Bliley PM
U.S. Environmental Protection Agency Science Advisory Board Environmental Health Committee
Abstract
Contains biographical sketches of the U.S. Environmental Protection Agency Scientific Advisory Board's Environmental Health Committee. Includes committee positions and provides contact information.
Fields
- Notes
Memorializes SAB Members
- Company
- Philip Morris Cos., Inc.
- Type
- Report
- Named Person
- Upton, A.C.
- Selikoff
- Gori, Gio Batta, Ph.D. (Tobacco Consultant, formerly w/ NCI, Industry Expert)
1993 Started career at NCI and then went to work for the industry. Believed a safer cigarette could be made, and that there were safe threshold levels for exposure to the chemicals in cigarette smoke.- Kensler, Dr.
- North, D.W.
- Abood, Leo (PM Researcher, Nicotine)
Outside research on nicotine analogs for PM. University of Rochester. Around 1980.- Kilgore, W.
- Ames, B.
- Carlson, G.P.
- Johnson, E.M., Dr.
- Kim, N.K.
- Radike, M.J.
- Jesse, M.J., Dr.
- Rappaport, S.M.
- Weiss, B.
- Laties, V., Dr.
- Wyzga, R.E.
- Barnes, D.G.
- Selikoff
- Named Organization
- EPA
- Environmental Protection Agency
- Science Advisory Board
- Environmental Health Committee
- Chemical Manufacturing Association
- National Center for Toxicological Research
- FDA
- North Carolina State University
- Chevron Oil
- Monsanto
- Iowa State University
- Food and Drug Administration
- University of Chicago
- Purdue University
- University of Michigan
- National Cancer Institute
- New York University's Institute of Environmental Medicine
- Liggett
- Frederich Cancer Research Center
- Medical Tribune
- NRC
- National Research Council
- Science
- Scientific American
- EPA Scientific Advisory Panel's Environmental Health Committee
- Yale University
- Stanford University
- Decision Focus, Inc.
- General Electric's Hanford Atomic Production Operation
- General Dynamics/Convair
- GE
- Vallecitos Atomic Laboratory
- Research Triangle Institute
- National Institute of Environmental Health Sciences
- North Carolina State University
- University of Arkansas Medical School
- American Statistical Association
- Biometrics Society
- Army Stockpile Assessment Panel
- CTR
- Council for Tobacco Research
- NIH
- National Institutes of Health
- NIEHS
- Work Group on Risk Assessment for the Interagency Regulatory Liaison Group
- Texas A&M University
- University of California at Berkley
- Jefferson Medical College
- Thomas Jefferson University
- Daniel Baugh Institute of Anatomy
- Teratology
- New York Department of Health, Division of Environmental Health
- AP
- Associated Press
- University of Cincinnati
- Environmental Criteria and Assessment Office
- School of Public Health
- NIOSH
- National Institute for Occupational Safety and Health
- Northern California Occupational Health Center
- ACGIH
- American Conference of Governmental Industrial Hygienists
- OSHA
- Occupational Safety and Health Administration
- American Chemical Society
- Los Angeles Times
- WHO
- World Health Organization
- Johns Hopkins
- Environmental Health Science Center, University of Rochester
- NAS
- National Academy of Science
- National Research Council's Committee on the Biological Effects of Atmospheric Pollutants
- IAQ/Total Human Exposure
- Harvard University
- Florida State University
- Electric Power Research Institute
- Environmental Protection Agency
- Keyword
- Surgeon General's Report
- Palladium
- Risk
- Exposure
- Trichloroethylene
- TCE
- BP
- Benzo(a)pyrene
- PAH
- Polycyclic Aromatic Hydrocarbons
- Fluoride
- Vinyl chloride
- Nickle
- Dichloromethane
- Methylene chloride
- Ethanol
- Dioxin
- Palladium
- Thesaurus Term
- government agency
- research activity
Document Images
ENVIRONMENTAL PROTECTION AGENCY
SCIENCE ADVISORY BOARD
ENVIRONMENTAL HEALTH COMMITTEE
017/23/90
TABLE O~ CONTENTS
Arthur C. Upton .............................
i
D. Warner N,orth ..................... •
........ 4
Gary P. Carlson .................................
6
David W. Gaylor .............................
7
E. Marshal~ Johnson, . ...........................
ii
Nancy K. K~m ....................................
12
Martha Jesse Ra,dike ............................ 73!
Stephen, M. Rappaport ............................ 14
Bernard W,eis:s ................................ 17
Ronaldi EdWardWyzga . .......................... 18
Do~nald G. Barn~es ............................ 20
Arthur C. Upton
A.rthu~ Canfield Upton was born~ in 1.923 in Ann Arbor,
Michigan. He receivedl the: M.D~ in 1946 and did his. residiency in~
pathology, both at the University of Michigan. He. is, a promlinent
scientist who has held various a,cademic posts and ha:s been widely
qu~oted in the media. He was the Director of th,e Na,tiona~ Cancer
Institute from m~d~197:7 through, 1979. He left NCI and became
Di.rector of New. York University"s Institute of Environmental
Medicin~e, his current academic appointment. He has authored many
chapters of books and n~merous oth,er publications. He ha,s. led,. or
served on many committees or specia,l groups including serving as
chairman of a, Task Group on. the differentiation, between genotox~c
and non-geno~toxic carcinogens (report publlshed in 19814). He sub-
mitred an affidavit supporting Mr. Sinai's cla,im that forcing dis-
closure of the Selikoff study data, would have a "chilling effect"
on medica~l research. He helped prepare the 19.85 Surgeon General's
Report, on cancer and chronic lung diseases in the workplace.
As d!irector of NCI, Dr.. Upton"s actions and statements
to the press were g!enera,lly cautious', and moderate and h.e appears
to have been fa~r and open-minded on issues. Significant actions
during the time. he w.as director inclu,de recommendations regarding
diet, approv~al to test laetrfle in humans, and increased empha,sis
on environmental fa~ctors a,s colntribut~ngl to: cancer. Dr. Upton was
head of NCI during the time thiat Dr. G. B. Gori was prom:ot~ngl th!e
id,ea of a "tolerable" cigarette (~978). Dr. Upton dlid not share
Dr. Gori's view~s andl stated: "Smoking any brand of cigarette in
any amount must be assumed to pose some r~sk. ''~ He w.as very critical
of Gori'~s research.. Dr.. Kensler v~sited both Drs.: Upton and Gori,
regarding Liggett ' s pa~ ladium cigarettes: (per testimony of
Dr. James Mold).
Th,ere was some scandal in 1979: regarding d,estruction of
diseased an~ma.ls at NCI's Frederich Cancer Research Center which
Dr. Upton was told to. defend at 1980 budget hear~nqs.. Dr. Upton's
testimony, as reported in, Medical Tribune in February, ~98.0,
referred to. "administrative problems" and the fact that disease
problems are common, and even expected ~n animal research fa:cili-
ties.
Dr. Upton's scientific area, of greatest expertise is in,
thee. biological effects of ionizing rad~atioln,. He recently ha,s
~eceived some publicity as the chairman of a National Research
Coun~cil panel which reviewed data on, low level radiation exposure
in humans and risk of can~cer. The resu~its, known as BEIR V
(Biological Effects of Ionizing Rad~atio~n, Fifth Study)i diverged
from the pre:ced~ng, four reports in estimating that the risk o~f
developing cancer following exposure to low levels, of X and gamma-
ray radiation, may be four times higher tha,n previously thought.
~t also conclud,ed that the risk of feta~l damage at ~ow ~eve~s is
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also. g.rea,ter than formerly bel~eved. Dr. Upton,'s lead,ership in
this capacity was highly lau,ded in an, article: in Science, Janulary
5, 1990 which d~scribed him a,s. "Scrupuloulsly balanced" in his
presentation~ of issues, and! gave him cred!it for the pan,el's bein'g~
able to reach a consensus whereas groups working on previou:s reports
ha,d been split into factions.
Dr. Upton's. work on ionizing radiations, consisting both
of experimental stu,dies (largely in. mice): andi review of human data,,
ha,s led him to the conclusion that there is no. threshold for
effects,~ i.e., there is n!o dose: of ionizing radiation below which
biological effects do not occur, and that thee dOse-response at low
doses ~s linear. H,e recognizes that this model is n:ot valid for
a~l chemical carcinogen~s.
Dr. Upton presentedl a ta~ik entitled "Are There Thresh,olds
For Carcinogenesis? The Thorny Problem Of Low, Leve~ Expo~sure, at
a, 19:88 international conference regarding environmenta:l chemical
exposures. The published a~ccount o~f h,is presentation disculsses
the epidemiologica,l evidence supporting the l inea,r non-threshold
mod,el of carcinogenesis with ionizing radiation,.
Regarding
chemicals, including cigarette smoke, he discuses th,e different
types of eviden~ce and the problems with fitting experimenta~ evi-
dence to mathematical models.
"Because of the complexity of carcin,og!enesis and
the variability of dose-incidence relationships, it
is not po~ssible on the basis of present knowledge
to extrapolate confidently across different species,
population groups, doses, and conditions o~ exposure
in, estimating the carcinogenic risks of a pa~rticular
c~arcinogen for human, populations, exposed at low do:ses'
levels. . The existing eviden:ce dices not
rigorously exclude a threshold for any carcinogen,
but the use o~f a non-threshold mod~l for iolnizing
radiation a~d moist chemicals, especially those, with
genotoxic activity, is generally recommended on thee
basis o~ present knowledg,e. "
Elsewhere,. he has stated: "[T]he relation between the excess in
risk an:d, thee n~mber of cigarettes smoked per day ind!icates that
there may be no thresholdl for the carcinogenic effects of cigar-
ette smoking.'" This. is extremely important for ETS, becaulse a
n~on-thresholdl rood,el assumes! that th,e b~ological effects of low
levels of exposure are thee same as effects' seen at h~igher exposure
levels, but that the incidence is ~ower.
Though Dr. Upton c~early believes that cigarette smoke
is carcinogenic, he recognizes tha,t cancer is! a multi-fa,ctorial
dlisease and that not al~ deaths due to: cancer in smokers can be
attributed solely to smoking. He ha~s a~ lot of experience in risk
assessment of occupationa~ and environmenta,l exposures including
asbestos. He has stated that cigarette sm~oking interacts syner-
gistically with asbestos and with, alpha-radiation.
A. Scientific American article in 1982, con!cerning the
biological effects of low-levell radiatioln, includ,es diiscussion,
about how people perceive the risks that they incur and how this.
perception ~s o~ften quite different from risks a:s determin~ed qua~nti-
tatively. One table presents a l!ist of activities, that incur a
one in a million, chance of dying as a result of the exposure. On~e:
of the situations ~s "Smoking from one to three cig.arettes". In.
th,is same article he states:
"Still, no r~sk can be regarded a:s acceptable if it
is readily a~oidable or if it is not a,ccompanied by
a commensurate benefit. In qeneral the acceptabil~ty
of a risk tends a~iso to decrease to the extent that
it is involuntary., particula~rly if it ~s imposed on
those who d,o not share equitably in, the related bene-
fits." (Emphasis add,ed),.
Passive or involuntary cigarette smoke exposure is not d~scussed
specifically in this article. In fa,ct, no references to environ,
mental tobacco, smoke were found in any of his materials that were
reviewed (:although review of someof the materials was rath~er super-
ficia~ because of the large: amount ~nvolve'd).
Based on the ~nformation obtained from public materials,
it is d!ffficult to predict how Dr. Upton wi~l view EPA's risk
assessment of enviro~nmental toba~cco smoke. He ~s very. experfencedl
in risk as:sessm~ent, he believ.es -- in general -- in the no-threshold
mode~ of carc~nogenicity, he has specifically expressed opin,ion,
that cigarette smok~ngl is carcinogenic n~o matter what the dose
involved, he believes, that can~cer is a multi-factorial disease an~d
that much research is needed to~und.erstand its. causes,, he recognizes
the uncerta~nties in the interpreta,tion of animal carcinog!enicity
diata, and short-term tests, h.e has a reputatio~n for being fair and
balanced in his treatment of controvers!ia~ issues!..
D.. Warner North
D:. Warner North. is Vice Chairman. of the EPA Scientific:
Advisory Pan,el's Environmental Health Committee. Bolrn in New York
City in 1941, h~e did h~s undiergraduate work at Yale,. and then ea~rned
a Masters and a Ph.D. in. mathematics from Stanford University.
Dr. North is a principal in Decision Focus, ~nc., a consulting
firm, specializing in diecision analysis. He has served on committees
of the EPA Science Advisory Board since 19:78. (iThe current review
of these EPA committee reports will reweal which, ones.) Among
North's activities was service on an Army Stockpile Assessment
Panel in late 19:84! with Leo G. Abood.
In the early 1980s., North served on a fourteen-member
NRC committee that examined whether changes in institutional
arrangements or procedures could improve government regulatory
performance. Although~ the committee ' s report contained no
recommendations a:s to scientific issues, related to risk assessment,
it d~scribed epidemiology as an evolutionary step. forward from
reliance on skin-pa,inting and subcutaneous inje~ction.. Epidiemiology
could "conf~rm" the findings of animal experiments and "providle
evidence'" linkingl exposures to particular chemicals to particullar
chronic health effects. While noting the difficulties involved! in
interpretingl epidemiologica~ stu,dy results, the committee was
~nclined to accept data from "w,e11-conducted" epidem~ologic stu~dies
as "the most convincing evidence about human risk."
On, a more: personal level and a:s a, statistician, North
accepts the concept of judgmental (:subj,ectiv.e)i probability (iBayes.'
Ru~e) .. That is., where data is sparse or nonexistent, probabilities
may st~ll be u:sed to summarize information,, assess po:ssible outcomes
and predict future events. He a~so recog~n,izes a need for regulation
of environmental chemicals "for wh,ich toxicity in animals h,as been
demon~strated at high d,oses." North: writes that although there
r~emains a great d.eal of uncerta,inty in the relationsh,ip between
human~ cancer incid,ence and exposure to. chemical substan~ces that
have induced tumors, in animals, bioa~ssays may st~ll be. appropriate
for predicting the potency relationship for the same substances in
humans.
North has d,one "extenlsive" consulting for the chemical and
petroleum industries. Among his c~ients: are the Chemica~l
Manufa,cturing Association, Chevroln Oil and Monsanto. This
association with, industry led to conflict of interest charges during
his tenure: in the late 1980is on a California Propo~sition 65 panel.
The g,overnor-appointed pane~ decid,ed which substances shou!id be
listed as carcinogenic or causing birth d,efects.. The panel's
sessions were open to thee public and toba,cco was among the
"chemicals of lifesty.l!e" colnsidered by the committee. Although
North protested that he ha,d filed the required do:cuments regarding
his sources of in~colme a,nd had disqualified him!self from, ruling on
"certain," chemicals, publicity regarding his close aslsociation.
with industries that could be affected by the panel's decisions
caused h~im to resigln, in, June, 1989, along with Chairman Welndell
Kilgore.
No~rth and Bruce Ames, anolther panel member, weredescribed
in. one~ news a,ccount as "vocal oppolnents of the initiative" and
"old! hands a~ the deba~e-and-delay ta,ctics favored! by industry-
oriented administratiolns! when it comes to. environmental
protection." At one point, N,orth publicly expressed reluctan~ce to
accept FDA rulings on the safety of food con~stitu,ents inthe absence
of diocumentedlrisk studies,, citing th,epanel's responsibility to. the
voters regardingl the actual intent of Proposition 615.. An
unsuccessful moltion by North would have allowe~dith~epanel to remove
EPA-d,esignatedi chemicals from the California~ list if it disagreed
with EPA findings. The more skeptical observer might interpret
North"s position as emanating from, a, desire to. increase the power
of the panel in order to thwart the goa~is of the voter initiative
and advance: the g!oals of industry and the govern:or who appointedi
him.
North dioes not appear to be philosophically opposedi to
the interests of large corporations and may be inclined to vote
the interests of his cliemts absent other, overriding concerns.
Alternatively, he is an, outspoken,, co~n,fident person who may simply
vote his own "conscien~ce." It is unclear what effeot, if any, his
forced resignation from the Proposition 615 panel might hav.e.
Although his views on tobacco use or passive smoking are not
apparent fro~ available materia,ls, it is: to be expected that he
will not be reluctant to express his v~ews as Vice Chairm~an of
this. panel. A. review of tran~scripts from th,e Proposition 615 pan,el
hearings (~f available), might provide: specific information on
North's views on cigarette smoking, and, possibly,, ambient cigarette
smoke.
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Gary P. Carlson
Gary P. Carlson was born in 1943 in Buf~falo, New York.
Me received a, Ph.D.~ in Pharmacology from the University of Chicago
and! is. currently a, Professor of Toxicology at Purdu,e Un~v.ersity.
Dr. Carlson has not received grant support flrom CTR but
ha:s been awarded! moniies from the EPA and NIH and from the NIEHS.
Additional ties with the EPA are reflected in a~ 19187 news article
on the EPA's drinking water safety standlardi for tricholorethylene
(TCE), wh,ich identified Dr. Ca~rlson as "Chairman of the Drinking
Water Subcommittee of the EPA.'s Scientific ~dvisory Board."
The body of Dr. Car!son's research has concerned the
experimental effect of different compounds on various metabolic
pathways in laboratory animals.. For example, his 198!3 paper
entitled "Effect of Carbon Menoxidle Inh,alation Exposure in M~ce on
Drug Metabolism,," found that high, levels of short duration of carbon
molnoxide have n~o effect on the metabolism of certain drugs and
moreover, that binding to cyto:chrome P-4!50 in the liver was not
found under these experimental conditions. None of his publications
relate tobacco to carcinogenesis except for the impl~ed relationship
of benzo{A)pyrene (BP) as a~ carcinog!en in h,is 198!3 article entitled
"Effect of Route of Administration on Macromolecu~ar Binding of
Benzo(A)Pyrene in Sencar and Balb/c Mice." This a,rtic~e did not,.
however, indicate that tobacco wa,s a, source of BP or that
extrapolation of th,e, results could be made to humans.
In conclusion,, neither Dr. Carlson's publicat~on:s nor
h,is tenuous ties with the EPA indicate: that his position on thee
Environmental Health Committee Science Advisory Bo~ardi would be
affected by bias: against the toba,cco indulstry.
David W. Gay~or
Dr. David William Gaylor,. 60, is Chief of B!iometric:s at
theNational Center for Toxicologica,l Riesearch for theFoodland Drug
Administration in Jefferson:, Arkansas, with a speciality in.
biostatistics.. He received! his Bach,elor of Science degree from
Iowa State University in, 1951 andl his. Master of Science degree
from the same university in, 1953. He receivedi his Ph.D. in
statistics from North Carolina, State University in 1960. His
d,octora~l thesis was entitled '"The Con~struction an~d Evaluation of
Some Designs for the:Estimation of Parameters in Rand,om Models.''~
Dr. Gaylor joined the biometry staff at thee National
Center for TOxicological Research in 197'2 after working as a,
sta~tistician, for General Electric"s Hanford! Atomic Production
Operation from 195!3-1955, G~ineral Dynamics/Convair from 19:55-19:57,
GE's Va!~ecitos Atomic Laboratory from 19,60-!9,62, the Resea~rcb
Triangle Institute from 19612-19618, and the Nationa~ Institute of
Environmental Hea~th Sciences from 19,681-197.2. He has held the
fo~lowing concurrent positions:~ adjunct associate professor at
North Carolina State University from 1967-197~2 a~nd adjun~ct professor
at the University of Arkan~sa:s: Medical Sch,ool since 19721. He is a
Fellow of thee American Statistical Asso:ciation and a member of the
Biometrics Society.
A review of Dr. Gaylor's publications indicate that his
research focus is on the statistical design and analysis, of
experiments and the quantitative risk assessments of chemicals.
Since he joined the Nationa~l Center for Toxicological ~esearch,
Dir. Gay~or ha,s. authored and coauthored numerous publications
concerning theoretical an~dl appliedi teratogenicity and
carcinogenicity testing, in animals and theoretical questions
pertaining to risk assessment. Only one of his publications refers
to cigarette smokingl. The latter is. a brief abstract of a
presentation given during an annual me,etinq of the Society for
Epidemio~og!ical Research in which he an~d his fellow coinvestigator
described a new simplified approa~ch to calculating relative risk
by utilizing case-exposure studies. They illustratedithepotentia:l
us,eful!ne~ss of this. approach with diata from a cohort stu,dy o~f
congenital heart defects and maternal ciga,rette smoking compared
to data constru~cted from~ hypothetical, case-exposure an~d! case-
control studies on the siame issue. However, there: is no discussion
of their co~nclusions, if any. (Citation: Hogue,~ C. and Gaylor,
D., ".Case-Exposu!re Studies: AN,ew,~ Simp~ifiedlApproachto Relative
Risk," American Journal of Epidemioloqy i~4(~3)i:: 427., September,
~981)
Several themes emerge from Dr. Gaylor's publication,s.
that appear relevant to the EPA's dra,ft risk a:ssessment of passive
smoking. These include frequ,ent references to the '"u~certainties
involved" in making quantitative estima,tions! of risk and the need
to take a "cons~ervative" approach~ to public health concerns.. This
theme is. illustrated by the followingl quotation from the 1979
report of the Work Group on Risk Assessment for the Interagency
Regulatory Liaison Group of which Dr. Gaylor was a member:
Qauntitat~ve assessment of human cancer risk
can be ba~sedl on epidiemiologic or animal data.
In either case, meth,odological problems, arise
because of the need to extrapolate: from effects
observed under one condition and level of
exposure andi in o~ne population group or
biologica.l system to: arrive at an estimate of
effects exp,ected in the human group or
individual of interest. Becauseextrapolations
a~re involve,dl,, there are unc:ertainties
n,ecessarily atta~ched to. the ca~ncer risk
estimates, tha~t can be ma~de~ with current
m~ethodc~og:ie,s. FUrthermore, un~certa~intJies
arise from other sources, particularly from
attempts to identify accurately conditio~ns andl
levels of expo:sure of the human group or
individual of interest.
Despite the uncertainties involved, risk
estimates can be and are being mad,e, not only
by some regulatory ag!encie~s but by other
scientific bodies. Because of the
uncert a,inties, however, an~d because of the
serious public hea~th consequences that could
ensure if the estimated risk were understated,
it has become common practice to make cautious
a,nd prud,ent assumptions wherever they are n,eed~d
to conduct a, risk a:ssessment. This approach
h~as a precedent in other areas of public health
protection where similar problems arise because
of ga,p:s in knowled,ge. Thus, current
methodologies, which permit only crude estimates
o~f hum~an risk, are designed to a~oid
understatement of the risk. It must
be
recognized, however, th,at there may
be
ci rcumst ance s in, which thi s cannot
be
guaranteed because of other factors that may
enhance human response, such as synergistic
effects.. Because o~ this., risk a,ssessments
should be used with, caution in the regulatory
process..
6Citation: Rodricks, J.V., Anderson, E.L.., Gaylor, D.W., Heller,
R.A.., Keller, A.M., Kov.er, F. and McLa~g,h~lin~, J., "Scientific Bases~
for Identifying Potential Carcinogens and Estimating~ Risks,"
Report of th,e Iinteraq.ency Regulatory Liaso~n, Group (IR~), W,or~
Group on Risk Assessment, 1-113 (.at 7'2-~3) 1979)i
--
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