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 G., Ph.D. (Biochemist, U of Rochester Med. Ctr.)
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
- 1 -
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.
- 5 -
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
--
- 8 -
Similar comments were expressed by Dr. Gaylor and his
coauth~ors in a recent publication prepared for a workshop on risk
assessment in reprodu,ctive andl deve~opmental toxicology. In that
report, they wrote:
CondUcting a: risk assessment is, however,
fraught with, many uncertainties due to a lack
of specific scientific information or knowledg!e
of how. to~ use certain types of data~.. Every
n,ecessary piece: of informat~on cann!ot be
obtained! for every chemical requiring a, risk
assessment; there are just too. many chemicals.
Add!itionally, there is a la,ck of pertinent
knowledge for some of the steps in the risk
assessment process, such as extrapolation from
experimenta~ animals to humans. In, the fa,ce
of th,ese uncertainties, conservative assumptions
by necessity must be made at many steps, in the
risk asslessment process. While
conservative assumptions may lead to a risk
asse~ssment that a~d~quately protects the human
population,~ this. may result in an, increased
financial burden on the public (e.q. ,
manuifa,cturing costs or loss o~f jobs) ; even
then it is impossible to be certain that the
total population will be protected. Conversely,.
errors leadingl to allowab~e exposure levels
which are too high reduce the safety margin
for human hea,lth and increa,se health care costs.
Thu~s., th~ere are compelling public health and
economic rea:son~s to obtain more precise risk
a ssessm,ents ; a~ll assumptions cannot be
compl ete~y el imina,t ed, but the d~g.ree of
uncertainty associated with~ certain specific
assumptions can at least be reduced.
(:Citation: Sheehan, D.M., Young, J.F'.,~ Slikker, W.., Gaylor, D.W'.
and Mattison,, D.R. ,~ "Worksh,op on Risk Assessment in R~eprodu~ctive
and Developmental Toxicology: Addressing the Assumptions and
Identifying the Research Needs, '" Regulatory TOxicology andl
Pharmacology 10(2)[: 110-122 (at I~0-ii~), Oictober, ~989)i
In this same publication,, Dr. Gaylor andi his co-authors also~ address.
thee issue of threshold dose:
The presence of a threshold for the toxic
effects of an agent is. frequently assumed! (EPA
Guidelines, 1986) but is the source of
considerable controversy (Gaylor, et a~l. , ~988)i-
Th,e difference in estimated acceptable exposure
levels can be enormous when usin,g a threshold
model with an un:certa,inty fa,ctor as opposed to
a mathematical extrapolation using any of a
variety of mod,els that do no~t assume a
threshold. (at 113)
He ad,dressed this issue in~ another publication~ that same year:
Most low-diose carcinogenic risk estimates are
based on conservative: procedures designed to
overestimate risks in order to provide public
safety. Notable among, these pro:cedures is the
use of nonthresho~d ~inear extrapolation for
the estimation of tumor risks at low doses.
(Citation : Gaylor, D. W~.., '"Compa,rison of Teratog!enic andl
Carcinogenic Risks," Regulatory Toxicoloqy and Pharmacoloqy 10~2) :
138-~43. (at 1138), Oictober, 19:89).
These qu~otations indicate: that Dr. Gaylor is very aware
of th,e numerous uncertainties an~d difficulties in making risk
assessments and in extrapolating! animal data to the human, situation.
Noneth~eless, he adheres, to the qov.ernment position~ on these matters
as illustrated by the following statement he ma,de~ to the press
earlier this. year regardling the FDA po~sition on "zero risk":
Our position is that linear do:se extrapolations
are the only ones we can justify as a general
principle. ~t's a default position unless
there is convincing evid,ence to the contrary,
which there rarely is.
(Citation: Gaylor, D.W.., Quoted in "Measuring Chemicals' Dangers:
To:o Much, Guessw,ork?,~" The Washinqton Po:st, A-3, March, 26, 1990)
Ba~sed on these comments, it can be assumed that even,
thou~gh Dr. Gaylor is cog~nizant of the shortcomingls of stu~dies such
a:s the draft EPA r~sk assessment report, h,e will follow officia~l
government position that a conservative approach is ne,eded in
matters that may impa,ct public: health.
E. Marshal~ Johnson~
Dr. E. Marsha~l J, ohn~son is. a, member of the Environmental
Mea~ith, Committee of the Scien,ce Advisory Board for the United States
Environmental Protection Agency. Me was born in I~linois. in, 1930
and receivedl his. Bach,elor andi Master's Degree from Texas A&M
University. H~is Ph.D. in anatomy was conferredi by the University
of California at Berkeley in 1959. At the present time,~ Dr. Johnson
is Chairman of the Diepartment of Anatomy of the Jefferson~ Medical
College at Thomas Jefferson University in Philadelphia. H,e is
also Director of the Daniel Baugh ~nstitute of Anatomy.
Dr. Johnson's publications in~dicate that the bulk of his
research has been in the field o~f experimental teratology. His
other areas of expertisein~cludereprodu,ctive phy.siology, molecu!lar
biology, electron microscopy and h,istochemistry.
Dr.. Johnson's writings do not indicate that he has any
interests in smoking or environmental tobacco, smoke. H,e ha~s
presumably been named to the Environmelnta~ Health Committee because
of his work on teratology (d,efined as that dlivision of embryology
and pathology dea,ling with abnorma,l development and con~genital
malformations). He seem~s to have no background in thie smoking~ and
hea~th debate.
His writings have shown concern that concepts and
terminology from carcinogenesis research not be inappropriately
ass~ociated with toxicology. "Lay perslons tend to think of birth
defects in thee same frame of reference, as cancer: carcinogen/non-
carcinog!en,~ teratogen/non-teratogen~,''~ Dr. Johnson writes in~ a,
letter to the editor of th,e jiournal Teratoloqy in, 1986. "Dosage
or exposure level is rarely considiered .... Though the exposure
may hav.e been trivia~l andl though the ch,emical in question ma,y bare
a low adult-to-d~v.elopmental toxicity ratio, there stil~ exists
the background 2-3% probability that a structurally abnormal ch~ild
will be born. Th,erefore in the context of safety eva:luations,
the designation of teratogen shouild be used dlifferently than is
the designation, carcinog,en."
In con,clusion,~ Dr. Johnson seems to have no strongly
h,eldi person~al views, against toba,cco smoking but d!oes hav.e well
developed views on teratology, which may explain his appointment
to. a board dealing with environmental toba,cco smoke issues.
Nancy K. Kim
Ava,~lable biographical information on Nancy K. K~m dDes.
not diescribe h,er a,cad,emic and professional background. She is.
currently the Director of the New York Department of Hea~th,
Division of Environmental Health.
Nancy Kim has one article (published in two pla,ces) that.
mentions! the smoking and health issue:. In "Air Pollution.
Evalu~ations Using Risk Asses:sment Meth,odology''~ (11981), shoe writes:
Voluntary risks are those risks to: which, we
knowingly and willingly subject ourselves;
examples, are smoking, drinking, overeating.
Involuntary risks are tho~se risks to which, we
are exposed and can n,ot control; examples are
breathing polluted air. . Smoking,. a
voluntary risk, is associated with a large
in,creased risk of mortality from lung or
bron!chial cancer. A perso~n~ smoking 0.00,05
ciga~rettes per day h,as an~ increased risk of one
in a mil~ion, of dying from lung or bronchial
cancer; a perso~n smoking one pa,ck of cigarettes
per day has an increased risk of 41 in 10i0,.
Many newspaper articles, were: found that quote Kim due to
h,er role w.ith the New. York Department of Health. A 1981 Associated!
Press article about the sa,fety of eat~ngl fish, frolm Lake Onta,rio
states:~
Dr. Nancy Kim:, a Health Department toxicologist,
once compared the d~c~sion to eat Lake Ontario.
fish with the decision to~ smoke a ciga~rette ....
a~ithough she agreed fish are far ~ess dangerous
tha~. tobacco.
The rest of th,e newspaper articles discuss variou!s environmental
hazards, but do not mention tobacco smoke in~ any context.
Martha Jesse Radike
Dr. Martha Radike is a, 7.0 year oldi biologist/researcher
at the Universilty of Cincinnati. None of the standard biograph,ical
resource~s had~ listing for Dr.. Radike; however, she and h,er sister,
Dr. Ma,ry Jame Jesse (Head of the Division of Hea~rt and Vascular
Disea:ses, National Institute of Mea~ith in the late 1970"s and early
1980's)i, were profiled in a book published in 19~80 entitled The
Late Bloomers. After raising six children, and pursuing a pa~rt
time~ career as a professional musician, Dr. Radike went ba~ck to
schooll in~ 1965 and by 19174 had earned her Ph.D. in Biology and
Biochemistry from the University of Cincinnati.
Dr. Rad!ike has published over 2:0 papers sin~ce the mid,
1970's. The bulk of her published! research is on the toxicity
and mutagenicity of a variety of inhalants, in~cluding benzo(a)ipyrene
and polycy'clic aromatic hydrocarbons. Dr. Radike has also done
work on th,e toxicity of fluoride., viny~ chloride and ethanol.
None of Dr. Radike's resea~rch is. specifically smokingl and heallth
related. The only clue to her view.s, regarding smoking comes from
a sign located in h,er kitchen which reads, "Smoking! Can Eat Your
Lungs Alive. "
Dr. Radike co-a~thor.ed the fina~l draft of a report
entitled "Drinking Water Criteria Document for Endrin" which was
prepared for the Environmental Criteria andl Assessment Office of
the EPA' s Cincilnnati reglion.
Stephen M. Rappaport
Dr. Stephen Morris. Rappaport has been affiliated~ with
the School of Public Hea,lth. at the University of California in
Berkeley sin~ce 1976.. He was an Assistant ProZessor there from,
1976-82 and ha,s been an Associate Professor of Industrial Hygien~e
since 19.8.2. His field o~f expertise is indUstrial hygiene; most of
his research during the 1980"s was related to chemical and other
exposures iln the workplace. He has performed research on suspected
mutagens related to chemical exposures, dies:el exhaust particulates,
other airborne particulates in, urban areas, and the effects of
variQu:s toxic substances in the wo~rkpla,ce. Cigarette smoke or
tobacco, exposure was not include,d in any of the publications
reviewed, unless it was to mention, that the subjects' smoking! habits
were taken into consideration, as a control factor.
In 1980, Dr. Ra~paport and two co-researchers performed
their own study and then prepared a commenta[y regarding a dlecision
by the U.S. EPA to examine diesel exhaust products for carcinogenic
andl other toxic properties. They conclud,ed that the mutag!ens found
in diesel exhaulst products may represent a new, unrecognized class
of environmental mutagens. However,~ the: fact that th,ese products
were mutagenic a,s conclud,ed by the Ames test method was not
sufficient to imply health hazards to h~mans; the mutagens needed
to be ~d.entified andl thee toxicology of the pure substan,ces
investigated in ordier to reach~ any definite: conclusion,s.. This
research wa~s supported in part by NIOSH and th,e Northern Californ,ia
Occupational H,ealth Center.
During the late 1970's, Dr. Rappaport wa:s involved in
research regarding particulate matter in city air, specifically
mutagens found in auto exhaust. This research was prompted in
part by the re,searchers' observation of a higher incid,ence of ~un:g
cancer in, urban dwellers that th~ey could not entire~y explain by
the in~dividuals ' smoking habits. Dr. Rappaport and his co-
researchers noted that air pollutants were suspected as contributing
factors for lung~ cancer. The substances tested to determine
potentia~ mutagenicity includ,ed used and! unused motor oil, fuels,
car and engine exhausts, and air particulate matter. All these
substances, with the exception of unused m~otor oil, were found to
be mutagenic when, the Ames test wa:s applied. This work was also
supported by a grant from NIOSH~.
Some of Dr. Rappaport' s additiona~l research in~ the areas
of occupational exposures and dliesel exhaust emissiolns ~nclu~d~d an
assessment of the ha,zards of comtinuous exposure to. a,cutely toxic
chemicals in the occupational environment. He was also: involvedl
in a study regarding the formation of mutagens produ~cedi by cooking!
beef at various temperatures. In this study, he found that a small
percentag!e of mutagens remained in the meats a.fter they were cooked,
but most eslcaped into the air around the co:okiing process. One of
the purposes of this research was to inv.estig~ate the excess of
lung an~dl bladdier cancer among cooks and kitch~en workers (~after
being, adjusted for smoking habits). In 19~6,. Dr. Rappaport was
also involved in a presentation at the annua~l American Conference
of Governmental Industrial Hygienists; the symposium was related
to workpla~ce control of carcinogens.
In a 1982 publ~cation, Dr. Rappaport and his co-authors
discussed and evaluated OSHA. standards for workers'~ exposures to.
airborn,e chemicals and particulates. The authors' '"critique" of
OSHA and the work o~f industrial hygienists in general stated that
the current standardis for monitoring toxic substances in the
w,orkplace were focused primarily on leg~al standards that were
incompatible with the collection of clinically useful data. The
shortcomings in, the legal criteria used by OSHA were identified
as: 1 ) Compliance was d~ fined in terms of absolute a~ir
con~centrations; and 2) Averaging! times for monitoring airborne
chemicals that pro~d~ced chronic effects were basedl upon
inappropriate time va~lu.es. Thie authors suggested one solution to
the problem, would be to adopt more flexible regulatory standiardS.
They also stated that hygienists, physicians and toxicologists
(whose work is currently at "cross-purposes") should make an effort
to w,ork tog!ether to, develop effective,, flexible environmental
monitoring strategies that would comprehensively protect workers,
rather than defining! the issue of exposure in a narrow legal
framework.
Dr. Rappaport co~autho~red a chapter in Chemical Hazards
in the Workpla,ce: Measurement and Control, American Ch,emica~l
Society, 1981. The book wa~s based oln. a symposium sponsored by a
division, of ACS. Dr. Rappaport's chapter, "An Evaluation of
Statistical Schemes for Air Sampling,'" discussed th,e c:ollection~ of
air sampling data in the field of industria,l hygiene. He and h~s
co-authors analyzed the air samplingl scheme d~v.eloped! by OSHA and
NIOSH to determine compliance with regulatory standards. The
authors concluded this scheme ha,d! limited scope and was poorly
suited to be used as a, d,ecision-making tool regarding acceptable
occupationa~ exposure levels. The authors dliscussed other possible
sampling schemes. Once a,gain, cigarette smoke or tobacco exp:osure
was not mentioned in the eva,luation.. This work was supported! by the
Northern Ca,lifornia Occupational Health Center.
Most recently, an article in the May 9', 19,90, issue of
the Lo~s Anqeles Times reportedl that a research team ledi by. Dr..
Rappaport had refined a process to trace human gen~etic mutation~s
in white blood cells ba,ck to~ a s~ng~e chemical, possibly helping
to establish a link between~ a ha,zard,ous chemical and human disease.
Kccording to, the a~rticle,, if this. technique ~s refined, it may
lead to more definitive ways to sort o~t human health, claims, as a
result of exposure to su~spected carcinogens and other toxic
chemicals. One example ment~onedi ~s that asbestos could be studied
to determine its precise effects upon workers exposed to. it. The
original technique was d,ev.elopedl by a"chemist, Kurt Randerath, in
~981. Dr. Rappaport and his team, adapted and: refined the process.
Randerath used the origina,l technique: to lo:ok for g!enetic damag!e
as the result of cigarette smoke, but the "many toxic substances"
~n tobacco made it ~mpossible to. link a. specific chem!ical w.~th, a
specific change, accordiing to Dr. Rappapolrt. Dr. Rappaport and
his team are currently using the techniquie, to stuldy the exposure
of fa,ctory workers to styrene,, a synthetic chemical ambient in the
air at a California plant. Iif further refined, Dr. Rappa~ort
believes the procedure could become a g!oodi tool to monitor expo:sure
to other hazardous chemicals in the w,orkplace. The article n,oted
thiat Dr. Rappaport andl his team discussed the,se findings at a WHO
international symposium on cancer epidemiology in H,elsinki, F~nland,
during 1989. Presumably, he is now spending th,e majority of h~s
time on th~is project.
Dr. Rappaport has been involved in at least two prior
evaluatio~ns of research performed by or standards used by
g!overnmental a,gen,cies. He was involved in a review of the EPA's
research into: d!iesel exhaust products, a~nd wa~s. later involved in, a~
review, of the standards used by OSHA and NIOSH to d,eterm~ne
a,cceptable: ~ev.els of workplace exposures.. Th~s, Dr. Rappaport has
had some experience in evaluating governmenta,l systems andl
standa,rds, even, thou,gh these evaluations have not specifica,lly
related to cigarette smoke or tobacco.. Dr. Rappapo~rt's research
gives no ~ndication of his opinions relating to a,ctive smoking or
ETS issues. It cannot be determined from available publications
whether he may have any strong opinions in the areas of cig!arette
smoke or tobacco exposure; however, there is no. indication in any
of his background information, of any bias or lack of objectivity
in this regard. "
Bernard Weiss
Dr. Bernardl Weiss is Professor of Toxicology and Deputy
Director of the Environmental Hea~lth Science Center, Univ.ersity of
Roch~ester, position,s h~e has held since 19179. He wa,s a,ffiliated
with John,s Hopkins University School o~f Medicine from ~96i5. through
1979. Dr. Weiss received his Ph.D. in 1953 in Psychology from th,e:
University of Rochester. He lists h~is expertise a,s being in
toxicology and behavioral pharma,co~ogy and his research, interests
as. chemical influences on behavior.
Dr. Weiss has been a, member of the EPA'sScien,ce Advisory
Board since 1.98!3. He was a member of the National Academy of
Science/National Research C~uncil's Committee on the Biologlical
Effects of! Atmospheric Pollutants from 1971 through 19~4. Dr.
Weiss has served on a number of g~vernment panels and committees
for a variety of agencies. He was! a member of the EPA panel which
published the final health~ assessment report ~n n~ickel in 19.86
an~dl on diichlo~omethane/methylene chloride in 19:85.
Dr. Weiss ha,s. over ~50 publications and is considered by
some to be one of the: founders of the specialty "behavio~raL
toxicology"', which he defines a:s the "~recognition that the a,dverse
health impa~ct o~ environmental chemicals should be gau,ged by how
people feel and function~, no~t solely by ~ieath or overt damage."
Interestingly, Dr. W,eiss co-authored! the first, major book on
behaviora~l toMicology in 1975 with Dr. Victor Laties, a member of
the IAQ/Tota~ Human EXposure subcommittee. They have published
together since~ at ~ea,st 19~63.
Dr. Weiss has not publish~ed anything specifica~lly, related
to. smoking an~ health. Thee majority o~f his publications are on
the behavioral response to a wariety of heavy metals (~ea,d, cadmium,,
mercury, nickel, etc.) and ozone, the effect olf fo:od a,dditives
(iincL~ding foodi colors) on ch,ildren, andi the ulse of computers in
behavioral research. Dr. Weiss recently published a paper entitled
"Neuro-Beh~avioral Toxicity as a Basis for Risk Asseslsment"'.
Dr. Weiss testified for the pla,intiffs in a 1986 su~it in
Oregon brought again:st Chevron, a,lleging permanent brain damag!e
caused by exposure to various solvents,, thinners and paints. Th,e
jury returned an unanimous verdiict for the defendants in the case..
Ronald Edward Wyzga
Dr. Ronald Edward Wyzga, was born in New Bedford!,
Ma:s:sa,chulsettsin 19~4i2!. His undergraduate work was dione at H~arvardl;
he received his M.Si.~ from Florida State University and h,is SC.D.
from Harvard in 1971. Dr. Wyzga has servedi a~s Project Manager,
Electric Power Research, Institute,. since 1905.
A list of publications indicates that Wyzga's area of
interest has been enviro~nmenta~l research, risk assessment and
control strategies. Much of his wo~rk focuses on damage to the
environment from aerosol p:o~utants such as sulfur oxides,. One
article written in the late: 1970s wa~s a cost-benefit analysis of
particula~te matter control: "In all nations the resources that
can be expended for any kind of protection are finite
environmental-pollution-control expenditures buy only a finite
amount of hea~lth~ benefit." He called for a focused program, which
would yield measurable h~ealth benefits to. justify regulatory c~ntrol
costs.
Wyz~a has consistently notediprob~ems a:ssociated with the
findings and methodology of studies d~sfgned to assess! risk from
environmental air pollutants, alth~ou,gh it appears that he wou~d
accept the results of a, "well-design~ed" study. Despite potential
problems, he apparently believes tha~ epidemiologfca~l data a,re
appropriate, for ~ndicating whether a chemical isa human carcinogen
and also that animal data may be used to predict the carcinogenicity
of chemica,ls in humans. Wyzga, recognizes th,e validity of attempts
at qu~antification of uncertainty in ca,rcinogenic r~sk estimates,
providing factors a~re controlled to the extent possible, andaccepts
Bayesian estimation, techniques (:also favored by another committee
member,~ D.. Warner North).
Dr. Wyzga authored a chapter titled, '"The Role of
Epidemiology and Risk Assessments of Carcinogens'" in Risk Assessment
and Risk Manaq,ement of IndUstrial and Environmenta,l Chemicals
(19:88). Wyzga listed problems in the ulse o~ epidemio~ogy in risk
assessment and su,ggested h,ow these problems might be han~dled.
Smoking is ad,dressed several times: during a d~scussio~n of death
rates for respiratory cancer among nickel workers (i"~high~y
associated with smoking"),; as: an exception, to: "the assumption
underlying most can~cer models used in ris~ assessment thiat deviation
from ad~tivity or intera,ction ~s negl~gible ~or exposures to
carcinogens encountered undler ambient conditions" (smoking can be
synergistic with olther all!eged carcinog,ens)i; and, as a caution, ~
that study results must be adjustedi folr smoking behavior s~nc~e:
smoking, is a confounding variable iin risk assessment, stu~dies. The
chapter contained no references to E~S.
As a va~idity check,~ Wyzga counseled that a sense of
perspective be appliiedl when assessing the significance of
- 18 -
epid,emiological studies. Although anima,l bioassays are an uncertain
predictor of thee effect of a contaminant on~ humans., animal study
results: that are consistent with human epidemiological studies may
increa,se conf~d,ence in the epidemiology results.
Wyzga. co-a~thored a chapter of Principals of Health Risk
Assessment (1985) titled "Interspecies Comparison for Carcinog!enic
Potency in Humans," in which the authors noted the w,eaknesses of
EPA criteria, for adjlustingi research models to fit experimental
data. The criticism is rather mild overal~; the authors
characterize the EPA. approach a~s. a "g!eneric" olne which "mu~st be
considered only a very cru.d~ approximat~o~n."'
Donald G. Barnes
Dr. Donald G. Barnes has been a~ffiliated with, the
Environmental Protection Agency since at ~ea,st ~981. No
biograph~ical information, is available for ~r. Barnes; how.ever,
through various press references and publication information., it
appears that Dr. Barnes has been the D~rector of the Science
Advisory Board of the EPA since early 1988.
Dr. Barnes is frequ,ently quoted by the press reg~ardiing
the EPA's po:sition on scientific controversies. He served as once
of the principal spokespersons on the dioxin issue~.
In newspaper c~fps, Dr. Barnes is described as
"Scientific Advisor to the Assistant Administrator for Pesticfd.es
an!d Toxfc Substances o4 the EPA" and "Chairman, EPA's Chlorinated
Dioxin. Advisory Group. ''~ Dr. Barnes has also been d~scribed as a
"chemist. ''~ A March, 1989 reference to Dr. Barnes i~dicated that he
has worked with Arthur Upton: on a panel to review the
carc~nogenicity of lead.
d!iolxins.
Mo:st of Dr. Barnes'~ publications are EPA reports on
102~03~41
U.S. ENVIRONMENTAL PROTECTION AGEN!CY
SCIENTIFIC ADVISORY BOARD
ENVIRONMENTAL H!EALTH COMMrITEE
Chairman
Dr. Arthur Upton
New York University Medical. Center
Institute of Environmental M,edicin~e
550 First Avenue
Room M'S:B-213
New Yo~k, NY li0016
~ce Chairman
Dr. D. Warner North
Members
Principal, Decision Focus; .Inc,
Los Altos Office Center
Suite 200
4984 Ell Camino Rea~
Los Altos, California 94002
Dr: Gary P: CarlSon
Department of Pharmacology and Toxicology
School of Pharmacy
Purdue University
West Lafayette, Indiana 47,9107
Dr., David Gaylor
Departmen~ of Health & Human Services
Food and Drug: Administration Building 15
National Center for Toxicological Research
Jefferson, Arkansas 72079
Dr. El. Marshall Johnson
Dr: Nancy
Professor, Department of Anatomy
Jefferson M,edieal! College
1020: Locust Street
Philadelphia, Pennsylvania 19:107
K. ~m
Director,. New York Department of Health,
Division of Environmental Health
2! University Place
Albany, New York 1!2203.
Dr. Martha: J. Radike
Department of Environmental Health
Medical Center
University of Cincinnati
3223 Eden Avenue,. ML # 56
Cincinnati,. Ohio 45267'
Dr. Stephen M. Rappaport
Department of Biomedical and Environmental Health Sciences
Earl Warren Hall,. Room 317'
School of Public: Health
University of Califo:rnia
Berkeley, California 94720
Dr. Bernard Weiss
Professor, Division of Toxicology
P.O. Box RBB
University of Rochester
School of Medicine
Rochester, New York 1!4,642
Dr. Ronaldi Wyzga
Electric Power Research Institute
341i2. Hillview Avenue
P.O.. Box: 11041
Palo: Aim, California 94303
Executive Secrcta~.
Mr. Samuel Rondberg
U2S.. Environmental Protection Agency
Science Advisory Board
499' South Capital Street,~ SW
Suite: 508 (A101F),
Washington, DC: 204i60
Staff Secreta~. :
Mrs. Mary L. Winstion
U.S. Environmental Protection Agency
Science: Advi,sory Board
499: South Capimll Street, SW
Suite 508 (A101F)
Washingtion; DC 2:0460:
Director, Scien,ce Adviso~_ Board
Dr., Donald G. Barn~es
U.S; Environmental Protection Agency
Science Advisory B0:ardl
401 M Street, SW
Washington, DC 204601
