450R80102
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GRIFT OF PROCEEDINGS
U.S. ENVIRONMENTAL PROTECTION AGENCY
PUBLIC HEARING
PROPOSED NATIONAL EMISSION STANDARDS FOR
IDENTIFYING, ASSESSING AND REGULATING
AIRBORNE SUBSTANCES POSING A RISK OF
CANCER AND ADVANCED NOTICE OP PROPOSED
GENERIC STANDARDS.
n.oorn 20 3
Post; Office & McCorrnack Eljd
10 Post; Office Square |
Boston, Massachusetts
Wednesday, March 1&, 1930
9:00 a.m.
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450R80102
U.S. ENVIRONMENTAL PROTECTION AGENCY
2 PUBLIC HEARING
3
4 PROPOSED NATIONAL EMISSION STANDARDS FOR
IDENTIFYING, ASSESSING AND REGULATING
5 AIRBORNE SUBSTANCES POSING A RISK OF
CANCER AND ADVANCED NOTICE OF
6 PROPOSED GENERIC STANDARDS.
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Room 208
10 Post Office & McCormack Building
Boston, Massachusetts
II
Wednesday, March 12* 1980
9:00 a.m.
13
14 BEFORE: Merrill S. Hohman, CHAIRMAN
Roy E. Albert, C)-CHAIRMAN
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16 PANELISTS:
17 TODD M. JOSEPH, Esq.
ROBERT G. KELLMAN
18 DAVID R. PATRICK
JOSEPH PADGETT
19 ELIZABETH L. ANDERSON
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Room 208
J.W. McCormick Building
Post Office Square
Boston, Massachusetts
March 12, 1980
Speaker
Organization
/Richard Wilson
/Anthony Cortese
•'Rose Caterino
ftiavid Ozonoff
Charlotte Ploss
*Ed Calabre'se
/Peter Fairchild
Oohn Groopman
Helena Brown
^Wayne Jaeschke
-John Ronan
^Sheldon Krimsky
«^Ken Nelson^
Kfohn Barr v
*^ill Cavellini^
—Grego
•RepreserrfcffH1
KioRichard Thompson1^
/ »-Wi 11 i am Mendez y
American Industrial Health Council
Massachusetts Department of Environ-
mental Quality Engineering
Somerville United Neighborhood
Individual
Mission Hill Planning Commission
Individual
Air Use Management
Individual
Individual
•St auf f e
Coordinated
Stauffer Chemical
Stauffer Chemical
Individual
ASARCO
Air ProductsJK
Cambridgefwt ofTHJirr fiJtiO.'K
Individtral—**
Fr4ends-o£-the-Earth-
Sierra Club
Individual
Regional Cancer Control Committee
Massachusetts League of Women Voters
Brook!ine Citizens to Protect the
Environment
•Robert Oabrow'-^
Krupp- v^
RoproGontativo-^
i/Eci Loechlerv^
Connecticut Fund for the Environment
^Rhys-ifciano-for S&e4-a4-Re&pQrmtnlity—
Individual
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ATTENDEES
PUBLIC HEARING--Proposed Airborne Carcinogen Policy
narui
\yo\J
BOSTON MA.
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ATTENDEES
PUBLIC HEARING—Proposed Airborne Carcinogen Policy
BOSTON MA.
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ATTENDEES
PUBLIC HEARING—Proposed Airborne Carcinogen Policy
riarun it,
BOSTON MA.
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ATTENDEES
PUBLIC HEARING—Proposed Airborne Carcinogen Policy
March 12, 1980
BOSTON MA.
! NAME
ORGANIZATION
TELEPHONE |
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T_ N D E X
WITNESSES; Page
Merrill S. Hohman, Introduction 2
Dr. Richard Wilson 6
Dr. Anthony Cortese 51
Miss~Rose Caterino 65
Dr. David Ozonoff 67
Miss Charlotte Ploss 84
Dr. Edward J. Calabrese 93
Mr. Peter Fairchild 109
Dr. John Groopman 113
Miss Helena Brown 122
Mr. Wayne Jaeschke 128
Mr. John Ronan ' 157
Mr. Sheldon Krimsky 171
Mr. Kennetn W. Nelson 176
Mr. John T. Barr 187
Mr. Bill Cavellini 212
Mr. Richard Thompson - 218
Mr. William Mendez 226
Miss Barbara Pegan 238
Mr. Fred Krupp 254
Mr. Ed Loechler 273
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MR. HOHMAN: Good morning. I'd like
to declare this public hearing open. I am Merrill S.
Hohman, the Director of the Air and Hazardous Materials
Division, EPA, Region One.
This is a public hearing to receive
comments on EPA's Airborne Carcinogen Policy and EPA's
advanced notice of proposed rule-making for generic
standards for sources of carcinogenic organic substance^,
both documents as published in the Federal Register on
October 10, 1979.
Today's hearing is the second in a
series of three public hearings. The first was held
in Washington, D.C. on Monday and Tuesday of this
week, and the final session will be in Houston, Texas
tomorrow.
The record of this hearing is open
until April 14th for any supplemental testimony anyone
wishes to make or any comments anyone wishes to make
in rebuttal to the testimony we hear.
Let me introduce the panel, and I'll
start on my far left is Bob Kellam, Standards Division,
Office of Air Quality Planning and Standards, EPA;
next to him, Roy Albert from the Cancer Assessment
Group, EPA; on my immediate left, Joe Padgett, Strate-
gies and Air Standards Division, Office of Air Quality
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Planning and Standards; on my immediate right, Todd
Joseph, Office of General Counsel; next to him, Eliza-
beth Anderson from the Office of Health and Environmenta
Assessment; and David Patrick from the Emission Standard
and Engineering Division, Office of Air Quality Planning
and Standards.
The gentlemen and lady in back of us
are representatives of Clemment Associates, a consulting
firm engaged by EPA to assist in developing this policy.
We also have three EPA staff people here available to
help you. They're at the back of the room; Frank Kerwin
Margaret McDonough and Joe Bedilcia (phonetically). If
any of you have any problems or need help in finding
your way around or in any other way, they're available
to help you.
Let me very briefly cover the ground rule
for today's hearing. The hearings are informal. Indi-
viduals providing oral testimony will not be sworn, nor
are there any formal rules of evidence to be followed.
Following the testimony, questions may be posed by the
EPA panel members, but there will be no cross examinatio!
by any other participant.
Questions from other participants may be
submitted for consideration by submitting them in
writing to me and then we'll consider those at that time
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and there are blank cards down at the back of the room
if you want to write your questions out.
We are asking, because we have a long
length of speakers, that all participants please try to
limit your oral presentations to no more than ten minutes
that any more detailed statements and any referenced
material that you refer to in your statement should be
submitted for the record.
We have made special arrangements for the
first speaker today to have more than the ten-minute
time, but unless other arrangements are made by others,
we're asking you to limit it to ten minutes.
When you come up to testify, please give
us your name and the organization, if any, that you
represent. Also, if you have copies of your statement,
please give them to the hearing staff down at the back
of the room.
These proceedings are being recorded by
a court stenographer and a verbatim transcript will be
prepared. Copies of that transcript will be available
for inspection at the EPA Regional Office Libraries,
including the one here in Boston at the John F. Kennedy
Building, and at the EPA Central Docket Section in
Washington, D.C. If anyone wishes their own copy, please
contact the stenographer directly.
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1 In the back of the room, we do have
2 copies of the Federal Register with the proposed policy
3 and advance notice of proposed rule making. There is an
4 index, I believe, of written comments received to date
5 on the policy, a listing of the hearing speakers and the
agenda for today's hearing.
7 We will call witnesses in the order on
8 that agenda. If any witness that is scheduled to
testify knows of any delay, time conflicts that might
give a problem, again, please see the hearing staff at
,, the rear of the room.
,« If there is anyone who needs any audio-
visual equipment for your presentation also, please
contact the hearing staff down at the back of the room
as soon as possible so we can make arrangements.
With that introduction, I'll call our
16
first speaker, Richard Wilson, representing the American
Industrial Health Council.
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MR. BAYS: Mr. Chairman, I'm Jerry Bays
(phonetically), associate counsel for AIHC and we have
been working with Dr. Wilson for the last few weeks with
respect to his testimony and we just have not had time
to get copies made for the panel as we had yesterday and
the day before in Washington, D.C., but we shall have
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copies made within the next few days and submit them for
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the record since it is a fairly lengthy submission. For
being unable to submit it today, we apologize.
DR. WILSON: Good morning. My name is
Richard Wilson. I'm a professor physics at Harvard
University and although I was asked to give this testi-
mony by the American Industrial Health Council, what I
say is going to be my own opinion and the comment that
I've had from the American Industrial Health Council is
solely what other people have been saying on their
behalf, and a correction of one or two pieces of my
English. In no case have they adjusted my opinions.
Firstly, I agree with the general dis-
cussion in the Federal Register on the problems of
carcinogens, but I want to point out that I disagree that
they should be logically regulated in a very distinct
way from other air pollutants such as sulfates. For
neither sulfates nor carcinogens is there proof of a
threshold below which adverse health effects are zero.
I've reviewed all this in a forthcoming book on air
pollution through coal burning and in particular, can-
cers caused by polycyclic aromatic hydrocarbons and by
radiation, and I append those chapters from the book to
the testimony. I believe there is evidence that air
pollution may cause cancer, at least among cigarette
smokers and the number of cancers is no more than about
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1 one or two thousand per year.
2 These will be caused by polycyclic aro-
3 matic hydrocarbons which are produced by incomplete
4 combustion. Coal used to be the source; now it is
5 mostly automobiles. If we are not careful, wood burning
6 will be the new major unregulated hazard. And now I
7 agree that for other cancers, we cannot wait until
8 people are dying before we take action.
9 Now, the procedure for using animal fats
10 which I want to discuss is by analogy, as for example
11 discussed in a paper by Crouch and myself which is
12 published and I attach to the testimony. I find no
13 direct evidence that any cancers are caused by the
14 chemical industry of more than ten a year. Calculations
15 show that no direct cancers of any cancers are caused
and calculations show no more than ten per year from
17 the chemical industry.
18 Even in the case of vinyl chloride, which
19 is regulated, an upper limit of ten environmental cancer
20 was derived from old exposures from EPA and these expo-
sures are now reduced by a factor of 100. I have checke
22 the EPA calculations. So, EDF and NRDC in its submissio
23 claimed that air dispersion calculations are too inaccu-
24 rate to be useful, but if you look at the calculations,
25 they are accurate to within a factor of 2, which is
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quite good enough to be used for this. Less than 5 or
less than 10 is not the question of issue here.
We can also estimate from work of Blot
a moderately large number of cancers, in the tens per
year, might come from arsenic if the Blot data is corred
though Blot thought my estimate from that of 30 per year
was a bit too much. And I point out that arsenic from
coal burning produces as much environmental arsenic as
from anywhere else and is unregulated.
Now, I want to proceed — leaving that —
to what I think is a logical structure for control, and
I will quote a statement by Mr. Train who used to be
my boss on May 25, 1976.
"I believe that it is important to empha-
dize the two-step nature of the decision-making process
with regard to the regulation of a potential carcinogen.
Although different EPA statutory authorities have differ-
ent requirements, in general two decisions must be made
with regard to each potential carcinogen. The first
decision is whether a particular substance constitutes
a cancer risk. The second decision is what regulatory
action, if any, should be taken to reduce the risk.
"Once the detailed risk and benefit
analyses are available, I must consider the extent of
the risk, the benefits conferred by the substance, the
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availability of substitutes, and the costs of control
2 of the substance. On the basis of careful review, I
3 may determine that the risks are so small or the benefit
4 so great that no action or only limited action is
5 warranted. Conversely, I may decide that the risks of
some of all uses exceed the benefits and that stronger
action is essential."
It is important to start with a struc-
ture such as this because even though there are infor-
mation gaps in the structure, without a structure illogi
cal actions may be suggested.
Firstly, it is clear from the general
,, wording of the proposed rule that the desired result
,, is the improvement of public health. It is important
. that we want to use our efforts to improve public health
.. in the best possible way, although we may not always
lo
._ quite know what it is. We may not be able to find that
optimum, but we can put bounds on what's sensible and
lo
rule out some foolish procedures.
Now, I want to show how a logical struc-
ture can sometimes lead to a risk benefit analysis when
information is available, on occasions when the risk is
very high, one can even sometimes justify best available
control technology — though I don't like it — but
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never can one justify zero risk.
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Now, although on Page 58654, Section D,
the EPA outlines a sensible proceudre for risk assess-
ment which roughly corresponds to mine, they seem to
reject risk benefit analysis in what I call a very extra
ordinary section on Page 58658, which I would like to
discuss.
Firstly, in the third column of that
page, the logical structure seems to be rejected and
a straw man set up in the paragraph, "Cost Per Life"
goals. It stated incorrectly that, "the basic assump-
tion is that it is appropriate to assign a single mone-
tary value to human life." I think that's an incorrect
assumption of risk benefit analysis. It's true that if
one does assign a monetary value to human life and does
a cost benefit analysis, one has a workable algebra.
But it is not necessary to assign any value to life —
and certainly not a single one — to have a workable
rish benefit calculation.
What is necessary is to decide how much
society wishes to pay in effort, other lives, and other
currencies such as money, to save lives. Society cannot
pay more than it has — however mush it may wish to do
so — whatever the "value" of human life. If I was
asked to pay a million dollars ransom for my children
and only had -- or could only borrow — a couple of
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1 dollars, I couldn't save their lives no matter what
2 their value.
3 There are indeed ethical problems in
4 discussing the value of a life, as pointed out by the
5 administrator, but discussion of these can be to a
considerable extent avoided by proper restriction to
7 the discussion at issue, and not allowing the discussion
8 to wander into addressing unnecessary decisions.
9 There are far bigger ethical problems
in spending all society's substance in trying to prevent
a circumstance in which one life might be lost and
leaving none for anybody else, and it is important to
13 remember that the whole discussion in this application
,, of the Clean Air Act is hypothetical; no one can tell
15 for sure whether even one life will be saved by reducing
the small exposures of the chemical industry, whatever
17 the expense. As shown below, some lives have been and
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will be lost by trying to reduce them. Ignoring the plees
19 from others whose need for society's substance is as
great or greater is grossly immoral.
Now, also stated in the column, "the
internalized and externalized expenditures for protec-
tion of human lives in American society ranges across
. . a vast spectrum, " but EPA does not prove that this range
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is not due to ignorance and incompetence of regulators
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and merely states that it is due to variations in desires
of the American people. I doubt that that's true. But
even if the EPA implications were right, that does not
rule out a proper risk benefit analysis. It merely
points out that in some cases society wants the benefit
to exceed the risk by much more than in other cases and
that no one number can suffice to account for society's
willingness to pay — a set of numbers must be used.
A rationale for one such set has been given in a paper
by Howard of Stamford University.
The administrator's next sentence is
also a straw man. Any good risk benefit analysis does,
"consider the balance of equities between those benefit-
ting from the activity creating the risk and those who
may die as a consequence of the activity." This is some-
times called disaggregation of the risk benefit balancing
We might have several analyses for different subgroups.
The way society balances these matters can vary in
different cases; a reduction of real estate tax for
those living near a polluting plant which is much
greater than for someone living further away. We tra-
ditionally treat occupational exposures differently from
the environmental ones. This sentence also seems to
deny the possibility of carrying out the risk analysis
demanded on another page, 58654, 2nd Column, Section D
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1 1 (e).
2 Finally, the administrator sets up a strav
3 man in implying that a sensible risk benefit analysis,
4 "ascribes more certainty to the risk assessment and cost
5 estimates underlying its use than is justifiable." This
5 may be true of EPA and possibly of FDA, but it is cer-
7 tainly not true in general. I append to this testimony
8 some notes on uncertainty in calculation of risk which
9 I presented to the FDA addressing this very question.
10 This section seems to be trying to satis-
fy others who (incorrectly) oppose risk benefit analysis
on this ground. One common statement is that since risk
assessments are uncertain by a factor of a million, then
they are of no use. In one sense, risk assessments are
,- uncertain by a infinite factor. There are those who
seriously believe there is no risk at low exposures and
the cautious procedure proposed by EPA, with which I
agree, is to assume proportionality of cancer incidence
,n (risk) to exposure, and therefore calculate a finite
20 risk. A finite risk divided by a zero risk is infinity.
Yet, this does not make the analysis meaningless. For
22 few people seriously propose that the risk is greater th;
given by the proportional relationship and so the risk
so calculated becomes a reasonable upper limit and use-
ful for public policy purposes. The statement, there-
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fore in Reference 8 I have, is a red herring and I am
glad the EPA did not endorse it, and I hope they continue
not to.
The whole section I find here is full of
straw men and one way of solving the energy crisis is to
take the straw and burn it.
I would point out that in this section,
although it is a different act, the Toxic Substances
Control Act requires the EPA to compare risks and bene-
fits.
Now, the right thing to do, in my view —
and I append the section of a book which we're just
getting ready on the subject, is firstly to assess the
risk; secondly to assess the uncertainties and highlight
the uncertainties — not ignore them, highlight them —;
thirdly to assess the benefits and the uncertainties
thereof; fourthly to compare the risks and benefits and
disaggregate the comparison groups; and finally, to
display the results as clearly as possible both for the
decision maker and the general public.
Unless each of these is done, and clearly
done, the decision will be correctly attacked as arbi-
trary and capricious, including the EPA proposal here.
Now, when we discuss how much money
one should figure society should spend on reducing can-
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1 cer, there is one agency I know that's done it —
2 they've made an attempt — and that's the Nuclear Regula-
3 tory Commission. It faced up to this after a long,
4 three-year hearing (the so-called As-Low-As-Practicable
5 Hearing) and they suggested that if exposure to radiatioi
6 could be reduced at a cost of $1,000 per man rem, it
7 should be.
8 The risk of radiation corresponds,
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9 according to the BEIR report to 10 per man rem, cal-
10 culated on a linear, non-threshold basis. That $1,000
per man rem corresponds to about $10 million per life
12 saved. The NRG considered this to be a temporary figure
13 and suggested a large, long public hearing, probably
with other agencies involved, to decide on this number.
15 Meanwhile, they chose $1,000 per man rem as being a
16 round number larger than any other presented in testimony
at the hearing.
18 The cost of reducing risk has also been
.- addressed by the International Commission on Radiologi-
_0 cal Protection. They have a slightly different unit,
the sievert, which corresponds to 10,000 man rems, and
they quote, translated into older units, anywhere from
-- $10 to $250 per man rem, not the $1,000 for NRC. So,
-. this risk factor comes to anything between $100,000 and
$2,500,000 per life saved with the same procedure.
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Now, another point to bear in mind,
another way of looking at it is that if you spend money
on control equipment, lives will necessarily be lost in
the process, the secondary effects of the decision pro-
cess, but since these decision processes are involved
with small items, we :musn't ignore the secondary result;
because the primary result is small.
Now, half the expenditure on reducing
occupational exposure — reducing environmental exposure
might be expected to be on capital equipment - often
construction equipment. In construction work, people hav«
all sorts of accidents from bulldozer accidents to
falling off roofs. The oft-quoted example is that three
people died in building the Brooklyn Bridge. The total
number of workers killed in construction work in 1975
in the United States was 2,200.
Now, I can calculate as follows: The
receipts from the construction industry were $164
billion in 1972, containing a great deal of duplication
due to subcontracts, so let's divide that by two to get
a rough guess of what was primary construction, and that
gives you a number of about $36 million spent in con-
struction, one life will be lost.
Thus, for this secondary effect alone,
we should be spending more than $72 million merely to
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25
1 save one life, particularly when that life is hypotheti-
2 cally calculated and may not be a fair statement at all.
3 Now, the NRC figure of $10 million to
4 save a life may be low, but a lot of distinguished men
5 think it high. I quote Nobel Laureate Joshua Lederberg,
now president of Rockefeller University: "We might be
willing to double our health expenditures for 20%
improvement in health; this would imply a willingness
to invest $400,000 to prevent a death, which is on the
high side of present day political judgments."
Now, McCarroll of Electric Power Research
12 Institute pleads for not spending too much on air pollu-
tion control, and reminds some advantages of cheap
electricity to public health. Now, I pointed out that
. if you properly set such a number, we will automatically
,, avoid over-expenditure on pollution control. I will also
17 remind you that there are many cases in medicine where
10 lives can be saved for $100,000 or less. An artificial
19 kidney unit costs $30,000 and an intensive care unit
often costs $20,000 per life saved. An average cost of
cancer treatment, from the figure I got from Boston
about two or three years ago, was $50,000 and saves per-
haps 30% of all cases, corresponding to about $150,000
5 per life saved.
So, the important feature of the discussiob
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here is that there was almost no objection during the
long NRC hearing to having some number being used by
NRC — only a discussion of the exact number and as noted
above, NRC chose a number larger than anyone had sugges-
ted. I suggest you might start off by doing the same and
if someone objects, then you can consider it more care-
fully. Better still, hold the public hearing.
I now want to go into the reason why I
feel there is no logical basis for best available con-
trol technology or zero risk in most cases. Now, there
are studies of non-carcinogenic air pollutants and one
of them is the Brookhaven Studies, that suggest that
about 50,000 people a year may have their lives shortened
by an'air pollution related disease. As I say, may.
These are probably due to small respirable particulates,
though whether they are due to sulfate particulates or
not is still a matter of controversy too.
Now, if we were to assign the $10 million
as a sum society is willing to spend to remove this
possibility, then we'd have to spend $500 billion a year
to stop this air pollution, which is a huge number and
would give very serious dislocations to society.
So, even if we say let's weight this
number of $500 billion by a probability of 1/3, assuming
the Brookhaven is correct, and weight the decision, then
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you come to $160 billion per year, which is still a
large number.
In this case, you might say, "We can't
do that. We want to do the best we possibly can," and
you could then say, "I'll use the best available control
technology," where you can take some degree of expense
into account.
Now, the number of cancers produced by
polycyclic aromatic hydrocarbons is maybe about 1,500 per
year and again, this recipe would give you $15 billion
per year - still higher than most people would think
reasonable to control benzyl chloride and other poly-
aromatic hydrocarbons. So, we probably would gain by
using best available control technologies.
But there is, and never was, for example,
best available control technology justification for
vinyl chloride exposures. Let me go into that one.
The need to reduce occupational exposure (with which
everyone agreed) caused enclosure of much of the sys-
tems, so the environmental emissions were already reduce
by a factor of 10 before EPA acted upon vinyl chloride.
So the EPA standard only reduced the hypothetical can-
cer rate from one per year to one in ten years, and I
reiterate that if there is a threshold, the standard did
nothing. The NRG rules suggest that regulation of this
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sort was necessary if it cost $10 million or less, but
not otherwise. In fact, it cost much more. We now know
it cost $200 million capital and $90 million annual
operating cost. Not only that, but due to unnecessarily
short deadlines, there was unseemly haste and therefore
unnecessary cost. Moreover, lives were lost; two people
are identified as lives lost in the construction process
Now, we might consider the list which
is circulated by EPA which I attach—I don't know how
I got it, but it's here. It's certainly from EPA —
of pollutants which might be considered under this rule.
Only the risks calculated by ethylene dibromide gives
a large number which might need regulation. The reason
why ethylene dibromide is it comes in huge quantities
out of one's automobile exhausts, not because it's
done — maybe it should be stopped. It's the only one
I can think of that you can right now apply this hearing
to.
The administrator is correct in rejec-
ting zero risk approaches, in my opinion, but incorrect
in the discussion thereof on Page 58660, Column 3.
"Where Congress has intended to require safety from the
risk of cancer to be absolute, it has known how to
express that intention clearly as it did in the Delaney
Cause of the Food and Drug Act." This is a careless and
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1 incorrect reading of that Act. The Act does not discuss
2 zero risk or zero exposure. The clause as I find it
3 reads as follows: "no (food) additive shall be demed
4 to be safe if it is found to induce cancer when ingested
5 by man or animal or when it is found after tests which
6 are appropriate for the evaluation of food additives
7 to induce cancer in man or animal ..." The word, "zero,
8 is not used.
9 The clause goes on to ban the use of
10 any such additive in "any detectable quantity."
11 A chemical which is not found to be
12 carcinogenic can nonetheless be present and therefore
13 present a finite risk because it may be carcinogenic.
14 A chemical not detected may still be present and present
15 a finite risk. It is clear that Congress, even in the
16 Delaney Clause, rejected zero risk in favor of a more
17 workable law. The law, though workable, produces incen-
18 tives for bad experiments and bad practices as stated
19 so eloquently in the paper by Schneiderman and Mantel.
20 The language of 112 is even weaker than
2i that of the Delaney Clause and so zero risk must be
22 rejected even more decisively than the administrator
23 states.
24 I now want to propose a procedure. I
25 propose, and some definition which you haven't defined
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and I think you should, a risk should be regarded as
significant if it is calculated to be one in a million
per year or greater. This risk may be significant only
to a small group of people, but nonetheless, if this
group can be defined, it must still be regarded as
significant.
For preliminary matters, the rish should
be calculated according to the standard procedures that
you outlined and other people have, linear, non-thresh-
old, basis and so on. Uncertainties must be combined
and I've suggested a procedure for combining them.
In combining the uncertainties, the
important point is that for an individual, it is not
relevant whether getting cancer is uncertain because it
is intrinsically undertain, an intrinsically random
process, or whether it is just not known. That enables
you to combine these uncertainties, including a linear
dose response relationship all together, and you then
take Risk (corrected for uncertainty) = Risk (uncorrecte
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1 spread and all the U.S. population has a risk of one
2 part per million, you may wish to take a stronger action
3 because that would still be calculated to 200 cancers
4 per year, as in the saccharin case. Reducing indivi-
5 dual rick only to one in a million per year may not be
6 adequate. In such cases, you may also want to calculate
7 the total societal impact and reduce that to ten per
8 year. I would, of course, add to the proposed method
9 of risk calculation the possibility that a chemical change
10 its form after emission and becomes more troublesome.
11 Thus, sulfur dioxide becomes sulfate particulates and
12 in purification of water, chlorine turns organic matter
13 to chloroform, as found out by one of my colleagues,
14 and that's a known carcinogen in animals. I twas at
15 pains to point out that vinyl chloride, in that article,
16 that vinyl chloride breaks down in light and becomes
17 less dangerous in the environment. This may not always
18 be true and we should watch for it.
19 Now, I suggest that significant risks
20 must be reduced if it can be done for a reasonable cost.
2i Like NRC, I don't know what is reasonable and expect
22 that a set of numbers is necessary. Like NRC, I suggest
23 $10 million to save a hypothetical life is a large number
24 which you could reasonably take as a first approximation
25 I suggest also that the above can only
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be the general rule. As noted before, it is generally
conceded that the linear, non-threshold extrapolation
gives a pessimistic estimate of the hazard although it
is one which is easy to understand. The analysis,
therefore, must be preliminary; if an important techno-
ology may be allowed to proceed without too much expense
for control, no more analysis will be needed. Perhaps
you might not want to put it on your list or maybe have
two lists, one which is a real list and the other one
your private list of what you're doing calculations on.
If it means that an industry would close, it should be
permitted — the industry should be permitted to make
a case for using whatever more realistic response they
may be able to justify, including, of course, human
epidemiology which if negative could show an effect as
being not as severe.
Likewise, if a case can be made, by
anology, for using a sum less than $10 million per
hypothetical life in any circumstances, that reduced
expenditure should be permitted.
Finally, and most importantly, continuing
efforts must be made to find better and cheaper ways of
reducing the remaining residual risk. There are a
variety of ways of doing this, none of which were
mentioned in the EPA proposal and I'm not going to waste
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1 time doing that here, which is a long business.
2 I how want to make some miscellaneous
3 comments. There was on reference, Reference 17, of the
4 Federal Register pointing out that occupational cancer
5 is a source of information on what is carcinogenic and
6 what is not. However, it is possible to have low occu-
7 pational — the connection between that may not be rele-
8 vant because it is possible to have low occupational
9 exposure and fairly important and high environmental
10 exposure and vice versa. That reference, in this
11 context then, is of dubious relevance and the most
12 important point, however, is that particular reference,
13 a reference to a draft estimate produced by Mr.Califano
14 in a speech on September 11, 1978 has been heavily dis-
15 credited; it had contributors, not authors, and to the
16 best of my knowledge, no single scientist has stood up
17 to say that he is willing to support that document,
18 including — as far as I know — none of the contributor
19 On this, the contributor allows his draft to be quoted
20 as if it were an ordinary scientific document. It shoul
be scrupulously ignored. It is unnecessary to quote thi
22 anyway because there are many good references to the
23 fact that occupational exposures have caused cancer and
24 many good references to the fact that they may cause
25 more and any one of these references could be used.
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Thank you.
MR. HOHMAN: Thank you, Dr. Wilson. Are
there any questions? Betty?
MS. ANDERSON: Yes. I'm not sure which
microphone I'm speaking to.
MR. HOHMAN: Either one.
MS. ANDERSON: If you can't hear me,
raise your hand. Dr. Wilson —
MR. HOHMAN: Louder.
MS. ANDERSON: — as you probably know
in the Federal Register notice, the EPA specifically
solicited comments on the nature of the airborne carci-
nogen problem. We have heard from a number of witnesses
on this. One witness stated that the nature of the
problem was absolutely negative. In other words, no
impact whatsoever from air pollution.
Another witness stated that it was
practically negligible, although did not state it in
such absolute terms. A third witness said that he
regarded the contribution as very significant, but could
not attach numbers to it.
Did I hear you correctly that you said
in your testimony that you think between 1,000 and 2,000
cases of cancer result from air pollution, mostly attri-
butable to POM?
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1 DR. WILSON: Well, I think one could
2 make all these statements consistent. Of course, it
3 depends what different people call significant. I would
4 remind you Richard Dahl (phonetically) in a paper on
5 this subject, who is one of the experts on these things,
6 took pains to point out that if there are effects due
7 to air pollution, they are a very small fraction of
8 those due to cigarette smoking - no more than 5%, and
9 of course, in lung cancers 5% is still 4,000 a year in
10 the United States.
11 So that if you say 5% is hard to find
12 in the middle of the background of lung cancers, however
13 I am now talking second-hand, but I remind you there
14 was a paper by Dahl and Petew (phonetically), which
15 points out the significant result that cigarette smoke
1$ due to, he believes, air pollution effects is statisti-
17 cally insignificant for non-smokers, and it would be
18 smaller than for cigarette smokers, so that number
19 would —
20 The other question was, there was
2] evidence by influence but not by direct data that if
22 you believe, for example, that data available for high
23 doses of poly aromatic hydrocarbons upon coke oven
24 workers, upon asphalt workers is extrapable by a linear
25 relationship to the lower levels of available air pollu-
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tion, even though the combination of hydrocarbons is
widely different. Then you get a number of about this
amount.
As you well know, the Carcinogen Assess-
ment Group have come up with a number which is a little
smaller than mine. But the main point is that number is
at the moment, certainly unproven. It's probably un-
proven.
MS. ANDERSON: But the 1,000 to 2,000,
are you including cigarette smoking in that?
DR. WILSON: This would be the number
additional to — this is including cigarette smokers,
but the cigarette smokers will probably have less
lung cancer.
MS. ANDERSON: Do you think it's possible
to subtract out the contribution from cigarette smoking?
DR. WILSON: Well, subtracting, of course
as you know, due to multiplicity is a funny way. If
you ask the effect on non-smokers, the effect on non-
smokers according to the studies, is probably smaller,
and sounds reasonable, and is certainly not statisti-
cally significant. But I think no one has claimed, to
my knowledge, to have found evidence which satisfies it
statistically that there is any effect on non-smokers.
MS. ANDERSON: In trying to grasp the
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1 significance of the contribution to cancer from airborne
2 carcinogens, we are certainly interested in any of your
3 calculations, but I notice that you also — I believe
4 you said that you think perhaps ten cancer deaths a
5 year could be attributed to the chemical industry.
I wondered in these calculations several
7 things. One, if you were able to take any co-carcinogen
8 into account and also in just looking at the numbers you
9 quoted for vinyl chloride, I believe you said you
reduced the ten per year by a hundred fold and from the
Blot data on arsenic, you reduced thirty to ten per year
12 and it seemed to me just, if I'm correct in understandin
you, that just with two chemicals, you're getting close
14 to the ten per year contribution from the chemical
industry. So, in other words, I'm wondering, does your
,, ten per year take co-carcinogenesis into account and
17 how did you calculate it?
10 DR. WILSON: Well, let me explain. Let
ID
me explain that in slightly more detail. Firstly, the
ten per year I don't think are direct evidence. If
you take the data of old exposures before there was any
control of vinyl chloride and carcionogenic air
.,, dispersion calculation. I particularly follow the
calculations of Cusmack and McCormack from EPA which
24
I've checked — McCormack was one of my students at
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1 one time-- they would give you about ten per year can-
2 cers on a linear proportional basis. However, we know
3 the exposures are now reduced
4 environmentally depends on the
5 particular plant and they're still coming on down because
people are finding small, fairly cheap ways if you give
7 them time to reduce them.
8 So they're now down a factor of a
9 hundred. That was one of the big ones in a certain
10 sense. Now, the arsenic is probably not — Blot's
paper was concerned with smelters not the chemical
12 industry, and he didn't actually give a number. I
13 calculated a number for him and wrote it up and later I
gave it the occupational carcinogen test on the calcula-
tion, but he thought that was, in a private letter to me,
16 thought I'd overestimated when I said thirty per year.
17 MS. ANDERSON: All right, just to insert
something here, Cusmack's policy covers smelters as well
as the chemical industry, so when you speak of ten per
2Q year, you're really talking about the contribution just
from the chemical industry.
DR. WILSON: That's right.
MS. ANDERSON: And so if you add smelters
in, the petroleum industry and so forth —
DR. WILSON: Smelters might be ten per
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1 year by themselves and the ethylene dibromide is high.
2 I haven't calculated it, but of course, one of the
3 reasons why that's high is because one of the purposes
4 of making ethylene dibromide is to deliberately put it
5 into gasoline and deliberately permit it to the general
public just at the level at which it goes into our servic
7 MS. ANDERSON: I see. I think we would
8 be interested in your calculations if those could be
9 submitted as part of the record.
DR. WILSON: I could submit my calcula-
tion on arsenic, I suppose, and Mr. Blot's letter saying
he thought I was pessimistic.
MS. ANDERSON: Yes, because I was wonderi
,, in our calculations on arsenic, I recall something in the
neighborhood of 7 to 10', but we were taking into account
smelters and all sources of air pollution covered by
,, this policy.
DR. WILSON: But I was trying to be
._ pessimistic in my calculation. I was not trying to be
Q realistic. I want to emphasize that. And indeed, I
understand there's evidence that — I want to emphasize
that paper by Blot was entirely circumstantial evidence,
nothing on which — it should not be regarded from a
_, scientific point of view as suggested and I would not
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even regard it as that .
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MS. ANDERSON: Okay, and so then overall,
in trying to get a handle on what you're saying the
contribution from air pollution might be in terms of
cancer deaths per year, we would have some from the
chemical industry and then some others which you have
not calculated?
DR. WILSON: Right. I haven't gone
through this whole list in detail, but I've just looked
at the numbers because I haven't got exposure data on
most of them. The ones, however, which stand out to
me and which I know are strong carcinogens in this
listing, ethylene dibromide as you well know is a car-
cinogen, and we just have to know it's a very strong
agent. That's the one which we just brought out.
MS. ANDERSON: I had just two other
things. One, you stated that you — I believe you said
that you don't think that the overall contribution from
the chemical industry, that is, ten cancer deaths per
year, would be substantially improved by regulation.
I wondered, if I heard you correctly,
the basis for that.
DR. WILSON: No, I'm not sure I did say
that and I didn't mean to say that. It might be improve
by regulation. My point is that if you have too tight
a regulation, you'll spend a fantastic amount of money
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1 and then end up by reducing the ten to three with severa
2 billion dollars and then in that process of spending
3 several billion dollars, you will even kill more people.
4 And so that's not a particularly good trade-off.
5 So, I am suggesting a calculation by a
procedure by which you decide which parts of the chemica
industry or any industry are worth paying attention to
and which parts are not. And one of them, incidentally,
I wish should be paid attention to is the desire of some
people to burn wood in open fireplaces.
MS. ANDERSON: And something else I thoug
I heard you say and let me just check on it, that anybod
,, dealing in risk assessment should be able to choose what
,. ever model they like.
.. If I heard you correctly, I'm sure you
16
25
know from the saccharine report issued by the NAS that
17 depending upon models, you can make the number vary five
1g million times, and it seems to me if anybody chooses any
model they want, it would serve little purpose except to
perhaps discard any consideration of quantitative risk
assessment altogether.
Did I understand you correctly and is
that what you really meant?
DR. WILSON: No. If I used those words,
24
I said the wrong ones. I said for preliminary analysis,
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I think it's appropriate to use a linear proportion
model because most people believe that that is a pessi-
mistic model and a reasonably bounding model. If you
can accept something since you want to lean over probabl
on the side of protecting public health, if you can
accept something on that linear proportion model, then
you can accept it and then forget about it.
If, however, you can't accept it and then
you find yourself in a dilema, you can't accept it and
it's much too expensive to control it and you find in
the dilema, do I shut down the automobile industry or do
I do something else? Then it is quite reasonable to
spend the extra effort on to very carefully what that
risk benefit analysis is, and to ask yourself, can I
justify a more reasonable dose of response relationship
than the linear one.
Now, I don't say that you should auto-
matically let the risk assessor choose what he wants,
but you should not rule him out by some legal process
saying, you must take the linear hypothesis. Take the
linear hypothesis, if you can accept something, fine,
but don't leave out the possibility of someone coming
back in this particular case, I think might justify
taking a quadratic term because of some evidence,
animal test or some such test, come back and justify tha
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1 in this case, it can be done. It would clearly take
2 much more work. The risk analysis would be required to
3 be more and amybe the emphasis would shift slightly,
4 but nonetheless, it should be allowed, and I think there
5 would be such cases.
6 MS. ANDERSON: I think just to comment
7 on that, the RRLG document on the scientific basis for
8 risk assessment in EPA's general approach has certainly
9 recognized that where such data can be generated, it
10 certainly would be used.
11 DR. WILSON: That's right.
12 MS. ANDERSON: Okay, that's all.
13 MR. HOHMAN: Just one question I have.
14 I take it from what you say, you're convinced that there
15 is a problem with air pollution, that air pollution,
l^ you're convinced, does cause some number of cancers.
17 The question that you have is basically, how many, and
15 the cost for control and the quantitative approach to
19 risk analysis and benefit analysis to establishing
2Q control. That's basically —
21 DR. WILSON: More or less. I will
22 explain. I was brought up in London in the 1930's.
23 Anyone brought up in London in the 1930's finds it hard
24 to believe that air pollution is good for you, so
25 instinctively, I think that it's — so, I tend to judge
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the evidence on that basis.
MR. HOHMAN: In the last several days,
we've heard, of course, pro and con in hearings in
Washington, but there have been several rather strong
statements to the effect that there basically is not an
air pollution problem.
DR. WILSON: Well, I think it's — I
believe the cancer problem due to air pollution is
smaller than the problem due to sulfate particulates
which is also present and not being properly regulated
and which I think, again, that's an unprovable problem
and unproven. Certainly unproven. There are strong
parties on either side and it's almost certainly not
provable in any rigorous way.
And the carcinogen problem, more so, is
unprovable in that rigorous way, except we can use analo-
gies slightly more, and it is only by anology, by
believing there might be a dose response relationship,
if it's there, but there are distinguished people who
believe the numbers of 2,000 may be too high.
MR. HOHMAN: One more question, then I'll
get off the microphone because we do have a lot to cover
today, but in your thinking about risk and the impact of
these pollutants, there are basically two approaches.
One is the risk to the individual, and another is the
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1 cumulative risk to populations.
2 Do you have any feeling as to which of
3 those two should predominate in the thinking?
4 DR. WILSON: I normally would like to
5 argue, at least in the preliminary analysis, that you
should assume that both groups must be satisfied. That
is to say — that's why I'm taking pains to point out
in my proposed procedure that the risk is regarded as
significant if it's greater than one in a million per
year for either any significant group of people and
identify, and that might mean within a small community,
not just people as a whole.
,o Now, I believe that if you were to
,, satisfy that, there's enough variation throughout the
country, the total societal impact — if that were
,, constant throughout the country, then you might still be
io
getting 200 cancers a year from this cause, which in the
.„ saccharine case is about the number we're talking for
saccharine and on the borderline of what people believe
_. you should regulate or not.
However, if it's more variability, you
might want to give it a try.
MR. HOHMAN: But if your preliminary
.. analysis, as you say, indicated a concern greater than,
24
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cause for getting into it in a little more detail.
DR. WILSON: That's, of course, not
necessarily for banning it, but going into it in more
detail, firstly doing more detailed calculations —
well, if I was in industry and I had gotten to that
level, I would firstly say, spend a reasonable amount
of money saying, can I reduce it, and of course if it
comes to a huge amount of money, then I'd start arguing
instead.
MR. HOHMAN: And then do you have any
feel for the concern as to total number of individuals
per year that might conceivably get cancer? Is there
some analogy to the one in a million that comes to mind
when you're thinking about the seriousness of a problem?
DR. WILSON: Well, I don't think the
problem is so serious that you've got to — it's not
like, for example, the risk of a coal miner in his work
which is so big that it's a national scandal that we've
allowed it to persist for so long and which must be
reduced almost at all cost.
What we're talking about here is a risk
which in any case, even the number which — I'm saying
a number and as Elizabeth was about to say earlier, that
other people have testified to you and said that they
don't believe there's any number provable. That means
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1 they say the number is very small. I agree it's very
2 small, much smaller than from cigarette smoking, and
3 probably smaller than being a passenger in the MBTA
4 where they still allow cigarette smoking, although it's
5 against the law.
MS. ANDERSON: I had a note on the same
question and that is, I thought you said that you would
be concerned if the nation-wide impact exceeded ten
deaths per year.
I wondered if you meant per chemical or
overall?
12 DR. WILSON: Oh, I hadn't really thought
that through very carefully. I would certainly per
chemical. I think overall, I think if you were to do
.. that, I don't think you'd find more than about half a
., dozen chemicals we'd in fact be concerned with in any
lo
._ detail at that point, so I think the difference is not
lg very big.
MR. HOHMAN: Roy?
MR. ALBERT: As I hear you speak, I
believe that your central point or points are that if
one does quantitative risk assessment using a linear,
non-threshold extrapolation model, one would find that
.. the risk from most chemical pollutants is trivial, and
24
I think this is the basis that you object to in the
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current policy.
So, the central issue here is the plausi-
bility of the linear, non-threshold extrapolation model
which is being seriously challenged in this policy
because the policy essentially says that it doesn't put
much credence in it.
Your position is that it's a plausible
upper limit risk, basis for assessing risk. How would
you express the degree of uncertainty in that sort of
thing? Let's skip the issue of the statistical uncertain
ty of the experimental data that you used to derive the
linear non-threshold model. If you come up with an
estimate of twenty extra deaths per year and you're
trying to talk to a decision maker who's got to do the
regulation and he says, "How good is that number? What
would you tell him?
DR. WILSON: Let me first correct one
thing. I'm not sure I'm objecting so much to that
part of the policy. There seem to be some inconsisten-
cies in what was written down here and that definition
of what you call significant risk and things like this,
and with that I thought ought to get clarified and I'm
suggesting that procedure.
MR. ALBERT: Well, the policy clearly
eschews doing a risk benefit assessment before taking
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2
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action.
DR. WILSON: Yes, I think that's
probably — I wasn't even clear of that as I read it.
4 it seemed to me a policy constructed to say all things
5 at once and therefore nothing at all.
6 What uncertainty would I apply? I think
7 the main uncertainty clearly will have to come from
8 the — comes from the ability to use animal data or
9 in vitro data before assessing carcinogenic potency in
10 man. Now, if we have epidemiological data —
11 MR. ALBERT: What do you propose we do
12 so there isn't any argument about it?
13 DR. WILSON: — then I think the uncer-
14 tainty is primarily uncertainty in exposures and that
15 can vary in the individual case. I mean, for example,
16 in the best of epidemiological data, which we have,
17 we don't really know what those poor workers were
18 exposed at. We know it was pretty high because a
19 relative of my wife's, from Johns Manville, used to
2o come out — as an executive, used to come out with his
2i suit absolutely white at the end of the day. That no
22 longer happens.
23 Now, what that means in terms of
24 exposure, no one knows, so that it's very hard to make
25 anything but a very crude estimate on exposure in that
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case. So, it will vary from case to case, but in the
vinyl chloride case, I think it's fairly good with that
amount of uncertainty. You know, it's very hard to be
up more than a factor of two or three.
MR. ALBERT: But if you just take the
linear, non-threshold model per se, and let's assume
that we know the exposures down to a gnat's eyelash
and that we're dealing with data that is obtained on
humans and it's very solid and very accurate, we still
have the issue of the uncertainty in the linear extrapo-
lation. And how would you describe it to somebody who
is trying to get a feel for the goodness of the number?
DR. WILSON: Well, firstly, it is and
must inherently be —
MR. ALBERT: I'm asking you because I
find this an exceedingly vexing problem.
DR. WILSON: Of course it is, yes. I
was only —
MR. ALBERT: And it's a central issue of
the whole business.
DR. WILSON: It is a central issue. I
believe the other one's even more central, but — is
more tricky, but this one is indeed central and it
comes up in radiation and everything else. I would say
that what happens at low doses must inherently be a
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1 theoretical assumption because it is an area where we,
2 at low dose levels, we have no data and in a very real
3 sense, I hope we never will have data because if we
on the
4 have good data then the evidence may be/wrong thing,
5 and so far the ideas, any of the theoretical ideas we
have about cancer all suggest — almost all suggest that
this straight line, proportional basis, is slightly
pessimistic and most of them fall below that line.
The basic random nature of radiation-
induced cancer, for example, whether or not a photon
induces damage in a cell, automatically gives a straight
,« line. Then you have to put in — you assume that a
,- human being has some repair mechanisms — we are
,. remarkably able to adapt to society — which will get
results below that straight line in almost all cases.
I J
,, MR. ALBERT: Well, does your position
lo
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estimate of twenty cases a year and strips that estimate
19
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of uncertainties of the statistics from the cancer data
itself, and just consider the uncertainties in the
linear extrapolation model per se, then would you say
that that represents an upper limit and the uncertainty
is downward?
J.O
In other words, it's from twenty down,
24
is the uncertainty, not twenty up?
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DR. WILSON: I would say it's a reasonabl
upper limit. I think the trouble is, any absolute state
ment is likely to be wrong. It used to be said that the
only thing certain in life is death and taxes, but peopl
have been known to avoid paying taxes, but death is
certainly certain. Nothing else I know is certain, so
in that sense, I would say it has to be just a reasonabl
upper limit and for that reason, that in any case that
one should not completely forget about anything one
does. One decides to continue to manufacture a chemical
completely enclosed and you think there's no exposure.
Why don't you continually watch it because maybe there's
a little hole somewhere you haven't thought of and thing
of that sort.
So, I don't think even though I think
that i s perfectly reasonable for public policy pur-
poses, as soon as you insist on anything stronger, then
you get into the possibility of the necessity of con-
trolling and even banning every human action.
MR. HOHMAN: Okay. Just a couple of more
short questions. Todd?
MR. JOSEPH: Yes, I do have some question
Dr. Wilson. If you concluded that the data you had
available were too uncertain to — the data on risk and
the data on benefits were too uncertain to do a meaning-
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1 my hypothesis as given.
2 DR. WILSON: No, but I reject that for
3 the following reason. Because it is not a real decision
4 you're asking me to deduce. If you present me a case
5 which is a real decision, then you can address that
real decision. In risk benefit analysis, most of the
controversy, most of the discrepancies, most of the
problems arise when people try and address questions
which are not real.
I said, what is the decision you're
trying to ask and what are the possible alternatives?
12 That, you can address. If you try to address something
hypothetical like what's the value of life, then you
start getting into problems which you'll just go on
talking forever.
., MR. JOSEPH: Okay, let me ask you a few
16
other questions. About the — you've discussed the
1Q NRC's proceeding to determine a value for as low as
Io
possible, the ALAP proceeding.
DR. WILSON: Yes.
MR. JOSEPH: My understanding is that
that proceeding was based solely in the context of
nuclear power plants. That's right, isn't it?
&w
DR. WILSON: I believe it was all radia-
24
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ful risk benefit or cost benefit analysis, would that
affect your recommendations to us?
DR. WILSON: I think you can usually give
some limits. I mean, if there's an unknown chemical
you haven't started producing yet, and then is when you
get into certain problems. It will depend a little bit
on what your decision is at that time if you haven't
started manufacturing the chemical or considered closing
down an industry.
But, I think the important feature to
bear in mind on any risk benefit calculation is the
more uncertain the result, the more necessary is the
calculation because only when you've attempted to put a
number on a risk, including its uncertainties — I want
to stress that you've got to include the uncertainties -••
only then are you sure that someone's thought the problen
through.
If someone doesn't attempt to do that,
then he is probably doing no better than tossing a coin.
MR. JOSEPH: What if you were unable to
conclude anything more than that the cost per life were
somewhere between $1,000 and $100 million?
DR. WILSON: Well, you're asking a very
hypothetical question and if any —
MR. JOSEPH: But I'm asking you to take
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1 ssion, which includes hospitals and all radioactive
2 isotopes in hospitals, but in principle, the main effort
3 was nuclear power plants. You're correct.
4 MR. JOSEPH: And the premise of the
5 proceeding was that there was already an upper, never-
6 to-be-exceeded limit, isn't that right?
7 DR. WILSON: That's correct.
8 MR. JOSEPH: So that the proceeding was
9 to determine how much residual, if you will, residual
10 risk ought to be permitted beyond some fixed limit?
11 DR. WILSON: It was also to determine
12 that upper limit, whether that upper limit was right.
13 In fact, that upper limit was lowered in that proceeding
14 MR. JOSEPH: Well, all right, but there
15 was an existing federal upper limit, government-wide
16 upper limit of 500 millirems, was there not?
17 DR. WILSON: Right. I mean, if you're
18 asking should there be an analagous thing here, I would
19 answer, in general, yes. In particular, I suspect at
20 the moment it's unnecessary because the upper limits
2i one is talking about would only be reached by the
22 fossil fuel burning type of carcinogen. That's part of
23 the distinction one makes between best available control
24 technology when it might be applicable and the time when
25 a risk benefit analysis is certainly more personal.
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MR. JOSEPH: I wasn't clear in your
recommendations on how you, taking your $10 million
per life suggestion as an upper limit on cost —
DR. WILSON: It wasn't mine. That's
NRC's suggestion.
MR. JOSEPH: Well, you suggested it as
a reasonable sort of thing, just whatever the number
might be. How does that address the risks borne by the
individuals most exposed? Were you recommending that
their risks be reduced towards one in a million —
DR. WILSON: Yes.
MR. JOSEPH: — in addition to the
population risk?
DR. WILSON: I was assuming significant
groups, significant definable groups of people. I
don't mean the crackpot who is going to lie down just
outside the effluent of a chemical plant and breathe the
stuff in.
MR. JOSEPH: I understand. I understand,
but I mean, people living in the immediate vicinity of
the emissions, for example.
DR. WILSON: People living in the immedia
quarter of a mile, half mile, or else if it becomes
larger, then one must discuss that particular case and
discuss particular — maybe compensation measures, what-
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1 ever one wants.
2 MR. HOHMAN: One more question.
3 MR. JOSEPH: One more question. If EPA
4 has a mandate here to, in the regulation of airborne
5 carcinogens to protect the public health with an ample
6 margin of safety, do you think allowing a specified
7 allowing a calculable deaths per year would fulfill that
8 mandate if that number were one or greater?
9 DR. WILSON: Well, I think the risk of
10 one in a million is lower than risks to which we're
11 normally exposed. The risk of being killed in an auto-
12 mobile accident, for example, is two in ten thousand or
13 a little more. The risk of — the average risk of air-
14 plane accidents is higher. Certainly, the 'risk of livinc
15 with a smoker is probably higher, ten times higher.
16 So, I think there is already in that
17 suggestion of going to the ten to the minus six per
18 year, a margin of safety.
19 MR. JOSEPH: But that's individual risk.
20 I'm asking for the whole population.
2i DR. WILSON: Well, again, we have a
22 considerable margin there in that ten per year is
23 considerably less than 200,000, which is the total
24 cancer rate. Now, indeed, I think one ought to steadily
25 work on the cancer rate and bring it down and we know,
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for example, from epidemiology, incidentally, not from
this other work which cause possibly half the cancers,
cigarette smoking, asbestos, alcohol and so on. We
must change our lifestyle to get them down and we should
work on them, but we don't start work at the bottom end
and work to the top.
MR. JOSEPH: Thank you.
MR. HOHMAN: Bob?
MR. KELLAM: Dr. Wilson, you, in attemp-
ting to assess the cost that society might be willing to
bear for a human life or to reduce the risk of cancer,
would you see any dinstinction between the risks that
we bear voluntarily as individuals compared to those
which we might bear involuntarily as a result, say, of
industrial emissions?
DR. WILSON: Oh, yes, of course. That's
part of the question of the different numbers one might
put in, and all of what I was addressing here, in fact,
for quoting NRG, was deliberately addressing involtary
risk. It's well known cigarette smoking is clearly
voluntary and traveling in a bus with a cigarette
smoker is involuntary.
I traveled here on the Green Line and
you can say that if you might consider traveling — the
risk of a car as a necessity in Boston and you travel
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on the Green Line, therefore car accidents can hardly
be called involuntary.
MR. KELLAM: So that if we looked across
the spectrum of costs that have been applied or can be
calculated for the reduction of risk in various types
of environmental hazards, then you would agree that in
the case such as air pollution, you might, in each case,
assign a higher value to a life saved than you would,
say, in the case of the location of a traffic signal
or location of a railroad crossing or other types of
cost benefit calculations that have been made?
DR. WILSON: Well, traffic signals and
railroad crossings are to avoid the deaths taken
involuntarily. The voluntary one might be, for example,
the seatbelt. I mean, even though you have seatbelts
installed, many people don't buckle them, and even
installing a seatbelt, a rough calculation gives you
$5,000 per life saved even if you haven't paid for it.
The fact that you don't buckle it is really rather
stupid.
MR. HOHMAN: All right, thank you very
much, Dr. Wilson. Dr. Cortese?
DR. CORTESE: Good morning. I have a
prepared statement and rather than read it — I'm sure
you've all received copies of the draft outlining some
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of the concerns.
MR. HOHMAN: I'm sorry, do we have copies'
DR. CORTESE: I'm not sure you have
received copies.
MR. HOHMAN: I don't think we have copies,
DR. CORTESE: Well, I did bring some
copies and I gave them to a member of your staff.
MR. HOHMAN: Okay, thank you.
DR. CORTESE: At this time, I'd like to
basically say several things. First, cancer is current!}
the second leading cause of death in Massachusetts,
and that is quite a big problem.
On the whole, we support the proposal that
you put forward as a reasonable approach to the controllam
of airborne carcinogens. However, I do have some specifd
comments I'd like to make, and I hope constructive criti-
cisms for handling the policies.
First of all, we have some concern over
the judgmental approach used in determining unreasonable
residual risk after the application of best available
control technology. Our concern there is that when you
allow a judgmental approach, it is likely in some cases
the benefits of the substance or activity will be
national while the risks to the public will be localized.
And if you allow a judgmental approach with changing
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1 political leadership in differing areas of the country
2 and in Washington, along with the ability of the
3 lobbying efforts of those potentially being regulated
4 may result in an inconsistent application of this
5 • policy, and we have a concern about this and we hope
6 that you can find some way to address that.
7 We strongly support the methodology
8 proposed in performing a preliminary evaluation of
9 risk. In particular, we believe that the evidence
10 from epidemiological studies and/or at least one well
11 designed mammalian study is sufficient to enable a
12 judgment to be made that a substance is a "high proba-
13 bility" carcinogen.
14 Without going into more detail, I think
15 that if you ask for more information than that and you
16 ask for a second study to attempt to replicate the
17 first, you can get into problems if you use a different
lg animal model which may not represent the most sensitive
19 individuals in the general population.
20 It is especially important that the
21 results from preliminary evaluations of the probability
22 of human carcinogenicity and preliminary evaluation of
23 population exposures be made available to the states for
24 review.
25 The reason for shis is very simple. A
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substance or an industry may not be a problem from a
national standpoint, but it may — and therefore not
merit high priority for your control, but if it is a
localized problem in a given state, we not only should
but we must deal with it and therefore any information
that you have available, we would appreciate making it
available to the states as quickly as possible.
If quantitative risk assessments are to
be used when making a determination of unreasonable
residual risk, we would propose that a predetermined
decision rule be established. A suggested acceptable
risk might be one chance of getting cancer out of a
million or ten million or a hundred million or whatever
EPA decides is the most acceptable risk factor to use,
but I think a decision rule is imperative.
And I'd like to digress for a minute
here and express a concern that I have and I hope
that through the cancer assessment group that you may
be able to address this. And that is that in looking
at safety factors and risk levels that we have set for
environmental standards, I believe there is a difference
in the risk level that we have allowed for drinking wate
versus air versus other means of exposure in the environ
ment.
And my feeling is that after you have
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1 quantified the differences in exposures and the differen
2 ces in dose, that the risk level ought to be the same.
3 You know, assuming that you're taking into account an
4 absorption rate'and detoxification of the body and
5 things of that nature. And I don't find that to be the
case and I have a concern about that.
7 Sometimes — Ifve asked for some research
8 to be done on this issue because I believe that in some
9 cases — for example, in drinking water — we have
10 accepted a lower risk level than for air, and what
bothers me about that is that people drink about two
to three litres of water a day and you breathe several
12 thousand litres os air a day, and so for an equivalent
concentration, the total body burden is much greater
1S from the air we breathe than from the drinking water.
16 For that reason, I can't see why we
,, would have a greater risk being allowed in the air
route than in the drinking water route, so I ask that
._ you address this problem and I think that it is signifi-
20 cant.
.. We do oppose the requirements for new
„ and modified sources as outlined in the proposal. And
the reason for this is that our concern is with
9. the plan to locate new sources in unpopulated areas.
, We have the responsibility of protecting each individual
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to the same degree. A family living next door to a
facility emitting a carcinogen would be at risk whether
they were located in a rural or urban area, and should
be given the same protection. Under EPA's proposal, it
is conceivable that a source whose emissions might be
predicted to result in one case of cancer per 100,000
individuals exposed would be prohibited from being in
Boston where the population density is very high. How-
ever, it is also conceivable that the facility could be
built in the Berkshires where the population density is
low. A criticism could be made that EPA is not protec-
ting rural dwellers to the same degree as urban dwellers
The ramifications are also great with
regard to the future growth potential of the area in
which the new source might locate. Do we plan to
restrict future residential, commercial and industrial
growth in a currently unpopulated area in order to allow
a source to emit a carcinogenic substance? I think not.
It would seem that if our society needs the benefits of
these substances, then we must accept the cost of con-
trol.
From an energy conservation viewpoint,
we would not necessarily recommend locating major indus-
trial sources in unpopulated areas. Transportation of
workers from their homes in a populated area to their
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1 place of employment in an unpopulated area could be
2 energy intensive and add to the pollution burden with
3 other kinds of chronic respiratory disease. Also,
4 little is known about the bioaccumulation of many
5 chemicals. It may not be wise to locate such sources
in rural agricultural areas where carcinogenic materials
7 may in fact get into the foodchain.
8 We endorse the idea of the presumptive
9 national emission standard as proposed and believe that
the criter for getting a waiver should be very stringent
It seems likely that permitting a waiver to best avail-
able control technology, including the option for an
,3 alternative source specific standard, will be cumbersome
j4 and resource intensive. I don't think either EPA or
1S the states have the manpower to administer this and it's
16 conceivable that most new facilities would apply for a
17 waiver to best available control technology or an
18 alternative standard since both options would be less
.. expensive to meet. And I think we might just be opening
Q up a Pandora's box in terms of making that kind of
.. decision.
We also have a concern about the offset
business, and our concern about the idea of offset is
£-J
.. not from the standpoint of whether the total risk to
24
society would be changed. I understand that what you're
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proposing is that the total risk be the same if an
offset is allowed, but the problem in siting any parti-
cular facility is the specific people that live in the
area, and if you offset an existing carcinogenic risk in
one community by giving it to another community, that is
not going to be acceptable to the second community, and
I assure you there would be great opposition to that
kind of policy.
Finally, I do hope that in making a
determination which I think is a good one, in judging
an unreasonable residual risk, you would look at the
range of expected cancer incidents from the operating
of existing sources. And presumably if a plant was only
going to be around five or ten more years, you might not
consider that an unusual residual risk.
I just caution you that in making that
calculation, you have to go back and determine whether
or not that source was emitting a carcinogenic sub-
stance for twenty or thirty or forty years before that
because that extra ten years might be the difference
in chronic dosage between whether or not people do get
cancer or not. We don't know that and can't say that
for sure, but I do recommend that we go back and take
a look at how many years it has been operating before
as opposed to 'just just looking at the future. I know
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1 that's not an easy thing to do, but I think we must do
2 it if we are to regulate it properly.
3 So, that is the sum and substance of my
4 comments and I'd be glad to answer questions.
5 MR. HOHMAN: Questions? Betty?
MS. ANDERSON: Tony, I have just a couple
7 of questions. When you mentioned the judgmental approach1,
8 did your concern go primarily to what you said about
9 having a decision rule for residual risk or are there
10 other parts of the policy that you regard as too judgmen-
tal, such as the weight of evidence approach to discussirg
12 carcinogenicity or other factors?
13 DR. CORTESE: The concern, the original
concern that I expressed was really the idea that in
determining unusual residual risk after the application
of best available control technology.
17 MS. ANDERSON: And just one other thing.
You mentioned that you thought that it's your perception
that the drinking water is accepting a lower risk than
20 air-
I was unaware of this, and I wondered if
22 you could give us some examples or set us on the right
23 track to figure this out.
DR. CORTESE: Yes, I can try to give you
some idea about that. My concern is not so much with
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1 the carcinogenic standards that have been set, but in
2 the other area in which the greatest safety factors have
3 been used in drinking water and I think can be used in
4 air contanimants because I'm more familiar with that
5 as a Chemist, but I also am concerned that we take a
6 look at total dosage and some of the lowest concern that
7 we're expressing in drinking water, if we were to trans-
8 late those into air levels, it would be much more
9 stringent than I think has been proposed to date
10 for existing types of pollution sources.
11 MR. HOHMAN: Todd?
12 MR. JOSEPH: Just one question. I'm not
13 sure from your suggestion that we use a decision rule
14 for residual risk. I take it you're talking about the
15 level of risk to individuals.
16 Do you have a comment on the suggestion
17 we heard earlier this morning that perhaps it would be
18 appropriate to permit a certain number of projected
•]9 deaths every year among the population even though
20 individual risk was reduced?
21 DR. CORTESE: I didn't hear the comment.
22 I'm not sure I understand it.
23 MR. JOSEPH: Well, we're considering
24 risks of two kinds. One is the level of risk to each
25 individual who may be exposed, and often, usually there
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1 will be a group of individuals living near a facility
2 with levels or risk or exposure higher than those of
3 the rest of the community, and particularly if we're
4 talking about a large metropolitan area.
5 And we might, if the number, total number
of people exposed is large enough, we might still project
7 that a certain number of people would contract cancer
3 even though we had reduced the maximum risk to each
9 individual, just by multiplication.
And there was a suggestion earlier, if I
understood it, that in deciding — that we shouldn't
spend more than a certain amount of money to avoid those
13 deaths.
DR. CORTESE: I think that's the most
of I
difficult public policy decision/the rules/have to make.
16 I don't we should do that -- I think we ought to spend
17 as much money as possible, as much as we can afford, to
,„ be able to reduce the cancer rate unless the cost is so
.„ out of line with the benefits, and that's a very difficult
calculation to make.
I think that's going to be the essence of
the problem. If you have a low probability carcinogen,
but the exposure to the general population is great,
„, for the amount of chemicals in use, I'm not so
24
sure it isn't a good idea to control that because while
25
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the probability of cancer may be minimal,
the exposure to the population is so great that you may
want to regulate that from a national standpoint more
than a higher probability carcinogen which may cause
only a localized problem.
I just don't have a good answer for how
you make that judgment.
MR. JOSEPH: Thank you.
MR. KELLAM: Mr. Cortese, I'd like to
ask you the same question as Mr. Padgett asked Dr.
Wilson, and that is, there are really two ways of lookinj
at risk. One is the maximum risk to the individual and
the second is to aggregate that risk across populations.
In determining whether or not a substance
should be regulated as a carcinogen, would you give
precedence to either of those risks? In other words,
would you consider the maximum risk to the individual
more important than the estimated incidence of cancer
to the entire population exposed?
DR. CORTESE: I think it would depend
on the substance involved if I were making the judgment.
For example, if the substance were the type that one
exposure or several short-term exposures to a particular
substance could cause cancer over a lifetime — because
it actually is a real lifetime exposure like asbestos
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where the fibers remain in the lungs for a long period
of time — it's like a continuous exposure over the
entire lifetime — then I would consider the maximum
risk to the individual as extremely important because a
short-term exposure because of
or something like that might be very impor-
tant.
If it was a chemical that you were
reasonably certain that you had to have an exposure over
a lifetime, a continuous exposure over a lifetime, then
I think the population-kind of calculation would be more
important. So I think it really depends upon the sub-
stance that you're looking at, and I would encourage
EPA to look at it in that respect.
MR. KELLAM: Thank you.
MR. ALBERT: Tony, you expressed concern
over the judgmental approach in determining unreasonable
risk after the application of best available technology
largely on the basis that some groups may sustain the
risk whereas other groups, the benefits.
But isn't this a problem that generally
applies to risk benefit judgments and is part of the
game, particularly in areas where the law calls for
doing this as under TOSCA (phonetically) and under
FIFRA (phonetically)?
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DR. CORTESE: Yes, sure. I understand
that, but you have to be in my position for awhile a
hear that a local group of people does not want to
experience that risk at all for somebody else's benefit,
and we see that in the siting of hazardous waste disposal.
facilities. People don't want a hazardous waste disposa
facility in their town because — particularly if you we
to site it—to use the EPA, their carcinogen policy —
and try to site it in an unpopulated area, the attitude
of the people there is that, look, those hazardous waste
are generated in industrial areas, we don't want it in
our town, and that's a uniform kind of reaction that you
find around the country, not just here in Massachusetts.
So, I think while in fact it may be a
matter of law under TOSCA (phonetically) that you have
to do it that way, the fact of the matter is that in the
real world, the public doesn't perceive it that way.
MR. ALBERT: But I'm not clear what your
point is. Are you objecting to the use of risk benefit
weighings or are you just cautioning the agency that
if they're going to get involved, they better watch out
for the pitfalls?
DR. CORTESE: I'm cautioning the agency
and I'm asking the agency to try, as much as possible,
to see that it is uniformly applied and not applied
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differently in different parts of the country. That's
my point. I guess that's really my concern.
MR. HOHMAN: Okay, thank you very much.
DR. CORTESE: Thank you.
MR. HOHMAN: Rose Caterino?
MS. CATERING: I have come here as a
citizen representing a group from Somerville and I belon
to the Public anonymous, of.which I'm a member.
We have a problem in that we feel the
DEQE hasn't been able to resolve and I feel and I'm
asking that the DEQE have tighter regulations to solve
such problems.
Now, the problem we have in Somerville
deals with the smoke pollution by foundries, and on
occasion oifferent groups have gotten together in Sonierv
trying in some way to get the DEQE responsible as to
measure the pollution coming from that smelting plant.
The pollution creates much, much soot. Everyone's com-
plaining about that. There is one man, depending on
which way the wind blows, especially on the down wind,
he complains of, especially on those days, of. burning
of the skin from these fumes that are being spewed from
this smelting plant.
Now, we find, as a group, or as concerned
people in Somerville, that the DEQE cannot do what we
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1 would expect them to do simply because they are not
2 equipped with the authority necessary to prohibit such
3 acts by either the smelting company or a factory.
4 Now, we have definite proof that there
5 are people being absolutely — oh, what is the word —
6 they're just sick from the pollution that is coming out
7 of this smelting plant.
8 I did not prepare a speech because I am
9 not educated in a manner that you people understand. I
JQ only know that we breathe and we can only tell you that
11 what we breathe is affecting us personally. There are
12 people that have gone to the hospital as a result of
13 being unable to breathe. They're either coughing,
14 choking. There could be many, many things coming from
15 this smelting plant that we are not aware of simply
16 because the DEQE has no way of measuring such elements
17 in that area.
lg So, I am here speaking for all us of
1^ involved in some kind of disability as a result of this
2Q kind of pollution.
21 MR. KELLAM: Okay, thank you very much.
22 I assume you and Tony have been talking from time to
23 time about —
24 MS. CATERING: I have never met Tony. In
fact, this is the first time I've seen him. I've seen
25
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1 Bruce and I've heard Bruce talk quite fluently, but I
2 felt that he was limited and that we as a group are
3 helpless when we found that one person that we depend
4 upon for at least clearing the air in our vicinity canno
5 do very much.
MR. KELLAM: Well, we appreciate your
7 bringing it to our attention. If Merrill Hohman from
8 the regional office were here — he started out as
9 chairman and will be back shortly — I'll make sure it's
brought to his attention too and we'll see what we can
do to follow up.
12 Are there any questions which the panel
has?
(No response)
MR. KELLAM: Okay, thank you very much.
David Ozonoff? If I'm not pronouncing your name correct
ly, please correct me.
DR. OZONOFF: My name is David Ozonoff,
19 ozone as in the well-known air pollutant (Laughter).
I'm a physician. I'm the Chief of the
.. Environmental Health Section of the Boston University
School of Public Health. Let me say that I appreciate
the opportunity to appear before you today here in Bos-
„. ton to give my views on what is a much needed policy for
24
regulating airborne carcinogens. It's a policy that I
25
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think will be helpful to those people in the Department
of Environmental Quality Engineering to have the neces-
sary regulatory tools at their disposal to tackle the
kinds of jobs that Ms. Caterino was talking about in
the densely populated neighborhood of Somerville. I'm
a neighbor of hers in the city next door in Cambridge.
I know that many of the people who are testifying here
today live out in the suburbs in less densely populated
areas where they are not subject to these kinds of expo-
sures, but I invite them to come to our neighborhood to
see what it's like.
I would like to give my very strong suppoi
to the notion which seems to be in dispute, very much to
my surprise, that some uniform and efficient regulatory
policy is necessary to deal with airborne carcinogens
and suspected carcinogens.
In the view of many of us, this proposed
policy is long overdue. The evidence — the link
between human cancers and physical and chemical agents
in the environment has been presented so very many times
before in hearings held by this agency and other agen-
cies charged with protecting human health in the environ-
ment, and one would think that it should not have to be
recounted again, and the same has to be said, I think,
for the scientific principles which underlie the common-
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1 ly accepted methods for identifying those agents which
2 pose a cancer risk to human beings. Yet, it seems that
3 with each and every rule-making, the same issues are
4 argued again and in the inevitable court challenge, they
5 are re-litigated again. It goes without saying that this
is very wasteful of resources and results in inordinate
7 and costly delays for implementing much needed regula-
9 tions and I think it is very heartening to see that EPA
9 is following the lead of OSHA in establishing some kind
10 of firm ground rules that just won't have to be gone over
11 each and every time contended at each and every rule-
12 making.
The evidence that chemical and physical
14 agents found in the environment are principal determinant s
15 of human cancer rests on several well-known lines of
16 argument. In brief, it's known — it's been observed
17 for some time that cancer rates among geographically
separated populations vary enormously. They are very
high in some places and low in others, both internation-
2Q ally and within the United States, as the Cancer Atlas
demonstrates, and that if one looks at sub-populations
22 which migrate from one place to another, one is able
23 to infer that a large proportion of cancers, and the
usual figure is 60% to 90%, are environmental in origin,
that is, that they do not stem from the genetic make-up
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of the populations involved. We have other lines of
evidence, of course, not the least of which is the very
large number of specific chemical and and physical agent
which are known to cause either cell transformation or
tumors in human beings and animals, and in addition,
there is almost a complete lack of evidence that any bio
logical agents such as viruses are capable of causing
cancers. And I think with all the information, the
case is well made and I haven't cited any particulars in
this testimony because these facts are so well known and
they are not ordinarily disputed.
However — and this is a subject that's
come up already in the first hour of these hearings —
to say that important factors in causing cancer in
human beings are environmental in nature does not
identify or locate them further. And a great deal of
effort — I think fruitless effort — has been expended
in recent years arguing about whether the responsible
environmental exposures are the result of so-called
voluntary activities like smoking or an imprudent diet -
I don't know how voluntary smoking is, I'm not a smoker
myself, but I know that most people who smoke, if you
asked them why they smoke, they say, "I'd love to quit,
but I can't." If that's how you describe a voluntary
behavior, I'm mystified by that use of the English
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1 language.
2 However, to argue about whether they're
3 voluntary or involuntary such as we might suffer by
4 incidentally having to breathe the air in our living or
5 working environment, I think is really not a very fruit-
6 ful line of argument. The truth is that no data now
7 exists or probably ever will exist that would allow us
8 to partition the blame amongst voluntary and involuntary
9 behaviours.
10 In any event, since we know that there
11 are synegistic relationships between both carcinogens
12 and non-carcinogens which promote carcinogenesis in the
13 environment, there's probably enough carcinogens out
14 there to go around for everybody and with one in every
15 four people getting cancer in their lifetime and one
16 out of every six dying from it, it seems that the pru-
17 dent policy would be to reduce all unnecessary exposures
18 to carcinogens to an absolute minimum. And this is
19 especially true, I think, for community air pollutants
20 where the exposure is involuntary and where the entire
2i spectrum of the population, the unborn fetus, the old,
22 the young, the acutely and chronically ill, as the
23 relatively young and healthy are exposed.
24 I'll leave to others — I hope that they
25 will do so — the task of commenting on specific cri-
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teria that the EPA has set up for evaluating substances
for carcinogenic risk, but I want to comment on one
aspect of it, and again, it came up in Professor Wilson's
testimony already today.
I think that the policy, when it's
finally issued, should be very explicit about what will
not be acceptable by the administrator as counter-
evidence of carcinogenicity. I believe it is very
important to state in that final policy that non-positive;
results from human epidemiological studies will not be
considered by the administrator when other positive
results from human or mammalian tests are available.
The reasons for the policy, again, are terribly well
known, although they seem to be consistently ignored.
so I'd like to go into them briefly.
There are two principal reasons for not
relying heavily on human observational studies, that
is, epidemiological studies, for identifying or even
setting risk limits on carcinogenic substances. The
first is the extreme insensitivity of these studies.
They're insensitive not only because they're very diffi-
cult to do — I am an epidemiologist and we are con-
tinually plagued with a whole host of confounding
factors, uncertainties in exposure and substantial time
analysis which make analysis difficult — but they're
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1 also insensitive for more important reasons, I believe,
2 because the sample sizes are invariably too small to be
3 able to detect cancer increases which may have enormous
4 significance when applied to large populations such as
5 would exposed in a community environment.
6 For example, the smallest increase in
7 cancer risk that has confidently been detected by epi-
8 demiological methods is the 30% excess of childhood
9 leukemia in the offspring of women irradiated in their
JO third trimester of pevimetric measurements. That's a
jj 30% increase and that took us many decades to be sure
12 of'
j. Yet even a 10% increase in the bladder
,, cancer rate in the Greater Boston area would result in
,, almost 5,000 cases from that source alone. I base that
16 on an approximate lifetime incidence of 150 cases per
,, 10,000 population, and surely 5,000 cases is an unaccep-
,« table level in almost any instance for one city.
,p And for more common cancers such as
_0 cancer of the trachea or bronchus or the lung, the
01 burden of morbidity and mortality would be much larger,
yet would not come close to approaching detectability by
even the largest and most refined epidemiological study
that one could realistically imagine.
24
The second reason for not relying on non-
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positive epidemiological studies, that is what is some-
times called a negative study although it is not nega-
tive, it's merely non-positive, is the very long latency
period that has to elapse between exposure and the devel
opment of the signs and symptoms of a clinical cancer.
This latency period is typically twenty years or more
and thus agents that have been in the environment for
a lesser period of time will not produce any actual
increases in cancer.
It's shocking to see how often this is
ignored. The latest issue of the New England Journal
of Medicine has a non-positive study on saccharine.
Saccharine has only been in the environment to any
significant extent for ten years and one wouldn't
expect to see any increase.
On the other hand, if one did see an
increase after an appropriate lag time, the immediate
removal of that offending agent won't do any good
because we're going to continue to suffer cancers from
that agent for the entire period of the lag time.
Therefore, epidemiological studies, used
as a sentinal system or to set up for bounds is insuffi-
cient because it's too late on two counts. First, it
takes decades before it can detect the effect and after
those decades have elapsed once you're detected it, it1
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1 too late - you're going to have them for several more
2 decades — the cancers for several more decades still.
3 To sum up, epidemiological studies are
4 likely to be non-positive for all but the very most
5 powerful carcinogens, and even very powerful carcinogens
6 like exogenous estrogens, perhaps, cigarettes, and so
7 on, it's taken us decades of arguing over it - probably
8 because the stakes are very high - before we've been
9 sure, and even for those powerful agents, they'll be
10 non-positive until the lag periods have elapsed and by
that time, it's going to be too late. Therefore, you
12 have to use other methods to identify and assess carcino
13 gens and the mainstay of any prudent policy would be the
14 use of the commonly accepted mammalian systems supple-
mented by short-term tests. And I believe that the EPA
policy is proper in relying heavily on those methods.
I just want to be clear here since there
18 has been confusion in the past about this, that I am
to not contesting the value of positive epidemiological
2Q studies. They are very important and in fact extremely
-i ominous because it means that we are dealing with a
22 powerful carcinogen. But non-positive studies should
23 never be allowed to outweigh positive human or animal
evidence and I think this should be made explicit in
25 the final policy.
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There are a number of other things that
have already been discussed, so I won't go into them in
great length. One that hasn't is the length of time
it's going to take from the first identification to list'
ing to the final rule-making. I'm not at all clear —
first of all, I'm not at all clear from reading the Fed-
eral Register on the order of events. I found it rather
confusing, and I would like to see some estimates of the
time periods or the time scales involved to accomplish
each of these steps.
Tony Cortese has already mentioned the
problem of siting. We've already lost a lot of industry
to the south and south-west in this state and I think
that this policy is going to compound that problem
further. And from the public health point of view, it
doesn't make any sense anyway because many of these
contaminants — in fact, probably most of them — are
persistent. They'll be carried for long distance by
prevailing winds and they can be magnified in the food
chain. Radioactive agents are a good example of this,
which is a concern.
And, again, I have concerns about the
large degree of judgmental and discretionary power
which is allowed to EPA in these instances. Your
resources are very limited and it really puts you at the
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1 mercy of claims and data submitted to you by the regu-
2 lated industries themselves .
3 For example, the large role reserved for
4 economic and other non-health considerations in various
5 decision-making note points in this policy, I think, are
ominous. They are an open invitation for those indus-
7 tries to pressure and manipulate the data and the agency
8 itself — for example, in deciding what is going to be
9 best available technology — and I'd feel much more
10 comfortable if EPA's latitude in making these decisions
on the basis of non-health matters were considerably
12 narrowed.
13 Again, let me thank you for coming here
to Boston for those of us who find it difficult, since
we are testifying as individuals and are not being paid
by any other concern to come and testify, to come here
17 to us so that we can give our views and I feel confi-
dent that this process of public participation will
improve the proposed policy, and it's a policy which I
2Q think is sound in essence.
-. And I'd be glad to answer any questions.
„ MR. HOHMAN: Thank you Dr. Ozonoff. Bob
Kellam?
. MR. KELLAM: I just have one question,
Dr. Ozonoff. You mentioned earlier in your testimony
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that at least one of the pieces of evidence that could
lead us to believe that air pollution may contribute to
human cancer have been the studies by the National
Cancer Institute in their mortality atlas and the fact
that cancer rates appear to be elevated in some parts
of the country as opposed to others.
One of the previous witnesses at the
Washington hearing presented some information which
compared three cities which are largely heavily indus-
trial with three other cities which I guess can be
characterized as having rather light industry. And his
conclusion based on the mortality from these six cities
was that there did not appear to be an increase in can-
cer incidence in the industrialized cities as opposed
to those which were not industrialized.
Would you have any comments on the
relevance of the use of cancer mortality in reaching
this kind of conclusion?
DR. OZONOFF: Well, of course, cancer
mortality is not a measure of cancer incidence. I mean,
this is another aspect of using epidemiological studies.
Even if they were any good, even if they were sensitive
enough and even if we didn't have to deal with a lag
period, we simply don't have the tools to practice good
epidemiology for cancer in this country because, for the
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1 most part, we don't have cancer registries. In this
2 state of Massachusetts, for example, where there is no
3 cancer registry, we don't really have any decent idea
4 how much cancer there is, who's getting it, where they're
getting, how often they're getting it, what kind of
cancer it is, and the best data available from the
third national cancer survey was a ten percent sample
of which Massachusetts is not included at all, so
although we are attempting to get a cancer registry
here, we have no idea and the relationship between
.. mortality and cancer incidence is unknown.
.. Second of all, studies which purport to
.. show relationships between some ecological variable
like industrialization and cancer mortality, even with-
14
out the problems I mentioned, really aren't any damned
good because you don't know what you're looking at. You
16
don't know what the pollutants are, you don't know how
long they've been there, you don't know what kind of
18
cancers you should be looking for against what kind of
background.
20 *
And with respect to your question about
21
the cancer atlas, that when you do begin to see sugges-
22
tive patterns, I think that's very frightening. If you
don't see patterns, I don't think that's surprising at
24
all. If you do see them, I think that's enough to scare
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the pants of almost anyone. If you look in their latest
American Journal of Public Health, which arrived yester-
day, there's a suggestion that people who live around
oil refineries and smelters may have increased rates of
cancer of the pancreas. They are only suggestive, but
things that suggest things through epidemiological
studies, I think are much more frightening that other
kinds of evidence and negative kinds of evidence like
the kind you cite just don't amount to a hill of beans
as far as what's really going on there.
Dr. Albert actually mentioned — asked
Tony about the rules of the game for risk benefit analy-
sis. I just want to make a quick comment on that.
I don't know who set the rules for that
game which says that we consider the risk to some people
and the benefits for others, but let me point out that
the rules are stacked against certain environments and
against some and for others, that the risks and benefits
are not randomly distributed throughout our population.
The people in Somerville are more likely
to suffer the risks and the people who live out in the
suburbs are more likely to get the benefits, and I think
that's a serious question about risk benefit analysis
which hasn't been addressed.
MR. HOHMAN: Todd?
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MR. JOSEPH: Dr. Ozonoff, just one
question. As an epidemiologist, do you think that the
evidence exists today by which we could know through
epidemiology whether industrial air pollution might be
resulting in one of two thousand cancers per year in
the United States?
DR. OZONOFF: No, I don't believe that
that evidence exists. I think it's possible to use all
sorts of data to make all sorts of plausible estimates.
I think the very low estimates as plausible and I think
the very high estimates are plausible and the ones in
between are plausible.
I doubt that we're every likely to get
the data that's going to enable us to make those, and I
think that the judgments have to be made on other
grounds if there's a great deal of scientific evidence
to indicate that these chemical and physical agents
cause cancer, that there are synergisms in promoting
interactions that occur in the environment and that a
prudent and plausible thing to do would be to reduce
exposures to a minimum. That data about how much it's
going to cost to reduce each one of these exposures —
the cost data usually comes from the industry and as
we know in the vinyl chloride case, their first estimate
of what it was going to cost vinyl chloride exposures
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in the workplace were not only inflated, but they were
inflated to an extent that one suspects fraudulent
motives on the part of coming up with those estimates.
I mean, it was just astronomical, the cost, and turned
out to be much, much lower than they estimated.
I don't have any good reason to believe
most of the cost estimates involved.
MR. JOSEPH: Is there any way for you
to estimate how many cancers per year there would have
to be as a result of industrial air pollution for us to
be relatively confident of seeing through that epidemio-
logy?
DR. OZONOFF: Well, if one accepts the
lowest excess that's been detected epidemiologically
and applies it to the bladder cancer case, we're talking
now about fifteen to twenty thousand cancers in the
Greater Boston area. It's a lot of cancer and bladder
cancer is not the most common kind. It's a lot of
cancer.
MR. JOSEPH: Thank you.
MR. ALBERT: Speaking for the Carcinogen
Assessment Group, I want to comment that on the fact that
in relationship to your testimony that the agency has
regarded epidemiology as a blunt tool, although a power-
ful one when it does demonstrate positive relationships,
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1 but it has never allowed negative epidemiologic data
2 to cancel out positive epidemiologic data that's solid
3 or positive animal data.
4 Negative epidemiologic data has been
5 used in quantitative risk assessment in terms of putting
, upper limits of risk where the judgment that an agent
is carcinogenic is based on the animal data and the
negative epidemiologic data has been used, as I say, to
set upper limits of risk, but we certainly appreciate
10 your expression of this position.
., DR. OZONOFF: Well, I came not only to
give my opinion but to recommend that you make this
.- explicit in the final policy. The OSHA generic stan-
.. dards, for example, have made it explicit and state
the conditions under which such evidence and other kinds
of evidence will be used and I recommend that to you as
16
]7 a policy.
MR. HOHMAN: Okay, thank you very much.
Charlotte Ploss?
19
MS. PLOSS: Hello. My name is Charlotte
Ploss. I live at —
21
MR. HOHMAN: (Interrupting) Excuse me.
I've been asked to ask the speakers to speak more
«w
directly into the microphone.
24
MS. PLOSS: Oh. Is this better?
25
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phone?
cally minded.
MR. HOHMAN: I guess. Who's the judge?
MS. PLOSS: Okay? Can everybody hear?
MR. HOHMAN: Can't we raise the micro-
MS. PLOSS: I don't — I'm not mechani-
MR. HOHMAN: Go ahead.
MS. PLOSS: My name is Charlotte Ploss.
I live at 12 Cherokee Street in Mission Hill. I am
here representing the Mission Hill Planning Commission.
Mission Hill is a neighborhood in Boston.
It is a congested, overpopulated, residential urban area
Many if not most of Mission Hill's residents are low
income and/or elderly, or very young, and/or suffering
from a chronic illness - all of the criteria to make us
a community at high risk. Yet, we are the one neighbor-
hood in Boston, if not the country, which shouldn't be
at risk.
Our community is host to a wide and
varied range of the finest medical institutions in the
world - Harvard Medical School and Dental School; Harvar
School of Public Health and Harvard's many affiliated
teaching hospitals, Peter Bent Brigham, Children's Medi-
cal Center and a dozen more renowned names, all of
which are clustered in a one-mile square area at the
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1 foot of Mission Hill. It is that medical industry
2 surrounding us, crowding us, swallowing our land and
3 our homes which in 1973 began to covet our air as well.
4 That medical industry which prides itself
5 for producing the healers, promoting the teachers of the
healers and for spawning Nobel Prize winners has given
7 birth to another offspring - the medical area total
8 energy plant.
9 Now, about now, some of you must be
wondering what I'm doing here. I did not intend to
give any scientific information. I do not intend to
12 offer detailed comments on individual or collective
12 particulates, effluents or chemicals from any source
stationary or otherwise. My credentials are my four
15 children, my granddaughter, my love for my community,
,, my active concern for its wellbeing and my consumer,
taxpayer status.
What I am here to do is give, quote,
,„ public testimony on the proposed policy and procedure
„ of the Environmental Protection Agency, unquote. And,
again, you wonder what I could possibly know about
environmental rules and regulations. Nothing until
-. 1974. At that time, Harvard University issued an
.. environmental imoact report, describing an oil-fed,
24
diesel-powered energy plant which would supply thirteen
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1 medical and educational institutions with electricity,
2 heat, hot water and air conditioning, enough power to
3 serve a city of 30,000. And they called this miracle
4 of co-generation the Medical Area Total Energy Plant,
5 further known as MATEP, and MATEP was to be constructed
in Mission Hill amid the medical institutions it was to
7 serve.
8 The EIR was not issued on April Fool's
9 Day, but it might as well have been. The neighborhood
10 considered it a joke, the scientific community considered
it a joke and even the local utility company guffawed.
12 Even though I and most of my neighbors were rank amateurs
13 when it came to environmental impact reports, we were
able to spot the numerous inadequacies, weaknesses and
inconsistencies in that one. And the very fact that
Harvard had to do this environment report and because it
was so shabbily and cavalierly done, we were falsely
reassured.
We thought the project would never get
20 off the ground. After all we learned, the air in Missior
~, Hill was already too dirty to meet federal standards
22 then. The rules and laws would stop Harvard from
23 pumping any more pollution in it. Moreover, Mission
Hill was included and cited in the study of Boston's
«c infamous death zone - God's waiting room, they called
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1 it - because of our having one of the highest infant
2 mortality rates in the country and the highest respira-
3 tory illness incidence. There were rules to protect the
4 sick people.
5 Further, within a three-mile radius of
the proposed plant site are concentrated more people
7 over the age of fifty-five than in all of St. Petersburg
8 Florida, a retirement community. Harvard can't build a
9 plant like that. The law would never allow it. There
10 are rules against that sort of thing.
11 But that's Harvard and Harvard has its
12 own golden rule: Them that got the gold make the rules.
13 I dare say that the same model hangs high on the execu-
14 tive boardroom rules of Exxon, Mobil, General Motors,
15 Ford, et al. And Harvard's gold was everywhere. The
wooden soldiers began toppling.
17 First, City Planning Agency okayed the
project before the ink was dry on the EIR. Next, sixty-
day eviction notices to tenants in the then-97 apartment
20 on the plant site were issued and enforced. An in-lieu-
of-tax-payment status was granted to the plant, saving
22 Harvard millions in property taxes. The plant secured
23 exemptions from all fire, health, safety and zoning
codes. The plant was granted a 24-hour variance from
noise pollution control limits. And all this was before
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the state's Environmental Secretary had finished reading
the title and/or the author on this draft environmental
impact report which was subsequently disapproved, amended
disapproved and amended three times.
The variances, the exemptions, waivers,
special case allowances went on and on and on, and our
community went to court. What chance did our rag tag
band of volunteers have against the well-armed legal
might of Harvard, especially when Harvard's lawyer is
president of the Mass. Bar Association, calls the Judge
by his college nickname and plans in court to meet him
on the 13th hole. But, we continued to inform and
organize other groups in the adjacent neighborhoods
about the MATEP issues. It was at that time we learned
of the Department of Environmental Quality Engineering,
DEQE, and the Division of Air and Hazardous Materials
and other lights at the end of the tunnel and other
tunnels where there were no lights.
The MATEP controversy was over three
years old and this would be the first opportunity we
had had, my community had, to address an agency about
the health effects and dangers of the proposed power
plant. But first, we had to slog through the morass
of rules and regulations and procedures. And each time
we finally got to understand one of the rules and regu-
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lations, Harvard already changed it and got a variance.
2 Whoever could not be bought was inundated
3 with paperwork, lawyers, scientists, experts, Harvard
4 alumni and special effects men.
Harvard had approached DEQE with, "Listen,
, this is what we want to build, show us how to build it."
, The community wanted the same consideration. "This is
g what we want to stop, show us how to stop it."
The community needed information, guaran-
tees and support and what we got was entertainment pro-
.. vided by Harvard's special effects team. One instance.
A solid four days of public hearings. Six hundred
community homemakers, job holders yawned and fidgeted
through slide show fantasies, feats of engineering
14
marvals, mathematical meandering and rhetoric delivered
with religious furvor. Masters of understatement,
16
experts in half truth and apostles of insurance and
assurance blanketed the audience with such good news
18
as — and I quote — "Oh, don't worry about the three
hundred and fifteen foot smokestack. We're going to
paint it so it blends in with the sky." And, "The
adjacent nursing home is safe, don't worry. In fact,
the environment of the home will be improved because
23
we're going to totally enclose the back yard with a
24
hundred and twenty foot wall which just happens to house
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the six diesel generators behind it." And, as a special
social amenity because we've all been so good, "We've
reduced the number of diesel trucks delivering fuel to
the plant by increasing the size of the trucks. More-
over so the trucks won't tie up traffic, we've secured
a right-of-way through the back yard of the nursing home
a safe thirty feet away from their back door, of course.
Community calculations showed a diesel
truck unloading fuel at MATEP every fifty-seven minutes
every day, every week of the year, three hundred and
sixty-five days. Harvard solved further objections.
They tore down the nursing home.
Time and again, at very meeting, hearing,
conference, coffee-klatch, the community was reassured
that MATEP would meet all city, state and federal stan-
dards and would employ best available technology. It's
now 1980. Harvard kept talking and kept pouring concret
Even though the Department of Environmental Quality
Engineering has disapproved the MATEP diesel three times
the power plant is almost completed. And Harvard is
sliding in a fourth set of plans under the Department's
door.
Mission Hill is grateful that DEQE has
held out against the Harvard bullion almost as long as
the community and we would welcome them in our community
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1 as volunteers and if their budget gets cut again this
2 year, they probably will be soon.
3 Most Americans assume that their partici-
4 pation and contribution in their community consists of
5 paying their taxes and curbing their dogs. When we
write out our checks to pay property, income, entertain-
7 ment and all other taxes, it is more or less done with
8 blind trust to create and fund agencies which we trust
9 to protect the public health.
The agency should not bite the hand that
feeds it. I should not have to be here today. I should
12 not have had to read thousands of pages of environmental
and legal texts, testimony, theories, calculations, pro-
jections, worst-case estimates, building plans, regula-
tions, rules, et cetera, et cetera. I should not have
had to sit through endless meetings, hearings and court
17 sessions listening to N02, SC>2 and too bad for you.
What I should be able to do is believe
.„ and trust that an agency with the moniker, "Environmenta:
Protection," does just that - protects the public's
environment.
Most consumers do not expect nor do they
wish industry to shut down. We're grateful to industry
for giving us cars, perma-press clothes and garbage
disposals. We do expect industry, however, to ply their
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wares with the least amount of damage to our health
and our environment and our economy.
I'm here today representing my community
to first recommend that the proposed rules and regulations
be translated to language other than that understood by
only environmental experts and lawyers. Industry under-
stands risk avoidance criteria and presumptive national
emission standards. The average consumer only knows thai.
whatever that means, industry has a means to get around
it.
Secondly, some of the proposed rules and
regulations set forth one policy let leave a loophole
large enough to drive a diesel truck through. We under-
stand that agencies such as yours suffer from chronic
low-budgetitis and cannot continually compete with the
multi-million dollar corporations and their resources,
and it's just that imbalanced that makes the strictest
possible controls and rules and regulations absolutely
necessary.
Because the corporations are going to
find loopholes, they're going to find the back doors
anyway no matter what you do — they're going to find
them. They have people who do that all day long. That'£
their job all day long. They have the time, they have
the money, the motivation, the lawyers, the soothsayers
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, and all other special effects people.
2 My grandmother once told me — she made
2 it a proverb to me — and she said, "It is harder £or
, a rich man to pass through the gates of heaven than for
. a camel to pass through the eye of a needle." Let me
assure you, Harvard not only got a two-humped camel
6
through, an entire caravan led by Lawrence of Arabia,
and all using applicable rules and regulations.
8
- Thank you.
MR. HOHMAN: Thank you. (Applause)
Are there any questions from the panel?
(No response)
MS. PLOSS: Okay.
13
MR. HOHMAN: Thank you very much for
14
coming. The next speaker is Ed Calabrese.
DR. CALABRESE: My name is Ed Calabrese
16
and I'm on the faculty in the Division of Public Health
17
at the University of Massachusetts at Amherst.
18
I strongly endorse the attempt by EPA to
19
develop a comprehensive and rational methodology for
20
reducing the exposure of the general public to airborne
21
carcinogens from stationary sources. In an effort to
22
provide the agency with my recommendations for improving
23
their proposed methodology, I offer the following commen
24
The use of a "single well-conducted ani-
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mal study" may be sufficient to establish if exposure to
an environmental agent results in a significant human
cancer risk. However, this depends on how closely the
animal model simulates the human condition. Concern
for only research design, statistical appropriateness
and proper laboratory procedures, while critically
important for the reliability of any animal model study,
is incomplete without careful concern for the appropriate
ness of the animal model to predict human responses.
Thus, positive or negative findings must
be interpreted in light of the adequacy of the model
to simulate the human condition. While much uncertainty
does exist as to the efficacy of specific models to
predict human responses, great progress has been made
in recent years in the area of comparative biochemistry
and this has led to general guidelines for the selection
of animal models for toxicity and carcinogenicity tes-
ting.
It is very clear that all animal models
are not equal in their ability to predict human response
from carcinogen exposures. For example, guindea pigs ar
refractory to the development of aromatic amine induced
bladder and/or liver cancer presumably because of a lack
of ability to bioactive such compounds via N-hydroxyla-
tion. Yet, since 1938, dogs have been generally con-
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1 sidered an effective model to predice human suscepti-
2 bility to aromatic amine induced bladder cancer because
3 both species, that is, the human and dog, metabolize
4 aromatic amines in a similar manner. More recently,
5 several rodent models have also been found to accurately
predict human susceptibility to several aromatic amines.
7 Not to take the appropriateness of the
8 animal model into consideration may marketly enhance
9 the occurrence of either false positives or false
10 negatives with respect to predicting the occurrence of
chemically-induced human cancer.
12 While EPA may not be able to effectively
13 deal with the issue of false negatives, the occurrence
of false positives will often result in not only the
smug and self-righteous conclusion of erring on the side
16 of safety, but also in the inappropriate assessment of
17 resources and priorities which ultimately compromise
human health.
19 Even though the knowledge of how accurately
20 animal models simulate the human responses to chemical
carcinogens remains imperfect, EPA should encorporate
22 its information, when appropriate, into the process of
23 how chemicals are assigned into priority groupings.
While the knowledge contributed from animal models at
25 the present state of the art would be undoubtedly minor,
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this should not lead EPA to ignore potentially valuable
contributions.
Second, the EPA carcinogen prioritization
scheme should be commended for taking into consideration
most of the important factors in the determination of
quantitative risk assessment including characterization
of carcinogen .levels, numbers of people exposed, and
potency of the carcinogen, amongst others. However,
one additional rea that should be considered for inclu-
sion within this process is that of further characteriza
tion of the population with respect to risk factors, and
I think that was pointed out very nicely by the previous
speaker, when you take a look at the potential high-risk
groups within certain sub-areas of any region. Back to
the text, however.
However, one additional area — Just
knowing how many people may be exposed, which is one of
the components of EPA's policy, okay? Just knowing how
many people may be exposed, while an important factor in
the development of risk assessments, does not provide
decision makers with an indication of whether those
exposed populations may have a higher than expected
proportion of individuals with enhanced risk to the
agents considered.
Dr. Richard Wadden of the University of
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1 of Illinois, School of Public Health, has utilized the
2 concept of increased susceptibility in environmental
3 planning for possible highway constructions routes
4 within Illinois. For example, several potential routes
5 for an interstate highway differed markedly in their
potential air pollution health problems since one route
7 came into close proximity with several hospitals,
8 elderly housing units and elementary schools. Since
9 the very young and old are known to be at enhanced risk
10 to the respiratory effects of automobile pollutants
11 such as carbon monoxide, nitrogen dioxide and sulfate,
12 it was clear that the highway route which affected the
lower number of high risk persons and not just the
total number of people was a better choice.
15 The same principle can be applied with
respect to carcinogens as well. Genetic susceptibility
to chemical carcinogenesis is very well documented and
18 in several instances the underlying causes are also
19 known. For example, it has been postulated that humans
with a low ability to acetylate aromatic amines may be
.. at enhanced risk to developing bladder cancer. This
trait is genetically transmitted via simple Mendelion
23 ratios.
Consequently, if the population were to
24
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1 number of that group were slow acetylators, this should
2 cause greater concern that if the population was uni-
3 formly fast acetylators. Knowledge of genetic and nutri--
4 tional factors which enhance susceptibility to environ-
5 mental carcinogens is rapidly progressing. Such know-
6 ledge, although limited, should be used by EPA to further
7 assist in the ranking of carcinogenic agents scheduled
8 for regulation.
9 A third point. While Section 112 of the
10 Clean Air Act which pertains to the National Emission
Standards for Hazardous Air Pollutants provides for the
12 listing of pollutants which cause or contribute — that's;
13 cause or contribute — to irreversible illness, that is
cancer, it is odd that the EPA proposed carcinogen polic]
does not provide a methodology for dealing with co-
carcinogens or promoters. Since certain promoters may
enhance the carcinogenic outcome within selected studies
by several orders of magnitude, this is not an issue to
take lightly. Clearly, carcinogenesis is a two stage
20 process - that of initiation and promotion. Since EPA
procedures are not designed to eliminate exposures to
.- initiators, there must be continued concern to reduce
2, exposure to promoters as well.
.. As indicated in my opening sentence, I
, support the attempt by EPA to deal with the airborne
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1 carcinogen problem. However, since the intention is to
2 reduce not just the theoretical risk of developing envi-
3 ronmentally induced cancer but the actual occurrence
4 of such cancers, how is EPA to know if all this planning
5 study, and financial expense to consumers is really
6 worth it?
7 While any program designed to reduce
8 the occurrence of cancer will meet with psychological
9 approval, how does EPA plan to evaluate the success of
10 its program? Just lowering the levels of suspected
11 carcinogens is not truly sufficient - although it is an
12 important goal to achieve. For the goal to be achieved,
13 EPA1s program must prevent the occurrence of at least
14 some cancers the Agency claims are being caused, in
part, by airborne carcinogens from stationary sources.
While the ultimate answers may await the
17 outcome of epidemiologic investigations some 30 to 40
18 years from now, isn't there some way to evaluate interim
potential benefits of such a program? For example, why
2Q not survey with proper epidemiological methodology the
occurrence of chromosomal breaks in circulating lympho-
22 cytes of humans in the risk areas of concern? This
23 methodology is used by industrial hygiene programs withii
24 industry and there is no reason why it could not be
adopted here. Clearly, EPA must be accountable and here
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is an interim way that it could evaluate its own pro-
gram.
In conclusion, it is my opinion that EPA
should re-evaluate their priority scheme for evaluating
chemical carcinogens by encorporating (1) the knowledge
of the appropriateness of animal models in simulating
the response of humans to carcinogenic agents and (2)
the concept of increased risk within the population to
carcinogenic agents.
In addition, the carcinogen policy,
while dealing exclusively with initiators, should also
include promoters. Finally, EPA should attempt to
evaluate how effectively their program is on an interim
basis by developing a population monitoring scheme
possibly concerned with assessing changes in the
chromosome aberration load.
I'd be happy to entertain any questions
from the panel.
MR. HOHMAN: Thank you, Dr. Calabrese.
Roy?
MR. ALBERT: I believe that your recommen-
dations are sound if theoretical, and probably applicable
more in the future than now. For example, although you
recommend that we take into account knowledge of the
appropriateness of animal models, I think you would have
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1 to agree that faced with bio-assay results at the
2 present time, it's very difficult to pass judgment on
3 the extent to which the responsiveness of a given strain
4 or species of animal is indeed appropriate.
5 DR. CALABRESE: I wholeheartedly agree
6 with your comment and my point with that particular
7 item was to indicate that in limited cases, there are
8 better than — you know, you can rank a model. It may
9 not give you the precise information you may be looking
10 for and it is preliminary in the sense of the state of
11 the art. But I think in terms of writing into a
12 methodology, I think it's important to take that into
13 consideration. I don't think it's wise to assume that
14 all are equal. Yet we may not have enough information
15 to differentiate among those which are better than
15 others at this present time.
17 MR. ALBERT: And also, I would take the
18 same tack in commenting on your discussion of including
19 the concept of sub-populations with increased risk. In
20 principle, I think this is fine, and presumably knowledg
2i in this area will develop, but it's awfully difficult to
22 make this a — convert this into a concrete approach
23 from a regulatory standpoint at the present time.
j^ DR. CALABRESE: I agree with you.
MR. ALBERT: Also, I believe that the
25
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notion of monitoring populations for changes ascribe to
improvement in pollution is fine. I'm not sure that
the study of chromosomal abnormalities is going ,to be
of sufficient sensitivity to do it, but there are other
possibilities on the horizon such as as looking at
carcinogenic adducts bound to hemoglobin proteins, but
this is a methodology which is still in the emerging
stage.
DR. CALABRESE: Right. I posed that
just as one of many examples that could be considered
by EPA.
MR. ALBERT: You say it is odd that the
policy doesn't consider co-carcinogens and promoters.
I think one of the reasons for that is that the scien-
tific basis for characterizing promotion and co-carcino-
genisis and knowing whether indeed it is applicable to
the human situation is at a pretty thin stage at the
present time.
For example, we don't have any good
characterization of dose response relationships even
for co-carcinogens and promoters. So, I think the
absence of this in the policy reflects the scientific
status of the field more than any oversight?.
Finally, I want to — I didn't understand
one point that you made here, and that is that you say
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1 carcinogenesis is a two-stage process - that of initia-
2 tion and promotion, and since EPA procedures are not
3 designed to eliminate exposure to initiators —
4 DR. CALABRESE: (Interrupting) Did I
5 say, "not?"
6 MR. ALBERT: Yes.
7 DR. CALABRESE: Yes.
8 MR. ALBERT: Well, that's an error then,
9 Obviously they're designed to eliminate or to reduce
initiators.
MR. ALBERT: Yeah, I see. So ~
12 DR. CALABRESE: Well, they're not
designed to eliminate initiators. They're designed, at
,, least as I read it, they address only initiators but
.. they're not designed to eliminate all exposure"necessari
to these compounds.
17
16
MR. ALBERT: I see. That's all.
18 MR. HOHMAN: Okay. Bob?
MR. KELLAM: Dr. Calabrese, you mentioned
that genetic susceptibility could be one factor which
would increase — might increase the risk of cancer for
specific sub-populations. Are you aware of other factor;
environmental in nature or otherwise, which might increa:
the population's sensitivity to the induction of cancer?
24
DR. CALABRESE: Yes. There is a wealth
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of information which has accumulated at least with respect
to animal studies, taking a look at the influence of
nutritional status on susceptibility to a wide variety
of carcinogenic agents. For example, the amazing work
which is coming out of NCI and Michael Sporen's (pho-
netically) group with respect to Vitamin A susceptibility
and low levels of Vitamin A in the diet and susceptibility
to — well, it could be any type of benzo-a-pyrene like
(phonetically) compound affecting epithelial cancers.
That's clearly well known.
There is the long-term association of
the azo dyes inversely with certain B Vitamins. The
documentation for dietary factors enhancing the suscepti-
bility to — or diminishing the susceptibility to agents
for example, there is some concern in Boston air and
apparently other air with respect to nitrosamines (pho-
netically) and although there has been a recent study
published in Nature and a follow-up one by a fellow
by the name of Gutenplan (phonetically), who has shown
that at least in an animal model that ascorbic acid,
given in sufficient doses, can prevent the occurrence
nitrosamine-induced bladder cancer.
Now, usually the ascorbic acid is thought
to prevent the occurrence or the formation of nitrosamim;
in the gastrointestinal tract and that's clearly well
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known from a dietary point of view, but Gutenplan's
work was the first that I knew that took a look at the
t
influence of a dietary factor affecting — at lea|>t
ascorbic acid affecting.the occurrence of nitro mine-
induced bladder cancer.
i
There's tremendous work from the group
of researchers at MIT, Paul Newburn's group, dealing
with marginal lipotropes with respect to a number of
carcinogens including af latoxins and nitrosamine and
several others.
From a dietary point of view, nutritional
status point of view, there's a wealth of information
on that. Genetic factors are becoming more well known
and more investigated. The work associating the ability
to induce aerohydrocarbon hydroxyles activity and suscep
tibility to lung cancer is at least in animal models and
some suggestive clinical studies in humans indicates
some differential susceptibility. I think that's in its
early stages of evaluation, but I think that clearly
nutritional status markedly enhances our retired sus-
ceptibility to a wide range of chemical carcinogens.
MR. KELLAM: One other question, jSeveral
witnesses who have testified before this hearing in
Washington have addressed the issue of whether or not
thresholds may exist for carcinogens. Do you have any
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comments on whether or not for such things as environmen
2 carcinogens there are indeed thresholds, levels in the
3 environment below which individuals would not be exposed
4 to a risk of cancer?
5 DR. CALABRESE: I feel very convinced
that there are definite thresholds at the individual
level and I think that there are no thresholds when you
take a look at the population. Let me elaborate on that
just a little bit.
I think if you take a look at any indi-
,, vidual and you try to do some type of pharmacokinetics
.„ with respeet to a carcinogen and you follow that carcino
13 gen from the point of entry into the body from distribu-
,. tion, protein binding, detoxification, excretion and so
forth, you'll find — and getting into, ultimately, the
., body has the capacity to not absorb the material, number
16
one, to bind it in a place where it may not reach a
10 critical site of action. If it does reach a critical
lo
site of action, it may come into contact with DNA and
cause a change in a non-critical site within the DNA.
If it does cause a change in a critical site and does
initiate a particular alteration which may possibly
result in the occurrence of a cancer, we certain do
know that there are highly evolved mechanisms of DNA
24
repair and so forth and I think that you can certainly
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overwhelm these repair mechanisms and there may be some
error-prone occurrences as well.
But, I think that each individual has
their limit with respect to — or their threshold with
regard to any particular agent. However, if you take a
look at the population as a whole, you'll find that in
our heterogeneous grouping in the United States, that
there is a broad range of genetic susceptibilities going
from people who have highly efficient DNA repair mecha-
nisms, detoxification mechanisms, to the spectrum way to
the left where these people are genetically impaired
with respect to their ability to repair damaged DNA.
There's a whole broad spectrum there.
If you take a look at our dietary status
within this country, you'll find we go from the vitamin
pill-popping crowd to those who have the most inappro-
priate nutritional status that one could imagine, and
what we have also are people coming from different
cultures where they will have either different propor-
tions of relative enzymes and so forth based upon their
own genetic capability.
For example, some work that I do is
with susceptibility to oxident stresses in the environ-
ment on red blood cells and we know that there is a
tremendous variability in susceptibility to oxident-
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induced stresses on red blood cells depending upon the
genetic make-up and nutritional status of the indivi-
dual.
And so, it's my feeling that if you look
at the whole population, you're going to have people
that are the very weak to the very strong, most of us
being in the middle, and there's going to be no single
threshold. There's going to be an adverse effect some-
time, somewhere within this heterogeneous population.
Whereas I think every individual has a threshold, collec-
tively as a group, there is no threshold.
It's going to be affecting some percentage
of the portion at some particular time. The big questior
is what percentage of the population is being affected?
Can they be identified? Can you deal with this in a
special administrative manner?
I think if you know more about the risk
factors involved, then you can begin to get a handle
on it. And this is — when you talk about a risk factor
of one in a million, it's my feeling that that risk
factor — or one in ten thousand — I think that this
suggests to me that there are some unique, relatively
rare occurrences, genetic occurrences or — we'll say
genetic in this particular sense — that may predispose
an individual.
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1 I don't believe the risk is randomly
2 distributed. The risk is there by biological or cultura
3 design and it's a matter of identifying that risk.
4 MR. HOHMAN: Okay, thank you very much.
5 I that's all the time we have right now. Peter Fairchil
6 MR. FAIRCHILD: My name is Peter Fairchil
7 I'm the Executive Director of NESCAUM, which is the Nort
3 east States for Coordinated Air Use Management. We are
9 the official regional air quality planning organization
10 for the northeast formed under the auspices of the New
England Governors' Conference. The membership consists
12 of the state air pollution control agencies from the six
13 New England states, New York and New Jersey.
Several of the states have commented
,c or will be commenting directly to you on the specifics
of the proposal and we have not formed NESCAUM or group
consensus on the policy because of the individual states
comments, but we have discussed it among ourselves.
,n Bob Kellam came to one of our recent
2Q meetings and discussed the proposed policy and there
have been several issues that have come up in these
22 discussions that I would like to pass along to you.
22 These are strictly from the regulatory agency point of
view. I'm not capable of commenting on some of the
scientific basis for the proposal.
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But there are three basic issues that
we are concerned about and one of the greatest benefits
that we as regulatory agencies see from the policy and
the work you're doing is the scientific data on risks anc
controls that will be developed during the process of
identification, assessment and evaluation.
This information will assist us in res-
ponding to the increasing number of questions coming to
our agencies regarding cancer risks, and it will also
provide us with the basis for state regulations, if they
become appropriate. Obvious, the state's role in regula-
ting carcinogens will be expanding, but we don't have the
staff or the scientific expertise to be developing all
this information ourselves. We will have to continue to
rely on EPA, and by that, I also mean the other agencies
working with the EPA and the assessment groups. We will
have to rely on the federal expertise to provide this
information.
Along this line, we would recommend
strongly that you consider establishing a mechanism for
routine transfer of information to the state regulatory
agencies of not just final listings and final determina-
tions, but even your preliminary assessments. In thinkiijic
about this, this may also be a benefit for you too. As
sister regulatory agencies, we may be able to respond and
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input into some of these difficult trade-offs you'll be
making from our perspective, so I think the benefits go
both ways to some routine back-and-forth trading of
information even on preliminary assessments that you
make.
The determinations of the appropriate
degree of control and ample margin of safety in the
proposed policy allow considerable judgment, and consid-
eration of economic and social impacts. This has been
mentioned by several speakers this morning. While we
don't feel that this is totally inappropriate, it does
raise a concern.
The effects of carcinogen exposures are
usually localized around a source or within some iden-
tifiable distance from the source , while significant
benefits may accrue nationally or at least regionally.
The obvious inequity between the distribution of benefit
and the concentration of risks must be handled fairly
and as responsibly as possible. It's essential that
the affected state and local areas have direct input
into this decision and evaluation process.
And it occurs to me from listening to
Dr. Ozonoff's comments, the same is true in discussing
the time distribution, the latency period. The detri-
mental effects may occur over a long period of time
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while the benefits can be shown to occur very — in a
short period of time, very immediate, and it is not fair
to trade off those immediate benefits for long-term
effects which are nevertheless real.
Speaking strictly for myself and not
on behalf of NESCAUM, it seems fair and obvious to me
that it's prudent as regulatory agencies that we try to,
as much as possible, relate the benefits and risks on
comparable scales and comparable timeframes. That seems
the only fair way to approach the problem.
The last point is the new source require-
ments . The new source requirements in the proposal are
of also great concern to us. They don't require, but
they tend to discourage industrial growth in densely
populated areas such as the northeast, while favoring
other regions of the country. The potential economic
impacts to the northeast must be given careful considera-
tion in the final policy. And, as a related concern,
unpopulated areas may seem like the ideal locations for
you to encourage siting of potential sources of carcino-
gens, they also are areas likely to encourage new commer-
cial and residential growth.
And it's a Catch-22 situation. This
industrial and residential growth are receptors of the
carcinogens that may be emitted from the plant you've
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1 located in that area, and we don't have the means to
2 control residential and commercial development to the
3 same degree as we do a potential source of carcinogens,
4 so we may be allowing receptors to come into an area at
5 a later time and posing as real a health problem as if
5 you located the potential carcinogen-emitting facility
7 in a populated area at the time.
8 So, there is a contradiction and, as I
9 say, a Catch-22 kind of concern that we urge you to
10 consider. Obviously we're not only concerned with
economic impacts, but as regulatory agencies, we work
12 in a political environment and we have to be able to
13 support policies that are not insensitive to economic
development, and from the northeast point of view, we
are concerned with the new source regulations -- the
requirements.
17 I appreciate the opportunity to comment.
jo I'll try to answer any questions if there are any.
19 MR. HOHMAN: Thank you. Does anyone
20 have any questions?
21 (No response)
„ MR. HOHMAN: Thank you for speaking.
23 MR. FAIRCHILD: Okay, thank you.
24 MR. HOHMAN: Mr. John Groopman?
DR. GROOPMAN: My name is John Groopman.
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I'm a toxicologist at the Massachusetts Institute of
Technology.
The EPA emission standards for identify-
ing and assessing and regulating airborne substances
that initiate or promote carcinogenesis is a significant
step towards cancer prevention. These regulations have
far-reaching implications since the vast majority of
chemical carcinogens are low-molecular weight compounds
which are either intrinsically volatile or else easily
complexed or absorbed by particulate matter.
Therefore, once these chemicals are
constituents of air, they can readily contaminate water
and soil and ultimately all living organisms. The
scientific basis of these regulations are that a
majority of human cancer is initiated by environmentally
present chemical compounds. The issue of whether these
compounds are synthesized by plants, microorganisms or
in an organic chemistry lab is moot since once they are
disseminated in the environment, they pose potential
carcinogenic risk.
Since these agents are environmentally
occurring, hence controllable, many scientists have come
to the logical conclusion that the majority of human
cancer is potentially preventable. Historically, many
forms of chronic human disease such as malaria, yellow
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1 fever and tuberculosis have been controlled through the
2 use of preventative health measures. In fact, in the
3 1890's cholera was eradicated here in the City of Boston
4 not through the understanding of the molecular biology
5 of how cholera toxin worked, but through the realization
6 that if you had an uncontaminated water supply, people
7 would not get the disease.
8 Therefore, we only need to know the
9 ideology of cause and not necessarily the mechanism of
10 action to eliminate the human suffering caused by these
11 diseases. An analogous case now exists with respect to
12 chemical carcinogens. The realization is that if an
13 individual is not exposed to these agents, that person
14 will have a miniscule probability of getting cancer.
15 As I'll be discussing in greater detail the precise
l^ mechanisms controlling each stage of malignant trans-
17 formation have yet been delineated. However, research
13 and experimental carcinogenesis has given us much insigh
^g into the basic mechanisms of how these agents initiate
2Q cancer.
-, These unifying concepts form a paradigm
22 for the molecular action of these agents and also serves
23 as the basis for the mutagenesis screening assays.
24 Despite the substantial efforts on the part of the
25 medical community over the last fifty years, treatment
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of cancer following clinical diagnosis works in only a
minority of instances. If one uses the five-year sur-
vival rate as a guideline, in the 1930"s, twenty percent
of all cancer patients lived longer than five years.
During the next twenty years, this was increased to a
third of all cases. However, since 1960, the five-year
survival for the vast majority of human cancers - lung,
breast, colon and stomach - have not changed.
We must not promulgate the misconception
by people who believe that they can afford the luxury
of getting cancer rather than preventing it — the
scientific literatures replete with research which
provides insight into the basic mechanism of initiation
of cancer by chemical carcinogens.
These compounds first enter a cell by
diffusion or active transport across the cell membrane.
Most chemical carcinogens are inherently inert and need
to be metabolically activated or chemically changed to
react as species i n this proximate or ultimate carcino-
genic form, and given the genetic nature of cancer,
interacts with nuclear macromolecules forming the
lesion. The nuclear macromolecules comprising the
genetic apparatus are DNA, which includes all potential
phenotypes; nuclear proteins which direct the expression
of genes and DNA; and some RNA.
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1 Damage to these macromolecules, and
2 specific with DNA, can be repaired or not and following
3 DNA replication, these unrepaired lesions can be fixed
4 as mutations. Eventually this transformed cell can
5 express its new phenotype and experimentally we have
found that cancers generally found to be monoclonal
7 in origin — that is, that tumors arise as a result of
8 changes in a single sell and its progeny.
9 After this, there is a multiplicity of
10 of steps where agents such as promoting chemical com-
pounds can potentiate the malignancy. One lesson of
12 this process is that many cell generations will have
12 occurred before the clinical manifestation of that
single transformed cell is seen, and we are all cogni-
., zant that this is already too late.
16 The postulates that I have just outlined
17 are widely accepted and are the products of classical,
conservative interpretations of properly-designed exper-
,n ments. For the sake of completion, I wish to briefly
discuss these experimental models.
The phenomena of initiative and promotion
_2 was discovered using mouse skin carcinogenesis studies.
-« The mechanism of action of compounds such as aromatic
amines and N-nitrosamines have been studied in rodents
where they are patocarcinogens (phonetically) . Inhala-
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1 tion of vinyl chloride in laboratory animals produces
2 apatoangiosarcomas (phonetically) of the same type that
3 occurs in humans.
4 Bronchiogenicarcinomas, again of the same
5 cell type seen in humans are found in experimental models
6 for lung carcinogenesis in mice, rats, hamsters and dogs,
7 Indeed, mammary cancer in rats, by injections using
8 N-methyl N-nitroceurea mimics its human counterpart in
9 that it metastasizes to bone and produces hypercalcemia.
10 Colon cancer models in mice and rats can
11 be produced by a number of chemical carcinogens. Pan-
12 creatic cancer can be induced in rats, guinea pigs and
13 hamsters. Other organ .sites for which animal models
14 exist include cervix, endometrium, esophagus, kidney
brain, hematological tumors and bladder; With the
possible exception of prostate cancer, there is an
animal model which mimics its mammalian cousin, the
human.
19. It is therefore shallow argument or
2Q hypocritical to say that scientists can experiment
with these animals to understand the molecular mecha-
22 nisms of cancer and be honored with prizes and awards
but at the same time state that these model systems
cannot be used to assess the carcinogenic potency of a
chemical compound.
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1 However, there is always the argument
2 of the extrapolation of data from experimental animals
3 to humans. Here too there are experimental models in
4 the form of explant human tissues in organ culture
5 that have been shown to have the same initiation reac-
tions as many chemical carcinogens in animals.
7 To date, these models include tissues
8 such as bronchus, breast, esophagus, pancreatic,
9 and colon.
In summation, basic scientific research
has resulted in a general understanding of the biology
of carcinogenesis in the molecular biology of malignant
transformation using animal and organ explant human
tissue models.
.- In order to prevent cancer, an obligatory
first step in public awareness is that we are dealing
with a preventable disease. This is defeated by the
active cultivation in the public's mind that, quote,
everything causes cancer.
The National Cancer Institute, having
looked at seven thousand likely chemical carcinogens
„ in the survey of compounds which have been tested for
23 carcinogenic activity have found that less than fifteen
.. percent or one thousand were positive. Out of the four
_, million known chemical compounds with about fifty
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thousand in use today, only a fraction of these are
carcinogenic.
It serves no end to admit futility when
we are dealing with a technologically, analytically and
conceptually manageable situation.
Finally, due to the generational latent
period of cancer from initiation to clinical manifesta-
tion, we are seeing today the results of our ignorance,
both active and passive, about cancer in the 1940's and
50"s. The agents responsible for the cancers of the
early 21st century are already present in our environ-
ment.
So, how arrogant must we be to allow one
after another generation to be condemned to the misery
of this disease?
MR. HOHMAN: Thank you. Are there any
questions from the panel? Bob?
MR. KELLAM: Dr. Groopman, I'd just like
to ask you the same question that I asked Dr. Calabrese,
and that is, with regard to thresholds for carcinogens,
do you feel that — I guess there are three possibilitie
that there are thresholds for some carcinogens for some
individuals, that there are not generally thresholds for
carcinogins —
DR. GROOPMAN: Well, it depends what you
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1 want to talk about. If you want to talk about an exper-
2 mental model in a laboratory where you have the luxury
3 of using, let's say, ten million animals so you can use
4 extremely low doses to see if you can get a significant
5 number producing a tumor. Then you could do the fine,
mathematical extrapolation to find out if you have the
7 answer to the question, "Is there a threshold at this
8 level."
9 But, if you're out in the environment
10 where you're dealing with a whole number of compounds
working synergistically, antagonistically and otherwise
together, I just fail to grasp the comment about thresh-
12 old. They're two different things.
-,. If you want to talk in the laboratory
,. situation, it's one thing. If you want to talk about
16 policy, I think it's a totally different question.
17 MR. KELLAM: Let, let's just address the
laboratory situation.
._ DR. GROOPMAN: Well, in my understanding,
there have been mega-mouse experiments where people have
used ten-to-the-eighth mice in order to test the —
excuse me, the proposals to do this — in order to look
at a threshold level down to extremely low doses. But
AW
you're talking about the type of experiments that are
expensive, time-consuming, and only looks at one parti-
25
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cular compound when you could be using those resources
to look at a whole series of compounds.
MR. KELLAM: Do you personally believe
though that there may be thresholds, that what's
commonly called the one-hit model, that a single
molecule of a carcinogen can induce a cancer is valid
or invalid?
DR. GROOPMAN: Well, I think at the
laboratory level, in a quantitative mutogenesis assay
that you would do in either mammalian cell culture or
in bacterial reversion assays, that if you calculate
how many hits you needed in that geno in order to get
a mutation that you can measure , it's on the order of
five to seven hits per geno . Whether you can extrapo
late that out to anything else is something I certainly
would never do.
MR. KELLAM: Thank you.
MR. HOHMAN: Okay, thank you very much.
Our next speaker is Helena Brown.
MS. BROWN: My name is Helena Brown and
I'm a researcher in the cancer area at MIT.
Presently, there are fifty thousand
synthetic chemicals used on the market in large quanti-
ties every day and about one thousand new ones are intro
duced every year. Many of these chemicals find their
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1 way into the environment in the form of air pollution.
2 There is a good reason, therefore, to be concerned about
3 the potential of proving carcinogenic activity of these
4 compounds to humans.
5 Most carcinogens are in effect pro-
carcinogens, which means that once entering a living
cell, they have to be metabolized by similar enzymes
before they can act. It is now well known that the
metabolism transforms most pro-carcinogens to electro-
filic reactants which in turn bind covalantly to cellular
macromolecules, including proteins, DNA and RNA.
12 It is now believed that binding to DNA,
the somatic mutation is in most cases the first neces-
sary, although not sufficient, stop in a complex chain
,e of events which leads ultimately to cancer. Somatic
,, mutation gives rise to cancer by changing the normal
17 cellular mechanisms coded foreign DNA that control and
prevent self-multiplication.
.- Now, there are three fundamental types of
Q evidence used at the present time by scientists to
determine the carcinogenic activity of an agent with
respect to humans—epidemiological data, animal testing
and short-term screening assays. Epidemiological evidence
. was addressed fairly well by David Ozonoff and I will no1
elaborate on that issue. Suffice it to say that althougl
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this kind of evidence is absolutely essential in determi
nation of environmental causes of human cancer, it has
a number of limitations.
One of its very serious problems is the
fact that people have already been exposed to a carcino-
gen for decades by the time a particular cause of cancer
was identified. The reason for that is that it takes
anywhere between ten and thirty years from the initial
assault on the human body to the actual appearance of
cancer in humans, so it's a very serious limitation of
the epidemiological evidence.
At the present time, the key method for
detecting potential human carcinogens is the animal
bio-assay, usually done with rats and mice. The weak-
ness of this technique very commonly stressed by those
who do not want to accept the data emerging from such
experiments are, and I list the two main ones.
First, there are wide differences in
response between species, so extrapolation of results
obtained with animals to human cancer is open to
question. And secondly, lack of correlation between
high doses administered to animals in a laboratory
situation and low doses in ambiant air relevant to
everyday human exposure is also open to question.
Now, I would like to address those weak-
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nesses which are sometimes discussed. All the animal
testing, even when done properly, perhaps not an ideal
method to determine risk to human health, there are some
basic facts about it.
First, metabolism of many carcinogens
in human and rodent cells follows the same pathways
and it doesn't always hold true, but it has been shown
over and over again with many polycyclic aromatics and
other carcinogenic compounds, that there are identical
or very similar metabolic pathways involved.
Secondly, recent work by Bruce Ames (pho-
netically) showed that the potency of the carcinogen
does not actually vary significantly between sexes and
between rats and mice.
Thirdly, that a very recently published -
actually, it's the last month's issue of Cancer Research
published by the International Agency for Research on
Cancer showed that among twenty-three compounds positi-
vely identified as human carcinogens, twenty-one were
also carcinogenic to test animals, so there is a pretty
good correlation between the data with humans which is
already proven and the animal testing data.
And lastly, as to the relevance of the
extrapolation of high experimental doses in animals to
low level environmental human exposure, there is a very
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1 good reason for that. It is illustrated as follows.
2 An environment carcinogen causing cancer in only one
3 percent of a hundred million people would result in a
4 million new cases of cancer. We're talking about weak
5 carcinogens, one percent. Detection of cancer in animal
6 tests at one percent level would require ten thousand
7 rats and involve astronomical expenses.
8 For example, an average experiment
9 involves fifty animals in each group and the cost of
10 an experiment like that can go up to a half a million
11 dollars as it is. Therefore, instead of increasing the
12 number of animals, the researchers simply increase the
13 dose.
14 Now, well documented positive linear
15 relationships between the dose of a carcinogen and the
l^ tumor incidence makes this extrapolation valid. Based
17 on the data collected there is a good scientific evidenc
18 pointing to the relevance of animal testing data to
19 human situations.
20 Now, briefly, the third alternative for
2i screening the chemicals is a battery of fast, inexpen
22 sive, short-term assays, the best known of which is a
23 bacterial mutation test, Ames1 assay. Here again, no
24 single assay is perfect because each system detects a
«e few carcinogens which others do not. The idea of a
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battery of short-term tests is now favored by many
investigators.
With this approach, there is a very good
correlation, anywhere between eighty and ninety percent -
there is a controversy among scientists here — but it's
a very good correlation between mutagenic activity of
a compound and its demonstrated carcinogenicity to
animals.
In short, there is a good reason to
believe that compounds shown to be positive either in
short-term screening assays or in animal testing studies
or both are potentially carcinogenic to humans and should
be strictly regulated.
MR. HOHMAN: Thank you. Any questions?
MS. ANDERSON: I just have a —
MR. HOHMAN: Betty?
MS. ANDERSON: It seems to me your state-
ment is pretty much an endorsement, at least on the
scientific side, of how the EPA has approached the risk
assessments with carcinogens.
MS. BROWN: That's correct.
MS. ANDERSON: I wondered if you were
suggesting that we do something that we are not doing
currently or you are endorsing what we are currently
doing.
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MS. BROWN: Well, one thing I can stress
is the time factor involved. From reading the EPA registei
I understand that the period of time between, I guess,
first naming the prospective chemical and actually
coming out with regulations is about three years. If
there is any possibility of shortening that period of
time — but in general, I endorse the EPA's approach.
MR. HOHMAN: Okay, thank you.
MS. BROWN: Thank you.
MR. HOHMAN: Let me reminate here for a
minute. We have a number of speakers — about twenty,
I think. My thought is that we will stop at some
convenient time around twelve-thirty for about a forty-
five minute break, after which we will get back to work
again and move through the afternoon.
If the average time is of the order of
fifteen minutes or so per speaker, I think we can
handle this pretty well. So, I will call the next
speaker or two and then around twelve-thirty or so
we'll take a break for about forty-five minutes.
Herb Northrop is next, I believe.
MR. JAESCHKE: Dr. Northrop is here and
he's available to answer medical questions that might
arise from my testimony. I'm Wayne Jaeschke, Vice Presi-
dent of Environmental Services for Stauffer and then Mr.
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1 Ronan, our counsel, wishes to make some comments on the
2 pertinent legal deficiencies of EPA's proposal.
3 I the position that I held in Stauffer, I
4 responsible for the activities of over 200 professionals
5 and other employees devoted to toxicology, health resear
, occupational medicine, product safety and environmental
7 regulations which affect our chemical production through
8 out the United States. I'm also a member of the Environ
^ mental Management Committee of the Chemical Manufacturer
10 Association, a member of the board of directors of
,, Chemical Industry Institute of Toxicology. I'm also a
12 parent, a taxpayer and certainly as concerned as anyone
., in this room with the issues of cancer and the air that
,. we all breathe.
14
I wish to discuss several of the policy
., issues relative to EPA's proposal. I'm deeply concerned
lo
that EPA's proposal is completely unnecessary, scientifi
cally unsound and will add yet another layer of bureau-
is
cratic procedure and counterproductive controls. It
will divert necessary and finite and limited resources
20
away from much more fruitful research and production of
essential goods. Anyone who has observed the ravaging
and dehumanizing effects of human cancer as I have and
I'm sure that many in this room have, particular in
24
its terminal stages, cannot help but be moved and moti-
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vated to seek a constructive action to alleviate suffer-
ing of future generations from cancer.
On the other hand, I feel a sense of
outrage towards nonscientific and simply bureaucratic
procedures and controls which will needlessly and addi-
tionally burden essential productive capacity without an
rational demonstration of human benefit.
I certainly think we should have a
moratorium on such potentially counterproductive regula-
tory activity until such time as there is scientific
understanding of the subject proposed to be regulated
and a clera demonstration of need. Our energies and
resources should be focused instead on the scientific
research and information which must be carried out in
order to predict whether, and at what levels, humans
are at increased risk of cancer from any type of environ
mental contamination.
Over the past ten years, Congress has
enacted many new laws and agencies have written hundreds
of thousands of pages of regulations, guidelines and
orders about environmental and toxic substance control.
My company and our industry have recognized the need and
support such actions where such a need has been clearly
demonstrated. Industry as a whole has spent billions of
capital dollars, and my company alone over two hundred
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million dollars, to control environmental pollution.
Stauffer spends about fifty million dollars annually to
operate facilities for pollution control and testing
for products for biological safety. We recently built
a new environmental health center in Farmington, of larg
production, to carry out animal, Ames' and other types
of testing.
Rules and regulations have grown from
those few which are basic and essential to a huge number
of conflicting, overlapping ones containing many serious
technical and legal flaws. In many cases, highly skille
doctors, lawyers and engineers cannot adequately under-
stand or cope with this bureaucratic maze. The simple
14 I! hamburger, for example, according to recent U.S. News an
,5 World Report, is the subject of no less than 41,000
,, regulations.
,, Now, the Clean Air Act and regulations
,„ provide ample room already for case-by-case regulation
._ of airborne pollutants. For example, EPA has already
0 regulated the suspect carcinogens asbestos and vinyl
chloride, as well as others, under Section 112 of the
Clean Air Act. There is no reason for adding more regu-
-. lations which will overlap and most likely conflict with
II
,.. the existing ones. Dealing with this overlapping layer
simply diverts our resources from projects which have a
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1 high probability of human benefit.
2 Now, I'd like to deal with the proposed
3 policy. I feel there is no evidence of a connection
4 between general air pollution and cancer, as much of the
5 testimony in Washington demonstrated. I feel that pru-
dent public policy as well as the law demand a clear
7 demonstration of need and benefit prior to implementing
8 a regulation of potentially huge impact. EPA is unable
9 to demonstrate that the present proposal is necessary or
likely to reduce cancer mortality in the general popula-
tion. I find several facts particularly impressive in
this regard in support of the conclusion that general
13 air pollution does not impact the incidence of cancer.
14 National Cancer Institute, NCI, cancer
statistics, when adjusted for smoking, show the cancer
16 mortality among women has decreased slightly while mor-
,, tality among men has increased slightly for the period
1970 to 1977, although, presumably, men and women are
.„ exposed equally to the general environment. And it is
. my understanding that NCI will soon publish a manuscript
. now in preparation that will state essentially the same
„ relationships and the decline of incidence rates as well
2_ Cancer mortality in certain heavily
-. . polluted cities is less than in comparable relatively
clean cities, which has been amply testified to by Dr.
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1 Dimopolous (phonetically) in the Washington hearings.
2 The general population has been exposed
3 to low levels of airborne pollutants over the last
4 thirty to forty years, yet no correlation exists with
5 increased cancer mortality.
There is no firm evidence to support the
7 hypothesis that the general air pollution increases the
3 risk of lung cancer.
9 Epidemiology, while I think all agree is
a blunt tool, it is sufficiently sensitive to flat
significantly increased human risks, as demonstrated
by liver cancer studies of aflatoxin in various African
states and the remarkable correlations of cancer and
smoking shown in both sexes by NCI statistics.
I feel it's totally improper to set regu-
16 latory policy on the basis of speculation in the absence
of scientific data. We should bear in mind that the
purpose of EPA's proposal is to regulate agents, which
if present in the general ambient environment at all
are at levels measurable in parts per billion. Rules
under this proposal might, for example, result in the
reduction of a chemical agent in the environment from,
say, 200 parts per billion to, let's say, 50 parts per
.. billion by expenditure of millions of dollars.
24
Prudent public policy, certainly, require
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1 a strong showing in such a case that there is a reasonabl
2 probability, based on some scientific data, that such a
3 miniscule change in the overall makeup of the environ-
4 ment will reduce cancer incidence.
5 I think it's shocking to find this type
of regulation being strongly pushed and considered since
7 there is simply no scientific understanding of low dose
8 effects, even at the levels of low parts per million,
9 let alone parts per billion and trillion. There is an
10 absolute lack of scientific information concerning the
11 difference in biological impact on live animal organisms
12 for example, when ambient exposure is changed from high
13 parts per billion to low.
EPA's argument for regulation must,
therefore, be based solely on speculation and philosophy
Private and public resources would be spent more produc-
tively, for example, on scientific research on the effed
18 of such ambient levels rather than on counterproductive
controls.
20 The speculation about potential synergis-
21 tic effects at parts per billion levels has even less
.„ scientific basis. Indeed, one could speculate about the
23 antagonistic effects equally as well. Either effect is
«, certainly extremely highly improbable in view of the
rarity of collisions amongst molecules present at parts
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] per billion levels. Scientific data, not speculation,
2 must be the basis for prudent regulation.
3 Now I'd like to address the question of
4 criteria because as has been said over and over again,
5 concerning goals of reducing carcinogens in the environ-
6 ment, is an important goal. And I think we might all
7 agree as to that. The real question is how does one,
8 absent epidemiological data, how do you spot those things
9 that might reasonably be considered to be a human carcinc
10 gen based on some form of predictive animal or other
11 data.
12 The establishment of criteria which would
12 enable EPA to regulate a substance as an airborne carcinc
14 gen, based on positive results on a single animal species
without more, is not supportable, in my view, from a
.. scientific point of view. Establishment of this type of
10
._ arbitrary criteria for the convenience of the agency is
.. certainly improper in this area where scientific measure-
ment and judgment of all of the facts are essential in
order to properly assess whether any substance should be
considered for regulation as an airborne carcinogen in
the general environment.
At the outset, scientific judgment is
*w
required to determine whether there actually exists an
24
increased risk of exposure of the experimental animal
25
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subject to massive doses of the agent or whether increase*
tumor formation might be due to other factors such as
metabolic overloads, dietary deficiencies, or poor animai
health caused by overexposure.
If a significant risk is established in
one of the species under test, then additional measure-
ment and scientific judgment certainly seem to be
required to extrapolate these findings to other species
and ultimately to man.
In the Dry Color Manufacturers case, the
court wisely recognized a need for evidence linking
effects in animals with risk to man. And I think there
has been testimony on that here this morning. In that
case, the chemical DCB induced tumors in rats as well as
in mice. The action was attributed, however, to a
metabolite produced in the rodents. Experiments with
dogs which appear to handle DCB in a way metabolically
similar to man, showed that the dogs failed to produce
the carcinogenic metabolite and were resistant to tumors
In that case, the agency's application for emergency
action was denied by the court.
There are numerous other examples of
differential tumor susceptibility of species by reason
of differing metabolism, including 2-acetylaminofluorine
which induces cancer in rodents but not in guinea pigs,
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1 and 2-naphthylamine, which is carcinogenic in dogs,
2 monkeys and hamsters, but not in rats and rabbits.
3 Recent research by the Chemical Industry
4 Institute of Toxicology revealed that under the same
5 exposure conditions, rats are susceptible to squamous
cell nasal carcinomas while mice are not susceptible.
7 This further demonstrates the futility of condemining
8 highly useful products on the basis solely of a single
9 positive test. Fortunately, this finding has caused
10 leading comparative biologists — for example at
Rockefeller University — to more vigorously explore
the scientific bases for the extrapolation of risk from
species to species.
It has further stipulated scientific
thinking as to the potential significanc of differences
., in enzymes, hormones and other biochemical factors which
._ might be important in cancer risk assessment. Research
by Dr. David Sachs at the National Institute of Health
on the relationship between surgical transplantation of
kidneys and tumor immunity suggests the necessity of
understanding the role of the immune system in predictin
the risk of human cancer promotion in relation to animal
models.
There are numerous other examples of
24
species specific carcinogens, including a wide range of
25
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chlorinated hydrocarbon solvents and pesticides. Also,
while phenobarbital is known to produce cancer in rats,
it has been used safely by thousands of human beings
for many, many years - long past the latency period.
While this subject has not been thoroughly
researched, species specific carcinogens are probably
the rule rather than the exception. Therefore, the basis
for indictment of any specific agent based solely on one
mouse study, for example, at massive doses, is fundamen-
tally without scientific merit.
Finally, scientific judgment and measurem^n
are essential requirements for the assessment of the
meaning of "no observable effect levels" in animal models
and consideration of "safe" levels of airborne substances .
There are numerous examples of chemicals such as selenium,
estrogen, both endogenous and exogenous chemicals of all
kinds, which are essential components of human survival
at low levels, yet they induce tumors in animals at high
dose levels.
Dr. Henry Pitot, who is Director of the
McArdle Laboratory for Cancer Research — and certainly
one of the leading cancer scientists in the United
States — recently said, "The determination of a thres-
old effect of a carcinogenic agent should be carried out
for a number of known exogenous and endogenous carcino-
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1 gens at low doses utilizing the extrapolation of 'time
2 to tumor". Thus far, studies have almost exclusively
3 been carried out looking only at the incidence of cancer
4 which statistically becomes meaningless very rapidly as
5 the dose approaches zero. Thus the 'effective threshold
5 should be sought rather than the 'absolute threshold'."
7 The FDA, for example, has even set a
8 safe level or "tolerance" for the presence of the
9 naturally occurring, extremely potent carcinogen,
10 aflatoxin, in peanut butter, by established risk assess-
ment procedures. The subject of effective or practical
thresholds must be given more attention particularly in
view of the extremely low levels which would be the
subject of regulation under EPA's proposal.
,, The foregoing discussion and examples of
16 risk factors clearly illustrate the futility of trying
to properly assess the carcinogenic risk to man, based
on arbitrary criteria alone in this area, where the cau-
._ sal factors are not understood and cannot yet be ration-
alized as a set of guiding principles.
Given our present lack of fundamental
„ understanding, meaningful risk assessment and extrapolation
-- can only be made by thorough scientific appraisal of the
data. A Science Panel, such as proposed by AIHC, would
be most useful for this purpose, and I urge the EPA to
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support creation of such a panel in the public interest.
There is a high priority need for a
greatly increased level of mechanistic research on tumor
effects in animals, for research on effects at low doses
found in the general environment, research on the princi-
ples of comparative toxicity amongst species, and the
value and limitations of toxicological procedures in
general as predictors of risk to man. There is no need
for more regulation until the scientific back up is in
hand. There is adequate mechanism under Section 112 for
regulating on a case-by-case basis.
These facts are beginning to gain recogni-
tion, for example, by the chairman of the President's
Cancer Panel and by other independent scientists, inclu-
ding the Nobel laureate scientists who helped form the
American Business Cancer Research Foundation for the
purpose of catalyzing such research.
EPA should recognize and support this
critical scientific endeavor since this is far more
likely to alleviate future human suffering than counter-
productive and needless added regulation. Thank you.
MR. HOHMAN: Thank you. Roy?
MR. ALBERT: I have a couple of comments
and then a question. I believe the points that you make
in quoting Dimopolous on Page 4 were dealt with in the
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Washington hearings and are on the record , the objec-
tions to his assertions.
I think your use of aflatoxin as an
example of epidemiology as a sensitive tool to flag
significantly increased human risks is a poor choice
because in the areas that you're talking about, in
Africa, liver cancer is not only the leading cause of
cancer, it's a leading cause of death. And so, you
practically don't need epidemiology at all to pick that
out.
Also, your objections to the use of
single — responses in single species is applicable to
the aflatoxin situation because if one were to apply it
to aflatoxin, aflatoxin would not be identified for
regulatory action because it would only show up as
positive in routine bio-assays in the rat, not the
mouse.
I think your objection to the induction
of squamous cancers in the nose of rats is not particu-
larly well founded because this was the prime response
that identified bischloromethyl ether as a carcinogen
and subsequently demonstrated to be a human carcinogen,
not of the nose, but of the bronchial tree.
Your reference to Pitot's recommendation
of using temporal thresholds I think is an opinion of
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his and I'm sure he would be the first to recognize that
there are sharp differences in opinions about — or at
least a major uncertainty about the temporal characteriz
tion of tumor responses, and that there are two differen
models that equally well fit the data at the present tim
one of which would support a temporal threshold and the
other wouldn't.
Now, finally, in terms of your recommenda
tion on Page 9 about the Science Panel, it seemed to me
that the entire thrust of your testimony is that there
is no scientific basis for estimating carcinogenic risks
whatsoever at the present time in humans and yet you
seem to call for the — well, at least you state that,
11... meaningful risk assessment and extrapolation can
only be made through scientific appraisal of data,"
when you went through a litany which seemed to indicate
that you couldn't do this. And then you call for the
creation of a Science Panel to do essentially what you'v
called an impossibility.
I find this a contradiction in terms of
the thrust of your testimony. I wonder if you would
respond to that.
MR. JAESCHKE: Well, which of the long
litany of questions would you like me to respond to
first?
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1 MR. ALBERT: The last.
2 MR. JAESCHKE: Because I disagree essen-
3 tially with the thrust of each and every one of the
4 comments —
5 MR. ALBERT: (Interrupting) I thought
you would. (Laughter)
7 MR. JAESCHKE: —- or discussions that
8 you made. I find no contradiction in the statement that
9 a Science Panel is needed. The position that's quite
10 clearly stated here is not that any rule-making should
not go on in cases — indeed, rule-making has gone down
12 in vinyl chloride, beryllium, asbestos. It's adequate
13 regulation, legislation which enables EPA to get on
with the business of regulating where regulation is
,c necessary
The argument, and the fundamental argu-
ment is that the one mouse criteria that EPA has set
up is totally unsound, that this is a matter where
19 there are no rationalized clear-cut principles. That's
been made abundantly clear by the litany of testimony
.. here on metabolism and other factors, and it certainly
22 seems to me that this is a matter of scientific judgment
23 and that's quite consistent with our position.
«. You must have the best scientific judgmen
24
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We're not saying that categorically — or I'm not saying
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categorically, and no one is — that in a case where
you simply have a rodent bio-assay that you can connect
by appropriate linking evidence, whether it's metabolism
or something else that might be appropriate to raise a
presumption of carcinogenicity in man, that regulations
shouldn't take place. But as a categorical rule, that's
not scientific at all. So, it's quite consistent.
MS. ANDERSON: I have just a follow-up
question.
MR. HOHMAN: All right, go ahead.
MS. ANDERSON: That makes me wonder if
indeed the tests which are now being reported from
formaldehyde studies indicating a positive result on
nasal squamous cell carcinoma in the rat, but a negative
result in the mouse, turn out indeed to be quite correc-
tive, that you would think that the agency should —
MR. JAESCHKE: Which one would turn out
to be correct?
MS. ANDERSON: That the results are
preliminary. The study is now at eighteen months.
MR. JAESCHKE: Right.
MS. ANDERSON: If indeed the results do
turn out as they certainly appear they will, that there
is an overwhelming positive response in the rats, a nega
tive response in the mouse, and you're seeing the kind
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1 of tumors that were first identified from bischloromethy
2 ether, would you think the agency should ignore that?
3 MR. JAESCHKE: I think that the actions
4 that are going on are epidemiology in human beings and
5 the class of individuals that have been heavily exposed
, to formaldehyde, namely morticians, that action at
7 industry's behest has been undertaken. A great number
g of people have expressed the indication that one ought
9 to find out what the biological factors are behind —
10 what's the reason for the difference, is it some sort
,, of hormonal or enzymatic excretion in one species that
12 does not happen in a second species or does not happen
,~ in man? After all, formaldehyde has been around for
,. many, many years. EPA has not taken any action. It's
not the government, in this case, that is promoting
action but industry.
16
MS. ANDERSON: I wasn't asking about
action or inaction, I was just asking what you would
lo
do with these kinds of results.
MR. JAESCHKE: I would certainly try to
find out why they were so. That's the whole point.
MS. ANDERSON: Suppose you can't get
that answer. How long do you think the agency should
*0
just hold data like this without regarding it as some
24
signal that should trigger some regulatory action?
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MR. JAESCHKE: Well, the agency has
sat on formaldehyde for the last forty years. I suspect
and has done nothing until industry has done the testing.
I suspect that reasonable prudence would say that one
ought to find out whether there is some reason to believe
that this is a human affect before he does something.
There's no reason to suspect that in
this case, but because of the intervention of industry
and the strong research that we've sponsored, perhaps
we will have the answers. At the point where there is
some reasonable link with human carcinogenesis, I would
say the agency should move forthwith, but not until.
MS. ANDERSON: In the absence of some
link with human studies, then you would think the
agency should not move?
MR. JAESCHKE; I would absolutely think
the agency should have some rational scientific under-
pinning for any action that it takes. That's a sine
qua non of the law and a reasonably prudent public policy
MS. ANDERSON: At the extreme, I understate
you're saying that can come from positive epidemiology
studies. Do you think there are other ways, other
sources of information to buttress this kind of data?
MR. JAESCHKE: I think that all evidence
needs to be considered and I think that's a very impor-
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1 tant point in these hearings, that no evidence — I'm
2 most dismayed to hear people calling for arbitrary exclu
3 sion of evidence, telling the EPA in effect that it is
4 not intelligent enough to assess the data, as I heard
5 . earlier this morning. I think all data, whether this is
done by a Science Panel or whether it's done by the EPA,
7 certainly all of the data ought to be considered by the
g professional toxicologists, medical people, as well as
9 the regulatory policy-makers in coming to their conclu-
sions, and therefore would strongly urge that you not
write, or eliminate from these regulations, anything to
12 the contrary. I think it's totally wrong.
13 MS. ANDERSON: EPA has had the interim
.. guidelines for assessing carcinogenesis for three and
a half years now. The thrust of the guideline and the
., weight of evidence approaches to consider all data in
16
the aggregate and make statements on a case-by-case
10 basis about the likely risk. This activity has been
ID
carried on by an internal group, the EPA's Carcinogen
Assessment Group.
I wondered what fault you might find
with what that group is doing that would make you
think the agency should endorse an external panel to
do the same thing.
24
MR. JAESCHKE: We complimented the agency
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in 1976 when it came out with guidelines because I think
that in the adoption of public policy, it's most impor-
tant that the agency communicate with the public what it
is doing, but guidelines are one thing. The rigidity of
criteria written into a regulation, particularly with
arbitrary rules as to exclusion or inclusion of data, is
just plain wrong.
Now, I think the thrust of your question
was, what's the benefit of a Science Panel. Is that —
MS. ANDERSON: Yes, since the agency has
an internal group that is doing what I think you're
proposing that an external group do. I wondered where
you saw the need for the agency to endorse an external
group as opposed to this internal —
MR. JAESCHKE: Well, the USCPA is but
one of a number of co-equal agencies of the federal
government which has a strong interest and need in
carcinogen regulation. Certainly I see no need to
squander the taxpayers' money on doing this job in what
I consider to be less than totally efficient way, spread
amongst a nuber of agencies.
I would think that the public interest
demands that we have one group, the best group of
scientists available as an independent group, make the
assessment of whether something is in fact a carcinogen
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1 that places humans at risk. To do that at the outset
2 and then feed that finding to the EPA, to OSHA, to FDA,
3 or to any other state, local — whatever regulatory
4 actions are interested in it, so there's an area of
5 efficiency and I think if you can put emphasis on that
at the front end of the process, you're much more likely
7 to get a better group of scientists who can concentrate
8 their efforts —
9 MS. ANDERSON: Yes. I just wondered if
10 this stemmed from efficiency or a central criticism of
the Carcinogen Assessment Group within EPA. I see that
it's the efficiency, so —
MR. HOHMAN: Todd, do you have anything?
MR. JOSEPH: I have just a few questions.
15 First, let me clarify what seems to be a misunderstanding
These regulations are not intended as anything more than
17 a decision framework and set of principles to guide case--
by-case regulation. They are not intended in lieu of
,„ case-by-case regulation. They're just intended —
2Q MR. JAESCHKE: Well, let me just say
_. something. I am a lawyer admitted to the New York Bar.
I've studied engineering at Cornell University, I've
23
been vice president of Stauffer Chemical for sometime,
„. I'm on a number of boards, and I'll tell you, I am
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certainly confused by the statement that you're making.
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I'm delighted to hear it, but I don't agree that that's
the rational interpretation of what you're doing. If
it is and if the regulations are written clearly, that
all that's intended is a case-by-case evaluation on the
merits, taking into account all scientific and other
available data, and dealing with controls on a case-by-
case basis, then we heartily endorse it.
MR. JOSEPH: Well, as I said, one thing
that the proposed regulations contain is certain princi-
ples that we're trying to resolve in this proceeding.
We will certainly — we have certainly seen in these
hearings to date the need to clarify what it is we're
trying to do, and it may be of some comfort to you that
a uniform comment of various environmental in the Washin
ton hearing was that these regulations were deficient in
that they really didn't commit EPA to doing anything
about any particular chemicals, but merely said what
EPA would do when it decided to do something about a
chemical or how it would decide to do something about
a chemical.
But let me ask you some more specific
questions, if I may. At a couple of points in your
statement you mentioned EPA's vinyl chloride regulation
under Section 112 in the context of case-by-case regula-
tion. Are you — I wasn't quite clear whether what you
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1 were saying is that is a sort of a generally, reasonable
2 approach, more or less, without asking you to endorse
3 exactly that regulation?
4 MR. JAESCHKE: Let me say that the case-
5 by-case approach is necessary, it's essential. We're
not saying that where something is appropriate when the
7 evidence is at hand that the EPA should not act. I
8 should point out, however, that there is no evidence
9 whatsoever in the case of vinyl chloride of the low-dose
effects on man.
MR. JOSEPH: So, do you think we should
12 or should not have acted in the case of vinyl chloride?
MR. JAESCHKE: I think it's a moot quest icj>n ,
I think you did act and I think I've said that there
., certainly may be other cases where EPA would more pro-
,, ductively spend its time than by trying to enunciate
,, principles of science that are not here yet. But, I
don't see the point of —
19 MR. JOSEPH: Well, it's not clear from
_0 your statement just what it is you think EPA should know
before acting, and that's why I am asking you to apply
your analysis to the vinyl chloride case.
23 MR. JAESCHKE: Yes, well, what I'm saying
„, is that if EPA — what EPA should do is to strongly
24
endorse a Science Panel of some type that would enable
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professional doctors, toxicologists, and so forth, to
review data on a case-by-case basis and recommend to
EPA and the other agencies whether there are data that
is sufficiently suggestive of human risk in order to
initiate action. That's what EPA needs to know.
You need to have a good, scientifically
based risk assessment of both the qualitative and quanti
tative aspects before you can energize the regulatory
process.
MR. JOSEPH: But it's not very helpful
to us for you to just tell us that we need to know
whether there is enough information to act. We need
to know what constitutes enough information to act.
MR. JAESCHKE: Well, certainly, I've
said- very plainly in my testimony that there are cases
where one might find a positive bio-assay, you might
find that that positive bio-assay was not due to some
extraneous factor. At least reasonable toxicologists
could draw the conclusion that the effect is related to
the compound being administered, and there may be evi-
dence which could be a second bio-assay in a second
species or there may be some linking evidence such as
we talked about in the Dry Colors Manufacturers case
where the metabolic patterns of the animals, it was
determined that the animal from a metabolic standpoint,
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1 for example, was a good surrogate for man.
2 It certainly seems to me that that's at
3 least a rational basis for raising some form of presump-
4 tion. Absent some sort of confirmation or linking
5 I evidence, merely to say that because it's positive in
one animal species, I don't think is adequate because a
7 I I say, I think that species specificity is the rule rath
8 than the exception. I think that's well borne out.
9 MR. JOSEPH: Thank you.
10 I MR. HOHMAN: Thank you. We have time
for one more question. Roy?
12 ii MR. ALBERT: Yes. Isn't it true that the
13 II main thrust in the AIHC's and your proposal for an out-
side scientific panel to do assessments is the hope that
such a panel would develop criteria that would set a
higher threshold for the acceptance of evidence of
17 ii human carcinogenecities than now exists in the EPA?
18 MR. JAESCHKE: I'm dismayed by that
,o question from the point of view that since all of us
2Q are susceptible of getting cancer at one stage of our
life or another, it seems to me that we all share the
22 very same common interest in understanding the basic
fundamental principles of cancer causation rather than
going on witch hunts and trying to damn everything in
25 site, and I think that that type of behavior isn't goinc
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to get us very far.
This type of proposal of the one mouse
criter doesn't advance science one little bit, so I
don't think that any of us wants anything more than
scientific understanding so that we know the factors
which place us at risk and might take adequate steps to
remove them from the environment or may take adequate
steps to protect ourselves in whatever regulatory or
personal way is available.
So, the answer is clearly, absolutely
no to your question.
MR. HOHMAN: I have another question from
Betty.
MS. ANDERSON: It's mainly a comment. I
think that the thrust of your testimony has left some
confusion when you say, "the one mouse criteria." There
is no such thing —
MR. JAESCHKE: (Interrupting) Excuse me,
that's a matter of characterization.
MS. ANDERSON: Yeah, but I think it's
very important to note that the whole thrust of the EPA
policy is to take all the data in the aggregate. There
is no one mouse criteria or one rat criteria or anything
of the kind. There is an earnest effort on the part of
the scientists in the agency doing this work to look at
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1 all of the available data, certainly looking at negative
2 studies as well as positive studies. . Any information we
3 have about mechanisms of action, short-term test data,
4 all of the information is put together to see what sense
5 we can make of the entire picture, so there is no search
in a haystack for one study that happens to show a posi-
7 tive signal and then just action going straight ahead
8 on that basis.
9 I think to leave that impression is
unfortunate and I just wanted to try to correct that.
MR. JAESCHKE: All right. Let me see if
,« I understand you correctly. You're saying that it is the
,, agency's intent, which will be a matter of record from
.. these proceedings, that all data concerning carcinogene-
sis of the species and compounds and so forth, the
,. compound under consideration, will be considered? There
to
17
is absolutely no arbitrary criteria such as the ruling
10 out of some negative data or any other data, that one
lo
will look at — that the EPA scientists and regulators
will look at all of the metabolic, hormonal or whatever
data on an unbiased and impartial way, and that that
is the sense of this commission, that's the sense of
this regulation? Is that right?
MS. ANDERSON: The guidelines that were
24
adopted by the agency, the interim guidelines for judginc
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carcinogenecity that were published in May of 1976 made
that statement in more than one way. The agency has beer
proceeding on that basis now for three and a half years.
The current air cancer policy for regulatory action under
Section 112 excerpts that statement and lists it in the
Federal Register notice.
I see no reason to think that the agency
is going to start doing anything on a different basis.
MR. JAESCHKE: Well, I'm delighted to
hear that you agree with my testimony. Thank you.
I'm sorry, are there further questions?
MR. HOHMAN: No, I think not. Thank you.
I understand that there's a cafeteria on the third floor
and I think probably that would be a prime candidate.
I think we'll adjourn now until one-thirty.
(Whereupon the hearing adjourned)
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1 AFTERNOON SESSION
2 THE CHAIRMAN, I might say to the assembled
3 group, we olo have a tighter and tighter scheduling
4 problem as the day wears on, and so I think we can get
5 through okay, but I'll have to pay fairly close attention
6 to it.
7 MR. RONAN: Good afternoon, distinguished
8 members of the Panel. My name is John Ronan, I am
9 Legal Counsel for Stauffer Chemical Company.
10 Stauffer Chemical Company endorses the comments
11 of the American Industrial Health Counsel, AIHC, relating
12 to the proposed U.S. EPA Policy and Procedure For
13 Regulating Airborne Carcinogens.
14 The proposed EPA Regulation for Airborne
15 Carcinogens fails to meet the statutory requirements
16 of Section 112 of the Clean Air Act.
17 Further, the proposed regulation is unsound
12 as a matter of Regulatory Policy.
19 We endorse and recommend for EPA's considera-
2Q tion, the Proposal for an Alternative Regulation, which
-, AIHC has submitted to the EPA in Formal Comments.
22 Section 307 of the Clean Air Act requires that
23 a Notice of Proposed Rulernaking shall be accompanied
-4 by a statement of its basis and purpose and shall
55 include a summary of the factual data on which the
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Proposed Rule is based, and the methodology used in
obtaining the data and in analyzing the data.
EPA has failed to present evidence demonstra-
ting a need for the Proposed National Policy.
The Agency has cited 37 references in support
of the Proposed Regulation, some of which show a
remarkable correlations between cigarette consumption
levels and lung cancer rates.
EPA, however, has utterly failed to show any
correlation between air pollution and increases in lung
cancer mortality.
To the contrary, the most recent authoritative
study by E. C. Hammond and L. Garfunkel, "General Air
Pollution and Cancer in the United States," states that
the authors concluded that there was no firm evidence
to support the hypothesis that general urban air
pollution increases the risk of lung cancer to an
important degree, if at all.
Data from our studies support that conclusion
and we are unaware of any evidence that convincingly
leads to a contrary conclusion.
Instead of a massive cancer epidemic, age-
adjusted U.S. cancer data indicates that except for
lung cancer, cancer rates have remained stable, or have
decreased over the past fifty years.
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1 Ninety per cent or more of the lung cancer
2 rate is attributable to pandemic cigarette smoking.
3 In contrast, there is no clear evidence linking lung
cancer to air pollution.
I refer the EPA to the AIHC comments,
particularly Appendix A to the comments on legal issues,
7 which analyzes the references cited by EPA.
8 Executive Order 12044 requires that meaningful
9 alternatives are to be considered and analyzed before
a regulation is issued, and that compliance costs and
,, other burdens on the public should be minimized.
,« Agencies are directed to insure that alterna-
,- tive approaches have been considered, and the least
.. burdensome of the acceptable alternatives has been
chosen.
.. Detailed Regulatory Analyses are required for
16
major regulations with potentially significant economic
10 consequences. The Regulatory Analysis is required on
I o
all regulations, which will result in an annual effect
on the economy of 1 million dollars or more.
A Cost Impact Study, by Arthur D. Little, Inc.,
included in the AIHC comments, demonstrates that the
22
very significant cost impact of the proposed rule would
£w
substantially exceed this criteria.
24
For benzyne alone, the initial cost of
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compliance with BAT requirements and the draft generic
standards, are estimated to be 82 million dollars, and
the annual costs are estimated to be 68 million, assuming
gasoline handling is not controlled.
Similarly, for perchloroethylene, compliance
with the draft Generic Standards, and BAT Requirements
would cost 213 million dollars, initially, with an
annual cost of 103 million dollars.
These highly conservative estimates concern
only two of the multiplicity of compounds, which would
be subject to regulation.
Despite the very significant potential impact
of the Proposed Regulation, EPA has failed to conduct
an economic and Regulatory assessment.
The EPA Proposal has been criticized by the
Regulatory Analysis Review Group on many of the same
grounds that have been outlined in the AIHC Comments.
Significantly, RARG has stated that the
Proposed Regulation might allow an unwarranted low
hurdle, which may result in listing substances for
which it later appears that controls that the levels
required are unjustified.
Considering the major Regulatory and economic
impacts, it would appear that the Propose Rule should
have received a more careful review by EPA, prior to
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1 proposal.
2 A detailed legal analysis of the Proposed
3 Regulation has been submitted in the AIHC Comments on
4 Legal Issues. I will, therefore, broadly outline key
5 aspects in which the Proposed Rule exceeds the
Statutory Authority of Section 112.
Section 112 of the Clean Air Act is not
intended for the regulation of a large number of
carcinogens. The legislative history clearly demonstrate
,g that Section 112 is concerned with only a few
extraordinary toxic pollutants within that narrow
category of substances, which pose an especially grave
., threat to human health.
.. Section 112 is simply inappropriate for the
massive regulation of a large number of substances.
The Proposed Regulations fails to conform to
16
the substantive requirements of Section 112, for listing.
10 Section 112 requires that a determination to list a
IB
substance as a hazardous air pollutant must be based
upon a reasoned weighing of all relevant evidence.
The Proposed Rule, however, would preclude
relevant scientific evidence from consideration in the
22
development of specific standards.
The two key criteria for listing a substance
24
as a hazardous air pollutant, create an unreasonably
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low hurdle for Regulatory action.
The first criteria is triggered when the
Administrator judges that there is a high probability
the substance is a human carcinogen, which could be
based upon a single animal test demonstrating the
induction of malignant tumors with or without additional
evidence, which could be inconclusive by itself.
This criteria would ignore scientific
evidence relating to dose response, metabolic overdose,
comparative metabolism, threshhold effects and species
sensitivity.
For reasons explained in the AIHC Comments,
and additional testimony presented at these Hearings,
this criteria is scientifically unsound.
The second criteria is triggered where there
is evidence of significant public exposure via the
ambient air from stationery sources based upon a
qualitative of preliminary estimate of the population
exposed.
This criteria fails to relate ambient levels
of exposure to levels of risk, which would be provided
by a definitive, quantitative risk assessment. A quan-
titative risk assessment would define whether ambient air
levels exceed an ample margin of safety, and would,
therefore, require Regulatory action.
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1 A quantitative risk assessment, therefore,
2 should be a prerequisite to statutory listing.
3 Although Section 112 provides a mechanism for
4 delisting of a compound, there is no provision for
5 delisting in the Proposed Rule. EPA has essentially
proposed a low-hurdle scheme for listing a large number
of compounds with a non-existent or impossibly high hurdl
for delisting, that is totally at odds with the
9 Regulatory approach envisioned under Section 112.
10 The establishment of interim design standards
under the Proposed Rule would clearly exceed the Agency's
statutory authority.
12 Section 112 of the Clean Air Act does not
authorize the two-phased approach to standard setting,
. . which would immediately propose and adopt BAT generic
,,
controls on substances when listed with subsequent
._ more owner control, based upon a quantative risk
10 assessment.
lo
The Regulatory options to be employed in setting
final standards, likewise, exceed statutory authority
granted to EPA under Section 112 in a number of respects.
To be specific, Section 112 does not provide
for didfferent standards for new and existing sources.
Section 112 does not authorize the Administrator to
24
consider the availability of substitutes in setting
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emission standards.
Section 112 does not provide for an emissions
offset policy.
Congress established an Inter-Agency Task
Force on Environmental Cancer, Heart and Lung Disease.
The Task Force, chaired by the EPA Administrator, is
specifically directed to recommend a comprehensive
research program to determine and quantify the
relationship between environmental pollution and
human cancer, and to recommend comprehensive strategies
to reduce or eliminate the risks of cancer or such
other decisions associated with environmental pollution.
The Administrator, however, has not proceed
as Congress directed, but has prematurely proposed a
sweeping and costly generic control strategy without
a proper scientific foundation.
The EPA has proposed a regulation that would
attempt to change the basic structure and requirements
of Section 112 of the Clean Air Act as enacted by
Congress to support a scheme for the wholesale generic
regulation of a very large number of chemical compounds.
This would exceed the statutory authority
granted to EPA.
The Proposed Regulation is unsound as a
matter of regulatory policy. More importantly, the
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1 Proposed Regulation is scientifically unsound. The
2 Agency has not undertaken the Regulatory Analysis before
3 proposing regulation required by Executive Order 12044.
4 The Proposed Regulation should be withdrawn
5 and reconsidered. We endorse and recommend for EPA1s
5 review the proposed alternative offered by the American
7 Industrial Health Council, which we believe offers,
3 scientifically and methodologically, sound recommenda-
9 tions for determining whether substances should be
10 regulated and suggest legally sound procedures for
regulation.
12 We urge EPA1s serious consideration of this
13 Proposal.
Thank you.
]5 THE CHAIRMAN: I'd like to limit this to one
question.
Todd?
MR. JOSEPH: I'll ask one question and make
19 one clarification.
_0 The clarification is that the Proposal for
21 Generic Standards is not associated with BAT. BAT is
-. not an element of that. The Generic Standard Proposal
-. which, at this point, is only an Advanced Notice of
5 Proposed Rulemaking, is a Fugitive Emission and Leak
Control Program, and nothing more.
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The question is, I would appreciate it if you
could specify where, in the Proposed Rule, there is state 1
any intention to preclude the consideration of any
evidence in deciding whether a particular compound may
be carcinogenic.
MR. RONAN: I'd like to refer you to page 58656
of the Federal Register Announcement, and I'd like to
read — I believe this begins at the top of the Column
No. 3, the righthand column:
"EPA considers well-conducted, single-species
tests and single test results substantial evidence of
carcinogenicity. Such tests are widely used in
industry and government laboratories. In light of
available evidence -delaying the implementation of control
for three or more years, etc."
It seems to me this is a pretty clear
endorsement of regulation based upon single-species,
single-test evidence. I think that's pretty clear.
Now, as Mr. Jasky has stated earlier, if
indeed, the EPA is not intending to regulate on single-
species tests, if you are going to consider all of the
evidence, if you are going to consider all of the relevan
scientific evidence, such as a battery of bio-assay
testing, consider questions such as threshhold dose
response, species sensitivity, comparative metabolism,
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I would appreciate you clarifying that at this point.
I also would appreciate you clarifying the
statement made earlier, that this is simply a guideline.
This is, in fact, a mechanism for massive regulation.
The Proposal is to adopt a number of generic
standards, a number of class performance standards or
source category standards, for very rapid regulation,
which would be immediately proposed and immediately
adopted upon listing of a compound with very little in
the way of scientific assessment, with very-little in
the way of risk analysis.
So, we're disabused if indeed you are willing
to accept a very broad range of scientific evidence,
if your approach is far more cautioned than envisioned,
I think it would be useful to elucidate on that.
DR. ANDERSON: I would like to point out that
the sentence that you have read is taken, I think,
somewhat out of context on page 58656, in that it's
taken out of the middle of a paragraph where different
kinds of evidence is set out in contrast -- that is,
human epidemiology, and then it mentions the animal test
and then surmises that short-term tests are not suffi-
ciently developed to serve as a basis.
But it concludes by saying that EPA feels that,
given the available scientific evidence, protection of
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public health requires the use of the criteria outlined
in the interim guidelines.
And then if you go back to the beginning of
the policy on page 58647, there is an excerpt from the
interim guidelines, which says judgements about the
weight of evidence involved, considerations of the
quality and adequacy of the data and the kinds of
responses induced by the suspect carcinogen, and then
goes through all types of data that would be considered.
And I think, furthermore, the entire statement
in the interim guidelines emphasizes the nature of the
exercise, that is to consider all of the data in the
aggregate.
MR. RONAN: Well, if this is so, this
certainly is progress.
DR. ALBERT: But I think, nevertheless, it
still does hold that the Agency has taken the position
for essentially the last four years that a single respons
that is a response of a single species can form the
basis of a judgement of substantial likelihood that an
agent is a
MR. RONAN: (Interrupting.) That's what we're
saying. That is exactly what we're concerned about
DR. ALBERT: (Interrupting.) This is
something that we've been doing now for four years.
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MR. RONAN: and we have called this
into very serious question as to scientific probity.
DR. ALBERT: Well, we'd like to hear the
evidence that it's a judgement that's a mistake. It
doesn't do much good, I don't think, to simply say,
that's not good enough, when we say it is good enough.
What's the evidence that it's not good enough?
MR. RONAN: I would like to refer you to a
very detailed AIHC Comments on this point. I think you
would find it useful.
MR. JOSEPH: There does seem to be some
misunderstanding, however, as to whether a particular
piece of evidence is automatically, automatically means
something. Any evidence and all evidence that we can
find we want and we consider in every case.
We may conclude that in a particular instance
with a particular chemical, the presence of one positive
animal test, if it's appropriately conducted, does
provide substantial evidence, enough evidence to consider
it carcinogenic for Regulatory purposes.
On the other hand, we may not. We may consider
that there is, that other of the evidence leads us to
not make that kind of conclusion at that point.
What has to be understood is that it is not
automatic in any way, that it's based on a weighing,
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in every case, of all the evidence we can get and, of
course, it bears emphasizing that determinations made
by EPA staff are reviewed by an independent Advisory
Committee, the Science Advisory Board.
Of course, that is open to -- those are
meetings open to the public, announced in the Federal
Register, and with an opportunity for the public to
submit comments in advance.
MR. RONAN: Well, of course, what we are
seeking is a careful consideration of all relevant
evidence and to the extent that the EPA is implementing
that approach, of course we are gratified.
DR. ALBERT: Could you direct me to where
in this Comment there is a discussion of the non-validity
of facing a judgement of human carcinogenicity on a
single species?
UNIDENTIFIED SPEAKER: It would be in the
Section 1 on Procedures and Comments, not in Section 2,
which is the Legal Comments, Dr. Albert. I can't cite
you the exact page, but it is in there.
DR. ALBERT: Okay, thank you.
MR. RONAN: Thank you.
THE CHAIRMAN: Alonzo Plough?
Is Alonzo Plough in the audience?
(No response.)
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Sheldon Krimsky.
MR. KRIMSKY: Good afternoon, my name is
Sheldon Krimsky and I am Assistant Professor in the
Department of Urban and Environmental Policy at Tufts
University. I'm particularly interested in Public
Policy and Environmental Issues.
The Proposed Emission Standards are a small
but important step in dealing with the larger issue
of environmental carcinogenesis, and I'm not going to
use my time to comment on the many positive features
of the standards. Instead, I shall raise some questions
where items are not sufficiently clear, or where I
believe there are some deficiencies.
My first comment is on the question of the
chemical by chemical approach to regulation. One of
the major difficulties I find with the standards is that
they would regulate on a chemical by chemical basis —
unless I am mistaken, and I would hope that the Panel
would please clarify this — we already have the exper-
ience of the failure of this approach through OSHA.
So, I wonder how EPA is going to make any
progress is regulating the known chemical carcinogens
released into the air, much less those pollutants which
have not as yet been identified.
EPA has, it seems to me, a mandate to regulate
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the airborne carcinogens in a reasonable period of
time. A goal of zero exposure should be sought for all
such carcinogens, to be consistent with EPA' s own
position that carcinogens be considered, for Regulatory
purposes, to pose some finite risk of cancer at any
exposure level above zero.
It seems to me that one should choose a
period of time in which to insure the regulation of
carcinogens, and one reasonable period of time would
be a decade. And it seems to me this implies two things.
First, a systematic carcinogen screening
program for all pollutants should be instituted
immediately.
And, second, a sufficient number of carcinogens
should be regulated per year to exhaust the list by the
end of the decade, otherwise, at least in terms of the
public confidence, there is going to be a question of
how long it will take before one gets through a formidabl
preliminary list at least.
Chemicals that their close family resemblances
to known carcinogens should be presumed suspect until
proven safe.
Chemicals that appear often in the same process
stream can be considered as one entry in the Regulatory
process, given that there are enough industrial processes
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for which groups of chemicals are used in the same
stream.
The second comment has to do with information
sources and scientific expertise. As in many issues
pertaining to environmental health, our knowledge of
the role of airborne carcinogens, the role that they
play in the onset of human cancer is still quite in its
infancy.
But even so, my own feeling is the references
cited in the Proposed Rules indicate that EPA has not
taken sufficient advantage of the available expertise
from the National Cancer Institute and the National
Institute of Environmental Health Sciences.
Without demonstrable epidemiological evidence
that the air pollution factor in carcinogenesis is
negligible, the prudent course to take is zero exposure
to carcinogens from air pollutants.
Again, and I'm sure you've heard this many
times, but as somebody who is not representing a
particular constituency, it seems — and also as an
individual who has a background, my doctorate is in
philosophy and I deal with a lot of value issues and
a lot of ethical issues — it seems to me that the
burden should be placed on the industrial sector to show
that they cannot achieve zero emissions and that they
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are, in fact, operating with the best available
technology.
In addition, on the question of the so-called
BAT, EPA should not settle for the best technology
presently on the market, or, in fact, in some operational
mode, it should rather set the appropriate level of BAT
at the state of the art, and maybe that's already
assumed or indicated in some of your documents, but I
didn't see it, and I hope it would be taken into
consideration.
The third point, I'd like to say something
about risk balancing. And this has become a question
of considerable controversy and debate.
It seems to me important from an ethical
and social welfare standpoint, that EPA use its finite
resources to protect the quality of as many laws as
possible.
This is a categorical imperative. It alone
can justify quantitative risk assessment. It is morally
indefensible, it seems to me, to trade off lives for
jobs or lives for contributions to the GNP.
If anyone doubts the efficacy of this
imperative, then I simply ask you to perform a simple
thought experiment. Would you support a policy that
raised economic output, or increased the number of
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jobs, if the overall effect of that policy meant an
increase in human mortality — that is, sometime in the
future.
If the answer is in the affirmative, then this
nation should actively pursue policies that raise the
average quality of life, while at the same time
sacrificing the lives of small groups of people. If
the answer is in the negative, then there is no more
justification in supporting a status quo of human
sacrifice. Jobs and economic goods are renewable and
replaceable and human lives are not.
The last point I want to make has to do with
new chemicals entering production. While the standards
do not address new chemicals entering production process
much more cautious standards must be used for potential
carcinogens.
I assume TOSCA will handle this aspect of the
problem. Every effort, it seems to me, must be made
to ensure that carcinogens do not escape screening and
assessment and therefore enter the production system.
Any new substances even suspected as carcinogens should
be severely restricted, far more restricted than the
restrictions placed on the substances that are already
in the sphere of economic activity, since, as is
obvious to everybody, it is a lot easier to regulate
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substances before the enter the economic sphere, than
after they enter the economic sphere.
That is the completion of my comments.
THE CHAIRMAN: Thank you.
Are there questions?
(No response.)
Thank you.
Ken Nelson.
MR. NELSON: Panel members, ladies and
gentlemen, I am Kenneth W. Nelson, Vice President for
Environmental Affairs of ASARCO Incorporated.
My purpose in appearing here today is to
emphasize certain concerns ASARCO has about the EPA's
proposed Policy for Regulating Airborne Carcinogens.
I want to add at this point, that I'm not going
to read the statement which you have, nor any part of,
or only small parts of the attached documents, but I
hope you will take the time, and can take the time to
read everything that I have passed out.
ASARCO operates a number of major nonferrous
smelters in this country. Nonferrous ores of metals
such as copper, lead and zinc, contain small amounts
and traces of quite a large number of different elements,
which in various chemical combinations become volatilized
during the smelting process. One of these, arsenic,
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and indeed it is a volatile element, may be considered
for listing under the proposed new carcinogen policy.
Now, the points in the next few paragraphs
have been made by the speakers from Stauffer. I will
skip over to near the bottom of page 2.
Now, arsenic, of course, is a natural substance
It occurs everywhere. We haven't analyzed any soil or
any living thing without finding it. And Dr. Leonard
Goldwater, who is a widely respected toxicolegist and
a Professor of Medicine at Duke University and the
University of North Carolina, has reviewed the collective
evidence about arsenic and given his opinion of its
carcinogenic properties, and its threat in ambient air, i
the statement which you have.
And I'll quote him to this effect: "The ubiquit
of arsenic must be taken into account in any discussion
of environmental control."
Because of this ubiquity, the human body
apparently has adapted to arsenic over the eons,
developing its "own mechanism for converting the arsenic
it receives from nature into forms which it can use and
which can be excreted if too much is taken in."
As a result, Dr. Goldwater says: "a threshold
for arsenic that must be exceeded — there is a
threshold for arsenic that must be exceeded before the
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body's defenses are overwhelmed."
Now, indeed, we have to consider the possible
essentially of arsenic. The traces of it may be
necessary for life.
Three investigators in different part of the
world have shown by their experiments that arsenic
may be an essential element for rats, for chicks, and
I believe it's for goats.
Drs. Schwartz, Nielson and Onkey are the
three investigators.
EPA, in viewing animal experimentation with
arsenic, would find that the attempts to produce cancer
in animals with arsenic have not been notably successful.
EPA, I think, should consider these findings of the
three investigators that I mentioned, that arsenic may
indeed be essential for human life.
Dr. Goldwater has concluded that the most
probably explanation of all the available evidence is
that there is a safe threshold for exposure to arsenic
not only in our food and drink, but also in the air we
breathe, and that arsenic at levels found in the ambient
air does not represent a danger to the public health.
New evidence is being developed almost daily
about arsenic. Dr. Enterline's current work on the
mortality of Tacoma smelter employees—our smelter, by
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the way -- promises to produce significant new informatio
Indeed, it already has. In your packet is a preliminary
report by Dr. Enterline on his latest study.
And if you will turn to the last page of that
preliminary report, you will see in Table 4, standardized
mortality rates among workmen, retired workmen, from
the Tacoma smelter, derived from an old study in which
527 people were involved, and the standardized mortality
rates from a new study in which there were 597.
Now, the two studies were very similar, except
that more people were found in the new study, people
that had escaped notice in the first study.
Also, in the old study, exposures were estimate
on the basis of 1973 measurements of arsenic in urine.
The new study uses measurements and extrapolations of
measurements of urine arsenic made between 1948 and 1952.
You will note that in the first three exposure
groups of the new study, there is shown no statistically
significant excess mortality rate, due to lung cancer.
This, to me, and I think to almost anyone,
suggsts a threshold, that there is indeed a threshold
for inhaled arsenic, as well as that ingested.
In addition, Dr. Enterline and Dr. Milham of
the State of Washington, are studying persons who
attended the school adjacent to the Tacoma smelter, to
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determine if the higher levels of ambient arsenic
prevailing in the past have effected those people.
To date, the findings have been negative, but the
study is still continuing.
The smelter Environmental Research Association
has funded an independent study of mortality in smelter
counties, the results of which are scheduled to be
announced this month. And just yesterday, I received
from Dr. Rohm (phonetic), at the University of Utah,
a copy of the paper which he proposes to give near the
end of this month at a conference in Utah, and let
me quote the last sentence of this report:
"In summary, the data evaluated did not
establish an association between community air
pollution due to smelter effluence and the incidents
of lung cancer in communities surrounding nonferrous
smelters."
You don't have this study. I'm sorry, there
wasn't time to make copies of it, but I can get them
to you if you wish.
There is a study going on in Pallor, Nevada,
by Dr. Vig. He is looking at the population there, which
has been exposed to a high concentration of arsenic in
its drinking water for, I believe, several generations.
We will try to keep EPA informed of all of
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the studies as they are completed. And you may have
other sources which we don't know about. I hope you
will consider all the evidence.
But so far as we can determine at this point,
trace amounts of arsenic in the ambient air do not
endanger the public health. A policy that would foreclos
EPA from considering such evidence, or any relevant evi-
dence, with respect to any substance that might become
a candidate for listing and regulation is indefensible,
legally, scientifically, and as a matter of prudent
public health policy.
I'm going to skip over, in my statement, now,
to page 6 , at the bottom. Putting aside the specifics
of various studies, we believe EPA should be free to
make a reasoned judgment, on the basis of all the
available evidence, about the health effects of smelter
arsenic emission at the time it makes a listing decision
or any decisions as to appropriate emission standards.
Rules which restrict EPA' s ability to make
such a reasoned judgment may make EPA's job easier,
but they do not serve the public interest and are not
what the Congress intended.
EPA must act in the real world. It is a world
in which resources are scarce. EPA's proposed rule
would increase inflation and reduce productivity. It
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certainly should not be adopted unless it can be
demonstrated that it addresses a real public need, that
is that air pollution contributes measurably to cancer
rates in this country.
EPA, we believe, should withdraw the Proposal
or at least substantially revise it, in accordance with
AIHC suggestions. Quantitative risk assessments
derived from all the available evidence/ including
of thresholds and best scientific judgment, should be
relied upon at all stages of decision-making.
That's all I have.
THE CHAIRMAN: Thank you, Ken.
MR. JOSEPH: I have one question, if I may.
Mr. Nelson, do you think that it's likely that
assuming the existence of a threshold for carcinogenesis
of arsenic in any given individual, do you think it's
likely that the level of these thresholds may vary by
some fair amount, from person to person?
MR. NELSON: Yes, I think that's evidence from
the standardized mortality rates we had from the various
levels of exposure.
THE CHAIRMAN: I wanted to ask what rules
you are referring to that restrict EPA's ability to make
judgments?
MR. NELSON: I'm not an attorney, as you well
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know. But I recall one statement that bothered me
very much and that was that negative epidemiological
studies should not be given much credence or no credence
at all.
I can't quite understand that, that foreclosure
which it seems to be.
DR. ANDERSON: Just to correct, I don't think
that's — if it came across that way, it's not what's
intended because I think the statement in here is that
EPA feels that while negative epidemiologic evidence
can sometimes provide upper bounds on possible risk,
that it's normally not sensitive enough to provide the
sole justification for ignoring other types of responses.
But I think it's important to point out that
the negative epidemiology evidence has been used by the
Carcinogen Assessment Group to set upper bounds. So,
it certainly is not ignored.
MR. NELSON: I'm glad to hear that.
THE CHAIRMAN: Anything else?
MR. NELSON: Not really, except my concern
is that because of certain set procedures and policies,
a number will emerge with which we cannot comply, and
that means shutdown to an enterprise and losses of jobs
and so on.
DR. ALBERT: I'm not sure of the logic of
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what you said about the existence of a threshold in
arsenic on Table 4, the new study. Although the three
lower doses do show elevated standard mortality ratios,
albeit they are not statistically significant.
That data is not evidence of a threshold, and
Enterline didn't say anything about that either, and
I think you're reading too much into that data.
MR. NELSON: He didn't say anything in it —
Well, you can interpret it your way and I'll interpret
it my way.
To me, this suggests a threshold, strongly
suggests it, and Dr. Enterline made a similar statement
in his appearance before OSHA, when the matter of arsenic
was considered.
DR. ALBERT: But the SMR's are elevated at
all theree of the lower doses.
MR. NELSON: How can you get any — What can
you do with one? I mean, it depends on the number of
people you have. You observe one lung cancer case. The
SMR might be 142 or it might be 42, it depends on the
number of people.
DR. ALBERT: Well, put all three lower doses
together.
MR. NELSON: I am.
DR. ANDERSON: Well, I've wondered about the
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same thing, and I was trying to recall some of the
exposure levels, but when you have these numbers of
people, you could have a reasonably high exposure level,
say an increased risk of 10~^ or something, and really
not be able to pick it up.
In other words, the sensitivity down there
wouldn't show this kind of increase.
MR. NELSON: That's a possibility, but I
believe we have to operate on the basis of evidence we
have not speculation, not maybe, might, perhaps.
DR. ANDERSON: But I'm saying, you really
wouldn't expect to see it if your dose response holds
at all, I don't believe, but I can't remember the
exposure levels.
MR. NELSON: But if there is a threshold, if,
as I said, arsenic is a natural substance, it's been
around for eons, we all have it, isn't that also evidence
of a threshold, and isn't that some comfort — and I
would apply the same reasoning to any naturally occurring
substance, selenium, tolurium, cobalt, whatever.
THE CHAIRMAN: Ken, another question. You make
a statement that the case is not proved that air pollutioji
contributes measurably to cancer rates in this country,
so I take it that you don't lend credence to some of
the studies of specific chemicals or specific emissions
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such as coke oven emissions or pollutants such as that
which
MR. NELSON: Were there neighborhood elevations
and lung cancer from coke oven emissions, to your
knowledge? I'm not aware of any study that showed that.
The Asbestos Study, by Selikoff and, I think,
Hammond, the neighborhood study of a plant in New Jersey,
showed no elevation of lung cancer rates. And one would
expect it, possibly, from asbestos.
THE CHAIRMAN: Roy, you had a question?
DR. ALBERT: Well, I think you've given
the answer to my question, and that is that if you take
Dr. Goldwater's position literally, it means that any
natural carcinogen automatically has a threshold, so
that if we assumed it to be the case for arsenic, then
we would have to assume that it's the case for ionizing
radiation
MR. NELSON: (Interrupting.) Perhaps so.
DR. ALBERT:' Paraphlatoxin, and polycyclic-
aromatic hydrocarbons?
MR. NELSON: Perhaps so, indeed.
DR. ALBERT: You don't grant that one could
simply develop a fairly resistant strain, namely humans
to these things, so that the time required to develop
cancer is so long that it doesn't affect the reproductive
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period, so in effect it becomes inocuous from an
evolutionary standpoint. Is that not possible?
MR. NELSON: Almost anything is possible,
Dr. Albert. I can't fault that statement.
But I'm saying when it comes to regulating,
when it comes to making the decisions which affect the
lives of people at work, in an enterprise, if a rule
based on speculation and not solid evidence is proposed
and adopted, it puts that enterprise out of business,
I think that's wrong.
T.HE CHAIRMAN: Any other questions.
(No response.)
Thank you, Ken.
John Barr.
MR. BARR: Mr. Chairman, ladies and gentlemen
of the Panel, my name is John T. Barr, I'm employed by
Air Products and Chemicals, whom I represent here today.
You should have in front of you a copy which
contains most of what I'm going to say. I will see that
you get a conformed copy of the complete presentation
within a few days.
Air Products and Chemicas has submitted
detailed written comments on the Proposed Airborne
Carcinogen Policy. The purpose of this statement is
to summarize our written comments in the perspective
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of the comments of others on this proposal, and to reply
to some of the statements made at the hearing held in
Washington earlier this week. We urge that you conisder
both of these statements in connection with your review
of this proposal.
The heart of the Agency policy is given in
the proposed principle that the presence of airborne
carcinogens in relatively low ambient concentrations
warrants regulatory action.
As is the case for so many other critical terms
in this proposal, no definition is provided for the meani
of "relatively low".
However, from the recent Agency action in the
case of the trihalomethanes in drinking water, and the
listing of radiation as a hazardous substance under
Section 112 of the Clean Air Act, we can deduce that
this is meant to include substantially any measurable
concentration.
Thuse, the Agency appears to be taking the
position that the mere presence of measurable amounts
of suspect animal carcinogens requires listing under
Stection 112 and regulation to at least Best Available
Technology.
This position is -un support able on at least
three counts:
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First, there has been no showing that the
presence of industrially-related suspect or proven
carcinogens at any concentration has caused or contrib-
uted to death or illness in the general population, despite
many serious attempts to demonstrate such a relationship.
Every effort to measure the effects of airborne
carcinogens in the ambient air has yielded negative
results. An early major study was may by this Agency
for vinyl chloride, and the Agency has stated that it
"produced no evidence that living around the vinyl
chloride-handling plants is a risk factor."
A later study of all the recorded national
cases of angiosarcoma for a ten-year peirod confirmed
these findings.
There was discussion at Washington on Tuesday,
of a report by Brady and coworkers on angiosarcoma cases
in New York. This study found that five of nineteen
non-occupational, or non-medical cases lived closer to
PVC operations than did their controls.
This speaker did not mention that four of these
five plants were PVC fabrication plants and not productiojn
units. This Agency has investigated the emissions from
this class of operations and found them not to be
significant, and these operations were not regulated
under the vinyl chloride standard.
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Considering the many small fabricating plants
in this state, it appears to be only coincidental that
these relationships appeared and the author has concluded
after a discussion of the shortcomings of their study,
only that this study lends some indirect support to the
supposition that there could be an association between
place of residence and that disease.
Hammond, Selikoff and Nicholson examined long-
term residents of a town with a large asbestos-producing
plant, and reported no significant difference in the
mortality rates from cancer, between this town and
another similar town used as the control.
Pike and coworkers performed a case-control
study of south central Los Angeles County to determine
if long-term residence :
was associated with the
there.
They had foun
lation between residenc
Their conclus
this study does not supj
pollution is the explan
of lung cancer.
A study was pi
the trends and the type
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n this area of high air pollution
excess of male lung cancer found
earlier that there was no corre-
and female lung cancer.
on was that the evidence from
ort the hypothesis that air
tion for the regional excess
rformed by this Agency, in which
and number of cancer deaths were
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examined, in which the trends and the type and number
of cancer deaths were examined, and eight of the fifteen
towns in this country containing copper smelters, and
which therefore are suspected of having higher arsenic
emissions.
It also looked at comparable cities with steel
and coal mining activities. The conclusions of the
authors were that abusive alcohol is a probably cause
of excessive digestive diseases, including cancer in
copper smelting communities, and that further study
is required to provide conclusive evidence of the
industry-disease relationship for the steel and
coal-mining industries.
Lung cancer, which is usually assumed to be
the mark of disease for arsenic exposure, was not elevateji
in these eight towns.
Our written comments contain many other
references to more generalized attempts to associate
ambient pollution with cancer death. All were negative.
A recent conference on air pollution and
cancer, which was sponsored by the American Health
Foundation was summarized by Hammond and Garfinkle, who
wrote: "We conclude the general air pollution at present
has very little effect, if any, on the lung cancer rate."
The references cited by the Agency in the
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preamble to its proposal policy provide no support for
the adoption of the so-called principle that any concen-
tration warrants regulation, other than to reiterate
the presumption that there is no absolutely safe
exposure. Even the proponents of this assumption presen
no supporting data, but offer it as an article of faith.
These hearings, I've received comments from
several scientist who do not believe that this presumptio
is correct.
We have reviewed all of the public comments
which were available in the docket, two weeks after
closing of the comment period, and of the dozen or so
which were supportive to any degree of this proposal,
only one, that of the EDF/NRDC, purported to provide
any factual data.
None of the references cited there contained
any acceptable scientific evidence that industrially
related air pollution can be related to cancer in a gener^.
population, and all such studies have been refuted by
more recent studies.
We did not hear any new evidence at the
Washington hearing, nor have we heard any factual data
today, which support the connection between industrial
air pollution and cancer.
Therefore, neither the Agency, nor the
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proponents of this proposal, have made a reasonable case
for the need for the Agency of any authority beyond that
which it now has.
The second reason that the position taken by
the Agency is unsupportable is that its quantitative
features are based on inappropriate data. The Agency
has relied on Type I risk assessments by the Carcinogen
Assessment Group to arrive at quantitative estimates
of the effect on the human population from animal test
results.
These Type I preliminary tests were never inten
ded for this purpose, and the Agency has recognized this
in the past. The purpose of Type I estimates has been
stated by the Agency as follows:
"The Type I study is one whereby we would ask
GAG for a preliminary assessment based perhaps on only
one health study (such as an NCI study). We would ask
CAG to make an estimate as to whether the compound is
a carcinogen, based on this study. Following this, we
would ask CAG to develop a preliminary unit risk value
for a 70-year exposure at 1 ug/m3. We would use this
risk value with our exposure data to develop a prelim-
inary risk assessment to aid us in determining whether
to proceed to a Type II study."
Notwithstanding this intention for a Type I
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study to be no more than a screening test to examine
the need for a more definitive study, the Agency has
used these results to support a claim of significant
risk to the general public.
The National Academy of Scient recently
recommended that the Agency stop all preparation of these
estimates because of their misuse by the Agency, and
the EDF has demanded that the Agency not use risk
assesments in the implementation of its policies.
We believe that this would be a serious mistake
for there is a place for such preliminary studies, such
as in determining priorities, and because we very badly
need to develop our presently incomplete knowledge of
extrapolation methods, which can only be done by use.
We do not agree with the use of only the
simplistic linear extrapolation method, nor the uncriticajL
acceptance of animal data of unknown quality, nor the
choice of the highest response point from the most
sensitive species, and we certainly do not agree with
the use of these preliminary studies as substantiation
of the need for regulatory action, but properly developed
quantitative risk assessment should be an important part
of the regulatory process.
Apparently there are those in the Agency who
agree with this, for we have been told by official in
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CAG that the Type I estimate is to be upgraded to make
it suitable for listing decisions under Section 112 of
the Clean Air Act.
The preamble to the proposed policy spoke of
some forty substances on the Agency priority list which
were to have been screened by the preparation of Type
I estimates by last December. This task has not been
eompleted, but we have been able to obtain a few of these
documents.
In our written comments we show that this
method, that is the linear method, overestimates the
risk by about a factor of three orders of magnitude,
wherever a comparison can be made with actual human
experience.
Nevertheless, and despite a total lack of demon
stration of credibility of this procedure, the Agency
has relied on these preliminary estimates for regulatory
decision-making in the air, water, and pesticide
programs.
The Agency can provide no basis for reliance
on these estimates as support for the need of regulating
pollution, which may be present in trace quantities in
the environment, and should not attempt to do so.
A third reason for the inability of the Agency
to rely on a presumption of need for regulation of these
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compounds is that it is contrary to law and to its own
administrative policy. The recent court decisions of
Bean versus CPSC and Monsanto versus Kennedy have in
both cases held that a regulation may not depend on an
assumption that a need may exist, but must demonstrate
that a risk is present, and that the proposed action
will reduce that risk.
Neither of those conditions is met by this
proposal.
Executive Order 12044 states, "after it has
been determined that a chemical substance is likely to
be a carcinogen, the next step in regulatory decision-
making is to assess the risk that people face..."
This Agency has prepared a program for complian
with this order, but it has failed in several instances
to comply with its own rules and in the proposal of this
policy. With one notable exception, it has prevented
public participation in the development of this proposal,
rather than encourage full public debate on the need
for or the wisdom of its actions, and it gave no public
notice of the forthcoming proposal until after it had
been published.
It has failed to prepare either the Notifica-
tion Form, a development plan, or a decision package,
all of which are required by its own rules, and it has
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1 has refused to prepare a regulatory analysis.
2 Thus, the present proposal is in conflict with
3 established legal and policy principles in both its basic
4 assumptions and in the formulation of the proposal, and
5 the Agency must not proceed until these conflicts have
6 been resolved.
7 The one exception to the Agency's closed door
8 policy was the Environmental Defense Fund, which initiate)!
9 the movement to develop this policy, and which has had
]0 considerable influence and the final form of the
II proposal.
12 That group has now announced that it has a
13 list of several hundred substances from which the Agency
j4 must regulate at least twenty per year, to attone for
,c its past deficiencies.
^ This action underscores the point which we
,, made in our written comments that the Agency will lose
,o control of its own future if it persists in promulgating
19 these rigid and unscientific rules.
-. We believe that these defects could best be
repaired if the Agency were to deem this proposal an
„ Advanced Notice of Proposed Regulations and to repropose
._ it only after careful consideration of the public comment
_. which it will receive.
24
. This reproposal should contain three
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major factors:
The first, a procedural rule for internal
Agency guidance in the steps leading up to the decision
for lifting. This would include the screening and
evaluation stages, the establishment of priorities among
the candidate substances, a detailed quantitative risk
assessment for determining the extend of regulation nec-
essary and the consideration of alternative control
strategies.
The Agency has said in the preamble that a
major reason for this proposal is for administrative
convenience, and it is appropriate for the Agency to
formalize the procedural process. This is the only rule
that should be promulgated now.
Second, a revised critera for risk assessment
should be presented for publi comment, as the second
point. The Agency recognized the preliminary nature
of the Interim Guidelines when they were published in
1976, but it has taken no action in this proposal to
revise this document, in the light of current science,
nor has there ever been an opportunity for full public
comment.
Both the Interim Guidelines and the risk
assessment methodology used by the Carcinogen Assessment
Group should be opened for public comment and possible
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revision.
And we would add, here, that the Carcinogen
Assessment Group ought to made a formal part of the
Agency, in some way, rather than being the informal
organization that it is now.
And third, it is important that the Agency
assure that a true weight-of-the-evidence evaluation
be applied to all scientific considerations, and that
the Agency not impose artificial limitations on the
examination of this evidence, nor should it intermingle
these considerations with socioeconomic decisions in
the overall regulatory process.
It is not at all clear why, if the Agency
merely intends to continue its present policy, it did
not simply say so, rather than present the lengthy list
of limitations on the evidence which would be acceptable.
To assume this, we urge the adoption of the
Alternative Proposal made by the American Industrial
Health Council, which calls for establishment of an
Independent Scientific Panel to work closely with the
Agency during the development of regulations to provide
the best available scientific basis for its actions.
This action will assist the Agency in rapid and
responsible response to any potential hazard.
We need very badly the "balanced approach to
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to the questions of protecting the environment within
a regulatory framework" of which the Administrator spoke
recents, and we believe that the steps recommended above
will be of major assistance in that direction.
In addition, the Agency must place the various
areas of its responsibility in proper perspective, both
as seen within the Agency, and on a national basis.
Potential problems should be allocated resource
on the basis of their relative seriousness on a national
scale. Despite the preliminary efforts of the Regulatory
Council and the National Toxicology Program to take a
broader view of our nation's needs in the health area,
individual agencies are still concentrating on extremely
narrow segments of the overall picture.
We urge that the federal agencies adopt a
rational and coherent approach to the control of airborne
health hazards that will provide proper emphasis on the
more significant problems.
We do not believe that the evidence supports
a presumption that cancer due to industrial pollutants
is a significant problem, nor that the present proposal
will produce any significant benefit to the public health
We believe that the steps which we have
recommended will enable the Agency to attack those
problems which may exist in this segment of its
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responsibilities in an efficient and orderly manner,
utilizing its existing authority.
We urge the adoption of our recommendations
and offer our assistance in developing the details of
such an action.
Thank you for your attention. I'll be glad
to try to answer any questions.
DR. ALBERT: You mentioned that on a couple
of the evaluations that the CAG has done, you have
tested them against epidemiclogic data and found that
they are off by three orders of magnitude.
I would like to point out that it's been our
policy in the CAG, where we do risk assessments based
on animal data to look around to see if we can qualify
these assessments based on data available from human
populations that have been exposed; even if the results
are negative, these type of data serves a very useful
function of qualifying the assessments based on animal
data alone.
So that if you have found that by testing
assessments based on animal data against epidemilogic
data, that we have been off by several orders of
magnitude. You have done something which we should
have done, and apparently didn't do.
Could you identify which agents you found this
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to be the case?
MR. BARR: I'd be happy to.
It's all spelled out clearly in my written
comments/ which has been in now for about a month and
a half, but I'll go through it again.
It's an even simpler test than epidemiology.
It's something that any schoolboy could have done. In
three water cases, I took the risk which CAG developed.
I multiplied it by the figure in the Water-Quality
Criteria document, for the average concentration in this
country, to get an incidence.
In the case of arsenic, the answer came out
to be something between 18 and 64 million cases of
skin cancer a year.
Now, you don't need epidemiology to tell you
whether or not you have 64 million cases of skin cancer
a year in this country.
In the second case, for the PAH's, the answer
came out to be 2 million cases of cancer a year. Again,
you don't need epidemiology to tell you where two
million people are dying a year of cancer.
For asbestos, the answer came out to be 2,000
cases of mesiothelioma. This would be non-occupational,
naturally, from drinking water, and so would occur in
areas where the mesiothelioma, which we see does not
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occur. Selikoff says he sees a handful of cases a year.
Those are three examples.
DR. ALBERT: Well, somebody's arithmetic
is wrong because we've done the same thing. We'll have
to look into it.
MR. BARR: Well, I'm glad you looked at my
written comments.
MR. KELLAM: Just one question, Mr. Barr,
you mentioned that with one notable exception, there
essentially was no public participation in the
development of this policy. could you clarify that
exception?
MR. BARR: Once again, let me refer you to
my written comments, which ha\e been in for a month and
a half.
There is a chronology given, which spells out
in great detail, the number of attempts which
industry, individuals and trade association made to
participate.
If you want to take the time to go through it,
when we found out in October of 1978, that you were
working on this, we visited you, Mr. Padgett, Mr. Patrick
and others, and Robert Durham, and asked you for a copy
of the draft, and we were refused.
We visited later on, we asked again. We were
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refused.
A copy of a draft dated December 8, was given
to the Environmental Defense Fund and they wrote a letter
to you dated February 22, which was about 20 pages long,
which contained a number of demands.
They had then met with you and discussed
that memorandum. After that, you changed from a Proposed
Policy to a Rule.
MR. KELLAM: Excuse me, my question was, though
you mentioned there was a notable exception
MR. BARR: I told you about that in the next
paragraph. The notable exception was the Environmental
Defense Fund. Those were the ones who were permitted
to participate in this.
MR. KELLAM: And the first time that you learned
of the development of the policy was in October of 1978?
MR. BARR: That's correct.
MR. KELLAM: In spite of the fact that in March
of that year, we held a public meeting, which specific
purpose was to solicit comments on the development of
an Airborne Carcinogen Policy and to solicit comments
on the petition by the Environmental Defense Fund.
MR. BARR: The record shows that we participate
at a March 23, 1978, meeting. What we learned about
was that you were then actually working on it and that
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you actually had a policy being developed and we, as
I told you, asked on several occasions to obtain a draft
of that policy, to discuss the contents with you, to
have it explained to us. It was refused to us on every
occasion, and this full chronology is in our written
comments.
THE CHAIRMAN: Betty, you had a comment?
DR. ANDERSON: Yes, some of this is a matter
of clarification.
In your statement, the first thing, you say
that in the policy there is the adoption of a principal
that any concentration warrants regulation. I wasn't
aware that that was in the policy, that any concentration
— perhaps later on, you could submit for the record,
if you cited, I'm not sure we need to take the time right
now, but I didn't think that was the thrust of the policy
MR. BARR: I have a quotation of page one of
my comments, in which the reference is cited.
DR. ANDERSON: Okay, we'll go back to that.
The second thing, you said that in reviewing
all the public comments you had found no acceptable
scientific evidence that industrially related air
pollution can be related to cancer in the general
population.
This morning, Dr. Wilson presented some numbers
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and he says he will give us the benefit of his calcula-
tions later. I wonder if you had seen his calculations
since he said that for the chemical industry alone, he
thinks that about at least ten cases per year can be
attributed to air pollution.
MR. BARR: I'm afraid there has been a
communication problem here. Perhaps Dr. Wilson's accent
made it difficult for you to understand him. I think
if you will examine his written comments, he didn't say
that he thought the chemical industry caused ten cases
a year.
What he said was that by calculation using
your methods, it could possibly be extrapolated to that
figure. But he also very carefully said that he had
no absolute data at all indicating that these cases had
occurred. This was merely a postulate, a speculation
that these cases could occur, based on your extrapolation
methods.
DR. ANDERSON: Well, to take it one step furthe
I think, again, one thing that has been solicited in
these hearings is opinions about the nature of the
airborne cancer problem.
MR. BARR: Yes, ma'am.
DR. ANDERSON: Are you then saying that you
think there >is no problem at all?
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MR. BARR: Ma'am, what I said, in my written
comments, and my spoken comments today is that I have
examined the 31 references which EPA put into the
document, and I was appalled by the poor quality of the
research going on there, but they show no connection
whatsoever.
I have examined the 161 written comments in
the docket which were available to us. Only one of those
purported even to cite a reference, and that was EDF
and EDF cited six or seven references in the front part
of that which was written by Joe Wagner, and we have
reviewed those references, one of which was the Brady
paper that I discussed now. And there are a few others.
And I will submit a written discussion of those
in our rebuttal comments. But none of those, and none
of the authors of those claim to have shown a firm
relationship, contrary to how they are quoted in the
EDF document. But if you will read what the authors
say
DR. ANDERSON: (Interrupting.) So, in your
opinion, then
MR. BARR: (Interrupting.) In my opinion,
there are no scientifically acceptable data which
demonstrates a connection between industrially-related
air pollution and cancer death in the general population,
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DR. ANDERSON: I thought that was what you
were saying, but I was not entirely sure.
The next thing, you mentioned the Type I, EPA
Report. You were quite correct that they were commenced
with one purpose in mind, they will be reissued.
Just a brief comment. I think you will see
that the basis, at least on the evaluation of the
carcinogenesis data will include a document that's
submitted for public review, it will be reviewed by the
Science Advisory Board, which will include a complete
discussion of metabolic pathways, mutagenesis data, the
toxicity data, epidemiology, both positive and negative
where it's available, animal bio-assay data, both
positive and negative where it's available, and also
some indication of potency.
So, I thought, just for the record, that you
and other witnesses who have commented on this should
know that there will be this type of backup documentation
MR. BARR: We are very happy to hear that you
are going to start doing that soon. I'm sure that it
will have a very beneficial effect on the value of those
documents.
DR. ANDERSON: Well, it's really something
we have been doing.
MR. BARR: I have no seen any of those yet.
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I have them — on record, it hasn't asked for every one
you prepared, and I would be glad to have one if I could.
DR. ANDERSON: One other important point, I
think you indicated that the existence of the Agency's
Carcinogen Assessment Group was an informal organization,
not a part of the Agency.
MR. BARR: No, I didn't say that. Not a part
of this Proposal.
DR. ANDERSON: The Carcinogen Assessment Group
is a formal part of the Agency, and I thought it was
certainly a formal part of this Proposal.
MR. BARR: This is one of our many problems
that we have with this. We have a very verbose preamble
which says all sorts of things various ways, but if you
read the Proposed Regulation, itself, it says, "We
currently will evaluate these by our 1976 Interim Policy.'
That implies a temporary status, that Interim
Policy. It does not mention CAG, it does not say who
will do the evaluation or how it will be done. It is
totally omitted from the Proposed Regulation itself.
DR. ANDERSON: Well, the CAG is mentioned,
certainly, in the Regulations and in the
MR. BARR: (Interrupting.) In the preamble,
it is, but not in the Regulations.
DR. ANDERSON: Well, I thought I heard you
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say that it was time for the GAG to become a part of
the Agency, and I wondered about that.
MR. BARR: Well, that too, perhaps, but for
the conversation here, today, it is time for it to
become a part of the Proposal.
We are very much in favor of risk assessment,
and one of the things we are concerned about here is
that risk assessment is not properly formalized in the
Proposal, that way it's put out.
And, therefore -- You see, GAG has never been
established by any sort of a formal rule that binds the
Agency to maintain GAG. The Administrator could abolish
GAG tomorrow if he cared to.
We would like to see GAG and the Policies and
Rules and Procedures formalized in such a way that they
are subject to public comment, that they are subject
to peer view, and that they cannot be wiped out by
someone's whim.
DR. ANDERSON: Well, for that matter, I believe
the Administrator could wipe out any part of the
organization if he wanted to. I don't think
MR. BARR: (Interrupting.) Not if it's a
Formal Rule, he can't. It would have to at least have
a rulemaking procedure.
DR. ANDERSON: But I don't think that — In
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short, I think that the GAG certainly isn't the Agency.
It's a part of the Agency and
MR. BARR: (Interrupting.) That, we understand
DR. ANDERSON: Okay. And then the other thing
was, you seemed to think that you had not had adequate
opportunity to comment on the Interim Guidelines, and
I just wanted to say that they have been published,
they were published for public comment. One reason they
were not revised was because the comment was largely
favorable.
The AIHC has submitted comment. We certainly
invite your comment. It's not too late to comment. So,
I just didn't want you to feel that you could not comment
on the Agency's policy here.
MR. BARR: Well, I wouldn't want you to feel
you are left out either, so why don't you take our
comments to IRLG and the Regulatory Council, and on
this proposal, all these parts are comments on the
Interim Procedure because they all deal with the same.
The reason that the Interim Guideline did not
get much attention in 1976 is that they were published
under FIFRA.
DR. ANDERSON: No, they weren't.
MR. BARR: Pardon?
DR. ANDERSON: They certainly were not.
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MR. BARR: If you will look at it, it says:
"We will use these for doing the Proposal for FIFRA,"
and then down at the footnote it says, "and other things
too. "
DR. ANDERSON: That's absolutely wrong. I
helped write them, and there is a whole procedure in
the very front part of the guildelines that, certainly
at the time, the Pesticide Act was a key act under which
the guidelines were needed, but other acts are mentioned
as well.
MR. BARR: I understand, but as I say, at the
time, it attracted attention of the FIFRA people, and
not unfortunately, of the general industry people, which
it should have.
I agree with you, we have been derelict in
not commenting, but I think we have given you some
comments in the last few weeks.
THE CHAIRMAN: I think we had best go on.
Do you have anything else?
(No response.)
Okay, thank you very much.
MR. BARR: Thank you.
THE CHAIRMAN: Bill Cavellini.
I'm sorry for the misprint on the organization,
that's the Cambridge Port Alliance. I'm sorry that we
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got that wrong.
MR. CAVELLINI: My comments will be very brief.
I'm here today with two other residents of
the Cambridge Port Community from Cambridge, Mass., and
we were, in 1977, beset with a problem of airborre styrene
pollution from the Advent Corporation's manufacture of
widescreen televisions.
The main point I want to make today is that
if styrene had been recognized as a carcinogen in 1976,
there should have been a way that the EPA could have
acted to help us, instead of us, the people of Cambridge
Port having to rely solely on the State and our own
devices.
Styrene is a toxic substance that up until
last year was suspected to being a carcinogen. Styrene
is highly irritating to the skin, eyes, nose, throat
and respiratory tract. The fumes can cause headache,
nausea and dizziness.
In high concentrations, styrene can damage
the liver and cause blood disorders and eventually
effect the central nervous system.
Workers at Advent used to get so much styrene
fumes that they had to wear masks and workers were often
seen being carried out on stretchers and taken to the
hospital.
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To correct this, a year after their operation
opened on Emily Street in Cambridge, they vented the
fumes outside. Immediately, residents began to
complain of the odor, of dizziness, of nausea, and skin
irritations.
But it was to take almost three years because
residents could breathe the air without inhaling styrene
fumes.
First, in 1977, the residents went to the
City Council. The Council directed them to go to the
State Air Quality Control Division of the Department
of Environmental Quality Engineering.
First, DEQE suggested that Advent cover the
odor, cover the odor with a banana scented masking agent.
And they did that.
Well, they did that, and the community continue
to complain. Air Quality officials began negotiating
with the company to install a carbon filter. These
negotiations lasted nine months. And amidst claims that
the filter had actually been installed, the fumes
continued to pour out of the plant.
Calls to EPA by our group got the same answer,
twice -- go to the State. Well, we were already there,
and they weren't doing such a good job. They didn't
even have the equipment to test for airborne styrene.
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Finally, after over a year of public protest,
on August 11, 1978, the Attorney General of Massachusetts
filed a Civil Complaint charging Advent with violation
of the State Air Pollution Control Regulations.
Before resolution of this court case, the
Advent Corporation announced abruptly that it was leaving
Cambridge, leaving Massachusetts, for the State of
New Hampshire.
This did solve our air pollution problem. But
it also took 600 jobs.
There was some talk about th leaving having
something to do with our fight to clean up the air
pollution. This view was spread primarily by officials
of the company, and it didn't stop until newspapers
revealed that the company had been looking for sites
outside Massachusetts for a year prior to the time when
we started the fight against the pollution.
Why didn't&dvent want to leave Cambridge, it
was running away from an organizing work force. It was
seeking lower taxes in New Hampshire. But it was not
trying to get away from installing a $15,000 filter in
a company that grossed $200 million a year.
We have some suggestions, as people who were
and still are affected by airborne pollutions, suggestion
for these rules. They, perhaps, are not as sophisticated
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encouched in scientific language as some of the previous
speakers, but we are the people that are affected by
the companies that are adjacent to where we live.
We ask you that when you consider the benefits
and costs of controlling airborne pollutants, that you
take into account the long-term affects of low level
concentrations of the pollutant on the human body.
When we were informing ourselves about the
affects of styrene, we found that a lot of the literature
and much of the research, I might say, was done in
Japan and Russia, and very little here.
We found that it was the long-term affects
of low-level concentrations that could be almost as
frightful in their effects as high concentrations that
workers would be exposed to.
And second, we ask you to consider the
psychological effects on people who know that they are
being exposed to a suspected carcinogen, and what that
does to the way they approach their lives and their
daily tasks.
And third, we ask you to consider, in your
Cost Benefit Analysis, the disruption of community and
neighborhood that results from the panic that sets in,
such as the panic that set in in Rutherford, New Jersey,
and here in Cambridge Port, when we saw this article
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on the first page of the Boston Globe: "Outbreak of
Cancer Scares Town." And the two substances that were
cited were benzene and styrene.
We ask you to take into consideration that
disruption that a town like Rutherford, New Jersey, faces
and what it does when families move out, when friendships
are severed, when children are pulled out of schools,
when workers leave jobs, when they must go on unemploymen
because they can't find another job in the new community
they move to.
And this disruption happens when people are
worried about an environment that is unhealthy and
unclean.
We ask that the potential for polluting should
be measured before a company moves into an area, that
levels of pollution should be monitored during its
first year of operation, particularly with a substance
that is suspected ot being a carcinogen.
So, generally, we ask that you value human
life and health as much, if not more, than the almighty
dollar, that you ask residents and workers in the
effected area what they want. Let them make the choice,
if there is one to be made, between health and potential
economic hardship.
Incorporate a formal porcedure for public
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participation through hearings, where expert testimony
and the opinions of all affected parties can be hears.
Thank you.
THE CHAIRMAN: Thank you.
Are there questions?
(No response.)
Thank you very much.
Is Gregor McGregor here or not?
(No response.)
The next speaker after Gregor McGregor is
someone from Friends of the Earth? I don't have a name.
Is someone here from Friends of the Earth?
(No response.)
Richard Thompson?
MR. THOMPSON: The Sierra Club welcomes and
appreciates the opportunity to speak before the EPA on
its Proposed Air Carcinogen Policy.
My name is Richard Thompson. I have a Bachelor
Degree in the Natural Resources Program at the University
of Massachusetts in Amhersfc, and I have been an active
member and volunteer in the Sierra Club for the past
two months.
The Sierra Club has been involved in the cancer
problem for a number of years. It was through our
organization that Samuel Epstein, author of the well-know
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book, 'Politics of Cancer" was able to publish his work.
We have expressed our concern avoer the use of
a number of known or suspected carcinogens. Most recentl
we have sent in written testimony in support of the Cancer
Registry in the State of Massachusetts.
As a non-profit, environmental advocacy
organization, we are concerned with carcinogens at the
human level as well as the role carcinogens play in
natural ecosystems and in the food chain. We have
consistently maintained that reduction of carcinogens
in the ambient air, the water, the workplace, and food,
and in the general environment is of vital importance.
This is a wholistic approach that takes into
account the synergistic qualities that carcinogens often
have. We strongly believe that Federal legislation and
efforts should be coordinated and spearheaded in this
direction.
We have been led to this general concern about
cancer and specifically here to the hearings, for two
reasons. The first is that 60 per cent to 90 per cent
of human cancers can be traced to environmental causes.
Of these causes, viruses evidently play an insignificant
role. This leaves us with radiation, industrial chemical
and chemical agents as causal examples.
John Cairns, a researcher at the Mill Hill
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Laboratories of the Imperial Cancer Research Fund in
London, states in a Scientific American article, and
I quote:
"...most of the common kinds of cancer seem
to be caused in large part by environmental factors;
because we can alter the environment, those cancers are
potentially avoidable."
Coupled with this is the almost epidemic
*
proportions that cancer has grown to in the United States
Cancer is the second leading cause of death, here in
Massachusetts, as well as in the nation as a whole.
Over 1,000 people die every day from this disease, as
I am sure you well know. It is expected that one out
of four people will contract some form of the disease,
while one out of five people will die from it in our
lifetime.
The Sierrra Club feels that the bulk of the
environmentally produced cancers are avoidable. For many
years, our country has energetically poured millions of
dollars into research for a cancer cure. Our considerate
with cancer has been largely after the fact. We have
ignored the potential of controling our environmental
exposures to carcinogens, thus reducing the cancers that
are caused by them.
The EPA Air Carcinogen Policy is an important
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large scale attempt at a preventative approach. This
policy acknowledges the exogenous factors inherent in
many of the cancers occurging today, and attempts to
deal with some of them at their source.
Sierra Club would like strongly to support
this policy as a single facet in what will hopefully
become a multi-faceted program of cancer prevention and
control.
We realize that not all cancers are cause by
exporsures to carcinogens in the ambient air. But it
is important to stress at this point that Sierra Club
agrees with the National Academy of Sciences and a
majority of the scientific community. These people have
proclaimed that because of statistical difficulties
inherent in conducting laboratory and epidemiological
studies, there has been no demonstration of a safe dose
level to any known carcinogens.
In other words, any dose from a carcinogen
above zero will produce cancers. There are some segments
of industry that would have us believe that the dose
response is not linear, but is a curve which rises up
beyond a certain, predictable and measurable threshold.
Even if this were true, what of biological concentration
and magnification?
Can it be expected and guaranteed that as long
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as the dose is under the stipulated amount at each
exposure, it will not accumulate over time?
We urge that the EPA uphold its position of
an ample margin of safety with regard to public health
under Section 112. Erring to the detriment of the health
of even a fraction of a per cent of the population would
translate itself into the death and suffering of
thousands of people.
There have even been questions raised as to
how a potential or suspect carcinogen will be positively
or negatively proven. Industry has been quick to ask
for an epidemiological study to determine carcinogenicity
Sierra Club feels that this is only a tactic designed
to prolong the outcome of regulation. Epidemiology studi
hold flaws that are difficult to control when dealing
with single chemicals or compounds.
Requirements of effectiveness are overwhelmed
by the multiple variables of the study.
Some of these requirements include the need
to identify the population that has been exposed at the
time of exposure. Also, what was the exposure in quan-
tity?
It is obviously difficult to determine how
much of the suspect carcinogen was absorbed. We may
need a gradation of exposures to show the effectiveness
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of the cancer. To weed out the possibility that it could
have been caused by a number of other carcinogens acting
alone, or carcinogens and promoters together, or carcin-
ogens acting synergistically.
Finally, can we ethically or even economically
justify using a highly suspect carcinogen on hundreds
of thousands of people, while waiting for a cancer
latency period of up to thirty years? Could we truly
expect the epidemiology study to make a positive identi-
fication of the particular substance?
We advocate a well-designed animal study to
determine the high to low probability carcinogens. The
study should be performed immediately in the case of
significant exposure to the public. If industry is
serious about epidemiclogical studies, we challenge them
to conduct well-designed studies. The results might
then be used to aftect subsequent legislation in the
long term, but could in no way be expected to halt
regulation up till that time.
Because of the adverse affect on public health,
potentially carcinogenic substances must be found guilty
until proven innocent. Shifting of the burden of proof
will cause industry to react quickly with studies which
can be reviewed by the EPA.
Compliance costs have been stated by industry
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as a major factor in opposing the Policy. But it may
be shown that the average consumer would be willing to
exchange a slightly higher price in return for an
environment subjecting them to lower amounts of
carcinogens, especially through the medium of ambient
air where the person has no choice in deciding to take
the substance in.
The costs must also be weighed against the
incredible costs of cancer. Your own Agency estimates
the hospital care costs of cancer patients alone as
1.8 billion dollars per year. Add to this, the tens
of millions of dollars spent on research, facilities,
supplies, time, personnel and the figure is enormous.
The estimated 1.8 million workyears lost, along
with the lost productivity must also be considered. This
does not include the immeasurable human suffering and
degeneration of a society wracked by cancer. These are
the costs easily hidden and intangible to the economic
system we have.
Industry can often express their increased
costs with hard figures and estimates. This does not
mean that the public health affects are any less importanjt
We at Sierra Club feel that any cost/benefit ratio of
a particular substance will hopefully consider some of
the public health costs, intangible as they may seem
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st first glance.
The Sierra Club must also express its concern
about EPA's desire to locate new sources in unpopulated
area. Part of our underlying philosophy is the protectioiji
of natural areas. We ask if consideration has been made
of the impacts on wildlife and the foodchain. Rural
residents may also be negatively impacted by the new
source siting. We hope that EPA may come up with a polic
that doesn't simply switch the problem and the burden
to rural area.
The EPA Air Carcinogen Policy is an excellent
first step in attaining a preventative approach to
carcinogens. It is greatly desired if we are to begin
to combat carcinogens and their presence in our
environment.
This policy deals with the ambient air, but
Federal, State, private and public organizations and
concerned citizens must work towards the control of human
carcinogens in water, our food, the workplace and in
the general environment.
Sierra Club advocates and supports a strong
policy directed at the identification, assessment and
effective regulation of airborne carcinogens.
Thank you for your time.
MR. HOHMAN: Thank you.
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Are there any questions?
(No response.)
I just wondered if you -- You mentioned the
new source siting, briefly, toward the end. I just
wondered if you had any suggestions on how that might
be handled?
MR. THOMPSON: That's something, I'm not
a scientist and I wouldn't — I was just concerned about
it because of our philosophy, the basic philosophy
of natural ecosystem protection.
THE CHAIRMAN: Thank you.
MR. THOMPSON: Thank you.
THE CHAIRMAN: William Mendez.
MR. MENDEZ: Good afternoon. My name is
William Mendez. I'm a Research Associate at the Center
for Policy Alternatives at the Massachusetts Institute
of Technology. I have a Doctorate in Biochemistry from
the University of Chicago and am currently a part-time
student in the Public Policy Program at the Kennedy
School of Government at Harvard.
During the past two years, I have been conducti
research concerning public health policies related to
the control and regulation of toxic substances exposure
in the workplace and in the general environment.
The views I am going to express are solely
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my own and do not represent the position of the
Massachusetts Institute of Technology or the Center for
Policy Alternatives.
The first issue that I would like to address
is the nature and magnitude of the airborne carcinogen
problem. There are several lines of evidence that
suggest to me that the EPA could accomplish a great deal,
in terms of improved public health, by adopting a program
for the rapid and efficient control of atmospheric
emission of carcinogenic substances.
A number of recent epidemiological studies,
and they are given in the reference list, have found
not only that high cancer rates are often associated
with urban development, but also that the geographical
patterns of incidence for a number of varieties of cancer
are strongly associated with the location of specific
industries.
For example, it has been found that the rate
for long cancer for men in the U.S. counties where paper,
chemical, petroleum and transportation industries are
located were significantly elevated compared to those
counties where no such facilities exist.
Similarly, elevated rates for cancer of the
lung, nasal cavity, liver and skin were found in counties
where the petroleum industry was highly concentrated.
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In addition, statistically significant eleva-
tions of cancer rates, for a number of other organs have
been found to occur in counties where specific chemical
manufacturing activities are performed, for example,
dye manufacturing.
It is possible that a large proportion of these
increases may be due to chemical exposures which occur
in the workplace, rather than to the general population.
It should be noted, however, that the findings of elevate
cancer rates in women, as well as men, in two of these
studies, strongly suggest that general population exposur
to carcinogenic substances arising from industrial
activity is an important public health problem.
Partially, in response to some comments that
were made earlier, I'm going to deviate for just a second
from my statement.
The first think I would like to do is call
the attention of the Panel to a study by William Weiss
of Urban Air Pollution in Philadelphia. This appeared
in the American Journal of Public Health in August of
1978.
Dr. Weiss compared death rates due to lung
cancer, in the ten publich health districts in Philadelph
in 1970, to measures of particulate air pollution that
occurred ten years previously.
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His hypothesis was that if there was in fact
a ten-year induction period, or some kind of lag period,
that these two variables should be correlated. He did,
in fact, find that there was a very strong correlation
between levels of particulate air pollution and cancer
rates in the public health districts in Philadelphia.
The magnitude of the effects that we're talking
about is such that the highly-polluted districts had
rates that were increased almost two-fold, over the
lightly polluted districts.
The second thing I would like to do is to
address the issue that was raised previously of time
patterns of cancer incidence in the general population.
The first point I would like to make is that
all of the data that I have seen has indicated that age
adjusted cancer incidence rates, as compared to mortality
rates, for most kinds of cancer are increasing in the
United States. Sources for this data include the three
national cancer surveys, taken by the National Cancer
Institute and the Sear data, which has just recently
become available.
An excellent discussion of this data can be
found in testimony by Marvin Schneiderman, who is the
Assistant Director for Science Policy of the NCI, that
was given in front of a Senate Sub-Committee last April.
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The second point I'd like to make is that the
attribution of 90 per cent of lung cancer to smoking,
and thus and then separating out the rest of cancer
rates, is spurious in the presence of other multiple
exposures that could also contribute to lung cancer,
for example, many occupational exposures are known to
contribute to lung cancer as well.
The third thing I would like to point out is
that stable and decreasing aggregate cancer rates
include great contributions from large decreases in
stomach cancer in men and women, and uterine cancer in
women, which can be ascribed to dietary and life-style
factors.
And, in fact, as I say, incidence, age-adjusted
incidence rates for most kinds of cancer in most age
groups is increasing in the United States.
The last point I would like to make is that
a recent paper given, again by Marvin Schneiderman,
presented at the Society for Occupational and
Epidemiclogic — the SOEH Conference in December of 1979,
studied, found that types of cancer for which there are
well-established occupational associations, cancers that
are known to be associated with various industrial
activities are uniformly increasing in the United States.
It is quite possible that the existing
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epidemiclogical data, in fact, understand the degree
of risk posed by airborne carcinogens. The practical
problems involved in conducting adequate epidemiclogical
studies are well know. Most substances have not and
could not be studied epidemiclogically, since significant
human exposure has occurred only recently.
Since as many as 1,000 new chemical substances
are produced in significant amounts per year, and many
of these are found to be carcinogenic in animal tests
and mutagenic and in vitro tests, and since the volume
of organic chemicals produced has doubled every seven
to eight years in the United States, since World War II,
it is likely that both the number and level of known
exposures to airborne carcinogens will increase unless
vigorous attempts to control emissions are made.
EPA1s initiative in this area is appropriate
and timely and could produce substantial benefits in
terms of reduced cancer incidence.
The general structure of the policy proposed
by EPA is well-suited to the control of the relatively
large numbers of substances and source categories that
would need to be regulated as posing serious carcinogenic
risks to the public. The automatic imposition of generic
standards immediately upon the agency listing of a substa:
as carcinogenic could greatly reduce the magnitude of
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exposure to most substances at relatively little cost
to firms without the expense and delay of protracted
regulatory proceedings.
Regardless of whether the control measures
under the applicable generic standards reduce emissions
to the point where the remaining emissions constitute
a reasonable residual risk, it is likely that, as long
as generic standards are in place, the initial reduction
of emissions upon the listing of a substance as a Section
112 carcinogen would result in significant reduction
in emissions.
For example, EPA could list a relatively large
number of substances as carcinogens, and achieve a
50, 75 or 90 per cent reduction in emissions of each
substance, while conserving regulatory resources to
expend on those substances where exposures are high or
inexpensive control measures are not available and where
further analyses and regulatory action are required to
reduce residual risks to acceptable levels.
In order for the generic approach to accomplish
these goals, however, it is necessary that the generic
standards developed are sufficiently broad to apply to
a large number of source classes and substances, yet
flexible enough so that meaningful exposure reductions
can be achieved for specific source classes without
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major tailoring and without imposing unreasonable
compliance costs. These goals are realistic and achiev-
able and the draft generic standards in the EPA Proposal,
such as housekeeping, leak detection procedures and
storage practices, are a good first step in controlling
airborne carcinogens.
The last issue that I'd like to talk about
is the use of quantitative risk assessment techniques
envisioned by the EPA Proposal. Under the Proposal,
rough risk assessment based on rough estimates of
carcinogenic potency and exposure, could be used to aid
decisions about whether to classify substances as a
Section 112 carcinogen, while exhaustive, detailed risk
assessments would be used to establish priorities for
regulation among source categories and in determining
the degree of control required in setting emissions
standards.
In my opinion, the use of the rough assessments
consisting mainly of a finding that given substance is
a carcinogen and that significant exposure occurs, or
based on a single, simple linear extrapolation, as a
guide for deciding whether a substance should be listed
as a Section 112 carcinogen is fully justified.
Great care must be taken, however, in using
the results of quantitative risk analyses for setting
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priorities for regulation among source classes, and in
setting permissible exposure limits.
In attempting to set priorities for regulation,
it is likely that the results of detailed risk assessment
will not be able to distinguish, with any degree of sta-
tistical significance, between similar source categories.
Priorities for regulating different source
categories for the same pollutant are liable to depend
to a large extent on particular analytical or modeling
assumptions, and different, equally reasonable modeling
assumptions could easily lead to a different set of
priorities.
Unless modeling and analysis procedures are
rather rigidly standardized, risk assessments for source
categories emitting different pollutants are likely to
incorporate different assumptions and use different tech-
niques and thus are not likely to be easily comparable.
The point I'm trying to make is that as far
as priority setting is concerned, detailed risk assessmen
are likely to be able to divide source categories into
a few very broadly defined classes and are not likely
to be useful in deciding close calls.
Perhaps it would be better not to expend the
resources necessary to conduct a full-scale risk
assessment if the only aim is to set priorities for
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regulation among source categories.
The use of quantitative risk assessments in
setting emissions standards again is likely to require
great care. The EPA was wise to refuse to limit itself
to a specific set of decision rules, such as cost-benefit
or cost-effectiveness analysis, and instead to reserve
to itself the right to make fully-informed policy choices
The Agency seems to have recognized most of
the practical and theoretical problems inherent in using
highly imprecise risk estimates in making policy. Again,
it is not likely that quantitative risk assessments be
accurate enough to help much with close calls.
It does not appear, however, that the EPA has
adopted any consistent policy to deal with the large
degree of uncertainty that would be encountered in
performing and using quantitative carcinogenic risk
assessments. Developing such a policy toward uncertainty
in risk estimates could help the EPA to more effectively
obtain and utilize information of this nature.
Such a policy would have to be developed care-
fully and reevaluated continuously, but would probably
consist of two major elements:
First, a procedure should be developed to assur
that at every stage of risk analysis, as much information
about uncertainty be developed and transmitted as possibl
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Too often, at each stage of such analyses,
such as estimation of emission factors, dispersion modelin
and so on, information about uncertainties surrounding
preceding steps in the analyses are lost, or the
analysts themselves are afraid to commit themselves to
quantitative estimates of the likely magnitude of error
surrounding their analyses.
This leaves the people who have to conduct
the final rsik assessment, usually the Carcinogenicity
Assessment Group, with the Herculean task of trying to
construct reasonable confidence intervals about the final
risk estimates from little or no data and produces a
situation where decision makers attempting to use risk
estimates are most unlikely to be aware of the magnitude
and sources of uncertainty associated with these
estimates.
The development of such a procedure for assurin
that sources of uncertainty are considered and included
in every stage of the analysis could probably best be
designed by those charged with conducting the final risk
analyses, the Carcinogenicity Assessment Group.
Second, the EPA should develop an explicit
risk posture with regard to the use of quantitative risk
assessments for setting emission standards. That is,
decisions should be made about whether, in setting
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standards, the Agency is going to use the man value
generated by the best, most accurate analytic method,
or whether they wish to be risk-averse, for instance,
by using upper confidence intervals associated with risk
estimates.
It seems to me that the EPA might want to be
somewhat risk-averse in interpreting quantitative risk
assessments for the purpose of setting standards. Doing
so would be totally consistent with the Agency's statutor
mandate to set standards with an ample margin of safety.
This does not mean that I favor the use of
analytical techniques that are, themselves, conservative,
that is, which tend to overstate risk. It is important
that accurate, unbiased analyses be conducted. If desire
these then can be interpreted in a manner tha, although
it may involve an explicity risk-averse attitude, also
assures that no impotant analytical assumptions or
sources of error are concealed.
In this manner, fully-informed decision-making
could be greatly facilitated.
Thank you.
THE CHAIRMAN: Thank you.
Roy?
DR. ALBERT: I'd like to compliment Dr. Mende.
for a very thoughtful statement.
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DR. ANDERSON: I just have one other comment,
and that is for the first time somebody did bring up,
in these hearings, the importance of the exposure assess-
ment work, and I just wanted to say that the Agency is
aware of this and currently has an effort under way to
try to establish mor econsistent ways of expressing expo-
sure assessments.
THE CHAIRMAN: Thank you.
Our next speaker will be Nancy Anderson.
(No response.)
Okay, Barbara Fegan?
MS. FEGAN: Thank you very much.
I have two hats, if you will. I am Barbara
Fegan, President of the League of Women Voters, of
Massachusetts, and I am very happy to have presented
you a telegram rather than a speech, and I am a generalis
here.
I would like to quote the Jr. Senator from
New York, and say, "The world is a dangerous place."
For many years, the League of Women Voters
has pursued the dual goals of environmental enhancement
and wise economic development. We were present at the
birth of the Environmental Protection Agency and have
supported its development as an efficient, competent
and strong federal regulatory body to set and enforce
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environmental standards that protect the health and
well-being of our citizens.
And as you heard before — I think I, perhaps,
will be telling you a lot of things that you already
know, and if it's so, forgive me.
Of the three major causes of death in the Unitefi
States, heart disease and stroke rates are decreasing
while the cancer death rate is increasing. And since
exposure to carcinogens is a significant health and life
threat, the League of Women Voters believes that such
exposure must be prevented.
The League supports a strong air carcinogen
policy implemented by the Environmental Protection
Agency to eliminate air borne carcinogens.
A prudent public policy must consider all of
the costs of environmental pollution control. The
reduction in the rate of cancer cases means more
productive worker time and days. That is a benefit.
Pollution control is a cost of doing business. Citizens
and taxpayers expect some of the cost to be passed on
to them, but they should not be expected to underwrite
only a change in profitability.
In order to maintain competition among
businesses, small businesses should have financial
assistance to enable them to purchase control equipment
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and develop substitute products. And that is singularly
important for we in New England because so many of
our manufacturing firms are small firms.
The fact that some areas of the country have,
quote, "cleaner" air than others should not be considered
a license to pollute. New facilities in cleaner areas
should be prevented from contributing to the deterioratio
of air quality.
We look to the timely implementation of this
policy. Since listing of a carcinogen triggers general
housekeeping rules in a state with an approved
implementation plan, we cannot see a need for lengthy
epidemiclogic studies.
The League has supported, and always will
support, the right of citizens to participate in the
decisions that affect their lives and encourage the con-
tinued effort of regulatory agencies to involve not only
the special interests but the public at learge.
I'd be happy to answer any questions on that
very specific, scientific document.
(Laughter.)
THE CHAIRMAN: Any questions?
MS. FEGAN: One thing I did leave out was the
matter of the burden of proof, and that has been a
cardinal rule in the League's positions on environmental
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quality that the burden of proof rests with the person
who would change the environment for the worse, so that
we would expect industry to come up and say that they
are really not doing a bad job.
I also chair a Sub-Committee of the Regional
Cancer Control Committee that is involved with environ-
mental and occupational health. And I'11 put that hat
on, if I may, to use up the rest of the time.
The Regional Cancer Control Committee strongly
supports the Environmental Protection Agency's Proposed
Policies and Procedures for identifying, assessing and
regulating airborie substances, which pose a risk of
cancer.
I think what is important here is the Regional
Cancer Control Committee is composed of thirteen agencies
and organizations and includes Boston's four major cancer
t reatment c enter s.
One of our goals is to reduce the incidence
of cancer in Massachusetts. We were among the people
who filed the legislation and are supporting the
legislation for an incidence of cancer registry in
Massachusetts.
Cancer is the second leading cause of death
in Massachusetts and in the United States. During 1977,
22.4 per cent of deaths in Massachusetts were caused
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by cancer. And despite significant improvement in the
treatment of many types of cancer, the treatment of lung
cancer has reamined a serious problem. Cure rates are
low. Lung cancer is presently the leading type of cancer
in males, and its incidence in females is rising.
Nationwide, there has been a twenty-fold
increase in lung cancer in males during the last forty
years.
Statistics cannot paint a gloomier picture.
Our lungs are those organs readily exposed to noxious
substances, and with few exceptions, we have little
choice as to the presence of these substances in the
air we breathe.
Establishment of a policy to limit those
substances to which we are exposed, is one that we
certainly can support.
Nationwide, it has been estimated that between
50 and 90 per cent of all cancer is associated with
environmental conditions. The Council on Environmental
Quality had that data in their first paragraph of their
yearbook published in 1976, and I do think that that
particular phrase comes back to haunt all of us.
We know, depending upon what you are looking
at, you are either looking at the small end of 60 per
cent, or the large end, the 90 per cent, when you are
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dealing with carcinogens.
At the same time, it is estimated that one-
fourth to one-third of all cancer deaths in the United
States are avoidable, through prevention or early
diagnosis, which is probably the more telling statistic.
The Regional Cancer Control Committee and other
organizations involved in cancer control deal with the
entire spectrum of. cancer interventions, and it should
be noted that we are planning an increasing emphasis
on prevention.
Certain important airborne substances that
cause cancer have already been identified, and one of
these is asbestos. Fortunately its use has come under
intense scrutiny and regulations have been written.
Whether they are fully enforceable for every small business
and service organizations is uncertain. The EPA may
need to focus on regulations for removal of dangerous
asbestos from schools and other public buildings.
It's interesting to note that we already have
some evidence that Congress is recognizing this as a
public health issue in the amendment to provide money
for just this procedure.
A second airborne carcinogen is cigarette smoke
which is one way of blaming the victim, in terms of
public policy. However, we do know that cigarette
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smoking has a symbiotic relationship with some of the
airborne carcinogens.
The third important area to which EPA should
direct its attention is a large group of substances that
have uncertain cancer risks and need further study and
classification.
Since cancer treatment is never as effective
as prevention, more of our health dollars should be
expended on prevention. For example, lung cancer is
preventable, yet payment to hospitals for treatment
by lung and bronchial patients reached 368.3 million
dollars.
Health care costs are escalating annually.
In 1979, they accounted for 9.1 per cent of the gross
national produce and predicted to be 10.2 per cent of
the gross national product in 1984.
Cancer alone exerts a tremendous economic
impact on patients, familiies and society as a whole.
In terms of assessing health benefits, medical care costs
and wage loss can be measured. Estimates for the total
cost of cancer, including direct costs for care and
treatment, as weall as the indirect costs, such as the
loss of earning power and productivity of patients,
range from $13.7 billion to $22.7 billion annually.
The cost of controls used in cancer prevention
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measures is an important issue and should be carefully
considered. The EPA has addressed many components of
a cost-effectiveness paradigm. We would like to
emphasize the necessity for including health care costs
in considering this issue. The objective of such a
cost effectiveness paradign is to achieve the greatest
possible health benefit for the amount of resources
expended on controls and regulation.
Looking to the users of a health care system,
cancer patients are unique due to the process of their
disease. Most cancer patients need both hospital-based
services and continuing care services. In addition,
the nature of the disease often results in patient's
readmission to acute care institutions years after
diagnosis and the use of services for monitoring and
continuing care.
Our assessment of health benefits comes to
a standstill when we try to put a price on human suffering
and loss of function. There is no way to estimate the
value of one life, let along the sixteen year average
reduction in the life expectancy of the cancer patient.
EPA1 s proposed Air Carcinogen Policy is an
important step in the prevention of cancer and its result-
ing social and medical costs. The Regional Cancer Control
Committee supports EPA1s Proposed Policy on National
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Emission Standards for Hazardous Air Pollutants.
We have appended a list of the members of the
Regional Cancer Control Committee and a description of
who we are and how we go about our business.
THE CHAIRMAN: Okay, thank you.
Any questions on that testimony?
(No response.)
Thank you.
Before our next speaker, I would like to
declare a ten-minute recess, so we will start again
in ten minutes, at quarter of four.
(Whereupon a ten-minute recess was taken.)
THE CHAIRMAN: John Hermos?
MR. HERMOS: My name is Dr. John Hermos, I'm
a resident of Brookline, Massachusetts. I'm an internist
and gastroenterologist at the Boston Veterans
Administration Medical Center and Assistant Professor
of Medicine at Boston Univeristy School of Medicine.
Today I am representing a group known as
Brookline Citizens to Protect the Environment. We are
a citizens group opposing Harvard University's proposed
Medical Area Total Energy Plant, or MATEP. This is a
large, diesel-powered cogeneration plant situated in
an urban and residential area on the Boston and Brookline
line.
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Our group is a member of a larger organization
of neighborhood groups from Brookline and Boston, the
NO MATEP Coalition. And in concert with the Town of
Brookline, we have provided extensive testimony to the
Commonwealth on the potential adverse health and environ-
mental impact of MATEP's diesel engine emissions.
Today, I'm here to urge that EPA adopt an
air carcinogen policy that is conservative, that allows
for the worst case analysis and that is enforcable.
And we take that stand for very personal reasons. Having
been engaged in literally a life or death struggle with
Harvard University for the last three years, we are horrified
to thing that we or any other community might have to
live under the constant threat of cancer from an
unavoidable source — not unavoidable that it can't be
disapproved, but unavoidable that it would be in the
air — source such as a large stationary source of air
pollution in a residential area.
For this hearing, it may be important for you
to know that we are a single issue group, that is we
are opposing one proposed diesel facility. Thus, we
are not an established environmental group. And I make
that distinction only because our membership is comprised
of people with a wide range of philosophies on this issue,
and as a whole, we would probably take a very balanced
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balanced view between the alleged conflicting issues
of industrial growth and environmental protection.
Also, we are not using this form to argue the
risks of the MATEP proposal because we have been doing
that very effectively in front of the Commonwealth, and
thus far, the Commonwealth and an independent hearing
office have already disapproved MATEP1s diesle engines
in three previous rulings on the basis of their NOX
emissions.
However, as the MATEP application is still
viable, and since the serious issue of carcinogenesis
from diesel exhaust has been raised by scientists and
by federal officials, we are very deeply troubles by
the potential effects this could have on our communities.
I'll leave my text for a moment. I understand
from one of my colleagues that the issue of diesel emissi
particulates has not been raised at this hearing.
I don't know if it's particularly relevant to that, but
I'd be willing to answer any questions that you might
have on that.
I think it's fair to say that — Let me say
one thing, in our research of it, which has been very
extensive, virtually all the work has been done on mobile
sources, yet with stationary sources, and one as large
as the power plant we're fighting, we have a potential
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emission of fine particulates that would be equivalent
to 261 million car miles — that's on a .2 gram,
fine particulate emission standard, which has been
proposed. That's from one source.
So, one can sense the importance of a stationar
source and how that might effect a community. And,
tragically, very little work has been done in this area,
and we look on that as a very important gap in our
knowledge. We are having a very difficult time trying
to extrapolate what is known about smaller engines, both
light and heavey-duty, towards a large, stationary source
But, again, a lot of particulates from this
one source.
Returning to my text, I think it's fair to
say that we are scared, and that we are not certain to
whom we can turn and who we can trust. Cancer can be
a devastating illness, as you know, and very little
progress has been made, if any, in either the palliation
or the cure of lung cancer.
More than 90 per cent of all patients with
carcinoma of the lung either have non-resectable
disease at diagnosis or recurrent lesions after surgey.
And five-year survivals are still only about 5 per cent.
As no familiy is immune to this potential
risk, and where some families may be even more susceptibL
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than others to all cancers, this threat is very real
to all of us.
We feel it is essential that EPA and the
federal government do not backslide or equivocate on
this issue. The intent of the Clean Air Act is clearly
to protect public health, and in doing so, must
necessarily be technology-forcing in its effect.
There are two statements I'd like to read which
articulate this mission.
This is from John Bonine, in the Environment
Reporter, in 1975: "A recent survey of the Act and its
interpretation in court said: 'Although the Act was
not the first federal statutory attempt to control air
quality, its perspective was unique; rather than regulate
from the standpoint of what was technically feasible",
it started from a point of determining what air standards
were necessary to protect the public health and it
required technology to meet those standards."
Senator Muskie stated in 1970: "Predictions
of technological impossibility or infeasibility are not
sufficient as reasons to avoid tough standards and
deadlines, and thus to compromise the public health...
Only a clear cut and tough public policy can generate
the needed effort."
We feel very strongly that when human cancer
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is the issue, following this mandate is prudent and
absolutely necessary.
We further suggest that it would be sound
public policy to be especially conservative in determining
the cancer risks from new, major sources of potential
airborne carcinogens. As in many aspects of life and
of law, it is usually greatly beneficial to have
established the ground rules for behavior before the
event, so that everyone will know them, and know
what the consequences are for not abiding by them.
Form our experiences, the proponents of a
polluting sources are not accountable to the public by
simply saying "trust us." We know, and you know that
if a new sources is approved, it is the economic factors
and not the environmental factors that will govern the
operation of the source by either the owners or the users
In this regard, EPA has some very difficult
problems with which to contend with existing sources
of dangerous air pollutants. Conversely, with new source
of air pollutants, you have an exciting challenge to
prevent costly errors before they become irretrievable.
In the case of diesel engines, whether they
be mobile or stationary, it would be a tragedy for the
country to become economically and emotionally hooked
to this type of energy production. Then, 10, 20, 30
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years later, discover the health consequences, including
cancer, that the scientific data of the 1970's indicated.
At the present time, due to this country's
real vulnerability in obtaining energy sources, this
quick fix of diesel engine seems quite attractive.
However, just as it is with cigarette smokers,
once hooked, it is very difficult to break the habit,
despite well-known and serious health consequences.
I believe that the industrial proponents of
a lax airbonrne carcinogen policy are asking the
government to get us hooked now and worry about the
consequences later when they occur. This does not
representa prudent policy for the government to follow.
An additional reason for setting a strict and
conservative policy for airborne carcinogens is the large
population put at risk by air pollutants.
For example, even if a carcinogen produced
only a 2:1 increment in lung cancer risk, when applied
to a large population, the absolute number of cases would
be substantil.
Further, when the exposure to this large popula
tion involves nor more than the obligatory process of
breathing, and in no way involves free choice, EPA should
show special concern in establishing its policy. I think
that the enormous response generated by the revelation
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of asbestos shields in hair dryers indicates how very
seriously the majority of the population considers the
problem of unwarranted exposure to potential and real
carcinogens.
Conclusions: As a representative of many peopl
suddenly faced with the possibility that a major new
source of potential airborne carcinogens will be intro-
duced into the air that we breathe, I want to convey
to you that we are scared. As a doctor, who has seen
far too many deaths from cancer, the goal of prevention
is mandatory.
As a tired, but experienced opponent of a devel
oper of a plant, that will necessarily pollute the air
because of its engines and modes of operation, I do not
believe that energy producers, in general, can be
trusted with the health of the population.
Therefore, we turn to EPA and ask that you
act with foresight and prudence in establishing the
country's policy for airborne carcinogens.
We urge that the decision or decisions that
you reach be appropriately conservative -- and again
by conservative, I mean, taking the worst case into
consideration — in a policy that allows for the
many unfavorable variables associated with widespread
air pollutants, and especially that the policy reflect
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the concerns of the people in the country who would be
most severely affected.
Thank you.
MR. JOSEPH: Dr. Hermos, I think we would
appreciate it if you could submit for our record, some
time in the next month or so, any information you might
have on emissions from stationary sources of diesels
and constituants of the emissions and the exposures.
DR. HERMOS: That sounds like the question
that I've been calling up everyone in EPA that I know,
asking you people for it.
MR. JOSEPH: Well, anything that you have
gathered, would be helpful.
DR. HERMOS: Surely.
THE CHAIRMAN: Any other questions?
(No response.)
Robert Dubrow? Is Robert Dubrow in the
audience?
(No response.)
Fred Krupp?
MR. KRUPP: My name is Fred Krupp. I am the
General Counsel of the Connecticut Fund for the Environ-
ment, a non-profit, public interest, state level,
environmental legal group. In the two years since we
have been established, we have attracted over 1,000
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members in the State of Connecticut, and even some
publicity in the State of Rhode Island.
Since June of 1979, CFE has been involved as
one of its cases, and an Instance of a residential
community being inundated by airborne pollution spewn
into it from synthetic organic chemical plant.
The situation exists in North Haven and
Hampden, Connecticut. The manufacturer is the
internationally famous Upjohn Company. The residents
complain of odors, headaches, tearing eyes, abrupt
awakenings in the night and sleepless nights.
The company, through legal efforts, is
resisting even a court order that we have obtained to
supply data necessary to determine the chemical
constituency of the fumes which waft their ways into
the neighbors homes.
Given this lack of data, we know very little.
One thing we do know is that benzene is one of the
substances released into the air by Upjohn. Benzene
is, as you are well aware, is one of the four airborne
carcinogens now regulated under Section 112.
At the outset, let me express my sincere hope
that EPA will be ever cognizant of the dynamics present
when it schedules a public hearing, whenever it makes
a rule or regulation, or calls for public input.
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A small segment of the public has an economic
incentive to develop highly funded testimony. Needless
to say, this is the segment of our society which stands
to profit from the continued absence of effective
regulation of chemical carcinogens. Unfortunately,
despite the fact that the interests of the huge majority
will suffer from the continued absence of effective
regulation of chemical carcinogens, no one individual
can martial the information or hire the resources to
put together this similarly funded rebutting testimony.
Thus, the large majority of the public is left
with a serious handicap in presenting its views to the
EPA. I hope EPA will not only recognize this, but take
necessary action to rectify the imbalance of testimony
which will undoubtedly result from hearings such as
these.
It is not good enough for you to view yourselve
as mediators between the public interest and the well-
funded special interests, between the well-funded
special interests and a few public interest groups
trying to address the panoply of issues. The public
interest is just diffused over too many individuals
to be martialed as effectively as the private interest.
And this is so even in this case of considering airborne
carcinogens, even though we already know the contribution
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that environmental factors play in increasing the
cancer rate.
Now, as I have indicated previously, my
statement today stems from the real world experience
of representing a large number of people -- over 2,000
people in North Haven and Hampden have expressed their
displeasure at what is going into their air — who are
being involuntarily held captives of chemical pollution.
The lives of these people are being placed at risk.
Our knowledge is far from perfect, and although
no threshold level for benzene has been shown, these
people, today, must endure the risks of involuntarily
being exposed to low ambient levels of the leukemogen
benzene.
I might add that although the tests today,
taken by EPA in our state, Connecticut State DEP, have
been very poor in methodology, and there have only been
two or three of them, we have found levels next to the
acres of lagoons, open-air, chemical lagoons, levels
of up to 2.7 parts per million, and we don't at all assum|e
that that is the worst case. They may be significantly
higher than that.
Those are ambient open-air levels.
Now, the situation in North Haven, not only
with benzene, but will all the other chemicals that are
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smelled and sensed in the air, gives rise to some
questions. Will children be affected more than adults?
Will the sick be affected more than the strong? -How
about pregnant women?
These are the awesome questions posed by the
deplorable situation. The chemicals Upjohn emits to
the adjacent residential neighborhood are very odorous,
causing considerable discomfort to joggers, high school
students during their outdoor recreation periods, as
well as neighbors in their homes, even in the winter,
even with their windows closed.
Moreover, there are physical health effects,
as I've mentioned, which may merely be the traces of
a much larger underlying problem.
Now, despite the high level of public concern
that exists now in Connecticut, the managers of the plant
have been far less than forthcoming with the data
necessary from which citizens and scientists, alike,
could evaluate the safety or hazards of these fumes.
Some of these chemicals are released through open air
stacks and some of the unknown chemicals volatilize from
acres of waste treatment lagoons.
The citizens are so stymied by the moneyed
company that they have yet even to gain the facts.
Recently, as I mentioned, the state court ordered Upjohn
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to yield the data, but the company has appealed this
order, rather than comply with it.
What we do know is that Congress instructed
the EPA, through the Clean Air Act, to have its
Administrator, within 90 days from December 31, 1970,
publish a list which includes each hazardous air pollutan
for which he intends to establish an emissions standard
under this Section.
Despite this mandate ten years ago, only four
chemicals have been listed under this Section. Now,
we know there are many, many more chemicals, some of
which are synthetic creations that are known to have
the ability to mutate genes, cause cancer, and other
diseases.
Furthermore, we know from analogous studies
of other toxic agents which work in part by destroying
or segmenting DNA that threshold levels have not been
shown and seem not to exist for radiation in many cancer
causing chemicals, that we know of.
Thus, when Congress instructed EPA to provide
an ample margin of safety for these hazardous air
pollutants, it is doubtful that what Congress had in
mind was the marked lack of progress with which EPA has
proceeded in the last ten years.
It is doubtful that Congress could have
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conceived that benzene, the only chemical known to man
capable of inducing leukemia, would be visited upon
citizens years after its powers were known, and even
after it had been listed under Section 112.
I suspect that the situation in North Haven
where benzene is among the maze of chemicals permeating
the community, and where a company refuses to even say
what is in the fumes which it spews off, would not have
been tolerated by a Congress whose legislation reflected
the judgment of the American public that it should not
be exposed to chemicals with effects as awesome as adding
to the increasing cancer rate.
Yet, today, there are still no EPA regulations
concerning even the already listed chemical benzene.
No standards which in any way protect the North Haven
citizens afflicted by this among other unknown chemicals.
Today there are no EPA regulations under Section 112
which place on industry the burden of even discloing
what chemicals it is releasing, and of controlling these
emissions.
How then are we to judge what type of program
is needed on behalf of the Federal Government to regulate
cancer causing chemicals. Having recognized that the
need is great, and that the probably number of chemicals
which must be controlled is very large, it seems as
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though the program which the government must implement
is one which will quickoy place ceilings and caps on
the vents, valves, tanks and lagoons, from which these
cancer causing chemicals are escaping.
If there can ever be an excuse for the emission
of these synthetic poisons whose power is that to wreck
the fundamental basis of life itself, then the burden
of developing such a rationale in each instance ought
fairly to be placed on those who seek to profit by such
air dumping.
No one knows better than those who work at
EPA that the burden on the regulators is already huge.
It seems as though the program which EPA develops, its
cancer policy, must, by necessity, and in response to
a fundamental notion of justice, place a share of the
burden on those whose activities give rise to the
problem, on those who have the best information necessary
to control the problem.
EPA's regulations proposed, and before us,
today, however, unfortunately, for reasons that I really
don't understand, give EPA itself the lion's share of
the information gathering and evaluation burden. The
burden is placed on EPA to come up with methods and
resources to aleviate the emission of carcinogens.
For example, on page 58, 650 of the Federal
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Register, a brief quote: "EPA will perform detailed
analyses to identify alternative, technologically
feasible control options and the economic, energy and
environmental impacts that would result from their
application. Where substitution is determined to be
a feasible option, the benefits of continued use of the
substance or process will be considered. These analyses
will rely primarily on the procedures and techniques..."
etcetera.
It seems that this system gives industry
itself no incentive to regulate and rectify the problem
itself. There are many responsible businessmen who
would voluntarily limit the risks associated with their
activity. But they will be put at a competitive
disadvantage unless there is an incentive for all their
competitors, some of which may be less scrupulous to
do likewise.
A program which set proposed limits and a pro-
posed time table would assure that industries which emit
these substances will make their own economic and
technological decisions as to the feasibility of
continued operations. In addition, such limits and
timetables would require industry, having gathered
that information to either implement the solution or
present a convincing, compelling case that such a
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} solution should be delayed or is totally impractical.
2 To implement these regulations, as they stand
3 now, and thus place on EPA an impossible burden, I think
4 guarantees that the program will be a failure.
5 Thus, I concur with the comments made by the
x Natural Resources Defense Council, that a minimum number
, of pollutants should be screened and regulated each year.
0 A candidate list should be drawn, and EPA ought to take
o
o 20 chemicals off the list each year, listing them as
10 hazardous air pollutants.
. I think the number 20 is minimal, in view of
the fact that the scope of the problem is so large
.. that quick and dramatic action is needed to solve it.
I «J
Similarly, a testing list should be established so that
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chemicals for which more information is needed could
be prioritized and channeled into the testing programs
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of EPA, other agencies, and private industry.
I also want to concur with the concept of
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setting a zero standard for carcinogens, which would
go into effect one year after their listing. The pre-
sumption, given the discussion in EPA's proposed regula-
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tions, and the extensive literature and testimony upon
which it is based, should be that we can achieve zero
through control measures and process changes.
Let us not underestimate the power of
25
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American technology. There could be an interim standard
which could be set during the year prior to when the
zero level would be achieved.
Inasmuch as economic dislocation is not
anyone's desire, it seems as though there could be some
flexibility for an extension of the zero standard,
delaying it for even more than a year. Here is where,
however, the burden must be placed on industry to show
that there are good reasons for such an extension.
Exemptions should be determined by individual source.
This is the scheme which seems to have been envisioned
by the Act itself.
Perhaps the criteria identified in the proposed
cancer policy could serve as guidelines for the type
of arguments which industry could make for an extension.
However, I must add my own extreme reluctance at
relying on quantitative risk assessments which are often
based upon data that is extremely sketchy, such that the
conclusions are extremely qualified and that the theory
is often verified by the data from which it was induced.
Quite simply, it is an impossible problem to
test low level dangers and we must always bear in mind
that the lower the exposure level, the longer the period
which one would have to endure in order to establish
either the safety or the danger of the chemical involved,
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Placing the emphasis on quantitative risk
assessments which EPA does in the regulations by
necessity, lets the threshold concept sneak in the back
door, despite EPA's redudiation of it, in the preamble.
It's almost like creating a scientific fiction, similar
to the legal fiction we lawyers have to deal with, and
I wouldn't recommend it.
Similarly, given the uncertainties of these
risk assessments, it risks the serious danger of having
the pseudo threshold, which the risk assessments
establish, be set at too high a level.
By establishing the timetable I've proposed,
finally, there would be an incentive on industry to come
forward and do the research which it is best capable
of doing, to cooperate and attempt to achieve the
zero standard.
EPA, I think, has been too quick to jump to
the conclusion that a zero standard for cancer causing
chemicals is impossible to achieve. I think it would
make more sense to require an industry showing of what
difficulties it is having, for which sources, for which
processes of emissions, for which chemicals.
In addition, as implied above, I think it is
essential that the regulations under Section 112 require
industries to completely disclose the names of all
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chemicals released into the air, and make reasonable
efforts to disclose information on the quantities
released. The public has a right to know what goes
into the community air. Such disclosure could increase
pressure on industry to develop closed systems and
thereby ease EPA's burden.
The regulations make clear that once a chemical
is listed, the emission controls will be applicable to
only certain designated source categories. Given the
wide range of ways in wich chemicals can and are used,
it seems dangerous to limit the applicability of the
implace of a carcinogen listing under Section 112 to
only particular source categories.
Let's go back for a second to my own experience
in North Haven, where benzene in part is being emitted
from open-air lagoons which are acres in size. In fact,
one of the large lagoons is aerated, which increases
the volitalization of benzene and the other chemicals
as yet unknown.
Some of the other peaks, by the way, have shown
up on our Mass spec tests, although we haven't identifie
them.
Yet although benzene is listed as a hazardous
chemical, as an airborne carcinogen, this particular
source type is not one which is now regulated, or which
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the regulators even contemplate addressing from their
own North Carolina think tanks.
Thus, it seems that the consequences of listing
a chemical as a hazardous air pollutant should also
trigger a ceiving on the amount of the toxin which
can be released by any facility by whatever process
it uses.
In this way, EPA, or citizens afflicted by
a problem, could spot and have some leverage to solve
the problem. One way to decide which source categories
should be addressed, might be to have the generic standarji
applicable across the board and place the burden of
exempting specific source categories on those who
seek to spew the dangerous chemicals into the community's
air.
Even though there may be only one particular
source which utilizes benzene in a way, maybe we have
the only lagoon source in the country, it seems as
though the national regulations, could, without high
burden on the federal regulators, establish interim and
final ceiling limits on how much of a chemical could
be emitted across the board.
Naturally, concurrent with the broadening of
source categories, I have already suggested that the
zero level be implemented one year from this listing
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unless industry has sustained their burden of making
a convincing case for delay in the attainment of that
standard.
EPA's proposal of a cancer policy is a step
forward. Unfortunately, however, adoption of this
policy, with the burden wrongly placed on the regulator,
and with an absence of timetables and incentives, will
not allow our society to effectively come to grips with
the airborne carcinogen problem.
America has expressed its faith in technology
and its risk adverse posture to carcinogens through
Congressional action. Let us pray that EPA will implemen
this collective decision and properly protect us from
this invidious threat.
THE CHAIRMAN: Any questions for Mr. Krupp?
DR. ALBERT: In listening to your story about
the pollution in this valley, the question comes to my
mind as to whether or not there are any resources that
exist at the present time for dealing with a situation
like this, which is clearly not low-level pollution,
but high-level pollution.
It's obviously a nusiance in the area. It
reminds me of the situation that existed in Hopewell,
Virginia, where both the EPA looked into the Life
Sciences Company, as well as OSHA, and neither did
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anything, but action was taken when a physician who
examined one of the workers that had neurological
disorders there, called the State Health Department and
the State Health Department came and looked at the plant
and shut it down the next day.
Can't they come in and do something about this?
MR. KRUPP: Rest assured that CFE, on behalf
of the citizens, and the citizens themselves, have
contacted the Municipal Planning and Zoning Commission,
the Wetlands Commission, the Town Health Officer, the
State — I've visited with Commissioner Douglas Lloyd
from the State Department of Health, who claims not to
have regulatory power, as well as, we are not involved
in extended proceedings before the Connecticut State
Department of Environmental Protection, concerning the
NPDES Permit, which allows a water discharge, but
concomitant with the water discharge is where these
chemicals are volitlizing from, at least in part.
And, unfortunately, the regulators, despite
the public outcry, are not willing, have not yet shown
a willingness to take the steps necessary, in my opinion,
to abate the hazard.
DR. ALBERT: But don't you think there is
something sick about the situation when a local problem
like this, which clearly needs rectification, can't be
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coped with by the local authorities. It's kind of
pathetic, isn't it, to rely on a federal agency to carry
out
MR. KRUPP: (Interrupting.) Well, Dr. Albert,
let me — I wish you could be with me at the hearing --
but let me explain to you what the state authorities
tell me. Today I met with the head of the State Air
Pollution Program, Len Brugman. He had proposed that
there be limits set on airborne carcinogens, not only
for the Upjohn plant, but across the board in the state
because there is no regulatory handles that they have
on the state level.
And he met with such fierce opposition, he
explained to me today, from industry, that it's his
sentiment that there is no way that Connecticut can
step out ahead of the rest of the nation until the
federal government takes action.
So, the local and the state regulators are
waiting for the feds to take action because Connecticut
as other states, don't want to put themselves at a
competitive disadvantage, can't afford to have rules
for the Upjohn Company here, that would be different
if they moved to Massachusetts, or New Hampshire.
And so, they are waiting for the feds, and
that is what I hear again and again, at the local and
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state levels.
I hope you are able to add your name and
credibility to our efforts.
THE CHAIRMAN: Let me ask you, have you talked
to Merrill Hohman, who started out as Chairman here
this morning, from Region I? Have you talked with him
at all? Or have you talked with anyone in Region I,
EPA?
MR. KRUPP: We have begun discussions with
people in Region I. We have had — there's a file.
THE CHAIRMAN: I think that's probably your
first step, and I'll talk to Mel also and make sure this
is brought to his attention.
DR. ANDERSON: I have just one quick comment,
and this has to do with your dismissal of quantitative
risk assessment. Before you dismiss it, I thought that
in light of the fact that we certainly do know that
chemicals vary in potency as much as a million-fold or
more, and as an example, if saccharin or cigarette smoke
were as potent as aplotoxin or dioxin, we would have
a major tragedy on our hands.
And I just wondered if, before you discard
it, if you don't think that it makes some sense to take
this into account in some fashion, and this policy that
is proposed to take a look at this, to set priorities,
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to try to take regulatory actions to solve the greatest
helath problems first, and to look at residual risk
to see just how bad the circumstance might be after
application of best available technology.
MR. KRUPP: I think it does make some sense.
I'm familiar with the Ames scale of toxicity and the
other indications of potency, but I think it does make
sense that risk assessments be used to prioritize which
chemicals should be listed first, but to try to use them
and the preamble, I might say is, I think, well written,
and disclaims that risk assessments will be used for
detailed decisions, but I think the regulations themselve
are at variance with the preamble. I think the regula-
tions themselves use risk assessments not only for settin
the initial priorities, but also in determining what
levels will be acceptable.
Maybe I'm misreading the regulations, but I
really don't think so. In other words, It hink the
regulations put far too much emphasis on risk assessments
THE CHAIRMAN: Okay, thank you.
DR. HERMOS: I'd like to say something in
response to your question on differences or similarities
between large and small diesels, we did do extensive
research in this area using as best we could, EPA
consultants and Dr. William Balgore (phonetic), from
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Environmental Resources Technology, from Connecticut,
and others as well, and as far as anyone would testify,
there is no intrinsic differences between small and
large diesels, light or heavy-duty, as far as their fine
particulate emissions and their poly-cyclic organic
compounds, which are the mutagenic and carcinogenic
compounds, in that it may be the fuel properties, the
higher residual fuels and the higher, with the higher
aromatic content, that would have the greater
mutagenicity, and this was work that came out of EPA
lab in North Carolina. Husing (phonetic), I believe,
was the lead author, and Bradow (phonetic) was one of
the collaborators in that study.
So, at this point, no one has demonstrated
any intrinsic differences between large or small diesel
engines, as far as their carcinogenic, or mutagenic
emissions.
THE CHAIRMAN: Thank you.
No one is here from the Physicians for Social
Responsibility, I gather.
(No response.)
Ed Loechler?
MR. LOECHLER: I'd first like to say I apprecia
the opportunity to appear at this EPA hearing, on this
important subject.
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My name is Dr. Edward L. Loechler, and I'm
a Research Fellow in the Biology Department of the
Massachusetts Institute of Technology, and my research
interests lie in the area of the molecular mechanisms
of toxicity. My concern for the environment has led
me to testify here today in support, general support
of your EPA Ambient Air Generic Carcinogen Standards.
Now, I have a testimony here that I'm going
to forego a large part of it, in lieu of the time.
What's basically in there are things that I think you
are well aware of at this point.
I was going to support your efforts to use
animal studies that are applicable to the human situation
and by and large, the evidence that I cite in here says
that the animal studies are applicable to the human
situation.
And, primarily, I refer to work by Tomatis
at the IARC Working Group, for example. And, as a matter
of fact, also, some of Dr. Albert's work, preliminary
work on potencies in humans versus animals.
In summary, I'd like to say that in spite of
the complications that have been alluded to between
extrapolation between animals and humans — for example,
pharmacal-kinetic difference and metabolic differences.
Animals seems to do pretty well as a model for the human
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situation.
I'll pick up on page 3. In summary, the
results I've cited above suggest to me that animal
experiments are efficaciously serving as human surrogates
in cancer tests. It is true that in detail vast
differences can exist between the response of animals
and humans to carcinogens.
However, to answer the question, "does this
chemical pose a human cancer risk," animal experiments
are reliable.
The I ARC Working Group recommended that in
the absence of adequate data in humans it is reasonable,
for practical purposes, to regard chemicals for which
there is sufficienc evidence of carcinogenicity in
animals, as if they presented a carcinogenic risk for
humans.
Tomatis, himself, said, "There is really no
justification to wait for the proof that a chemical
causes cancer in man before measures to avoid exposure
are taken.."
One lesson from history accentuates the need
to consider animal studies in evaluating cancer causing
substances.
In 1941, both diethylstilbesterol and
2-acetylaminofluorene were shown to be carcinogenic
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in animals. 2-AAF, developed as a pesticide, was
banned based on this single animal experiment.
Although we will never know how many lives
were saved or what benefits were lost from this ban,
I think the general concensus was that the correct choice
was made.
Diethylstilbesterol, on the other hand, wasn't
banned. The result has been untold misery for many
young women. In this case, the animal experiment was
disregarded. And I think the concensus today would have
been that the wrong choice was made as far as the
animal experiments go.
I would also like to support your decision
to require evidence from only a single well-conducted
animal study. One positive study sufficiently demonstrat
a chemical's carcinogenic potential. The delays involved
in further confirmatory studies do seem unwarranted to
me.
A comment about this, appropros of something
that was mentioned earlier — For example, something
like formaldehyde is positive in rats and negative in
mice, imagine a situation where in rats, let's say,
in your hundred animals, you had 20 that showed some
signs of getting cancer, and let's imagine that the
potency is five-fold less in mice. You would get maybe
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four, and four is not statistically significant, so it
would be scored as a negative, and yet it could very
well be that formaldehyde was carcinogenic to mice, but
you just couldn't pick it up.
So, this whole idea of negative results as
meaning it isn't carcinogenic, it may very well just
mean that the carcinogen is less potent in that particula
species.
And for that reason, I think then, that you
can say that perhaps the carcinogen is less potent or
not the same potency in all species, but the rat data
shows you that it is really, has the potential for being
a carcinogen in humans.
This work, of course, has been done quite
extensively by Bruce Ames and Kim Hooper.
I would like to make two additional brief
comments. I also support your use of short-term tests,
such as the Ames Test to help prioritize chemicals for
animal tests and to help confirm the hazards suggested
by animal tests.
In addition, I urge you to consider the issue
other than cancer, raised by the Ames Test, namely the
problem of exposure to environmental mutagens. Any
chemical shown to be positive in the Ames Test and to
which humans are exposed, should not be treated lightly,
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whether it is carcinogenic or not.
Finally, I support your desire to include the
public in the process of controlling ambient air quality.
In this regard, I believe community groups and/or
citizens in an affected area should be notified when
a potential problem is identified. This will allow them
to evaluate for themselves how they are being affected
and given them the opportunity to respond to the problem.
I know community groups may sometimes seem
like they are a pain in the neck, but I think it's very
important that they have the opportunity to decide for
themselves if they feel like they are being exposed to
an undue risk, and since it really is that group of
people that you are trying to protect, I think that they
have the right to participate in that decision.
I would say that I hope, in general, that these
rules are passed, and that they are used prudently and
I think that there should be rules of this sort in the
EPA's docket to address these problems, if need be.
That's the end of my statement. I'll be
happy to take questions.
THE CHAIRMAN: Any questions.
DR;' ANDERSON: I have just one comment, just
quickly, and this is along the same lines as the
comment I made in response to earlier testimony, and
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that is, I think that it's incorrect to say the EPA
is only requiring a single animal test. I think you
would have bio-assay requirements under the Toxic
Substances Act and the Pesticide Act. It's clear the
Agency would like to see more evidence than that.
In the Interim Guidelines, we certainly
consider everything we know about the chemical. On the
other hand, if there is the single convincing animal
study, and we don't know anything else, then that's
certainly a conceivable basis.
But I just didn't want this to come across,
again, as a single criteria, go look as hard as you can
for one single test in the absence of any other consider-
ation. It's just not the way we do business.
DR. LOECHLER: Right, but what I was supporting
was, if somebody does a lousy mouse study, and somebody
does a good rat study, you shouldn't regard the mice
study very heavily, as I'm sure you won't.
DR. ANDERSON: Yes, I understand.
THE CHAIRMAN: Anything else?
(No response.)
Thank you, Dr. Loechler.
Is there anyone else who was listed as a
speaker whom I failed to call?
If not, then, the meeting will be — Oh, yes,
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the Hearing record will remain open for thirty days from
tomorrow, the 14th.
With no further speakers, then, I declare
the meeting adjourned. We will hold a session in
Houston tomorrow, to complete the public testimony on
this proposed rule.
The meeting is adjourned.
(Whereupon the meeting was adjourned.)
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CERTIFICATE
UNITED STATES OF AMERICA
ENVIRONMENTAL PROTECTION AGENCY
This is to certify that the attached
proceedings before the Environmental Protection Agency,
RE: PROPOSED POLICY FOR REGULATING AIRBORNE CARCINOGENS
held at Boston, Massachusetts, on Wednesday, March 12,
1980 consisting of 281 pages was held as herein
appears and that this is tne original transcript
thereof for the file of the Department.
//
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