPA repeatedly has refused to
respond to requests that it reevaluate its handling of the ETS controversy in
general and the risk assessment in particular in light of the recommendations
contained in "Credible Science." This refusal raises questions about EPA's
ability and desire to implement fully the reforms urged by "Credible
Science."
It also is deeply disturbing that Administrator Reilly, who
professed to be "proud" of "Credible Science," did not choose to abide by its
recommendations in his own statements about the ETS risk assessment. As
noted, continuing the pattern of media hype and sensationalism that has
marked every aspect of EPA's consideration of ETS, Administrator Reilly and
HHS Secretary Sullivan held a joint press conference on January 7, 1993,
announcing the finalization of the risk assessment. The press conference
proceeded as though the "Credible Science" report and recommendations did not
exist.
One of the important conclusions of "Credible Science" is
that EPA has done a poor job in communicating with the public about the
uncertainties in its determinations. In addition, the Agency's own guidance
document emphasizes the importance of explaining fully scientific
uncertainties in describing risks. At the January 1993 ETS press conference,
however, the Administrator conveyed the clear impression that there is no
uncertainty whatsoever so far as ETS is concerned -- that the risk
assessment has shown "conclusively" that ETS exposure is responsible for
approximately 3,000 cases of lung cancer among U.S. nonsmokers each year and
specific numbers of respiratory problems among children.(31) The
Administrator also made the ridiculous statement that "the risks associated
with environmental tobacco smoke are at least an order of magnitude greater
than they are for virtually any chemical or risk that EPA regulates."(32)
Among other things, that statement cannot possibly be reconciled with Dr.
Lippmann's earlier statement that the risk supposedly associated with ETS is
less than the risk of a single trip through Washington traffic.
Finally, the Administrator disingenuously claimed that "[m]y
philosophy is, first do the scientific analysis, and only then build the
policy, determine the priority and devise the strategy based on a firm
scientific foundation. With this report we have laid the firm foundation
upon which policy can now be built."(33) The fact that EPA released, several
years ago, a "Fact Sheet" and a draft policy guide recommending smoking bans
and restrictions renders the Administrator's statement misleading at best.
Some may argue that applying a double standard to ETS is
justifiable, or at least understandable, on the ground that the target of
EPA's action is tobacco smoking. Regardless of one's personal beliefs about
smoking, however, the spectacle of a huge, well-funded government bureaucracy
with enormous power engaged in the deliberate manipulation of the public is
profoundly disturbing.
Further, if policy decisions are not based on sound science,
the integrity of both the political and the scientific processes suffers. As
Dr. Feinstein has pointed out --
[t]he "bad guys" * * * are not always
right, but if they are denied a fair and
proper scientific hearing, neither society
nor science will benefit. Society is
entitled to make political decisions based
on advocacy. The scientific basis for
those decisions however, should depend not
on political advocacy, but on scholar-
ship -- no matter how it is produced or by
whom (p. 305).
These concerns are not limited to ETS. The suspicion that
too many scientists and government officials are using "scare of the month"
tactics to generate media attention and mobilize public opinion in support of
personal political agendas has fueled widespread public cynicism. At some
point, people simply stop paying attention. As the public television program
"Technopolitics" noted in its June 11, 1991, program on the first draft of
the ETS risk assessment --
[t]he question remains whether the public
health scare now being created through
leaked draft documents and emotional
public appeals is real, or is the anti-
smoking movement merely using bad science
to organize the nonsmoking majority
against the smoking minority?
The record of the EPA is not reassuring.
On one environmental concern after
another, from Alar apples to acid rain to
dioxin, the EPA has first put out alarming
information and then backed off. Critics
charge that the EPA is more interested in
being politically correct than scientifi-
cally accurate.
In essence, EPA has declared war on smokers. Because of
EPA's pursuit of sensational headlines at the expense of objective scientific
evaluation, some smokers have lost their jobs and many employers are
practicing overt discrimination in hiring and promotion based solely on
whether a person smokes. People who think that such interference is unlikely
to go beyond smoking should be warned: a report last year on the television
show "20/20" indicated that moderate social drinking off the job and
participation in employer-defined "dangerous activities" also have become
targets of workplace discrimination policies. Can a government-sponsored
"technical compendium" or "policy guide" on those subjects be far behind?
EPA's mandate to clean up the nation's air, water, and waste
enjoys public support. But conduct by the Agency like its handling of ETS
will continue to undermine that support unless the Agency decides to get
serious about implementing the recommendations of "Credible Science." If
EPA's leaders will not step up to the task of reforming from within, it will
become necessary for Congress to do the job for them.
July 1993
______________________________________________________________________________
END NOTES
(1) EPA Blowing Its Own Smoke?, Investor's Business Daily, January 28,
1993, p. A1.
(2) Presentation by Richard Daynard, International Council for
Coordinating Cancer Research: Conference on Cancer Prevention
(February 1991).
(3) S. Glantz, Achieving a Smokefree Society, Circulation, vol. 76,
pp. 746-752, 747 (1987).
(4) R.C. Brownson et al., Passive Smoking and Lung Cancer in Nonsmoking
Women, Am. J. Pub. Health, vol. 82, pp. 1525-1530 (1992).
(5) Investor's Business Daily, supra note 1.
(6) Ibid. In addition to these deficiencies, classification of ETS as a
Group A carcinogen cannot be reconciled with EPA's own "Guidelines
for Carcinogen Risk Assessment." The Scientific Advisory Board that
reviewed the risk assessment acknowledged that the document did not
adhere to the Agency's guidelines, but dismissed such concerns with
the suggestion that the guidelines simply be changed. The report
also selectively uses data that support its conclusions while
omitting evidence that does not. For example, the report completely
ignores workplace and male exposure data, which do not show any
association between exposure to ETS and lung cancer.
Such treatment by both EPA and the SAB is unprecedented. No other
substance has been classified as a Group A carcinogen in the face of
a clear majority of epidemiologic studies showing no statistically
significant association or on an assumed similarity with another
substance. Other substances that have been considered for
classification as known or probable human carcinogens, including
electromagnetic fields and diesel exhaust, have been accompanied by
considerably stronger evidence of carcinogenicity in both human and
animal studies than ETS. Comparing those risk assessments to the ETS
report only reinforces the view that the report is intended to
support a policy decision to restrict ETS exposure and not to assess
risk objectively.
(7) The risk assessment does not address the data concerning ETS exposure
and cardiovascular disease. Two earlier documents prepared by EPA
staff, however, an ETS "technical compendium" and a related
"workplace policy guide," asserted that ETS exposure is a cause of
cardiovascular disease. In fact, exposure to ETS has not been proven
to cause or exacerbate cardiovascular disease among nonsmokers. In
1986, the U.S. Surgeon General and the National Academy of Sciences
reviewed the data and concluded that there was insufficient evidence
even of an association between ETS and cardiovascular disease. U.S.
Surgeon General, "The Health Consequences of Involuntary Smoking,"
U.S. Department of Health and Human Services (1986); National
Research Council, "Environmental Tobacco Smoke: Measuring Exposures
and Assessing Health Effects" (1986). No studies have been published
since 1986 that would alter their conclusions.
(8) A. Feinstein, Critique of Review Article, Environmental Tobacco
Smoke: Current Assessment and Future Directions, Toxicologic
Pathology, vol. 20(2), pp. 303-305, 304 (1992).
(9) J.M. Samet and M.J. Utell, The Environment and the Lung: Changing
Perspectives, J. Am. Med. Ass'n., vol. 266, p. 673 (1991).
(10) Risk Studies Differ on Passive Smoking, Washington Times,
November 20, 1992, p. A3.
(11) A.H. Lowrey and J.L. Repace, Indoor Air Pollution, Tobacco Smoke and
Public Health, Science, vol. 208, pp. 464-472 (1980).
(12) See, e.g., S. Turner, et al., Measurements of Environmental Tobacco
Smoke in 585 Offices, Env. Int., vol. 18, pp. 18-28 (1992);
C. Proctor, N. Warren, and M. Bevan, Measurements of ETS in an
Air-Conditioned Office Building, Env. Tech. Lett., vol. 10,
pp. 1003-1018 (1989).
(13) Repace and Lowrey (1980), supra note 11, at 471.
(14) J.L. Repace and A.H. Lowrey, A Quantitative Estimate of Nonsmokers'
Lung Cancer Risk From Passive Smoking, Env. Int., vol. 11, pp. 3-22,
at 12 (1985). This study was not funded or sponsored by EPA. Repace
apparently undertook the study on his own initiative. The source of
his funding has never been revealed.
(15) Reviews critical of the Repace and Lowrey risk assessment, calling
their methodology and conclusions into question, were completed by
EPA's Carcinogen Assessment Group prior to publication of the Repace
and Lowrey paper. See E. Anderson, Repace and Lowrey's Estimate of
the Lung Cancer Risk from Passive Smoking (undated); H. Gibb, Repace
and Lowrey's Estimate of the Nonsmokers' Lung Cancer Risk from
Passive Smoking (undated). In addition, the Repace and Lowrey paper
was criticized by the Congressional Office of Technology Assessment
in Passive Smoking in the Workplace: Selected Issues, pp. 21-22
(May 1986). Other scientific articles criticizing the Repace and
Lowrey risk assessment as well as their earlier work on ETS include
A. Gross, Risk Assessment Relating to Environmental Tobacco Smoke,
Environmental Tobacco Smoke, Proceedings of the International
Symposium at McGill University, D.J. Ecobichon and J.M. Wu, (eds.),
Lexington Books, Lexington, Mass., pp. 293-302 (1990); N. Balter
et al., Causal Relationship Between Environmental Tobacco Smoke and
Lung Cancer in Non-Smokers: A Critical Review of the Literature,
Proceedings of the 79th Annual Meeting of the Air Pollution Control
Association (1986); A. Arundel et al., Nonsmoker Lung Cancer Risks
From Tobacco Smoke Exposure: An Evaluation of Repace and Lowrey's
Phenomenological Model, J. of Env. Sci. and Health, vol. 84(1),
pp. 93-118 (1986); M. Lebowitz, The Potential Association of Lung
Cancer With Passive Smoking, Env. Int., vol. 12, pp. 3-9 (1986);
P. Burch, Health Risks of Passive Smoking: Problems of
Interpretation, Env. Int., vol. 12, pp. 23-28 (1986).
(16) A few representative examples include: G. Gori and N. Mantel,
Mainstream and Environmental Tobacco Smoke, Reg. Tox. and Pharm.,
vol. 14, pp. 88-105 (1991); M. Reasor and J. Will, Assessing Exposure
to Environmental Tobacco Smoke: Is It Valid to Extrapolate From
Active Smoking?, J. Smoking-Related Dis., vol. 2, pp. 111-127 (1991);
J. Fleiss and A. Gross, Meta-Analysis in Epidemiology, With Special
Reference to Studies of the Association Between Exposure to
Environmental Tobacco Smoke and Lung Cancer: A Critique, J. Clin.
Epidemiol., vol. 44, pp. 127-139 (1991); F. Adlkofer et al., Exposure
of Hamsters and Rats to Sidestream Smoke of Cigarettes, Preliminary
Results of a 90-day-Inhalation Study, Proc. Indoor Amb. Air Qual.
Conf., London, pp. 252-258 (1988); A. Arundel, T. Sterling and
J. Weinkam, Exposure And Risk Based Estimates of Never Smoker Lung
Cancer Deaths in the U.S. in 1980 From Exposure to ETS, Proc. Indoor
Amb. Air Qual. Conf., London, pp. 242-250 (1988); J.P. Vandenbrocke,
Passive Smoking and Lung Cancer: A Publication Bias?, Br. Med. J.,
pp. 296, 390-391 (1988).
(17) Committee on the Institutional Means for Assessment of Risks to
Public Health, National Academy of Sciences/National Research
Council, Risk Assessment in the Federal Government: Managing the
Process, pp. 151, 153 (1983).
(18) This statement was contained in an undated background summary of the
risk assessment entitled "Findings in a Nutshell," prepared by EPA
sometime in mid-l991. The summary was given to the Occupational
Safety and Health Administration, the federal agency that has
authority to regulate indoor air quality in the workplace.
(19) According to his resume, Mr. Rosner has a bachelor of science degree
in occupational therapy and a master's degree in business
administration. His work experience includes jobs as a press intern,
restaurant manager, recruitment coordinator of Big Brothers/Big
Sisters of Tacoma, radio announcer, founder of an organization "to
tackle Seattle's rising crime rate" and as Executive Director of the
Smoking Policy Institute. Nothing in Mr. Rosner's education or
professional background suggests that he is "uniquely" qualified to
assess the "technical and scientific literature on tobacco smoke
exposure and health impacts," as was claimed in an undated memorandum
purporting to justify the award of the policy guide subcontract to
SPI on a sole-source basis.
(20) A June 1991 Report by the House Subcommittee on Oversight and
Investigations identifies ICF as one of EPA's ten largest
contractors, with active contracts having a potential total value of
more than $300 million. The Report notes that audits of ICF's work,
performed for EPA by the Defense Contract Audit Agency, had found
"numerous problems," including instances in which ICF billed EPA for
subcontractor charges before ICF had paid the subcontractors
(Report, p. 25). Apparently, EPA also has made it a practice to use
ICF as a vehicle to provide subcontracts to consultants selected by
EPA. As indicated earlier, EPA's cozy relationship with its
contractors and negligent management practices in connection with
contracting procedures have been the subject of an ongoing
investigation by the Oversight Subcommittee.
(21) United States Environmental Protection Agency, Advisory Committee
Charter, Science Advisory Board, November 6, 1987.
(22) The decision subsequently was reversed on legal grounds, although
determinations concerning the persuasiveness of the expert testimony
and other factual matters were left undisturbed. Le Procureur
General du Canada v. RJR-MacDonald. Inc., No. 500-09-001296-912
(Quebec Court of Appeals, January 15, 1993).
(23) Impartial Panel for Smoking Study Proves Hard to Find, Los Angeles
Times, November 24, 1990, p. A-27.
(24) Drs. Benowitz, Blot, Eatough, Hammond, Kabat, Lebowitz, Samet and
Weiss had been responsible for scientific studies concerning ETS
cited in the first or second drafts of the risk assessment.
(25) Dr. Rockette, for example, observed that "there is this issue of the
bias and potentially the systematic bias which the meta-analysis will
not control for * * *. [Y]ou are dealing with an estimate of risk
[of] about thirty percent * * *. [M]ost epidemiologists, if they did
a single study where they got a thirty percent risk, even if it
[were] statistically significant, [would] not be very excited about
it" (II, p. 19). Even Dr. Samet concluded that "the [lung cancer]
chapter falls far short of doing an adequate job of hazard
identification and needs to go much further, in light of the Agency's
guidelines on hazard identification * * *" (II, p. 30).
With respect to the quantitative risk estimates, the panel voiced
even stronger doubts. Dr. Wesolowski stated that he thought "what
we're hearing is that we are a little bit weak on exposure, to say
the least, and there's going to be a need for a lot of research" (II,
p. 82). Dr. Blot agreed, noting that "we're less sure than the
chapter presents as to the actual numbers of lung cancer deaths that
are due to environmental tobacco smoke * * * " (II, p. 87). He also
felt that the inclusion of ex-smokers in the draft's risk estimates
was "really poorly justified" (II, p. 94). Dr. Laties, one of the
few panelists who actually had read the public comments, strongly
recommended that a Japanese study by Dr. Hirayama be dropped based on
what he characterized as "devastating" criticism by Dr. Kilpatrick,
one of the outside scientists who had reviewed and commented on the
draft (II, p. 99). EPA's risk estimates in the first draft depended
heavily on this early, extremely controversial study.
(26) The second draft revealed for the first time that the authors of
several of the chapters had acted as subcontractors to ICF
Incorporated. As noted earlier, the EPA Inspector General has
concluded that all of those subcontracts were awarded non-
competitively and that at least two violated federal contracting
procedures. In addition, as with the technical compendium and
policy guide, some of the people who contributed to the revised ETS
risk assessment are vocal antismoking activists. Judson Wells, who
contributed an important appendix to the revised risk assessment on
smoker misclassification rates, is a retired chemist who now devotes
most if not all of his time to doing volunteer work for the American
Lung Association on the ETS issue. Wells' claims about
misclassification rates were of vital importance to the lung cancer
conclusions of the revised risk assessment.
(27) Specifically, the revised risk assessment used a 90% confidence
interval to judge statistical significance even though (1) a 95%
confidence interval had been utilized in all of the underlying
studies, (2) a 95% confidence interval is the more accepted measure
and (3) EPA had not previously utilized a 90% standard in any
previous risk assessment. EPA has never attempted to explain this
departure from previous and accepted scientific practice. One
commentator noted that "[t]o get scientifically valid data, there are
very strict rules and requirements on how and when you can apply
meta-analysis, and virtually all of them were violated in the EPA
analysis." Investors' Business Daily, supra note 1.
(28) The draft report stated, for example, that "[t]his assumption
[comparing MS and ETS to calculate lung cancer risks] may not be
tenable, * * * as MS and SS differ in the relative composition of
carcinogens and other components identified in tobacco smoke and in
their physicochemical properties in general * * *" (p. 6-6). The
draft report also acknowledged that "[t]he concentration of smoke
components inhaled by subjects exposed to ETS is small compared with
that from active smoking. * * * Breathing patterns for inhalation of
mainstream smoke and ETS differ considerably * * *. There are also
important differences in the physicochemical properties of ETS and MS
(see chapter 3). These have been extensively reviewed earlier by the
National Research Council * * * and the Surgeon General * * *"
(pp. 7-2; 7-3).
(29) As noted, EPA "stopped" in a most curious place. It fully
incorporates data from a still incomplete study by Elizabeth Fontham
and coworker while ignoring the much larger, complete and fully
reported Brownson study -- which had been funded in part by NCI. In
addition to having several years to run, Dr. Fontham and her group
have not yet published any data on ETS/lung cancer confounding
factors.
(30) Committee on the Institutional Means for Assessment of Risks to
Public Health, National Academy of Sciences/National Research
Council, Risk Assessment in the Federal Government, pp. 151, 153
(1983).
(31) Statement by William K. Reilly, Administrator, U.S. Environmental
Protection Agency, on Environmental Tobacco Smoke, January 7, 1993,
p. 1.
(32) Id. at 3.
(33) Id. at 4.